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EU Pharmaceutical Law: Voucher system may be open to abuse

MedExpress Team


Published Sept. 14, 2023 10:29

EU Pharmaceutical Law: Voucher system may be open to abuse - Header image
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National Drug Manufacturers, at a meeting on the revision of the EU pharmaceutical law organized by the Health Ministry on September 13, stressed that the planned revision of the law extends the monopoly of drugs in the European market, which will limit the availability of therapies due to their high cost. Delaying competition that drives down prices is a barrier to access to medicines for patients and health systems.

Currently - in addition to 20 years of patent protection - the market monopoly in the EU is provided by 8 years of data exclusivity protection, followed by a 2-year period of market exclusivity that can be extended for another year (the so-called 8+2+1). This protection is the longest in the world. By comparison, the system used in the U.S., off-patent, provides for a standard 5-year period of data exclusivity. Meanwhile, in the proposed changes to the law, the European Commission plans to extend these exclusivities by up to 2 years, i.e. to a maximum of 13 years, through, among other things, the possibility of acquiring a special Voucher.

According to the National Drug Manufacture...

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