What changed between the plenary report and the adopted text

Added:(5) The COVID-19 pandemic has spotlightedfurther underlined critical issues, which require a reform of the Union pharmaceuticals framework to strengthen its resilience, while improving the availability of medicinal products and to ensure that it corresponds to public health needs and serves the people under all circumstances. [Am. 7]

Removed:Recital 26 a (new): (26a) Pharmaceutical research plays a decisive role in the continuing improvement in public health and in ensuring the Union’s competitiveness. Medicinal products, in particular those that are the result of long, costly research will not continue to be developed in the Union unless they are covered by favourable rules that provide for sufficient protection to encourage such research. However, it is difficult to establish a direct link between these favourable rules and Union competitiveness. Such rules, while making Union markets more attractive, are agnostic to the medicines’ geographical origin and authorised medicines from third countries are equally eligible to receive Union incentives, just as Union-based innovative companies can equally benefit from incentives in third countries.

Added:(5a) The COVID-19 pandemic also highlighted disparities in terms of the capacity of health systems, national immunisation infrastructure, shortages and preparation. In addition to the measures in this Regulation, Member States should strengthen their national immunisation programmes, ensuring their population is better sufficiently protected against infectious diseases and strengthening pandemic preparedness and response. [Am. 8]

Removed:Recital 29: (29) Legal entities that are not engaged in an economic activity such as universities, public bodies, research centres or not-for-profit organisations, represent an important source of research in unmet medical needs, of research in different subpopulations, repurposing and optimisation and of innovation and should also benefit from this support scheme. Whereas it should be possible to take account of the particular situation of these entities on an individual basis, such support can best be achieved by means of a dedicated support scheme, including administrative support and through the reduction, deferral and waiver of fees.

Added:(6) For the sake of clarity, It is therefore necessary to replace Regulation (EC) No 726/2004 of the European Parliament and of the Council with a new Regulation. [Am. 9]

Removed:Recital 30: (30) The Agency should be empowered to give scientific recommendations on whether a product under development, which could potentially fall under the mandatory scope of the centralised procedure, meets the scientific criteria to be a medicinal product. Such an advisory mechanism would address, as early as possible, questions related to borderline cases with other areas such as in particular substances of human origin, cosmetics or medical devices, which may arise as science develops. To ensure that recommendations given by the Agency take into account the views of equivalent advisory mechanisms in other legal frameworks, the Agency should consult the relevant advisory or regulatory bodies. Where there is a doubt about whether the regulatory status of a particular product under development, which could potentially fall under the mandatory scope of the centralised procedure, meets the scientific criteria to be a medicinal product, the Agency and the relevant advisory bodies responsible for other regulatory frameworks, namely medical devices and substances of human origin should engage in consultations. In such cases, the compendium referred to in Regulation (EU) 2024 /... of the European Parliament and of the Council1a[SoHO Regulation] should be consulted, where relevant. If after consulting the compendium, there remains doubt about the regulatory status the relevant bodies should further consult to determine the regulatory status. The Commission should facilitate the cooperati…

Added:(7) Veterinary medicinal products are governed by Regulation (EU) No 2019/6 of the European Parliament and of the Council. These medicinal products are outside the scope of this Regulation, even if certain provisions regarding the governance and general tasks of the Agency set out in this Regulation apply to these medicinal products. The specific tasks of the Agency in respect to veterinary medicinal products are laid down in Regulation 2019/6 and Regulation 470/2009 of the European Parliament and of the Council.

Removed:Recital 31: (31) To increase transparency of scientific assessments and all other activities, a user-friendly European medicines web-portal should be created and maintained by the Agency. The portal should provide information for all centrally authorised medicinal products, inter alia on safety, efficacy, environmental risk, patient populations, and where relevant information on antimicrobial resistance, shortages, and pending obligations for marketing authorisation holders. Sufficient budgetary resources should be allocated to the Agency to ensure its transparency obligations and commitments are appropriately implemented.

