89 Amendments of Laura BALLARÍN CEREZA related to 2023/0131(COD)
Amendment 37 #
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1 a) Ensuring that Europeans receive the medicines they need, when they need them, regardless of where they live in the EU is a central objective of the European Health Union. Boosting the competitiveness of the European pharmaceutical industry, whilst also ensuring better availability of medicines and more equal and timely access for patients is a key deliverable of the proposed EU pharmaceutical reform.
Amendment 41 #
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2 a) The digital transformation of health and care will help increase the capacity of healthcare systems to deliver more personalised and effective health and care with less resource wasting. This regulation will contribute to the delivery of healthcare to European citizens, the design of health technologies and their manufacturing to be more sustainable by reducing energy consumption, waste, pollution and the release of harmful substances, including pharmaceuticals, into the environment.
Amendment 42 #
Proposal for a regulation
Recital 2 b (new)
Recital 2 b (new)
(2 b) It is of outmost importance to involve patients and healthy citizens, healthcare professionals, providers and payers, public health authorities and regulators, researchers or innovators from academia and industry - early in the knowledge generation or technology development process, including through patient and citizen engagement, community involvement or other forms of social innovation approaches, such that research and innovation activities are adjusted to the users’ particular expectations, needs, constraints and potential.
Amendment 45 #
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5 a) Beyond cooperating along the value chain of knowledge and know-how production and valorisation or within the knowledge triangle (research-education- innovation), it is in the EU’s strategic interest to also reach out and cooperate with other countries outside the EU and on other continents. This applies in particular for multi-lateral cooperation on global health issues with countries associated to Horizon Europe but also with other partner countries and regions in the world. Involving international partners should lead to increased scientific knowledge and transfer of technology among partner countries allowing to address global health challenges across the world, thus creating sustainable growth and jobs.
Amendment 47 #
Proposal for a regulation
Recital 9
Recital 9
(9) As to the scope of this Regulation, the authorisation of antimicrobials is, in principle, in the interest of patients' health at Union level and therefore it should be made possible to authorise them at Union level.
Amendment 49 #
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(26 a) Research in the pharmaceutical sector has a decisive role in alleviating patients’ conditions and improving public health. Favourable but balanced rules, facilitating innovation and sufficient protection to encourage such research, including through regulatory sandboxes, will contribute to make the EU markets more attractive and to promote the development of efficacious, safe, accessible, and affordable innovations for antimicrobial resistance, poverty-related and neglected diseases, and other conditions of global public health interest. Research and innovation should continue to ensure the highest standards in health products.
Amendment 61 #
Proposal for a regulation
Recital 39
Recital 39
(39) To allow for a more informative decision making and for exchange of information and pooling of knowledge on general issues of scientific or technical nature related to the tasks of the Agency regarding medicinal products for human use, in particular to scientific guidelines on unmet medical needs and the design of clinical trials, or other studies and the generation of evidence along the life cycle of medicinal product, the Agency should be able to have recourse to a consultation process of authorities or bodies active along the life cycle of medicinal products. These authorities could be, as appropriate, representatives from Heads of Medicines Agencies, the Clinical Trial Coordination and Advisory Group, the SoHO Coordination Board, the Coordination Group on Health Technology Assessment, Medical Devices Coordination Group, medical devices national competent authorities, national competent authorities for pricing and reimbursement of medicines, national insurance funds or healthcare payers. The Agency should also be able to extend the consultation mechanism to consumers, patients, healthcare professionals, industry, associations representing payers, academia or other stakeholders, as relevant.
Amendment 63 #
Proposal for a regulation
Recital 42 a (new)
Recital 42 a (new)
(42 a) Beyond cooperating along the value chain of knowledge and know-how production and valorisation or within the knowledge triangle (research-education- innovation), it is in the EU’s strategic interest to also reach out and cooperate with other countries outside the EU. This applies in particular to multi-lateral cooperation on global health issues with countries associated to Horizon Europe but also with other partner countries and regions in the world. Involving international partners should lead to increased scientific knowledge and transfer of technology among partner countries allowing to address global health challenges across the world, thus creating sustainable growth and jobs.
