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UNITARY PATENT

In 2012 Member States and the European Parliament agreed on the "patent package" - a legislative initiative consisting of two...

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Comparison of Bolar Exemption Across Europe

We now have various flavours of Bolar exemption in Europe, which can be categorised by (a) acts exempted, (b) whether the testing is for marketing authorisation in the EU or beyond and (c) whether the testing can also be for Heath Technology Assessment. The following table summarises the differences:


Exempted Acts


Exemption is limited to activities relating to marketing approval of generic medicines, bioequivalents and biosimilars
Broader exemption for any act required for marketing approval, as well as acts relating to innovative medicines*
Further exemption for Health Technology Assessment (e.g. for drugs that already have marketing approval)
Marketing authorizations in the EU onlyBelgium, Cyprus, Netherlands and Sweden
Bulgaria, the Czech Republic, Estonia, Finland, France, Hungary, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovakia, Slovenia, and Spain

Marketing authorizations inside or outside the EU or European Economic Area (EEA).

Austria, Germany, Denmark, Ireland, Italy and UK

Ireland and UK

*Source – WIPO: http://www.wipo.int/wipo_magazine/en/2014/03/article_0004.html

We now have various flavours of Bolar exemption in Europe, which can be categorised by (a) acts exempted, (b) whether the testing is for marketing authorisation in the EU or beyond and (c) whether the testing can also be for Heath Technology Assessment. The following table summarises the differences:
                         Exempted acts
    Exemption is limited to activities relating to marketing approval of generic medicines, bioequivalents and biosimilars    Broader exemption for any act required for marketing approval, as well as acts relating to innovative medicines*    Further exemption for Health Technology Assessment (e.g. for drugs that already have marketing approval)
Marketing authorizations in the EU only    Belgium, Cyprus,
Netherlands and
 Sweden
    Bulgaria, the Czech Republic, Estonia, Finland, France, Hungary, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovakia, Slovenia, and Spain    
Marketing authorizations inside or outside the EU or European Economic Area (EEA).        Austria, Germany,
Denmark, Ireland, Italy and UK
    Ireland and UK
*Source – WIPO: http://www.wipo.int/wipo_magazine/en/2014/03/article_0004.html