Added:(8) The scope of centrally authorised medicinal products has been adapted to the realities of the market and technological development as well as the need to ensure a centralised assessment for certain categories of medicinal products. In the light of the Commission's report on the experience gained, it has proved necessary to improve the operation of the marketing authorisation procedures for the placing of medicinal products on the Union market and to amend certain administrative aspects of the European Medicines Agency. In addition, the regulatory framework should be adapted to the current market conditions and economic reality, while continuing to safeguard a high level of protection of public health and the environment. The conclusions of that report call for corrections to some of the operating procedures and require adaptations to take account of scientific and technological development. It also emerges from the report that the general principles previously established which govern the centralised marketing authorisation procedure ('centralised procedure’) should be maintained.

Removed:Recital 31 a (new): (31a) The Union Register of medicinal products lists all medicinal products for human and veterinary use as well as orphan medicinal products that have received a marketing authorisation by the Commission through the centralised procedure. The information provided in the Union Register can be used to search for pertinent information on the medicinal product in question, including the active substance, the international non-proprietary name, the anatomical therapeutic chemical (ATC), the indications of the medicinal product, information on the authorisation and any post-authorisation requirements as well as applicable regulatory protection periods.

Added:(9) As to the scope of this Regulation, the authorisation of antimicrobials is, in principle, in the interest of patients' health at Union level and therefore it should be made possible to authorise them at Union level. [Am. 10]

Removed:Recital 33 a (new): (33a) To ensure the adequate expertise and evaluation of the environmental risk assessments of pharmaceutical substances, the Agency should establish a new ad hoc Environmental Risk Assessment working party. That working party should be involved where necessary depending on the application for a marketing authorisation. The working party should have the scientific knowledge necessary to characterise and assess the risks, and the mitigation measures for such risks, related to the manufacture, use and disposal of medicinal products. The working party should contribute towards the implementation of the One Health Approach and closing the gap between pharmaceutical and environmental assessment.

Added:(10) With a view to maintain a high-level of scientific evaluation for new medicinal products and medicinal products that will serve the entire Union population, the centralised procedure should be mandatory for high-technological medicinal products, particularly those resulting from biotechnological processes, priority antimicrobials, orphan medicinal products, paediatric use medicinal products and any medicinal product that includes an active substances not authorised before the last important change to the scope of the centralised procedure in 2004.

Removed:Recital 35: (35) The Agency’s scientific committees should be supported, in relation to their evaluation duties, by working parties which should be open to experts from the scientific world and appointed for this purpose whilst retaining complete responsibility for the scientific opinions issued by them.

Added:(11) As regards medicinal products for human use, optional access to the centralised procedure should also be foreseen in cases where use of a single procedure produces added value for the patient. The centralised procedure should remain optional for medicinal products which, although not belonging to the categories of products to be authorised by the Union, are nevertheless therapeutically innovative. It is also appropriate to allow access to this procedure for medicinal products which, although not innovative, may be of benefit to society or to patients, including paediatric patients, if they are authorised from the outset at Union level, such as certain medicinal products which can be supplied without a medical prescription. This option may be extended to generic and biosimilar medicinal products authorised by the Union, provided that this in no way undermines either the harmonisation achieved when the reference medicinal product was evaluated or the results of that evaluation. At the same time, to ensure wide availability of generic medicinal products, those medicinal products may be authorised in any case by the competent authorities of the Member States, even if they are based on a centrally authorised reference medicinal product.