Amendment 64 #
Proposal for a regulation
Recital 43
Recital 43
(43) In the interest of public health, marketing authorisation decisions under the centralised procedure should be taken on the basis of the objective scientific criteria of quality, safety and efficacy of the medicinal product concerned, to the exclusion of economic and other considerations. However, Member States should be able, exceptionally, to prohibit the use in their territory of medicinal products for human useprovide due justification for such prohibition to the Agency.
Amendment 75 #
Proposal for a regulation
Recital 77 a (new)
Recital 77 a (new)
(77 a) The above mentioned market failures highlight the need for considering the establishment of a mission oriented R&D and manufacturing infrastructure at Union level which acts in the public interest. This initiative should be tasked to research and develop novel antimicrobials as well as other areas of unmet medical need, to respond to health threats and emergencies, to support the Union to overcome market failures, to conduct treatment optimisation studies and to prevent shortages and guarantee security of supply of critical medicinal products.
Amendment 80 #
Proposal for a regulation
Recital 79
Recital 79
Amendment 82 #
Proposal for a regulation
Recital 79 a (new)
Recital 79 a (new)
(79 a) In order to address the threat of antimicrobial resistance and its impact on public health and national healthcare budgets, the development and uptake of new economic models, pilot projects and push and pull incentives to boost the development of new therapies, diagnostics, antibiotics, medical devices and alternatives to using antimicrobials should be supported. Providing Member States with a toolkit of push and pull incentives will be decisive in tackling the growing negative impacts caused by antimicrobial resistance and will serve to address this market failure.
Amendment 83 #
Proposal for a regulation
Recital 80
Recital 80
Amendment 87 #
Proposal for a regulation
Recital 81
Recital 81
Amendment 88 #
Proposal for a regulation
Recital 82
Recital 82
Amendment 91 #
Proposal for a regulation
Recital 83
Recital 83
Amendment 92 #
Proposal for a regulation
Recital 84
Recital 84
Amendment 121 #
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, 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 strict regulatory supervision ensuring that appropriaterobust 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 125 #
Proposal for a regulation
Recital 135
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. It is of utmost importance to ensure a harmonised implementation of these provisions across Member States. Where appropriate, adapted frameworks may be developed by the Commission on the basis of the results of a regulatory sandbox.
Amendment 131 #
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 should be able to introduce or maintain more robust measures to achieve security of supply for medicines than the safeguards provided for in this Regulation as long as these measures do not have a negative impact on the security of supply of other Member States.
Amendment 145 #
Proposal for a regulation
Article 2 – paragraph 2 – point 4
Article 2 – paragraph 2 – point 4
(4) ‘orphan medicineal products 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 156 #
Proposal for a regulation
Article 2 – paragraph 2 – point 14 a (new)
Article 2 – paragraph 2 – point 14 a (new)
(14 a) ‘supply’ means the total volume of stock of a given medicinal product that is placed on the market by a marketing authorisation holder or a manufacturer;
Amendment 157 #
Proposal for a regulation
Article 2 – paragraph 2 – point 14 b (new)
Article 2 – paragraph 2 – point 14 b (new)
(14 b) ‘demand’ means the request for a medicinal product by a healthcare professional or patient in response to clinical the demand is satisfactorily met when the medicinal product is acquired in appropriate time and in sufficient quantity to allow continuity of provision of the best care to patients.
Amendment 170 #
Proposal for a regulation
Article 6 – paragraph 5 – subparagraph 2
Article 6 – paragraph 5 – subparagraph 2
The marketing authorisation applicant shall not carry out animal tests in case scientifically satisfactory non-animal testing methods are available. Where scientifically satisfactory non-animal testing methods are not available, applicants that use animal testing shall ensure that the principle of replacement, reduction and refinement of animal testing for scientific purposes has been applied in compliance with Directive 2010/63/EU with regard to any animal study conducted for the purpose of supporting the application.
