What changed between the plenary report and the adopted text

Added:(32) Procedures should be in place to facilitate joint animal testing, wherever possible, in order to avoid unnecessary duplication of 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. [Am. 24]

Removed:Recital 67: (67) The provision of information to healthcare professionals and to patients on the appropriate use, storage and disposal of antimicrobials is a joint responsibility of marketing authorisation holders and of Member States. Member States should ensure appropriate collection and disposal system for all medicinal products.

Added:(33) With respect to clinical trials, in particular those conducted outside the Union, on medicinal products destined to be authorised within the Union, it should be verified, at the time of the evaluation of the marketing authorisation application, that these trials were conducted in accordance with the principles of good clinical practice and the ethical requirements equivalent to the provisions of Regulation (EU) 536/2014 of the European Parliament and of the Council.

Removed:Recital 67 a (new): (67a) Pharmacists and other health care professionals should play a role in antimicrobial stewardship, including advising on the prudent use of antibiotics and other antimicrobials, as well as their correct disposal.

Added:(34) There is the possibility under certain 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 therapeutic indications to be authorised on a conditional basis or under exceptional circumstances. The 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. The grounds for refusal of a marketing authorisation should apply mutatis mutandis for such cases.

Removed:Recital 68: (68) While this Directive restricts the use of antimicrobials by setting antibiotics and antimicrobials wich have an identified risk of resistance under prescription status, due to the growing antimicrobial resistance in the Union, competent authorities of the Member States should consider further a number of measures, including expanding the prescription status of antimicrobials, restricting the use of certain antimicrobials to the use in hospitals, mandatory training of healthcare professionals on the environmental impact of medicines use and stewardship regarding the use of antimicrobials, or the mandatory use of diagnostic tests before prescription. Member States should also ensure that measures are in place to safeguard the prescription for antibiotic products from influence by any form of economic incentive provided directly or indirectly to persons who prescribe medicinal products, given the risks associated with antimicrobial resistanceand for avoiding risks to the environment, in line with the European Union Strategic Approach to Pharmaceuticals in the Environment. Additionally, the combined use of several antimicrobial active substances may represent a particular risk with respect to the development of antimicrobial resistance. Such combined use should therefore only be prescribed in exceptional cases where the benefit-risk balance of the combination is favorable. Competent authorities of the Member States should promote the availability of rapid diagnostic tests in…

Added:(34a) Where the environmental risk assessment is incomplete or insufficiently substantiated for a medicinal product authorised before 30 October 2005, it should be possible for the national marketing authorisation to be revoked. However, due consideration to avoid restricting patient access to such medicinal products should be given before any decision is taken on revocation. [Am. 25]

Removed:Recital 69: (69) The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem, and there is scientific evidence that the presence of those substances in the environment from their manufacturing, use and disposal poses a risk to the environment and public health. The evaluation of the legislation showed that strengthening of existing measures to reduce the impact of medicinal products' lifecycle on the environment and public health is required. Measures under this Directive complement the main environmental legislation, in particular the Water Framework Directive (2000/60/EC50), the Environmental Quality Standard Directive (2008/105/EC51) the Groundwater Directive (2006/118/EC52), the Urban Wastewater Treatment Directive (91/271/EEC53), the Drinking Water Directive (2020/218454), the Industrial Emissions Directive (2010/75/EU55) and the Waste Framework Directive (2008/98/EC55a). / 55a Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).

Added:(35) With the exception of those medicinal products that are subject to the centralised authorisation procedure established by [revised Regulation (EU) No. 726/2004], a marketing authorisation for a medicinal product should be granted by a competent authority in one Member State. In order to avoid unnecessary administrative and financial burdens for applicants and competent authorities, a full in-depth assessment of an application for the authorisation of a medicinal product should be carried out only once. It is appropriate therefore to lay down special procedures for the mutual recognition of national authorisations. Moreover, it should be possible to submit the same application in parallel in several Member States for the purpose of a common assessment under the lead of one of the Member States concerned.

Removed:Recital 69 a (new): (69a) Emissions of active substances during manufacturing can be a threat to the environment and public health. Therefore, environmental risks should be assessed and addressed through the entire lifecycle of medicinal products, starting from manufacturing, through use and to disposal.

