Skip to content
EU Parl Watch

amendment list, 27 March 2026

EU rare disease action plan

Document SANT-AM-786802 · (2025/2130(INL))

Committee on Public Health

On Parliament’s site PDF Word

Full text

Jump to an amendment (360)
Text 2,183 paragraphs

Amendment 1

Michele Picaro

Motion for a resolution

Citation 1

Motion for a resolutionAmendment
– having regard to Article 225 of the Treaty on the Functioning of the European Union,– having regard to Article 292 of the Treaty on the Functioning of the European Union,

Or. en

Amendment 2

Michele Picaro

Motion for a resolution

Citation 2

Motion for a resolutionAmendment
– having regard to Articles 16, 114 and 168 of the Treaty on the Functioning of the European Union,– having regard to Articles 16 and 168 of the Treaty on the Functioning of the European Union,

Or. en

Read the rest (2,171 paragraphs)

Amendment 3

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti

Motion for a resolution

Citation 5 a (new)

Motion for a resolutionAmendment
– having regard to Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products,

Or. en

Amendment 4

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Citation 5 a (new)

Motion for a resolutionAmendment
– having regard to the report of 9 September 2024 by Mario Draghi entitled ‘The future of European competitiveness’ (the Draghi report),

Or. en

Amendment 5

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Citation 5 b (new)

Motion for a resolutionAmendment
– having regard to the Commission communication of 29 January 2025 entitled ‘A Competitiveness Compass for the EU’,

Or. en

Amendment 6

Ondřej Dostál

Motion for a resolution

Citation 11 a (new)

Motion for a resolutionAmendment
– having regard to Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems6a,
6a OJ L 40, 11.2.1989, p. 8, ELI: http://data.europa.eu/eli/dir/1989/105/oj

Or. en

Amendment 7

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti

Motion for a resolution

Citation 12 a (new)

Motion for a resolutionAmendment
– having regard to the Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004,

Or. en

Amendment 8

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Citation 13 a (new)

Motion for a resolutionAmendment
– having regard to the proposal for a Regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act),

Or. en

Amendment 9

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti

Motion for a resolution

Citation 13 a (new)

Motion for a resolutionAmendment
– having regard to the proposal for a regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act),

Or. en

Amendment 10

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Citation 13 b (new)

Motion for a resolutionAmendment
– having regard to the proposal for a Regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795,

Or. en

Amendment 11

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti

Motion for a resolution

Citation 13 b (new)

Motion for a resolutionAmendment
– having regard to the proposal for a Regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795,

Or. en

Amendment 12

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti

Motion for a resolution

Citation 15 a (new)

Motion for a resolutionAmendment
– having regard to the Commission communication of 2 July 2025 on Choose Europe for life sciences: A strategy to position the EU as the world’s most attractive place for life sciences by 2030,

Or. en

Amendment 13

Stine Bosse, Billy Kelleher, Vlad Vasile-Voiculescu

Motion for a resolution

Citation 17 a (new)

Motion for a resolutionAmendment
– having regard to the report of 23 May 2024 of the European Parliamentary Research Service and of the Panel for the Future of Science and Technology (STOA) on Addressing challenges to European multi-country collaboration models for rare diseases,

Or. en

Amendment 14

Kateřina Konečná

Motion for a resolution

Citation 21 a (new)

Motion for a resolutionAmendment
– having regard to the Commission communication of 11 November 2008 on Rare Diseases: Europe’s challenges and to the Council Recommendation of 8 June 2009 on an action in the field of rare diseases,

Or. en

Amendment 15

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti

Motion for a resolution

Recital A

Motion for a resolutionAmendment
A. whereas rare diseases affect an estimated 27 to 36 million people in the Union and the number of recognised conditions continues to grow as science advances;A. whereas rare diseases affect an estimated 27 to 36 million people in the Union and the number of recognised conditions continues to grow as advances in genomics and clinical research enhance rare diseases identification;

Or. en

Amendment 16

Nicolae Ștefănuță

on behalf of the Verts/ALE Group

Motion for a resolution

Recital A

Motion for a resolutionAmendment
A. whereas rare diseases affect an estimated 27 to 36 million people in the Union and the number of recognised conditions continues to grow as science advances;A. whereas rare diseases affect an estimated 27 to 36 million people in the Union and the number of recognised conditions continues to grow as science advances; whereas 75% of people living with rare diseases are children;

Or. en

Amendment 17

Sirpa Pietikäinen

Motion for a resolution

Recital A a (new)

Motion for a resolutionAmendment
A a. whereas around one in seventeen people in Europe are living with a rare disease1a, meaning that, collectively, such conditions are not rare but represent a significant burden on patients and healthcare systems;
1a https://www.eurordis.org/rare-disease-policy/european-policy/

Or. en

Amendment 18

Nicolae Ștefănuță

on behalf of the Verts/ALE Group

Motion for a resolution

Recital B

Motion for a resolutionAmendment
B. whereas of the estimated 6 000-8 000 rare diseases identified, even a minimal level of scientific knowledge only exists for fewer than 1 000 of them and about 95 % lack approved treatment, contributing to unmet medical needs7 ;B. whereas of the estimated 6 000-8 000 rare diseases identified, even a minimal level of scientific knowledge only exists for fewer than 1 000 of them and about 95 % lack approved treatment, contributing to unmet medical needs7; whereas currently 154 orphan medicinal products are authorised for approximately 6000 rare diseases;
7 Rare diseases – strengthening EU action - https://www.europarl.europa.eu/RegData/etudes/ATAG/2025/779215/EPRS_ATA(2025)779215_EN.pdf7 Rare diseases – strengthening EU action - https://www.europarl.europa.eu/RegData/etudes/ATAG/2025/779215/EPRS_ATA(2025)779215_EN.pdf

Or. en

Amendment 19

Billy Kelleher, Vlad Vasile-Voiculescu, Stine Bosse

Motion for a resolution

Recital B

Motion for a resolutionAmendment
B. whereas of the estimated 6 000-8 000 rare diseases identified, even a minimal level of scientific knowledge only exists for fewer than 1 000 of them and about 95 % lack approved treatment, contributing to unmet medical needs7 ;B. whereas of the estimated 6 000-8 000 rare diseases identified, even a minimal level of scientific knowledge only exists for fewer than 1 000 of them and about 95 % lack approved treatment or a cure, contributing to unmet medical needs7;
7 Rare diseases – strengthening EU action - https://www.europarl.europa.eu/RegData/etudes/ATAG/2025/779215/EPRS_ATA(2025)779215_EN.pdf7 Rare diseases – strengthening EU action - https://www.europarl.europa.eu/RegData/etudes/ATAG/2025/779215/EPRS_ATA(2025)779215_EN.pdf

Or. en

Amendment 20

Giorgos Georgiou, Catarina Martins

Motion for a resolution

Recital B a (new)

Motion for a resolutionAmendment
B a. whereas health is a public and social good and a fundamental right; therefore, equitable access to diagnosis, treatment, care and medicines for people living with rare diseases should be guaranteed as a universal social right across the Union, irrespective of income, place of residence or insurance status; whereas the European rare disease action plan should contribute to reducing social and territorial inequalities in access to healthcare services.

Or. en

Amendment 21

Margarita de la Pisa Carrión

Motion for a resolution

Recital B a (new)

Motion for a resolutionAmendment
Ba. whereas the Union's strategic initiatives, such as the EU Biotech Act, can strengthen the Union’s competitiveness, innovation and scientific leadership; whereas these initiatives present an opportunity to drive the development of innovative treatments, particularly for patients suffering from genetic conditions or rare diseases;

Or. es

Amendment 22

Nicolae Ștefănuță

on behalf of the Verts/ALE Group

Motion for a resolution

Recital B a (new)

Motion for a resolutionAmendment
B a. whereas the rates of reimbursement for orphan drugs vary significantly across the Member States, with an average value of 51%;

Or. en

Amendment 23

Billy Kelleher, Vlad Vasile-Voiculescu, Stine Bosse

Motion for a resolution

Recital C

Motion for a resolutionAmendment
C. whereas around 80 % of rare diseases have a genetic origin, and the symptoms can overlap with common conditions, further complicating early detection and diagnosis;C. whereas around 80 % of rare diseases have a genetic origin, and the symptoms can overlap with common conditions, further complicating the ability of medical practitioners to detect, diagnose and begin treatment protocols at the earliest possible moment;

Or. en

Amendment 24

András Tivadar Kulja

Motion for a resolution

Recital C

Motion for a resolutionAmendment
C. whereas around 80 % of rare diseases have a genetic origin, and the symptoms can overlap with common conditions, further complicating early detection and diagnosis;C. whereas around 80 % of rare diseases have a genetic origin, and the symptoms can overlap with common conditions, especially in the case of neurological disorders, further complicating early detection and diagnosis;

Or. en

Amendment 25

Emmanouil Fragkos, Galato Alexandraki, Geadis Geadi

Motion for a resolution

Recital Γ

Motion for a resolutionAmendment
C. whereas around 80 % of rare diseases have a genetic origin, and the symptoms can overlap with common conditions, further complicating early detection and diagnosis;C. whereas around 80 % of rare diseases have a genetic origin, and the symptoms can overlap with common conditions, specifically with neurological disorders, further complicating early detection and diagnosis;

Or. el

Amendment 26

Elena Nevado del Campo, Dolors Montserrat, Michalis Hadjipantela, Adam Jarubas, Letizia Moratti

Motion for a resolution

Recital C

Motion for a resolutionAmendment
C. whereas around 80 % of rare diseases have a genetic origin, and the symptoms can overlap with common conditions, further complicating early detection and diagnosis;C. whereas around 80 % of rare diseases have a genetic origin, many of which manifest in childhood, and the symptoms can overlap with common conditions, further complicating early detection and diagnosis;

Or. en

Amendment 27

Kateřina Konečná

Motion for a resolution

Recital C

Motion for a resolutionAmendment
C. whereas around 80 % of rare diseases have a genetic origin, and the symptoms can overlap with common conditions, further complicating early detection and diagnosis;C. whereas around 72 % of rare diseases have a genetic origin, and the symptoms can overlap with common conditions, further complicating early detection and diagnosis;

Or. en

Amendment 28

Margarita de la Pisa Carrión

Motion for a resolution

Recital C a (new)

Motion for a resolutionAmendment
Ca. whereas data from Eurostat and research by Graaf, Buckley and Skotko (European Journal of Human Genetics, 2020) estimate that between 2011 and 2015 there were approximately 8 031 births per year of children with Down’s syndrome in the Union, that there has been a reduction in the number of live births of around 54 % due to voluntary terminations of pregnancy, and that an estimated 419 000 people with Down’s syndrome were living in the EU in 2015; whereas these figures show that current prenatal practices have had a substantial impact on demographic trends; consequently, Down’s syndrome should be recognised within the Union’s research framework on rare diseases, and research into clinical care, long-term outcomes, quality of life and support systems should be supported, in order to ensure equitable inclusion and a thorough understanding of people living with Down’s syndrome;

Or. es

Amendment 29

François-Xavier Bellamy

Motion for a resolution

Recital C a (new)

Motion for a resolutionAmendment
C a. whereas, in its concluding observations of 31 March 2025 on the combined second and third periodic reports of the European Union, the United Nations Committee on the Rights of Persons with Disabilities expressed concern about 'discriminatory eugenic attitudes towards persons with disabilities in prenatal medical diagnosis of impairments', particularly affecting persons with intellectual and/or psychosocial disabilities and autistic persons; whereas the Committee recommended that the Union takes sustained measures to counter stigma, ableism and discrimination in prenatal diagnosis and ensure adequate support for persons with disabilities and their families;

Or. en

Amendment 30

Nicolás González Casares, Vytenis Povilas Andriukaitis

Motion for a resolution

Recital C a (new)

Motion for a resolutionAmendment
C a. whereas, in line with a One Health and exposome approach, rare diseases can be influenced not only by genetic factors but also by environmental, chemical, physical, biological and social determinants and cumulative exposures across the life course, which should be better integrated into research and evidence generation where relevant, in full respect of the interlinkage of human health, animal health and the environment;

Or. en

Amendment 31

Elena Nevado del Campo, Dolors Montserrat, Tomislav Sokol, Michalis Hadjipantela, Adam Jarubas, Letizia Moratti, Oliver Schenk

Motion for a resolution

Recital C a (new)

Motion for a resolutionAmendment
C a. whereas patients affected by rare diseases often experience significant diagnostic delays; whereas the average time to diagnosis is estimated to be approximately four to five years, and up to 25 - 30 % of patients wait more than five years to receive an accurate diagnosis1a;
1a Faye F, Crocione C, Anido de Peña R, et al., 2024, Time to diagnosis and determinants of diagnostic delays of people living with a rare disease: results of a Rare Barometer retrospective patient survey. Eur J Hum Genet. 32(9):1116–26. https://doi.org/10.1038/s41431-024-01604-z.

Or. en

Amendment 32

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Recital C a (new)

Motion for a resolutionAmendment
C a. whereas a significant proportion of rare diseases affect children and require early diagnosis, adapted care pathways and targeted research efforts;

Or. en

Amendment 33

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Recital C b (new)

Motion for a resolutionAmendment
C b. whereas the Council Recommendation of 8 June 2009 on an action in the field of rare diseases constitutes a foundational policy framework at Union level, and that recommendation was instrumental in initiating coordinated work on rare diseases and in supporting the development of national plans and strategies across Member States;

Or. en

Amendment 34

François-Xavier Bellamy

Motion for a resolution

Recital C b (new)

Motion for a resolutionAmendment
C b. whereas the Union, as a Party to the United Nations Convention on the Rights of Persons with Disabilities, is bound to ensure that its legislation and policies fully respect, protect and promote the rights, dignity and equal worth of persons with disabilities, including in the development and use of genetic and prenatal technologies;

Or. en

Amendment 35

Elena Nevado del Campo, Dolors Montserrat, Tomislav Sokol, Adam Jarubas, Letizia Moratti

Motion for a resolution

Recital C b (new)

Motion for a resolutionAmendment
C b. whereas a significant proportion of patients with suspected rare diseases remain without a confirmed diagnosis; whereas addressing the needs of undiagnosed patients requires improved access to specialised expertise, advanced diagnostic technologies and cross-border collaboration across the Union;

Or. en

Amendment 36

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Recital C c (new)

Motion for a resolutionAmendment
C c. whereas the Commission Implementation report of 5 September 2014 on the Commission communication "Rare Diseases: Europe’s Challenges" and the Council Recommendation of 8 June 2009 on an action in the field of rare diseases highlighted both the progress achieved and the remaining gaps, underlining the need to maintain and strengthen coordinated action at Union level;

Or. en

Amendment 37

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti, Oliver Schenk

Motion for a resolution

Recital C c (new)

Motion for a resolutionAmendment
C c. whereas artificial intelligence has significant potential to support more accurate diagnosis of rare diseases; whereas its use may help reduce diagnostic delay, improve detection of complex or undiagnosed cases, provided that it is developed in accordance with high ethical, legal and data protection standards;

Or. en

Amendment 38

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Recital C d (new)

Motion for a resolutionAmendment
C d. whereas the Special report no 07/2019 of the Court of Auditors entitled EU actions for cross-border healthcare: significant ambitions but improved management on the implementation of Directive 2011/24/EU identified shortcomings in the functioning of cross-border healthcare for patients with rare diseases and called for the development of a more robust and coherent European framework for rare diseases;

Or. en

Amendment 39

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Recital C e (new)

Motion for a resolutionAmendment
C e. whereas the Union plays a key coordinating role in the development of a rare disease policy, and continued Union action is essential to support Member States in designing, implementing, and sustaining effective national policies, while ensuring coherence, knowledge-sharing, and added value at the Union level;

Or. en

Amendment 40

Elena Nevado del Campo, Dolors Montserrat, Tomislav Sokol, Michalis Hadjipantela, Adam Jarubas, Letizia Moratti

Motion for a resolution

Recital E

Motion for a resolutionAmendment
E. whereas existing Union action on rare diseases has delivered important tools, but significant disparities continue to exist between and within Member States;E. whereas existing Union action on rare diseases has delivered important tools and initiatives including the establishment of European Reference Networks (ERNs), the development of the Orphanet database and nomenclature, the adoption of Regulation (EC) No 141/2000, the creation of the European Platform on Rare Disease Registration, and the support of research and innovation through Union programmes such as Horizon Europe and the European Partnership on Rare Diseases;

Or. en

Amendment 41

Nicolae Ștefănuță

on behalf of the Verts/ALE Group

Motion for a resolution

Recital E

Motion for a resolutionAmendment
E. whereas existing Union action on rare diseases has delivered important tools, but significant disparities continue to exist between and within Member States;E. whereas existing Union action on rare diseases has delivered important tools, but significant disparities continue to exist between and within Member States, as concerns access to early diagnosis, screening, genomic testing, specialised care and innovative treatments, resulting in unequal health outcomes for persons living with rare diseases across the Union;

Or. en

Amendment 42

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Recital E

Motion for a resolutionAmendment
E. whereas existing Union action on rare diseases has delivered important tools, but significant disparities continue to exist between and within Member States;E. whereas existing Union action on rare diseases has delivered important tools, but significant disparities continue to exist between and within Member States; whereas disparities and inequalities of care also exist based on factors such as sex or age;

Or. en

Amendment 43

Ondřej Dostál

Motion for a resolution

Recital E a (new)

Motion for a resolutionAmendment
E a. whereas real-life access to treatments for rare diseases largely depends on national pricing and reimbursement decisions; whereas pricing and reimbursement fall within national competence, while being subject to the procedural requirements laid down in Council Directive 89/105/EEC; whereas those differences continue to lead to inequitable access to rare disease treatments for patients across the Union;

Or. en

Amendment 44

Elena Nevado del Campo, Dolors Montserrat, Tomislav Sokol, Adam Jarubas, Letizia Moratti

Motion for a resolution

Recital E a (new)

Motion for a resolutionAmendment
E a. whereas recent and forthcoming Union initiatives, including the proposal for a Regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union's biotechnology and biomanufacturing sectors particular in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act), the revision of the Union pharmaceutical legislation and the proposal for a Regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 are expected to improve the regulatory framework for rare diseases, strengthen innovation and investment in the development of orphan medicinal products and advanced therapies, facilitate more efficient clinical research, and enhance the competitiveness of the Union life sciences sector;

Or. en

Amendment 45

Nicolae Ștefănuță

on behalf of the Verts/ALE Group

Motion for a resolution

Recital E a (new)

