The European Commission had opened a public consultation on ‘Intellectual property (IP) – revised framework for compulsory licensing of patents’. This was opened from 7 July 2022 to 29 September 2022.
Within the European Union (EU), individual countries currently regulate and implement the framework for compulsory licensing of patents in the EU using different, fragmented procedures. The possible need for this revised framework has arisen as this setup is not efficient enough to tackle EU-wide crises, such as the recent COVID-19 pandemic.
The consultation also examined the efficiency of the current EU procedure on compulsory licensing of patents for export to countries with public health problems.
The public consultation came following the ‘Call for evidence’ that received feedback in April 2022. It included a questionnaire and was designed to gather the opinions of all stakeholders who include intellectual property (IP) right holders, users of IP-protected technologies and products, the health sector (including generics manufacturers, start-ups and patient associations), public authorities, national IP offices, non-profit organizations, civil society representatives, consumer associations, research centres, the European Medicines Agency, and IP lawyers. The consultation gathered the different grounds and procedures for issuing compulsory licensing in a crisis and hopes to discover bottlenecks and the possible impact on stakeholders. The consultation supports the preparation of the impact assessment.
Overall, this initiative aims to revise the current framework so that the EU is more adequately prepared and coordinated to tackle future crises. It is possible that this may include extending the scope of compulsory licenses beyond patents to other forms of protection such as data exclusivity.
The possible revised framework is also supported by a recent review of the European Pharmaceutical Strategy [1]. This suggested that the framework should focus on IP initiatives, particularly those that support the earlier authorization of biosimilars and ensure timely, equitable and affordable access of biological medicines to all EU citizens.
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Europe’s IP framework should support earlier authorization of biosimilars, review finds [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 25]. Available from: www.gabionline.net/biosimilars/research/europe-s-ip-framework-should-support-earlier-authorization-of-biosimilars-review-finds
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