Changes from plenary report to adopted text

RemovedThe Committee on the Environment, Climate and Food Safety submits the following to the Committee on Public Health, as the committee responsible:

RemovedRecital 4: (4) Industrial challenges and a lack of investments in manufacturing capacities in the Union have contributed to increased dependency on third country suppliers, in particular, for key raw pharmaceutical materials and active substances. Setting up new, or modernising existing manufacturing capacities in the Union for critical medicinal products, their key inputs and active substances, which have often been on the market for a long time and are considered to be relatively inexpensive, is currently not seen as a sufficiently attractive option for private investment, also in view of lower energy costs, lesser environmental and other legal requirements elsewhere in the world. Workforce shortages and the need for specialised skills in pharmaceutical manufacturing further add to the industrial challenges to manufacturing in the Union. Targeted financial incentives, simplified administrative processes, upholding social, health and environmental standards, and better Union-level coordination can contribute to supporting efforts to increase manufacturing capacities in the Union and strengthen the supply chains for critical medicines.

RemovedRecital 4 a (new): (4a) The 2019 Commission Strategic Approach to Pharmaceuticals in the Environment acknowledges that pharmaceuticals may pose risks to the environment and human health and highlights the need for a comprehensive and proportionate strategy, consistent with the Union’s commitment to the One Health approach.

RemovedRecital 17: (17) Certain projects can have a positive impact on security of supply as they increase the Union’s manufacturing capacity for critical medicinal products and strengthen the resilience of the Union’s supply chains. In order to encourage private investments in these projects, the concept of strategic projects should be introduced. Given their role in ensuring the Union’s security of supply for critical medicinal products, the relevant permitting authority should consider strategic projects to be in the public interest. To ensure their expedient implementation, national authorities should ensure that the relevant permit granting processes are carried out in the fastest way possible making available, in particular any form of accelerated procedures that exists in applicable Union and national law, upholding social, health and environmental standards. National authorities should consider, when possible, their streamlining as well as enable digital submission of required information.

RemovedRecital 18 a (new): (18a) It is essential to ensure that the production of pharmaceutical products within the Union is conducted in a safe, responsible and sustainable manner over the long term, such as by reducing environmental pollution by manufacturing waste, this form of pollution may contribute to the spread of antimicrobial resistance, impact ecosystems and biodiversity, and thereby create possible risks for public health.

RemovedRecital 19: (19) The production of medicinal products has environmental implications and may negatively impact not only the environment itself but also human health. The environmental assessments and authorisations required under Union law are an integral part of the permit-granting process for strategic projects and an essential safeguard to ensure negative environmental impacts are prevented or minimised. However, to ensure that permit-granting processes for strategic projects are predictable and timely, it should be possible to streamline the required assessments and authorisations by the relevant authority, without undermining the quality and robustness of the assessments and while not lowering the level of health and environmental protection.

RemovedRecital 24: (24) Given that public authorities or entities are the principal buyers of medicinal products for the inpatient sector and that the public procurement of medicinal products is a powerful tool to improve security of supply and the availability and accessibility of other medicinal products of common interest, it is necessary to establish rules that require the use of the procurement requirements referring to Most Economically Advantageous Tender (MEAT) that take into account the supply security and availability considerations. Procurement requirements based on such considerations should include an appropriate and predictable balance of qualitative criteria including product quality measured by patient impact and clinical value, environmental sustainability, such as the use of sustainable and innovative manufacturing technologies and the minimisation of active substance emissions during production, pharmaceutical innovation for patients, and the society, in addition to stockholding obligations, a number of diversified suppliers, state of the art monitoring of supply chains, their transparency to the contracting authority and contract performance clauses on timely delivery and measures in case of non-timely delivery.

RemovedRecital 39: (39) The Union could further enhance the availability and security of supply of critical medicinal products by providing access to alternative sources of supply in third countries through international trade agreements or other forms of international cooperation. The Union could, to that end, rely on its network of existing trade agreements and additionally pursue strategic partnerships with third countries to further deepen bilateral cooperation, especially with candidate countries. In this context, the Commission should assess whether existing partnerships effectively address the intended aims or could be further improved or upgraded, and what types of potential partnerships could be concluded with the most relevant third countries. This should be done without prejudice to the prerogatives of the Council in accordance with the Treaties. Any such partnership should support a high level of safety, environmental protection, quality, and efficacy.

