The European Parliament has been challenged to amend a proposed law to enable  countries outside the European Union (EU) to benefit from medical products produced under compulsory licences during crises.

The proposed regulation aims to ensure that, “during specific crises or emergencies”, the EU can issue a compulsory licence to enable the production of certain products – such as vaccines and medicines during a pandemic.

A compulsory licence gives governments the power to allow a third party to use a patent without the authorisation of the patent-holder, subject to certain conditions. 

“Compulsory licensing can therefore complement current EU efforts to improve its resilience to crises,” according to the EU.

But the draft regulation currently prohibits the export of any products produced under compulsory licences outside the EU.

On Tuesday, a group of over 70 influential civil society organisations and academics wrote a letter to the European Parliament challenging them to “support crucial amendments allowing the export of medical tools to third countries in the proposed Union Compulsory License”.

“The COVID-19 pandemic has made clear that major health emergencies need to be addressed at local, national, regional and global level and showcased that the EU’s advanced industrial capacity can be used to help protect EU citizens while also aiding and supplying non-EU countries, aligning with the principle that “No one is safe until everyone is safe”,” the letter notes.

“It is therefore disheartening to note that, when preparing for the next crisis, the EU risks turning its back on the rest of the world, including non-EU countries in Europe, with this compulsory licence proposal,” it adds.

EU harmonisation

Impetus for the new regulation stems from the fact that there is “no EU-wide harmonisation of compulsory licensing for the domestic market”, according to the EU, which adds that the new regulation has two main objectives.

“First, it aims to enable the EU to rely on compulsory licensing in the context of the EU crisis instruments. Second, it introduces an efficient compulsory licensing scheme, with appropriate features, to allow a swift and appropriate response to crises, with a functioning internal market, guaranteeing the supply and the free movement of crisis-critical products subject to compulsory licencing in the internal market.”

The letter’s signatories, including Médecins Sans Frontières, Health Action International (HAI) and Oxfam, state that they support EU compulsory licences as they have “the potential to foster a more effective response to public health challenges”.

But by prohibiting exports, the current draft – which has been put forward for a plenary vote of the European Parliament – goes against flexibilities enshrined in the World Trade Organization (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement), according to the letter.

“This limitation is problematic, especially considering the use of a Union compulsory license would likely be triggered by situations that would affect not only EU countries but also countries outside of the EU, either in the region or globally,” they add.

Pandemics ‘don’t respect borders’

Making exports available under an EU compulsory licence “is not just a matter of international solidarity but is also in the EU’s interest” as it could “help in controlling potential outbreaks and emergencies that could spill over into the EU, allowing EU-based manufacturers to respond promptly to the needs of non-EU countries”.

“This vote is important for a number of reasons,” according to HAI Senior Policy Advisor Jaume Vidal.

“Embracing TRIPS flexibilities is, of course, a welcome step, but the current proposal risks becoming an ‘EU First’ response when it comes to pandemics and health emergencies, reminiscent of the inequities seen during the COVID-19 pandemic.

“Secondly, at a time when countries are negotiating a pandemic accord, a restrictive use of the proposed Union compulsory license that would limit exports would be sending an ominous message to negotiators. Finally, in times of greatest need, the EU would do well to remember that pandemics don’t respect borders or blocs,  and that no one is safe, until everyone is safe.”

Image Credits: Thijs ter Haar.