Amendment 174 #
Proposal for a regulation
Article 8 – paragraph 1 – point b
Article 8 – paragraph 1 – point b
(b) identification and characterisation of hazards for the environment, animals and for human health; for the purpose of this point, ‘hazards for human health’ includes the risks to the health of human beings other than the treated patient as the risk to the treated patient shall be assessed as part of the benefit-risk assessment of the medicinal product;
Amendment 175 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. In case of first-in-class medicinal products or when a novel question is raised during the assessment of the submitted environmental risk assessment, the Committee for Medicinal Products for Human Use, or the rapporteur, shall carry out necessary consultations with bodies Member States have set up in accordance with Directive 2001/18/EC. They mayshall also consult with relevant Union bodies, inter alia the European Environment Agency. Details on the consultation procedure shall be published by the Agency at the latest by [OJ:12 months after the date of entry into force of this Regulation].
Amendment 179 #
Proposal for a regulation
Article 12 – paragraph 4 – point m a (new)
Article 12 – paragraph 4 – point m a (new)
(m a) a stewardship plan in accordance with Article 17 of [revised Directive 2001/83/EC] and special information requirements in accordance with Article 69 of that Directive for any antimicrobials, as well as any other obligations imposed on the marketing authorisation holder;
Amendment 180 #
Proposal for a regulation
Article 12 – paragraph 4 – point m b (new)
Article 12 – paragraph 4 – point m b (new)
(m b) where applicable, a confirmation as to whether the medicinal product satisfies the criteria of Article 83 of [revised Directive 2001/83/EC] regarding medicinal products addressing an unmet medical need;
Amendment 181 #
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 5
Article 13 – paragraph 1 – subparagraph 5
Where the draft decision differs from the opinion of the Agency, the Commission shall provide a detailed explanation of the reasons for the differences and make that information publicly available at the same time as the decision.
Amendment 185 #
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 applicantrisk mitigation measures proposed by the applicant in accordance with Article 22(3) of [revised Directive 2001/83/EC];
Amendment 190 #
Proposal for a regulation
Article 16 – paragraph 3 – subparagraph 2 – indent 1
Article 16 – paragraph 3 – subparagraph 2 – indent 1
– a summary of the assessment report written in a manner that is understandable to the public. The summary shall contain in particularthe complete environmental risk assessment submitted to the Agency by the marketing authorisation applicant as well as a summary of environmental risk assessment studies and their results as section relating to the conditions of use of the medicinal product;ubmitted by the marketing authorisation holder and the assessment of the environmental risk assessment and the information referred to in Article 22(5) of [revised Directive 2001/83/EC] by the Agency.
Amendment 191 #
Proposal for a regulation
Article 16 – paragraph 3 – subparagraph 2 – indent 2 a (new)
Article 16 – paragraph 3 – subparagraph 2 – indent 2 a (new)
– for antimicrobials, all information referred to in Article 17 of and Annex I to [revised Directive 2001/83/EC] as well as any other obligations imposed on the marketing authorisation holder.
Amendment 192 #
Proposal for a regulation
Article 17 – paragraph 2 – subparagraph 4 a (new)
Article 17 – paragraph 2 – subparagraph 4 a (new)
Where post-authorisation studies to be performed in accordance with Article 20(1) justify it, the Commission may decide to withdraw a marketing authorisation for a medicinal product based on evidence pointing to a risk to public health.
Amendment 197 #
Proposal for a regulation
Article 19 – paragraph 1 – subparagraph 2
Article 19 – paragraph 1 – subparagraph 2
In emergency situations, as referred to in Article 2(1) of Regulation (EU) 2022/2371, a conditional marketing authorisation or a new conditional therapeutic indication referred to in the first subparagraph may be granted also where comprehensive non-clinical or pharmaceutical data have not been supplied.
Amendment 201 #
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 favour in accordance with Article 20, with a view to confirming the safety and efficacy of the medicinal product. The Agency shall make relevant deadlines and criteria for ongoing and new studies publicly available.
Amendment 202 #
Proposal for a regulation
Article 19 – paragraph 6
Article 19 – paragraph 6
6. By way of derogation from Article 17(1), an initial conditional marketing authorisation granted pursuant to this Article shall be valid for one year, on a renewable basis for the first three years after granting the authorisation and every two years thereafter. However, where the Commission terminates the recognition of a public health emergency in accordance with Article 23(2) of Regulation (EU) 2022/2371, the marketing authorisation holder shall pursue a marketing authorisation in accordance with Article 5 of this Regulation.
