A new strategy for the European Union pharmaceutical regulation

A new strategy for the European Union pharmaceutical regulation

On April 26th 2023 the European Commission (the “Commission”) announced its views on the implementation of the pharmaceutical reform in the European Union. The proposals of the Commission are determined to be the largest reform in this matter over the last 20 years.

The Commission adopted a proposal for a new Regulation and a new Directive, which shall revise and replace the existing general pharmaceutical legislation, aiming to achieve the following objectives:

  1. Creating a single market for medicines – The aim of the Commission is to ensure that all the patients across the European Union would have timely and equitable access to safe, effective and affordable medicines. This is an important step to resolve the problem with the shortage of medicines. The Commission introduced its proposals for new measures of control over the shortage of medicines by the national authorities and the European Medicines Agency (EMA), which contain some new obligations for the business for earlier reporting of shortages and withdrawals of medicines. To that extent, by the end of this year, the EMA should prepare a list of critical medicines, which shall support the competent authorities to undertake the necessary measures in a timely manner.
  2. Creating an innovation-friendly framework for research, development and production of medicines – The Commission proposed a minimum regulatory protection of 8 years, which may be extended in the following circumstances: if the medicines are launched in all the Member States, if they address unmet medical needs, if comparative clinical trials are conducted or a new therapeutic indication is developed.
  3. Reducing the administrative burden and speeding up some procedures – One of the most essential proposals of the Commission in this point is the acceleration of the authorization procedures. According to the Commission they should take 180 days, instead of the present 400 days. It is also envisaged to eliminate the need for renewal of expired marketing authorizations in some cases, as well as the possibility of electronic submission of applications and electronic product information.
  4. Resolving the antimicrobial resistance (AMR) problem through the One Health approach – The Commission proposed the following incentives to address this challenge:
    • transferable data exclusivity vouchers for the development of new antimicrobials – This measure aims to support companies investing in the development of new antimicrobials, which can be able to treat resistant pathogens. The Commission envisages a limit of 10 vouchers for new antimicrobials and a test period of 15 years. The voucher should provide an additional year of regulatory data protection of the developer, which the developer can either use for one of its own products or sell to another marketing authorization holder.
    • measures for prudent use of antimicrobials, including packaging and prescribing requirements.
  5. Developing environmentally sustainable medicines – The Commission proposes that the EMA may be entitled to refuse to approve a medicine in case that its developer does not provide sufficient information about any potential risks, that may be caused to the environment.

Please note that the proposals of the Commission could become reality only after their adoption by the European Parliament and the Council and the proposed Directive – after its implementation under the relevant national legislation.

Please note that the present article does not constitute a legal opinion or consultation.

For further information contact:

Ilya Komarevski, Partner

Boryana Dzhupanova, Attorney-at-law