How The EU Prepares For the Next Global Pandemic Domestically: An Examination of the Union Compulsory Licence [Guest Essay]

Newsletter Edition #214 [The Files In-Depth]

Hi,

The European Union has cast itself as a leader in global health at a time of swiftly changing geopolitics. From incubating the ACT Accelerator at the beginning of the COVID-19 pandemic, to germinating the idea for a new Pandemic Treaty, the EU has been a decisive player in also shaping WHO finances, and its key strategic health investments across the African industry and institutions.

The EU’s aspirations are also striking in the context of a retreating United States where globalization is under attack.

And yet, the EU’s resistance to alter the status quo in the response to health emergencies, whether at the TRIPS Waiver discussions at the WTO, or its positions on many health and trade related matters at WHO, suggests a lack of coherence in its overall goal towards leadership in global health.

In today’s edition, we look at policy discussions within the EU on some of these difficult matters. Our guest authors from Health Action International [HAI], have tracked the evolution of the recent processes on IP related matters, particularly the proposal for the use of a region-wide compulsory license, through the institutions in Brussels.

We hope you find this guest essay useful, also in the light of the ongoing global health negotiations in Geneva. We are grateful to HAI activists, Jaume Vidal and Alice Beck for charting this out for our readers.

Apart from providing our readers with original reporting, we are keen on bringing diverse perspectives from global health experts. Get in touch with us if you wish to access our audience of diplomats, decision-makers, scholars, the private sector and other experts who shape global health policy.

Support public interest global health journalism, become a paying subscriber. Tracking global health policy-making in Geneva is tough and expensive. Help us raise important questions, and in keeping an ear to the ground. Readers paying for our work makes this possible.

Our gratitude to our subscribers who help us stay in the game!

Later this week, we are pleased to have our first in-person event in Geneva for our readers. Drop by on Thursday for a discussion on the role of journalism in global health diplomacy. RSVP here: genevahealthfiles@gmail.com.

Until later.

Best,

Priti

Feel free to write to us: patnaik.reporting@gmail.com. Follow us on X: @filesgeneva

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Illustration Credit: Amy Clarke, Chembe Collaborative

I. GUEST ESSAY

How The EU Prepares For the Next  Global Pandemic Domestically: An Examination of the Union Compulsory Licence

By Jaume Vidal and Alice Beck

Vidal is Senior Policy Advisor at Health Action International [HAI] you can reach him at Jaume@haiweb.org; Beck is a Policy Officer at HAI you can reach her at Alice@haiweb.org

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The discussions in Brussels on the proposed European Union-wide Compulsory Licence (Union Licence) are interesting to follow as it is the first time the lessons from the COVID-19 pandemic are being brought into legislation. 

This is a part of the Intellectual Property package, which also addresses essential patents and the reforms on the Supplementary Protection Certificates regime.

The deliberations are even more compelling as they are taking place at the same time as new reforms for Pandemic Prevention Preparedness Response (PPPR) are being discussed and negotiated.

For both processes, the EU has a different  negotiation position and strategy. Further, pre-COVID elements which greatly underlined the EU response and stance remain very much present in both, including the role of the flexibilities of the Trade-Related Aspects of Intellectual Property Agreement (TRIPS) agreement, the balance between internal needs and global commitments and, more importantly, the role of governments in responding to pandemics and health emergencies.

At different phases of the COVID-19 pandemic, some EU Members were faced with difficulties in accessing crucial life-saving health goods such as personal protection equipment.

These obstacles cast doubt over one of the most cherished features of the EU: the single market which became strained under the scramble for health goods by Member States. Other tenets of the single market were re-examined, with several EU members reforming (or attempting to reform) their domestic IP protection framework to expedite access to medicines and vaccines.

These are momentous times for pharmaceutical policy in the EU, from the revision of the EU pharmaceutical legislation to the Intellectual Property Package (originating from DG GROW).

There has been a long-awaited overhaul of the incentives system and wide-ranging proposals on shortages and regulatory oversight. This is being discussed in parallel, albeit in different committees.

Twice delayed, the proposal for revision of the pharmaceutical strategy was to be one of the milestone legislative acts of the outgoing Commission, especially of DG Sante.

The Proposal

The idea of an Union Compulsory Licence was intended as a response to challenges to the single market posed by pandemics or health emergencies, designed to co-exist with national instances. Thus, this would form a domestic tool that would offer expedited access to EU Member State markets on the same grounds as those established in the TRIPS agreement with some additional requirements (most notably the identification of rights holders) and inaccuracies (need for an agreement from rights holders to proceed with the compulsory licence).

The external component of the proposal, namely the possibility of exports under the Union Compulsory Licence, is covered by Regulation 816/2006. This regulation essentially incorporates Art.31 bis of the TRIPS agreement to the EU framework. It is this regulation which is to be updated and become part of the future Union Compulsory Licence.

Image Credit: Photo by Jeremy Bishop, Pexels