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DRAFT OPINION (COM(2023)0192 – C90143/2023 – 2023/0132(COD))

On the proposal for a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC

ITRE-PA-754773

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 directive on a Union code for medicinal products for human use. It supports the reform's objectives but proposes amendments to strengthen regulatory data protection, narrow the Bolar exemption, and adjust environmental risk rules. The draft opinion proposes extending regulatory data protection from six to nine years, adding one-year extensions for unmet medical need and comparative trials, and deleting the 24-month recovery mechanism. It also proposes new obligations for marketing authorisation holders to apply for pricing and reimbursement in all member states. It recommends limiting the Bolar exemption to activities solely related to obtaining marketing authorisation, and proposes that marketing authorisations not be suspended, revoked or varied solely for environmental reasons, instead requiring binding post-authorisation commitments.

Committee position. The rapporteur supports the Pharmaceutical Package and many of the Commission's priorities, but proposes amendments to strengthen regulatory data protection, narrow the Bolar exemption, broaden the unmet medical need definition, and limit environmental grounds for suspending or varying marketing authorisations.

Key points

  1. The draft opinion supports the Pharmaceutical Package's objectives: a competitive and innovation-friendly R&D environment, strategic autonomy, action on antimicrobial resistance, and better medicine accessibility.
  2. It calls for legislation that is predictable, transparent, stable and clear to keep research, development and production of medicines in the EU.
  3. It proposes extending the regulatory data protection period from six to nine years from the date the marketing authorisation was granted.
  4. It proposes deleting the 24-month extension tied to release and continuous supply, saying it penalises industry for factors outside its control.
  5. It proposes one-year extensions of regulatory data protection for products addressing an unmet medical need and for products using a relevant comparator in clinical trials.
  6. It proposes that prolongations for unmet medical need, comparative trials and new active substances may each be granted only once and only during the regulatory data protection period.
  7. It proposes a new obligation for marketing authorisation holders to submit a pricing and reimbursement application within two years of a member state's request, or four years for SMEs, not-for-profit entities and certain undertakings.
  8. It proposes an EU Access to Medicines Notification System as a single-entry point for notifying compliance with the pricing and reimbursement application obligation.
  9. It proposes broadening the definition of unmet medical need to include progressive, life-threatening, severely debilitating or chronic diseases, and to cover quality of life and prevention or delay of disease.
  10. It proposes that the Agency consult patients' organisations, healthcare professionals, industry and other stakeholders when adopting scientific guidelines on unmet medical need.
  11. It proposes limiting the Bolar exemption to necessary studies and trials for a marketing authorisation, deleting references to health technology assessment and pricing and reimbursement.
  12. It proposes that marketing authorisations not be suspended, revoked or varied for environmental reasons unless serious risks are not addressed through conditions in Articles 44(h) or 87(c).

Who is affected

  • Marketing authorisation holders, who would face new pricing and reimbursement application deadlines and notification duties.
  • SMEs, not-for-profit entities and certain undertakings, which would get four years instead of two to apply for pricing and reimbursement.
  • Generic and biosimilar manufacturers, who would face a narrower Bolar exemption limited to marketing authorisation activities.
  • Patients, who the rapporteur says should keep swift access to innovative therapies and not lose access over environmental rules.

Figures and deadlines

  • nine years, the proposed regulatory data protection period from the date of marketing authorisation.
  • two years from a member state's request for a marketing authorisation holder to apply for pricing and reimbursement.
  • four years from the request for SMEs, not-for-profit entities and certain undertakings to apply for pricing and reimbursement.
  • seven centralised marketing authorisations, the threshold for the four-year pricing and reimbursement deadline.
  • one year, the proposed extension of regulatory data protection for unmet medical need and for comparative trials.
  • 18 months after entry into force, deadline for the Commission to adopt delegated acts on SME criteria.
  • 3 years following entry into force, deadline for implementing acts on the EU Access to Medicines Notification System.
  • 5 years after entry into force and every 3 years thereafter, reporting on the notification system.