RemovedRecital 41: (41) In order to ensure that this Regulation effectively meets its objectives, it is essential to assess its implementation and impact over time. The Commission should carry out an evaluation of this Regulation five years after its application and every five years thereafter. This evaluation should include an assessment of the extent to which the Regulation’s objectives, as set out in Article 1, have been achieved, including its impact on stakeholders, regulatory procedures, and market dynamics. In particular, the Commission’s evaluation should take into account the views of Member States, economic operators, and other relevant stakeholders, ensuring that their feedback contributes to the continuous improvement of the regulatory framework. At the same time and to safeguard the availability and security of supply of critical medicinal products, all market actors, competent authorities, Member States and the Commission should ensure that all barriers, such as regulatory, economic and market-based, are identified and evaluated as part of the Commission’s assessment on the achievement of the objectives of this Regulation. The results of this evaluation should be presented to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. In order to facilitate this evaluation, national authorities and economic operators should provide relevant data and information upon request to support the Commission’s assessment.

RemovedRecital 41 a (new): (41a) This Regulation should be implemented in line with existing Union legislation. Where the evaluation has identified that such legislation has the possibility to impact in an adverse manner on the accessibility, availability or affordability of medicinal products, the Commission should carry out comprehensive, evidence-based assessments and, where appropriate, propose proportionate mitigating measures to safeguard supply, availability and affordability of medicinal products and to support the Union's competitiveness.

RemovedArticle 3 – paragraph 1 – point 13: (13) ‘innovative manufacturing process’ means a novel manufacturing process and technology or novel application of an existing technology, including, but not limited to, decentralised manufacturing, continuous manufacturing, yield improvements or other chemistry or biotechnology process that contribute to increasing the level of security, energy efficiency and environmental performance of the production, Artificial Intelligence, platform techniques, 3D manufacturing and sustainable manufacturing methods;

RemovedArticle 5 – paragraph 1 – point b: (b) it modernises an existing manufacturing site for one or more critical medicinal products or their active substances to ensure greater environmental sustainability, overall sustainability or increased efficiency, such as innovative processes that improve production quality, resilience, or reliability;

RemovedArticle 7 – paragraph 2: The Member States’ authorities shall ensure that the relevant permit granting processes related to strategic projects are carried out in the fastest way possible, making available, in particular, any form of accelerated procedures that exists in applicable Union and national law, while ensuring compliance with the highest social, health and environmental standards.

RemovedArticle 12 – paragraph 1 – subparagraph 1: A project promoter may request, where the obligation to assess the effects on the environment arises simultaneously from two or more of Council Directive 92/43/EEC15 , Directive 2000/60/EC of the European Parliament and of the Council16 , Directive 2001/42/EC of the European Parliament and of the Council17 ,Directive 2008/98/EC of the European Parliament and of the Council18 , Directive 2009/147/EC of the European Parliament and of the Council19 , Directive 2010/75/EU of the European Parliament and of the Council20 , Directive 2011/92/EU of the European Parliament and of the Council21 or Directive 2012/18/EU of the European Parliament and of the Council22 , that a coordinated or joint procedure fulfilling the requirements of those Union legislative acts are applied. The application of the joint or coordinated procedure shall not affect the content or quality of the environmental impact assessment.

RemovedArticle 12 – paragraph 2: 2. Member States shall ensure that the competent authorities issue the reasoned conclusion referred to in Article 1(2), point (g)(iv), of Directive 2011/92/EU on the environmental impact assessment within 45 days of receiving all necessary information pursuant to Articles 5, 6 and 7 of that Directive and after completing the consultations referred to in Articles 6 and 7 of that Directive, with a possibility of extension by a maximum of 45 days in duly justified cases.

RemovedArticle 12 – paragraph 5 a (new): 5a. Member States shall ensure that their competent authorities and other authorities designated pursuant to Article 6(1) of Directive 2011/92/EU have a sufficient number of qualified staff and sufficient financial, technical and technological resources necessary to fulfil their obligations under this Article.