Motion for a resolutionAmendment
E a. whereas the caregivers of persons with rare diseases, the majority of whom are women, face significant financial, social and psychological burdens, and should therefore be supported through coordinated measures in health, employment and social protection policies;

Or. en

Amendment 46

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Recital E a (new)

Motion for a resolutionAmendment
E a. whereas world-leading research on rare diseases is undertaken by public and private actors in the Union; whereas an efficient and flexible regulatory framework is essential in order to translate this research into treatments and therapies that benefit patients;

Or. en

Amendment 47

Sirpa Pietikäinen

Motion for a resolution

Recital E a (new)

Motion for a resolutionAmendment
E a. whereas no Member State can, on its own, ensure the adequate identification, diagnosis and treatment of all rare diseases;

Or. en

Amendment 48

Elena Nevado del Campo, Dolors Montserrat, Tomislav Sokol, Michalis Hadjipantela, Adam Jarubas, Letizia Moratti

Motion for a resolution

Recital E b (new)

Motion for a resolutionAmendment
E b. whereas significant disparities continue to exist between and within Member States in the field of rare diseases, particularly with regard to diagnosis, access to specialised care, availability of orphan medicinal products and advanced therapies, and inclusion in clinical trials; whereas those inequalities result in unequal health outcomes and place an additional burden on patients and their families depending on their place of residence;

Or. en

Amendment 49

Ondřej Dostál

Motion for a resolution

Recital E b (new)

Motion for a resolutionAmendment
E b. whereas Member States are required to take decisions on the pricing of medicinal products within 90 days and on their inclusion in national health insurance systems within 90 days; whereas those timeframes are frequently not respected in practice; whereas enforcement and monitoring by the Commission remain insufficient, leading to persistent delays in patient access to medicines across the Union;

Or. en

Amendment 50

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Recital E b (new)

Motion for a resolutionAmendment
E b. whereas research and development on rare diseases within the Union face multifaceted challenges, differentiated from research on other conditions, including small patient populations, limited knowledge of the natural history of rare diseases, lack of existing data and regulatory fragmentation across Member States;

Or. en

Amendment 51

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Recital E c (new)

Motion for a resolutionAmendment
E c. whereas the Union's life science sector is a major driver of European competitiveness and an important asset in developing new therapies for rare diseases; whereas that sector needs an adapted and efficient regulatory framework to enable innovation in that field, with appropriately designed incentive structures, including strong intellectual property rights;

Or. en

Amendment 52

Elena Nevado del Campo, Dolors Montserrat, Michalis Hadjipantela, Adam Jarubas, Letizia Moratti

Motion for a resolution

Recital E c (new)

Motion for a resolutionAmendment
E c. whereas patients with rare diseases incur a substantial financial burden, comprising direct medical costs, costs related to access to diagnosis and specialised care, including travel and accommodation, and indirect costs such as loss of income and reduced labour market participation;

Or. en

Amendment 53

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti

Motion for a resolution

Recital E d (new)

Motion for a resolutionAmendment
E d. whereas gender differences in diagnosis, access to care and participation in research also persist, requiring a more inclusive and gender-sensitive approach to rare disease policies;

Or. en

Amendment 54

Elena Nevado del Campo, Dolors Montserrat, Michalis Hadjipantela, Adam Jarubas, Letizia Moratti

Motion for a resolution

Recital F

Motion for a resolutionAmendment
F. whereas the European partnership on research on rare diseases represents a significant collaborative effort, bringing together partners from across the Union to drive research in prevention, diagnosis and treatment;F. whereas the European Partnership on Rare Diseases - and its successor ERDERA - represent a significant collaborative effort, bringing together partners from across the Union to drive research in prevention, diagnosis and treatment; whereas that effort is complemented by international cooperation, including within the International Rare Diseases Research Consortium (IRDiRC), contributing to the alignment of research priorities and the acceleration of scientific progress at global level;

Or. en

Amendment 55

Emmanouil Fragkos, Galato Alexandraki, Geadis Geadi

Motion for a resolution

Recital ΣΤ

Motion for a resolutionAmendment
F. whereas the European partnership on research on rare diseases represents a significant collaborative effort, bringing together partners from across the Union to drive research in prevention, diagnosis and treatment;F. whereas the European partnership on research on rare diseases and the European partnership for brain health represent significant collaborative efforts, bringing together partners from across the Union to drive research in prevention, diagnosis and treatment;

Or. el

Amendment 56

Sirpa Pietikäinen

Motion for a resolution

Recital F a (new)

Motion for a resolutionAmendment
F a. whereas significant gender and age disparities persist in the diagnosis of diseases, with women and children facing notably longer waiting times for accurate diagnoses compared to men and adults; whereas survey data show that women with rare diseases wait an average of 5.4 years to receive a diagnosis, compared to 3.7 years for men1a;
1a https://www.eurordis.org/survey-reveals-lengthy-diagnostic-delays/#

Or. en

Amendment 57

Kateřina Konečná

Motion for a resolution

Recital G

Motion for a resolutionAmendment
G. whereas civil society organisations have repeatedly called for a comprehensive Union action plan on rare diseases, reaffirming that fragmented national approaches limit effectiveness and equity in care;G. whereas civil society organisations and other stakeholders in the rare disease community have repeatedly called for a comprehensive Union action plan on rare diseases, reaffirming that fragmented national approaches limit effectiveness and equity in care;

Or. en

Amendment 58

Billy Kelleher, Vlad Vasile-Voiculescu, Stine Bosse

Motion for a resolution

Recital G

Motion for a resolutionAmendment
G. whereas civil society organisations have repeatedly called for a comprehensive Union action plan on rare diseases, reaffirming that fragmented national approaches limit effectiveness and equity in care;G. whereas civil society and patient organisations, as well as the pharmaceutical sector, have repeatedly called for a comprehensive Union action plan on rare diseases, reaffirming that fragmented national approaches limit effectiveness, and access to care and equity in health care outcomes;

Or. en

Amendment 59

Billy Kelleher, Vlad Vasile-Voiculescu, Stine Bosse

Motion for a resolution

Recital H

Motion for a resolutionAmendment
H. whereas the European Parliament has called for a European plan in rare and neglected diseases in its resolution of 10 July 2020 on the EU’s public health strategy post-COVID-198 ;H. whereas the European Parliament called for a European plan in rare and neglected diseases in its resolution of 10 July 2020 on the EU’s public health strategy post-COVID-198;
8 OJ C 371, 15.9.2021, p. 102.8 OJ C 371, 15.9.2021, p. 102.

Or. en

Amendment 60

Kateřina Konečná

Motion for a resolution

Recital I

Motion for a resolutionAmendment
I. whereas the European Economic and Social Committee encouraged further action to establish a coherent framework that guides national policies and encourages collaborative action beyond European Reference Networks (ERNs);I. whereas the European Economic and Social Committee encouraged further action to establish a coherent framework that guides national policies and encourages collaborative action beyond European Reference Networks (ERNs) and issued opinions in 2022 and 2024 recommending the establishment of a Rare Diseases Action Plan;

Or. en

Amendment 61

Giorgos Georgiou, Catarina Martins

Motion for a resolution

Recital I

Motion for a resolutionAmendment
I. whereas the European Economic and Social Committee encouraged further action to establish a coherent framework that guides national policies and encourages collaborative action beyond European Reference Networks (ERNs);I. whereas the European Economic and Social Committee encouraged further action to establish a coherent framework that guides and harmonises national policies and encourages collaborative action beyond European Reference Networks (ERNs);

Or. en

Amendment 62

Billy Kelleher, Vlad Vasile-Voiculescu, Stine Bosse

Motion for a resolution

Recital I

Motion for a resolutionAmendment
I. whereas the European Economic and Social Committee encouraged further action to establish a coherent framework that guides national policies and encourages collaborative action beyond European Reference Networks (ERNs);I. whereas the European Economic and Social Committee encouraged further action to establish a coherent framework that guides national policies and encourages collaborative action beyond the existing European Reference Networks (ERNs);

Or. en

Amendment 63

Elena Nevado del Campo, Dolors Montserrat, Tomislav Sokol, Michalis Hadjipantela, Adam Jarubas, Letizia Moratti

Motion for a resolution

Recital I a (new)

Motion for a resolutionAmendment
I a. whereas the European Reference Networks (ERNs) have a strong potential to improve access to specialised expertise and support more coordinated care for patients with rare and complex diseases; whereas, however, that potential is not yet fully realised, in particular due to the uneven integration into national healthcare systems and the absence of systematic referral mechanisms; whereas ongoing Union initiatives, including projects such as JARDIN, contribute to advancing the integration, interoperability and use of rare disease data across the Union;

Or. en

Amendment 64

Billy Kelleher, Vlad Vasile-Voiculescu, Stine Bosse

Motion for a resolution

Recital J

Motion for a resolutionAmendment
J. whereas a coherent Union rare disease action plan including the introduction of legislation for a rare diseases action framework could address gaps and deliver better coordination and equity across the care pathway;J. whereas a coherent Union rare disease action plan including the introduction of legislation for a rare diseases action framework could address gaps and deliver better coordination and equity across the entire care pathway;

Or. en

Amendment 65

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Viktória Ferenc

Motion for a resolution

Recital J a (new)

Motion for a resolutionAmendment
J a. whereas the organisation, financing and delivery of healthcare services remain the exclusive competence of the Member States, and Union action should therefore complement, support and coordinate national policies without leading to harmonisation;

Or. en

Amendment 66

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti

Motion for a resolution

Recital J a (new)

Motion for a resolutionAmendment
J a. whereas Orphanet has identified more than 880 rare disease registries at Union level, reflecting a fragmented landscape resulting from the absence of common standards, coordination and interoperability;

Or. en

Amendment 67

Kateřina Konečná

Motion for a resolution

Recital K a (new)

Motion for a resolutionAmendment
K a. whereas advancing a European policy framework for rare diseases represents an opportunity to support the Union’s competitiveness by stimulating research, innovation and investment in areas of high European added value, including biotechnology, genomic medicine, advanced therapies, health data infrastructures and specialised cross-border expertise; whereas such a framework can help translate scientific excellence into economic and social value, strengthen the resilience and attractiveness of the Union’s life sciences ecosystem, and deliver benefits for patients, healthcare systems and the wider economy;

Or. en

Amendment 68

Elena Nevado del Campo, Dolors Montserrat, Tomislav Sokol, Adam Jarubas, Letizia Moratti, Oliver Schenk

Motion for a resolution

Recital K a (new)

Motion for a resolutionAmendment
K a. whereas the European Health Data Space provides an opportunity to improve interoperability, facilitate secure cross-border data sharing and enable the use of health data for research and innovation; whereas Orphanet provides unique and time-stable numerical identifiers for rare diseases, known as ORPHAcodes, covering main names and synonyms; whereas their integration in national databases and registries would significantly improve data standardisation and interoperability;

Or. en

Amendment 69

Victor Negrescu

Motion for a resolution

Recital K a (new)

Motion for a resolutionAmendment
K a. whereas early detection of rare diseases, including during the prenatal and perinatal periods where medically appropriate and in full respect of fundamental rights, informed consent and national competences, can substantially improve clinical outcomes, reduce avoidable complications and support timely referral to specialised care pathways;

Or. en

Amendment 70

Romana Jerković

Motion for a resolution

Recital K a (new)

Motion for a resolutionAmendment
K a. whereas rare cancers constitute one of the largest subgroups within rare diseases in the Union; whereas those patients face many of the same structural challenges as other rare conditions, including delayed diagnosis, limited specialised expertise, fragmented research efforts and restricted access to innovative treatments;

Or. en

Amendment 71

Nicolae Ștefănuță

on behalf of the Verts/ALE Group

Motion for a resolution

Recital K a (new)

Motion for a resolutionAmendment
K a. whereas environmental factors, including exposure to hazardous chemicals, endocrine disruptors and pollution, may contribute to certain rare diseases and congenital conditions, and the Union rare disease action framework should therefore be coherent with Union environmental, chemicals and zero-pollution policies;

Or. en

Amendment 72

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Viktória Ferenc

Motion for a resolution

Recital K a (new)

Motion for a resolutionAmendment
K a. whereas the sharing of health data must fully respect patients’ rights, including explicit consent, and ensure that Member States retain control over sensitive health data generated within their territory;

Or. en

Amendment 73

François-Xavier Bellamy

Motion for a resolution

Recital K a (new)

Motion for a resolutionAmendment
K a. whereas policies addressing rare diseases must avoid reinforcing stigma or negative perceptions of disability and should promote the full inclusion and equal dignity of persons with disabilities in society;

Or. en

Amendment 74

Elena Nevado del Campo, Dolors Montserrat, Tomislav Sokol, Michalis Hadjipantela, Adam Jarubas, Letizia Moratti

Motion for a resolution

Recital K b (new)

Motion for a resolutionAmendment
K b. whereas adequate funding under the post-2027 Multiannual Financial Framework (2028-2034) is essential to support research, innovation, data infrastructure and access to care in the field of rare diseases; whereas Union programmes, including Horizon Europe, as well as the future European Competitiveness Fund, are expected to play a key role in supporting research, clinical development and innovation ecosystems in the area of rare diseases;

Or. en

Amendment 75

Victor Negrescu

Motion for a resolution

Recital K b (new)

Motion for a resolutionAmendment
K b. whereas regional and national centres of expertise, together with accredited diagnostic and genomic laboratories, play a central role in ensuring early detection, confirmatory diagnosis, genetic counselling and equitable access to specialised rare disease care across the Union;

Or. en

Amendment 76

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Recital K b (new)

Motion for a resolutionAmendment
K b. whereas the development of advanced therapies, including genome-editing technologies, must be strictly regulated to prevent ethical abuses and ensure that applications remain limited to therapeutic purposes;

Or. en

Amendment 77

Billy Kelleher, Vlad Vasile-Voiculescu, Stine Bosse

Motion for a resolution

Subheading 1

Motion for a resolutionAmendment
Rare diseases plan frameworkdeleted

Or. en

Amendment 78

Tomislav Sokol

Motion for a resolution

Subheading 1

Motion for a resolutionAmendment
Rare diseases plan frameworkFramework and financing of a European Rare Diseases Plan

Or. en

Amendment 79

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 1

Motion for a resolutionAmendment
1. Calls on the Commission and Member States to develop a comprehensive Union rare disease action plan that addresses the full rare disease care pathway;1. Calls on the Commission and the Member States to establish, in close cooperation with patients, healthcare professionals and relevant stakeholders, a comprehensive, integrated and binding Union rare disease action plan addressing the full care pathway, from prevention and early detection to diagnosis, treatment, care and social inclusion, ensuring coherence across all relevant Union policies, accompanied, where appropriate, by a package of measures including a Council Recommendation and targeted legislative proposals in areas of clear Union competence, together with a funding roadmap and implementation scoreboard;

Or. en

Amendment 80

Kateřina Konečná

Motion for a resolution

Paragraph 1

Motion for a resolutionAmendment
1. Calls on the Commission and Member States to develop a comprehensive Union rare disease action plan that addresses the full rare disease care pathway;1. Calls on the Commission and Member States to develop a comprehensive Union rare disease action plan that addresses the full range of unmet needs of people living with rare diseases, focusing on actions with clear Union added value, while guiding the implementation of consistent national plans and strategies. The framework will aim to provide access to timely and accurate diagnosis and the highest available quality of treatment and care for people living with a rare disease, no matter where they live in the Union, and support their inclusion in society;

Or. en

Amendment 81

Elena Nevado del Campo, Dolors Montserrat, Tomislav Sokol, Adam Jarubas, Letizia Moratti

Motion for a resolution

Paragraph 1

Motion for a resolutionAmendment
1. Calls on the Commission and Member States to develop a comprehensive Union rare disease action plan that addresses the full rare disease care pathway;1. Calls on the Commission and Member States to develop a comprehensive Union rare disease action plan that addresses the full rare disease care pathway, including diagnosis, access to treatment, research, data infrastructure and patient support, to ensure coherence with existing Union legislation and initiatives, and to provide for the necessary financial instruments to support its implementation;

Or. en

Amendment 82

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 1

Motion for a resolutionAmendment
1. Calls on the Commission and Member States to develop a comprehensive Union rare disease action plan that addresses the full rare disease care pathway;1. Calls on the Commission and Member States to develop a coordinated and non-binding Union rare disease action plan based on voluntary cooperation that addresses the full rare disease care pathway;

Or. en

Amendment 83

András Tivadar Kulja

Motion for a resolution

Paragraph 1

Motion for a resolutionAmendment
1. Calls on the Commission and Member States to develop a comprehensive Union rare disease action plan that addresses the full rare disease care pathway;1. Calls on the Commission and Member States to develop a comprehensive Union rare disease action plan that addresses the full rare disease care pathway across the entire life course;

Or. en

Amendment 84

Emmanouil Fragkos, Galato Alexandraki, Geadis Geadi

Motion for a resolution

Paragraph 1

Motion for a resolutionAmendment
1. Calls on the Commission and Member States to develop a comprehensive Union rare disease action plan that addresses the full rare disease care pathway;1. Calls on the Commission and Member States to develop a comprehensive Union rare disease action plan that addresses the full rare disease care pathway, throughout a person's lifetime;

Or. el

Amendment 85

Tomislav Sokol

Motion for a resolution

Paragraph 1 a (new)

Motion for a resolutionAmendment
1 a. Recognises the added value of comprehensive Union strategic frameworks such as Europe’s Beating Cancer Plan and ongoing initiatives on cardiovascular health, including the Safe Hearts Plan; calls for the establishment of a comprehensive Union rare diseases action plan, to be developed within the Union’s health policy framework, setting out clear objectives, measurable targets and benchmarks, as well as appropriate and dedicated funding, in order to ensure a coordinated, effective and equitable Union response to rare diseases;

Or. en

Amendment 86

Margarita de la Pisa Carrión

Motion for a resolution

Paragraph 1 a (new)

Motion for a resolutionAmendment
1a. Welcomes the Commission’s proposal to extend the Supplementary Protection Certificate (SPC) for advanced therapies, with the aim of encouraging investment in and the development of innovative treatments;

Or. es

Amendment 87

Tomislav Sokol

Motion for a resolution

Paragraph 1 b (new)

Motion for a resolutionAmendment
1 b. Calls for the establishment, within the Union’s financial framework, of a dedicated Union fund for rare diseases in order to ensure sustainable and coordinated support for research, early diagnosis, and equitable access to treatment across all Member States; considers that such a fund should contribute to reducing fragmentation and disparities, while prioritising unmet medical needs, in particular for ultra-rare conditions; emphasises that the fund should support cross-border cooperation, including European Reference Networks and interoperable data infrastructures, and should operate under clear governance rules ensuring transparency, cost-effectiveness, and the structured involvement of patient organisations and clinical experts in the definition of funding priorities;