Removed:Recital 36: (36) The expertise of the Committee for Advanced Therapies (CAT), the Committee for Orphan Medicinal Products (COMP), the Paediatric Committee (PDCO) and Committee for Herbal Medicinal Products (HMPC) is retained through working groups, working parties, ad hoc working groups, and a pool of experts who are organised based on different domains and who are giving input to the CHMP and PRAC. Their evaluation will continue to encompass all the necessary expertise for each product as part of the rapporteur teams, with the possibility for CHMP and PRAC to call upon additional scientific experts to provide specific input and advice on specific aspects raised during the evaluation. In addition, patients and healthcare professionals will be part of the pool of experts and will also be brought into EMA’s work according to their expertise in a certain disease area. The CHMP and PRAC consists of experts from all Member States while working parties and expert groups consist in majority of experts appointed by the Member States, based on their expertise, and of external experts. The model of rapporteurs remains unchanged. Representation of patients, their caregivers and health care professionals, with expertise in all areas, including rare and paediatric diseases, is increased at the CHMP and PRAC, in addition to the dedicated working groups representing patients and health care professionals. Information regarding the composition and work of the committees and working groups should be publ…

Added:(12) The structure and operation of the various bodies making up the Agency should be designed in such a way as to take into account the need to constantly renew scientific expertise, the need for cooperation between Union and national bodies, the need for adequate involvement of civil society, and the future enlargement of the Union. The various bodies of the Agency should establish and develop appropriate contacts with the parties concerned, in particular with representatives of patients, consumers and healthcare professionals. [Am. 11]

Removed:Recital 39: (39) To allow for a more informative decision making and for exchange of information and pooling of knowledge on general issues of scientific or technical nature related to the tasks of the Agency regarding medicinal products for human use, in particular to scientific guidelines on unmet medical needs and the design of clinical trials, or other studies and the generation of evidence along the life cycle of medicinal product, the Agency should be able to have recourse to a consultation process of authorities or bodies active along the life cycle of medicinal products. Additionally, to improve regulatory certainty and cross-sectoral cooperation the Commission should, on an annual basis, or more frequently where deemed necessary, organise joint meetings with the advisory bodies established under other Union legislation to assess emerging trends and questions on the regulatory status of products and find agreement on common regulatory status principles. These authorities could be, as appropriate, representatives from Heads of Medicines Agencies, the Clinical Trial Coordination and Advisory Group, the SoHO Coordination Board, the Coordination Group on Health Technology Assessment, Medical Devices Coordination Group, medical devices national competent authorities, national competent authorities for pricing and reimbursement of medicines, national insurance funds or healthcare payers. The Agency should also be able to extend the consultation mechanism to consumers, patients and thei…

Added:(13) The chief task of the Agency should be to provide Union institutions and Member States with the best possible scientific opinions to enable them to exercise the powers of authorisation and supervision of medicinal products conferred on them by Union legal acts in the field of medicinal products. Marketing authorisation should be granted by the Commission only after a single scientific evaluation procedure addressing the quality, safety and efficacy of high-technology medicinal products has been conducted by the Agency, applying the highest possible standards and the completion of an environmental risk assessment. [Am. 12]

Removed:Recital 43: (43) In the interest of public health, marketing authorisation decisions under the centralised procedure should be taken on the basis of the objective scientific criteria of quality, safety and efficacy of the medicinal product concerned, to the exclusion of economic and other considerations. However, Member States should be able, exceptionally, to prohibit the use in their territory of medicinal products for human use. Member States should provide justification for such prohibition of use to the Commission and the Agency.

Added:(14) To ensure close cooperation between the Agency and scientists operating in Member States, the composition of the Management Board should be such as to guarantee that the competent authorities of the Member States are closely involved in the overall management of the Union system for authorising medicinal products.

Removed:Recital 43 a (new): (43a) The Union is required, pursuant to Article 208 of the Treaty on the Functioning of the European Union (TFEU), to take account of development objectives in policies that are likely to have an impact on low- and middle-income countries. Union pharmaceutical legislation has a role to play in the realisation of global public health objectives by promoting the development of efficacious, safe, accessible, and affordable innovations for antimicrobial resistance, poverty-related, emerging and re-emerging health threats, and neglected diseases, and other conditions of global public health interest. The Commission should continue to encourage research, development and innovation in areas of major global health interest, in line with its international commitments.