RemovedArticle 13 – paragraph 1: 1. National, regional and local authorities responsible for preparing plans, including zoning, spatial plans and land use plans, shall consider including in such plans, where appropriate, provisions for the development of Strategic Projects, as well as the necessary infrastructure. To facilitate the development of strategic projects, Member States shall ensure that all relevant planning authorities have the resources needed to decide upon, in a timely manner, any planning application and that all relevant spatial planning data is available and accessible, including online.

RemovedArticle 13 – paragraph 2: 2. Where plans including provisions for the development of strategic projects are subject to an assessment pursuant to Directive 2001/42/EC of the European Parliament and of the Council and pursuant to Article 6(3) of Directive 92/43/EEC, those assessments shall be combined. Where applicable, the combined assessment shall also address the impact on potentially affected water bodies referred to in Directive 2000/60/EC. Where Member States are required to assess the impacts of existing and future activities on the marine environment, including land-sea interactions, in accordance with Article 4 of Directive 2014/89/EU of the European Parliament and of the Council23, the combined assessment shall also cover those impacts. The fact that assessments are combined pursuant to this paragraph shall not affect their content or quality or robustness of the assessment.

RemovedArticle 14 – paragraph 2: 2. All decisions adopted pursuant to the Articles in this section shall be made publicly available in an easily understandable manner, including online, and all decisions concerning one project shall be available on the same website.

RemovedArticle 18 – paragraph 1: 1. For award procedures of critical medicinal products falling within the scope of Directive 2014/24/EU of the European Parliament and of the Council, contracting authorities in the Member States shall wherever feasible implement multi-winner procurements, which scope is designed based on clinical needs in consultation with healthcare professionals and relevant experts, with predictable procurement timelines. Contracting authorities in the Member States shall apply procurement requirements, other than price-only award criteria such as procurement requirements that promote the resilience of supply in the Union. Those procurement requirements shall be defined in accordance with Directive 2014/24/EU and shall include several qualitative criteria, such as patient impact and clinical value, environmental sustainability, innovation, diversity and robustness of supply chain, may relate to stockholding obligations, the number of diversified suppliers, monitoring of supply chains, their transparency to the contracting authority, and contract performance clauses on timely delivery.

RemovedArticle 18 – paragraph 4: 4. This Article shall not preclude contracting authorities from using additional qualitative requirements, including in relation to environmental sustainability, and social rights. In order to safeguard the integrity of the Single Market, the Commission shall support coordination and the exchange of best practices between Member States.

RemovedArticle 19 – paragraph 1 – subparagraph 1 a (new): Member States shall aim to ensure that the design and periodic review of such programmes involve health professionals and patient organisations, as well as environmental expertise, to balance public health needs, affordability and sustainability.

RemovedArticle 20 – paragraph 2 a (new): Stockpiling management system shall apply a “first in, first out” principle and promote the use of shelf-life extension studies, in order to reduce expiry-related waste. The Commission, in cooperation with the Member States and the relevant agencies, shall adopt guidelines on sustainable stockpiling, including measures to reduce emissions, improve packaging, manage expiry dates, and ensure the environmentally sound disposal of unused or obsolete medicinal products.

RemovedArticle 26 – paragraph 2 – point d a (new): (da) recommend minimum common indicators for monitoring the environmental and supply-resilience performance of procurement programmes, ensuring proportionality and avoiding duplication.

RemovedArticle 27 – paragraph 1: Without prejudice to the prerogatives of the Council, the Commission, shall explore possibilities of concluding strategic partnerships aiming to diversify sourcing of critical medicinal products, their active substances and key inputs to increase the security of supply of critical medicinal products in the Union. The Commission shall also explore the possibility of building on existing forms of cooperation, when possible, to support security of supply and reinforce efforts to strengthen the production of critical medicinal products in the Union. Such partnership shall support a high level of safety, environmental protection, quality, and efficacy.

RemovedArticle 30 – paragraph 1: 1. By [OP please insert the date of:] five years after the date of application of this Regulation and every five years thereafter, the Commission shall within its evaluation assess the impact of other relevant Union legislation on this Regulation and present a report on the main findings to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.

RemovedArticle 30 – paragraph 2 a (new): 2a. Where the evaluation referred to in paragraph 1 identifies a potential risk to the availability or security of supply of a critical medicinal product in the Union, the Commission shall carry out a coordinated, evidence-based impact assessment and, where appropriate, propose proportionate and appropriate mitigating measures in consultation with the Member States and relevant stakeholders.