Amendment 204 #
Proposal for a regulation
Article 19 a (new)
Article 19 a (new)
Article19a Revocation of conditional marketing authorisation The Commission may in justified cases revoke the conditional marketing authorisation that was granted in accordance with Article 19 where the benefit of the immediate availability of the medicinal product on the Union market no longer outweighs the risk due to missing confirming data or noncompliance with the obligations set out in Article 19.
Amendment 206 #
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 2
Article 20 – paragraph 1 – subparagraph 2
If this obligation would apply to several medicinal products, the Agency shall encouraoblige the marketing authorisation holders concerned to conduct a joint post authorisation environmental risk assessment study.
Amendment 210 #
Proposal for a regulation
Article 24 – paragraph 1 – subparagraph 2 – point f
Article 24 – paragraph 1 – subparagraph 2 – point f
(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder; in such cases, the Agency shall immediately inform the Commission who is to be responsible for informing the relevant national and Union authorities.
Amendment 212 #
Proposal for a regulation
Article 24 – paragraph 1 – subparagraph 2 – point f a (new)
Article 24 – paragraph 1 – subparagraph 2 – point f a (new)
(f a) commercial considerations
Amendment 238 #
Proposal for a regulation
Article 40
Article 40
Amendment 262 #
Proposal for a regulation
Article 40 a (new)
Article 40 a (new)
Article 40a Push and pull incentives scheme to boost the development of priority antimicrobials 1. The Commission shall establish a Union push and pull incentives scheme to promote and urgently accelerate the development of priority antimicrobials. Member States shall be encouraged to participate in the Union level scheme. 2. 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’, specifically those listed as priority 1 (critical) or priority 2 (high), or an equivalent list established at Union level 3. The Commission is empowered to adopt delegated acts in accordance with Article 175 to supplement this Regulation by further defining the scheme and its funding, which shall at least include the following incentives: (a) research grants under Union fund with conditionalities linked to the affordability and supply of new and existing antimicrobials; (b) milestone prizes for novel antimicrobial developers with conditionalities linked to the affordability and supply of new and existing antimicrobials; (c) voluntary joint procurement with subscription payment mechanisms or market entry rewards that delink or partially delink revenues and sales; (d) an annual revenue guarantee scheme, aimed at securing access to antibiotics in line with the 2021 Health Council Conclusions. 4. The Union push and pull incentives scheme shall be coordinated and managed by the Commission. provide information on all direct financial support received for research related to the development of the priority antimicrobial. 5. By ... [one year after the date of entry into force of this Regulation], the Commission shall have developed, and commenced the implementation of the Union push and pull incentives scheme. 5. By ... [six years after the date of entry into force of this Regulation], the Commission shall present a report to the European Parliament and to the Council reviewing the application of the scheme laid down in this Article.
Amendment 265 #
Proposal for a regulation
Article 41
Article 41
Amendment 271 #
Proposal for a regulation
Article 42
Article 42
Amendment 274 #
Proposal for a regulation
Article 43 – paragraph 1
Article 43 – paragraph 1
Amendment 320 #
Proposal for a regulation
Article 66 – paragraph 5
Article 66 – paragraph 5
5. At any time, an orphan designation may be withdrawn at the request of the orphan medicine sponsor. The orphan medicine sponsor shall provide a reasoned justification for the withdrawal request which shall be made publicly available.
Amendment 321 #
Proposal for a regulation
Article 67 – paragraph 3 – point f a (new)
Article 67 – paragraph 3 – point f a (new)
(f a) where applicable, any request made in accordance with Article 66(2) and any decisions taken in that respect.
Amendment 327 #
Proposal for a regulation
Article 68 – paragraph 2
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 not-for-profit entities provided for in framework programmes for research and technological development.
Amendment 342 #
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 or bodies and other relevant stakeholders referred to in Article 162.
