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
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