EU Parliament Takes Steps to Increase Manufacture and Export of European Generics and Biosimilars During Protected Period

Market Analyses

The Committee on Internal Market and Consumer Protection of the European Parliament has adopted its report on the “Single Market Strategy” – a strategy that aims to consolidate industries in European countries under one umbrella. Included in the report is a section on “consolidating Europe’s intellectual property framework.” The report states that Europe’s recent adoption of the Unitary Patent System will allow for more certainty in the IP sphere, but acknowledges that there are still concerns regarding the endgame of such patents, particularly when it comes to national “Supplementary Protection Certificates,” which are European IP rights that extend protection of certain rights associated with a patent beyond the patent’s expiry date.

To address those concerns, the report proposes a unitary SPC that would provide enhanced certainty to industries whose products are subject to regulated market authorizations. The report asserts that a unitary SPC would improve transparency and certainty on the protection of medicines, and thus would facilitate the development of new products by manufacturers of novel and generic/biosimilar medicines. The report also states that a unitary SPC would allow Member States to optimize their health budgets, resulting in improved patient access to medicines. The report also proposes an SPC manufacturing waiver that would permit manufacturing during the SPC period, which would allow the European generic and biosimilar medicines industries to create thousands of high-tech jobs in the EU. These generic and biosimilar medicines could then be exported to countries that do not have SPC protection, such as developing nations, who would otherwise not have access to these generics and biosimilars until after the SPC period had terminated.

The full report can be viewed here. For more biosimilar news, stay tuned to Big Molecule Watch.

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