AN ASSESMENT OF THE EU PARLIAMENT AMENDMENTS TO THE COMMISSION PROPOSAL OF THE EU PHARMA PACKAGE

The European Parliament recently published its amendments to the draft text on the Commission’s proposal for updating the EU pharmaceutical legislation. This blog covers the significant updates, including regulatory data protection, managing supply shortages, environmental impact assessments, and transparency enhancements. The amendments also address accelerated approvals, platform technology master files, and electronic product information. As the Council of the European Union prepares to finalize its position, these changes will influence pharmaceutical regulation for years to come.

Key changes that are introduced after the first reading include the following:

• Significant changes related to regulatory data protection, both related to conditions and duration (see Figure ‘Regulatory Data Protection (RDP) Period’ below).
• Additional details and requirements related to the management of supply shortages.
• Further increased focus on environmental impact in the benefit-risk assessment of medicinal products (in addition to the assessment of quality, safety, and efficacy).
• Expansion of the environmental risk assessment to also include the environmental impact of manufacturing, besides the impact of usage and disposal.
• Further increased focus on transparency: an increasing amount of information to be made publicly available (e.g. redacted PSUR, RMP, ERA, info on experts involved in scientific advice, and separation of those involved in pre-submission activities and the actual dossier review).
• Additional details on penalties in cases of non-compliance with the legislation.
• Additional details on the involvement of (ad-hoc) working parties will be established to ensure that expertise will remain despite the discontinuation of the specialized committees (PDCO, COMP, and CAT).
• Introduction of the possibility for accelerated approval for variations (in addition to initial MAAs).
• Introduction of the use of platform technology master files, which will also be applicable to cell and gene therapy.
• Additional details on the use of electronic product information and paper leaflets.
• Additional details on non-routine hospital exemptions for ATMPs.

It is now up to the council, consisting of all 27 EU member states, to reach a consolidated council position on the pharma package. Once the Council has adopted its position, trilogue negotiations between the Commission, the Council and the European Parliament can begin. During that trilogue they can decide on adoption of the package or agree on a second reading.

The file will be followed up by the new Parliament after the European elections on 6-9 June 2024.

Assuming that trilogue will not take place until 2026 and accounting for a transition period of 18 months after the entry intro force, it is generally not expected the new legislation will go into effect until 2028. However, given the long development timeline of pharmaceutical products, the proposal (especially RDP related provisions) might impact products currently in the development pipeline.