Added:(15) The Agency's budget should be transparent and composed of fees and charges paid by the private sector and contributions from the Union budget to implement Union policies and contributions paid from third countries. Although the majority of its funding comes from fees, the Agency is a public authority. It is of utmost importance to safeguard its integrity and independence in order to maintain public trust in the Union regulatory framework. [Am. 13]

Removed:Recital 45 a (new): (45a) The Agency should pay particular attention to the composition of clinical trials to ensure gender based equity and comprehensive clinical data.

Added:(16) Exclusive responsibility for preparing the Agency's opinions on all questions concerning medicinal products for human use should be vested in the Committee for Medicinal Products for Human Use.

Removed:Recital 46: (46) Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes49 lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Any study involving the use of live animals, which provides essential information on the quality, safety and efficacy of a medicinal product, should take into account those principles of replacement, reduction and refinement, where they concern the care and use of live animals for scientific purposes, and should be optimised in order to provide the most satisfactory results whilst using the minimum number of animals. The procedures of such testing should be only used where necessary and be designed to avoid causing pain, suffering, distress or lasting harm to animals and should follow the available Agency and the International Committee for Harmonisation (ICH) guidelines. In particular, the marketing authorisation applicant and the marketing authorisation holder should take into account the principles laid down in Directive 2010/63/EU, giving priority to new approach methodologies (NAMs) in place of animal testing. These can include but are not limited to: in vitro models, such as microphysiological systems including organ-on-chips, (2D and 3D) cell culture models, organoids and human stem cells-based models; in silico tools, in chemico technologies and any combination thereof or read-across, aquatic egg…

Added:(17) The creation of the Agency through Council Regulation (EEC) No 2309/93 which was replaced by Regulation (EC) No 726/2004 has made it possible to reinforce the scientific evaluation and monitoring of medicinal products in the Union, in particular through its scientific bodies and committees for which competent authorities of the Member States provide experts and expertise, ensuring a high quality and independent assessment. This Regulation does not establish a new Agency. The Agency mentioned in this Regulation is the Agency established by Regulation (EC) No 726/2004.

Removed:Recital 47: (47) Procedures should be in place to facilitate joint animal testing, wherever possible, in order to avoid unnecessary testing using live animals covered by Directive 2010/63/EU. Marketing authorisation applicants and marketing authorisation holders should make all efforts to reuse animal study results and make the results obtained from animal studies publicly available. For abridged applications marketing authorisation applicants should refer to the relevant studies conducted for the reference medicinal product.

Added:(18) The field of activity of the scientific committees should be enlarged and their operating methods and composition modernised. In this regard it is important to ensure patient and healthcare professional representation in the Committee for Human Medicinal Products as it is the main evaluation committee of the Agency for medicinal products for human use.

Removed:Recital 51 a (new): (51a) As a matter of good practice, marketing authorisations should be granted based on comparative clinical trials on patients who are representative of the population that is to be treated with the product. In addition, patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) should be an integral part of clinical data submitted with the marketing authorisation application in order to assess the quality of care and the impact of the treatments on patients.

Added:(18a) The Agency should set transparent criteria for the appointment of patients’ and healthcare professionals’ representatives to the Committee for Medicinal Products for Human Use and the Pharmacovigilance Risk Assessment Committee in order to ensure there is a well-balanced representation of medical specialties and diseases amongst appointed members and alternates, and there are robust rules on the prevention of conflicts of interests. Declaration of direct or indirect financial or other interests in the pharmaceutical or other medical industry which could affect the impartiality of appointed stakeholders should be an integral part of the selection process and subsequently should be made publicly available. [Am. 14]

Removed:Recital 53 a (new): (53a) Several care pathways should be explored to make therapies available in all Member States, including by advancing provisions for access to cross border care, such as Directive 2011/24/EU1a and Regulation (EC) No 883/20041b of the European Parliament and of the Council. This is particularly important for the advanced therapy medicinal products, as their unique characteristics result in significant infrastructural complexities and system barriers, which can substantially limit their continuous supply. / 1a Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45). / 1b Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems (OJ L 166 30.4.2004, p. 1).