Or. en

Amendment 88

Emmanouil Fragkos, Galato Alexandraki, Geadis Geadi

Motion for a resolution

Paragraph 2

Motion for a resolutionAmendment
2. Urges the creation of mechanisms to improve access and affordability of therapies, including targeted support for ultra-rare conditions and advanced therapies;2. Urges the creation of mechanisms to improve access and affordability of therapies, including targeted support for ultra-rare conditions and advanced therapies; in particular, calls on Member States to consider the possibility of reimbursing therapies that provide relief to patients with rare and ultra-rare diseases; underlines that cross-border therapies should be included among these reimbursable therapies;

Or. el

Amendment 89

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 2

Motion for a resolutionAmendment
2. Urges the creation of mechanisms to improve access and affordability of therapies, including targeted support for ultra-rare conditions and advanced therapies;2. Urges the creation of mechanisms to improve access and affordability of therapies, including targeted support for ultra-rare conditions and advanced therapies, with particular attention to paediatric rare diseases and age-appropriate treatments and strengthening European production capacities for rare disease treatments to reduce external dependencies;

Or. en

Amendment 90

Elena Nevado del Campo, Dolors Montserrat, Tomislav Sokol, Adam Jarubas, Letizia Moratti

Motion for a resolution

Paragraph 2

Motion for a resolutionAmendment
2. Urges the creation of mechanisms to improve access and affordability of therapies, including targeted support for ultra-rare conditions and advanced therapies;2. Urges the creation of mechanisms to improve access and affordability of therapies, including targeted support for ultra-rare conditions, orphan medicinal products and advanced therapies, taking into consideration existing Union frameworks and ongoing legislative proposals on health technology assessment, joint procurement and pharmaceutical incentives;

Or. en

Amendment 91

Nicolás González Casares, Vytenis Povilas Andriukaitis

Motion for a resolution

Paragraph 2

Motion for a resolutionAmendment
2. Urges the creation of mechanisms to improve access and affordability of therapies, including targeted support for ultra-rare conditions and advanced therapies;2. Urges the development of effective, comprehensive and coordinated Union-level mechanisms to improve the availability, accessibility and affordability of therapies, including targeted measures for ultra-rare conditions and advanced therapy medicinal products, ensuring equitable access for patients across all Member States;

Or. en

Amendment 92

Victor Negrescu

Motion for a resolution

Paragraph 2

Motion for a resolutionAmendment
2. Urges the creation of mechanisms to improve access and affordability of therapies, including targeted support for ultra-rare conditions and advanced therapies;2. Urges the creation of mechanisms to improve access and affordability of therapies, including targeted support for ultra-rare conditions and advanced therapies, as well as innovative medicinal products addressing unmet medical needs in rare diseases;

Or. en

Amendment 93

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti

Motion for a resolution

Paragraph 2

Motion for a resolutionAmendment
2. Urges the creation of mechanisms to improve access and affordability of therapies, including targeted support for ultra-rare conditions and advanced therapies;2. Urges the creation of mechanisms to improve access and affordability of orphan and ultra orphan medicinal products, as well as therapies, including targeted support for ultra-rare conditions and advanced therapies;

Or. en

Amendment 94

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Paragraph 2 a (new)

Motion for a resolutionAmendment
2 a. Calls for continued evaluation of the regulatory framework governing medicinal products, with special attention to the impact of intellectual property and data protection regulations on the development of new rare diseases therapies;

Or. en

Amendment 95

Stine Bosse, Billy Kelleher, Vlad Vasile-Voiculescu

Motion for a resolution

Paragraph 2 a (new)

Motion for a resolutionAmendment
2 a. Recognises that low patient volumes in rare and ultra-rare diseases hamper clinical data generation, the development of clinical expertise, research, innovation and the undertaking of clinical trials in the Union;

Or. en

Amendment 96

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 3

Motion for a resolutionAmendment
3. Encourages strategic Union-level research and innovation coordination, aligning research agendas, pooling resources for shared infrastructures;3. Calls for strengthened strategic coordination of research and innovation at Union level, including the alignment of research agendas, the pooling of financial and scientific resources, and the reinforcement of shared infrastructures in order to maximise impact and avoid duplication;

Or. en

Amendment 97

Billy Kelleher, Vlad Vasile-Voiculescu, Stine Bosse

Motion for a resolution

Paragraph 3

Motion for a resolutionAmendment
3. Encourages strategic Union-level research and innovation coordination, aligning research agendas, pooling resources for shared infrastructures;3. Encourages strategic Union-level research and innovation coordination, aligning research agendas, pooling resources for shared infrastructures irrespective of national borders;

Or. en

Amendment 98

Oliver Schenk

Motion for a resolution

Paragraph 3 a (new)

Motion for a resolutionAmendment
3 a. Emphasizes that the defining challenges of rare disease therapies is the lack of knowledge about the conditions, biological origins, and the scientific understanding. In recognition of ongoing initiatives and to maximise the impact of ongoing research, the European rare disease research agenda should consider existing initiatives such as the European Rare Diseases Research Alliance (ERDERA).

Or. en

Amendment 99

Stine Bosse, Billy Kelleher, Vlad Vasile-Voiculescu

Motion for a resolution

Paragraph 4

Motion for a resolutionAmendment
4. Calls for comprehensive frameworks for patient and family support and Union-wide evidence generation on socio-economic impacts, with attention to gender and caregiving inequalities;4. Calls for comprehensive frameworks for patient and family support and Union-wide evidence generation on socio-economic impacts, with attention to gender and caregiving inequalities, while recognising that the cost of care for rare disease patients may be lower than the benefits of quickly providing the correct diagnosis, identifying the right care pathways, and helping families, carers, and the patients themselves return to the labour market following successful treatment or cure;

Or. en

Amendment 100

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti

Motion for a resolution

Paragraph 4

Motion for a resolutionAmendment
4. Calls for comprehensive frameworks for patient and family support and Union-wide evidence generation on socio-economic impacts, with attention to gender and caregiving inequalities;4. Calls for comprehensive frameworks for patient and family support, taking into consideration the needs of individuals living with undiagnosed rare conditions as well as those diagnosed but without an approved treatment, and Union-wide evidence generation on socio-economic impacts, with attention to gender and caregiving inequalities;

Or. en

Amendment 101

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 4

Motion for a resolutionAmendment
4. Calls for comprehensive frameworks for patient and family support and Union-wide evidence generation on socio-economic impacts, with attention to gender and caregiving inequalities;4. Calls for the establishment of comprehensive frameworks to support patients and their families, including the systematic generation of Union-wide evidence on the socio-economic impact of rare diseases, with particular attention to gender inequalities, informal caregiving burdens and risks of social exclusion;

Or. en

Amendment 102

Billy Kelleher, Vlad Vasile-Voiculescu, Stine Bosse

Motion for a resolution

Paragraph 4

Motion for a resolutionAmendment
4. Calls for comprehensive frameworks for patient and family support and Union-wide evidence generation on socio-economic impacts, with attention to gender and caregiving inequalities;4. Calls for comprehensive frameworks for patient and family support and Union-wide evidence gathering and collation on socio-economic impacts, paying particular attention to gender and caregiving inequalities;

Or. en

Amendment 103

Kateřina Konečná

Motion for a resolution

Paragraph 4

Motion for a resolutionAmendment
4. Calls for comprehensive frameworks for patient and family support and Union-wide evidence generation on socio-economic impacts, with attention to gender and caregiving inequalities;4. Calls for comprehensive frameworks for patient and family support and their social inclusion, the generation of evidence on socio-economic impacts, with attention to gender and caregiving inequalities;

Or. en

Amendment 104

Michele Picaro

Motion for a resolution

Paragraph 4 a (new)

Motion for a resolutionAmendment
4 a. Underlines that the early and accurate diagnosis of rare diseases remains a significant challenge, with patients often experiencing long diagnostic delays and misdiagnoses; stresses that such diagnosis requires the central involvement of medical professionals, whose clinical training, ethical responsibility, and ability to integrate complex and heterogeneous information are essential to ensuring quality of care, patient safety, and the appropriate interpretation of advanced diagnostic technologies;

Or. en

Amendment 105

Margarita de la Pisa Carrión

Motion for a resolution

Paragraph 4 a (new)

Motion for a resolutionAmendment
4a. Emphasises the need to establish public support mechanisms to meet the needs of families with a member suffering from a rare disease, given that those suffering from these conditions often require round-the-clock care;

Or. es

Amendment 106

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 5

Motion for a resolutionAmendment
5. Stresses the need to strengthen governance and cross-border coordination by enhancing the sustainability, integration, geographical coverage and referral pathways of ERNs, and exploring mechanisms for stable financing and legal status of the ERNs;5. Stresses the need to strengthen governance and cross-border coordination and cross-border accessibility, by reinforcing the sustainability, integration, geographical coverage and referral pathways of ERNs, and by ensuring stable and predictable financing as well as an appropriate legal and operational framework for their functioning;

Or. en

Amendment 107

Elena Nevado del Campo, Dolors Montserrat, Michalis Hadjipantela, Adam Jarubas, Letizia Moratti, Oliver Schenk

Motion for a resolution

Paragraph 5

Motion for a resolutionAmendment
5. Stresses the need to strengthen governance and cross-border coordination by enhancing the sustainability, integration, geographical coverage and referral pathways of ERNs, and exploring mechanisms for stable financing and legal status of the ERNs;5. Stresses the need to strengthen governance and cross-border coordination by enhancing the sustainability, integration into the national healthcare systems, geographical coverage and referral pathways of ERNs, and exploring mechanisms for stable financing of the ERNs;

Or. en

Amendment 108

Victor Negrescu

Motion for a resolution

Paragraph 5 a (new)

Motion for a resolutionAmendment
5 a. Urges the Commission to institutionalise a more frequent and predictable cycle for ERN expansion calls, replacing ad-hoc procedures with a transparent, regular schedule; recalls that there has not been a new expansion call since 2019; emphasises that a clearly defined timeline is essential for the timely integration of national centers of excellence, thereby bridging the gap between local expertise and Union-wide collaboration to ensure rare disease patients receive specialised care and shared medical insights without administrative delays;

Or. en

Amendment 109

Giorgos Georgiou, Catarina Martins

Motion for a resolution

Paragraph 5 a (new)

Motion for a resolutionAmendment
5 a. Stresses that the successful implementation of a Union rare disease action plan requires strong and resilient public health systems; calls on the Commission and the Member States to ensure adequate and sustainable public funding, recruitment and training of specialised healthcare professionals, and investment in healthcare infrastructure, diagnostic capacity and specialised centres for rare diseases;

Or. en

Amendment 110

Kateřina Konečná

Motion for a resolution

Paragraph 5 a (new)

Motion for a resolutionAmendment
5 a. Stresses the need to strengthen governance and cross-border coordination by enhancing the sustainability, integration, geographical coverage and referral pathways of ERNs, and exploring mechanisms for stable financing and legal status of the ERNs;

Or. en

Amendment 111

Billy Kelleher, Vlad Vasile-Voiculescu, Stine Bosse

Motion for a resolution

Paragraph 5 a (new)

Motion for a resolutionAmendment
5 a. Calls for strengthened education and upskilling of healthcare professionals in genomic testing, early diagnosis and newborn screening, building on the role of ERNs as hubs for training and expertise exchange and on awareness/education initiatives;

Or. en

Amendment 112

Giorgos Georgiou, Catarina Martins

Motion for a resolution

Paragraph 6

Motion for a resolutionAmendment
6. Calls on the Commission and Member States to accelerate efforts to reduce diagnostic delay for rare diseases;6. Calls on the Commission and Member States to accelerate efforts to reduce diagnostic delay and strengthen cooperation for the early diagnosis of rare diseases across the Union, including through the exchange of best practices in newborn screening programmes, the development and responsible use of genomic diagnostic technologies, and the promotion of common guidelines and quality standards aimed at reducing diagnostic delays for patients with rare diseases;

Or. en

Amendment 113

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti

Motion for a resolution

Paragraph 6

Motion for a resolutionAmendment
6. Calls on the Commission and Member States to accelerate efforts to reduce diagnostic delay for rare diseases;6. Calls on the Commission and Member States to accelerate efforts to reduce diagnostic delay for rare diseases by documenting national good practices, facilitating knowledge exchange among Member States, strengthening the digitalisation and interoperability of data in national registries and databases, including through the use of harmonised coding systems;

Or. en

Amendment 114

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 6

Motion for a resolutionAmendment
6. Calls on the Commission and Member States to accelerate efforts to reduce diagnostic delay for rare diseases;6. Calls on the Commission and Member States to accelerate efforts to reduce diagnostic delay for rare diseases, including by setting measurable targets, improving early referral pathways, and strengthening access to specialised expertise within national healthcare systems;

Or. en

Amendment 115

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 6

Motion for a resolutionAmendment
6. Calls on the Commission and Member States to accelerate efforts to reduce diagnostic delay for rare diseases;6. Calls on the Commission and the Member States to significantly reduce diagnostic delays for rare diseases, including through the establishment of measurable indicators, benchmarks and indicative timelines, with the objective of achieving diagnosis within one year where possible;

Or. en

Amendment 116

András Tivadar Kulja

Motion for a resolution

Paragraph 6

Motion for a resolutionAmendment
6. Calls on the Commission and Member States to accelerate efforts to reduce diagnostic delay for rare diseases;6. Calls on the Commission and Member States to accelerate efforts to drastically reduce diagnostic delay for rare diseases, and strengthen coordinated efforts among Members States;

Or. en

Amendment 117

Margarita de la Pisa Carrión

Motion for a resolution

Paragraph 6 a (new)

Motion for a resolutionAmendment
6a. Highlights the importance of ensuring comprehensive early intervention and stimulation from birth, including the involvement of specialists such as speech and language therapists and physiotherapists, amongst others, in order to fully address the developmental needs of patients with rare diseases;

Or. es

Amendment 118

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 6 a (new)

Motion for a resolutionAmendment
6 a. Encourages Member States to establish structured diagnostic pathways, including early referral mechanisms and multidisciplinary assessment, to avoid prolonged diagnostic journeys for patients;

Or. en

Amendment 119

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 6 b (new)

Motion for a resolutionAmendment
6 b. Highlights the key role of primary care practitioners in the early identification of rare diseases and calls for strengthened training, awareness and support tools at primary care level;

Or. en

Amendment 120

Nicolae Ștefănuță

on behalf of the Verts/ALE Group

Motion for a resolution

Paragraph 7

Motion for a resolutionAmendment
7. Urges the development of common principles for the screening of newborns and early detection to tackle social and territorial inequality across the Union;7. Urges the development of common principles and benchmarks for the screening of newborns and early detection to tackle social and territorial inequality across the Union; considers that Member States facing structural challenges should receive targeted financial support to achieve progress towards the benchmark;

Or. en

Amendment 121

Kateřina Konečná

Motion for a resolution

Paragraph 7

Motion for a resolutionAmendment
7. Urges the development of common principles for the screening of newborns and early detection to tackle social and territorial inequality across the Union;7. Urges the development of for the screening of newborns and early detection to tackle social and territorial inequality across the Union and a Union Roadmap for diagnostics of rare diseases, including post-diagnosis support by healthcare systems for individuals following diagnosis and with undiagnosed conditions;

Or. en

Amendment 122

Victor Negrescu

Motion for a resolution

Paragraph 7

Motion for a resolutionAmendment
7. Urges the development of common principles for the screening of newborns and early detection to tackle social and territorial inequality across the Union;7. Urges the development of common principles for the screening of newborns and early detection to tackle social and territorial inequality across the Union, including prenatal and perinatal detection where medically appropriate, and ensuring access to specialised diagnostic services through regional or national centres and accredited laboratories;

Or. en

Amendment 123

Michalis Hadjipantela

Motion for a resolution

Paragraph 7

Motion for a resolutionAmendment
7. Urges the development of common principles for the screening of newborns and early detection to tackle social and territorial inequality across the Union;7. Urges the development of common principles for the screening of newborns, including through Union guidance setting out a harmonised best-in-class Union newborn screening panel and providing for its regular review in light of newly authorised therapies, and early detection to tackle social and territorial inequality across the Union;

Or. en

Amendment 124

Billy Kelleher, Vlad Vasile-Voiculescu, Stine Bosse

Motion for a resolution

Paragraph 7

Motion for a resolutionAmendment
7. Urges the development of common principles for the screening of newborns and early detection to tackle social and territorial inequality across the Union;7. Urges the development of common principles for the screening of newborns, including through Union guidance setting out a harmonised best-in-class Union newborn screening panel and providing for its regular review in light of newly authorised therapies, and early detection to tackle social and territorial inequality across the Union;

Or. en

Amendment 125

András Tivadar Kulja

Motion for a resolution

Paragraph 7

Motion for a resolutionAmendment
7. Urges the development of common principles for the screening of newborns and early detection to tackle social and territorial inequality across the Union;7. Urges the development of common principles for the screening of newborns, including through Union guidance setting out a harmonised exemplary Union newborn screening panel and providing for its regular review in light of newly authorised therapies, and early detection to tackle social and territorial inequality across the Union;

Or. en

Amendment 126

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti, Oliver Schenk

Motion for a resolution

Paragraph 7

Motion for a resolutionAmendment
7. Urges the development of common principles for the screening of newborns and early detection to tackle social and territorial inequality across the Union;7. Urges the development of common principles for the screening of newborns and early detection, including the harmonisation of testing practices where appropriate, to tackle social and territorial inequality across the Union, including within Member States;

Or. en

Amendment 127

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 7

Motion for a resolutionAmendment
7. Urges the development of common principles for the screening of newborns and early detection to tackle social and territorial inequality across the Union;7. Urges the development of common principles and minimum criteria for newborn and prenatal screening and early detection, in order to address social and territorial inequalities and promote more equitable access across the Union;

Or. en

Amendment 128

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Viktória Ferenc

Motion for a resolution

Paragraph 7

Motion for a resolutionAmendment
7. Urges the development of common principles for the screening of newborns and early detection to tackle social and territorial inequality across the Union;7. Urges Member States to develop or strengthen national newborn screening programmes based on scientific evidence, while ensuring that any Union-level coordination remains voluntary and respects national competences;

Or. en

Amendment 129

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Paragraph 7

Motion for a resolutionAmendment
7. Urges the development of common principles for the screening of newborns and early detection to tackle social and territorial inequality across the Union;7. Urges the development of evidence-based common principles for the efficient screening of newborns and early detection to tackle social and territorial inequality across the Union;

