Activities of Andrey SLABAKOV related to 2023/0131(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006
Amendments (145)
Amendment 217 #
Proposal for a regulation
Recital 5
Recital 5
(5) The COVID-19 pandemic has spotlighted critical issues which require a reform of the Union pharmaceuticals framework to strengthen its resilience and to ensure that it serves the people under all circumstances. In light of the disparities in terms of national immunization infrastructures and preparation, Member States should evaluate their national immunization programmes, and determine whether they are fit to protect their population.
Amendment 227 #
Proposal for a regulation
Recital 19
Recital 19
(19) Scientific advice for future applicants seeking a marketing authorisation should be provided more generally and in greater depth. Similarly, structures allowing the development of advice for companies, in particular small and medium-sized enterprises (‘SMEs’), should be put in place. It is important to ensure that this robust, efficient and transparent advice mechanism also applies to health technologies, in order to support timely and effective evaluation of all health products and technologies, including particularly promising medical devices that have the potential to significantly address patients’ unmet medical needs.
Amendment 231 #
Proposal for a regulation
Recital 20
Recital 20
(20) Promising medicinal products and certain medical devices that have the potential to significantly address patients’ unmet medical needs should benefit from early and enhanced scientific support. Such support will ultimately help patients benefit from new therapies as early as possible.
Amendment 274 #
Proposal for a regulation
Recital 40
Recital 40
(40) Member States should ensure adequate funding of competent authorities to carry out their tasks under this Regulation and under [revised Directive 2001/83/EC]. In addition, in line with the Joint Statement of the European Parliament, the Council of the EU and the European Commission on decentralised agencies48 , Member States should ensure adequate resources are assigned by the competent authorities of the Member States for the purpose of their contributions to the work of the Agency, taking into account the cost-based remuneration they receive from the Agency, while ensuring that adequate resources are also available for their national tasks. _________________ 48 https://europa.eu/european- union/sites/europaeu/files/docs/body/joint_ statement_and_common_approach_2012_e n.pdf
Amendment 287 #
Proposal for a regulation
Recital 48
Recital 48
(48) The summary of product characteristics and the package leaflet should reflect the assessment of the Agency and be part of its scientific opinion. The opinion may recommend certain conditions that should be part of the marketing authorisation, for example on the safe and efficacious use of the medicinal product or on post-authorisation obligations that have to be complied with by the marketing authorisation holder. Those conditions may include the requirement to conduct post-authorisation safety or efficacy studies or other studies that are considered necessary to optimise the treatment, for example where the proposed dose scheme by the applicant, whilst acceptable and justifying a positive benefit-risk balance, could be further optimised post-authorisation. Where the applicant disagrees with parts of the opinion, the applicant may request its re- examination. To address second medical use patents, and their implications on legal, regulatory and market access matters, off-patent companies should be permitted to carve out indications covered by patent while being allowed to retain the complete safety profile if requested by the authority, to safeguard public health and patient safety.
Amendment 312 #
Proposal for a regulation
Recital 67 a (new)
Recital 67 a (new)
(67 a) To ensure patients with unmet medical needs, or suffering from life- threatening, or highly debilitating conditions treatable through the use or implant of a medical device are subject to the same quality, access and availability of treatment as other patients, EMA should have a a greater role in the evaluation of all health products and technologies. This may include the introduction of a dedicated priority review process which enhances patient access and facilitates interaction and early dialogue with manufacturers of certain class III and class IIb medical devices addressing unmet needs.
Amendment 329 #
Proposal for a regulation
Recital 77
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 R&D is hampered by the low commercial value of antimicrobial medicinal products; it is therefore necessary to consider new measures to promote the development of priority antimicrobials that are effective against antimicrobial resistance and to support undertakings, often SMEs, which choose to invest in this area.
Amendment 334 #
Proposal for a regulation
Recital 78 a (new)
Recital 78 a (new)
(78 a) Addressing Antimicrobial Resistance requires a rethinking of the approach to incentives both at Union and national level. Member States must be willing to re-valuate their commitment to generating pharmaceutical R&D in key areas of priority and in public expenditure directed towards health. The European Commission, the Council and the European Parliament have published a large number of studies and recommendations, addressing the need to refocus on producing novel antimicrobials as soon as possible. These approaches need to be evaluated, consolidated and made operational under a single, comprehensive long-term Action Plan on addressing Antimicrobial Resistance in the Union, which will contain all the necessery measures to stimulate research and developing novel antimicrobials.
Amendment 339 #
Proposal for a regulation
Recital 78 b (new)
Recital 78 b (new)
(78 b) To ensure that the Union has the most efficient and rapid access to innovations in priority antimicrobials, a short-term incentive measure must be put in place to bridge the gap until the Action Plan begins to have effect on the research and development ecosystem and on the pharmaceutical market for antimicrobials. The transferable exclusivity voucher is, therefore, introduced as a short-term tool to incentivise innovation.
Amendment 354 #
Proposal for a regulation
Recital 79
Recital 79
(79) The creation of a voucher rewarding the development of priority antimicrobials, particular narrow- spectrum antibiotics, through an additional year of regulatory data protection has the capacity to provide the needed financial support to developers of priority antimicrobials. However, in order to ensure that the financial reward which is ultimately borne by health systems is mostly absorbed by the developer of the priority antimicrobial and not the buyer of the voucher, the number of available vouchers on the market should be kept to a minimum. It is therefore necessary to establish strict conditions of granting, transfer and use of the voucher and to further give the possibility to the Commission to revoke the voucher under certain circumstances.
Amendment 361 #
Proposal for a regulation
Recital 80
Recital 80
(80) A transferable data exclusivity voucher should only be available to those antimicrobial productnarrow-spectrum antibiotics that bring a significant clinical benefit with respect to antimicrobial resistance, and which have the characteristics described in this Regulation. It is also necessary to ensure that an undertaking which receives this incentive is in turn capable to supply the medicinal product to patients across the Union in sufficient quantities and to provide information on all funding received for research related to its development in order to provide a full account of the direct financial support given to the medicinal product.
Amendment 375 #
Proposal for a regulation
Recital 83
Recital 83
(83) The provisions related to transferable data exclusivity vouchers shall be applicable for a specified period from the entry into force of this Regulation orand until a maximum number of vouchers are granted by the Commission in order tspecified time, as indicated in the Action Plan do address Antimicrobial Resistance in the Union, when the long- term measures foreseen in this Regulation commence to take effect. This will also limit the total cost of the measurevoucher to Member State health systems. The limited application of the measure will also provide the possibility to assess the effect of the measure in addressing the market failure in the development of new antimicrobials addressing antimicrobial resistance and assess the cost on national health systems. Such assessment will provide the necessary knowledge to decide whether to extend the application of the measureit should be extended in some form under the Action Plan.
