Changes from plenary report to adopted text

AddedOn receipt of the Court of Auditors’ observations on the Agency’s provisional accounts pursuant to Article 246 of Regulation (EU, Euratom) 2018/1046, the Agency’s accounting officer shall draw up the Agency’s final accounts and the Executive Director shall submit them to the Management Board for an opinion.

Added5. The Management Board shall deliver an opinion on the Agency’s final accounts for year n.

Added6. The Agency’s accounting officer shall, by 1 July of financial year n+1, send the final accounts, together with the Management Board’s opinion, to the European Parliament, to the Council, to the Court of Auditors and to the Commission’s accounting officer.

Added7. The final accounts for year n shall be published in the Official Journal of the European Union by 15 November of financial year n+1.

Added8. The Executive Director shall send to the Court of Auditors a reply to its observations by 30 September of financial year n+1. The Executive Director shall also send that reply to the Management Board.

Added9. The Executive Director shall submit to the European Parliament, at the latter’s request, any information required for the smooth application of the discharge procedure for the financial year concerned, as laid down in Article 261(3) of Regulation (EU, Euratom) 2018/1046.

Added10. The European Parliament, upon a recommendation from the Council, shall, before 15 May of financial year n+2, give a discharge to the Executive Director in respect of the implementation of the budget for year n.

Added11. The financial rules applicable to the Agency shall be adopted by the Management Board after the Commission has been consulted. They shall not depart from Commission Delegated Regulation (EU) 2019/715 unless specifically required for the Agency’s operation and with the Commission’s prior consent.

AddedArticle 156 Fraud prevention

Added1. In order to combat fraud, corruption and other unlawful activities, the Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council shall apply without restriction.

Added2. The Agency shall accede to the Interinstitutional Agreement of 25 May 1999 between the European Parliament, the Council of the European Union and the Commission of the European Communities and shall adopt, without delay, the appropriate provisions applicable to all the employees of the Agency using the template set out in the Annex to that Agreement.

Added3. The European Court of Auditors shall have the power of audit, on the basis of documents and on the spot, over all grant beneficiaries, contractors and subcontractors who have received Union funds from the Agency.

Added4. OLAF may carry out investigations, including on-the-spot checks and inspections with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with a grant or a contract funded by the Agency, in accordance with the provisions and procedures laid down in Regulation (EU, Euratom) No 883/2013 and Council Regulation (Euratom, EC) No 2185/96.

Added5. Working agreements with third countries and international organisations, contracts, grant agreements and grant decisions of the Agency shall contain provisions expressly empowering the European Court of Auditors and OLAF to conduct such audits and investigations, according to their respective competences.

Added6. In accordance with Council Regulation (EU) 2017/1939, the EPPO may investigate and prosecute fraud and other illegal activities affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council.

AddedSection 4 General provisions governing the Agency

AddedArticle 157 Liability

Added1. The contractual liability of the Agency shall be governed by the law applicable to the contract in question. The Court of Justice of the European Union shall have jurisdiction pursuant to any arbitration clause contained in a contract concluded by the Agency.

Added2. In the case of non-contractual liability, the Agency shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by it or by its staff in the performance of their duties.

AddedThe Court of Justice shall have jurisdiction in any dispute relating to compensation for any such damage.

Added3. The personal liability of its staff towards the Agency shall be governed by the provisions laid down in the Staff Regulations or Conditions of Employment of Other Servants applicable to them.

AddedArticle 158 Access to documents

AddedRegulation (EC) No 1049/2001 shall apply to documents held by the Agency.

AddedThe Agency shall set up a register pursuant to Article 2(4) of Regulation (EC) No 1049/2001 to make available all documents that are publicly available pursuant to this Regulation.

AddedThe Management Board shall adopt the arrangements for implementing Regulation (EC) No 1049/2001.

AddedDecisions taken by the Agency pursuant to Article 8 of Regulation (EC) No 1049/2001 may give rise to the lodging of a complaint with the Ombudsman or form the subject of an action before the Court of Justice, under the conditions laid down in Article 228 and Article 263 of the Treaty respectively.

AddedArticle 159 Privileges

AddedProtocol No 7 on the Privileges and Immunities of the European Union annexed to the Treaty on the Functioning of the European Union shall apply to the Agency and its staff.

AddedArticle 160 Staff

AddedThe Staff Regulations and the rules adopted by agreement between the institutions of the Union for giving effect to those Staff Regulations and Conditions of Employment of Other Servants shall apply to the staff of the Agency.

AddedThe Agency may make use of seconded national experts or other staff not employed by the Agency.

AddedThe Management Board, in agreement with the Commission, shall adopt the necessary implementing provisions.

AddedArticle 161 Security rules on the protection of classified and sensitive non-classified information

AddedThe Agency shall adopt own security rules equivalent to the Commission's security rules for protecting European Union Classified Information (EUCI) and sensitive non-classified information, as set out in Commission Decisions (EU, Euratom) 2015/443 and 2015/444. The security rules of the Agency shall cover, inter alia, provisions for the exchange, processing and storage of such information.

AddedMembers of the Management Board, the Executive Director, members of the committees, external experts participating in ad hoc working groups, and members of the staff of the Agency shall comply with the confidentiality requirements under Article 339 TFEU, even after their duties have ceased.

