5 juin 2023
Following a public consultation in 2022, the Commission has provided a draft regulation for a Union compulsory license (Regulation COM(2023)224). This proposal forms part of the EC pharma and patent package presented on 26 April 2023.
The background of the Commission’s proposal for a Union compulsory licence is a conflict between the following circumstances in the status quo:
Due to this conflict, it can be difficult and burdensome to obtain compulsory licences covering the entire value chain. Before this background the Commission has presented a draft Regulation for a Union compulsory licence which aims at
The basic requirement for a Union compulsory license is provided in Art. 4 of the draft regulation and lies in the activation or declaration of a crisis mode or emergency mode listed in the Annex to the draft regulation. In addition to this basic requirement, the grant of a Union compulsory license inter alia requires that there is a need for a Union compulsory licence in the context of this crisis or emergency. This might, in particular, be due to a shortage of crisis-relevant products.
Art. 5 of the draft regulation governs the general conditions of a Union compulsory licence and inter alia provides:
The procedure for grant of a Union compulsory licence is initiated by the Commission. In a first step, it involves the consultation of an advisory body (Art. 6 of the draft regulation). Besides other tasks, the advisory body shall provide an opinion to the Commission with regard to the need for a Union compulsory licence and the conditions for such licence (Art. 7 Sec. 1 of the draft regulation).
According to Art. 7 Sec. 3 of the draft regulation, the grant procedure shall further involve the concerned right holder and the potential licencee who shall, in particular, comment on the possibilities to reach a voluntary agreement which would make a compulsory licence obsolete. Also the public shall be informed, if the grant of a Union compulsory licence is considered (Art. 7 Sec. 5 of the draft regulation).
If the requirements for Union compulsory licence are met, the Commission grants it by means of an implementing act (Art. 7 Sec. 7).
In general, implementing acts of the Commission are subject to judicial review by the CJEU but there are no specific provisions in the draft regulation in that regard for the grant of the Union compulsory licence.
Once granted, the Union compulsory licence, has, inter alia, the following effects:
Another interesting question is the question of export.
In general, export of products manufactured under Union compulsory licence shall be prohibited (Art. 11 of the draft regulation). However, there is an exception for pharmaceutical products:
Regulation (EC) No. 816/2006 already provides the possibility of national compulsory licences for export of medicines to non-EU countries with health problems. According to the present proposal, this regulation will be amended to the effect that also the Commission may grant a compulsory licence where the activities of manufacture and sale for export spread across different Member States and would therefore require compulsory licences for the same product in more than one Member State (Art. 23 of the draft regulation).
The proposed Union compulsory licence is not intended to replace national compulsory licence regimes but supplements them in order to be able to effectively tackle future EU-wide crises or emergencies.