Amendment 385 #
Proposal for a regulation
Recital 87 a (new)
Recital 87 a (new)
(87 a) The European Parliament adopted a resolution of 10 July 2020 on the EU’s public health strategy post-COVID-19, which requested an EU Action plan for rare diseases
Amendment 387 #
Proposal for a regulation
Recital 88
Recital 88
(88) Regulation (EC) No 141/2000 of the European Parliament and of the Council55 has proved to be successful in boosting developments of orphan medicinal products in the Union; therefore an action at Union level remains preferable to uncoordinated measures by the Member States which may result in distortions of competition and barriers to intra-Union trade. The Union should not neglect or disregard the success of the Regulation since its entry into force in 2000; it should build upon its success, in order to ensure an even greater degree of innovation under this Regulation; _________________ 55 Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1).
Amendment 398 #
Proposal for a regulation
Recital 92 a (new)
Recital 92 a (new)
(92 a) Significant benefit should remain the main determining factor for a therapy's eligibility for orphan status when assessing an orphan medicinal product that meets the incidence threshold.
Amendment 402 #
Proposal for a regulation
Recital 92 b (new)
Recital 92 b (new)
Amendment 416 #
Proposal for a regulation
Recital 102
Recital 102
(102) In order to incentiviseze investment and innovation, research and development of orphan medicinal products addressing high unes where either no other treatment needs, to ensure market predictability and to ensure a fair distribution of incentives, a modulation of market exclusivity has been introduced; orphan medicinal products addressing high unmet medical needs benefit from the longest market exclusivity, whileexists or, if other treatments already exist, they would constitute a significant benefit to the target population, a modulation of market exclusivity has been introduced. Such modulation is science-driven and informed by the principles that guide research, with incentives based on the concrete barriers, unique attributes, and needs for development of novel therapies that address patient needs; four main incentive archetypes are foreseen by the Regulation, each addressing unique needs and knowledge gaps in research; market exclusivity for well-established use orphan medicinal productes, requiring less investment, is the shortest. In order to ensure increased predictability for developers, the possibility to review the eligibility criteria for market exclusivity after six years after the marketing authorisation has been abolished.
Amendment 421 #
Proposal for a regulation
Recital 103
Recital 103
(103) In order to encourageEnsuring faster and wider access also to orphan medicinal products, an additional period of one year of market exclusivity is granted to orphan medicinal products for a Union market launch, with the exception of well- established use medicinal produc remains a Union-wide issue. This impacts in particular Member States with smaller purchasing power, smaller populations, and therefore with smaller rare disease patient populations. The result is reduced or delayed access to treatments that are available on the Union market, but not in each Member State. Solutions can only be found through joint action that involves manufacturers, national and Union-level regulators, Member States, clinicians and patients.
Amendment 423 #
Proposal for a regulation
Recital 103 a (new)
Recital 103 a (new)
(103 a)Information is key to ensuring access to novel treatments for patients with rare diseases. Large dispariteis remain between Member States as to the level of information access for both clinicians and patients. Without addressing this crucial break of communication starting at the manufacturer of a novel orphan medicinal product and ending with the relevant patient population, awareness of and takeup of novel treatments will remain low. Clinicians must continuously be kept up-to-date with developments in the fields of rare diseases, in order to provide their patients with the best possible treatment. In order to address this gap, action is needed across the board, starting with applicants for a marketing authorisation for an orphan medicinal product. They must prove their commitment to continuously provide the necessary information not only in the Member States where their treatments are sold, but within the entire Union. This can only be achieved with the support of the Agency and with the full cooperation of national and Union-level professional and patient organisations. Member States should take all necessary measures to ensure financial and structural support enabling the flow of information.
Amendment 424 #
Proposal for a regulation
Recital 103 b (new)
Recital 103 b (new)
(103 b)Informing clinicians and other medical professionals of available orphan medicinal products placed on the Union markets should be accopmanied by measures ensuring their upskilling. Member States must invest in the creation of Centres of Excellence for one or a group of rare diseases, with the material base and skilled professionals to offer the latest available treatments. These Centres may be established on a national or regional level. Furthermore, Member States may elect to enter into cooperation and co-financing, in order to establish joint Centres of Excellence, based on their patient populations, territorial proximity, ease of access/travel and material conditions.
Amendment 425 #
Proposal for a regulation
Recital 103 c (new)
Recital 103 c (new)
(103 c) The Union must build on the successful implementation since 2017 of the European Reference Networks (ERNs) for rare diseases. As highlighted in the EU Joint Action on Rare Diseases Plan, the support for and cooperation with the ERNs must be enchanced both from the public and private sectors. Therefore, applicants for market authorisation of orphan medicinal products must prove that they have put in place robust pathways for partnering with ERNs and for the exchange and use of relevant data. Member States must guarantee appropriate levels of funding - an estimated €77 million, in order to realise the full potential of the ERNs.
Amendment 426 #
Proposal for a regulation
Recital 103 d (new)
Recital 103 d (new)
(103 d)Presently, conditions under which a patient may travel from one Member State to another to receive medical care and reimbursement are established in the Directive 2011/24/EU on patients’ rights in cross-border healthcare, as well as in Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems. Patients seeking cross-border healthcare continue to face issues with regards to their rights, partially due to the incomplete transposition of Directive 2011/24/EU by all Member States. For many patient populations in certain Member States these pathways remain the only way to seek treatment for rare diseases, which are available in other Member States. Directive 2011/24/EU must, therefore, be fully transposed and used by all Member States to guarantee their patients access to orphan medicinal products put on the Union markets.
Amendment 430 #
Proposal for a regulation
Recital 104
Recital 104
(104) To reward research into and development of new therapeutic indications, an additional period of one year of market exclusivity is provided for a new therapeutic indication (with a maximum of twoUndertaking research and clinical trials for a rare disease is complex and time-consuming, especially due to the small patient population and lack of knowledge that characterises many rare diseases with no authorised treatment. Using the knowledge and experience gained from clinical evidence in one indication is not immediately transferable into a new indication, but it can provide important insights. Therefore, research into and development of new therapeutic indications should be rewarded. Sufficient incentives should be provided so that it is viable for industry to continue exploring new indications and ensure patients benefit from incremental innovation and support new technologies to move into additional indications).;
Amendment 431 #
Proposal for a regulation
Recital 104 a (new)
Recital 104 a (new)
Amendment 432 #
Proposal for a regulation
Recital 105
Recital 105
(105) This Regulation includes several provisions aimed to avoid not-justified benefits being derived from the market exclusivity and to improve accessibility of medicinal products by ensuring faster entry of generics and biosimilars, and similar medicinal products on the market, i.e. on day one after the market exclusivity expires. It also clarifies the concurrence of market exclusivity with data protection and defines situations when a similar medicinal product may be granted a marketing authorisation, despite the ongoing market exclusivity. The market exclusivity of the orphan medicinal product shall not prevent the submission, validation, assessment of an application for and granting of a marketing authorisation for a similar medicinal product, including generics and biosimilars, where the remainder of the duration of the initial market exclusivity is less than two years.
Amendment 435 #
Proposal for a regulation
Recital 110
Recital 110
(110) In order to not endanger the health of children and avoid to expose them to unnecessary clinical trials, the obligation to agree and conduct paediatric studies in children should be waived when the medicinal product is likely to be ineffective or unsafe in part or all of the paediatric population, the specific medicinal product does not represent a significant therapeutic benefit over existing treatments for children or the disease for which the medicinal product is intended occurs only in adult populations. Nevertheless, in the last case, if on the basis of existing scientific evidence, the medicinal product due to its molecular mechanism of action is expected to be effective against a different disease in children, the obligation should be maintained.
