BETA

61 Amendments of Ville NIINISTÖ related to 2023/0131(COD)

Ville NIINISTÖ

Proposal for a regulation
Recital 29

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

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Recital 41 a (new)

(41 a) Protecting global health is one of the priorities of the EU and under Article 178 of the Treaty, the Union should take into account the development policy aspects in any measure and promote the creation of conditions fit for human beings worldwide. To this end, this Regulation should particularly allow for the development of efficacious, safe, accessible, and affordable innovations to address global public health needs, including antimicrobial resistance, poverty-related and neglected diseases, widespread tropical disease and ensure high quality standards for medicinal products that are exported.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Recital 45 a (new)

(45 a) Particular attention should be given to the gender balance of clinical trials so that women can fully and safely benefit from medicines throughout their life-course.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Recital 51

(51) As a general rule a marketing authorisation ~~should be granted for an unlimited time; however~~for products other than generics should be granted for a period of five years in order to allow for the integration of real world evidence and re- assessment of the risk-benefit balance and in case of orphan medicines, also the related criteria related to population size and generated profit, once renew~~al may be decided only on justified grounds related to the safety of the medicinal product~~ed, the marketing authorisation shall be valid for an unlimited period, unless the Agency decides on justified grounds related to the safety of the medicinal product to proceed with an additional five-year renewal period or revocation of the marketing authorisation.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Recital 65

(65) In the preparation of scientific advice and in duly justified cases, the Agency should ~~also~~promote an open discussion about latest scientific developments and the update of scientific guidelines and should be able to consult authorities established in other relevant Union legal acts or other public bodies established in the Union, as applicable. These may include experts in clinical trials, medical devices, substances of human origin or any other as required for the provision of the scientific advice in question.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
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; 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 and not- for profit entities, which choose to invest in this area.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Recital 78

(78) To be considered a ‘priority antimicrobial’, a medicinal product should represent a real advancement against antimicrobial resistance and should therefore bring forward non-clinical and clinical data that underpin a significant clinical benefit with respect to antimicrobial resistance. When assessing the conditions for antibiotics, the Agency shall take into account the prioritisation of pathogens as regards the risk of antimicrobial resistance 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 in case there is an equivalent list of priority pathogens adopted at Union level, the Agency should take such Union list into account as a priority. In order to address market failures for the development of antimicrobials, the priority focus should be on the research and development and subsequent production and fair distribution of new antimicrobials. However, addressing AMR will not be solved by R&D alone. To ensure prudent use of existing antibiotics, the Authority should also support the development and procurement of rapid diagnostic tools to ensure appropriate prescriptions.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Recital 78 a (new)

(78 a) As the Commission’s study on bringing antimicrobial medical countermeasures to the market1a demonstrated, different kinds of push and pull incentives are needed to face this public health emergency. These tools may include market entry rewards, advance purchase agreements, milestone payments, innovation prizes, or subscription payments. In order to maximize the benefits from such public investments, the allocation of these financial and other incentives should respect the following principles and conditions of open science, affordability and EU-wide availability of developed products, delinking revenue from sale volumes of procured products, full transparency of all received funding and purchase agreements, gradient incentive scheme that rewards according to the innovation level, and the development of a stewardship and access plans. These principles and conditions should ensure that public money will be allocated with the objective of a rapid public return on investment for patients. _________________ 1a [1] https://op.europa.eu/en/publication- detail/-/publication/51b2c82c-c21b-11ed- 8912-01aa75ed71a1/language-en/format- PDF/source-282347876

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Recital 78 b (new)

(78 b) The principle of open science is pivotal to ensure rapid progress in the field of scientific research for priority antimicrobials. Over the past 30 years, the lack of sharing of results, failed trials and ongoing research has created bottlenecks for scientific development and contributes to the current market failure for the placing on the market of new antimicrobials. It is therefore of the utmost importance to have a paradigm shift towards open science, particularly in the area of publicly-funded research, to reduce duplication of research, allow for peer-verification of results and building further evidence based on most recent findings, as to making research and development funding efforts more efficient.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Recital 79

(79) The creation of a voucher rewarding the development of priority antimicrobials 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.deleted

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Recital 80

(80) A transferable data exclusivity voucher should only be available to those antimicrobial products 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.deleted

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Recital 81

(81) To ensure a high level of transparency and complete information on the economic effect of the transferable data exclusivity voucher, notably as regards the risk of overcompensation of investment, a developer of a priority antimicrobial is required to provide information on all direct financial support received for research related to the development of the priority antimicrobial. The declaration should include direct financial support received from any source worldwide.deleted

