28th Feb 2024


Why EU's proposed medicines overhaul needs global outlook

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Proposals aimed at overhauling the EU's compulsory licencing system offer hope for a unified approach to medicine production across EU member states.

However, they fail to recognise the realities of our interconnected world — and risk being a missed opportunity to save lives and send a much-needed signal of solidarity and global cooperation.

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The Covid-19 pandemic is far from over, as demonstrated by the high levels of new infections over the past weeks.

As respiratory illnesses continue to spread across the EU and beyond, we learned recently that countries in the EU have let over 200 million doses of the vaccine go to waste.

Once the lifeline of the continent, these vaccines had become redundant due to an abating pandemic or an increasing unwillingness to be vaccinated.

Donating the excess medicines, nevertheless, could have helped to alleviate the pressure on countries' public health systems worldwide.

These developments bring to the fore the question of preparedness against future pandemics.

To increase resilience in this regard, in April last year the European Commission published a proposal for a new, Union-wide, compulsory licencing system that will make it easier to produce medicines under such a licence if multiple EU countries are involved.

Inspired by the pandemic, the commission proposed to change the compulsory licencing system — a temporary measure whereby a competent state authority can issue a licence that obliges the holder of a patent to share this with, for instance, a generic medicines producer to overcome a lack of supply.

This would replace the current piecemeal approach where every member state has to issue a compulsory licence.

Given both the transnational supply chains of medicine production and the cross-border nature of pandemics, the commission proposal seeks to introduce an EU compulsory licence valid in multiple member states.

But this laudable proposal falls short in one very important respect: it essentially considers the EU an island without connection to the outside world.

That is to say, products made under an EU compulsory licence are exclusively destined for the internal market. With the exception of a restrictive case in which least developed countries with no production capacities can apply to benefit from this licence, exports of such products are prohibited.

Considering that the EU and its member states have wasted €4bn on unused vaccines, even though these were not produced under a compulsory licence, it seems crucial to include safeguards in the new proposal that allow for the export of such excess capacity.

The good news is that the cure to this already exists: the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (also known as the TRIPS Agreement) foresees the possibility that a non-predominant part of products (i.e., up to 49 percent) produced under a compulsory licence can be exported.

By including this internationally agreed principle, the EU would not only avoid wasting medicines, it would also ensure that in the next pandemic, it can help countries in need and, in doing so, help itself because we know that pandemics do not stop at borders.

Including the possibility of exports under an EU compulsory license will not only save lives, it says to the world: we do not only care about our own — a message that is of growing importance in an increasingly isolationist global context.

Author bio

Helmut Scholz is a German MEP from The Left group. Heidi Hautala is a Finish MEP from The Greens/EFA, the vice-president of the European Parliament and a former minister for international development.


The views expressed in this opinion piece are the author's, not those of EUobserver.

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