Amendment 437 #
Proposal for a regulation
Recital 112
Recital 112
(112) With a view to ensuring that research is conducted only when safe and ethical and that the requirement for study data in the paediatric population does not block or delay the authorisation of medicinal products for other populations, the Agency may defer the initiation or completion of some or all of the measures contained in a paediatric investigation plan for a limited period of time. Such deferral should be extended only in duly justified cases.
Amendment 453 #
Proposal for a regulation
Recital 133
Recital 133
(133) Regulatory sandboxes can provide the opportunity for advancing regulation through proactive regulatory learning, enabling regulators to gain better regulatory knowledge and to find the best means to regulate innovations based on real-world evidence, especially at a very early stage of development of a medicinal product, which can be particularly important in the face of high uncertainty and disruptive challenges, as well as when preparing new policies. Regulatory sandboxes provide a structured context for experimentation, enable where appropriate in a real-world environment the testing of innovative technologies, products, regulatory methods, services or approaches – at the moment especially in the context of digitalisation or the use of artificial intelligence and machine learning in the life cycle of medicinal products from drug discovery, development to the administration of medicinal products including where medical devices or in- vitro diagnostics are used as combination products – for a limited time and in a limited part of a sector or area under regulatory supervision ensuring that appropriate safeguards are in place. In its conclusions of 23 December 2020 the Council has encouraged the Commission to consider the use of regulatory sandboxes on a case-by-case basis when drafting and reviewing legislation.
Amendment 467 #
Proposal for a regulation
Recital 136
Recital 136
(136) Shortages of medicinal products represent a growing threat to public health, with potential serious risks to the health of patients in the Union and impacts on the right of patients to access appropriate medical treatment. The root causes of shortages are multifactorial, with. The primary root cause of shortages is the economic model for medicines in Europe, and especially for generic medicines. Other challenges can be identified along the entire pharmaceutical value chain, from quality and manufacturing problems. In particular, shortages of medicinal products can result from supply chain disruptions and vulnerabilities affecting the supply of key ingredients and components. Therefore, all marketing authorisation holders of critical and strategic medicinal products, and especially those that do not have alternatives, should have shortage prevention plans in place, to prevent shortages. The Agency should provide guidance to marketing authorisation holders on approaches to streamline the implementation of those plans. Preventing and monitoring shortages should also go through better use of data, including from existing IT systems such as the European Medicines Verification System which can aid in the monitoring and timely response to supply shortages, and has the potential to detect supply issues through predictive models.
Amendment 478 #
Proposal for a regulation
Recital 137
Recital 137
(137) To achieve a better security of supply for medicinal products in the internal market and to contribute thereby to a high level of public health protection, it is appropriate to approximate the rules on monitoring and reporting of actual or potential shortages of medicinal products, including the procedures and the respective roles and obligations of concerned entities in this Regulation. It is important to ensure continued supply of medicinal products, which is often taken for granted across Europe. This is especially true for the most critical medicinal products which are essential to ensure the continuity of care, the provision of quality healthcare and guarantee a high level of public health protection in Europe. Member States may indroduce measures to ensure the security of supply of critical or strategic medicinal products on national level according their needs.
Amendment 479 #
Proposal for a regulation
Recital 138
Recital 138
(138) The national competent authorities and the Agency should be empowered to monitor shortages of medicinal products that are authorised through both national and centralised procedures, based on notifications of marketing authorisation holders. The Agency should be empowered to monitor shortages of medicinal products that are authorised through the centralised procedure, also based on notifications of marketing authorisation holders in a centralised, digitalised and automated system. When critical shortages are identified, both national competent authorities and the Agency should work in a coordinated manner to manage those critical shortages, whether the medicinal product concerned by the critical shortage is covered by a centralised marketing authorisation or a national marketing authorisation. Marketing authorisation holders and other relevant entities must provide the relevant information to inform the monitoring. Wholesale distributors and other persons or legal entities, including patient organisations or health care professionals, may also report a shortage of a given medicinal product marketed in the Member State concerned to the competent authority or the Agency. The Executive Steering Group on Shortages and Safety of Medicinal Products (‘the Medicines Shortages Steering Group’ (MSSG)) already established within the Agency pursuant to Regulation (EU) 2022/123 of the European Parliament and of the Council56 , should adopt a list of critical shortages of medicinal products and ensure monitoring of those shortages by the Agency. The MSSG should also adopt a list of critical medicinal products authorised in accordance with [revised Directive 2001/83/EC] or this Regulation to ensure monitoring of the supply of those products. The MSSG may provide recommendations on measures to be taken by marketing authorisation holders, the Member States, the Commission and other entities to resolve any critical shortage or to ensure the security of supply of those critical medicinal products to the market. Implementing acts can be adopted by the Commission to ensure that appropriate measures, including the establishment or maintenance of contingency stocks, are taken by marketing authorisation holders, wholesale distributors or other relevant entitiescreation of strategic reserves are taken. _________________ 56 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).
Amendment 502 #
(141) To ensure the enforcement of certain obligations relating to the marketing authorisation for medicinal products for human use granted in accordance with this Regulation, the Commission should be able to impose appropriate and adequate financial penalties. When assessing the responsibility for failures to comply with those obligations and imposing such penalties, it is important that means exist to address the fact that marketing authorisation holders could be part of a wider economic entity. Otherwise, there is a clear and identifiable risk that the responsibility for a failure to comply with those obligations could be evaded, which might have an impact on the ability to impose effective, proportional and dissuasive penalties. The penalties imposed should be effective, proportionate and dissuasive, having regard to the circumstances of the specific case. For the purposes of ensuring legal certainty in the conduct of the infringement procedure, it is necessary to set maximum amounts for penalties. Those maximum amounts should not be linked to the turnover of a particular medicinal product but the economic entity involved.
Amendment 522 #
Proposal for a regulation
Article 2 – paragraph 2 – point 4
Article 2 – paragraph 2 – point 4
(4) ‘orphan medicineal product sponsor’ means any legal or natural person, established in the Union, who submitted an application for or has been granted an orphan designation by a decision referred to in Article 64(4);
Amendment 530 #
Proposal for a regulation
Article 2 – paragraph 2 – point 7
Article 2 – paragraph 2 – point 7
(7) ‘significant benefit’ means a clinically relevant advantage or a major contribution to patient care of an orphan medicinal product if such an advantage or contribution benefits a substantialrelevant part of the target population;
Amendment 554 #
Proposal for a regulation
Article 2 – paragraph 2 – point 11 a (new)
Article 2 – paragraph 2 – point 11 a (new)
(11 a) 'demand' means the request for a medicinal product by a healthcare professional or patient in response to a clinical need; the demand is satisfactorily met when the medicinal product is acquired in appropriate time and in sufficient quantity to allow continuity of the care of patients;
Amendment 557 #
Proposal for a regulation
Article 2 – paragraph 2 – point 12
Article 2 – paragraph 2 – point 12
(12) ‘shortage’ means a situation in which the supply of a medicinal product that is authorised and placed on the market in a Member State does not meet the demand for that medicinal product in that Member Statat a national level, regardless of the cause.