Or. en

Amendment 130

Billy Kelleher, Stine Bosse

Motion for a resolution

Paragraph 7 a (new)

Motion for a resolutionAmendment
7 a. Where the medicinal product is a designated orphan medicinal product, the Commission and the Member States should allow the package leaflet to be made available in electronic form only, and should permit the particulars listed in Article 54 of revised Directive 2001/83/EC to appear in only one of the official languages of the Union. In addition, measures should be taken to harmonise or streamline Member State–specific “blue box” requirements on packaging in order to facilitate multi-country packs and enable the efficient movement of orphan medicinal products across Member States;

Or. en

Amendment 131

Margarita de la Pisa Carrión

Motion for a resolution

Paragraph 7 a (new)

Motion for a resolutionAmendment
7a. Stresses the importance of ensuring that genetic and prenatal screening is carried out in full compliance with the European Union’s obligations under the United Nations Convention on the Rights of Persons with Disabilities and taking into account the recommendations of the Committee on the Rights of Persons with Disabilities, in particular with regard to the need to prevent discriminatory or eugenic practices;

Or. es

Amendment 132

Victor Negrescu

Motion for a resolution

Paragraph 8

Motion for a resolutionAmendment
8. Encourages the creation of a Union coordination mechanism to align and strengthen screening programmes and diagnostic pathways across Europe;8. Encourages the creation of a Union coordination mechanism to align and strengthen screening programmes and diagnostic pathways across Europe, including support for regional and national centres of expertise, specialised laboratories and cross-border access to diagnostic services;

Or. en

Amendment 133

Nicolae Ștefănuță

on behalf of the Verts/ALE Group

Motion for a resolution

Paragraph 8

Motion for a resolutionAmendment
8. Encourages the creation of a Union coordination mechanism to align and strengthen screening programmes and diagnostic pathways across Europe;8. Calls for the creation of a Union coordination mechanism to align and strengthen screening programmes and diagnostic pathways across Europe, including common referral pathways, quality criteria and support for Member States with weaker diagnostic capacity;

Or. en

Amendment 134

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 8

Motion for a resolutionAmendment
8. Encourages the creation of a Union coordination mechanism to align and strengthen screening programmes and diagnostic pathways across Europe;8. Calls for the establishment of a Union-level coordination mechanism to support the alignment and strengthening of screening programmes and diagnostic pathways across Member States;

Or. en

Amendment 135

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 8

Motion for a resolutionAmendment
8. Encourages the creation of a Union coordination mechanism to align and strengthen screening programmes and diagnostic pathways across Europe;8. Encourages voluntary cooperation between Member States to exchange best practices in screening programmes and diagnostic pathways;

Or. en

Amendment 136

Emmanouil Fragkos, Galato Alexandraki, Geadis Geadi

Motion for a resolution

Paragraph 8

Motion for a resolutionAmendment
8. Encourages the creation of a Union coordination mechanism to align and strengthen screening programmes and diagnostic pathways across Europe;8. Taking into account the different occurrence rates of rare and ultra-rare diseases which may vary from region to region;

Or. el

Amendment 137

Billy Kelleher, Vlad Vasile-Voiculescu, Stine Bosse

Motion for a resolution

Paragraph 8 a (new)

Motion for a resolutionAmendment
8 a. Among the defining challenges of rare disease therapies is the lack of knowledge about the conditions, biological origins, and the general scientific understanding. In recognition of the various ongoing initiatives and to maximise the impact of ongoing research and resources, the European rare disease research agenda should consider and build on existing initiatives, such as the European Rare Diseases Research Alliance (ERDERA);

Or. en

Amendment 138

András Tivadar Kulja

Motion for a resolution

Paragraph 8 a (new)

Motion for a resolutionAmendment
8 a. Encourages the exchange of best practices on screening and early detection strategies for rare diseases, including targeted screening programmes, and highlights the importance of recognising early signs and symptoms across different medical disciplines, including paediatrics, neurology, dermatology, metabolic medicine and ophthalmology;

Or. en

Amendment 139

Billy Kelleher, Vlad Vasile-Voiculescu, Stine Bosse

Motion for a resolution

Paragraph 9

Motion for a resolutionAmendment
9. Supports greater use of genomic and advanced diagnostic technologies, telemedicine and digital tools, facilitating cross-border diagnostic;9. Urges widespread use of genomic and advanced diagnostic technologies, telemedicine and digital tools, facilitating cross-border diagnostic, and calls for equitable access to such technologies across and within Member States, alongside systematic monitoring of inequalities in access and implementation;

Or. en

Amendment 140

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti

Motion for a resolution

Paragraph 9

Motion for a resolutionAmendment
9. Supports greater use of genomic and advanced diagnostic technologies, telemedicine and digital tools, facilitating cross-border diagnostic;9. Supports greater use of genomic and advanced diagnostic technologies including next-generation sequencing, multi-omics approaches and other specialised diagnostic tools, as well as telemedicine and digital tools, in order to achieve a timely diagnosis and to facilitate cross-border diagnostic;

Or. en

Amendment 141

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 9

Motion for a resolutionAmendment
9. Supports greater use of genomic and advanced diagnostic technologies, telemedicine and digital tools, facilitating cross-border diagnostic;9. Supports greater use of genomic and advanced diagnostic technologies, telemedicine and digital tools, including decision-support tools accessible to primary care practitioners to facilitate early suspicion and referral, to facilitate cross-border diagnostic;

Or. en

Amendment 142

Nicolae Ștefănuță

on behalf of the Verts/ALE Group

Motion for a resolution

Paragraph 9

Motion for a resolutionAmendment
9. Supports greater use of genomic and advanced diagnostic technologies, telemedicine and digital tools, facilitating cross-border diagnostic;9. Supports greater use of genomic and advanced diagnostic technologies, telemedicine and digital tools, to facilitate faster and more accurate cross-border diagnosis, in full compliance with Regulations (EU) 2024/1689, (EU) 2016/679 and (EU) 2025/327;

Or. en

Amendment 143

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 9

Motion for a resolutionAmendment
9. Supports greater use of genomic and advanced diagnostic technologies, telemedicine and digital tools, facilitating cross-border diagnostic;9. Supports greater use of genomic technologies, advanced diagnostics, telemedicine and digital tools, ensuring equitable access and facilitating cross-border cooperation in diagnosis and clinical decision-making;

Or. en

Amendment 144

Victor Negrescu

Motion for a resolution

Paragraph 9 a (new)

Motion for a resolutionAmendment
9 a. Calls on the Commission and the Member States to promote the development and strengthening of regional and national rare disease diagnostic centres and accredited laboratories, including capacities for genomic and prenatal testing, in order to ensure timely and equitable access to early diagnosis across the Union;

Or. en

Amendment 145

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti, Oliver Schenk

Motion for a resolution

Paragraph 9 a (new)

Motion for a resolutionAmendment
9 a. Encourages the development and responsible use of artificial intelligence tools to support the diagnosis of rare diseases, with a view to reducing diagnostic delay and improving accuracy, while ensuring high ethical, legal and data protection standards;

Or. en

Amendment 146

Emmanouil Fragkos, Galato Alexandraki, Geadis Geadi

Motion for a resolution

Paragraph 9 a (new)

Motion for a resolutionAmendment
9a. Increased rare disease awareness and training among general practitioners, accident and emergency doctors, and nurses, while at the same time strengthening referral pathways for specialised care;

Or. el

Amendment 147

András Tivadar Kulja

Motion for a resolution

Paragraph 9 a (new)

Motion for a resolutionAmendment
9 a. Calls on improved awareness and specialised training on rare diseases among general practitioners, emergency physicians and nurses, while strengthening referral pathways to specialist care and empowering patients' communities;

Or. en

Amendment 148

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 9 a (new)

Motion for a resolutionAmendment
9 a. Calls for improved access to genetic and advanced diagnostic testing within Member States, based on clinical need and scientific evidence;

Or. en

Amendment 149

András Tivadar Kulja

Motion for a resolution

Paragraph 9 b (new)

Motion for a resolutionAmendment
9 b. Recognises the work of European Reference Networks (ERNs) bringing together cross-border expertise and networks and calls for their strengthened role during the implementation of the European Health Data Space (EHDS);

Or. en

Amendment 150

Elena Nevado del Campo, Dolors Montserrat, Michalis Hadjipantela, Adam Jarubas, Letizia Moratti, Oliver Schenk

Motion for a resolution

Paragraph 9 b (new)

Motion for a resolutionAmendment
9 b. Calls for strengthened training and awareness-raising for healthcare professionals, in particular paediatricians and professionals in primary care, in order to improve the early recognition of rare diseases;

Or. en

Amendment 151

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 10

Motion for a resolutionAmendment
10. Stresses the need for reinforced Union-level coordination on health technology assessment and evidence evaluation for rare disease treatments;10. Calls for reinforced coordination at Union level on health technology assessment and evidence evaluation for rare disease therapies, including medicinal products, medical devices, digital health solutions and other relevant technologies or procedures, taking into account the specific challenges related to small patient populations and limited clinical data;

Or. en

Amendment 152

Emmanouil Fragkos, Galato Alexandraki, Geadis Geadi

Motion for a resolution

Paragraph 10

Motion for a resolutionAmendment
10. Stresses the need for reinforced Union-level coordination on health technology assessment and evidence evaluation for rare disease treatments;10. Stresses the need for reinforced Union-level coordination on health technology assessment and evidence evaluation for rare disease treatments; bearing in mind that treatments providing relief may not be supported by strong clinical evidence but may nevertheless improve the lives of patients;

Or. el

Amendment 153

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti

Motion for a resolution

Paragraph 10

Motion for a resolutionAmendment
10. Stresses the need for reinforced Union-level coordination on health technology assessment and evidence evaluation for rare disease treatments;10. Stresses the need for reinforced Union-level coordination on health technology assessment, through the implementation of Regulation (EU) 2021/2282, and evidence evaluation for rare disease treatments;

Or. en

Amendment 154

Billy Kelleher, Vlad Vasile-Voiculescu, Stine Bosse

Motion for a resolution

Paragraph 10

Motion for a resolutionAmendment
10. Stresses the need for reinforced Union-level coordination on health technology assessment and evidence evaluation for rare disease treatments;10. Stresses the need for enhanced and funded Union-level coordination on health technology assessment and evidence evaluation for rare disease treatments;

Or. en

Amendment 155

Margarita de la Pisa Carrión

Motion for a resolution

Paragraph 10 a (new)

Motion for a resolutionAmendment
10a. Calls for the concept of unmet medical needs to also encompass situations where treatments exist which, whilst not curing the disease, provide significant gradual improvements in the patient’s quality of life, functionality or clinical management, as is the case with Vyjuvek in the case of dystrophic epidermolysis bullosa;

Or. es

Amendment 156

Tomislav Sokol

Motion for a resolution

Paragraph 10 a (new)

Motion for a resolutionAmendment
10 a. Strongly supports the inclusion of orphan medicinal products within the definition of medicinal products of common interest under the proposal for a Regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, as this would contribute to strengthening their availability, accessibility and affordability across the Union, in particular for patients with rare and ultra-rare conditions;

Or. en

Amendment 157

András Tivadar Kulja

Motion for a resolution

Paragraph 10 a (new)

Motion for a resolutionAmendment
10 a. Calls for strengthened cooperation between Member States to reduce disparities in timely access to treatments for rare diseases, including orphan medicinal products and advanced therapies; stresses the need to ensure patients benefit from appropriate treatments and specialised care without undue delay across the Union;

Or. en

Amendment 158

Billy Kelleher, Stine Bosse

Motion for a resolution

Paragraph 11

Motion for a resolutionAmendment
11. Calls on Member States to support voluntary joint clinical evidence generation, joint procurement and solidarity-based approaches;11. Calls on Member States to support voluntary joint clinical evidence gathering and collation, the full implementation of Directives 2011/24/EU and (EU) 2023/970, as well as cross-border cooperation initiatives; further calls for action to enable harmonised packaging for OMPs to facilitate availability across Member States, joint procurement and solidarity-based approaches to ensure the best possible outcomes for people living with rare diseases;

Or. en

Amendment 159

Elena Nevado del Campo, Dolors Montserrat, Tomislav Sokol, Michalis Hadjipantela, Adam Jarubas, Letizia Moratti

Motion for a resolution

Paragraph 11

Motion for a resolutionAmendment
11. Calls on Member States to support voluntary joint clinical evidence generation, joint procurement and solidarity-based approaches;11. Calls on Member States to support voluntary joint clinical evidence generation, joint procurement of orphan medicines as envisaged in the context of the proposal for a Regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest and other forms of voluntary cooperation with the aim to improve access and affordability of treatment for rare diseases;

Or. en

Amendment 160

András Tivadar Kulja

Motion for a resolution

Paragraph 11

Motion for a resolutionAmendment
11. Calls on Member States to support voluntary joint clinical evidence generation, joint procurement and solidarity-based approaches;11. Calls on Member States to support voluntary joint clinical evidence generation, joint procurement and solidarity-based approaches, as well as the full implementation of Directive 2011/24/EU;

Or. en

Amendment 161

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 11

Motion for a resolutionAmendment
11. Calls on Member States to support voluntary joint clinical evidence generation, joint procurement and solidarity-based approaches;11. Calls on Member States to engage in voluntary joint clinical evidence generation, approach, negotiation and procurement initiatives and solidarity-based approaches, particularly for high-cost therapies;

Or. en

Amendment 162

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Viktória Ferenc

Motion for a resolution

Paragraph 11

Motion for a resolutionAmendment
11. Calls on Member States to support voluntary joint clinical evidence generation, joint procurement and solidarity-based approaches;11. Calls on Member States to support voluntary joint clinical evidence generation, while preserving full national competence over pricing, reimbursement and procurement decisions;

Or. en

Amendment 163

Nicolae Ștefănuță

on behalf of the Verts/ALE Group

Motion for a resolution

Paragraph 11

Motion for a resolutionAmendment
11. Calls on Member States to support voluntary joint clinical evidence generation, joint procurement and solidarity-based approaches;11. Calls on Member States and the Commission to support voluntary joint clinical evidence generation, joint negotiation and procurement and solidarity-based approaches;

Or. en

Amendment 164

Michele Picaro

Motion for a resolution

Paragraph 11

Motion for a resolutionAmendment
11. Calls on Member States to support voluntary joint clinical evidence generation, joint procurement and solidarity-based approaches;11. Calls on Member States to support voluntary joint clinical evidence generation;

Or. en

Amendment 165

Margarita de la Pisa Carrión

Motion for a resolution

Paragraph 11 a (new)

Motion for a resolutionAmendment
11a. Calls for measures to ensure that patients with rare diseases receive effective reasonable adjustments, including not only medical treatment but also essential equipment and support such as special beds, wheelchairs, prosthetics and other necessary devices, which should be regarded as a fundamental part of healthcare;

Or. es

Amendment 166

Sirpa Pietikäinen

Motion for a resolution

Paragraph 11 a (new)

Motion for a resolutionAmendment
11 a. Calls for the establishment of a European joint procurement mechanism for orphan medicinal products, supported by Member States, in order to ensure timely and equitable access to effective treatments for all patients, while fostering innovation and the development of new therapies within the Union;

Or. en

Amendment 167

Victor Negrescu

Motion for a resolution

Paragraph 11 a (new)

Motion for a resolutionAmendment
11 a. Calls on the Commission and Member States to establish a European strategic reserve and joint stockpiling mechanisms for essential orphan drugs and specialised therapies, to prevent shortages and guarantee that no patient is left without treatment due to supply chain vulnerabilities;

Or. en

Amendment 168

Billy Kelleher, Vlad Vasile-Voiculescu

Motion for a resolution

Paragraph 12

Motion for a resolutionAmendment
12. Encourages tailored regulatory pathways and incentives for ultra-rare conditions and advanced therapies;deleted

Or. en

Amendment 169

Nicolás González Casares, Vytenis Povilas Andriukaitis

Motion for a resolution

Paragraph 12

Motion for a resolutionAmendment
12. Encourages tailored regulatory pathways and incentives for ultra-rare conditions and advanced therapies;12. Encourages the development of tailored regulatory pathways like the hospital exemption for advanced therapy medicinal products, sandboxes and incentive frameworks, including adaptive and flexible approaches for ultra-rare conditions and advanced therapies, while maintaining high standards of safety, quality and efficacy;

Or. en

Amendment 170

Nicolae Ștefănuță

on behalf of the Verts/ALE Group

Motion for a resolution

Paragraph 12

Motion for a resolutionAmendment
12. Encourages tailored regulatory pathways and incentives for ultra-rare conditions and advanced therapies;12. Encourages tailored regulatory pathways and incentives for ultra-rare conditions and advanced therapies, particularly for orphan medicinal products and advanced therapies where market fragmentation leads to major access inequalities;

Or. en

Amendment 171

Victor Negrescu

Motion for a resolution

Paragraph 12

Motion for a resolutionAmendment
12. Encourages tailored regulatory pathways and incentives for ultra-rare conditions and advanced therapies;12. Encourages tailored regulatory pathways and incentives for ultra-rare conditions and advanced therapies, including innovative medicinal products and breakthrough therapies;

Or. en

Amendment 172

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Paragraph 12

Motion for a resolutionAmendment
12. Encourages tailored regulatory pathways and incentives for ultra-rare conditions and advanced therapies;12. Encourages tailored regulatory pathways and stronger incentives, including through intellectual property rights, for ultra-rare conditions and advanced therapies;

Or. en

Amendment 173

Michele Picaro

Motion for a resolution

Paragraph 12 a (new)

Motion for a resolutionAmendment
12 a. Stresses that the clinical evaluation and use of innovative diagnostic and therapeutic approaches should ensure the appropriate involvement of qualified medical professionals, in order to guarantee accurate clinical interpretation, patient safety, and the effective integration of complex diagnostic information;

Or. en

Amendment 174

András Tivadar Kulja

Motion for a resolution

Paragraph 12 a (new)

Motion for a resolutionAmendment
12 a. Calls for strengthening healthcare professionals’ capacity to recognise early signs of rare diseases through structured training, including on the links between common childhood or adult conditions and potential underlying rare diseases, across primary and specialised care, in order to reduce diagnostic delays;

Or. en

Amendment 175

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Viktória Ferenc

Motion for a resolution

Paragraph 13

Motion for a resolutionAmendment
13. Supports greater transparency in treatment availability and pricing components where feasible;13. Supports greater transparency in treatment availability and pricing components where feasible, while safeguarding commercially sensitive information and ensuring continued incentives for innovation;

