EU Regulatory Reform For Medicinal Products: Changes To MAs, Supply, And Transparency

In the first blog in this series on the new EU regulatory framework governing medicinal products, we set out the expected timeline to adoption of the proposed regulatory framework (which is not expected to be adopted before 2026) and the current status of Parliament's reforms to RDP and orphan market exclusivity.

In this second blog, we continue our review of some of the key changes proposed by Parliament to the Commission's proposed amendments to the EU regulatory framework governing medicinal products. Specifically, we consider the reforms to the process for marketing authorisations (MAs), supply and shortages of medicines, and transparency of research and development costs in the EU.

• Process for marketing authorisations
  
  Parliament has adopted various changes to the scope of MAs and the processes of obtaining MAs, including the following:
  
  For the centralised procedure:
  
  • The deadline for the CHMP to assess the MA application and issue an opinion has been reduced from 210 to 180 days from receipt of the MA application.
  • The scope of medicines for which it is compulsory to go through the centralised procedure has been extended to include priority antimicrobial products and products seeking paediatric use.
  • A centralised MA will have an unlimited validity period, rather than the current 5-year duration, with the possibility for the Commission to limit the validity to 5 years where there are safety concerns.
  • There is greater scope for the Commission to grant a centralised MA under exceptional circumstances for a new therapeutic indication of an existing MA, and a conditional MA where there is an unmet medical need or where it is subject to post-authorisation conditions.

• For national proceedures:
  
  • The deadline for completing the national procedures has been reduced, with Member States required to take all appropriate measures to ensure the procedure for granting a MA is completed within a maximum of 180 days from receipt of the MA application.
  • The timeframe for approving assessment reports for a medicinal product have also been reduced for the decentralised and mutual recognition procedures, with the Concerned Member States required to approve the assessment report within 60 days of receipt, rather than the current 90 days.
  • A Member State may request to enter the decentralised or mutual recognition procedure, even if the Member State was not identified by the MA applicant as a Reference or Concerned Member State, provided there are "justified public health reasons".
  • For the decentralised procedure, if an applicant is considered to have submitted data that is not of sufficient quality or maturity for examination of the MA application, the examination can be terminated within 90 days. If the applicant fails to address the deficiencies within a time limit set by the Reference Member State, the application will be considered as withdrawn.

• Supply and shortages of medicinal products in the EU
  
  The Commission initially proposed a requirement that products granted MA via the centralised procedure which are continuously supplied in all Member States within a strict timeframe could obtain an extension of regulatory data protection or orphan market exclusivity. This could have been a significant hurdle for many companies.
  
  Parliament however has not adopted the Commission's original proposal, and has instead proposed that this supply condition should not be a requirement to obtaining additional RDP or orphan market exclusivity, but instead the company could be subject to financial penalties.
  
  Parliament maintained the Commission's proposed requirements for MA holders to prepare a shortage prevention plan and notify the Member State authority or the European Medicines Agency (EMA) of potential and actual shortages of a medicinal product. Parliament also added additional obligations for MA holders to:
  
  i. explain the reasons for any supply disruptions or suspensions of MAs; and
  
  ii. notify any temporary suspension or supply disruption as soon as possible and no later than 6 months in advance, or as soon as they become aware.

• Transparency of research and development costs
  
  Parliament has expanded the list of organisations for which a company will be required to publish information on all direct financial support received for R&D of medicines to include any philanthropic or not-for-profit organisation based anywhere globally.
  
  Parliament also proposed that a company will be required to publish information on all indirect (as well as direct) financial support received from any EU or Member State public authority or publicly funded body.

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