Added:(19) Scientific advice for future applicants seeking a marketing authorisation should be provided more generally and in greater depth and should be adapted to the specificities of the medicinal product concerned. Similarly, structures allowing the development of advice for companies, in particular small and medium-sized enterprises (‘SMEs’) and not-for-profit entities, should be put in place. The Agency should also promote open and public exchanges about latest scientific developments and updates of scientific guidelines. [Am. 15]

Removed:Recital 54: (54) [revised Directive 2001/83/EC] permits Member States to temporarily allow the use and supply of unauthorised medicinal products for public health reasons or individual patient needs and that includes medicinal products to be authorised under this Regulation. It is also necessary, that Member States are allowed under this Regulation to make a medicinal product available for compassionate use prior to its marketing authorisation. In those exceptional and urgent situations, where there is a lack of a suitable authorised medicinal product, the need to protect public health or the health of individual patients must prevail over other considerations, in particular the need to obtain a marketing authorisation and consequently, to have available complete information about the risks posed by the medicinal product, including any risks to the environment from medicinal products containing or consisting of genetically modified organisms (GMOs). To avoid delays in making these products available or uncertainties as regards their status in certain Member States, it is appropriate, in those exceptional and urgent situations, that for a medicinal product containing or consisting of GMOs, an environmental risk assessment or consent in accordance with Directive 2001/18/EC or Directive 2009/41/EC of the European Parliament and of the Council52 should not be a prerequisite. Nevertheless, in these cases, Member States should implement appropriate measures in line with the precautionary princ…

Added:(20) Promising medicinal products and certain combinations products of medicinal products and medical devices, as well as medicinal products in exclusive use with medical devices that have the potential to significantly address patients’ unmet medical needs should benefit from early and enhanced scientific support, including through supporting patient-relevant in vitro and in silico technologies which are key to the development of those products. Such support will ultimately help patients benefit from new therapies as early as possible. [Am. 16]

Removed:Recital 57 a (new): (57a) Given the underserved needs in the area of mental health, the revision should contribute to increased access to treatments, and the development of novel treatments, for patients who need them most.

Added:(20a) Next to unmet medical needs already recognised in the pediatric, antimicrobial, oncological, rare, and neurodegenerative diseases, attention should also be given to unmet medical needs in the mental health sphere and treatments therein. [Am. 17]

Removed:Recital 57 b (new): (57b) The Commission should support the use of early access pilot programmes to treat patients with complex comorbidities, including physical and mental health conditions who are often excluded from clinical trials. Allowing this would support evidence gathering on the safety and efficacy of these treatments. Such programmes should provide treatment experience for healthcare providers and generate valuable real-world data to inform future authorisations of these treatments.

Added:(21) In order to allow for advice that is more informative and an exchange of information between different bodies, scientific advice provided by the Agency should sometimes take place in parallel to scientific advice provided by other bodies. This should be the case for the joint scientific consultation carried out by the Member State Coordination Group on Health Technology Assessment foreseen in Regulation (EU) 2021/2282 of the European Parliament and of the Council and, in cases of medicinal products involving a medical device, the consultation of the expert panels as described in Article 106 of Regulation (EU) No 2017/745 of the European Parliament and of the Council. Where parallel scientific advice consultation mechanisms are established under other relevant Union legal acts, a similar mechanism should apply.

Removed:Recital 58: (58) There is the possibility under certain duly justified circumstances for marketing authorisations to be granted, subject to specific obligations or conditions, on a conditional basis or under exceptional circumstances. The legislation should allow under similar circumstances for medicinal products with a standard marketing authorisation for new indications to be authorised on a conditional basis or under exceptional circumstances. The medicinal products authorised on a conditional basis or under exceptional circumstances should in principle satisfy the requirements for a standard marketing authorisation with the exception of the specific derogations or conditions outlined in the relevant conditional or exceptional marketing authorisation and shall be subject to specific review of the fulfilment of the imposed specific conditions or obligations. It is also understood that the grounds for refusal of a marketing authorisation shall apply mutatis mutandis for such cases.