Added:(36) Moreover, rules should be established under those procedures to resolve any disagreements between competent authorities in a coordination group for mutual recognition and decentralised procedures medicinal products (‘the coordination group’) without undue delay. In the event of a disagreement between Member States about the quality, the safety or the efficacy of a medicinal product, a scientific evaluation of the matter should be undertaken according to a Union standard, leading to a single decision on the area of disagreement binding on the Member States concerned. Whereas this decision should be adopted by a rapid procedure ensuring close cooperation between the Commission and the Member States.

Removed:Recital 69 b (new): (69b) Unitary packaging of medicinal products, in particular in hospital pharmacies, where this packaged and distributed in bulk could result in a decrease of packaging materials used and thereby contribute to environmental footprint of medicinal products, including its waste. It can also contribute to mitigating medicine shortages and antimicrobial resistance. The use of single dose unit containing all relevant information, in hospital environment, could furthermore represent an improvement in the risk of medication errors and therefore increase patient protection. Member States should promote the use of unit dose pre-cut blisters in hospital environment and, progressively, in dispensing pharmacies, when necessary.

Added:(37) In certain cases of major disagreement that cannot be solved, the case should be escalated and be subject to a scientific opinion of the Agency, which is then implemented through a Commission Decision.

Removed:Recital 69 c (new): (69c) The use of pharmaceuticals in human and veterinary medicinal products, including antimicrobials, has increased their concentrations in many environmental reservoirs such as soils, sediments and waterbodies in the past 20 years, and the environmental concentration is likely to increase further as the population grows and ages. The discharge of pharmaceuticals into the environment can not only harm ecosystems and wildlife, but can also undermine the effectiveness of those same pharmaceuticals. The chemical and metabolic stability of certain pharmaceuticals means that up to 90 % of their active substances are released into the environment in their original form after use.

Added:(38) In order to better protect public health and avoid any unnecessary duplication of effort during the examination of application for a marketing authorisation for medicinal products, Member States should systematically prepare assessment reports in respect of each medicinal product that is authorised by them, and exchange the reports upon request. Furthermore, a Member State should be able to suspend the examination of an application for authorisation to place a medicinal product on the market that is currently under active consideration in another Member State with a view to recognising the decision reached by the latter Member State.

Removed:Recital 70 a (new): (70a) In exceptional cases where the ERA is incomplete due to missing data and this can be duly justified and substantiated by the marketing authorisation holder, it should still be possible, for reasons in the interest of public health, for the medicinal product to be placed on the market with certain post-authorisation conditions and obligations. Where a medicinal product has been authorised and the ERA is incomplete due to missing data, the marketing authorisation holder should submit the completed ERA in the timeline agreed with the authorities and deliver upon any other post-authorisation obligations.

Added:(39) In the interest of as broad as possible access to medicinal products, a Member State that has an interest in receiving access to a particular medicinal product undergoing authorisation through the decentralised and mutual recognition procedures should be able to opt-into that procedure.

Removed:Recital 71: (71) Marketing authorisation applicants should take into account environmental risk assessment procedures of other EU legal frameworks that may apply to chemicals dependent on their use. Further to this Regulation, there are four main other frameworks: (i) Industrial chemicals (REACH, (Regulation (EC) No 1907/2006); (ii) Biocides (Regulation (EC) No 528/2012); (iii) Pesticides (Regulation (EC) No 1107/2009); and (iv) Veterinary medicines (Regulation (EU) 2019/6)). As a part of the Green Deal, the Commission has proposed a ‘one-substance one-assessment’ (OS-OA) approach for chemicals56 , in order to increase the efficiency of the registration system, reduce costs and unnecessary animal testing. The ERA covers the risks associated with production. Compliance with relevant Union and Member State legislation in terms of environmental protection at the stage of manufacturing should generally be considered as a relevant risk mitigation measure in terms of production. This should also apply for production in third countries with a level of environmental protection equivalent to that of the Union. More environmentally friendly pharmaceuticals would contribute positively to human health.

