29 Amendments of Sirpa PIETIKÄINEN related to 2023/0132(COD)
Amendment 159 #
Proposal for a directive
Recital 8
Recital 8
(8) This revision maintains the level of harmonisation that has been achieved. Where necessary and appropriate, it further reduces the remaining disparities, by laying down rules on the supervision and control of medicinal products and the rights and duties incumbent upon the competent authorities of the Member States with a view to ensuring compliance with legal requirements. In the light of experience gained on the application of the Union pharmaceutical legislation and the evaluation of its functioning, the regulatory framework need to be adapted to scientific and technological progress, the current market conditions and economic reality within the Union. Scientific and technological developments induce innovation and development of medicinal products, including for therapeutic areas where there is still unmet medical need and of medicinal products with less harmful impacts on environment. To harness these developments, the Union pharmaceutical framework should be adapted to meet scientific developments such as genomics, accommodate cutting edge medicinal products, e.g. personalised medicinal products and technological transformation such as data analytics, digital tools and the use of artificial intelligence. These adaptations also contribute to competitiveness of the Union pharmaceutical industry.
Amendment 163 #
Proposal for a directive
Recital 9 a (new)
Recital 9 a (new)
(9 a) Member States should form and take part to an EU-wide Rare Medicines Fund where each Member State should invest 5% of its average costs resulting from medicinal expenses that is the share of rare diseases. The Fund should negotiate, jointly for all Member States, the prices of medicines and medicinal products for rare diseases, and the Member States should commit to the purchase of these medicines by public procurement to respond to the needs of their citizens.
Amendment 173 #
Proposal for a directive
Recital 13 a (new)
Recital 13 a (new)
(13 a) The Commission should create a process to prioritize less environmentally harmful medicines by enabling Member States to withdraw the marketing authorisation of medicines where a less environmentally harmful, equivalent alternative exists for the medicine. Life- saving medicines or medicines responding to unmet medical needs should be excluded from this process. Member States should equally fund capacities that facilitate the development of enviromentally less harmful medicines.
Amendment 227 #
Proposal for a directive
Recital 49
Recital 49
(49) Joint procurement, whether within a country or across countries, can improve access, affordability, and security of supply of medicines, in particular for smaller countries. Member States interested in joint procurement of medicines canshould make use of Directive 2014/24/EU47 , which sets out purchasing procedures for public buyers, the Joint Procurement Agreement48 and the proposed revised Financial Regulation49 . Upon request from the Member States the Commission may support interested Member States by facilitating coordination to enable access to medicines for patients in the Union as well as information exchange, in particular for medicines for rare and chronic diseases. _________________ 47 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). 48 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU. 49 COM/2022/223 final.
Amendment 229 #
Proposal for a directive
Recital 49 a (new)
Recital 49 a (new)
Amendment 282 #
Proposal for a directive
Recital 63
Recital 63
(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products during the term of protection of thewithout this being considered patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being considered patent or SPC infringement. The application of thinfringement. The application of this limited exemption is however fragmented across the Union and the objective of enabling a day-one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is limited exemption is however fragmented across the Union and iportant in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal products that relon day one a reference medicinal product,fter loss of the patent or SPC protection to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conducting studies and, trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessment and, obtaining pricing and reimbursement request, the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing, both by the applicants and by third party suppliers or service providers. During the term of protection in a Member State of the patent or SPC of, for the reference medicinal product, there can be no commercial uslevant product or process, there can be no placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process.
Amendment 293 #
Proposal for a directive
Recital 64
Recital 64
(64) It will allow all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct studactivities to support pricing and reimbursementregulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of patent protected active substances for the purpose of seeking marketing authorisations during that period, contributing toaforementioned purposes, contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars on day one ofafter loss of the patent or SPC protection, under fair competitive conditions.
Amendment 299 #
Proposal for a directive
Recital 65
Recital 65
(65) The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal productAvoiding that circumstances may encourage inappropriate market behaviours hampering the emergence of generic and biosimilar medicinal products, ensuring timely availability of generic and biosimilar medicinal products and ending patent linkage were highlighted as priorities by Council conclusions and a resolution of the European Parliament. The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal product or for an application for pricing and reimbursement or for the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC only on the basis of the grounds set out in this Directive. The same applies to any decision to grant, vary, suspend, restrict or revoke the marketing authorisation or pricing and reimbursement. The competent authorities cannot base their decision on any other grounds. In particular, those decisions cannot be based on the patent or SPC status of the reference medicinal product and cannot be subject to any requirements that expose an applicant to a risk of infringement of the relevant patent or SPC.