Amendment 343 #
Proposal for a regulation
Article 71 – paragraph 2 – point a
Article 71 – paragraph 2 – point a
(a) nineeight years for orphan medicinal products other than those referred to in points (b), (ba) and (c);
Amendment 358 #
Proposal for a regulation
Article 71 – paragraph 2 – point b a (new)
Article 71 – paragraph 2 – point b a (new)
(b a) five years for a new orphan therapeutic indication of medicinal products which have already received marketing authorisation in the Union ;
Amendment 362 #
Proposal for a regulation
Article 71 – paragraph 2 – point c
Article 71 – paragraph 2 – point c
(c) fiveour years for orphan medicinal products which have been authorised in accordance with Article 13 of [revised Directive 2001/83/EC].
Amendment 366 #
Proposal for a regulation
Article 71 – paragraph 2 a (new)
Article 71 – paragraph 2 a (new)
2 a. For the medicinal products referred to in paragraph 2, points (ba) and (c), the market exclusivity in respect of the orphan indication shall not prevent the entry of generic and biosimilar medicinal products on the market, provided that they are for other uses that are not subject to the market protection applicable in accordance with paragraph 2.
Amendment 395 #
Proposal for a regulation
Article 72 – paragraph 4
Article 72 – paragraph 4
4. Article 71(3) equally applies to the prolongations of market exclusivity referred to in paragraphs 1 and 2.
Amendment 410 #
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 and the accompanying summaries of the risk management plans;
Amendment 414 #
Proposal for a regulation
Article 113 – paragraph 1 a (new)
Article 113 – paragraph 1 a (new)
1 a. The creation of a regulatory sandbox is intended to fulfill the following objectives: a) improve legal certainty and contribute to the sharing of best practices in the field of emerging medicinal products and collecting information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients through cooperation with the authorities involved in the sandbox with a view to ensuring compliance with this Regulation and, where appropriate, with other Union and Member States legislation; b) assisting prospective marketing authorization applicants in the experimentation and advancement of innovative medicinal products or product categories; c) contribute to evidence-based regulatory learning within a managed setting and identify possible future adaptations of the legal framework.
Amendment 423 #
Proposal for a regulation
Article 115 – paragraph 4
Article 115 – paragraph 4
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, cases in which a regulatory sandbox had to be suspended or revoked as established in Article 113 (8), 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.
Amendment 424 #
Proposal for a regulation
Article 115 – paragraph 5 a (new)
Article 115 – paragraph 5 a (new)
5 a. By ... [12 months after the date of entry into force of this Regulation], in order to ensure a harmonised approach across Member States and support to the implementation of the regulatory sandboxes, the Commission, in consultation with the Agency, shall issue guidelines, without prejudice to other Union legislative acts. Where necessary, the guidelines should be updated to incorporate any relevant findings in the annual reports submitted by the Agency, as established in the fourth paragraph of this Article.
Amendment 435 #
Proposal for a regulation
Article 117 – paragraph 1
Article 117 – paragraph 1
1. TBy ... [12 months after the date of entry into force of this Regulation], the marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the market and send it to the competent authority upon request. 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 441 #
Proposal for a regulation
Article 118 – paragraph 1 – subparagraph 2
Article 118 – paragraph 1 – subparagraph 2
The Agency shall carry out that monitoring, in collaboration with the relevant competent authority of the Member State when those medicinal products are authorised under this Regulatioworking party referred to in Article 121(1) and after consultation with healthcare professionals and patient and consumer organisations, draw up guidance to marketing authorisation holders as defined in Article 116(1) to put in place the shortage prevention plan.
Amendment 443 #
Proposal for a regulation
Article 118 – paragraph 2
Article 118 – paragraph 2
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 445 #
Proposal for a regulation
Article 120 – paragraph 1
Article 120 – paragraph 1
1. Wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] to the public mayshall report a shortage of a given medicinal product marketed in the Member State concerned to the competent authority in that Member State.
Amendment 446 #
Proposal for a regulation
Article 120 – paragraph 1 a (new)
Article 120 – paragraph 1 a (new)
1 a. For the purposes of the reporting in accordance with Article 118(1) and for the early detection of supply shortages, wholesalers shall transmit the information set out in Part Va of Annex IV to the competent authorities of the Member States in a timely manner.