Added:(21a) Based on the European Ombudsman’s decision in its strategic inquiry OI/7/2017/KR of 17 July 2019 on how the European Medicines Agency engages with medicine developers in the period leading up to applications for authorisations to market new medicines in the Union, the Agency should enhance the transparency of scientific advice. In addition, staff and experts from national competent authorities providing scientific advice should, to the extent possible, not be involved in a subsequent evaluation of a marketing authorisation application for the same products. However, in duly justified cases, such as where the indication of a medicinal product concerns a rare disease, that expert should be able to carry out a subsequent evaluation of the same product, provided that that is duly documented. [Am. 18]

Removed:Recital 60: (60) Regulatory decision-making on the development, authorisation and supervision of medicinal products may be supported by access and analysis of health data, including real world data, where appropriate, i.e. health data generated outside of clinical studies, and data generated via in silico methods, such as computational modelling and simulation, digital molecular representation and mechanistic modelling, digital twin technology and artificial intelligence (AI). The Agency should be able to use such data, including via the Data Analysis and Real World Interrogation Network (DARWIN) and the European Health Data Space interoperable infrastructure. Through these capabilities the Agency may take advantage of all the potential of supercomputing, artificial intelligence and big data science, including results of studies conducted via in silico methods, to fulfil its mandate, without compromising privacy rights. The Agency should put in place sufficient, effective and specific technical and organisational measures to safeguard the fundamental rights and interests of data subjects in line with Regulations (EU) 2016/6791a and (EU) 2018/17251b of the European Parliament and of the Council. Where necessary the Agency may cooperate with the competent authorities of the Member States towards this objective. / 1a Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and …

Added:(22) It is also necessary to reinforce the role of the scientific committees in such a way as to enable the Agency to participate actively in international scientific dialogue and to develop certain activities that will be necessary, in particular regarding international scientific harmonisation and technical cooperation with the World Health Organization.

Removed:Recital 65: (65) In the preparation of scientific advice and in duly justified cases, the Agency should consult authorities established in other relevant Union legal acts or other public bodies established in the Union, as applicable. These may include experts in clinical trials, medical devices, substances of human origin or any other as required for the provision of the scientific advice in question. In addition to providing scientific advice, the Agency should ensure that scientific guidelines are updated and promote an open and public discussion on latest scientific developments.

Added:(23) Furthermore, without prejudice to the provisions laid down in Regulation (EU) 2019/6, which remain applicable for veterinary medicinal products, in order to create greater legal certainty, it is necessary to define the responsibilities regarding the transparency rules for the Agency's work, to set certain conditions for the marketing of medicinal products authorised by the Union, to confer on the Agency powers to monitor the distribution of medicinal products authorised by the Union, to carry out inspections together with the Member States in third countries, and to specify the sanctions and the procedures for implementing them in the event of failure to observe the provisions of this Regulation and the conditions contained in the marketing authorisations granted under the procedures it establishes.

Removed:Recital 67: (67) The Agency, in consultation with the Member States and the Commission, should set the scientific selection criteria for medicinal products that receive pre-authorisation support with priority to be given to public health needs and the most promising developments in therapies. In the case of medicinal products for unmet medical needs, based on the scientific selection criteria set by the Agency, any interested developer can submit preliminary evidence to demonstrate that the medicinal product has the potential to provide a major therapeutic advancement with respect to the identified unmet medical need.

Added:(24) In particular, the Agency should be empowered and given the capacity to carry out inspections, where this is in the interest of the Union and where the competent authorities of the Member States request support in carrying out their tasks under revised Directive 2001/83/EC of the European Parliament and of the Council. The interest of the Union may concern situations where, to ensure faster access to medicinal products, challenges with inspections capacities at national level have to be addressed in a timely manner or where a response to a public health emergency or a major event requires immediate action. Providing the Agency with appropriate inspection capacity will also, in the interest of the Union, facilitate the dissemination of best practices, know-how, and improve the oversight of manufacturing of medicinal products worldwide. Following the request from a competent authority of the Member State, the Agency, at its own discretion, can accept to either provide support to the inspections of sites located in the Union or to carry out inspections of sites located in third countries.

