Activities of Ville NIINISTÖ related to 2023/0132(COD)
Shadow opinions (1)
OPINION on the proposal for a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
Amendments (74)
Amendment 69 #
Proposal for a directive
Recital 50
Recital 50
(50) The establishment of a criteria- based definition of ‘unmet medical need’ is required tonecessary to ensure incentivisees for the development of medicinal products in therapeutic areas that are currently underserved. To ensure that the concept of unmet medical need reflects scientific and technological developments and current knowledge in underserved diseases, the Commission should specify and update using implementing acts, the criteria of satisfactory method of diagnosis, prevention or treatment, ‘remaining high morbidity or mortality’, ‘relevant patient population’ following scientific assessment by the Agency. The Agency will seek input from a broad range of authorities or bodies active along the lifecycle of medicinal products in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004] and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs, burden of disease and priority setting for research and development are appropriately allocated and to prevent unintended extensions of data protection based on unclear interpretation of unmet medical need. The criteria for ‘unmet medical need’ can be subsequently used by Member States to identify specific therapeutic areas of interest.
Amendment 78 #
Proposal for a directive
Recital 52
Recital 52
Amendment 86 #
Proposal for a directive
Recital 54
Recital 54
(54) Micro, small and medium-sized enterprises (‘SMEs’), not-for-profit entities or entities with limited experience in the Union system should benefit from additional time to market a medicinal product in the Member States where the marketing authorisation is valid for the purposes of receiving additional regulatory data protection.
Amendment 88 #
Proposal for a directive
Recital 55
Recital 55
(55) When applying the provisions on market launch incentives, mMarketing authorisation holders and Member States should do their utmost to achieve a mutually agreed supply of medicinal products in accordance with the needs of the Member State concerned, without unduly delaying or hindering the other party from enjoying its rights under this Directive.
Amendment 92 #
Proposal for a directive
Recital 56
Recital 56
(56) Member States have the possibility to waive the condition of launch in their territorrequest a market launch of a centrally for the purpose of the prolongation of data protection for market launch. This can be done through a statement of non-objection to prolong the period of regulatory data protection. This is expected to be the case particularly in situations where launch in a particular Member State is materially impossible or because there are special reasons why a Member State wishes that launch take place ldecentrally approved product at any time after the marketing authorisation is valid in their Member State. Subsequently, marketing authorisation holders have nine months to apply for a pricing and reimbursement in that Member State, 18 months where the marketing authorisation holder is a SME, an entitiy not engaged in economic activity or an entity with limited experience in the Union system. Alternative timelines may be agreed between the Member State and the marketing authorisation holder. Marketing authorisation holders have the right to launch a product in a Member State before beign proactively approached by that Member Stater.
Amendment 93 #
Proposal for a directive
Recital 57
Recital 57
(57) The issuing of documentation from the Member States as regards the prolongation of data protection for the purpose of supply of medicinal productsapplication for pricing and reimbursement in allthe Member States where a marketing authorisation is valid, in particular the waiver to the conditions for such prolongation, does not affect at any time the powers of the Member States as regards the supply, setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes. Member States do not waive the possibility to request release or supply of the product concerned at any time before, during or after the prolongation of the data protection period.
Amendment 95 #
Proposal for a directive
Recital 58
Recital 58
(58) An alternative way of demonstrating supply relates to the inclusion of medicinal products in a positive list of medicinal products covered by the national health insurance system in accordance with Directive 89/105/EEC. The related negotiations between companies and the Member State should be tranparent and conducted in good faith.