Amendment 568 #
Proposal for a regulation
Article 2 – paragraph 2 – point 12 a (new)
Article 2 – paragraph 2 – point 12 a (new)
(12 a) 'supply' means the total volume of stock of a given medicinal product or medical device that is placed on the market by a marketing authorisation holder or a manufacturer;
Amendment 579 #
Proposal for a regulation
Article 4 – title
Article 4 – title
Member State authorisation of generics of centrally authorisedcertain categories of medicinal products
Amendment 580 #
Proposal for a regulation
Article 4 – paragraph 1 – introductory part
Article 4 – paragraph 1 – introductory part
A generic medicinal product of a reference medicinal product authorised by the Union may be authorised by the competent authorities of the Member States in accordance with [revised Directive 2001/83/EC] under the following conditions:
Amendment 582 #
Proposal for a regulation
Article 4 – paragraph 1 – point a
Article 4 – paragraph 1 – point a
(a) the application for marketing authorisation is submitted in accordance with Article 9, 10, 13 of [revised Directive 2001/83/EC], or for active substances used in fixed dose combination medicinal products that have previously been used in the composition of authorised medicinal products;
Amendment 587 #
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
Point (b), first subparagraph, shall not apply to those parts of summary of product characteristics and package leaflet referring to indications, posologies, pharmaceutical forms, methods or routes of administration or any other way in which the medicinal product may be used which were still covered by a patent or a supplementary protection certificate for medicinal products at the time when the generic medicinal product was marketed and where the applicant for the generic medicinal product has requested not to include this information in their marketing authorisation.
Amendment 588 #
Proposal for a regulation
Article 5 – paragraph 5
Article 5 – paragraph 5
5. Within 20 days of receipt of an application, the Agency shall check whether all the information and documentation required in accordance with Article 6 have been submitted, that the application does not contain critical deficiencies as defined in guidelines established under paragraph 7 that may prevent the evaluation of the medicinal product and decide whether the application is valid.
Amendment 590 #
Proposal for a regulation
Article 5 – paragraph 6 – subparagraph 3
Article 5 – paragraph 6 – subparagraph 3
Amendment 635 #
Proposal for a regulation
Article 10 – paragraph 2
Article 10 – paragraph 2
2. Where within 90 days of the validation of the marketing authorisation application and during the assessment the Committee for Medicinal Products for Human Use considers that the submitted data are not of sufficient quality or maturity to complete the assessment, the assessment can be terminated. The Committee for Medicinal Products for Human Use shall summarise the deficiencies in writing. On this basis, the Agency shall inform the applicant accordingly and set a time limit to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the Agency, the application shall be considered as withdrawn.
Amendment 651 #
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1
Article 13 – paragraph 1 – subparagraph 1
Within 12 days of receipt of the opinion of the Committee for Medicinal products for Human Use the Commission shall submit to the Standing Committee on Medicinal Products for Human Use referred to in Article 173(1) a draft of the decision on the application, including details on any rewards and incentives granted.
Amendment 663 #
Proposal for a regulation
Article 15 – paragraph 1 – point d
Article 15 – paragraph 1 – point d
(d) the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant;
Amendment 681 #
Proposal for a regulation
Article 16 – paragraph 3 – subparagraph 2 – indent 2 a (new)
Article 16 – paragraph 3 – subparagraph 2 – indent 2 a (new)
– a summary of any rewards and incentives granted.
Amendment 714 #
3. Conditional marketing authorisations or a new conditional therapeutic indication granted pursuant to this Article shall be subject to specific obligations. Those specific obligations and, where appropriate, the time limit for compliance shall be specified in the conditions to the marketing authorisation. Those specific obligations shall be reviewed annually by the Agency for the first three years after granting the authorisation and every two years thereafter. Accurate, comprehensive and up-to-date real world evidence shall be submitted by the marketing authorisation holder on regular basis before granting the renewed conditional marketing authorisation.
Amendment 725 #
Proposal for a regulation
Article 19 – paragraph 4
Article 19 – paragraph 4
4. As part of the specific obligations referred to in paragraph 3, the marketing authorisation holder of a conditional marketing authorisation granted pursuant to this Article shall be required to complete ongoing studies, or to conduct new studies, with a view to confirming that the benefit- risk balance is favourablee safety and efficacy of the medicinal product. A possibility to conclude a risk-sharing agreement to ensure the availability of medicinal products on national level shall be allowed for those Member States that require it.
Amendment 758 #
Proposal for a regulation
Article 25 – paragraph 1 – subparagraph 3
Article 25 – paragraph 1 – subparagraph 3
As soon as the relevant patent or supplementary protection certificate referred to in point (a) expires, the marketing authorisation holder shall, without undue delay, withdraw the initial or duplicate marketing authorisation.
Amendment 772 #
Proposal for a regulation
Article 26 – paragraph 10
Article 26 – paragraph 10
10. The Agency mayshall adopt detailed guidelines laying down format and content of notifications referred to in paragraphs 3 and 5, and data exchange under this Article.
Amendment 776 #
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
Without prejudice to the law on the protection of industrial and commercial property, medicinal products for human use which have been authorised in accordance with this Regulation shall benefit from the periods of regulatory protection set out in Chapter VII of [revised Directive 2001/83/EC]. The granting of periods of regulatory protection shall be published and updated by the Agency in a designated registry.
Amendment 822 #
Proposal for a regulation
Chapter III – title
Chapter III – title
III ADDRESSING PHARMACEUTUCAL MARKET FAILURES IN THE UNION AND FURTHER INCENTIVES FOR THE RESEARCH AND DEVELOPMENT OF ‘PRIORITY ANTIMICROBIALS’
Amendment 830 #
Proposal for a regulation
Article 40 – title
Article 40 – title
Granting the right to a transferable data exclusivity voucher as a short-term measure of addressing Antimicrobial Resistance
Amendment 853 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – point a
Article 40 – paragraph 3 – subparagraph 1 – point a
(a) it represents a new class of antimicrobialnarrow- spectrum antibiotics;
Amendment 937 #
Proposal for a regulation
Article 42 – paragraph 2
Article 42 – paragraph 2
2. The Commission may revoke the voucher prior to its transfer as referred to in Article 41(3) if a request for supply, procurement or purchase of the priority antimicrobial in the Union has not been fulfilled. Such a decision to revoke shall take into account whether the non- fulfilment is not due to circumstances beyond the control of the marketing authorisation holder.
Amendment 952 #
Proposal for a regulation
Article 43 – paragraph 1
Article 43 – paragraph 1
This Chapter shall apply until [Note to OP: insert the date of 15 years after the date offrom the entry into force of this Regulation and until the measures established in the Action Plan referred to in Article 43a entery into force of this Regulation], or until the date when the Commission has granted a total of 10 vouchers in accordance with this Chapter, whichever date is the earliest.