Removed:Recital 68 a (new): (68a) There is still a lack of sufficiently detailed and comparable data at Union level to determine the trends and identify possible risk factors that could lead to the development of further measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced. Therefore it is important to collect data on the sales and use of antimicrobials, and data on antimicrobial resistant organisms found in animals, humans and food. To ensure that the information collected can be used effectively, appropriate rules should be laid down concerning the collection and the exchange of data. The Member States should be responsible for collecting data on the use of antimicrobials under the coordination of the Agency.

Added:(25) In certain cases, shortcomings in Member States’ system of supervision and related enforcement activities could risk to substantially hinder the achievement of the objectives of this Regulation and those of revised Directive 2001/83/EC which could even lead to the emergence of risks to public health or to the environment. To address these challenges, harmonised inspection standards should be ensured through the establishment of a joint audit programme within the Agency. This joint audit programme will also further harmonise the interpretation of good manufacturing and distribution practices on the basis of Union legislative requirements. Moreover, it will support further mutual recognition of inspection outcomes between Member States and with strategic partners. Within the joint audit programme, the competent authorities are subject to regular audits conducted by other Member States to maintain an equivalent and harmonised quality system and to ensure an appropriate implementation of relevant good manufacturing and distribution practices into national laws and equivalence with other EEA inspectorates. [Am. 19]

Removed:Recital 76: (76) It is considered appropriate to also have the possibility for the Commission to grant temporary emergency marketing authorisations, to address public health emergencies. Temporary emergency marketing authorisations may be granted provided that, having regard to the circumstances of the public health emergency, the benefit of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent to the fact that additional comprehensive quality, non-clinical, clinical data may still be required. A temporary emergency marketing authorisation should be valid only during the public health emergency. The Commission should be given the possibility to vary, suspend or revoke such marketing authorisations in order to protect public health or when the marketing authorisation holder has not complied with the conditions and obligations set out in the temporary emergency marketing authorisation or when a standard or conditional marketing authorisation has been granted for the relevant indication.

Added:(26) An inspection working group, which provides input and recommendations on all matters relating, directly or indirectly, to good manufacturing practice and good distribution practice irrespective of the marketing authorisation procedure through different reporting lines, should be established within the Agency. In particular, that working group should be responsible for the establishment, development and overall supervision of the joint audit programme.

Removed:Recital 76 a (new): (76a) It is appropriate to have in place transparency measures and standards regarding the Agency’s regulatory activities in relation to medicinal products, in particular those that receive a temporary emergency marketing authorisation. Those measures should include the timely publication of all relevant information on approved medicinal products and medical devices and of clinical data, including clinical trial protocols. The public information regarding clinical trials and marketing authorisation decisions should be in accordance with Regulation (EU) 2022/123 of the European Parliament and of the Council1a. / 1a Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1).

Added:(26a) Pharmaceutical research plays a decisive role in the continuing improvement in public health and in ensuring the Union’s competitiveness. Medicinal products, in particular those that are the result of long, costly research will not continue to be developed in the Union unless they are covered by favourable rules that provide for sufficient protection to encourage such research. However, it is difficult to establish a direct link between these favourable rules and Union competitiveness. Such rules, while making Union markets more attractive, are agnostic to the medicines’ geographical origin and authorised medicines from third countries are equally eligible to receive Union incentives, just as Union-based innovative companies can equally benefit from incentives in third countries. [Am. 20]