Or. en

Amendment 176

Ondřej Dostál

Motion for a resolution

Paragraph 13

Motion for a resolutionAmendment
13. Supports greater transparency in treatment availability and pricing components where feasible;13. Supports greater transparency in treatment availability and pricing components where feasible, while respecting the timeframes for pricing and reimbursement decisions set by European law;

Or. en

Amendment 177

Nicolás González Casares, Vytenis Povilas Andriukaitis

Motion for a resolution

Paragraph 13

Motion for a resolutionAmendment
13. Supports greater transparency in treatment availability and pricing components where feasible;13. Supports greater transparency where appropriate, in treatment availability, pricing components and reimbursement conditions, in order to support fair access and informed decision-making;

Or. en

Amendment 178

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Paragraph 13

Motion for a resolutionAmendment
13. Supports greater transparency in treatment availability and pricing components where feasible;13. Supports greater transparency in treatment availability and pricing components, where appropriate and feasible;

Or. en

Amendment 179

Michele Picaro

Motion for a resolution

Paragraph 13

Motion for a resolutionAmendment
13. Supports greater transparency in treatment availability and pricing components where feasible;13. Supports greater transparency in treatment availability;

Or. en

Amendment 180

Sirpa Pietikäinen

Motion for a resolution

Paragraph 13 a (new)

Motion for a resolutionAmendment
13 a. Urges the Commission and the Member States to ensure the effective implementation of Directive 2011/24/EU, so as to guarantee patients’ access to specialised treatment in other Member States where such treatment is not available in their Member State of affiliation;

Or. en

Amendment 181

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 13 a (new)

Motion for a resolutionAmendment
13 a. Calls for improved transparency in the pricing of orphan medicinal products and advanced therapies in order to ensure the sustainability of national healthcare systems and fair access for patients;

Or. en

Amendment 182

Emmanouil Fragkos, Galato Alexandraki, Geadis Geadi

Motion for a resolution

Paragraph 14

Motion for a resolutionAmendment
14. Calls for systematic monitoring of inequalities in access, reimbursement timelines and availability of authorised treatments across Member States;14. Calls for systematic monitoring of inequalities in access, reimbursement timelines and availability of authorised treatments across Member States, especially for cross-border healthcare; calls on Member States to give priority to such reimbursements for rare and ultra-rare diseases;

Or. el

Amendment 183

Michalis Hadjipantela

Motion for a resolution

Paragraph 14

Motion for a resolutionAmendment
14. Calls for systematic monitoring of inequalities in access, reimbursement timelines and availability of authorised treatments across Member States;14. Calls for systematic monitoring of inequalities in access, reimbursement timelines, the full implementation of Directives 2011/24/EU and (EU) 2023/970 and the availability of authorised treatments across Member States;

Or. en

Amendment 184

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Viktória Ferenc

Motion for a resolution

Paragraph 14

Motion for a resolutionAmendment
14. Calls for systematic monitoring of inequalities in access, reimbursement timelines and availability of authorised treatments across Member States;14. Calls for greater transparency and cooperation between Member States in order to reduce unjustified disparities in access to authorised rare disease treatments across the Union, while preserving national competence over reimbursement decisions;

Or. en

Amendment 185

Billy Kelleher, Vlad Vasile-Voiculescu, Stine Bosse

Motion for a resolution

Paragraph 14

Motion for a resolutionAmendment
14. Calls for systematic monitoring of inequalities in access, reimbursement timelines and availability of authorised treatments across Member States;14. Calls for systematic monitoring of inequalities in access, reimbursement timelines and the full implementation of the Directives 2011/24/EU and (EU) 2023/970;

Or. en

Amendment 186

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti

Motion for a resolution

Paragraph 14

Motion for a resolutionAmendment
14. Calls for systematic monitoring of inequalities in access, reimbursement timelines and availability of authorised treatments across Member States;14. Calls for systematic monitoring of inequalities in access, reimbursement timelines and availability of authorised medicinal products and treatments across Member States and within;

Or. en

Amendment 187

Michele Picaro

Motion for a resolution

Paragraph 14

Motion for a resolutionAmendment
14. Calls for systematic monitoring of inequalities in access, reimbursement timelines and availability of authorised treatments across Member States;14. Calls for systematic monitoring of inequalities in access and availability of authorised treatments across Member States;

Or. en

Amendment 188

Nicolae Ștefănuță

on behalf of the Verts/ALE Group

Motion for a resolution

Paragraph 14 a (new)

Motion for a resolutionAmendment
14 a. Calls for a strengthened role of the European Medicines Agency in coordinating evidence generation, including for small patient populations, enhancing post-authorisation data collection, and facilitating accelerated, equitable and timely access pathways for rare disease treatments across all Member States;

Or. en

Amendment 189

Nicolae Ștefănuță

on behalf of the Verts/ALE Group

Motion for a resolution

Paragraph 14 b (new)

Motion for a resolutionAmendment
14 b. Calls for the Health Emergency Preparedness and Response Authority to contribute, where appropriate, to ensuring the availability and equitable distribution of critical treatments and advanced therapies for rare diseases, including through preparedness planning, coordination and support for joint procurement where relevant;

Or. en

Amendment 190

Victor Negrescu

Motion for a resolution

Paragraph 15 a (new)

Motion for a resolutionAmendment
15 a. Calls for strengthened Union-level coordination to support timely, equitable and sustainable access to innovative medicinal products for rare diseases, including through joint evidence generation, early access pathways and voluntary cooperation between Member States;

Or. en

Amendment 191

Nicolae Ștefănuță

on behalf of the Verts/ALE Group

Motion for a resolution

Paragraph 15 a (new)

Motion for a resolutionAmendment
15 a. Calls on the Commission to ensure that public funding for research into orphan medicinal products and advanced therapies is accompanied by conditions securing affordability, accessibility, availability and a fair public return across all Member States;

Or. en

Amendment 192

Elena Nevado del Campo, Dolors Montserrat, Michalis Hadjipantela, Adam Jarubas, Letizia Moratti

Motion for a resolution

Paragraph 16

Motion for a resolutionAmendment
16. Calls for a Union-wide rare disease research strategy aligned with Horizon Europe funding;16. Calls for a Union-wide rare disease research strategy aligned with Horizon Europe funding, building on and ensuring coordination with existing initiatives and instruments, including the European Rare Diseases Research Alliance (ERDERA), the European Reference Networks (ERNs), the International Rare Diseases Research Consortium (IRDiRC) and the Innovative Health Initiative, in order to avoid duplication;

Or. en

Amendment 193

Oliver Schenk

Motion for a resolution

Paragraph 16

Motion for a resolutionAmendment
16. Calls for a Union-wide rare disease research strategy aligned with Horizon Europe funding;16. Calls for a Union-wide rare disease research strategy aligned with Horizon Europe funding, building on and ensuring coordination with existing initiatives and instruments, particularly the European Rare Diseases Research Alliance (ERDERA) and the European Reference Networks (ERNs);

Or. en

Amendment 194

Kateřina Konečná

Motion for a resolution

Paragraph 16

Motion for a resolutionAmendment
16. Calls for a Union-wide rare disease research strategy aligned with Horizon Europe funding;16. Calls for a Union-wide rare disease research strategy supported by the Union budget and programmes, that builds on the Strategic Research and Innovation Agenda of the European Rare Diseases Research Alliance;

Or. en

Amendment 195

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 16

Motion for a resolutionAmendment
16. Calls for a Union-wide rare disease research strategy aligned with Horizon Europe funding;16. Calls for the establishment of a Union-wide rare disease research and innovation strategy, aligned with Union funding programmes, including Horizon Europe and its successors;

Or. en

Amendment 196

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Viktória Ferenc

Motion for a resolution

Paragraph 16

Motion for a resolutionAmendment
16. Calls for a Union-wide rare disease research strategy aligned with Horizon Europe funding;16. Calls for a Union-wide rare disease research strategy aligned with Horizon Europe funding, including dedicated research streams for paediatric rare diseases;

Or. en

Amendment 197

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 16 a (new)

Motion for a resolutionAmendment
16 a. Calls, in the context of the European Competitiveness Fund (ECF) and the post-2027 Multiannual Financial Framework (2028-2034), for structural, predictable and long-term funding across the entire health value chain for rare diseases, from research and innovation to governance, healthcare delivery, digitalisation, and the availability of medicinal products, medical devices and other health technologies;

Or. en

Amendment 198

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 16 b (new)

Motion for a resolutionAmendment
16 b. Stresses the need to explicitly support cross-cutting health priorities within Union funding instruments, including the impact of climate change on health, the long-term sustainability and further development of the European Reference Networks (ERNs), and the advancement of digital health infrastructures, in particular the European Health Data Space (EHDS) and the uptake of emerging technologies such as artificial intelligence;

Or. en

Amendment 199

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 16 c (new)

Motion for a resolutionAmendment
16 c. Calls for urgent and sustained investment to ensure the interconnection and interoperability of biobanks, registries, the 1+ Million Genomes initiative, and national research infrastructures with a view to creating a fully functioning pan-European rare disease research and innovation ecosystem supported by stable and continuous funding;

Or. en

Amendment 200

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 17

Motion for a resolutionAmendment
17. Encourages the pooling of research infrastructures and biobanks;17. Encourages the pooling and networking of research infrastructures, biobanks and data platforms at Union level, ensuring their accessibility, interoperability and long-term sustainability;

Or. en

Amendment 201

Giorgos Georgiou, Catarina Martins

Motion for a resolution

Paragraph 17 a (new)

Motion for a resolutionAmendment
17 a. Calls on the Commission and the Member States to support and strengthen public and non-profit research institutions, universities and public manufacturing facilities engaged in the development and production of medicines and treatments for rare diseases, with the aim of diversifying supply, strengthening strategic autonomy and reducing excessive dependence on highly concentrated or oligopolistic pharmaceutical markets;

Or. en

Amendment 202

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Viktória Ferenc

Motion for a resolution

Paragraph 17 a (new)

Motion for a resolutionAmendment
17 a. Calls for strengthened investment in Union biomedical research capacities, including public laboratories, hospitals and universities, in order to reduce dependency on third countries for the development of innovative therapies;

Or. en

Amendment 203

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 18

Motion for a resolutionAmendment
18. Supports coordinated research agendas to avoid duplication;18. Supports the development of coordinated research agendas at Union level to maximise impact and avoid duplication of efforts;

Or. en

Amendment 204

Giorgos Georgiou, Catarina Martins

Motion for a resolution

Paragraph 18 a (new)

Motion for a resolutionAmendment
18 a. Calls on the Commission to ensure that all research, development and innovation projects on rare diseases receiving Union or public funding are subject to binding social and pricing conditionalities, including fair and transparent pricing, affordability for public health systems, and open access to research data, results and publicly funded intellectual property, in order to maximise public value and patient access;

Or. en

Amendment 205

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 18 a (new)

Motion for a resolutionAmendment
18 a. Calls for the integration, where scientifically relevant, of environmental and occupational exposure data and social determinants data into rare disease research cohorts, registries and real-world evidence generation, in full compliance with data protection rules, to improve understanding of disease onset, severity, progression and inequalities in outcomes;

Or. en

Amendment 206

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti

Motion for a resolution

Paragraph 19

Motion for a resolutionAmendment
19. Calls for increased patient involvement in research governance;19. Calls for increased patient involvement in research governance, including through the systematic collection of patient-reported data, with a view to enabling a more detailed understanding of disease symptoms and patients needs;

Or. en

Amendment 207

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 19

Motion for a resolutionAmendment
19. Calls for increased patient involvement in research governance;19. Calls for the systematic and meaningful involvement of patients and patient organisations in research governance, priority setting and evaluation processes;

Or. en

Amendment 208

András Tivadar Kulja

Motion for a resolution

Paragraph 19

Motion for a resolutionAmendment
19. Calls for increased patient involvement in research governance;19. Calls for increased patient involvement in research governance; through among others Real-World Experience, and Patient-Reported Outcomes;

Or. en

Amendment 209

Billy Kelleher, Vlad Vasile-Voiculescu, Stine Bosse

Motion for a resolution

Paragraph 19

Motion for a resolutionAmendment
19. Calls for increased patient involvement in research governance;19. Calls for increased patient involvement, led by their patient-representative organisations, in research governance;

Or. en

Amendment 210

Nicolae Ștefănuță

on behalf of the Verts/ALE Group

Motion for a resolution

Paragraph 19 a (new)

Motion for a resolutionAmendment
19 a. Calls for increased research and monitoring of environmental determinants of rare diseases, including exposure to hazardous chemicals, endocrine disruptors and industrial pollution;

Or. en

Amendment 211

Nicolás González Casares, Vytenis Povilas Andriukaitis

Motion for a resolution

Paragraph 20

Motion for a resolutionAmendment
20. Encourages public-private partnerships focused on unmet needs;20. Encourages the development of public-private partnerships with accessibility and affordability conditions targeting unmet medical needs in the field of rare diseases;

Or. en

Amendment 212

Marie-Luce Brasier-Clain, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 20

Motion for a resolutionAmendment
20. Encourages public-private partnerships focused on unmet needs;20. Encourages public-private partnerships focused on unmet needs, while ensuring transparency, public oversight and fair access to resulting innovations;

Or. en

Amendment 213

Nicolás González Casares, Vytenis Povilas Andriukaitis

Motion for a resolution

Paragraph 20 a (new)

Motion for a resolutionAmendment
20 a. Calls for increased attention to paediatric ultra-rare diseases, which represent a critical area of unmet medical need owing to their extremely low prevalence, severe clinical impact, and the insufficient research effort and investment devoted to the development of effective treatments; notes that those conditions pose particular challenges for innovation, including small patient populations, clinical heterogeneity and limited commercial incentives; stresses therefore the need for proportionate regulatory, financial and scientific support measures to facilitate the development of and access to therapies for affected children;

Or. en

Amendment 214

Ondřej Dostál

Motion for a resolution

Paragraph 20 a (new)

Motion for a resolutionAmendment
20 a. Calls on the Commission and the Member States to ensure that public-private partnerships in the field of rare diseases and pharmaceutical research are based on fair and transparent governance, and that public investments deliver public value, by preventing situations in which investments and risks are borne primarily by public authorities while profits are privatised, and by promoting equitable return on public funding, affordable pricing, and accessible outcomes for patients;

Or. en

Amendment 215

Margarita de la Pisa Carrión

Motion for a resolution

Paragraph 20 a (new)

Motion for a resolutionAmendment
20a. Highlights the importance of fostering support networks among families, by providing spaces for people to meet and support one another, enabling them to share experiences, reduce the emotional burden associated with the diagnosis, and offer practical guidance on how to organise daily life in the face of the illness, from a realistic perspective;

Or. es

Amendment 216

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 21

Motion for a resolutionAmendment
21. Supports Union funding for translational and clinical research;21. Supports Union funding for translational, clinical and implementation research, in order to bridge the gap between scientific discovery, preclinical research and patient access;

Or. en

Amendment 217

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Paragraph 21

Motion for a resolutionAmendment
21. Supports Union funding for translational and clinical research;21. Supports leveraging Union funding for translational and clinical research;

Or. en

Amendment 218

Billy Kelleher, Vlad Vasile-Voiculescu, Stine Bosse

Motion for a resolution

Paragraph 21

Motion for a resolutionAmendment
21. Supports Union funding for translational and clinical research;21. Supports Union funding for transnational and clinical research;

Or. en

Amendment 219

Ondřej Dostál

Motion for a resolution

Paragraph 21 a (new)

Motion for a resolutionAmendment
21 a. Calls on the Commission and the Member States to ensure that publicly funded transnational and clinical research deliver public ownership, fair returns, and affordable access, and to prevent the privatisation of publicly funded innovations and excessive pricing of treatments financed by public health systems;

Or. en

Amendment 220

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 22

Motion for a resolutionAmendment
22. Calls for improved cross-border clinical trial coordination;22. Calls for improved cross-border coordination of clinical trials across the Union, including the simplification of administrative procedures and improved patient access; calls, in particular, for proportionate and flexible clinical development pathways for rare and ultra-rare diseases, by streamlining requirements where appropriate, without lowering regulatory standards, in order to facilitate the translation of research into clinical applications and avoid disproportionate burdens that may hinder the development of therapies for very small patient populations, improving the accesibility for patients with those conditions;

Or. en

Amendment 221

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti

Motion for a resolution

Paragraph 22 a (new)

Motion for a resolutionAmendment
22 a. Welcomes the measures set out in the proposal for a Regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union's biotechnology and biomanufacturing sectors particular in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) to improve the functioning of cross-border and multinational clinical trials for rare diseases; notes that those measures are intended to facilitate more flexible and efficient trial conduct, including through proportionate regulatory requirements, flexible handling of protocol modifications, support for combined studies involving medicinal products, medical devices or diagnostics, and the use of innovative tools, while maintaining high standards of patient safety, data quality and regulatory oversight;

Or. en

Amendment 222

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 22 a (new)

Motion for a resolutionAmendment
22 a. Calls for measures to simplify administrative procedures for clinical trials on rare diseases in the Union in order to increase the attractiveness of the Union for biomedical innovation and accelerate patient access to innovative therapies;

Or. en

Amendment 223

Emmanouil Fragkos, Galato Alexandraki, Geadis Geadi

Motion for a resolution

Paragraph 23

Motion for a resolutionAmendment
23. Requests measurable targets for research collaboration and output;deleted

Or. el

Amendment 224

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 23

Motion for a resolutionAmendment
23. Requests measurable targets for research collaboration and output;23. Requests the establishment of measurable targets and indicators for research collaboration, output and impact at Union level;

Or. en

Amendment 225

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Paragraph 23 a (new)

Motion for a resolutionAmendment
23 a. Welcomes the proposal for a Regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union's biotechnology and biomanufacturing sectors particular in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act); calls for sustained focus on creating a more efficient regulatory framework for the Union’s life science sector, on shortening timelines and on increasing incentives for further research, development and production of innovative therapies within the Union;

Or. en

Amendment 226

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 23 a (new)

Motion for a resolutionAmendment
23 a. Calls for strengthening European scientific leadership in rare disease research and ensuring that strategic research infrastructures remain under European control;

Or. en

Amendment 227

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Paragraph 23 b (new)

Motion for a resolutionAmendment
23 b. Encourages Member States to streamline and shorten regulatory processes to support research and development of rare diseases therapies, specifically with regard to clinical trials;

Or. en

Amendment 228

Giorgos Georgiou, Catarina Martins

Motion for a resolution

Paragraph 24

Motion for a resolutionAmendment
24. Calls for full interoperability of rare disease registries and further development of data sharing and rare disease registry infrastructures;24. Calls for full interoperability of rare disease registries and further development of data sharing and rare disease registry infrastructures; calls on the Commission to support the development, interoperability and long-term sustainability of European rare disease patient registries, based on common standards ensuring informed patient consent and robust safeguards for personal data protection, with the aim of improving research capacity, strengthening knowledge on rare diseases and facilitating the development of new diagnostics and treatments;