Added:(40) In order to increase availability of medicinal products, in particular on smaller markets, it should, in cases where an applicant does not apply for an authorisation for a medicinal product in the context of the mutual-recognition procedure in a given Member State, be possible for that Member State, for justified public health reasons, to authorise the placing on the market of the medicinal product.

Removed:Recital 72: (72) The emissions and discharges of antimicrobials to the environment from manufacturing sites may lead to antimicrobial resistance (“AMR”), which is a global concern regardless where the emissions and discharges take place. Therefore, the ERA scope should be extended to cover the risk of AMR selection during the entire life cycle of antimicrobials, including manufacturing. At the date of adoption of this Directive, for the purpose of the ERA, there is not a scientifically agreed method to measure antimicrobial resistance other than for antibiotic resistance. The Commission should therefore issue, after consulting the European Medicines Agency (EMA), the European Centre for Disease Prevention and Control (ECDC) and the European Environment Agency (EEA), guidelines on how to conduct ERAs for AMR selection for microbials other than bacteria.

Added:(41) In the case of generic medicinal products of which the reference medicinal product has been granted a marketing authorisation under the centralised procedure, applicants seeking marketing authorisation should be able to choose either of the two procedures, on certain conditions. Similarly, the mutual-recognition or decentralised procedure should remain available as an option for certain medicinal products, even if they represent a therapeutic innovation or are of benefit to society or to patients. Since generic medicines account for a major part of the market in medicinal products, their access to the Union market should be facilitated in the light of the experience acquired, therefore, the procedures to include other Member States concerned to such procedure should be further simplified.

Removed:Recital 74 a (new): (74a) According to the Aarhus Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters1a, the public has a right to obtain information on environmental matters, including on the ERA of a pharmaceutical product. / 1a OJ L 124, 17.5.2005, p. 4.

Added:(42) The simplification of procedures should not have an impact on standards or the quality of scientific evaluation of medicinal products to guarantee the quality, safety and efficacy and therefore, the scientific evaluation period should remain. However, the reduction of overall period for marketing authorisation procedure from 210 days to 180 days is foreseen.

Removed:Recital 93: (93) To optimise the use of resources for both applicants for marketing authorisation and competent authorities and avoid duplication of assessment of chemical active substances of medicinal products which includes cell and gene therapies, marketing authorisation applicants should be able to rely on an active substance master file certificate or a monograph of the European Pharmacopeia, instead of submitting the relevant data as required in accordance with Annex II. An active substance master file certificate may be granted by the Agency when the relevant data on the active substance concerned is not already covered by a monograph of the European Pharmacopeia or by another active substance master file certificate. The Commission should be empowered to establish the procedure for the single assessment of an active substance master file. To further optimise the use of resources, the Commission should be empowered to allow use of a certification scheme also for additional master files, including quality master files, i.e. for active substances other than chemical active substances, or for other substances present or used in the manufacture of a medicinal product, required in accordance with Annex II, e.g. in case of novel excipients, adjuvants, raw materials, viral vectors and other starting materials, growth media, radiopharmaceutical precursors and active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biolo…

Added:(43) Member States should ensure adequate funding of competent authorities to carry out their tasks under this Directive and [revised Regulation (EU) 726/2004]. In addition, Member States should ensure adequate resources are assigned by the competent authorities for the purpose of their contributions to the work of the Agency, taking into account the cost-based remuneration they receive from the Agency.

Removed:Recital 101: (101) The increasing use of electronic networks for communication of information on adverse reactions to medicinal products marketed in the Union is intended to allow competent authorities to share the information at the same time. In that regard, Member States should seek to inform directly those stakeholders who report adverse reactions in case there exists any update on the safety profile of the medicinal products.

