The revised Pharmaceutical Legislation must deliver more access to medicines, fair competition and prevent artificial extensions of monopolies beyond what the EU system foresees.
In order to effectively allow timely access to generic and biosimilar medicines for patients and achieve the stated objectives of the ‘Bolar exemption’ (ie. early generic/biosimilar development and approvals for immediate competition after Intellectual Property expiry), it is pivotal to ensure
that the final revised Bolar leave no room for diverging interpretations in different Member States and provide clear, unequivocable provisions removing any grey area or legal uncertainty that may allow the use of ‘patent linkage’ to delay competition