Or. en

Amendment 229

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Viktória Ferenc

Motion for a resolution

Paragraph 24

Motion for a resolutionAmendment
24. Calls for full interoperability of rare disease registries and further development of data sharing and rare disease registry infrastructures;24. Calls for full interoperability of rare disease registries and further development of data sharing and rare disease registry infrastructures, ensuring consistent integration of Orphacodes across registries and healthcare systems;

Or. en

Amendment 230

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Paragraph 24

Motion for a resolutionAmendment
24. Calls for full interoperability of rare disease registries and further development of data sharing and rare disease registry infrastructures;24. Calls for full interoperability of rare disease registries and further development of data sharing and rare disease registry infrastructures, leveraging the potential of already existing registries within Member States;

Or. en

Amendment 231

Elena Nevado del Campo, Dolors Montserrat, Michalis Hadjipantela, Adam Jarubas, Letizia Moratti

Motion for a resolution

Paragraph 24

Motion for a resolutionAmendment
24. Calls for full interoperability of rare disease registries and further development of data sharing and rare disease registry infrastructures;24. Calls for full interoperability of rare disease registries and further development of data sharing and rare disease registry infrastructures, including the European Platform on Rare Disease Registration;

Or. en

Amendment 232

Kateřina Konečná

Motion for a resolution

Paragraph 24

Motion for a resolutionAmendment
24. Calls for full interoperability of rare disease registries and further development of data sharing and rare disease registry infrastructures;24. Calls for full interoperability of rare disease registries and further development of data sharing and rare disease registry infrastructures including biobanks;

Or. en

Amendment 233

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Aleksandar Nikolic, Valérie Deloge, Viktória Ferenc

Motion for a resolution

Paragraph 25

Motion for a resolutionAmendment
25. Supports the integration of rare disease data into the European Health Data Space established by Regulation (EU) 2025/327 as an essential step of the process of its implementation;25. Supports the integration of rare disease data into the European Health Data Space established by Regulation (EU) 2025/327 as an essential step of the process of its implementation provided that it does not result in centralised storage of sensitive health data at Union level and that it fully respect patients’ rights, including explicit consent;

Or. en

Amendment 234

Sirpa Pietikäinen

Motion for a resolution

Paragraph 25 a (new)

Motion for a resolutionAmendment
25 a. Encourages the effective use of the European Health Data Space (EHDS) for rare disease care, including the responsible sharing and secondary use of health data to improve diagnosis, treatment, and research outcomes, while fully respecting data protection and ethical standards;

Or. en

Amendment 235

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti

Motion for a resolution

Paragraph 26

Motion for a resolutionAmendment
26. Encourages the systematic use of standardised coding systems;26. Encourages the systematic use of standardised coding systems such as the ORPHAcodes maintained by Orphanet, which have already identified over 22.000 main names and synonyms and assigned them unique and time-stable numerical identifiers that can be readily integrated into national registries and databases to enhance data standardisation, comparability and interoperability;

Or. en

Amendment 236

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Viktória Ferenc

Motion for a resolution

Paragraph 26

Motion for a resolutionAmendment
26. Encourages the systematic use of standardised coding systems;26. Encourages the systematic use of standardised coding systems, including Orphacodes, to improve the identification, visibility and comparability of rare diseases across Member States;

Or. en

Amendment 237

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 26

Motion for a resolutionAmendment
26. Encourages the systematic use of standardised coding systems;26. Encourages the systematic use of standardised coding systems and common data standards for rare diseases across Member States;

Or. en

Amendment 238

Giorgos Georgiou, Catarina Martins

Motion for a resolution

Paragraph 26

Motion for a resolutionAmendment
26. Encourages the systematic use of standardised coding systems;26. Encourages the systematic use of a common coding system for all member states provided and financed by the Union;

Or. en

Amendment 239

Billy Kelleher, Vlad Vasile-Voiculescu, Stine Bosse

Motion for a resolution

Paragraph 26

Motion for a resolutionAmendment
26. Encourages the systematic use of standardised coding systems;26. Encourages the systematic use of standardised coding systems in every Member State;

Or. en

Amendment 240

Kateřina Konečná

Motion for a resolution

Paragraph 26

Motion for a resolutionAmendment
26. Encourages the systematic use of standardised coding systems;26. Encourages the systematic use of Orphacodes;

Or. en

Amendment 241

Marie-Luce Brasier-Clain, Aleksandar Nikolic, Valérie Deloge, Viktória Ferenc

Motion for a resolution

Paragraph 27

Motion for a resolutionAmendment
27. Calls for a federated European rare disease data network as a step to be incorporated in the deployment of the European Health Data Space;27. Calls for a federated European rare disease data network as a step to be incorporated in the deployment of the European Health Data Space, based on a decentralised and federated architecture ensuring Member States’ control over data access and use;

Or. en

Amendment 242

Elena Nevado del Campo, Dolors Montserrat, Michalis Hadjipantela, Adam Jarubas, Letizia Moratti

Motion for a resolution

Paragraph 27

Motion for a resolutionAmendment
27. Calls for a federated European rare disease data network as a step to be incorporated in the deployment of the European Health Data Space;27. Calls for a European rare disease data network building on existing Union infrastructures, including the European Platform on Rare Disease Registration, as a step to be incorporated in the deployment of the European Health Data Space;

Or. en

Amendment 243

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 27

Motion for a resolutionAmendment
27. Calls for a federated European rare disease data network as a step to be incorporated in the deployment of the European Health Data Space;27. Calls for the development of a federated European rare disease data network, enabling secure and efficient cross-border access to data as a first step to data integration at Union-level;

Or. en

Amendment 244

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 27 a (new)

Motion for a resolutionAmendment
27 a. Advocates for the creation of a European framework for rare disease data governance, standardising rules for data access, reuse, and stewardship across Member States. This framework shall include transparent mechanisms for research access, meaningful patient involvement, and seamless coordination among registries, genomic databases, and clinical data infrastructures;

Or. en

Amendment 245

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 28

Motion for a resolutionAmendment
28. Encourages secure cross-border data sharing respecting privacy rules;28. Encourages secure and interoperable cross-border data sharing for clinical and research purposes, while ensuring full compliance with Union data protection and privacy rules, in particular Regulation (EU) 2016/679; stresses the importance of robust governance frameworks, high standards of data security, and the use of privacy-preserving technologies, including pseudonymisation and anonymisation, to safeguard patients’ rights; underlines the need to ensure transparency, informed consent and patient trust, while facilitating the secondary use of health data for research and innovation, notably in the field of rare diseases;

Or. en

Amendment 246

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti

Motion for a resolution

Paragraph 28

Motion for a resolutionAmendment
28. Encourages secure cross-border data sharing respecting privacy rules;28. Encourages secure cross-border data sharing respecting data protection and privacy rules, in order to strengthen patients´ trust in the use of their health data;

Or. en

Amendment 247

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Viktória Ferenc

Motion for a resolution

Paragraph 28

Motion for a resolutionAmendment
28. Encourages secure cross-border data sharing respecting privacy rules;28. Encourages secure cross-border data sharing subject to explicit, informed and freely given patient consent and the highest data protection standards;

Or. en

Amendment 248

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Paragraph 28 a (new)

Motion for a resolutionAmendment
28 a. Calls for clear guidance on the use of digital tools and artificial intelligence in research, development, screening, monitoring and treatment of rare diseases; further calls for an assessment of the potential of using artificial intelligence to support innovation;

Or. en

Amendment 249

Sirpa Pietikäinen

Motion for a resolution

Paragraph 28 a (new)

Motion for a resolutionAmendment
28 a. Calls on the Commission and Member States to strengthen international cooperation and mutual learning in health sciences and medical technologies, including by drawing lessons from third countries, in order to foster innovation, improve healthcare delivery, and enhance the Union’s global competitiveness in the health sector;

Or. en

Amendment 250

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 29

Motion for a resolutionAmendment
29. Calls for Union guidance on integrated, multidisciplinary care pathways;29. Calls for Union guidance on integrated, multidisciplinary care pathways ensuring the integration of primary care practitioners as key entry points into the healthcare system;

Or. en

Amendment 251

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 29

Motion for a resolutionAmendment
29. Calls for Union guidance on integrated, multidisciplinary care pathways;29. Calls for the development of Union-level guidance on integrated, multidisciplinary and patient-centred care pathways covering the entire life course;

Or. en

Amendment 252

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti

Motion for a resolution

Paragraph 29

Motion for a resolutionAmendment
29. Calls for Union guidance on integrated, multidisciplinary care pathways;29. Calls for Union guidance on holistic, patient - centred and multidisciplinary care pathways for people living with rare diseases;

Or. en

Amendment 253

Kateřina Konečná

Motion for a resolution

Paragraph 29

Motion for a resolutionAmendment
29. Calls for Union guidance on integrated, multidisciplinary care pathways;29. Calls for improved cross-border healthcare and continuity from paediatric to adult care continuity of care;

Or. en

Amendment 254

Victor Negrescu

Motion for a resolution

Paragraph 29 a (new)

Motion for a resolutionAmendment
29 a. Stresses that rare disease policies shall ensure continuity of care across the life course, including appropriate follow-up, monitoring and coordination between paediatric and adult services, taking into account the chronic and progressive nature of many rare diseases;

Or. en

Amendment 255

Michele Picaro

Motion for a resolution

Paragraph 29 a (new)

Motion for a resolutionAmendment
29 a. Supports the establishment of coordinated, patient-centred care pathways, including access to psychosocial and mental health support, particularly for persons living with complex, disabling or long-term conditions requiring highly specialised and coordinated care;

Or. en

Amendment 256

Sirpa Pietikäinen

Motion for a resolution

Paragraph 29 a (new)

Motion for a resolutionAmendment
29 a. Stresses the importance of ensuring sustainable and transparent funding for patients’ organisations, recognising their essential role in advocacy, awareness-raising, data collection and support services, particularly in the field of rare diseases;

Or. en

Amendment 257

Elena Nevado del Campo, Dolors Montserrat, Tomislav Sokol, Adam Jarubas, Letizia Moratti, Oliver Schenk

Motion for a resolution

Paragraph 29 a (new)

Motion for a resolutionAmendment
29 a. Calls on the Commission and Member States to promote the integration of mental health support into the care pathways for patients diagnosed with a rare disease, in particular for those without access to effective treatment;

Or. en

Amendment 258

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 29 a (new)

Motion for a resolutionAmendment
29 a. Calls for the development of adapted care pathways for children with rare diseases, including coordinated paediatric care, support for families and continuity of care into adulthood;

Or. en

Amendment 259

Nicolae Ștefănuță

on behalf of the Verts/ALE Group

Motion for a resolution

Paragraph 30

Motion for a resolutionAmendment
30. Encourages recognition of the socio-economic impact on families and carers;30. Calls for recognition of the socio-economic impact on families and carers, and calls for comprehensive support for families and caregivers, including financial support, social protection, access to respite services and psychological support; stresses that performance indicators should also monitor the socio-economic wellbeing of patients but also caregivers as a key indicator of successful policy;

Or. en

Amendment 260

Giorgos Georgiou, Catarina Martins

Motion for a resolution

Paragraph 30

Motion for a resolutionAmendment
30. Encourages recognition of the socio-economic impact on families and carers;30. Encourages recognition of the socio-economic impact on families and carers; stresses the need to fully integrate the social dimension of rare diseases into relevant Union policies, including those related to social protection, education and employment, and calls on the Commission and the Member States to develop measures supporting patients and their families in daily life, ensuring equal opportunities, social inclusion and access to education and quality jobs;

Or. en

Amendment 261

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 30

Motion for a resolutionAmendment
30. Encourages recognition of the socio-economic impact on families and carers;30. Encourages the recognition and systematic assessment of the socio-economic impact of rare diseases on patients, families and carers, including financial hardship and barriers to employment;

Or. en

Amendment 262

Emmanouil Fragkos, Galato Alexandraki, Geadis Geadi

Motion for a resolution

Paragraph 30

Motion for a resolutionAmendment
30. Encourages recognition of the socio-economic impact on families and carers;30. Encourages recognition of the socio-economic impact on families and carers, and calls on Member States to consider issuing a disability card where appropriate;

Or. el

Amendment 263

Margarita de la Pisa Carrión

Motion for a resolution

Paragraph 30 a (new)

Motion for a resolutionAmendment
30a. Calls for full recognition of the central role played by families in caring for people with rare diseases, and for specific measures to be developed to ensure that this responsibility does not result in disadvantages of a financial, employment or social nature;

Or. es

Amendment 264

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 30 a (new)

Motion for a resolutionAmendment
30 a. Highlights the heavy social and financial burden borne by families caring for patients with rare diseases and calls on Member States to strengthen support mechanisms for carers, including financial assistance, access to social protection and adapted care services;

Or. en

Amendment 265

Nicolae Ștefănuță

on behalf of the Verts/ALE Group

Motion for a resolution

Paragraph 30 a (new)

Motion for a resolutionAmendment
30 a. Calls for persons living with rare diseases to be treated as a priority vulnerable group in the Union and national policies on disability, education, employment and social inclusion;

Or. en

Amendment 266

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Paragraph 30 a (new)

Motion for a resolutionAmendment
30 a. Recognises the need for further action to combat gender inequality of care; calls for measures to improve diagnosis and treatment for women with rare diseases;

Or. en

Amendment 267

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 31

Motion for a resolutionAmendment
31. Supports harmonised principles for disability assessment based on functional impact;31. Supports the exchange of best practices for disability assessment based on functional impact, while fully respecting national systems and avoiding mandatory harmonisation;

Or. en

Amendment 268

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 31

Motion for a resolutionAmendment
31. Supports harmonised principles for disability assessment based on functional impact;31. Supports the development of harmonised principles for disability assessment based on functional impact, ensuring fair and consistent access to social rights and benefits;

Or. en

Amendment 269

Elena Nevado del Campo, Dolors Montserrat, Michalis Hadjipantela, Adam Jarubas, Letizia Moratti

Motion for a resolution

Paragraph 32

Motion for a resolutionAmendment
32. Calls for improved cross-border continuity of care;32. Calls for improved cross-border continuity of care building on the framework established by Directive 2011/24/EU and on the expertise of the European Reference Networks; calls for reducing administrative burdens and costs that this might entail for patients and their families;

Or. en

Amendment 270

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 32

Motion for a resolutionAmendment
32. Calls for improved cross-border continuity of care;32. Calls for improved cross-border continuity of care, including the recognition of medical prescriptions, care plans and clinical expertise across Member States;

Or. en

Amendment 271

Kateřina Konečná

Motion for a resolution

Paragraph 32

Motion for a resolutionAmendment
32. Calls for improved cross-border continuity of care;32. Calls for improved cross-border healthcare and continuity from paediatric to adult care;

Or. en

Amendment 272

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 32 a (new)

Motion for a resolutionAmendment
32 a. Stresses the importance of promoting social inclusion, including equal access to education, employment and social protection systems for persons living with rare diseases;

Or. en

Amendment 273

Michele Picaro

Motion for a resolution

Paragraph 33

Motion for a resolutionAmendment
33. Calls for a comprehensive Union rare disease action plan with clear milestones setting a strategic roadmap for all pillars of rare disease policy;33. Calls on the Commission to submit, without undue delay and on the basis of Article 292 TFEU, a proposal for a Council recommendation on a Union action plan on rare diseases, in line with Article 168 TFEU, in particular by supporting and complementing Member States’ actions, while fully respecting their competence for the organisation and delivery of health services and medical care, with a view to strengthening public health outcomes across the Union;

Or. en

Amendment 274

Emmanouil Fragkos, Galato Alexandraki, Geadis Geadi

Motion for a resolution

Paragraph 33

Motion for a resolutionAmendment
33. Calls for a comprehensive Union rare disease action plan with clear milestones setting a strategic roadmap for all pillars of rare disease policy;33. Calls on the Commission to further clarify possible actions aimed specifically at rare and ultra-rare diseases in the next MFF, calls on the Commission to evaluate the significance of a complementary and comprehensive Union rare disease action plan with clear milestones setting a strategic roadmap for all pillars of rare disease policy;

Or. el

Amendment 275

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 33

Motion for a resolutionAmendment
33. Calls for a comprehensive Union rare disease action plan with clear milestones setting a strategic roadmap for all pillars of rare disease policy;33. Calls for a comprehensive Union rare disease action plan with clear milestones setting a strategic roadmap for all pillars of rare disease policy based on flexibility, subsidiarity and national implementation;

Or. en

Amendment 276

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 33

Motion for a resolutionAmendment
33. Calls for a comprehensive Union rare disease action plan with clear milestones setting a strategic roadmap for all pillars of rare disease policy;33. Calls for the adoption of a comprehensive Union rare disease action plan with clear milestones, timelines and responsibilities, establishing a coherent strategic roadmap across all policy areas;

Or. en

Amendment 277

Giorgos Georgiou, Catarina Martins

Motion for a resolution

Paragraph 33 a (new)

Motion for a resolutionAmendment
33 a. Calls for the creation of a European rare disease person's card as an identification tool designed to improve care, particularly in emergencies, by displaying crucial diagnosis information and special needs coded through ORPHAcodes. Bridging the gaps in care, reducing emergency diagnostic delays, and improving communication between patients and medical teams, the full Union standardisation of this card will empower patients, increase safety, and ensure that emergency medical professionals can immediately recognise the condition and its needs;

Or. en

Amendment 278

Sirpa Pietikäinen

Motion for a resolution

Paragraph 33 a (new)

Motion for a resolutionAmendment
33 a. Calls on the Commission and Member States to explore the creation of a dedicated Union fund for rare diseases, aimed at supporting cross-border access to specialised care, reducing duplication of efforts in research and treatment, and enhancing equality across borders by enabling patients to receive the best available treatment across the Union, thereby ensuring a more efficient and patient-centred use of resources;

Or. en

Amendment 279

Elena Nevado del Campo, Dolors Montserrat, Tomislav Sokol, Michalis Hadjipantela, Adam Jarubas, Letizia Moratti

Motion for a resolution

Paragraph 33 a (new)

Motion for a resolutionAmendment
33 a. Calls for the involvement of patient organisations in the design, implementation and evaluation of the Union rare diseases action plan, as well as ensuring their presence in the governance structures and the development of Union - level benchmarks and scoreboards;