Amendment 111 #
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 requiremeThe timely entry of generics and biosimilars onto the Union market is importants, necessarotably to obtain cregulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being consideredase competition, to reduce prices and to ensure both the sustainability of national healthcare systems and better access to affordable medicines by patient or SPC infringement. The application of this limited exemption is however fragmented across the Union ands in the EU. The importance of such timely entry has been underlined by the Council in it is considered necessary, in order to facilitate the market entry of generic, biosimilar, hybrid and bio-hybrid medicinal products that rely on a reference medicinal product, 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 confinedclusions of 17 June 2016 on strengthening the balance in the pharmaceutical systems in the Union and its Member States. It is currently possible for applicants for marketing authorisation of medicinal products to conduct studies and, trials and other activities needed for the regulatory approval process, health technology assessment and pricing reimbursement request, even subsequent practical requirements necessary to obtain regulatory approvals and variations thereof, withought this may require substantial amounts of test production to demonstrate reliable manufacturing. During the term of protection of the patent or SPC of the reference medicinal product, there can be no commercial use of the resulting final medicinal products obtained for the purposes of the regulatory approval processbeing considered patent or Supplementary Protection Certificate (SPC) infringement.
Amendment 115 #
Proposal for a directive
Recital 63 a (new)
Recital 63 a (new)
(63 a) The application of this limited exemption is however fragmented across the Union and it is considered necessary, in order to facilitate entering the market of any Member State of medicinal products and in particular generic, biosimilar, hybrid and bio-hybrid medicinal products, upon expiry of the corresponding patent or supplementary protection certificate (EU ‘Day-one’ entry) that rely on a reference medicinal product, 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 conduct studies, trials and other activities needed for the administrative or regulatory approval process, health technology assessment and and for obtaining pricing and reimbursement, as well as the public and private procurement of medicinal products to be supplied immediately after tbe expiry of the corresponding patent or supplementary protection certificate), even though this may require substantial amounts of test production to demonstrate reliable manufacturing both by the applicant or third party suppliers or service providers. During the term of protection of the patent or SPC of the medicinal product, 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 118 #
Proposal for a directive
Recital 64
Recital 64
(64) It will allow all steps required to effectively launch on day-one after patent and SPC protection, inter alia, to conduct studactivities to support regulatory approval, health technology assessment, pricing and reimbursement as well as the manufacture or purchase of patent protected active substances for the purpose of seeking marketing authorisations during that periodaforementioned purposes, contributing to the market entry of generics and biosimilars on day one of loss of the patent or SPC protection.
Amendment 124 #
Proposal for a directive
Recital 65 a (new)
Recital 65 a (new)
(65 a) Under EU law, originator reference product patent protection status is not a criterion to be considered by authorities when granting a marketing authorisation, approving pricing or granting reimbursement status or any regulatory approval for a generic medicinal product, due to its anitcompetitive effects. In the context of the goals of the revision of the pharmaceutical framework, it is therefore appropriate to explicitly prohibit patent linkage practices in this context.
Amendment 134 #
Proposal for a directive
Recital 70
Recital 70
(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or, they do not propose risk mitigation measures to sufficiently address the risks identified or the environmental risk is deemed unacceptable in the environmental risk assessment, the marketing authorisation should be refused. The ERA should be updated wheneach time new data or knowledge about relevant risks become available.
Amendment 140 #
Proposal for a directive
Recital 72
Recital 72
(72) TLike every industrial sector, the production of medicines has a negative impact on the environment through CO2 emissions deriving from the medicines' global supply chains and through pharmaceutical effluents from the production, use and disposal. In addition, the emissions and discharges of antimicrobials to the environment from manufacturing sites may lead to antimicrobial resistance (“AMR”), which is a global concern regardless where the emissions and discharges take place. Therefore, the ERA scope should be extended to cover the risk of AMR selection during the entire life cycle of antimicrobiaddressing manufacturing, use and disposal through monitoring, assessing and preventing the negative impact, addressing inefficiencies and developing greener pharmaceuticals, including manufacturings crucial to mitigate threats to public health.
Amendment 145 #
Proposal for a directive
Recital 74 a (new)
Recital 74 a (new)
(74 a) In order to reduce duplication, optimise resources, reduce the use of animals in research, address current lack of understanding and resources on the individual and aggregated impact of pharmaceutical substances in the environment, and in line with the Aarhus Convention, all data related to the environmental risk assessment studies should be made publicly available and easily accessible in a database established by the Agency.