Amendment 954 #
Proposal for a regulation
Article 43 a (new)
Article 43 a (new)
Article43a Establishing long-term measures to address Antimicrobial Resistance in the Union 1. The Commission shall, by [one year after the date of entry into force of this Regulation], develop a comprehensive Action Plan against Antimicrobial Resistance (the "Action Plan"), building on the current and ongoing work in the field. The goal of the Action Plan will be to establish long-term measures addressing the pharmaceutical market failures in the Union and to develop appropriate incentives in order to secure access to novel antimicrobials. 2. The Action Plan shall: (a) serve as a continuation and replacement of the measure established in Article 40 of this Regulation; (b) set out long-term health priorities in the public interest at Union level, in the form of a strategic roadmap with a number of specific purpose-led R&D projects; the roadmap will be elaborated and updated through continuing, transparent consultations with: (i) representatives of each Member State, including national public health authorities; (ii) relevant stakeholders, including public health authorities at Union level, clinician representatives and patient organisations; (iii) relevant agencies established at Union level; (c) establish a portfolio of priority R&D projects addressing at least the development of priority antimicrobials provided for in the ‘WHO priority pathogens list for R&D of new antibiotics’, specifically those listed as priority 1 (critical) or priority 2 (high), or taking into account any equivalent list of priority pathogens adopted at Union level; (d) establish a Union push and pull incentive scheme to promote and accelerate the development of novel antimicrobials, as well as promote increased access to existing and newly developed antimicrobials. Member States shall be encouraged to participate in the Union level scheme. The scheme will be established through separate legislative acts and contain at least the following elements: (i) research grants under Union funds with conditionalities linked to the affordability and supply of new and existing antimicrobials; (ii) milestone prizes for novel antimicrobial developers with conditionalities linked to the affordability and supply of new and existing antimicrobials; (iii) voluntary joint procurement with subscription payment mechanisms or market entry rewards that delink or partially delink revenues and sales; (iv) an annual revenue guarantee scheme, aimed at securing access to antibioticsin line with the 2021 Health Council Conclusions; (e) contain appropriate and proportionate requirements for transparency and compliance, monitored by the Commission with assistance from public health authorities at Union and national level; 3. The Commission shall, as part of the Action Plan, develop a roadman for the application, and cessation thereof, of Article 40, in accordance with Article 43.
Amendment 983 #
Proposal for a regulation
Article 58 – paragraph 1 – subparagraph 2
Article 58 – paragraph 1 – subparagraph 2
Such advice can also be requested for medicinal products referred to in Articles 83 and 84 of [revised Directive 2001/83/EC]. The scientific advice provided for medicinal products falling under Articles 9 to 13, 15 and 84 of [revised Directive 2001/83/EC] shall be adapted to the specificities of these products.
Amendment 999 #
Proposal for a regulation
Article 58 – paragraph 4 a (new)
Article 58 – paragraph 4 a (new)
4 a. The Agency shall, to the greatest extent possible, ensure that there is continuation between those responsible for providing scientific advice to a given medicinal product developer and those subsequently responsible for the evaluation of the marketing authorisation application for the same medicinal product.
Amendment 1007 #
Proposal for a regulation
Article 60 – paragraph 1 – introductory part
Article 60 – paragraph 1 – introductory part
1. The Agency may offer enhanced scientific and regulatory support, including as applicable consultation with other bodies as referred to in Articles 58 and 59 and accelerated assessment mechanisms, for certain medicinal products or certain medical devices that, based on preliminary evidence submitted by the developer fulfil the following conditions:
Amendment 1018 #
Proposal for a regulation
Article 60 – paragraph 1 – point a
Article 60 – paragraph 1 – point a
(a) are likely to address an unmet medical need as referred to in Article 83(1) and (2) of [revised Directive 2001/83/EC];
Amendment 1020 #
Proposal for a regulation
Article 60 – paragraph 1 – point b
Article 60 – paragraph 1 – point b
Amendment 1034 #
Proposal for a regulation
Article 60 – paragraph 2
Article 60 – paragraph 2
2. The Agency, at the request of the Commission and after consulting the EMA Emergency Task Force or expert panel referred to in Article 61(2) of Regulation (EU) 2017/745, may offer enhanced scientific and regulatory support to developers of a medicinal product or certain medical devices preventing, diagnosing or treating a disease resulting from serious cross border threats to health if access to such products is considered necessary to ensure high level of Union preparedness and response to health threats.
Amendment 1037 #
Proposal for a regulation
Article 60 – paragraph 3
Article 60 – paragraph 3
3. The Agency may stop the enhanced support if it is established that the medicinal product or the medical device will not address the identified unmet medical need to the anticipated extent.
Amendment 1038 #
Proposal for a regulation
Article 60 – paragraph 4
Article 60 – paragraph 4
4. The compliance of a medicinal product with the criteria set out in Article 83 of [revised Directive 2001/83/EC] or of a medical device as set out in Regulation (EU) 2017/745 shall be assessed on the basis of the relevant criteria, independently of whether it has received priority medicinal product support under this Article.
Amendment 1039 #
4 a. The Commission may adopt an implementing act, establishing the enhanced scientific and regulatory support for priority medical devices, taking into consideration the requirements set by Regulation (EU) 2017/745.
Amendment 1097 #
Proposal for a regulation
Article 67 – paragraph 3 – point f a (new)
Article 67 – paragraph 3 – point f a (new)
(f a) any request and related decision under article 66 (2).
Amendment 1133 #
Proposal for a regulation
Article 70 – paragraph 1 – point a
Article 70 – paragraph 1 – point a
(a) there is no medicinal product authorised in the Union for such condition, orwhere, despite medicinal products being authorised for such condition in the Union, the applicant demonstrates that the orphan medicinal product, in addition to having a significant benefit, will bring exceptional therapeutic advancement;
Amendment 1135 #
Proposal for a regulation
Article 70 – paragraph 1 – point a a (new)
Article 70 – paragraph 1 – point a a (new)
(a a) despite medicinal products being authorised for such condition in the Union, the applicant demonstrates that the orphan medicinal product, in addition to having a significant clinical benefit based on improved efficacy, safety and contribution to patient care, will bring a therapeutic advancement to a part of the relevant patient population;
Amendment 1136 #
Proposal for a regulation
Article 70 – paragraph 1 – point b
Article 70 – paragraph 1 – point b
Amendment 1153 #
Proposal for a regulation
Article 70 – paragraph 3
Article 70 – paragraph 3
3. Where the Agency adopts scientific guidelines for the application of this Article, it shall consult the Commission and, the authorities orand bodies referred to in Article 162.
Amendment 1154 #
Proposal for a regulation
Article 71 – paragraph 1
Article 71 – paragraph 1
1. Where an orphan marketing authorisation is granted and without prejudice to intellectual property law, the Union and the Member States shall not grant a marketing authorisation or extend an existing marketinga similar medicinal product authorisation,zed for the same therapeutic indication, in respect of a similar medicinal produc shall not be placed on the market for the duration of market exclusivity set out in paragraph 2.