Or. en

Amendment 280

Nicolae Ștefănuță

on behalf of the Verts/ALE Group

Motion for a resolution

Paragraph 33 a (new)

Motion for a resolutionAmendment
33 a. Stresses that key objectives, benchmarks and targets of the Union rare disease action framework should be defined in the legislative act itself, and not primarily through delegated acts, in order to ensure democratic accountability and legal certainty;

Or. en

Amendment 281

Emmanouil Fragkos, Galato Alexandraki, Geadis Geadi

Motion for a resolution

Paragraph 34 a (new)

Motion for a resolutionAmendment
34a. Encourages the development of National Centres of Excellence, in the context of the Knowledge and Innovation Communities of the European Institute of Innovation and Technology, with maximum geographical coverage across the Union;

Or. el

Amendment 282

Giorgos Georgiou, Catarina Martins

Motion for a resolution

Paragraph 35

Motion for a resolutionAmendment
35. Supports reinforced ERNs infrastructure to enhance and regulatory strength to ensure the Commission’s coordination and leadership;35. Highlights the crucial role of the European Reference Networks in improving diagnosis, treatment and knowledge sharing on rare diseases across the Union; calls on the Commission and the Member States to ensure their sustainable and long-term funding, to strengthen their operational capacity and to promote their effective integration into national health systems;

Or. en

Amendment 283

Elena Nevado del Campo, Dolors Montserrat, Michalis Hadjipantela, Adam Jarubas, Letizia Moratti

Motion for a resolution

Paragraph 35

Motion for a resolutionAmendment
35. Supports reinforced ERNs infrastructure to enhance and regulatory strength to ensure the Commission’s coordination and leadership;35. Supports the reinforcement of the ERNs infrastructure and capacity in order to ensure the Commission´s coordination and leadership role in cross border cooperation;

Or. en

Amendment 284

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 35

Motion for a resolutionAmendment
35. Supports reinforced ERNs infrastructure to enhance and regulatory strength to ensure the Commission’s coordination and leadership;35. Supports the strengthening of the governance framework of ERNs, including their infrastructure, coordination capacity and long-term sustainability under the leadership of the Commission;

Or. en

Amendment 285

Giorgos Georgiou, Catarina Martins

Motion for a resolution

Paragraph 35 a (new)

Motion for a resolutionAmendment
35 a. Calls for the establishment of structured and meaningful participation of patient organisations, carers, healthcare professionals and researchers in the design, implementation and monitoring of the European rare disease action plan, through transparent governance mechanisms, clear consultation procedures and strong accountability safeguards;

Or. en

Amendment 286

Michalis Hadjipantela

Motion for a resolution

Paragraph 35 a (new)

Motion for a resolutionAmendment
35 a. Calls for assessing the feasibility of establishing a dedicated European rare disease coordination Agency, building on the existing functions of the EMA's Committee for Orphan Medicinal Products and the European Reference Networks, to serve as the central institutional anchor for the implementation of the rare disease action framework;

Or. en

Amendment 287

Stine Bosse, Billy Kelleher, Vlad Vasile-Voiculescu

Motion for a resolution

Paragraph 35 a (new)

Motion for a resolutionAmendment
35 a. In the context of reinforced ERN infrastructures, supports in-depth integrated cooperation models among small and medium-sized clinical expert centres embedded in national healthcare systems to strengthen clinical expertise;

Or. en

Amendment 288

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti

Motion for a resolution

Paragraph 35 a (new)

Motion for a resolutionAmendment
35 a. Supports increased efforts to strengthen the presence of expert centres for rare diseases across all Member States to ensure more equitable access to specialised expertise throughout the Union;

Or. en

Amendment 289

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Paragraph 36

Motion for a resolutionAmendment
36. Encourages the development of Union-level benchmarks and scoreboards;36. Encourages the development of Union-level benchmarks and scoreboards while avoiding undue administrative burden and respecting national specificities;

Or. en

Amendment 290

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 36

Motion for a resolutionAmendment
36. Encourages the development of Union-level benchmarks and scoreboards;36. Encourages the development of Union-level benchmarks, scoreboards and monitoring tools to assess progress, identify gaps and support policy learning;

Or. en

Amendment 291

Giorgos Georgiou, Catarina Martins

Motion for a resolution

Paragraph 36 a (new)

Motion for a resolutionAmendment
36 a. Calls on the Commission, in cooperation with the Member States, to establish measurable and time-bound targets aimed at reducing cross-border inequalities in access to diagnosis, treatment and care for rare diseases across the Union, including targeted financial and technical support for Member States with limited diagnostic capacity, specialised centres or treatment availability;

Or. en

Amendment 292

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Paragraph 37

Motion for a resolutionAmendment
37. Calls for evaluation mechanisms to measure socio-economic impact and cost savings;37. Calls for the establishment of evaluation mechanisms to measure health outcomes, socio-economic impact and cost savings resulting from improved diagnosis, treatment and care;

Or. en

Amendment 293

Ondřej Dostál

Motion for a resolution

Paragraph 37 a (new)

Motion for a resolutionAmendment
37 a. Calls on the Commission and the Member States to strengthen cooperation with third countries in the field of rare diseases, with a view to sharing lessons learned, exchanging best practices, promoting joint research and data sharing, and enhancing collaboration on diagnosis, treatment, and patient care, in order to improve access to rare disease therapies and reduce inequalities for patients worldwide;

Or. en

Amendment 294

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Paragraph 37 a (new)

Motion for a resolutionAmendment
37 a. Calls for the Commission to propose, and the Council to adopt, a Council Recommendation on a rare disease action plan;

Or. en

Amendment 295

Giorgos Georgiou, Catarina Martins

Motion for a resolution

Paragraph 38 a (new)

Motion for a resolutionAmendment
38 a. Calls on the Commission to include in the post-2027 Multiannual Financial Framework (2028-2034) an earmarked funding to support patients and families with rare diseases, in order to ensure access to treatment for all rare disease patients, especially those with unmet medical needs, ensuring a genuine solidarity in the Union;

Or. en

Amendment 296

Emmanouil Fragkos, Galato Alexandraki, Geadis Geadi

Motion for a resolution

Annex I – Part Α – Recommendation 1 – paragraph 1

Motion for a resolutionAmendment
The European Parliament considers that the legislative act to be adopted should establish a comprehensive and binding European rare disease action framework in order to address fragmentation, inequalities and inefficiencies in diagnosis, treatment, research coordination and data infrastructure across the Union.deleted

Or. el

Amendment 297

Michele Picaro

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 1

Motion for a resolutionAmendment
The European Parliament considers that the legislative act to be adopted should establish a comprehensive and binding European rare disease action framework in order to address fragmentation, inequalities and inefficiencies in diagnosis, treatment, research coordination and data infrastructure across the Union.The European Parliament considers that the Commission should submit, without undue delay, a proposal for a Council Recommendation in the field of rare diseases, which establishes a comprehensive European rare disease action framework, with a view to addressing fragmentation, inequalities and inefficiencies in diagnosis, treatment, research coordination and data infrastructure across the Union.

Or. en

Amendment 298

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 1

Motion for a resolutionAmendment
The European Parliament considers that the legislative act to be adopted should establish a comprehensive and binding European rare disease action framework in order to address fragmentation, inequalities and inefficiencies in diagnosis, treatment, research coordination and data infrastructure across the Union.The European Parliament considers that the legislative act to be adopted should establish a comprehensive, coordinated and non-binding European rare disease action framework based on cooperation between Member States in order to address fragmentation, inequalities and inefficiencies in diagnosis, treatment, research coordination and data infrastructure across the Union.

Or. en

Amendment 299

Stine Bosse, Billy Kelleher, Vlad Vasile-Voiculescu

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 1

Motion for a resolutionAmendment
The European Parliament considers that the legislative act to be adopted should establish a comprehensive and binding European rare disease action framework in order to address fragmentation, inequalities and inefficiencies in diagnosis, treatment, research coordination and data infrastructure across the Union.The European Parliament considers that the legislative act to be adopted should establish a comprehensive and binding European rare disease action framework in order to address fragmentation, patient and data volume, inequalities and inefficiencies in diagnosis, treatment, research coordination and data infrastructure across the Union.

Or. en

Amendment 300

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 1

Motion for a resolutionAmendment
The European Parliament considers that the legislative act to be adopted should establish a comprehensive and binding European rare disease action framework in order to address fragmentation, inequalities and inefficiencies in diagnosis, treatment, research coordination and data infrastructure across the Union.The European Parliament considers that the recommendation to be adopted should establish a comprehensive and binding European rare disease action framework in order to address fragmentation, inequalities and inefficiencies in diagnosis, treatment, research coordination and data infrastructure across the Union.

Or. en

Amendment 301

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 2 – introductory part

Motion for a resolutionAmendment
The European Parliament considers that the legislative act to be adopted should:The European Parliament considers that the recommendation to be adopted should:

Or. en

Amendment 302

Kateřina Konečná

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 2 – indent 1

Motion for a resolutionAmendment
– establish a coherent Union framework covering early diagnosis, screening coordination, access to medicinal products and advanced therapies, research cooperation, interoperable data infrastructures, integrated care pathways, governance mechanisms and monitoring systems;– establish a coherent Union framework addressing the full range of unmet needs of people living with rare diseases, focusing on actions with clear Union added value, covering early diagnosis, screening coordination, access to medicinal products and advanced therapies, research cooperation, interoperable data infrastructures, integrated care pathways, patients participation, inclusion of society of people living with rare diseases and their families, governance mechanisms and monitoring systems. The framework is supported by measurable outcomes that are monitored and assessed by a multistakeholder body on a regular basis; and adequate funding from the Union budget;

Or. en

Amendment 303

Stine Bosse, Billy Kelleher, Vlad Vasile-Voiculescu

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 2 – indent 1

Motion for a resolutionAmendment
– establish a coherent Union framework covering early diagnosis, screening coordination, access to medicinal products and advanced therapies, research cooperation, interoperable data infrastructures, integrated care pathways, governance mechanisms and monitoring systems;– establish a coherent Union framework covering early diagnosis, screening coordination, access to medicinal products and advanced therapies, research cooperation, interoperable data infrastructures, integrated care pathways, governance mechanisms, novel cooperation models and monitoring systems;

Or. en

Amendment 304

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 2 – indent 1

Motion for a resolutionAmendment
– establish a coherent Union framework covering early diagnosis, screening coordination, access to medicinal products and advanced therapies, research cooperation, interoperable data infrastructures, integrated care pathways, governance mechanisms and monitoring systems;– establish a coherent Union framework covering early diagnosis, screening coordination, access to medicinal products and advanced therapies, research cooperation, interoperable data infrastructures, integrated and patient-centred care pathways, governance mechanisms and monitoring systems;

Or. en

Amendment 305

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 2 – indent 1

Motion for a resolutionAmendment
– establish a coherent Union framework covering early diagnosis, screening coordination, access to medicinal products and advanced therapies, research cooperation, interoperable data infrastructures, integrated care pathways, governance mechanisms and monitoring systems;– establish a coherent Union framework covering early diagnosis, screening coordination, access to medicinal products and advanced therapies, medical devices, research cooperation, interoperable data infrastructures, integrated care pathways, governance mechanisms and monitoring systems;

Or. en

Amendment 306

Emmanouil Fragkos, Galato Alexandraki, Geadis Geadi

Motion for a resolution

Annex I – Part Α – Recommendation 1 – paragraph 2 – indent 1

Motion for a resolutionAmendment
- establish a coherent Union framework covering early diagnosis, screening coordination, access to medicinal products and advanced therapies, research cooperation, interoperable data infrastructures, integrated care pathways, governance mechanisms and monitoring systems;– establish a coherent Union framework aimed at achieving the following objectives: faster diagnosis, broader coordination of newborn screening, improved access to medicinal products and advanced therapies, research cooperation, interoperable data infrastructures and integrated care models;

Or. el

Amendment 307

Kateřina Konečná

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 2 – indent 1 a (new)

Motion for a resolutionAmendment
– the European framework will guide the implementation of consistent national plans and strategies, ensuring that all measures are designed to reflect continuity with the national plans and strategies for rare diseases and deliver measurable improvements in patient outcomes, including reduced diagnostic delay, increased life expectancy, improved quality of life and reduced socio-economic burden;

Or. en

Amendment 308

Emmanouil Fragkos, Galato Alexandraki, Geadis Geadi

Motion for a resolution

Annex I – Part Α – Recommendation 1 – paragraph 2 – indent 2

Motion for a resolutionAmendment
- lay down common principles and coordination obligations to ensure interoperability of rare disease registries, compatibility with the European Health Data Space and structured exchange of real-world evidence across Member States;– lay down common principles and coordination objectives to ensure interoperability of rare disease registries, compatibility with the European Health Data Space;

Or. el

Amendment 309

Marie-Luce Brasier-Clain, Aleksandar Nikolic, Valérie Deloge

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 2 – indent 2

Motion for a resolutionAmendment
– lay down common principles and coordination obligations to ensure interoperability of rare disease registries, compatibility with the European Health Data Space and structured exchange of real-world evidence across Member States;– lay down common principles and coordination obligations to ensure interoperability of rare disease registries based on real-word evidence, in a decentralised and federated approach ensuring that Member States retain full control over health data and its use;

Or. en

Amendment 310

Kateřina Konečná

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 2 – indent 2

Motion for a resolutionAmendment
– lay down common principles and coordination obligations to ensure interoperability of rare disease registries, compatibility with the European Health Data Space and structured exchange of real-world evidence across Member States;– lay down common principles and coordination obligations to ensure the uptake of OrphaCodes and interoperability of rare disease registries, compatibility with the European Health Data Space and structured exchange of real-world evidence across Member States;

Or. en

Amendment 311

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Aleksandar Nikolic, Valérie Deloge, Viktória Ferenc

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 2 – indent 2 a (new)

Motion for a resolutionAmendment
– ensure that no centralised storage of sensitive health data is established at Union level and that all data sharing is subject to explicit, informed and freely given patient consent;

Or. en

Amendment 312

Nicolae Ștefănuță

on behalf of the Verts/ALE Group

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 2 – indent 3

Motion for a resolutionAmendment
– strengthen and structurally reinforce the legal base of the European Reference Networks (ERNs) and the leadership of the Commission including sustainable Union financing and clearer governance mechanisms;– strengthen and structurally reinforce the legal base of the European Reference Networks (ERNs) and the leadership of the Commission including sustainable Union financing, namely via support from the ECF and complementary support from other elements of the NRPP, including targeting Member States and regions facing structural capacity gaps, and clearer governance mechanisms;

Or. en

Amendment 313

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Viktória Ferenc

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 2 – indent 3

Motion for a resolutionAmendment
– strengthen and structurally reinforce the legal base of the European Reference Networks (ERNs) and the leadership of the Commission including sustainable Union financing and clearer governance mechanisms;– strengthen and support the development of European Reference Networks as complementary tools to national centres of expertise, without replacing national healthcare structures or creating centralised governance mechanisms;

Or. en

Amendment 314

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 2 – indent 3

Motion for a resolutionAmendment
– strengthen and structurally reinforce the legal base of the European Reference Networks (ERNs) and the leadership of the Commission including sustainable Union financing and clearer governance mechanisms;– strengthen and structurally reinforce the legal base of the European Reference Networks (ERNs) while effectively integrating them across the entire health systems, and the leadership of the Commission including sustainable Union financing and clearer governance mechanisms;

Or. en

Amendment 315

Kateřina Konečná

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 2 – indent 3

Motion for a resolutionAmendment
– strengthen and structurally reinforce the legal base of the European Reference Networks (ERNs) and the leadership of the Commission including sustainable Union financing and clearer governance mechanisms;– strengthen and structurally reinforce the legal base of the European Reference Networks (ERNs), including secure and sustainable Union financing and clearer governance mechanisms;

Or. en

Amendment 316

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 2 – indent 3

Motion for a resolutionAmendment
– strengthen and structurally reinforce the legal base of the European Reference Networks (ERNs) and the leadership of the Commission including sustainable Union financing and clearer governance mechanisms;– strengthen and structurally reinforce the European Reference Networks (ERNs) and the leadership of the Commission including sustainable Union financing and clearer governance mechanisms;

Or. en

Amendment 317

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 2 – indent 3

Motion for a resolutionAmendment
– strengthen and structurally reinforce the legal base of the European Reference Networks (ERNs) and the leadership of the Commission including sustainable Union financing and clearer governance mechanisms;– strengthen and structurally reinforce the European Reference Networks (ERNs) and the leadership of the Commission including sustainable Union financing and clearer governance mechanisms;

Or. en

Amendment 318

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Viktória Ferenc

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 2 – indent 4

Motion for a resolutionAmendment
– introduce a Union-level monitoring and reporting mechanism, including common indicators and measurable targets, to assess progress in reducing diagnostic delay, improving equitable access to treatment and enhancing cross-border cooperation;– encourage the development of voluntary monitoring tools and indicators, while avoiding excessive administrative burden and respecting national specificities;

Or. en

Amendment 319

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 2 – indent 4

Motion for a resolutionAmendment
– introduce a Union-level monitoring and reporting mechanism, including common indicators and measurable targets, to assess progress in reducing diagnostic delay, improving equitable access to treatment and enhancing cross-border cooperation;– introduce a Union-level monitoring and reporting mechanism, including common indicators and measurable targets, to assess progress in reducing diagnostic delay, improving equitable access to different methods of treatment and enhancing cross-border cooperation;

Or. en

Amendment 320

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 2 – indent 4

Motion for a resolutionAmendment
– introduce a Union-level monitoring and reporting mechanism, including common indicators and measurable targets, to assess progress in reducing diagnostic delay, improving equitable access to treatment and enhancing cross-border cooperation;– support Union-level harmonisation of monitoring and reporting, including common indicators and measurable targets, to assess progress in reducing diagnostic delay, improving equitable access to treatment and enhancing cross-border cooperation;

Or. en

Amendment 321

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 2 – indent 5

Motion for a resolutionAmendment
– provide mechanisms to promote the use of cross-border pathways for advanced therapy medicinal products, and the scaling-up of its developments;– provide mechanisms to promote the use of cross-border pathways for advanced therapy medicinal products, and the scaling-up of its developments and also other medicinal products and treatments susceptible to benefit from these pathways;

Or. en

Amendment 322

Stine Bosse, Billy Kelleher, Vlad Vasile-Voiculescu

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 2 – indent 5

Motion for a resolutionAmendment
– provide mechanisms to promote the use of cross-border pathways for advanced therapy medicinal products, and the scaling-up of its developments;– provide mechanisms to promote the use of cross-border pathways and standardised Union-wide procedures for the Member States and payers to follow for advanced therapy medicinal products, and the scaling-up of its developments;

Or. en

Amendment 323

Kateřina Konečná

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 2 – indent 5

Motion for a resolutionAmendment
– provide mechanisms to promote the use of cross-border pathways for advanced therapy medicinal products, and the scaling-up of its developments;– provide mechanisms to promote the use of cross-border healthcare pathways, including for advanced therapy medicinal products, and the scaling-up of its developments;

Or. en

Amendment 324

Nicolás González Casares, Vytenis Povilas Andriukaitis

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 2 – indent 5 b (new)

Motion for a resolutionAmendment
– implement, promote and coordinate patient-centric medicines repurposing, which has been recently recognised as new form of affordable innovation in the Union, making use of the legal provisions on repurposing of medicinal products to favour knowledge generation and access to medicines already available without the need to re-entry it into the system as a new medicine;

Or. en

Amendment 325

Elena Nevado del Campo, Dolors Montserrat, Michalis Hadjipantela, Adam Jarubas, Letizia Moratti

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 2 – indent 6

Motion for a resolutionAmendment
– promote the openness of platform technology master files, enabling faster and further research while lowering costs of developments through public fund development partnerships;– promote the openness of platform technology master files, enabling faster and further research while lowering costs of developments through public-private development partnerships;

Or. en

Amendment 326

Billy Kelleher, Vlad Vasile-Voiculescu, Stine Bosse

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 2 – indent 7

Motion for a resolutionAmendment
– ensure structured, integrated and regular consultation of patient organisations, healthcare professionals and civil society in the governance and evaluation of the framework;– ensure structured, integrated and regular consultation of patient organisations, healthcare professionals and civil society, representatives of the industry and industry associations, in the governance and evaluation of the framework;

Or. en

Amendment 327

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 3

Motion for a resolutionAmendment
The European Parliament considers that the appropriate legal instrument is a Regulation, in order to guarantee uniform application of coordination standards, interoperability requirements and governance mechanisms across the Union, thereby preventing further legal and operational fragmentation that could arise from divergent national transposition.The European Parliament considers that the appropriate legal instrument is a Regulation designed as a flexible framework, ensuring coordination while fully respecting the competence of Member States and avoiding excessive harmonisation, in order to guarantee efficient application of coordination standards, interoperability requirements and governance mechanisms across the Union.

