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REPORT (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

A-9-2024-0140

Committee on the Environment, Public Health and Food Safety · Rapporteur: Pernille Weiss

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Parliament's amended version of the Commission proposal for a directive on a Union code for medicinal products for human use, replacing Directive 2001/83/EC and Directive 2009/35/EC. It sets rules on authorisation, environmental risk assessment, antimicrobial resistance, labelling and package leaflets, advertising, pharmacovigilance and regulatory data protection. It requires marketing authorisation holders to submit pricing and reimbursement applications on request, and sets up an EU Access to Medicines Notification System. It extends environmental risk assessment to manufacturing, requires antimicrobial stewardship and access plans, and bans gifts to prescribers. It sets regulatory data protection at seven years and six months, with possible extensions, capped at eight years and six months.

Committee position. The committee proposes to amend the Commission proposal to strengthen incentives for innovation, ensure access to medicines through pricing and reimbursement obligations, reinforce environmental risk assessment and antimicrobial resistance measures, and improve patient information.

Key points

  1. The directive applies to medicinal products for human use placed on the market in Member States, and clarifies regulatory status questions with other bodies.
  2. Advanced therapy medicinal products prepared under hospital exemption must meet good pharmacy preparation practices, traceability and pharmacovigilance requirements, with data reported annually.
  3. Member States may authorise cross-border exchange of hospital-exemption advanced therapy medicinal products in justified cases of medical need.
  4. Marketing authorisation applicants must not carry out animal testing where scientifically satisfactory non-animal methods are available.
  5. The environmental risk assessment must cover manufacturing, use and disposal, and for antimicrobials include antimicrobial resistance selection.
  6. Marketing authorisation holders must submit pricing and reimbursement applications within 12 months of a Member State request, or 24 months for SMEs, not-for-profit entities and certain undertakings.
  7. The Commission shall set up an EU Access to Medicines Notification System for compliance with pricing and reimbursement obligations.
  8. Regulatory data protection is set at seven years and six months, with extensions for unmet medical need, Union-based research and development, and new therapeutic indications.
  9. The total regulatory protection shall not exceed eight years and six months.
  10. Member States may decide that package leaflets are available electronically only, following consultation, with a paper copy on request free of charge.
  11. Advertising must not negatively highlight another medicinal product or suggest it is safer or more effective unless supported by the summary of product characteristics.
  12. Member States shall set up national transparency registers of transfers of value for advertising to persons qualified to prescribe medicinal products.

Who is affected

  • Marketing authorisation holders, who must comply with supply, pricing and reimbursement, environmental and advertising obligations.
  • Patients, who gain rights to paper package leaflets on request and information on access to medicines.
  • Member States, which must set up collection systems, transparency registers and national plans on disposal.
  • Healthcare professionals, who must be informed about antimicrobial resistance and disposal.
  • SMEs and not-for-profit entities, which get longer deadlines for pricing and reimbursement applications.

Figures and deadlines

  • 12 months from a Member State request for pricing and reimbursement applications.
  • 24 months for SMEs, not-for-profit entities and certain undertakings.
  • Seven years and six months of regulatory data protection.
  • Eight years and six months maximum regulatory protection.
  • 12 months for the Commission to adopt implementing acts on reporting format.
  • 24 months from entry into force for the Agency to make available an electronic product information system.
  • 30 months for the proof-of-concept pilot of ERA monographs.
  • 60 days for examination of samples of blood-derived medicinal products.

Legal basis: Article 294(2), Article 114(1) and Article 168(4), point (c), of the Treaty on the Functioning of the European Union.