Amendment 1155 #
Proposal for a regulation
Article 71 – paragraph 2 – point a
Article 71 – paragraph 2 – point a
Amendment 1185 #
Proposal for a regulation
Article 71 – paragraph 2 – point b
Article 71 – paragraph 2 – point b
(b) twelven years for orphan medicinal products addressing a high unmet medical need as referred to in Article 70;
Amendment 1193 #
Proposal for a regulation
Article 71 – paragraph 2 – point b a (new)
Article 71 – paragraph 2 – point b a (new)
(b a) ten years for an orphan medicinal product where: 1. fewer than three orphan medicinal products have been approved in the Union for the indication in question, or; 2. despite medical products being authorised for such a condition, no orphan medicinal product has been approved in the Union for a part of the target population or subpopulation that is covered by the therapeutic indication for the new medicinal product, or; 3. an orphan medicinal product has been approved in the Union for the indication, but the orphan medical product will represent a new mechanism of action or technology;
Amendment 1196 #
Proposal for a regulation
Article 71 – paragraph 2 – point b b (new)
Article 71 – paragraph 2 – point b b (new)
(b b) eight years for an orphan medicinal product that does not fall under paragraphs (b), (ba) or (bb);
Amendment 1213 #
Proposal for a regulation
Article 71 – paragraph 3 a (new)
Article 71 – paragraph 3 a (new)
3 a. Where the orphan marketing authorisation holders benefit from market exclusivity for an orphan medicinal product under paragraph 1 of this Article, they must demonstrate that they meet the requirements set in paragraph 1 of Article 72a of this Regulation.
Amendment 1216 #
Proposal for a regulation
Article 71 – paragraph 5
Article 71 – paragraph 5
5. The submission, validation and assessment of the application for the marketing authorisation and granting the marketing authorisation for a generic or biosimilar product to the reference medicinal product for which market exclusivity has expired, shall not be prevented by the market exclusivity of a similar product to the reference medicinal product.
Amendment 1217 #
6. The market exclusivity of the orphan medicinal product shall not prevent the submission, validation and, assessment of an application for and granting of a marketing authorisation for a similar medicinal product, including generics and biosimilars, where the remainder of the duration of the initial market exclusivity is less than two years.
Amendment 1224 #
Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 1
Article 72 – paragraph 1 – subparagraph 1
Amendment 1233 #
Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 2
Article 72 – paragraph 1 – subparagraph 2
Amendment 1243 #
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 1
Article 72 – paragraph 2 – subparagraph 1
The period of market exclusivity shall be prolonged by an additional 1236 months for orphan medicinal products referred to in Article 71(2), points (a), (b) and (bc), if at least twofour years before the end of the exclusivity period, the orphan marketing authorisation holder obtains a marketing authorisation for one or more new therapeutic indications for a different orphan condition.
Amendment 1256 #
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 2
Article 72 – paragraph 2 – subparagraph 2
Amendment 1258 #
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 2 a (new)
Article 72 – paragraph 2 – subparagraph 2 a (new)
When the marketing authorisation holder obtains any further marketing authorisations for one or more therapeutic indications covering different orphan conditions for the same orphan medicinal product, these specific therapeutic indications shall be protected by a separate market exclusivity of three years, starting from the expiration of the market exclusivity for the entire product under Article 71, where relevant as extended under paragraphs 1 and 2 of this Article.
Amendment 1279 #
Proposal for a regulation
Article 72 a (new)
Article 72 a (new)
Amendment 1284 #
Proposal for a regulation
Article 74 – paragraph 2 – subparagraph 1 – point a
Article 74 – paragraph 2 – subparagraph 1 – point a
(a) when the active substance concerned is not yet authorised in any medicinal product in the EU and is intended to treat a novel, diagnose or prevent a paediatric condition;
Amendment 1287 #
Proposal for a regulation
Article 75 – paragraph 1 – point b
Article 75 – paragraph 1 – point b
(b) that the disease or condition for which the specific medicinal product or class is intended occurs only in adult populations, unless wheon the product is directed at a molecular targetbasis of existing scientific data, there is medical plausibility that on the basis of existing scientific data, is responsible forproduct, due to its mechanism of action, could address an unmet medical need in a different disease or condition in the same therapeutic area in children than the one for which the specific medicinal product or class of medicinal products is intended for in the adult population. Where that is the case, the applicant shall be required to conduct one paediatric investigation plan based on the product’s mechanism of action in a single disease or condition for which there is such an unmet medical need;
Amendment 1292 #
Proposal for a regulation
Article 75 – paragraph 1 – point c
Article 75 – paragraph 1 – point c
(c) that the specific medicinal product is likely to not represent a significant therapeutic benefit over existing methods of diagnosis, prevention or treatments for paediatric patients.
Amendment 1295 #
Proposal for a regulation
Article 75 – paragraph 3
Article 75 – paragraph 3
Amendment 1297 #
Proposal for a regulation
Article 75 – paragraph 3 a (new)
Article 75 – paragraph 3 a (new)
3 a. The Agency shall, in consultation with the Commission and with all interested parties, draw up guidelines for the application of this Article.
Amendment 1299 #
Proposal for a regulation
Article 76 – paragraph 1
Article 76 – paragraph 1
1. A paediatric investigation plan or an application for waiver shall be submitted to the Agency with a request for agreement, except in duly justified cases, before the initiation of confirmatory safety and efficacy clinical studies in adults or children so as to ensure that a decision on use in the paediatric population of the medicinal product concerned can be given at the time of the marketing authorisation or other application concerned.
Amendment 1307 #
Proposal for a regulation
Article 77 – paragraph 2
Article 77 – paragraph 2
Amendment 1308 #
Proposal for a regulation
Article 77 – paragraph 3
Article 77 – paragraph 3
Amendment 1309 #
Proposal for a regulation
Article 77 – paragraph 3 – subparagraph 1
Article 77 – paragraph 3 – subparagraph 1
Amendment 1311 #
Proposal for a regulation
Article 77 – paragraph 3 – subparagraph 2
Article 77 – paragraph 3 – subparagraph 2
Amendment 1312 #
Proposal for a regulation
Article 77 – paragraph 4
Article 77 – paragraph 4
Amendment 1313 #
Proposal for a regulation
Article 77 – paragraph 5
Article 77 – paragraph 5
5. Within the time periods referred to in paragraphs 1, 2, 3 or 4 the Agency may request the applicant to propose modifications to the plan or ask for additional information, in which case the time-limits referred to in paragraphs 1, 2, 3 and 4 shall be extended for a maximum of the same number of days. Theseis time- limits shall be suspended until the supplementary information requested has been provided.
Amendment 1318 #
Proposal for a regulation
Article 80 – paragraph 1
Article 80 – paragraph 1
If, having considered a paediatric investigation plan, the Agency concludes that Article 75(1), points (a), (b) or (c), applies to the medicinal product concerned, it shall adopt negative a decision under Article 77, paragraphs 1, 2 or 4.
Amendment 1319 #
Proposal for a regulation
Article 81 – paragraph 2 – subparagraph 1
Article 81 – paragraph 2 – subparagraph 1
The Agency shall adopt a decision on the request referred to in paragraph 1 and inform the applicant thereof. The Agency shall adopt such decision at the same time as the adoption of the positive decision under Article 77, paragraphs 1 or 2.