Or. en

Amendment 328

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 3

Motion for a resolutionAmendment
The European Parliament considers that the appropriate legal instrument is a Regulation, in order to guarantee uniform application of coordination standards, interoperability requirements and governance mechanisms across the Union, thereby preventing further legal and operational fragmentation that could arise from divergent national transposition.The European Parliament considers that the appropriate legal instrument is a Council Recommendation, in order to support coordination and harmonisation of actions of Member States, decreasing legal and operational fragmentation that could arise from divergent national standards, while acknowledging that healthcare is a matter of national competence.

Or. en

Amendment 329

Michele Picaro

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 3

Motion for a resolutionAmendment
The European Parliament considers that the appropriate legal instrument is a Regulation, in order to guarantee uniform application of coordination standards, interoperability requirements and governance mechanisms across the Union, thereby preventing further legal and operational fragmentation that could arise from divergent national transposition.The European Parliament considers that proposal for a Council Recommendation on a Union action plan on rare diseases, should respect the competences of the Member States concerning the organisation and delivery of healthcare, with a view to strengthening public health outcomes across the Union.

Or. en

Amendment 330

Michele Picaro

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 4

Motion for a resolutionAmendment
The European Parliament considers that the Regulation should respect the competences of the Member States concerning the organisation and delivery of healthcare, while establishing binding cooperation mechanisms and minimum coordination requirements necessary to achieve European added value.deleted

Or. en

Amendment 331

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Viktória Ferenc

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 4

Motion for a resolutionAmendment
The European Parliament considers that the Regulation should respect the competences of the Member States concerning the organisation and delivery of healthcare, while establishing binding cooperation mechanisms and minimum coordination requirements necessary to achieve European added value.The European Parliament considers that the Regulation should respect the competences of the Member States concerning the organisation and delivery of healthcare, while establishing realistic binding cooperation mechanisms and minimum coordination requirements necessary to achieve European added value.

Or. en

Amendment 332

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Annex I – Part A – Recommendation 1 – paragraph 4

Motion for a resolutionAmendment
The European Parliament considers that the Regulation should respect the competences of the Member States concerning the organisation and delivery of healthcare, while establishing binding cooperation mechanisms and minimum coordination requirements necessary to achieve European added value.The European Parliament considers that the recommendation should respect the competences of the Member States concerning the organisation and delivery of healthcare, while supporting the establishment of cooperation mechanisms and increased coordination to achieve European added value.

Or. en

Amendment 333

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 1

Motion for a resolutionAmendment
The European Parliament considers that the legislative act to be adopted should ensure coherence between policy objectives and implementation mechanisms, based on the principle that the scale and cross-border nature of rare diseases require coordinated Union action in accordance with subsidiarity and proportionality.The European Parliament considers that the legislative act to be adopted should ensure coherence between policy objectives and implementation mechanisms, based on the principle that the scale and cross-border nature of rare diseases benefit from enhanced cooperation between Member States in accordance with subsidiarity and proportionality.

Or. en

Amendment 334

Jessica Polfjärd, Niels Flemming Hansen

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 1

Motion for a resolutionAmendment
The European Parliament considers that the legislative act to be adopted should ensure coherence between policy objectives and implementation mechanisms, based on the principle that the scale and cross-border nature of rare diseases require coordinated Union action in accordance with subsidiarity and proportionality.The European Parliament considers that the recommendation to be adopted should ensure coherence between policy objectives and implementation mechanisms, based on the principle that the scale and cross-border nature of rare diseases require coordinated Union action in accordance with subsidiarity and proportionality.

Or. en

Amendment 335

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 1

Motion for a resolutionAmendment
– be structured around six interdependent pillars: early and accurate diagnosis; equitable access to treatments and advanced therapies; research coordination and innovation; interoperable data and digital infrastructure; integrated and patient-centred care pathways; and governance, monitoring and financing;– be structured around six interdependent pillars: early and accurate diagnosis; equitable access to treatments, orphan medicinal products and advanced therapies; research coordination and innovation; interoperable data and digital infrastructure; integrated and patient-centred care pathways; and governance, monitoring and financing;

Or. en

Amendment 336

Elena Nevado del Campo, Dolors Montserrat, Michalis Hadjipantela, Adam Jarubas, Letizia Moratti

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 2

Motion for a resolutionAmendment
– ensure that the place where expertise is located and the place where the patient resides do not determine the level of access to diagnosis or treatment;– ensure that the place where expertise is located and the place where the patient resides do not determine the level of access to diagnosis or treatment by strengthening the integration of ERNs into national healthcare systems, promoting telemedicine and digital tools, and supporting coordinated approaches to access, including joint procurement mechanisms and the continuity of care in rural and underserved areas;

Or. en

Amendment 337

Billy Kelleher, Vlad Vasile-Voiculescu, Stine Bosse

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 2

Motion for a resolutionAmendment
– ensure that the place where expertise is located and the place where the patient resides do not determine the level of access to diagnosis or treatment;– ensure that the place where expertise is located and the place where the patient resides do not limit access to diagnosis or treatment;

Or. en

Amendment 338

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 3

Motion for a resolutionAmendment
– reduce diagnostic delay through coordinated principles on screening of newborns, voluntary convergence of genomic testing standards and strengthened cross-border referral mechanisms to promote social equality and tackle the social disadvantages for children due to the unavailability of early diagnosis and screening programmes;– reduce diagnostic delay through exchange of best practices on newborn screening, based on scientific evidence and national capacities, voluntary convergence of genomic testing standards and practices, and strengthened cross-border referral mechanisms to promote social equality and tackle the social disadvantages for children due to the unavailability of early diagnosis and screening programmes;

Or. en

Amendment 339

Nicolae Ștefănuță

on behalf of the Verts/ALE Group

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 3

Motion for a resolutionAmendment
– reduce diagnostic delay through coordinated principles on screening of newborns, voluntary convergence of genomic testing standards and strengthened cross-border referral mechanisms to promote social equality and tackle the social disadvantages for children due to the unavailability of early diagnosis and screening programmes;– reduce diagnostic delay through coordinated principles on screening of newborns, voluntary convergence of genomic testing standards and strengthened cross-border referral mechanisms, and targeted Union support for Member States with weaker screening and diagnostic capacity, to promote social equality and tackle the social disadvantages faced by children due to the unavailability of early diagnosis and screening programmes;

Or. en

Amendment 340

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti, Oliver Schenk

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 3

Motion for a resolutionAmendment
– reduce diagnostic delay through coordinated principles on screening of newborns, voluntary convergence of genomic testing standards and strengthened cross-border referral mechanisms to promote social equality and tackle the social disadvantages for children due to the unavailability of early diagnosis and screening programmes;– reduce diagnostic delay through coordinated principles on screening of newborns, voluntary convergence of genomic testing standards and strengthened cross-border referral mechanisms, in order to promote social equality both across and within Member States and to tackle social and territorial disparities for children due to the unavailability of early diagnosis and screening programmes;

Or. en

Amendment 341

Billy Kelleher, Vlad Vasile-Voiculescu, Stine Bosse

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 3

Motion for a resolutionAmendment
– reduce diagnostic delay through coordinated principles on screening of newborns, voluntary convergence of genomic testing standards and strengthened cross-border referral mechanisms to promote social equality and tackle the social disadvantages for children due to the unavailability of early diagnosis and screening programmes;– reduce diagnostic delay through coordinated principles on enhanced and standardised screening of newborns, voluntary convergence of genomic testing standards and strengthened cross-border referral mechanisms to promote social equality and tackle the social disadvantages for children due to the unavailability of early diagnosis and screening programmes;

Or. en

Amendment 342

Michele Picaro

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 3 a (new)

Motion for a resolutionAmendment
– ensures that the clinical evaluation and use of innovative diagnostic and therapeutic approaches involve the appropriate participation of qualified medical professionals, in order to guarantee accurate clinical interpretation, patient safety, and the effective integration of complex diagnostic information;

Or. en

Amendment 343

Stine Bosse, Billy Kelleher

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 4

Motion for a resolutionAmendment
– enhance equitable access to orphan medicinal products and advanced therapies through coordinated evidence generation, voluntary joint procurement mechanisms and strengthened cooperation in health technology assessment;– enhance equitable access to orphan medicinal products, paediatrics and advanced therapies through coordinated evidence generation, increased Commission and European Medicines Agency (EMA) support towards voluntary joint procurement mechanisms and to coalitions of the willing on joint pricing and reimbursement negotiations such as Beneluxa and the Nordic Pharmaceutical Forum, support towards making the International Horizontal Scanning Initiative (IHSI) available and to support its uptake and use in all Member States with regard to orphan and paediatric medicinal products as well as ATMPs, and strengthened cooperation in health technology assessment;

Or. en

Amendment 344

Billy Kelleher, Stine Bosse

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 4

Motion for a resolutionAmendment
– enhance equitable access to orphan medicinal products and advanced therapies through coordinated evidence generation, voluntary joint procurement mechanisms and strengthened cooperation in health technology assessment;– enhance equitable access to orphan medicinal products and advanced therapies through coordinated evidence gathering and collation, the full implementation of Directives 2011/24/EU and (EU) 2023/970, cross-border cooperation initiatives and further strengthen voluntary joint procurement mechanisms and strengthened cooperation in health technology assessment procedures. Support action to enable harmonised packaging for OMPs in order to facilitate, as one factor among others, availability across Member States;

Or. en

Amendment 345

Nicolae Ștefănuță

on behalf of the Verts/ALE Group

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 4

Motion for a resolutionAmendment
– enhance equitable access to orphan medicinal products and advanced therapies through coordinated evidence generation, voluntary joint procurement mechanisms and strengthened cooperation in health technology assessment;– enhance equitable access to orphan medicinal products and advanced therapies through coordinated evidence generation, voluntary joint procurement mechanisms and strengthened cooperation in health technology assessment, as well as improved transparency on research and development costs supported by public contributions, and reimbursement timelines;

Or. en

Amendment 346

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 4

Motion for a resolutionAmendment
– enhance equitable access to orphan medicinal products and advanced therapies through coordinated evidence generation, voluntary joint procurement mechanisms and strengthened cooperation in health technology assessment;– enhance and facilitate equitable access to orphan medicinal products and advanced therapies through coordinated evidence generation, voluntary cooperation mechanisms, including joint procurement where appropriate and decided by Member States and strengthened cooperation in health technology assessment;

Or. en

Amendment 347

Elena Nevado del Campo, Dolors Montserrat, Adam Jarubas, Letizia Moratti

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 5

Motion for a resolutionAmendment
– integrate rare disease registries and data infrastructures within the European Health Data Space in a manner that ensures interoperability, cybersecurity and full compliance with Union data protection legislation;– integrate rare disease registries and data infrastructures within the European Health Data Space in a manner that ensures interoperability, cybersecurity and full compliance with Union data protection legislation, through the use of standardised coding systems such as the ORPHAcodes maintained by Orphanet;

Or. en

Amendment 348

Billy Kelleher, Vlad Vasile-Voiculescu, Stine Bosse

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 5 a (new)

Motion for a resolutionAmendment
– remember that certain Member States share significant cross-border health obligations with non-EU states and this should not, wherever possible, reduce the ability to share data needed to ensure full visibility of rare disease prevalence across the European continent;

Or. en

Amendment 349

Kateřina Konečná

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 5 a (new)

Motion for a resolutionAmendment
– promote the uniform uptake of OrphaCodes;

Or. en

Amendment 350

Kateřina Konečná

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 6

Motion for a resolutionAmendment
– strengthen ERNs as hubs for clinical expertise, data exchange, training and research coordination, ensuring sustainable financing and integration with national systems;– strengthen Orphanet and ERNs to enhance the coordination and sharing of information—including clinical pathways and healthcare practices—while reinforcing ERNs as sustainable, well-integrated hubs for clinical expertise, data exchange, training, and research coordination, bridging primary and specialist care systems– promote cross-border continuity of care and multidisciplinary support services, including psychosocial and socio-economic support for patients and caregivers;

Or. en

Amendment 351

Stine Bosse, Billy Kelleher, Vlad Vasile-Voiculescu

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 6

Motion for a resolutionAmendment
– strengthen ERNs as hubs for clinical expertise, data exchange, training and research coordination, ensuring sustainable financing and integration with national systems;– strengthen ERNs as hubs for training and research, enabling them to systematically collect and generate high-quality real-world evidence through interoperable data collection to support regulatory decision making, HTA processes and equitable access to novel therapies, clinical expertise, data exchange, training and research coordination, ensuring sustainable financing and integration with national systems;

Or. en

Amendment 352

Nicolae Ștefănuță

on behalf of the Verts/ALE Group

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 6

Motion for a resolutionAmendment
– strengthen ERNs as hubs for clinical expertise, data exchange, training and research coordination, ensuring sustainable financing and integration with national systems;– strengthen ERNs as hubs for clinical expertise, data exchange, training and research coordination, ensuring sustainable financing, broader geographical coverage, stronger referral pathways and deeper integration with national systems, with targeted support for underrepresented Member States;

Or. en

Amendment 353

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 6

Motion for a resolutionAmendment
– strengthen ERNs as hubs for clinical expertise, data exchange, training and research coordination, ensuring sustainable financing and integration with national systems;– strengthen ERNs as hubs for clinical expertise, data exchange, training and research coordination, ensuring sustainable financing and integration with national systems, in cooperation with national centres of expertise;

Or. en

Amendment 354

Nicolás González Casares, Vytenis Povilas Andriukaitis, Nikos Papandreou

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 6 a (new)

Motion for a resolutionAmendment
– emphasise the need to embed early identification and referral mechanisms within national healthcare systems, through the co-design of ERN pathways with Member States to standardise early recognition in paediatrics, including red flags, links to newborn screening programmes, and primary care triggers, alongside time-bound referral to accredited centres and ensured continuity across local, regional, and ERN levels, with clearly defined roles and sustainable financing;

Or. en

Amendment 355

Stine Bosse, Billy Kelleher, Vlad Vasile-Voiculescu

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 6 a (new)

Motion for a resolutionAmendment
– provide, under the ERN umbrella and supervised by the Board of Member States, the organisational, legal and technical framework to facilitate the development of transnational ecosystems within a limited number of rare disease centres to generate the necessary patient and clinical data volume facilitating the development of expertise, innovative research and treatment, as well as industry partnerships;

Or. en

Amendment 356

Elena Nevado del Campo, Dolors Montserrat, Michalis Hadjipantela, Adam Jarubas, Letizia Moratti

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 7

Motion for a resolutionAmendment
– promote cross-border continuity of care and multidisciplinary support services, including psychosocial and socio-economic support for patients and caregivers;– promote cross-border continuity of care and multidisciplinary support services, including psychosocial and socio-economic support for patients and caregivers while reducing the administrative burden associated with cross-border healthcare and facilitating reimbursement of costs, in accordance with Directive 2011/24/EU;

Or. en

Amendment 357

Nicolae Ștefănuță

on behalf of the Verts/ALE Group

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 7

Motion for a resolutionAmendment
– promote cross-border continuity of care and multidisciplinary support services, including psychosocial and socio-economic support for patients and caregivers;– promote cross-border continuity of care and multidisciplinary support services, including psychosocial and socio-economic support for patients and caregivers, as well as measures to support inclusive education, employment and transition to adulthood;

Or. en

Amendment 358

Elena Nevado del Campo, Dolors Montserrat, Letizia Moratti

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 8

Motion for a resolutionAmendment
– establish and coordinate the development of a hospital exemption cross-border exchange scheme;deleted

Or. en

Amendment 359

Marie-Luce Brasier-Clain, Margarita de la Pisa Carrión, Laurent Castillo, Aleksandar Nikolic, Valérie Deloge, Ondřej Knotek, Viktória Ferenc

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 8

Motion for a resolutionAmendment
– establish and coordinate the development of a hospital exemption cross-border exchange scheme;– support voluntary cooperation between Member States to facilitate access to hospital exemption therapies in justified cases;

Or. en

Amendment 360

Nicolás González Casares, Vytenis Povilas Andriukaitis

Motion for a resolution

Annex I – Part A – Recommendation 2 – paragraph 2 – indent 8 a (new)

Motion for a resolutionAmendment
– explore the creation of Union-level coordinated national reimbursement frameworks for orphan treatments, particularly orphan medicinal products, to ensure equitable, timely, and consistent access for patients across all Member States and their regions;

Or. en