Added:(44) As regards access to medicinal products, previous amendments to the Union pharmaceutical legislation have addressed this issue by providing for accelerated assessment of marketing authorisation applications or by allowing conditional marketing authorisation for medicinal products for unmet medical need. While these measures accelerated the authorisation of innovative and promising therapies in some areas, some public health priorities are still unaddressed and these medicinal products do not always reach the patient and patients in the Union still have different levels of access to medicinal products. Patient access to medicinal products depends on many factors. Marketing authorisation holders are not obliged to market a medicinal product in all Member States; they may decide not to market their medicinal products in, or withdraw them from, one or more Member States often due to commercial reasons. National pricing and reimbursement policies, the size of the population, the organisation of health systems and national administrative procedures are other factors influencing market launch and patient access. In addition, a complex regulatory environment and associated administrative burden can prevent SMEs, research institutes and academic institutions from developing promising innovative treatments and from applying for conditional market authorisation. [Am. 26]

Removed:Recital 109: (109) There may be cases where manufacturing or testing steps of medicinal products need to take place in sites close to patients, for example advanced therapy medicinal products with short shelf-life. In such cases, these manufacturing or testing steps may need to be decentralised to multiple sites to reach patients across the Union. When the manufacturing or testing steps are decentralised, they should be carried out under the responsibility of the qualified person of an authorised central site. Additionally, in order to ensure the smooth functioning of decentralised sites under this framework with the activities relevant for other Union legal frameworks, competent authorities of Member States supervising the decentralised site should coordinate their acitivities and supervisory tasks with the relevant authorities responsible for the supervision of the manufacturing or testing activities under other Union acts. The decentralised sites should not require a separate manufacturing authorisation from the one granted to the relevant central site but should be registered by the competent authority of the Member State in which the decentralised site is established. In the case of medicinal products containing, consisting or derived from autologous SoHO, the decentralised sites have to be registered as a SoHO entity as defined in and pursuant to [SoHO Regulation] for the activities of donor review and eligibility assessment, donor testing and collection, or just for collection in t…

Added:(44a) In order to increase the availability of medicines and contribute to reducing access inequalities within the Union, the marketing authorisation holders of medicinal products should submit an application for pricing and reimbursement in Member States upon request. [Am. 27]

Removed:Recital 123 a (new): (123a) Pharmacists and other health care professionals have an important role in primary care, particularly to compound, dispense and sell medicinal products that patients need, to provide advice on their proper use and possible adverse effects and to support patients suffering of acute and chronic illnesses. In a hospital environment, hospital pharmacists set up pharmaceutical consultations and designate personalised pharmaceutical plans, in cooperation with other health professionals, patients and carers. Hospital pharmacists and community pharmacists could play a significant role in the use of electronic package leaflets, as well as for understanding the information contained in paper leaflets.

Added:(45) Addressing unequal patient access and affordability of medicinal products has become a key priority of the Pharmaceutical Strategy for Europe, as also highlighted by Council conclusions and a resolution of the European Parliament. Member States called for revised mechanisms and incentives for development of medicinal products tailored to the level of unmet medical need, while ensuring health system sustainability, patient access and availability of affordable medicinal products in all Member States. Monitoring and evaluating access to medicinal products at Union level is important to understand the results achieved through incentives. [Am. 28]

Removed:Recital 124: (124) Rules should be laid down as to how the labelling and package leaflets are to be presented. The package leaflet should be easily legible, clearly comprehensible by users, including especially the target patient groups, and indelible. Patient leaflets are in the category of consultative reading which means that relevant information should be found without reading the whole leaflet. For readability and legibility, the package leaflet can benefit from a typographic hierarchy and a legible typeface. Design choices should primarily serve function and readability, rather than aesthetics.

Added:(46) Access also comprise affordability. In this regard, the Union pharmaceutical legislation respects the competence of the Member States in terms of pricing and reimbursement. In a complementary manner, it aims to have a positive impact on affordability and sustainability of health systems with measures that support competition from generic and biosimilar medicinal products. The competition from generic and biosimilar medicinal products should also, in turn, increase patient access to medicinal products.

Removed:Recital 125: (125) Sharing accurate information with the general public in order to promote trust in science and the regulatory system and supporting health literacy of patients and consumers is crucial. Where relevant, competent authorities should also share up to date information with healthcare professionals, including pharmacists, and the scientific community. The provisions governing the information supplied to users should provide a high degree of consumer protection, in order that medicinal products may be used correctly on the basis of full and comprehensible information.

