In accordance with the agreement of the council of ministers of 23 february 2021 for improving the process of negotiation and mainstreaming the right of the european union to the domestic legal order, it proceeded to query the proposal to the european parliament and council regulation on compulsory licensing for crisis management and amending council regulation(EC)nº816/2006.

Patent rights, in particular played a key role in supporting innovation in theEUand create the appropriate environment for investment. To european innovation to prosper, it is necessary to create a solid legal framework, predictable and flexible to intellectual property rights, including patents. The plan of action of the commission on intellectual property rights has identified several areas of patent legislation that must continue to improve and harmonise. One is compulsory licences.

A compulsory licence is the possibility that a government to allow a third party to use a patent without the permission of the rights to certain conditions. Therefore, compulsory licenses can complement the ongoing efforts of theEUto improve their resilience to the crisis.

At present there is no harmonisation atEUcompulsory licensing for the domestic market. Instead, there is a mosaic of different national rules and procedures on compulsory licences.

In addition there are three legislative actsEUcontaining provisions on compulsory licences: the rules of procedure(EC)no. 2100/94 of 27 july 1994, on the community protection of plant varieties (art.29); the directive 98/44/ec of the european parliament and of the council of 6 july 1998 on the protection of biotechnological inventions (article 12) and the rules of procedure(EC)no. 816/2006 of the european parliament and of the council of 17 may 2006, on the granting of compulsory licences on patents relating to the production of pharmaceuticals for export to countries with public health problems. This proposal does not affect the first two acts of theEUThe proposal in question. change the Rules Of Procedure(EC)no. 816/2006 to add the possibility, in the context of cross-border production process, based on a compulsory licence granted by the commission and applicable in the territory of the european

This initiative intended to give the internal market of an effective system of compulsory licences for crisis management. The initiative has two main objectives: firstly, looking atEUcan go to the compulsory licensing in the context of crisisEU. Secondly, it introduces an effective regime of compulsory licences, with adequate, to allow for rapid response and appropriate to the crisis, with a functioning internal market, ensuring the provision and the free movement of critical products to the crisis subject to compulsory licences in the internal market.

More specifically, this initiative responds to the following objectives:

1. Improving the key features of compulsory licences, as the trigger, the extent and conditions of compulsory licences and improve the coherence of compulsory licences in the european Union to improve its effectiveness and efficiency to a crisis. That is, this goal would aim to reduce the fragmentation and mainly affect the internal market.
2. Enhancing the effectiveness of the granting of compulsory licences inEUin a crisis; Ensure an effective procedure for granting compulsory licences for exports [Regulation (EC) no. 816/2006] in accordance with article 31 bis of the agreement on theTRIPS.
3. Ensure that the territorial scope of a compulsory licence, including for export to countries outside the european Union, is appropriate to the reality of the cross-border value chains that operate in the single market.
4. Supporting the resilience of the european union to improve the coordination, streamlining decision-making and permitting the complementarities of compulsory licences by the european union in crisis situations and ensure a proper coherence between the regimes of compulsory licensing (national) and human crisis of the european Union.
5. Improving the coordination of mechanisms for granting compulsory licences inEUamong other things, to ensure that they are appropriate for their intended purpose in the crisis of the wholeEUand entirely consistent and complementary to other initiativesEU(for example, in the health sector, this would include strategyEUfor vaccinations against COVID-19 strategyEUon Therapeutic Options against COVID-19,HERAin particular the draftEUFABPharmaceutical and strategy for europe);

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Propuesta de Reglamento sobre la concesión de Licencias Obligatorias para la gestión de crisis [PDF] [477.53 KB]

Proposal for a Regulation on compulsory licensing for crisis management [PDF] [587.5 KB]