In November 2020, the European Commission (EC) adopted its Pharmaceutical Strategy for Europe in which one commitment was to conduct a review of its pharmaceutical legislation. The EC has now released a roadmap outlining how it plans to deliver this regulatory overhaul.
As stated in the roadmap, the key objectives of the initiative are to ensure access to affordable medicines in the European Union (EU), foster innovation in areas of unmet medical need, improve the efficiency/flexibility of the existing regulatory framework and enhance the security of the supply of medicines while adapting to new scientific and technological developments.
In order to meet these objectives, 14 key elements have been defined:
- Reach a common understanding on the notion of ‘unmet medical needs’
- Simplify legislation and enhance regulatory flexibility whilst maintaining high standards of quality assessment
- Revise the system of incentives to promote innovation, particularly in areas of highest medical need
- Consider specific incentives to promote antimicrobial developments
- Use initiatives such as the priority medicines scheme (PRIME) to support accelerated product development and authorisation in areas of unmet medical need
- Introduce elements of flexibility in the legislation to allow them to be adapted to new innovations in medicine development
- Improve competition considerations, particularly in generics/biosimilars such as faster market entry of competitor products
- Allow a single assessment across member states for active substances used for different generic medicines
- Ensure security of supply by implementing more stringent reporting obligations with regards to shortages, withdrawals and transparency of stocks
- Further improve the transparency and oversight of the supply chain by revising the manufacturing and distribution provisions in the legislation.
- Enhance environmental sustainability of medicines production
- Improve crisis management related provisions (with particular regard to pandemics)
- Review the European Medicines Agency’s (EMA) role in relation to related bodies/authorities
- Develop non-legislative tools to aid with implementing EU legislation
In addition, the roadmap outlines the predicted social, economic and environmental impacts of the review. The EC are requesting feedback on the roadmap in the period until 27 April 2021. A public consultation is planned for the fourth quarter of 2021 followed by an adoption of the proposal in the fourth quarter of 2022.
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