Amendment 155 #
Proposal for a directive
Recital 110
Recital 110
(110) The quality of medicinal products manufactured or available in the Union should be guaranteed by requiring that the active substances used in their composition comply with the principles of good manufacturing practice in relation to those medicinal products and that manufacturing is carried out in compliance with local environmental and occupational health and labour rights standards. It has proved necessary to reinforce the Union provisions on inspections and to compile a Union database of the results of those inspections.
Amendment 159 #
Proposal for a directive
Recital 127
Recital 127
(127) The use of electronic and technological possibilities other than paper package leaflets, which are complementary to the paper leaflet that is crucial for patients with limited digital health literacy can facilitate access to medicinal products, medicinal products distribution and should always guarantee equal or better quality of information to all patients compared to the paper form of product information. Ensuring the protection of personal data pursuant to Regulation 2016/679 and prohibition of the identification, profiling or tracking of individuals is necessary in this regard.
Amendment 160 #
Proposal for a directive
Recital 128
Recital 128
(128) Member States have varying levels of digital literacy and internet access. In addition, patient and healthcare professional needs may differ. It is therefore necessary that Member States have a discretion on the adoption of measures enabling the electronic provision of product information while ensuring that no patient is left behind, taking into account the needs of different age categories and the different levels of digital literacy in the population, and making sure that product information is easily accessible to all patients. Member States should progressively allow the possibility for electronic product information, as an addition to the paper leaflet, while ensuring full compliance with the rules on protection of personal data, and adhere to harmonised standards developed at EU level. The information in digital format should be easily accessible to all patients, for instance by including in the outer packaging of the product a digitally readable barcode, which would direct the patient to the electronic version of the package leaflet.
Amendment 162 #
Proposal for a directive
Recital 129
Recital 129
Amendment 166 #
Proposal for a directive
Recital 131
Recital 131
(131) To ensure a high level of transparency of public support to the research and development of medicinal products, the reporting of public contribution for the development of a particular medicinal product should be a requirement for all medicines. Given however the practical difficulty to identify how indirect public funding instruments, such as tax advantages, have supported a particular product, the reporting obligation should only concern the direct public financial support, such as direct grants or contracts. Therefore, tThe provisions of this Directive ensuare, without prejudice to the rules on the protection of confidential and personal data, and ensure transparency regarding any direct and indirect financial support received from any public authority or, public body, philantropic and other not-profit organisation including academia to carry out any activities for the research and development of medicinal products. In addition, when submitting a request for pricing and reimbursement, marketing authorisation holders should disclose, upon request, the company’s expenditure related to the research and development costs of the product.
Amendment 275 #
Proposal for a directive
Article 22 – paragraph 1
Article 22 – paragraph 1
1. When preparing the environmental risk assessment (‘ERA’) to be submitted pursuant to Article 6(2), the applicant shall take into account the scientific guidelines on the environmental risk assessment of medicinal products for human use as referred to in paragraph 65, or provide the reasons for any divergence from the scientific guidelines to the Agency or, as appropriate to the competent authority of the Member State concerned, in a timely manner. Where available, the applicant shall take into account existing ERAs performed under other Union legislation.
Amendment 277 #
Proposal for a directive
Article 22 – paragraph 1 a (new)
Article 22 – paragraph 1 a (new)
1 a. The ERA shall evaluate possible risks to the environment due to use and disposal of the medicinal product according to the requirements referred to in Annex II. With regard to risks resulting from manufacturing, the ERA shall provide information on discharges and emissions of the active substance and other environmentally relevant substances according to the requirements referred to in Annex II.
Amendment 287 #
Proposal for a directive
Article 22 – paragraph 3
Article 22 – paragraph 3
3. The applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, to reduce discharges and emissions of the medicinal product to the environment and information on available techniques that will be used to reduce those discharges and emissions, in particular those occurring in manufacturing effluents before these effluents leave the manufacturing sites and to limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.
