On the proposal for a regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006
ITRE-PA-754772
Committee on Industry, Research and Energy · Rapporteur: Henna Virkkunen
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The Committee on Industry, Research and Energy's draft opinion responds to the Commission's proposed regulation on authorising and supervising medicines and on the European Medicines Agency. It supports the reform but proposes amendments on transferable exclusivity vouchers, unmet medical needs, the regulatory sandbox, orphan incentives and medicine shortages.¶¶¶ It would let companies request a transferable data exclusivity voucher before marketing authorisation, base 'priority antimicrobial' status on clinical benefit against resistance, and allow vouchers for products with at least two years of data protection remaining.¶¶¶ It would delete the separate 'high unmet medical need' category for orphan medicines and instead raise orphan market exclusivity to ten, eleven or six years depending on the product, with extra extensions for new indications and paediatric studies.¶¶¶ It would widen the regulatory sandbox to cover medical devices, in-vitro diagnostics and substances of human origin, and let the Agency request data and consult more widely.¶¶¶ It would shorten the shortage notification period to three months and require shortage prevention plans only for medicines on the Union list of critical medicinal products.¶¶
Committee position. The rapporteur supports the pharmaceutical package and its objectives but proposes amendments to refine the transferable exclusivity voucher, delete the high unmet medical need category, raise orphan exclusivity, widen the regulatory sandbox and focus shortage rules on critical medicines.¶¶¶
Key points
- The rapporteur supports the pharmaceutical reform's goals: a competitive research environment, strategic autonomy, action on antimicrobial resistance and better access to medicines.¶
- The rapporteur warns that strict conditions on transferable exclusivity vouchers, which extend only regulatory data protection, could weaken the incentive, and calls for them to be reconsidered.¶
- The rapporteur says classifying some unmet medical needs as 'high' is ethically problematic and could discourage investment in treatments for future patients.¶¶
- Amendment 1 would allow a transferable data exclusivity voucher to be requested before marketing authorisation is granted, rather than only when applying.¶
- Amendments 2 to 6 would define a 'priority antimicrobial' by clinical benefit against resistance alone, deleting the three alternative criteria, and have the Agency use the WHO priority pathogens list.¶¶¶
- Amendment 7 would require disclosure of direct financial support only from EU public authorities or publicly funded bodies for research on the priority antimicrobial.¶
- Amendment 8 would allow a voucher to be used for a product with at least two years of regulatory data protection remaining, instead of four.¶
- Amendment 9 would delete Article 70, removing the separate category of orphan medicines addressing a high unmet medical need.¶
- Amendments 10 to 15 would set orphan market exclusivity at ten years, eleven years for products meeting new criteria, and six years for products authorised under the revised directive.¶¶¶
- Amendments 16 to 23 would delete the link between market exclusivity and access conditions in member states, add 24 months for a new indication, allow a 36-month total, cap exclusivity at 15 years and add 24 months for paediatric studies.¶¶¶
- Amendments 24 to 33 would broaden the regulatory sandbox to medical devices, in-vitro diagnostics and substances of human origin, let the Agency request data and consult, and allow derogations from other Union legislation.¶¶¶
- Amendments 34 to 36 would cut the shortage notification period from six to three months, require shortage prevention plans only for critical medicines, and make the ESMP interoperable with member states' systems without duplicate reporting.¶¶¶
Who is affected
- Pharmaceutical companies and developers, who would face changed rules on vouchers, orphan exclusivity and shortage reporting.¶¶¶
- Marketing authorisation holders, who would report shortages sooner and keep prevention plans only for critical medicines.¶¶
- The European Medicines Agency, which would assess priority antimicrobials, run the sandbox and expand the ESMP.¶¶¶
- Member states and national competent authorities, which would receive shortage notifications and share interoperable data.¶
- Patients with rare diseases or unmet needs, who could gain from new orphan incentives and wider sandbox scope.¶¶
Figures and deadlines
- At least two years of regulatory data protection remaining for a product to be linked to a voucher.¶
- Ten years of orphan market exclusivity for products other than those in points (b) and (c).¶
- Eleven years of orphan market exclusivity for products meeting the new requirements.¶
- Six years of orphan market exclusivity for products authorised under Article 13 of the revised directive.¶
- An additional 24 months of market exclusivity for a new therapeutic indication for a different orphan condition.¶
- A 36-month total prolongation where the new indication meets the requirements and the first authorisation did not get the eleven-year period.¶
- A maximum of 15 years of orphan marketing exclusivity from first authorisation.¶
- A temporary supply disruption of more than two weeks, notified at least three months before it starts.¶