Amendment 1323 #
Proposal for a regulation
Article 81 – paragraph 3
Article 81 – paragraph 3
3. The length of the deferral shall be specified in a decision of the Agency and shall not exceed five years.
Amendment 1324 #
Proposal for a regulation
Article 82 – paragraph 1 – subparagraph 1
Article 82 – paragraph 1 – subparagraph 1
In duly justified cases, a request for a prolongation of the deferral, may be submitted, at least 6 months before the expiry of the deferral period. A prolongation of the derogation shall not exceed the duration of the deferral period given under Article 81(3).
Amendment 1328 #
Proposal for a regulation
Article 84 – paragraph 1 a (new)
Article 84 – paragraph 1 a (new)
1 a. The procedure foreseen in paragraph 1 shall also apply when the applicant updates the elements of an initial paediatric investigation plan submitted in accordance with Article 74(2).
Amendment 1330 #
Proposal for a regulation
Article 84 – paragraph 2 – subparagraph 1
Article 84 – paragraph 2 – subparagraph 1
If, following the decision agreeing the paediatric investigation plan referred to in Article 77, paragraphs 1, 2 and 4, or on the basis of the updated paediatric investigation plan received in accordance with Article 77(3), the Agency, on the base of new scientific information available, considers that the agreed plan or any of its elements are no longer appropriate, it shall request, based on detailed scientific grounds, that the applicant to propose changes to the paediatric investigation plan.
Amendment 1331 #
Proposal for a regulation
Article 84 – paragraph 2 – subparagraph 2
Article 84 – paragraph 2 – subparagraph 2
The applicant shall submit the changes requesteda response to the request for changes within 60 days.
Amendment 1335 #
Proposal for a regulation
Article 84 – paragraph 2 – subparagraph 3
Article 84 – paragraph 2 – subparagraph 3
Within 30 days, the Agency shall review these changes applicant’s response and adopt a decision on theirits refusal or acceptance.
Amendment 1342 #
Proposal for a regulation
Article 87 – paragraph 2 a (new)
Article 87 – paragraph 2 a (new)
2 a. Within the timelines for adoption of a decision foreseen in Articles 77, 78, 80, 81, 82 and 84, the Agency shall transmit its scientific conclusions to the applicant.
Amendment 1346 #
Proposal for a regulation
Article 87 – paragraph 2 b (new)
Article 87 – paragraph 2 b (new)
2 b. Within 30 days following receipt of the scientific conclusions, the applicant may submit to the Agency a written request, citing detailed grounds, for a re- examination.
Amendment 1347 #
Proposal for a regulation
Article 87 – paragraph 2 c (new)
Article 87 – paragraph 2 c (new)
2 c. Within 30 days following receipt of a request for re-examination pursuant to paragraph 2b, the Agency shall confirm or revise its previous scientific conclusions. The Agency shall be able to question the applicant directly. The applicant may also offer to be questioned. Where the Agency considers it necessary, it may consult the Committee for Medicinal Products for Human Use or the appropriate working parties when re- examining the above mentioned scientific conclusions.
Amendment 1349 #
Proposal for a regulation
Article 87 – paragraph 2 d (new)
Article 87 – paragraph 2 d (new)
2 d. If, within the 30-day period referred to in paragraph 2b, the applicant does not request re-examination, the scientific conclusions shall become definitive.
Amendment 1352 #
Proposal for a regulation
Article 87 – paragraph 2 e (new)
Article 87 – paragraph 2 e (new)
2 e. The Agency shall adopt a decision within a period not exceeding 10 days following the date on which the scientific conclusions have become definitive. This decision shall be communicated to the applicant in writing and shall annex the final scientific conclusions.
Amendment 1353 #
Proposal for a regulation
Article 88 – paragraph 1
Article 88 – paragraph 1
Where a paediatric investigation plan, agreed in accordance with the provisions of Article 77, paragraphs 1, 2 and 4, is discontinued, the applicant shall notify the Agency of its intention to discontinue the conduct of the paediatric investigation plan and provide the reasons for such discontinuation as soon as possible and no less than six months before the discontinuation. In cases where such a time-frame is not possible, the applicant shall notify the Agency no later than 6 months of its decision to discontinue the investigation plan.
Amendment 1366 #
Proposal for a regulation
Article 98 – paragraph 1 – point g
Article 98 – paragraph 1 – point g
Amendment 1377 #
Proposal for a regulation
Article 104 – paragraph 1 – subparagraph 1 – point c
Article 104 – paragraph 1 – subparagraph 1 – point c
(c) a summary of the risk management plans for medicinal products authorised in accordance with this Regulation;
Amendment 1381 #
Proposal for a regulation
Article 104 – paragraph 1 – subparagraph 2
Article 104 – paragraph 1 – subparagraph 2
The summarierisk management plans referred to in point (c) shall include a description of any additional risk minimisation measures and distribution/implementation plans.
Amendment 1466 #
Proposal for a regulation
Article 116 – paragraph 1 – point a
Article 116 – paragraph 1 – point a
(a) its decision to permanently cease the marketing of a medicinal product in that Member State no less than twelvesix months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder;
Amendment 1468 #
Proposal for a regulation
Article 116 – paragraph 1 – point b
Article 116 – paragraph 1 – point b
(b) its request to permanently withdraw the marketing authorisation for that medicinal product authorised in that Member State no less than twelvesix months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder;
Amendment 1470 #
Proposal for a regulation
Article 116 – paragraph 1 – point c
Article 116 – paragraph 1 – point c
(c) its decision to temporarily suspend the marketing of a medicinal product in that Member State no less than sixthree months before, and in all cases at the earliest possible time, the start of the temporary suspension of supply of that medicinal product into the market of a given Member State by the marketing authorisation holder, unless such suspension is triggered by a relevant competent authority;
Amendment 1473 #
Proposal for a regulation
Article 116 – paragraph 1 – point d
Article 116 – paragraph 1 – point d
Amendment 1487 #
Proposal for a regulation
Article 116 – paragraph 1 a (new)
Article 116 – paragraph 1 a (new)
1 a. The marketing authorisation holder of a medicinal product in possession of a centralised marketing or a national marketing authorisation shall notify the Agency of a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than three months before the start of such temporary disruption of supply or, if this is not possible, as soon as they become aware of such temporary disruption.The temporary disruption in supply of a medicinal product for which another pack size of that same product is available shall not need to be notified. The Agency shall make available the information to the concerned Member States to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).
Amendment 1500 #
Proposal for a regulation
Article 117 – paragraph 1
Article 117 – paragraph 1
1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for anycritical and strategic medicinal products placed on the market. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.
Amendment 1507 #
Proposal for a regulation
Article 117 – paragraph 2
Article 117 – paragraph 2
2. TWhere relevant, the Agency, in collaboration with the working party referred to in Article 121(1), point (c), and other interested parties, shall draw up guidance to marketing authorisation holders as defined in Article 116(1) to put in place the shortage prevention plan.
Amendment 1519 #
2. For the purposes of paragraph 1, the competent authority concerned as defined in Article 116(1) may request any additional information from the marketing authorisation holder as defined in Article 116(1). In particular, it may request the marketing authorisation holder to submit a shortage mitigation plan in accordance with Article 119(2), a risk assessment of impact of suspension, cessation or withdrawal in accordance with Article 119(3), or the shortage prevention plan referred to in Article 117. The competent authority concerned mayshall set a deadline for the submission of the information requested.