Added:(46a) Member States apply diverse procedures and measures in the pricing and reimbursement of medicinal products. Those procedures and measures significantly affect access to medicinal products, especially with regard to the speed at which access is achieved. Likewise, Member States apply specific procedures and measures pertaining to the promotion of competition from generic and biosimilar medicinal products. Having regard to Member State competences, and recognising the disparities which can be observed in access to medicinal products across the Union, the exchange of best practice among national competent authorities in that area should be given greater priority. In that regard, the Commission should play a distinct role in facilitating the exchange of best practices. [Am. 29]

Removed:Recital 127: (127) The use of electronic and technological possibilities other than paper package leaflets, which is complementary to the paper leaflets which are crucial for patients with limited digital health literacy, can facilitate access to medicinal products, medicinal products distribution and should always guarantee equal or better quality of information to all patients compared to the paper form of product information. Ensuring the protection of personal data in accordance with Regulation (EU) 2016/679 and prevention of the identification, profiling or tracking of individuals is necessary in that regard.

Added:(47) To ensure dialogue among all actors in the medicines lifecycle, discussions on policy issues related to the application of the rules related to prolongation of regulatory data protection for market launch shall take place in the Pharmaceutical Committee. The Commission may invite bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 or national bodies responsible for pricing and reimbursement, as required, to participate in the deliberations of the Pharmaceutical Committee. [Am. 30]

Removed:Recital 128: (128) Member States have varying levels of digital literacy and internet access. In addition, patient and healthcare professional needs may differ. It is therefore necessary that Member States have a discretion on the adoption of measures enabling the electronic provision of product information while ensuring that no patient is left behind, taking into account the needs of different age categories and the different levels of digital literacy in the population, and making sure that product information is easily accessible to all patients. A package leaflet should be made available electronically and be included in paper format, except where the Member State, following a consultation, decides to make only the electronic product information available. Electronic product information should be available in full compliance with the rules on protection of personal data, and adhere to harmonised standards developed at EU level. The information in digital format should be easily accessible to all patients. Based on the findings from hospital pilots, the obligation to provide a paper leaflet should not be applied for medicinal products which are not intended for self-administration by the patient.

Added:(48) While pricing and reimbursement decisions are a Member State competence, the Pharmaceutical Strategy for Europe announced actions to support cooperation of Member States to improve affordability. While the price paid within a given Member State reflects the preference of a national health system, more coordination on pricing and procurement could contribute to more equal and timely access to medicinal products, including for Member States with lower purchasing power. The Commission can support initiatives such as the Beneluxa Initiative on Pharmaceutical Policy and the Valletta Declaration. The Commission has transformed the group of National Competent Authorities on Pricing and Reimbursement and public healthcare payers (NCAPR) from an ad-hoc forum to a continuous voluntary cooperation with the aim to exchange information and best practices on pricing, payment and procurement policies to improve the affordability and cost-effectiveness of medicines and health system’s sustainability. The Commission is committed to stepping up this cooperation and further supporting information exchange among national authorities, including on public procurement of medicines, while fully respecting the competences of Member States in this area. The Commission should issue guidance on how to best implement ‘most economically advantageous tender’ (‘MEAT’ criteria) in public procurement, which aims to ensure the best value for money rather than looking at the lowest price criteria alone. The Commission may also invite NCAPR members to participate in deliberations of the Pharmaceutical Committee on topics that may have an impact on pricing or reimbursement policies, such as the market launch incentive. Joint procurement should aim not to have detrimental impact on access to medicinal products for countries that do not take part in the tender process concerned. [Am. 31]

Removed:Recital 129: (129) Member States should make the package leaflet available electronically and in paper format, except where the Member State decides to make only the electronic product information available. Where the package leaflet is only available electronically, Member States should also ensure that a paper version of the package leaflet is to be made available on demand and without additonal cost to patients. They should also ensure that the information in digital format is easily accessible to all patients, for instance by including in the outer packaging of the product a digitally readable barcode, which would direct the patient to the electronic version of the package leaflet.