Amendment 451 #
Proposal for a regulation
Article 121 – paragraph 1 – point b
Article 121 – paragraph 1 – point b
(b) publish information on all expected or actual shortages of medicinal products, in cases in which that competent authority has assessed the shortagethe reason for the shortage, as well as measures taken to counter the expected or actual shortage, as soon as that competent authority has assessed the shortage and provide clear recommendations and possible alternatives to healthcare professionals and patients, on a publicly available and user-friendly website;
Amendment 455 #
Proposal for a regulation
Article 121 – paragraph 2 – point f
Article 121 – paragraph 2 – point f
(f) inform the Agency of any actions foreseen or taken by that Member State to mitigate the shortage at national level without undue delay.
Amendment 458 #
Proposal for a regulation
Article 121 – paragraph 5 – point a
Article 121 – paragraph 5 – point a
(a) report to the Agency on any information received from the marketing authorisation holder as defined in Article 116(1) of the medicinal product concerned or from other actors pursuant to Article 120(1a) and (2);
Amendment 462 #
Proposal for a regulation
Article 122 – paragraph 4 – introductory part
Article 122 – paragraph 4 – introductory part
4. For the purposes of fulfilling the tasks referred to in Articles 118(1), 123 and 124, the Agency shall ensure the following, in consultation with the working party referred to in Article 121(1), point (c) and in consultation with relevant patient and consumer organisations:
Amendment 469 #
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 471 #
Proposal for a regulation
Article 124 – paragraph 3
Article 124 – paragraph 3
3. The Agency shall establish within its web-portal referred to in Article 104 a publicly available and user-friendly webpage that provides information on all actual critical shortages of medicinal products, in cases in which the Agency hascluding the reasons for the shortages. After assesseding the shortage and hass, the Agency shall provided recommendations to healthcare professionals and patients. This webpage shall also provide references to the lists of actual shortages published by the competent authorities of the Member State pursuant to Article 121(1), point (b).
Amendment 473 #
Proposal for a regulation
Article 125 – paragraph 1 – point c
Article 125 – paragraph 1 – point c
(c) take into accountcomply with the recommendations referred to in Article 123(4);
Amendment 474 #
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 475 #
Proposal for a regulation
Article 125 – paragraph 1 – point f a (new)
Article 125 – paragraph 1 – point f a (new)
(f a) inform the Agency of the cause of the critical shortage.
Amendment 478 #
Proposal for a regulation
Article 127 – paragraph 1
Article 127 – paragraph 1
1. The competent authority of the Member State shall, after consultation with healthcare professionals and national patient and consumer organisations, identify critical medicinal products in that Member State, using the methodology set out in Article 130(1), point (a).
Amendment 484 #
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – introductory part
Article 130 – paragraph 1 – subparagraph 1 – introductory part
The Agency shall, in collaboration with the working party referred to in Article 121(1), point (c) and after consultation with patient organisations, ensure the following:
Amendment 488 #
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 vulnerabilitithe therapeutic indication, vulnerabilities and the availability of appropriate alternatives with respect to the supply chain of those medicines, in consultation, where appropriate, withith patient and consumer organisations, as well as other relevant stakeholders;
Amendment 493 #
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), and patient and consumer organisations, as well as other relevant stakeholders as set out in Article 162 of this Regulation. 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”).
Amendment 495 #
Proposal for a regulation
Article 131 – paragraph 2
Article 131 – paragraph 2
2. The MSSG mayshall propose updates to the Union list of critical medicines to the Commission, where necessary.
Amendment 498 #
Proposal for a regulation
Article 133 – paragraph 1 – point c
Article 133 – paragraph 1 – point c
(c) take into accountcomply with the recommendations referred to in Article 132(1);
Amendment 499 #
Proposal for a regulation
Article 134 – paragraph 1 – introductory part
Article 134 – paragraph 1 – introductory part
1. The Commission may, where it considers it appropriate and necessaryshall:
Amendment 502 #
Proposal for a regulation
Article 134 a (new)
Article 134 a (new)
Article 134a General provisions 1. Member States may introduce or maintain more robust provisions than those provided for in this Regulation with regard to the security of supply of and the availability of medicinal products. These provisions should not have a negative impact on the security of supply and availability of medicinal products in other Member States. 2. The implementation of this Regulation shall in no circumstances constitute grounds for a reduction of the level of safeguards already afforded by Member States with regard to the security and availability of supply of medicinal products. Where Member States detect infringements of measures in relation to Chapter X, penalties in accordance with Article 171(1) shall be imposed without undue delay.
