European Parliament report calls for increased use of off-patent medicines to improve patient access

The European Parliament has adopted a report calling for increased use of off-patent medicines in Europe to improve patient access, highlighting lessons learned during the Covid-19 pandemic and urging the European institutions to address them directly in future healthcare policy initiatives.

The Parliament, in its own initiative report, stresses the central role of generic, biosimilar and value-added medicines as the European Commission works to revise the legislative framework of the European pharmaceutical industry. Off-patent medicines already account for close to 70% of those used by patients in Europe.

The call for increased use of off-patent medicines also implies a tailored regulatory pathway for value added medicines innovation, an area where the EU has been lagging behind the US for years.

The report highlights that an efficient and optimised regulatory system for pharmaceuticals is also a priority. This includes digitalising regulatory processes and embracing environmentally friendly solutions like electronic patient information leaflets.

The report calls on the European Commission to actively remove barriers to competition from loss of exclusivity. This includes reviewing the use of intellectual property incentives and assessing the framework for off-patent orphan and paediatric medicines. Adapting these frameworks could enable increased access for the rare disease population but a level playing field is needed to facilitate the development and manufacturing of these

You can read the press release here and the report here.

The report is quite detailed and is well worth reading. It is divided into the following sections:

  • Putting patients at the centre of all health policies
  • Pharmaceuticals and antimicrobial resistance
  • Research in pharmaceuticals
  • Pricing and costs of pharmaceuticals
  • Role of generic and biosimilar medicines
  • Public-private partnerships and innovation
  • European Health Emergency Preparedness and Response Authority (HERA)
  • Procurement practices
  • Access to medicines in the EU
  • Supplementary protection certificates
  • Clinical trials
  • Health technology assessment
  • Current framework for authorisation
  • SMEs and pharmaceuticals
  • European Health Data Space, health data and GDPR
  • Structured dialogue with stakeholders
  • Sustainable and environmentally friendly medicines
  • The EU is leading the world in healthcare
  • Patents and the TRIPs agreement

Source: Medicines for Europe