What changed

Recital 12 a (new): (12 a) Contraceptives and abortifacient medicinal products are essential for safeguarding sexual and reproductive health rights, gender equality and the full enjoyment of fundamental rights everywhere in the Union. Shortages and supply disruptions affecting these medicinal products of common interest undermine patient safety and contribute to unequal access to healthcare across the Union. In order to safeguard sexual and reproductive health rights and equal access to contraceptive and abortifacient medicinal products for all women in the Union, Member States should ensure the availability, affordability and security of supply of these medicinal products of common interest.

Article 3 – paragraph 1 – point 4 a (new): (4a) ‘substance of human origin’ or ‘SoHO’ means a ‘substance of human origin’ or ‘SoHO’, as defined in Regulation (EU) 2024/19381a; / 1a Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC.

Article 3 – paragraph 1 – point 5: (5) ‘medicinal product of common interest’ means a medicinal product, other than a critical medicinal product, for which in three or more Member States the functioning of the market does not sufficiently ensure the availability, affordability and accessibility to patients in the quantities and presentations necessary to cover the needs of patients in those Member States or is designated as an orphan medicinal product pursuant to Article 67 of Regulation (EU).../...(EU) .../... [reference to be added after adoption cf. COM(2023)COM(2023)193 193final)], final)];or as a contraceptive or abortifacient medicinal product;

Article 3 – paragraph 1 – point 5 b (new): (5b) ‘systemic wholesaler’ means a wholesaler of medicinal products that holds a wholesale distribution authorisation and fulfils all obligations laid down in Article 166 of Directive (EU) …/… [reference to be added to corresponding Article after adoption of cf. COM(2023)192 final]. They wholesale and continuously distribute either the full range of prescription medicines, meaning more than 80% of the 80%,prescription medicines available for retail sale in a Member State market, or above 20% of the total market share of prescription medicines,medicines available for retail sale in a Member State market;

Article 5 – paragraph 1 – point d a (new): (da) it reserves a defined portion of manufacturing capacity, within a fixed timeframe, to produce specific critical medicinal products or, where applicable, medicinal products of common interest, their pharmaceutical forms, their active substances, key inputs, or enabling technologies, at the request of the Critical Medicines Coordination Group, in order to address current, emerging or potential shortages.

Article 15 – paragraph 2 a (new): 2a. The Member State providing financial support to a strategic project shall require the beneficiary economic operator to adopt measures that contribute to the availability and affordability of the critical medicinal product and medicinal projectproduct of common interest in the Union market, following guidelines referred to in Article 26(2)(ca).

Article 18 – paragraph 3 – subparagraph 1 a (new): For the purposes of this paragraph, a ‘significant proportion' of the manufacture of a medicinal product of common interest shall be considered to take place within the Union if at least one of the following conditions is met: / (a) at least 50 % of the active substance used in the manufacture of the product is produced within the Union or, where appropriate, the EFTA countries; or, in the case of medicinal products of common interest for which no relevant substitute is produced within the Union, any third country with which the Union has established a strategic partnership within the meaning of Article 27 of this Regulation; / (b) at least 50 % of the value of the final medicinal product results from manufacturing or processing operations carried out within the Union or, where appropriate, the EFTA countries; or, in the case of medicinal products of common interest for which no relevant substitute is produced within the Union, any third country with which the Union has established a strategic partnership within the meaning of Article 27 of this Regulation; / (c) at least 50 % ofessential themanufacturing valuesteps, ofincluding the final medicinalsynthesis productor resultsbiological fromproduction manufacturingof oractive processingsubstances, operationsare carried out within the Union or, where appropriate, the EFTA countries; or, in the case of medicinal products of common interest for which no relevant substitute is produced within the Union, any third country with which the Union has established a strategic partnership within the meaning of Article 27 of thi…this Re…

Article 22 – paragraph 1 – introductory part: 1. By way of derogation from Article 168(3) of Regulation (EU, Euratom) 2024/2509 where five or more Member States jointly request the Commission to procure on their behalf, or in their name, the Commission shall initiate a procurement procedure under the conditions set out in this Article when the procurement relates to medicinal products belonging to one of the following categories below:

Article 27 – paragraph 1 a (new): The Commission shall endeavour to incorporate health security aspects into strategic partnerships. Such aspects may include measures to promote open and resilient supply chains, including through crisis response mechanisms and collaboration to prevent export restrictions during public health emergencies and to foster regulatory convergence and cooperation in the pharmaceutical sector. The Commission shall endeavour the inclusionto ofinclude access to active substances and API starting materials within strategic partnerships, in order to ensure timely availability of critical medicinal products under this mechanism.