Added:(49) Joint procurement, whether within a country or across countries, can improve access, affordability, and security of supply of medicines, in particular for smaller countries. Member States interested in joint procurement of medicines can make use of Directive 2014/24/EU, which sets out purchasing procedures for public buyers, the Joint Procurement Agreement and the proposed revised Financial Regulation. Upon request from the Member States the Commission may support interested Member States by facilitating coordination to enable access to medicines for patients in the Union as well as information exchange, in particular for medicines for rare and chronic diseases. In the event of joint procurement of medicinal products as a medical countermeasure in cases of serious cross-border threats to health, Regulation (EU) 2022/2371 of the European Parliament and of the Council applies. [Am. 32]

Removed:Recital 130: (130) The use of multi-language packages can be a tool for access to medicinal products, in particular for small markets and in public health emergencies. Where multi-language packages are used, Member States may allow the use on the labelling and package leaflet of an official language of the Union that is commonly understood in the Member States where the multi-language package is marketed. While electronic medicinal product information can facilitate the redistribution of packages between Member States, language requirements on labels can remain a challenge. The granting of an exemption to the requirement for an official language, as well as the obligation to use the international non-proprietary name for medicinal products not intended for self-administration by the patient, in addition to providing electronic product information, could improve the availability of medicinal products and enable easier redistribution between Member States.

Added:(50) The establishment of a criteria-based definition of ‘unmet medical need’ is required to incentivise the development of medicinal products in therapeutic areas that are currently underserved. To ensure that the concept of unmet medical need reflects scientific and technological developments and current knowledge in underserved diseases, and prevents extensions of data protection that would not be in line with this objective due to unclear interpretation of ‘unmet medical need’, the Commission should specify and update using implementing acts, the criteria of satisfactory method of diagnosis, prevention or treatment, ‘remaining high morbidity or mortality’, ‘relevant patient population’ following scientific assessment by the Agency. The Agency will seek input from a broad range of authorities or bodies active along the lifecycle of medicinal products in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004] and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs, burden of disease and priority setting for research and development. The Agency should also seek input from other relevant stakeholders, including relevant patient populations. The criteria for ‘unmet medical need’ can be subsequently used by Member States to identify specific therapeutic areas of interest, but does not need to have any automatic effect on Member States’ decisions on pricing and reimbursement of medicinal products which should take into account factors, in particular the Health Technology Assessment, other than the definition established under this Directive. [Am. 33]

Removed:Recital 131: (131) To ensure a high level of transparency of public support to the research and development of medicinal products, the reporting of public contribution for the development of a particular medicinal product should be a requirement for all medicines. Given however the practical difficulty to identify in third countries how indirect public funding instruments, such as tax advantages, have supported a particular product, the reporting obligation on financial support from entities outside of the Union should only concern the direct public financial support, such as direct grants or contracts. Therefore, the provisions of this Directive ensure, without prejudice to the rules on the protection of confidential and personal data, transparency regarding financial support received from any public authority or public body or philanthropic or non-for profit organisation or fund to carry out any activities for the research and development of medicinal products.

Added:(50a) The concept of morbidity in the definition of ‘unmet medical need’ should encompass a multiplicity of factors. Morbidity should be understood to include aspects of quality of life of patients, a high burden of disease and treatment and the inability to perform daily life activities. The assessment of ‘unmet medical need’ should therefore take into account relevant patient experience data. [Am. 34]

Removed:Recital 135 a (new): (135a) Clear, impartial and independent information from healthcare professional to the public about a medicinal product and its correct use can play an important role in informing citizens and combatting misinformation, in particular during health emergencies such as the COVID-19 pandemic. Member States should ensure that the ability of healthcare professionals to share clear, impartial and independent information, whether in a direct conversation with a patient or in broader communication, should not be hindered.

Added:(51) The inclusion of new therapeutic indications to an authorised medicinal products contributes to the access of patients to additional therapies and therefore should be incentivised.

Removed:Recital 136: (136) Advertising of medicinal products should aim at disseminating objective and unbiased information about the medicinal product. For that purpose, it is expressly forbidden highlight negatively another medicinal product or to suggest that advertised medicinal product might be safer or more effective than another medicinal product. Comparison of medicinal products should only be allowed if such information is listed in the summary of product characteristics for the relevant indications and patient population of the medicinal product being advertised. This prohibition covers any medicinal product, also biosimilars, and therefore it would be misleading to refer in the advertising, that a biosimilar medicinal product would not be interchangeable with the original biological medicinal product or another biosimilar from the same original biological medicinal product. Additional strict rules about negative and comparative advertising of competitor medicinal products will prohibit claims that can mislead persons qualified to prescribe, administer or supply them.