Amendment 503 #
Proposal for a regulation
Article 138 – paragraph 1 – subparagraph 2 – point ze
Article 138 – paragraph 1 – subparagraph 2 – point ze
(ze) cooperating with EU decentralised agencies and other scientific authorities and bodies established under Union law, notably the European Chemicals Agency, the European Food Safety Authority, the European Centre for Disease Prevention and Control and the European Environment Agency as regards the scientific assessment of relevant substances, exchange of data and information and development of coherent scientific methodologies, including replacing, reducing or refining animal testing, and where possible prioritising replacement strategies such for example as non-animal in vitro and silico approaches, taking into account the specificities of the assessment of medicinal products;
Amendment 517 #
Proposal for a regulation
Article 153 – paragraph 1
Article 153 – paragraph 1
At the request of the Commission, the Agency shall, in respect of authorised medicinal products for human use, collect any available information on methods that Member States' competent authorities use to determine the added therapeutic value that any new medicinal product for human use provides. Guidelines for the determination of added therapeutic value shall be drawn up in collaboration with patient organisations and healthcare professionals.
Amendment 526 #
Proposal for a regulation
Article 175 – paragraph 2
Article 175 – paragraph 2
2. The power to adopt delegated acts referred to in Articles 3(5), 19(8), 21, 40a, 47(4), 49(2), 63(2), 67(4), 75(3), 81(4) and 172(10) shall be conferred on the Commission for a period of five years from [date of entry into force]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 529 #
Proposal for a regulation
Annex II – point 25 a (new)
Annex II – point 25 a (new)
(25 a) the obligation to notify the competent authority of the Member State and, where relevant, the Agency about cessation, withdrawal, temporary suspension or temporary disruption in accordance with the deadlines provided for in Article 116;
Amendment 530 #
Proposal for a regulation
Annex II – point 25 b (new)
Annex II – point 25 b (new)
(25 b) the obligation to have in place and keep up to date a shortage prevention plan as provided for in Article 117;
Amendment 531 #
Proposal for a regulation
Annex II – point 25 c (new)
Annex II – point 25 c (new)
(25 c) the obligation to comply with the recommendations and measures taken in case of a critical shortage as provided for in Article 125;
Amendment 532 #
Proposal for a regulation
Annex II – point 25 d (new)
Annex II – point 25 d (new)
(25 d) the obligation to comply with the recommendations and measures taken in relation to critical medicinal products as provided for in Article 133.
Amendment 533 #
Proposal for a regulation
Annex IV – Part III – paragraph 1 – point 2 – point e
Annex IV – Part III – paragraph 1 – point 2 – point e
(e) Reason for shortage; including information on; (i) Raw material disruption, due to… (ii ) API disruption, due to… (iii) Excipient disruption, due to… (iv) Production problem, due to.. (v) Quality problem, due to… (vi) Production capacity, due to… (vii) Logistics problem, due to… (viii) Distribution problem, due to… (ix) Inventory and storage practices (x) Increase in demand (xi) Commercial reasons
Amendment 535 #
Proposal for a regulation
Annex IV – Part V a (new)
Annex IV – Part V a (new)
V a For the purposes of reporting in accordance with Article 118(1) and for the early detection of supply shortages, wholesalers shall provide the following information in a timely manner: 1. Product availability information: Product availabilities shall be reported per wholesale warehouse and shall be indexed as yes/no. 2. Service level information: Service level information which captures the level of fulfilment of wholesale orders by marketing authorisation holders and suppliers shall be reported. Such information involves comparing the quantity ordered with the quantity actually received at the product level. The resulting difference describes the service level.