Removed:Recital 77: (77) The development of antimicrobial resistance is a growing concern and the pipeline of effective antimicrobials is obstructed due to a market failure whereby antimicrobial research and development (R&;amp;D) is hampered by the low commercial value of the antimicrobial medicinal product market. It is therefore necessary to maintain the efficacy of existing antimicrobials for as long as possible and to consider a number of new measures to promote the development of priority antimicrobials that are effective against antimicrobial resistance and to support undertakings, often SMEs, and not-for-profit entities which choose to invest in this area. It is equally necessary to support research and development of novel antimicrobials through the different phases of antimicrobial development, in particular through market entry rewards and milestone reward payments. Additionally, the establishment of subscription models which delink the volume of antimicrobial sales from the reward received, in particular through voluntary joint procurement, can help overcome such market failures. Such measures should facilitate the development of alternative treatments, such as bacteriophages, which are effective against multi-drug resistant bacteria and can be used as an alternative treatment or together with antibiotics. However, addressing anti-microbial resistance will not be possible by relying on R&D alone. To ensure prudent use of existing antibiotics, the Authority should also support the dev…

Added:(27) To promote innovation and the development of new medicinal products by SMEs within the meaning of Commission Recommendation 2003/361/EC, and to reduce the cost of the placing on the market of medicinal products for human use authorised via the centralised procedure, these undertakings should benefit from a support scheme from the Agency.

Removed:Recital 77 a (new): (77a) Reluctance to invest in the development of antimicrobials exists in part because the development of antimicrobials is costly and many developers, often SMEs, cannot afford to proceed to the next stage of development. Additionally, when an antimicrobial is developed, the market is naturally limited by virtue of the need to use antimicrobials prudently. Therefore, it is necessary to consider further Union level action to support the development of antimicrobials and address existing market failures. Accordingly, a milestone payment reward scheme, complemented by a subscription model voluntary joint procurement scheme, should be developed to ensure that a market exists for developers that delink volumes sold from payment received.

Added:(28) The support scheme should be composed of regulatory, procedural and administrative support, and of a reduction, deferral or waiver of fees. The scheme should cover the various steps involved in pre-authorisation procedures, such as scientific advice, the submission of the marketing authorisation application, and post-authorisation procedures.

Removed:Recital 77 b (new): (77b) Milestone payments are an early-stage financial reward granted upon achieving certain R&D objectives prior to market approval, for example successful completion of phase I. While such mechanisms would serve primarily to provide access to existing antimicrobials, they could also support new antimicrobials in the development phase. A subscription model consists of a series of financial payments to an antibiotic developer for successfully obtaining regulatory approval for an antibiotic that meets specific pre-defined criteria. A subscription model scheme through voluntary joint procurement agreements should alleviate concerns for developers by ensuring there is a market for the antimicrobial when developed.

Added:(29) Legal entities that are not engaged in an economic activity such as universities, public bodies, research centres or not-for-profit organisations, represent an important source of research in unmet medical needs, of research in different subpopulations, repurposing and optimisation and of innovation and should also benefit from this support scheme. Whereas it should be possible to take account of the particular situation of these entities on an individual basis, such support can best be achieved by means of a dedicated support scheme, including administrative support and through the reduction, deferral and waiver of fees. [Am. 21]

Removed:Recital 78 a (new): (78a) To effectively address major ongoing and upcoming public health challenges, in particular antimicrobial resistance, while also building on existing resources, the Health Emergency Preparedness and Response Authority (‘HERA’ or the ‘Authority’) should be established as a separate structure under the legal personality of the European Centre for Disease Prevention and Control (ECDC), which was established by Regulation (EC) No 851/2004 of the European Parliament and of the Council1a. The Authority should be responsible for creating, coordinating and implementing the long-term European portfolio of biomedical research and development agenda for medical countermeasures against current and emerging public health threats, as well as providing tools to ensure Union-wide access to those products, including tools to support the production, procurement, stockpiling and distribution capacity for medical countermeasures and other priority medical products in the Union. The Authority will play a crucial role in addressing health threats globally. The Authority should primarily focus on the fight against the most urgent health threats, including antimicrobial resistance and shortages of medicinal products. However, in the future as its capacity increases, the Authority should expand the scope of its mission, specifically to tackle other areas of unmet medical need such as rare and neglected diseases. The Authority should have adequate resources to fulfil its mandate. / 1a Regulation (…