Amendment 292 #
Proposal for a directive
Article 22 – paragraph 4
Article 22 – paragraph 4
4. The ERA for antimicrobialsFor antimicrobials and other substances which may cause antimicrobial resistance, including products with an antimicrobial mode of action, the ERA shall include an evaluation of the risk for antimicrobial resistance selection in the environment due to the entire manufacturing supply chain inside and outside the Union, use and disposal, including by healthcare professionals and patients, of the antimicrobial taking into account, where relevant, the existing international standards that have established predicted no effect concentration (PNECs) specific for antibiotics.
Amendment 300 #
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, tThe Agency shall consult the European Centre for Disease Prevention and Control (ECDC), the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA) and other stakeholders, including drinking water and wastewater operators, on the drafting of these scientific guidelines.
Amendment 301 #
Proposal for a directive
Article 22 – paragraph 6 – subparagraph 1
Article 22 – paragraph 6 – subparagraph 1
The marketing authorisation holder shall include analytical techniques and explanations in the methodology on the ERA and update the ERA with new information without undue delay to the relevant competent authorities, in accordance with Article 90(2), if new information pertaining to the assessment criteria referred to in Article 29 becomes available and could lead to a change of the conclusions of the ERA. The update shall include updates on the emissions of the medicinal product in manufacturing effluents and any relevant information from environmental monitoring, including monitoring under Directive 2000/60/EC, from eco-toxicity studies, from new or updated risk assessments under other Union legislation, as referred to in paragraph 1, and environmental exposure data.
Amendment 307 #
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 if missing information has been identified for medicinal products potentially harmful to the environment. The ERA shall be updated when new information becomes available, every 5 years at the latest.
Amendment 308 #
Proposal for a directive
Article 22 – paragraph 7
Article 22 – paragraph 7
7. For medicinal products referred to in Articles 9 to 12, the applicant may, where appropriate, refer to ERA studies conducted for the reference medicinal product when preparing the ERA and shall provide any other data required in accordance with Annex II and the scientific guidelines as referred to in the first paragraph.
Amendment 310 #
Proposal for a directive
Article 22 – paragraph 7 a (new)
Article 22 – paragraph 7 a (new)
7 a. In line with the Aarhus Convention1a, full environmental assessment studies and summaries with outcomes shall be made publicly available and proactively shared with drinking water and wastewater operators. The competent authorities shall include this information in their repository of medicinal products. _________________ 1a UN Convention on access to information, public participation in decision-making and access to justice in environmental matters, done at Aarhus, Denmark, on 25 June 1998.
Amendment 314 #
Proposal for a directive
Article 23 – paragraph 1 – subparagraph 1
Article 23 – paragraph 1 – subparagraph 1
By [OP please insert the date = 3012 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 Centre for Disease Prevention and Control (ECDC), 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 319 #
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 mayshall consult all relevant stakeholders and request from marketing authorisation holders the submission of relevant data or information.
Amendment 323 #
Proposal for a directive
Article 23 – paragraph 3
Article 23 – paragraph 3
3. The marketing authorisation holders for medicinal products identified in the programme referred to in paragraph 1 shall submit the ERA to the Agency. The outcome of the assessment of the ERA, including the datafull data sets and summaries of conducted ERA studies submitted by the marketing authorisation holder, shall be made publicly available by the Agency and shall be proactively shared with drinking and wastewater operators.
Amendment 400 #
Proposal for a directive
Article 57 – paragraph 1
Article 57 – paragraph 1
1. The marketing authorisation holder shall declare to the public any direct and indirect financial support received from any public authority or publicly funded body, philantropic or non-for profit organisation or fund in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity that received that support.
Amendment 404 #
Proposal for a directive
Article 57 – paragraph 1 a (new)
Article 57 – paragraph 1 a (new)
1 a. The marketing authorisation holder shall declare all cases where the product was acquired at any stage of development from an entity not engaged in an economic activity (‘not-for-profit entity’) or a public-private research consortium.