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Recital 82

(82) A transfer of a voucher for a priority antimicrobial may be conducted by sale. The value of the transaction which may be monetary or otherwise agreed between the buyer and the seller, shall be made public so as to inform regulators and the public. The identity of the holder of a voucher that has been granted and not yet used should be publicly known at all times so as to ensure a maximum level of transparency and trust.deleted

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
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 or until a maximum number of vouchers are granted by the Commission in order to limit the total cost of the measure 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 measure.deleted

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Recital 84

(84) The period of application of the provisions on transferable exclusivity vouchers for priority antimicrobials and the total number of vouchers may be extended by the Parliament and the Council upon proposal by the Commission on the basis of the experience acquired.deleted

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Recital 90

(90) Objective criteria for the orphan designation based on the prevalence of the life-threatening or chronically debilitating condition for which diagnosis, prevention or treatment is sought and the existence of no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the Union should be maintained; a prevalence of not more than five affected persons per 10 000 is generally regarded as the appropriate threshold. The orphan designation criterion on the basis of return on investment has been abolished, ~~since it has never been used~~nevertheless, products may still lose the orphan status in cases where the population criterion is no longer met or when sufficient profit was generated after five years on the market.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Recital 90 a (new)

(90 a) The aim of intellectual property and regulatory incentives is to benefit society and promote innovation in areas of public health and unmet medical needs, such as rare diseases. It is of utmost importance that such incentives are not misused or abused, nor pose threats to affordability and patient access to treatments. In particular, the practice of artificially subdividing diseases to create subgroups of patients in order to fall under the orphan medicine prevalence criterion should be prohibited.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Recital 100

(100) Orphan medicinal products addressing a high unmet medical need prevent, diagnose or treat conditions where either no other method of prevention, diagnosis or treatment exists or, if such method already exists, they would bring exceptional therapeutic advancement. In both cases, the criterion of ~~meaningfu~~substantial reduction in disease morbidity or mortality for the relevant patient population should ensure that only most effective medicinal products are covered. The Agency should draw up scientific guidelines on the category of ‘orphan medicinal products addressing a high unmet medical need’.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Recital 102

(102) In order to incentivise research and development of orphan medicinal products addressing high unmet 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, while market exclusivity for well-established use orphan medicinal products, 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.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Recital 103

(103) In order to encourage faster and wider access also to orphan medicinal products, an additional period of ~~one year~~six months of market exclusivity is granted to orphan medicinal products for a Union market launch, with the exception of well- established use medicinal products.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
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 two indications).deleted

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Recital 132

(132) The Union and Member States have developed a scientific evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing medicinal products. This process focuses specifically on the added value of a medicinal product in comparison with other new or existing health technologies However, this evaluation should not be conducted in the context of the marketing authorisation, for which it is agreed that the fundamental criteria should be retained. It is useful in this respect to allow for the possibility of gathering information on the methods used by the Member States to determine the therapeutic benefit obtained by each new medicinal productTo ensure that medicine developers generate the right type of data for regulators throughout the market access pathway, the marketing authorisation applicants should submit, unless where duly justified and ethical, data from active-control clinical trials. This is important to avoid the unnecessary repetition of clinical studies, and to uphold high scientific standards and ethical principles at the point of marketing authorisation.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
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, 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 – 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.deleted

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Recital 134

(134) In the area of medicinal products, a high level of protection of inter alia citizens, consumers, health, as well as legal certainty, a level playing field and fair competition always need to be ensured and existing levels of protection need to be respected.deleted

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Recital 135

(135) The establishment of a regulatory sandbox should be based on a Commission Decision following a recommendation of the Agency. Such decision should be based on a detailed plan outlining the particularities of the sandbox as well as describing the products to be covered. A regulatory sandbox should be limited in duration and may be terminated at any time based on public health considerations. The learning stemming from a regulatory sandbox should inform future changes to the legal framework to fully integrate the particular innovative aspects into the medicinal product regulation. Where appropriate, adapted frameworks may be developed by the Commission on the basis of the results of a regulatory sandbox.deleted

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Recital 138

(138) The national competent authorities 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. When critical shortages are identified, both national competent authorities and the Agency should work in a coordinated manner to communicate the necessary information to patients, consumers, and healthcare professionals, including on estimated duration and available alternatives, and 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 and register such information in the European Shortages Monitoring Platform. . 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~~importers, manufacturers, suppliers, patient and consumer 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. 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 entities. _________________ 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).

