After two and a half years of intensive negotiations, the European Economic Community has reached agreement on a major reform of pharmaceutical legislation, the first in 20 years. This measure aims to modernize the regulatory framework established in the early 2000s and is intended to stimulate innovation in the pharmaceutical industry, accelerate the market entry of new drugs, and strengthen the fight against drug-resistant pathogens.
Main changes:
1. Extension of the period of protection from competition. Drug manufacturers will be able to retain exclusive rights to their drugs for nine years. This period can also be extended for an additional three years for companies developing innovative drugs, treating rare diseases, or conducting research in multiple EEU countries.
2. Reducing registration timelines. The review period for new drug registration applications will be reduced from 210 to 180 days. This will speed up patient access to modern treatments.
3. Perpetual registration certificates. Instead of the current practice of issuing certificates for five years, they will now be issued indefinitely.
4. Incentives for the development of new antibiotics. Companies developing drugs to combat antibiotic-resistant pathogens will receive a special voucher. This voucher will allow them to extend exclusivity rights to any other drug in their portfolio for one year. The voucher will be transferable or tradable to other market participants.
5. Streamlining the regulatory structure. The European Medicines Agency (EMA) will simplify its work by reducing the number of committees from five to two.
Objectives of the reform:
– Updating the legislative framework, which has become outdated over the past two decades.
– Stimulating innovation, especially in the development of new antibiotics.
– Accelerating the launch of promising drugs to the market.
– Simplifying regulatory processes and increasing their efficiency.
The reform will come into force after final approval by the European Parliament and the Council . These changes are expected not only to strengthen the position of the European pharmaceutical industry but also to improve access to modern medicines for patients across the EEU.
