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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

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Committee on Industry, Research and Energy · Rapporteur: Henna Virkkunen

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The Committee on Industry, Research and Energy gives its opinion on the proposed directive on a Union code for medicinal products for human use. It proposes amendments to strengthen regulatory data protection, refine the unmet medical needs definition, limit the Bolar exemption, and add incentives for EU-based research and production. The opinion extends the regulatory data protection period from six to nine years and adds several prolongations, including for EU-based preclinical development, unmet medical needs, and EU-produced active substances, combinable up to a maximum of 13 years. It recommends limiting the Bolar exemption to activities solely related to obtaining marketing authorisation and calls for a clear definition of unmet medical needs that considers a wide range of patient outcomes. It proposes new rules on decentralised and mutual recognition procedures, supply obligations for marketing authorisation holders, and a Commission strategy to foster research, innovation and production of medicinal products in the Union.

Committee position. The committee supports the pharmaceutical package and proposes amendments to strengthen regulatory data protection, refine the unmet medical needs definition, limit the Bolar exemption, and add incentives for EU-based research and production.

Key points

  1. The rapporteur supports the pharmaceutical reform's objectives but says some methodologies need refinement, and stresses legislation must be predictable, transparent, stable and clear.
  2. The rapporteur agrees it is important to strengthen, not weaken, regulatory data protection and other incentives in Europe, in line with the European Council's conclusions in March 2023.
  3. The rapporteur worries the proposed unmet medical needs definition might hinder progress in preventing, treating and caring for patients, and says assessment should consider a wide range of patient outcomes.
  4. The rapporteur recommends limiting the Bolar exemption to activities solely related to obtaining marketing authorisation, to avoid weakening intellectual property protection.
  5. Environmental considerations are vital, but patients' needs and swift access to innovative therapies should remain the primary focus.
  6. The regulatory data protection period is extended from six to nine years from the date the marketing authorisation was granted.
  7. New prolongations of 12 months are added for EU-based preclinical development, unmet medical needs, use of a relevant comparator, EU clinical trial applications, public-private partnerships, and EU-produced critical active substances.
  8. The incentives may be combined up to a maximum of 13 years.
  9. Marketing authorisation holders must make the product available to patients or prescribing doctors who requested it in Member States where the authorisation is valid, to receive the supply-related prolongation.
  10. A new Article 82a grants a one-year data protection prolongation where the majority of preclinical development was performed in the Union.
  11. Member States may enter decentralised and mutual recognition procedures within 30 days of submission, and a second opportunity to opt in is added for the decentralised procedure.
  12. The Commission shall establish a strategy on research, innovation and production of medicinal products in the Union, based on an impact assessment due two years after entry into force.

Who is affected

  • Pharmaceutical industry: faces a longer data protection period and new prolongation conditions tied to EU-based development and supply.
  • Marketing authorisation holders: must ensure continuous supply and may face Commission checks on prolongation applications.
  • Member states: gain a second opportunity to opt into the decentralised procedure and must confirm supply conditions for prolongations.
  • Small and medium-sized enterprises: the directive aims to promote their competitiveness and EU-based innovation.

Figures and deadlines

  • Regulatory data protection period of nine years from the date the marketing authorisation was granted.
  • Prolongation of 24 months where conditions are fulfilled within two years, or four years for certain entities.
  • Prolongation of 12 months for significant preclinical development done within the Union.
  • Prolongation of 12 months where the medicinal product addresses an unmet medical need.
  • Prolongation of 12 months for medicinal products containing a new active substance using a relevant comparator.
  • Incentives may be combined up to a maximum of 13 years.
  • One-year data protection prolongation for medicinal products developed primarily within the Union.
  • Six-month extension of the supplementary protection certificate for paediatric investigation plans, or 12 months where the plan concerns a different disease.