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Recital 138 a (new)

(138 a)To facilitate appropriate communication between patients and consumers, on the one hand, and competent authorities on the other, Member States should collect data on the impact of shortages of medicinal products on patients and consumers, and share relevant information through the MSSG, in order to inform approaches to management of shortages of medicinal products. Marketing authorisation holders should set up and maintain a minimum safety stock of critical medicinal products which shall be sufficient to cover two months demand of all Member States where the product has been placed on the market. Delegated 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 entities. The setting up of safety stocks of critical medicinal products should not hamper the availability and affordability of these products or harm the environment by inappropriate disposals at both European and global level. Given the global nature of pharmaceutical supply chains, the safety stocks should be proportionate and take into account the potential impacts on shortages in other Member States and third countries. In order to avoid any interruption of access to critical medicinal products, national competent authorities may, in duly justified cases, grant an exemption from stockpiling obligations to the marketing authorisation holder, upon request, or adopt other complementary measures on the safety of stocks.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 2 – paragraph 2 – point 10

(10) ‘regulatory sandbox’ means a regulatory framework during which it is possible to develop, validate and test in a controlled environment innovative or adapted regulatory solutions that facilitate the development and authorisation of innovative products which are likely to fall in the scope of this Regulation, pursuant to a specific plan and for a limited time under regulatory supervision.deleted

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Chapter III – title

III ~~INCENTIVES FOR THE DEVELOPMENT OF ‘PRIORITY ANTIMICROBIALS’~~deleted

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 40

Article 40 Granting the right to a transferable data exclusivity voucher 1. Following a request by the applicant when applying for a marketing authorisation, the Commission may, by means of implementing acts, grant a transferable data exclusivity voucher to a ‘priority antimicrobial’ referred to in paragraph 3, under the conditions referred to in paragraph 4 based on a scientific assessment by the Agency. 2. The voucher referred to in paragraph 1 shall give the right to its holder to an additional 12 months of data protection for one authorised medicinal product. 3. An antimicrobial shall be considered ‘priority antimicrobial’ if preclinical and clinical data underpin a significant clinical benefit with respect to antimicrobial resistance and it has at least one of the following characteristics: (a) it represents a new class of antimicrobials; (b) its mechanism of action is distinctly different from that of any authorised antimicrobial in the Union; (c) it contains an active substance not previously authorised in a medicinal product in the Union that addresses a multi-drug resistant organism and serious or life threatening infection. In the scientific assessment of the criteria referred to in the first subparagraph, and in the case of antibiotics, the Agency shall take into account the ‘WHO priority pathogens list for R&D of new antibiotics’, or an equivalent list established at Union level. 4. To be granted the voucher by the Commission, the applicant shall: (a) demonstrate capacity to supply the priority antimicrobial in sufficient quantities for the expected needs of the Union market; (b) provide information on all direct financial support received for research related to the development of the priority antimicrobial. Within 30 days after the marketing authorisation is granted, the marketing authorisation holder shall make the information referred to in point (b) accessible to the public via a dedicated webpage and shall communicate, in a timely manner the electronic link to that webpage to the Agency.deleted

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 41

Article 41 Transfer and use of the voucher 1. A voucher may be used to extend the data protection for a period of 12 months of the priority antimicrobial or another medicinal product authorised in accordance with this Regulation of the same or different marketing authorisation holder. A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product is within its first four years of regulatory data protection. A voucher may only be used if the marketing authorisation of the priority antimicrobial for which the right was initially granted has not been withdrawn. 2. To use the voucher, its owner shall apply for a variation of the marketing authorisation concerned in accordance with Article 47 to extend the data protection. 3. A voucher may be transferred to another marketing authorisation holder and shall not be transferred further. 4. A marketing authorisation holder to whom a voucher is transferred shall notify the Agency of the transfer within 30 days, stating the value of the transaction between the two parties. The Agency shall make this information publicly available.deleted

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 42

Article 42 Validity of the voucher 1. A voucher shall cease to be valid in the following cases: (a) where the Commission adopts a decision in accordance with Article 47 to extend the data protection of the receiving medicinal product; (b) where it is not used within 5 years from the date it was granted. 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. 3. Without prejudice to patent rights, or supplementary protection certificates69 , if a priority antimicrobial is withdrawn from the Union market prior to expiry of the periods of market and data protection laid down in Articles 80 and 81 of [revised Directive 2001/83/EC], those periods shall not prevent the validation, authorisation and placing on the market of a medicinal product using the priority antimicrobial as a reference medicinal product in accordance with Chapter II, Section 2 of [revised Directive 2001/83]. _________________ 69 Regulation (EC) No 469/2009 of the European Parliament and of the Council, (OJ L 152, 16.6.2009, p. 1).deleted

