The European Union (EU) has been under increasing pressure to address problems faced across Europe with access to medicines. Recent shortages of essential drugs such as antibiotics and painkillers as well as the COVID-19 pandemic have highlighted issues faced in Europe and the EU plans to reform European pharmaceutical laws in an attempt to revive investment and boost access to affordable treatments. With country health budgets drained following the pandemic, the European Commission aims to publish a draft of the reforms on April 26th, which will address the following:
Shorter intellectual property protection:
- The period of time that a company has to develop and sell drugs under IP protection will be decreased from 10 years.
- Companies will be able to gain an extra year of exclusivity by launching in all 27 EU member states simultaneously.
- Companies will be obliged to be more transparent with costs of research and development and level of public funding received when submitting for regulatory approval.
Expedited regulatory process:
- Aims to streamline the EMA regulatory approval process by reducing the number of scientific committees and cutting the time regulator takes to review medicines.
- “Regulatory sandbox” for testing of innovative technologies to achieve rapid approval.
- Shorter notification periods for companies to disclose shortages or withdrawals of products.
- Incentives for investment in antibiotics to combat the problem of antibiotic resistant “superbugs”.
Once the draft has been published, details will have to be finalised by the European Parliament, Commission and member states. The final legislation is not likely to be adopted before 2025.
After Covid and drug shortages, European Union revamps drug laws. Times of India. Published 03/04/2023. Accessed 20/04/2023. https://timesofindia.indiatimes.com/world/europe/after-covid-and-drug-shortages-european-union-revamps-drug-laws/articleshow/99206264.cms?from=mdr