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Proposed Changes to EU Legislation for Human Medicines

Date
April 11, 2024
Category

EU Regulations

Description

Draft legislative proposals for a new Directive and Regulation for human medicinal products in the EU were published by the European Commission on 26 April 2023. See attached my White Paper on these proposals for details.

On 10 April 2024 the European Parliament (EP) adopted revised proposals for both the proposed Directive and Regulation which had been approved by their environment and public health (ENVI) committee on 19 March. 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 to be 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 revised draft legislation still contains areas that are opposed by industry, such as asking GMP inspectors to enforce standards for environmental and workers’ safety and the measures that strengthen the possibility to revoke or refuse a Market Authorisation based on environmental concerns.

The Council of the EU, which has representatives of each of the EU member states, is also assessing the commission’s proposals and must adopt its position before high-level final negotiations, known as trialogue discussions, between the parliament, council and commission can begin. This process will not start until after the European elections that will be held from 6-9 June 2024.

Draft legislative proposals for a new Directive and Regulation for human medicinal products in the EU were published by the European Commission on 26 April 2023. See attached my White Paper on these proposals for details.

On 10 April 2024 the European Parliament (EP) adopted revised proposals for both the proposed Directive and Regulation which had been approved by their environment and public health (ENVI) committee on 19 March. 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 to be 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 revised draft legislation still contains areas that are opposed by industry, such as asking GMP inspectors to enforce standards for environmental and workers’ safety and the measures that strengthen the possibility to revoke or refuse a Market Authorisation based on environmental concerns.

The Council of the EU, which has representatives of each of the EU member states, is also assessing the commission’s proposals and must adopt its position before high-level final negotiations, known as trialogue discussions, between the parliament, council and commission can begin. This process will not start until after the European elections that will be held from 6-9 June 2024.