On 28 September 2021, the European Commission took another step in the implementation of its  new pharmaceutical strategy (discussed in more detail in our previous blog posts on the strategy, proposed amendments to orphan and paediatric legislation and the industry response).

As part of its work on the revision of the EU pharmaceutical legislation, the Commission launched a dedicated public consultation. The purpose of this consultation is to gather views and information to support the Commission’s impact assessment for the revision of the EU pharmaceutical legislation. This is, therefore, a good opportunity for all stakeholders to share their views and concerns, as well as their vision for the future EU pharmaceutical legislation.

The consultation is open until 21 December 2021 and seeks the views of all stakeholders on key issues such as:

  • The issues that need to be addressed by the revision of the EU pharmaceutical legislation and whether there are issues that were not identified so far by the Commission;
  • Assessment of the performance and adequacy of the current legislation;
  • The definition of “unmet medical need”;
  • Improvement of patient access to and affordability of medicines in the EU;
  • Adequate measures to support innovation, including in areas of “unmet medical need”;
  • Need for incentives for the development of new antimicrobials;
  • Steps to create better regulatory framework for novel medicinal products;
  • Changes to the definitions and scope of the current EU pharmaceutical legislation;
  • Stimulating repurposing of off-patent medicinal products;
  • Measures to ensure security of supply of medicinal products in the EU;
  • Ensure the high quality of medicinal products manufactured and distributed in the EU;
  • Addressing environmental challenges.

The consultation document is an online questionnaire form that requires registration with the Commission’s platform, as well as registration in the EU Transparency Register for organisation and businesses.