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 43

Article 43 Duration of application of Chapter III This Chapter shall apply until [Note to OP: insert the date of 15 years after the date of entry 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.deleted

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 68 – paragraph 1 – point a

(a) the conduct of the various tests and trials necessary to demonstrate the quality, safety ~~and~~, efficacy and environmental impact of the medicinal product, as referred to Article 138(1), second subparagraph, point (p);

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 68 – paragraph 2

2. Medicinal products designated as orphan medicinal products under the provisions of this Regulation shall be eligible for incentives made available by the Union and by the Member States to support research into, and the development and availability of, orphan medicinal products and in particular aid for research for small- and medium-sized undertakings and entities not engaged in economic activities provided for in framework programmes for research and technological development.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 70 – paragraph 1 – point a

(a) there is no medicinal product authorised in the Union for such condition or where, 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; and

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 70 – paragraph 1 – point b

(b) the use of the orphan medicinal product results in a ~~meaningfu~~substantial reduction in disease morbidity or mortality for the relevant patient population.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 71 – paragraph 2 – point a

(a) ~~nine~~seven years for orphan medicinal products other than those referred to in points (b) and (c);

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 71 – paragraph 2 – point b

(b) ~~ten~~eight years for orphan medicinal products addressing a high unmet medical need as referred to in Article 70;

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 71 – paragraph 2 – point c

~~(c) five years for orphan medicinal products which have been authorised in accordance with Article 13 of [revised Directive 2001/83/EC].~~deleted

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 71 – paragraph 4 – point c a (new)

(c a) a compulsory license has been granted in accordance with [Regulation on compulsory licensing for crisis management and amending Regulation (EC) 816/2006].

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 71 – paragraph 7

7. ~~Where t~~The Agency shall adopts scientific guidelines for the application of paragraphs 1 and 4~~, it shall consult the Commission~~.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 72 – title

Prolongation and reduction of market exclusivity period

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 1

The periods of market exclusivity referred to in Article 71, paragraph 2, points (a) and (b), shall be prolonged by 12 months, where the orphan marketing authorisation holder can demonstrate that the conditions referred to in Article 81(2), point (a), and Article 82(1) [of revised Directive 2001/83/EC] are fulfilled.deleted

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 2

~~The procedures set out in Articles 82(2) to (5) [of revised Directive 2001/83/EC] shall accordingly apply to the prolongation of market exclusivity.~~deleted

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 1

The period of market exclusivity shall be prolonged by an additional 126 months for orphan medicinal products referred to in Article 71(2), points (a) and (b), if at least two 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.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 72 – paragraph 4

~~4. Article 71(3) equally applies to the prolongations of market exclusivity referred to in paragraphs 1 and 2.~~deleted

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 72 – paragraph 4 a (new)

4 a. The market exclusivity period shall be reduced to five years if, at the end of the fifth year, it is established, in respect of the medicinal product concerned, that the criteria laid down in Article 63 are no longer met or where it is shown on the basis of available evidence that the product is sufficiently profitable not to justify maintenance of market exclusivity. The sponsor shall provide the Agency with the information necessary to re- assess the criteria laid down in Article 63 and the externally audited product-related profit margins for all authorised indications at least nine months before end of the fifth year.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Chapter IX – title

IX ~~REGULATORY SANDBOX~~deleted

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 113

~~[...]~~deleted

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 114

Article 114 Products developed under a sandbox 1. When authorising a clinical trial application for products covered by a regulatory sandbox, Member States shall take the sandbox plan referred to in Article 113(1) into consideration. 2. A medicinal product developed as part of a regulatory sandbox may be placed on the market only when authorised in accordance with this Regulation. The initial validity of such authorisation shall not exceed the duration of the regulatory sandbox. The authorisation may be prolonged at the request of the marketing authorisation holder. 3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation and [revised Directive 2001/83/EC]. Those derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation. 4. For medicinal products developed as part of a regulatory sandbox for which a marketing authorisation has been granted in accordance with paragraph 2 and where appropriate paragraph 3, the summary of product characteristics and the package leaflet shall indicate that the medicinal product has been developed as part of a regulatory sandbox. 5. Without prejudice to Article 195 of [revised Directive 2001/83/EC], the Commission shall suspend a marketing authorisation granted in accordance with paragraph 2, where the regulatory sandbox has been suspended or revoked in accordance with Article 113(7). 6. The Commission shall immediately vary the marketing authorisation to take account of the mitigation measures taken in accordance with Article 115.deleted