Added:(51a) Repurposing of off-patent medicinal products to develop new therapeutic options should be supported as it can expand access in an affordable manner, providing significant benefits to patients. [Am. 35]

Removed:Recital 138 a (new): (138a) Because of the global reach of social media, patients and consumers are increasingly exposed to the promotional practices of using celebrities to advertise medicinal products. The Commission should assess the exposure and impact of pharmaceutical advertising and promotions online, and adopt specific rules to regulate such advertising and promotional practices.

Added:(52) For the initial marketing authorisation application for medicinal products containing a new active substance, the submission of clinical trials that include as a comparator an evidence-based existing treatment should be incentivised, in order to foster the generation of comparative clinical evidence that is relevant and can accordingly support subsequent health technology assessments and decisions on pricing and reimbursement by Member States. National competent authorities and the Agency should promote, where possible, the use of comparative studies that compare the new active substance to the existing treatment when giving regulatory advice prior to granting a marketing authorisation for medicinal products. [Am. 36]

Removed:Recital 139 a (new): (139a) Even minimal inducement can result in biased decisions with regard to prescription behaviour by physicians. Therefore, to avoid conflict of interest, Member States should maintain a transparency register of transfer of value regarding advertising activities which target persons qualified to prescribe medicinal products. The Commission should establish a web portal to list all national registers of transfers of value to persons qualified to prescribe medicinal products.

Added:(53) A marketing authorisation holder should, within its responsibilities, ensure the appropriate and continuous supply of a medicinal product throughout its lifetime irrespective of whether that medicinal product is covered by a supply incentive or not. [Am. 37]

Removed:Recital 145: (145) In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council66 .

Added:(54) Micro, small and medium-sized enterprises (‘SMEs’), not-for-profit entities or entities with limited experience in the Union system should benefit from additional time to marketsubmit an application for pricing and reimbursement for a medicinal product in the Member States where the marketing authorisation is valid for the purposes of receiving additional regulatory data protection, and where a Member State has requested it. [Am. 38]

Removed:Recital 149: (149) In order to supplement or amend certain non-essential elements of this Directive, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of specifying the procedure for examination of application of active substance master file certificate, the publication of such certificates, the procedure for changes to the active substance master file and its certificate, access to the active substance master file and its assessment report; specifying additional master files to provide information on a constituent of a medicinal product, the procedure for examination of application of a quality master file certificate or a platform technology master file certificate, the publication of such certificates, the procedure for changes to the master file and its certificate, and access to the master file and its assessment report; determining the situations in which post-authorisation efficacy studies may be required; specifying the categories of medicinal products to which a marketing authorisation subject to specific obligations could be granted and specifying the procedures and requirements for granting such a marketing authorisation and for its renewal; specifying exemptions to variation and the categories in which variations should be classified and establishing procedures for the examination of applications for variations to the terms of marketing authorisations as well as specifying conditions and procedures for cooperation with…

Added:(55) When applying the provisions on market launch incentives, Marketing authorisation holders and Member States should do their utmost to achieve a mutually agreed supply of medicinal products in accordance with the needs of the Member State concerned, without unduly delaying or hindering the other party from enjoying its rights under this Directive. [Am. 39]

Removed:Article 1 – paragraph 2: 2. This Directive shall apply to medicinal products for human use intended to be placed on the market in Member States.

Added:(56) Member States have the possibility to waive the condition of launch in their territory for the purpose of the prolongation of data protection for market launch. This can be done through a statement of non-objection to prolong the period of regulatory data protection. This is expected to be the case particularly in situations where launch in a particular Member State is materially impossible or because there are special reasons why a Member State wishes that launch take place later. [Am. 40]

Removed:Article 1 – paragraph 4 – subparagraph 1 a (new): In cases where, taking into account all its characteristics, questions arise as to the regulatory status of a substance or a product, the competent authority or, in the case of a centralised marketing authorisation the Agency shall consult other relevant advisory and regulatory bodies with a view to reaching a decision on the regulatory status f the substance or a product concerned. In any decision on such question, the competent authority or the Agency shall make publicly available the views of other authorities or bodies consulted.