Amendment 343 #
Proposal for a directive
Recital 90
Recital 90
(90) It is recognised that the development of pharmaceuticals is an area where neither science, nor technology stand still. The last decades have seen new categories of medicinal products emerging from biological medicinal products to biosimilars or advanced therapy medicinal products or in the future phages therapies. Those categories of products may in some instances require adapted rules to fully take account of their specific characteristics. For that reason a forward looking legal framework should include provisions to enable such adapted frameworks subject to strict criteria and under a Commission empowerment guided by the scientific input of the European Medicines Agency, as well as incentives for the industry to develop pharmaceuticals that are less harmful to the environment.
Amendment 366 #
Proposal for a directive
Recital 129
Recital 129
(129) Where Member States decide that the package leaflet should be made available in principle only electronically, they should also ensure that a paper version of the package leaflet is to be made, by default, available on demand and without additonal cost to patients, for example printed by pharmacies. They should also ensure that the information in digital format is easily accessible to all patients, for instance by including in the outer packaging of the product a digitally readable barcode or a QR code, which would direct the patient to the electronic version of the package leaflet.
Amendment 410 #
Proposal for a directive
Article 1 – paragraph 10 – point a
Article 1 – paragraph 10 – point a
Amendment 527 #
Proposal for a directive
Article 4 – paragraph 1 – point 35 – point b
Article 4 – paragraph 1 – point 35 – point b
(b) of undesirable effects or risks on the environment posed by the medicinal product;
Amendment 532 #
Proposal for a directive
Article 4 – paragraph 1 – point 41
Article 4 – paragraph 1 – point 41
(41) ‘benefit-risk balance’ means an evaluation of the positive therapeutic effects of the medicinal product in relation to the risks referred to in point (35), subpoint (a);
Amendment 534 #
Proposal for a directive
Article 4 – paragraph 1 – point 58
Article 4 – paragraph 1 – point 58
(58) ‘risk management system’ means a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise public health or environment risks relating to a medicinal product, including the assessment of the effectiveness of those activities and interventions;
Amendment 554 #
Proposal for a directive
Article 6 – paragraph 4
Article 6 – paragraph 4
4. The risk management system referred to in Annex I shall be proportionate to the identified risks and the potential public health or environment risks of the medicinal product, and the need for post-authorisation safety data.
Amendment 637 #
Proposal for a directive
Article 22 – paragraph 5
Article 22 – paragraph 5
5. The Agency shall draw up scientific guidelines in accordance with Article 138 of [revised Regulation No (EC) 726/2004], to specify technical details regarding the ERA requirements for medicinal products for human use. Where appropriate, the Agency shall consult the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA), and relevant stakeholders including drinking water and wastewater operators, on the drafting of these scientific guidelines.
Amendment 641 #
Proposal for a directive
Article 22 – paragraph 6 – subparagraph 2
Article 22 – paragraph 6 – subparagraph 2
For an ERA conducted prior to [OP please insert the date = 18 months after the date of entering into force of this Directive], the competent authority shall request the marketing authorisation holder to update the ERA to include risk mitigation measures as referred to in paragraph 3. The competent authority shall also request the marketing authorisation holder to update the ERA if missing information has been identified for medicinal products potentially harmful to the environment.
Amendment 649 #
Proposal for a directive
Article 22 – paragraph 7 a (new)
Article 22 – paragraph 7 a (new)
7 a. Priority in market authorisation shall be given to pharmaceuticals that are proven to have less harmful impacts on environment than their equivalents.
Amendment 655 #
Proposal for a directive
Article 23 – paragraph 1 – subparagraph 1
Article 23 – paragraph 1 – subparagraph 1
By [OP please insert the date = 3024 months after the date of the entry into force of this Directive] the Agency shall, after consultation with the competent authorities of the Member States, the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA), establish a programme for the ERA to be submitted in accordance with Article 22 of the medicinal products authorised before 30 October 2005 that have not been subject to any ERA and that the Agency has identified as potentially harmful to the environment in accordance with paragraph 2.
