At a recent EU meeting in Luxembourg, Poland supported a European Commission proposal to shorten the time new drugs are protected by data exclusivity rules. Health Minister Izabela Leszczyna said Poland prefers one year of market protection over longer periods of data protection.
In April 2023, the European Commission suggested reducing the data exclusivity period for drugs from eight to six years. Minister Leszczyna agreed, saying this would help people access new treatments more quickly without adding extra paperwork. She also proposed one year of market protection for new uses of existing drugs instead of extending data protection.
Balancing Incentives and Access
Minister Leszczyna emphasised that Poland supports measures to ensure all EU countries have access to modern treatments. She suggested that incentives should focus on market protection and not last longer than a year. For drugs treating rare diseases, extending protection could be considered, but for other drugs, different solutions should be found.
Challenges in Generic Drug Production
Krzysztof Kopeć, President of the Polish Association of Pharmaceutical Industry Employers, highlighted issues with drug shortages, especially for generic drugs. He explained that producing drugs in Europe is becoming less profitable, leading to shortages. Although the European Commission wants to boost drug production in Europe, current regulations do not support this, and production costs are higher in Europe than in Asia.
Concerns from Innovative Drug Companies
Innovative drug companies argue that changing existing intellectual property rules is not the answer to drug access problems. They believe the current rules should continue to support innovation and ensure EU patients can access new treatments. Michał Byliniak, General Director of INFARMA, stressed the need for EU reforms to improve drug supply security, availability, and affordability while also supporting new drug development.
INFARMA is discussing potential risks of shorter protection periods with the Ministry of Health and other stakeholders. They warn that reducing protection could limit access to advanced treatments. INFARMA supports keeping current data protection levels and creating incentives to promote innovation, address unmet medical needs, and encourage research in the EU.
Poland's support for a shorter data exclusivity period shows its commitment to balancing access to new treatments, innovation, and economic realities in the EU drug industry. As discussions continue, the goal remains to create rules that ensure safe, effective, and affordable medicines are available to everyone in Europe.