Bolar Beyond Regulatory Preparation: EU Pharma Package, Türkiye’s Experience, And TRIPS Compliance

The Bolar exemption was originally conceived as a limited mechanism enabling generic and biosimilar manufacturers to complete the regulatory steps necessary to enter the market immediately after patent expiry. The EU Pharma Package now seeks to broaden the exemption substantially, both in terms of the activities covered and the parties entitled to rely on it. This development invites a re-examination of Turkiye’s long-standing – and already notably broad – interpretation of the Bolar exemption.

Significantly, despite its breadth, the Turkish approach has not extended the Bolar safe harbour to conduct amounting to an ‘offer for sale’. The issue becomes even more compelling when considered alongside the WTO’s interpretation of the TRIPS Agreement, which suggests that extending the exemption to commercial conduct such as offers for sale and participation in public tenders may not be compatible with TRIPS.