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DRAFT 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

ENVI-PR-753470

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

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This is the rapporteur's draft report on 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. The draft proposes amendments to raise baseline regulatory data protection to nine years, add 12 months for unmet medical need and six months for comparative clinical trials, and delete the market launch incentive. It would require marketing authorisation holders to file pricing and reimbursement applications in requesting Member States within two years, or four years for small and medium-sized enterprises, not-for-profit entities and less experienced companies. It adds rules on hospital exemption for advanced therapy medicinal products, environmental risk assessments including antimicrobial resistance, electronic and paper package leaflets, and collection of unused medicines.

Committee position. The rapporteur supports the Commission proposal but proposes amendments to strengthen innovation incentives, replace the market launch incentive with a pricing and reimbursement application obligation, adjust environmental risk assessment rules, and improve patient information.

Key points

  1. Parliament's position would amend the Commission proposal, including recitals on innovation, competitiveness, hospital exemption, unmet medical need, pricing and reimbursement, and cross-border healthcare.
  2. The amended text defines 'non-routine basis' for hospital exemption and requires hospital exemption approvals to be valid for 12 months, notified to the Agency and published in a repository.
  3. It requires data on use, quality, safety and efficacy of hospital exemption products to be collected annually, reviewed by competent authorities, and reported by the Agency every three years then every five years.
  4. It adds definitions for radionuclide radiopharmaceuticals, complex radiopharmaceuticals, kits for radiopharmaceutical preparation, platform technology and platform technology master files.
  5. It allows marketing authorisations based on active substance master files, additional quality master files or platform technology master files, and empowers the Commission to adopt delegated acts on platform technology master files.
  6. It requires environmental risk assessments to cover antimicrobial resistance, allows a three-year derogation for antibiotics only, and requires Commission guidelines on antimicrobials other than antibiotics within 18 months.
  7. It requires the Agency to establish a programme for environmental risk assessments of pre-2005 products, not exceeding 10 years, and to conduct a proof-of-concept pilot on ERA monographs within three years.
  8. It requires marketing authorisation holders to declare direct public financial support from Union public authorities or publicly funded bodies, and the Agency to provide a publicly accessible website.
  9. It requires marketing authorisation holders to submit pricing and reimbursement applications within two years of a Member State request, or four years for small and medium-sized enterprises, not-for-profit entities and less experienced companies.
  10. It sets up an EU Access to Medicines Notification System and requires the Commission to adopt implementing acts within three years and report every three years thereafter.
  11. It sets regulatory data protection at nine years, adds 12 months for unmet medical need and six months for comparative clinical trials, and deletes the market launch incentive.
  12. It requires Member States to set up collection systems for unused or expired medicines, draw up national plans within 18 months, and empowers the Commission to adopt delegated acts after five years.

Who is affected

  • Marketing authorisation holders, who must file pricing and reimbursement applications, declare public support and ensure supply.
  • Small and medium-sized enterprises, not-for-profit entities and less experienced companies, which get four years for pricing and reimbursement applications.
  • Member States, which must set up collection systems, draw up national plans and may decide on electronic package leaflets.
  • Hospitals and competent authorities, which must obtain and notify hospital exemption approvals valid for 12 months.
  • Patients, who gain rights to printed package leaflets and awareness cards, and to information on public support.

Figures and deadlines

  • 12 months: validity of hospital exemption approval.
  • Three years after entry into force: first Agency report on hospital exemption.
  • 18 months after entry into force: Commission guidelines on environmental risk assessment for antimicrobials other than antibiotics.
  • 30 months after entry into force: Agency programme for environmental risk assessment of pre-2005 products.
  • 10 years: maximum duration of the Agency programme for environmental risk assessment of pre-2005 products.
  • Two years: deadline for pricing and reimbursement application after a Member State request.
  • Four years: deadline for pricing and reimbursement application for small and medium-sized enterprises, not-for-profit entities and less experienced companies.
  • Nine years: baseline regulatory data protection period.

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