Amendment 1529 #
Proposal for a regulation
Article 120 – paragraph 1 a (new)
Article 120 – paragraph 1 a (new)
1 a. When a marketing authorisation holder notifies a temporary disruption in supply of a medicinal product, wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products shall provide information requested in a timely manner to the Agency and to the competent authority in a Member State, to confirm that the temporary disruption in supply of the product in a Member State was not caused by parallel distribution to another Member State.
Amendment 1553 #
Proposal for a regulation
Article 121 – paragraph 1 – point c a (new)
Article 121 – paragraph 1 – point c a (new)
(c a) consider the use of appropriate regulatory measures to mitigate the shortage.
Amendment 1556 #
Proposal for a regulation
Article 121 – paragraph 1 a (new)
Article 121 – paragraph 1 a (new)
1 a. The competent authority of the Member State may recommend to the relevant authority or social security schemes to raise the prices of medicinal products for which they have identified a risk of shortage or of consolidation. The recommendation must be justified in writing, stating the active substance and the dosage forms concerned. Based on the recommendation, the relevant authority or social security schemes can increase the regulated price caps.
Amendment 1568 #
Proposal for a regulation
Article 122 – paragraph 1
Article 122 – paragraph 1
1. For the purposes of Article 118(1), the Agency may request additional information from the competent authority of the Member State, through the working party referred to in Article 121(1), point (c). The Agency mayshall set a deadline for the submission of the information requested.
Amendment 1570 #
Proposal for a regulation
Article 122 – paragraph 2
Article 122 – paragraph 2
2. On the basis of Article 118(1), the Agency, in collaboration with the working party referred to in Article 121(1), point (c), shall identify the the critical and/or other medicinal products for which the shortage cannot be resolved without EU coordination.
Amendment 1572 #
Proposal for a regulation
Article 122 – paragraph 3
Article 122 – paragraph 3
3. The Agency shall inform the MSSG of the shortages of the critical or strategic medicinal products that have been identified pursuant to paragraph 2.
Amendment 1589 #
Proposal for a regulation
Article 122 – paragraph 6
Article 122 – paragraph 6
6. For the purposes of implementing this Regulation, the Agency shall expand the scope of the ESMP. The Agency shall ensure that, where relevant, data is interoperable between the ESMP, Member States’ IT systems and other relevant IT systems and databases, without duplication of reporting, and that the ESMP is fully digitalised and automated.
Amendment 1595 #
Proposal for a regulation
Article 123 – paragraph 1
Article 123 – paragraph 1
1. Based on the monitoring referred to in Article 118(1), and following consultation with the Agency and the working party referred to in Article 121(1), point (c), the MSSG shall adopt a list of critical shortages of critical and strategic medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC]and for which co-ordinated Union level action is necessary (‘the list of critical shortages of medicinal products’).
Amendment 1603 #
Proposal for a regulation
Article 123 – paragraph 4
Article 123 – paragraph 4
4. The MSSG may provide recommendations on measures to resolve or to mitigate the critical shortage of critical or strategic medicinal products, in accordance with the methods referred to in Article 122(4), point (d), to relevant marketing authorisation holders, the Member States, the Commission, the representatives of healthcare professionals or other entities.
Amendment 1607 #
1 a. The competent authority of the Member State, the Agency and the Commission shall be entitled to restrict parallel distribution of medicinal products following their additions to the list of critical shortages of medicinal products in accordance with Article 123, paragraphs 1 and 2.
Amendment 1611 #
Proposal for a regulation
Article 124 – paragraph 2 – subparagraph 2
Article 124 – paragraph 2 – subparagraph 2
For the purposes of this paragraph, the Agency mayshall set a deadline for the submission of the information requested.
Amendment 1627 #
Proposal for a regulation
Article 125 – paragraph 1 – point f
Article 125 – paragraph 1 – point f
(f) inform the Agency of the end date of the critical shortage, without undue delay.
Amendment 1633 #
Proposal for a regulation
Article 127 – title
Article 127 – title
Identification and management of critical and strategic medicinal products by the competent authority of the Member State
Amendment 1635 #
Proposal for a regulation
Article 127 – paragraph 1
Article 127 – paragraph 1
1. The competent authority of the Member State shall identify critical and strategic medicinal products in that Member State, using the methodology set out in Article 130(1), point (a).
Amendment 1636 #
Proposal for a regulation
Article 127 – paragraph 2
Article 127 – paragraph 2
2. The competent authority of the Member State acting through the working party referred to in Article 121(1), point (c), shall report to the Agency the critical and strategic medicinal products in that Member State identified pursuant to the paragraph 1, as well as the information received from the marketing authorisation holder as defined in Article 116(1).
Amendment 1638 #
Proposal for a regulation
Article 127 – paragraph 3
Article 127 – paragraph 3
3. For the purposes of the identification of critical and medicinal products referred to in paragraph 1, the competent authority of the Member State may request relevant information including the shortage prevention plan referred to in Article 117on a product-by-product basis from the marketing authorisation holder as defined in Article 116(1).
Amendment 1639 #
Proposal for a regulation
Article 127 – paragraph 4
Article 127 – paragraph 4
4. For the purposes of the identification of critical and strategic medicinal products referred to in paragraph 1, the competent authority of the Member State may request relevant information from other entities including other marketing authorisation holders, importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public.
Amendment 1656 #
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – point a
Article 130 – paragraph 1 – subparagraph 1 – point a
(a) develop a common methodology to identify critical medicinal products, including the evaluation of the therapeutic indication and importance, the availability of appropriate alternatives, and vulnerabilities with respect to the supply chain of those medicines, in consultation, where appropriate, with relevant stakeholders;
Amendment 1671 #
Proposal for a regulation
Article 131 – title
Article 131 – title
The Union List of Critical and Strategic Medicinal Products
Amendment 1674 #
Proposal for a regulation
Article 131 – paragraph 1
Article 131 – paragraph 1
1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c). Based on this consultation, the MSSG shall propose a Union list of critical medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”). The Union list of critical and strategic medicinal products shall be coordinated with the list identified in the Member State by the competent authority of that Member State.
Amendment 1680 #
Proposal for a regulation
Article 131 – paragraph 1
Article 131 – paragraph 1
1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c). Based on this consultation, the MSSG shall propose a Union list of critical and strategic medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”).
Amendment 1688 #
Proposal for a regulation
Article 132 – paragraph 1
Article 132 – paragraph 1
1. Following the adoption of the Union list of critical medicinal products pursuant to Article 131(3), in consultation with the Agency and the working party referred to in Article 121(1), point (c), the MSSG may provide recommendations, in accordance with the methods referred to in Article 130(1), point (d), on appropriate security of supply measures to marketing authorisation holders as defined in Article 116(1), the Member States, the Commission or other entities. Such measures may include recommendations on diversification of suppliers and inventory management, on pricing mechanisms, tender practices and cost-containment measures, and on the use of regulatory flexibilities.