Crisis preparedness: Council and Parliament strike deal on last-resort patent licensing

Ensuring the supply of critical products

In crisis situations (i.e. a pandemic or a natural disaster), compulsory licensing can help provide access to key products and technologies, when, for example, the holder of a patent does not have the capacity to produce the necessary amounts of a critical product, and voluntary agreements are not available or feasible. Currently, compulsory licensing mechanisms are regulated only at national level, which could result in a fragmented approach in the event of cross-border crises or emergencies. To address this problem, the Commission proposed a regulation providing for EU-wide compulsory licensing framework that would be triggered only after the activation of an emergency or crisis mode at EU level in accordance with the relevant crisis legislation (the proposal included a list of laws that could activate the compulsory licensing framework).

Voluntary agreements first

The provisional agreement reached today enshrines the last-resort nature of compulsory licensing and gives priority to voluntary agreements between intellectual property rights-holders and potential users of the license in the event of a crisis. However, to avoid endless negotiations, voluntary agreements must be concluded within a reasonable timeframe, otherwise compulsory licensing can be activated.

Next steps

The provisional agreement reached with the European Parliament now needs to be endorsed and formally adopted by both institutions.

Background

In the aftermath of the COVID-19 crisis, the EU has tabled several crisis instruments at European level, such as the proposal for a regulation establishing a Single Market Emergency Instrument (SMEI, now IMERA) or the Council regulation on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level. These instruments provide the EU with a means for ensuring access and the free movement of products needed to tackle a crisis in the Internal Market.

The instruments focus on voluntary approaches, which remain the most efficient tool to enable rapid manufacturing of patent-protected products, including in crises. However, in some cases where such voluntary agreements are not available or appropriate, compulsory licensing can provide a way to allow the rapid manufacturing of products needed during a crisis.

The Commission proposed an initiative on compulsory licensing for crisis management on 27 April 2023. The Parliament adopted its position on 13 March 2024 and the Council reached its negotiating mandate on 26 June 2024.

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  Crisis preparedness: Council adopts position on compulsory licensing regulation (press release, 26 June 2024)
  
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  Mandate for negotiations with the European Parliament
  
  

  Únicamente disponible, en estos momentos, en la(s) siguiente(s) lengua(s):

  
  

  
  EN
  

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  Commission’s proposal on compulsory licensing for crisis management
  
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  SMEI / IMERA: Council and Parliament strike a provisional deal on crisis preparedness (press release, 1 February 2024)
  
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  How the EU responds to crises and builds resilience (background information)
  
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  EU single market (background information)
  
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  Internal market emergency and resilience act