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National Drug Manufacturers on changes to European pharmaceutical law

MedExpress Team


Published May 16, 2023 11:34

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26 IV this year. The European Commission adopted a package of amendments to European pharmaceutical law. The National Drug Manufacturers have submitted their comments to the government side, which will prepare Poland's position on the issue.

Unfortunately, the draft does not provide for the introduction of a legal and financial mechanism for the restoration of Europe's drug safety, i.e. the restoration of API and drug production. - A reference calling on the European Commission to urgently develop a legislative act implementing the provisions of the Pharmaceutical Strategy and EU strategic documents should be introduced into the draft directive and regulation, Krzysztof Kopeć, president of the National Drug Manufacturers, urges. Instead, the document introduces incentives for the production of drugs that address urgent health needs in the form of extending their monopoly, which could ultimately hinder access to these therapies. The PZPPF believes that the protection period for monopoly drugs, which is already the longest in the world, should not be extended. - Although the pharmaceutical package talks about shortening drug exclusivity periods, the de facto regulations open up a whole range of possibilities for its extension," points out Grzegorz Rychwalski, vice president of the PZPPF.

The National Drug Manufacturers, however, view positively the proposal for incentives in the form of 4-year data exclusivity for generic drugs in the new indication. - After al...

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