Amendment 406 #
Proposal for a directive
Article 57 – paragraph 2 – point a – point ii
Article 57 – paragraph 2 – point a – point ii
(ii) the public authority or, publicly funded body, philantropic or non-for profit organisation or fund that provided the financial support referred to in point (i);
Amendment 412 #
Proposal for a directive
Article 57 – paragraph 2 – point a – point iii a (new)
Article 57 – paragraph 2 – point a – point iii a (new)
(iii a) the percentage of total research and development costs covered by the financial support referred to in paragraph 1;
Amendment 414 #
Proposal for a directive
Article 57 – paragraph 2 – point a – point iii b (new)
Article 57 – paragraph 2 – point a – point iii b (new)
(iii b) where applicable, information related to acquiring of product license from a not-for-profit-entity or a public- private consortium, including the amount of public funding invested prior to acquisition of the product, stage of development and name of the entity.
Amendment 416 #
Proposal for a directive
Article 57 a (new)
Article 57 a (new)
Article57a Responsibility to report on research and development costs In addition to the information listed in Article 57, the marketing authorisation holder shall, when submitting an application for reimbursement in a Member State for a nationally or centrally authorised product, declare upon request from the national competent authority responsible for pricing and reimbursement a detailed externally- audited reporting on the company’s expenditure related to the research and development cost of the medicinal product.
Amendment 417 #
Proposal for a directive
Article 58 – title
Article 58 – title
Traceability of substances used in the manufacture of medicinal products and manufacturing in the environmental impact assessment
Amendment 419 #
Proposal for a directive
Article 58 – paragraph 1
Article 58 – paragraph 1
1. The marketing authorisation holder shall, when necessary, ensure the traceability of an active substance, starting material, excipient or any other substance intended or expected to be present in a medicinal product at all stages of manufacturing and distribution.
Amendment 420 #
Proposal for a directive
Article 58 – paragraph 1 a (new)
Article 58 – paragraph 1 a (new)
1 a. The marketing authorisation holder shall include the manufacturing process of the substances referred to in paragraph 1 as an integral part of the environmental impact assessment referred to in Article 22 and in line with requirements set in Annex II.
Amendment 424 #
Proposal for a directive
Article 58 a (new)
Article 58 a (new)
Article 58a Obligation to launch products in Member States 1. The marketing authorisation holder shall, upon request by a Member State in which the marketing authorisation is valid, release and continuously supply into the supply chain the requested product in a sufficient quantity and in the presentations necessary to cover the needs of the patients in the Member State no later than nine months from the date when the Member State made its request, or within 18 months from that date for any of the following entities: (i) SMEs; (ii) entities not engaged in an economic activity (‘not-for-profit entity’); or (iii) undertakings that, by the time of granting the marketing authorisation, have received not more than seven centralised marketing authorisations for the undertaking concerned or, in the case of an undertaking belonging to a group, for the group of which it is part, since the establishment of the undertaking or the group, whichever is earliest. 2. The obligation laid down in paragraph 1 shall not prevent the marketing authorisation holder from submitting a pricing and reimbursement application in a Member State before receiving the request. 3. Following agreement between a Member State and a marketing authorisation holder, timelines other than those set out in paragraph 1 may apply. 4. For products authorised under [revised Regulation 726/2004], the marketing authorisation holder shall notify the Agency about the result of placing on the market of the products, in order to fulfil obligations set out in Article 138(2) of [revised Regulation 726/2004]. 5. Following the filing for pricing and reimbursement by the marketing authorisation holder, Directive 89/105/EEC shall apply. 6. Where a marketing authorisation is transferred to a different legal entity before the end of the period referred to in paragraph 1, the obligations shall be transferred to the new marketing authorisation holder.
Amendment 430 #
Proposal for a directive
Article 63 – paragraph 3
Article 63 – paragraph 3
3. Member States may decide that tThe package leaflet shall be made available in paper format or electronically, or both. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packaging of a medicinal product. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it shouldboth electronic and paper format. The printed copy of the package leaflet shall be included in the product's packaging. It shall be ensured that the information in digital format is easily accessible to all patients.
Amendment 446 #
Proposal for a directive
Article 63 – paragraph 5
Article 63 – paragraph 5
Amendment 467 #
Proposal for a directive
Article 63 – paragraph 7
Article 63 – paragraph 7
7. Where the package leaflet is made available electronically, the individual right to privacy shall be ensured. Any technology giving access to the information shall ensure the protection of personal data pursuant to Regulation 2016/679 and not allow the identification, profiling or tracking of individuals, nor shall it be used for commercial purposes.