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 115

Article 115 General sandbox provisions 1. The regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. In case of identification of risks to public health or safety concerns associated with the use of products covered by a sandbox, competent authorities shall take immediate and adequate temporary measures in order to suspend or restrict their use and inform the Commission in accordance with Article 113(2). Where such mitigation is not possible or proves to be ineffective, the development and testing process shall be suspended without delay until an effective mitigation takes place. 2. Participants in the regulatory sandbox, in particular the marketing authorisation holder of the medicinal product concerned, shall remain liable under applicable Union and Member States liability legislation for any harm inflicted on third parties as a result from the testing taking place in the sandbox. They shall inform the Agency without undue delay of any information which might entail the amendment of the regulatory sandbox or concerns the quality, safety or efficacy of products developed as part of a regulatory sandbox. 3. The modalities and the conditions of the operation of the regulatory sandboxes, including the eligibility criteria and the procedure for the application, selection, participation and exiting from the sandbox, and the rights and obligations of the participants shall be set out in implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2). 4. The Agency with input from Member States shall submit annual reports to the Commission on the results from the implementation of a regulatory sandbox, including good practices, lessons learnt and recommendations on their setup and, where relevant, on the application of this Regulation and other Union legal acts supervised within the sandbox. These reports shall be made publicly available by the Commission. 5. The Commission shall review the reports and put forward, as appropriate, legislative proposals with a view to update the regulatory framework referred to in Article 113(2) or delegated acts in accordance with Article 28 of [revised Directive 2001/83/EC].deleted

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 116 – paragraph 1 – point d

(d) 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 and public authorities, where available, no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 117 – paragraph 1 a (new)

1 a. Shortage prevention plans shall be without delay submitted to the competent authority concerned defined in Article 116(1) and be made publicly available, upon request.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 120 – paragraph 2

2. For the purposes of Article 118(1), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), 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 shall provide any information requested in a timely mannerAll entities, including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or wholesale distributors, shall provide every three months, or more frequently as requested by the competent authority, stock level data reports indicating available quantities of all medicinal products in each of their warehouses.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 122 – paragraph 6

6. For the purposes of implementing this Regulation, the Agency shall expand the scope of the ESMP and include, among others, information on the duration, reasons and mitigation measures of medicine shortages. The Agency shall ensure that, where relevant, data is interoperable between the ESMP, Member States’ IT systems, including the repositories system containing information on safety features referred to in Article 67, paragraph 2, second subparagraph, point (e) of Directive 2023/0132 (COD), and other relevant IT systems and databases, without duplication of reporting.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 128 – paragraph 2 a (new)

2 a. The marketing authorisation holder shall set up and maintain a minimum safety stock of critical medicinal products which shall be sufficient to cover two months demand of all Member States where the product has been placed on the market.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 128 – paragraph 2 b (new)

2 b. By derogation from paragraph 2a, national competent authorities may, in duly justified cases, grant an exemption from stockpiling obligations to the marketing authorisation holder, upon request, or adopt other complementary measures on the safety of stocks.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 129 – paragraph 1

For the purposes of Article 127(4) and Article 130(2), point (c), and Article 130(4), point (c), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), 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 shall provide any information requested ~~in a timel~~by the deadline set by the Agency man~~ner~~d provide updates whenever necessary.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Article 167 – paragraph 2

For the purposes of the first subparagraph, the Agency shall actively ~~identify and implement cybersecurity best practices adopted within Union institutions, bodies, offices and agenci~~take measures to ensure its compliance with a high common level of cybersecurity within Union entities, identify and implement up- to-date cybersecurity best practices for preventing, detecting, mitigating, and responding to cyber attacks.

2023/11/30
Committee: ITRE

Ville NIINISTÖ

Proposal for a regulation
Annex IV – Part V – paragraph 1 – point 2 – point d a (new)

(d a) For the purpose of reporting in accordance with Article 118, wholesale distributors shall provide regular stock level data reports indicating available quantities of all medicines in each of their warehouses.

2023/11/30
Committee: ITRE