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The European Generic medicines Association (EGA) launched its latest report today on the barriers hindering the access of generic medicines to European markets and to patients.
The report, Patent-related Barriers to Market Entry for Generic Medicines in the European Union: a review of weakness in the current European patent system and their impact on the market access of generic medicines, was presented in Paris at the 14th EGA Annual Conference.
Earlier in the morning, Eric Gorka, president of EGA, reminded the 400 delegates that generic medicines play a key role in providing lower-cost medicinal care to millions of Europeans, thus helping to ensure the affordability and sustainability of European public healthcare systems. For this reason, he said, “it is imperative to ensure that no hurdles exist to hinder the access of generic medicines to markets immediately upon patent expiry.”
The report details a number of these hurdles resulting from weaknesses in the European patent system. It focuses on three main areas in which the patent system and the surround legal and regulatory framework fail to ensure an appropriate balance between incentives and competition:
1. Failings in the system for granting quality patents.
2. Patent thickets and follow-on patents.
3. Patent litigation procedures.
In addition, the report identifies several related types of barriers, including patent linkage, statements to the authorities, using marketing campaigns to shift consumer demand, and granting SPCs based on incorrect information.