Amendment 482 #
Proposal for a directive
Article 67 – paragraph 6
Article 67 – paragraph 6
6. Member States may, for the purposes of reimbursement, pharmacovigilance, pharmacoepidemiology or for data protection prolongation for market launchmonitoring of medicine shortages use the information contained in the repositories system referred to paragraph 2, second subparagraph, point (e).
Amendment 512 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a
Article 81 – paragraph 2 – subparagraph 1 – point a
Amendment 527 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point c
Article 81 – paragraph 2 – subparagraph 1 – point c
Amendment 532 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point d
Article 81 – paragraph 2 – subparagraph 1 – point d
(d) 12six months, where the marketing authorisation holder obtains, during the data protection period, an authorisation for an additional therapeutic indication for which the marketing authorisation holder has demonstrated, with supporting data, a significant clinical benefit in comparison with existing therapies.
Amendment 539 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 2
Article 81 – paragraph 2 – subparagraph 2
In the case of a conditional marketing authorisation granted in accordance with Article 19 of [revised Regulation (EC) No 726/2004] the prolongation referred to in the first subparagraph, point (b), shall only apply if, within fourthree years of the granting of the conditional marketing authorisation, the medicinal product has been granted a marketing authorisation in accordance with Article 19(7) of [revised Regulation (EC) No 726/2004.
Amendment 543 #
Proposal for a directive
Article 81 – paragraph 3
Article 81 – paragraph 3
Amendment 544 #
Proposal for a directive
Article 81 – paragraph 3 a (new)
Article 81 – paragraph 3 a (new)
3 a. All product-specific regulatory protection periods shall be made publicly available in the medicine repository on the website of the national competent authority and the Agency.
Amendment 548 #
Proposal for a directive
Article 82
Article 82
Amendment 579 #
Proposal for a directive
Article 83 – paragraph 1 – point a
Article 83 – paragraph 1 – point a
(a) there is no medicinal product authorised in the Union, medical service or SoHO preparation authorised in the Member State or the Union or other therapeutic option available for such disease, or, where despite medicinal products being authorised or therapeutic options available for such disease in the Union, the disease is associated with a remaining high morbidity or mortality; and
Amendment 596 #
Proposal for a directive
Article 83 – paragraph 2
Article 83 – paragraph 2
Amendment 607 #
Proposal for a directive
Article 84 – paragraph 1 – introductory part
Article 84 – paragraph 1 – introductory part
1. A regulatory data protection period of fourtwo years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:
Amendment 609 #
Proposal for a directive
Article 84 – paragraph 1 – point a
Article 84 – paragraph 1 – point a
(a) adequate non-clinical or clinical studies were carried outith an active-comparator were carried out by the marketing authorisation holder in relation to the therapeutic indication demonstrating that it is of significant clinical benefit, and
Amendment 623 #
Proposal for a directive
Article 85 – paragraph 1 – introductory part
Article 85 – paragraph 1 – introductory part
Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when a reference medicinal product is used for the purposes of:
Amendment 629 #
Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part
Article 85 – paragraph 1 – point a – introductory part
(a) studies, trials and other activities are conducted to generate data for an application, forfor the purpose of:
Amendment 635 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point i
Article 85 – paragraph 1 – point a – point i
(i) obtaining a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinalfor products and for subsequent variations;
Amendment 639 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point ii
Article 85 – paragraph 1 – point a – point ii
(ii) conducting health technology assessment as defined in Regulation (EU) 2021/2282;
Amendment 645 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii
Article 85 – paragraph 1 – point a – point iii
(iii) obtaining pricing and reimbursement. approval;
Amendment 649 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)
Article 85 – paragraph 1 – point a – point iii a (new)
(iii a) participating in public and private procurement tenders of medicinal products for which the fulfillment of the obligations laid out in the tender will commence after the expiry of the relevant patents or supplementary protection certificates;
Amendment 653 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii b (new)
Article 85 – paragraph 1 – point a – point iii b (new)
(iii b) complying with any other regulatory or administrative requirements necessary for the purpose of placing the medicinal product on the Union market or for export in third countries markets, after expiration of the patent or supplementary protection certificate.
