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Milestone Reached in Progress of the Proposals To Change the EU Legislation on Human Medicines

Date
March 20, 2024
Category

EU Regulations

Description

On 19 March 2024 the European Parliament’s environment and public health (ENVI) committee voted to approve the “pharmaceutical package” for human medicines proposed in April 2023. Reaching this milestone required a significant set of compromise amendments to reconcile opposing political positions. The changes agreed are as follows:

  • Cutting the baseline regulatory data protection (RDP) from the current 8 years to 7.5 years, rather than 6 years that was in the original proposal.
  • One year of RDP to be added if product addresses and unmet medical need.
  • Six months of RDP to be added for carrying out comparative clinical trials.
  • Six months of RDP added if a “significant share” of the product’s R&D is carried out in the EU “and at least partly in collaboration with EU research entities.”
  • The combined maximum RDP to be capped at 8.5 years, where the original proposal would have allowed up to 10 years in the unlikely event that the product qualified for all of the proposed allowances.
  • The proposal to allow an additional 2 years of RDP if a new product was launched in all EU member states within two years of approval, has been dropped.
  • A one-time 12-month market exclusivity extension of the two-year period if a company obtained a new indication offering “significant clinical benefits” compared with existing therapies.
  • Nine years of market exclusivity for orphan medicines plus two more years if the product addressed a “high unmet medical need”. The original proposal was for nine years plus one year.

The following proposals in the April 2023 draft Directive and Regulation were approved, unchanged:

  • Proposals to boost R&D into new antimicrobials; including the proposal to introduce a “transferable data exclusivity voucher” for priority antimicrobials that would bring with it a maximum one year of added RDP for an approved product.
  • The requirement to submit an environmental risk assessment with a marketing authorisation application.

The amended text will now go for a vote at the plenary session of the parliament on 10-11 April. It will then be discussed with the Council of the EU after the European elections on 6-9 June.