Amendment 658 #
Proposal for a directive
Article 23 – paragraph 2
Article 23 – paragraph 2
2. The Agency shall set the scientific criteria for the identification of the medicinal products as potentially harmful to the environment and for the prioritisation of their ERA, using a risk based approach. For this task, the Agency shall consult relevant stakeholders including drinking water and wastewater operators and may request from marketing authorisation holders the submission of relevant data or information.
Amendment 669 #
Proposal for a directive
Article 24 – paragraph 1
Article 24 – paragraph 1
1. The Agency shall, in collaboration with the competent authorities of the Member States, set-up an active, public substance based review system of ERA data (‘ERA monographs’) for authorised medicinal products. An ERA monograph shall include a comprehensive set of physiochemical data, fate data and effect data based on an assessment of a competent authority.
Amendment 734 #
Proposal for a directive
Article 43 – paragraph 6
Article 43 – paragraph 6
6. The competent authorities of the Member States shall make the environmental risk assessment and its the assessment report publicly available without undue delay, together with the reasons for their opinion, after deletion of any information of a commercially confidential nature. The justification shall be provided separately for each therapeutic indication applied for.
Amendment 766 #
Proposal for a directive
Article 47 – paragraph 1 – point e a (new)
Article 47 – paragraph 1 – point e a (new)
(e a) there is an equivalent alternative product on the market with scientifically proven less negative environmental impacts.
Amendment 783 #
Proposal for a directive
Article 51 – paragraph 1 – point f
Article 51 – paragraph 1 – point f
(f) contains an active substance listed in Article 22, paragraph 2 of this Directive or listed as an individual priority substance in Annex I to Directive 2008/105/EC [Environmental Quality Standards Directive] and which are persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, or persistent, mobile and toxic, or very persistent and very mobile for which medical prescription is required as risk minimisation measure with regard to the environment, unless the use of the medicinal product and the patient safety require otherwise. Emergency contraception shall be exempted from this requirement.
Amendment 1344 #
Proposal for a directive
Article 85 a (new)
Article 85 a (new)
Article 85a 1. Applications, decision-making procedures and decisions to regulate marketing authorizations or the prices of medicinal products or to determine their inclusion within the scope of public health insurance systems or the public and private procurement of medicinal products shall be considered by Member States as regulatory or administrative procedures which, as such, are independent from the enforcement of intellectual property rights. 2. The protection of intellectual property rights shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions relating to marketing authorisations, the price of a medicinal product or its inclusion within the public health insurance system, or the public and private procurement of medicinal products. 3. The applications, decision-making procedures and decisions referred to in paragraph 1 shall not be subject to conditions which expose applicants to a risk of infringement of the intellectual property rights. 4. Paragraphs 1, 2 and 3 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.
Amendment 1354 #
Proposal for a directive
Article 87 – paragraph 1 – subparagraph 1 – point a
Article 87 – paragraph 1 – subparagraph 1 – point a
(a) to conduct a post-authorisation safety study if there are concerns about the risks of an authorised medicinal product to public health or environment. If the same concerns apply to more than one medicinal product, the competent authority of the Member State shall, following consultation with the Pharmacovigilance Risk Assessment Committee, encourage the marketing authorisation holders concerned to conduct a joint post- authorisation safety study;
Amendment 1476 #
Proposal for a directive
Article 177 – paragraph 1 – point b a (new)
Article 177 – paragraph 1 – point b a (new)
(b a) contain substances listed as individual priority substances in Annex I to Directive 2008/105/EC [Environmental Quality Standards Directive].
Amendment 1561 #
Proposal for a directive
Article 197 – paragraph 3
Article 197 – paragraph 3
3. If the medicinal product in question is suspected of presenting a serious risk to public health or to environment, the competent authority of the Member State in which that product was first identified shall, without undue delay, transmit a rapid alert notification to all Member States and all actors in the supply chain in that Member State. In the event of such medicinal products being deemed to have reached patients, urgent public announcements shall be issued within 24 hours in order to recall those medicinal products from the patients. Those announcements shall contain sufficient information on the suspected quality defect or falsification and the risks involved.
Amendment 1636 #
Proposal for a directive
Annex VI – paragraph 1 – point 8 a (new)
Annex VI – paragraph 1 – point 8 a (new)
(8 a) for products containing substances listed in Article 22 paragraph 2 of this Directive, a warning that improper use and disposal of the medicinal product, inter alia through toilets, contributes to deteriorating the aquatic environment.