Amendment 663 #
Proposal for a directive
Article 85 – paragraph 1 – point b
Article 85 – paragraph 1 – point b
(b) the activities conducted exclusively for the purposes set out in point (a), mayshall cover the submission of the application for a marketing authorisation and the offering, manufacture, sale, supply, storage, import, export, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.
Amendment 668 #
Proposal for a directive
Article 85 – paragraph 2
Article 85 – paragraph 2
This exception shall not cover the placing on the market of the medicinal products resulting from such activities before expiry of relevant patent or supplementary protection certificates.
Amendment 671 #
Proposal for a directive
Article 85 a (new)
Article 85 a (new)
Article 85a Prohibition on patent linkage 1. Member States shall not, when conducting regulatory or administrative procedures in regards to activities carried out in accordance with Article 85, enforce intellectual property rights as a valid ground for refusal, suspension, delay, withdrawal or revocation of marketing authorisation, pricing and reimbursement decisions or tender bids in regards to public and private procurement of medicinal products. 2. If the market authorization holder ceases to commercialise a medicinal product in the Union, the Commission shall have a public purchase option for all related intellectual property rights.
Amendment 691 #
Proposal for a directive
Article 143 – paragraph 1 – subparagraph 2 – point a a (new)
Article 143 – paragraph 1 – subparagraph 2 – point a a (new)
(a a) environmental impact assessment of the product’s manufacturing process;
Amendment 692 #
Proposal for a directive
Article 143 – paragraph 1 – subparagraph 2 – point b a (new)
Article 143 – paragraph 1 – subparagraph 2 – point b a (new)
(b a) proof that the product’s supply chain is diversified, identifying alternatives for each component;
Amendment 701 #
Proposal for a directive
Article 159 – paragraph 1 – subparagraph 1
Article 159 – paragraph 1 – subparagraph 1
At the request of a third country, the Commission shall assess whether that country’s regulatory framework applicable to active substances exported to the Union and the respective control and enforcement activities ensure a level of protection of public healthand worker's health and environment equivalent to that of the Union.
Amendment 702 #
Proposal for a directive
Article 159 – paragraph 2 – subparagraph 2 – point a
Article 159 – paragraph 2 – subparagraph 2 – point a
(a) the country’s rules for good manufacturing practice; including local environmental manufacturing standards, occupational health and labour rights standards;
Amendment 709 #
Proposal for a directive
Article 166 – paragraph 1 – point g – point v
Article 166 – paragraph 1 – point g – point v
(v) the batch number and serial number of the medicinal products, at least for medicinal products bearing the safety features referred to in Article 67;
Amendment 735 #
Proposal for a directive
Article 195 – paragraph 2
Article 195 – paragraph 2
2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission mayshall suspend, revoke or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder.
Amendment 736 #
Proposal for a directive
Article 195 – paragraph 3
Article 195 – paragraph 3
3. A marketing authorisation may also be suspended, revoked or varied where the particulars supporting the application as provided for in Articles 6, 9 to 14 or Annexes I to V are incorrect or have not been amended in accordance with Article 90, or where any conditions referred to in Articles 44, 45 and 87 have not been fulfilled or where the controls referred to in Article 191 have not been carried out.
Amendment 765 #
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 classified based on Annex I of Regulation (EC) No 1272/2008 as persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), very persistent and very mobile (vPvM) or are endocrine active agents, a warning that improper use and disposal of the medicinal product, inter alia through toilets, contributes to deteriorating the aquatic environmen[A1] t. [A1]Justification: Patients, healthcare professionals and pharmacists must be informed of the impact on the aquatic environment of products containing PBT, vPvB, PMT and vPvM substances, as well as endocrine disruptors, so they dispose properly of products and can make informed choices between alternative treatments.