AddedThe Agency may take the necessary measures to facilitate the exchange of information relevant to its tasks with the Commission and the Member States and, where appropriate, the relevant Union institutions, bodies, offices and agencies. Any administrative arrangements concluded to that end with regard to the sharing of EU classified information (EUCI) or, in the absence of such arrangements, any exceptional ad hoc release of EUCI, shall have received the Commission’s prior approval.

AddedArticle 162 Consultation process

Added1. The Agency shall establish a consultation process with relevant national authorities or bodies for the exchange of information and pooling of knowledge on general issues of scientific or technical nature related to the tasks of the Agency, in particular guidelines on unmet medical needs and the design of clinical trials, other studies and the generation of evidence along the life cycle of medicinal products.

AddedThe consultation process shall include bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 and national bodies responsible for pricing and reimbursement.

AddedThe conditions of participation shall be set by the Management Board in agreement with the Commission.

Added2. The Agency mayshall extend the consultation process to patients, medicine developers, healthcare professionals, industries or other stakeholders, as relevant. [Am. 337]

AddedArticle 163 Contacts with civil society representatives

AddedThe Management Board shall, in agreement with the Commission, develop appropriate contacts between the Agency and the representatives of the industry, consumers and patients and the healthcare professions, including through the Patients’ and Consumers’ Working Party (PCWP), the Healthcare Professionals’ Working Party (HCPWP) and the Industry Standing Group (ISG). These contacts may include the participation of observers in certain aspects of the Agency's work, under conditions determined beforehand by the Management Board, in agreement with the Commission. [Am. 338]

AddedArticle 164 Support to SMEs and to not-for profit entities

Added1. The Agency shall ensure that micro, small and medium-sized enterprises (‘SMEs’) and not-for-profit entities are offered a support scheme.

Added2. The support scheme shall be comprised of regulatory, procedural and administrative support and reduction, deferral or waivers of fees.

Added3. The scheme shall cover the various steps involved in pre-authorisation procedures, and in particular scientific advice, the submission of the marketing authorisation application, and the post-authorisation procedures.

Added4. SMEs shall benefit from the incentives laid down in Commission Regulation (EC) No 2049/2005 and [revised Council Regulation (EC) No 297/95].

Added5. For not-for-profit entities, the Commission shall adopt specific provisions clarifying the definitions, establishing waivers, reductions or deferrals of fees, as appropriate, in accordance with the procedure referred to in Article 10 and Article 12 of and Annex V to [revised Regulation (EC) No 297/95]. [Am. 339]

AddedArticle 165 Transparency

AddedTo ensure an appropriate level of transparency, the Management Board shall, on the basis of a proposal by the Executive Director and in agreement with the Commission, adopt rules to ensure the availability to the public of regulatory, scientific or technical information concerning the authorisation or supervision of medicinal products for human use which is not of a confidential nature.

AddedThe internal rules and procedures of the Agency, its committees and its working groups shall be made available to the public at the Agency and on the Internet.

AddedThe Agency may engage in communication activities on its own initiative within its field of competence. The allocation of resources to communication activities shall not be detrimental to the effective exercise of the tasks of the Agency. Communication activities shall be carried out in accordance with relevant communication and dissemination plans adopted by the Management Board.

AddedSufficient resources shall be allocated to the Agency to ensure appropriate implementation of its transparency obligations and commitments. [Am. 340]

AddedArticle 166 Personal health data

Added1. To support its public health tasks and in particular the evaluation and monitoring medicinal products or the preparation of regulatory decisions and scientific opinions, the Agency may process personal health data, from sources other than clinical trials, including real world data for the purpose of improving the robustness of its scientific assessment or verifying claims of the applicant or marketing authorisation holder in the context of the evaluation or supervision of medicinal product. The Agency shall put in place sufficient, effective and specific technical and organisational measures to safeguard the fundamental rights and interests of data subjects in line with Regulations (EU) 2016/679 and (EU) 2018/1725, including but not limited to clear and targeted data minimisation policies, state-of-the-art anonymisation and pseudonymisation requirements. [Am. 341]

Added1.a Such data shall in particular include personal electronic health data as defined in Regulation (EU) .../... [EHDS Regulation 2022/0140(COD)], data from the Eudravigilance database, clinical data and, where applicable, data from monitoring studies on the use, effectiveness and safety of medicinal products intended for treatment, prevention or the diagnosis of disease, including health data provided by public authorities. [Am. 342]

Added2. The Agency may consider and decide upon additional evidence available, independently from the data submitted by the marketing authorisation applicant or marketing authorisation holder. On that basis, the summary of product characteristics shall be updated if the additional evidence has an impact on the benefit-risk balance of a medicinal product. Such update shall only take place after the consultation with the marketing authorisation applicant or marketing authorisation holder concerned. Marketing authorisation applicants and marketing authorisation holders shall have the opportunity to respond within a reasonable timeline set by the Agency. Marketing authorisation applicants and marketing authorisation holders may submit to the Agency questions and shall be offered the opportunity of an explanation to any proposed update to the summary of product characteristics as appropriate. The reasons for the conclusions reached shall be included in the final opinion. [Am. 343]

Added3. The Agency shall adopt adequate data governance practices and the required standards to ensure the appropriate use and protection of personal health data, in accordance with this Regulation and Regulation (EU) 2018/1725.

AddedArticle 167 Protection against cyber attacks