Using TRIPS Flexibilities: Easier Said Than Done? [Update from WIPO SCP]

Newsletter Edition #237 [The Files In-Depth]

Hi,

At a recent meeting at the World Intellectual Property Organization (WIPO) in Geneva, member states considered a study that takes a closer look at some of the policy challenges associated with the access to medicines, specifically what prevents the full use of TRIPS flexibilities. This discussion was not uncontested.

The study arrives at a crucial time when countries are considering international obligations that touch areas of balancing patent protection with public health needs, at WHO. In addition, a wider review of intellectual property rules could potentially begin at the WTO.

Therefore, an inspection of the study and the subsequent deliberation at the Standing Committee on Patents at WIPO, is relevant in the context of simultaneous policy discussions in global health in Geneva and beyond.

My colleague Sreenath brings you this report from the WIPO meeting that took place in October 2024.

We continue to track negotiations at WHO, watch out for our analyses on the same in the coming week.

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Until later!

Priti

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Illustration Credit: Amy Clarke, Chembe Collaborative

I. ANALYSIS

Using TRIPS Flexibilities: Easier Said Than Done?

By Sreenath Namboodiri

An update from the 36^th session of the WIPO Standing Committee on Patents [October 2024]

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Recent health crises have raised persistent policy concerns on affordability and availability of medical products. In this context, most of the discussions have focused on patents.

Interestingly, both the critics and supporters of the Trade-Related Aspects of Intellectual Property Rights [TRIPS] Agreement at the WTO, cite the existence of flexibilities in the Agreement in order to support their argument.

Sceptics of the TRIPS Agreement advocate for greater use of enshrined flexibilities. The maximalist position on intellectual property often denies patents as a barrier to access to medicines or technologies and calls for applying flexibilities. (To be sure, even calling for flexibilities has indeed been a shift in the back drop of the COVID-19 pandemic - a period that also saw negotiations for a temporary suspension of certain IP rights to respond to the health emergency.)

Since the adoption of the Doha Declaration on the TRIPS Agreement and Public Health (Doha Declaration), many UN and WHO documents have cited the use of flexibilities. The use of flexibilities got a clear legal footing for the tobacco plain packaging case at the WTO where the Panel referred to the status of the Doha Declaration as a subsequent agreement among parties.

Notwithstanding the Doha Declaration which recognizes these policy tools - particularly for public health protection and the access to medicines - their ease of use has remained a concern.

The COVID-19 pandemic also exposed this gap when many countries did not, or could not use existing flexibilities to address vaccine and therapeutic shortages. (The TRIPS waiver discussions took place in this context.)

Paragraph 4 of the Doha Declaration states: “The TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all.”.

Further, para 5 of the Doha Declaration provides for a list of non-exhaustive examples of how flexibilities in the TRIPS agreement exist.

There is a disconnect between the theoretical scope of flexibilities (embedded in Articles 7 and 8 of TRIPS) with their practical utility, raising critical questions about their real-world impact.

Very little formal examination has taken place with regard to the challenges and the limitations on the use of flexibilities.  A recent report prepared by the WIPO Secretariat was discussed the 36^th session of the WIPO Standing Committee on Patents. This report lists major challenges faced by Member States in using the flexibilities.

Image Credit: Photo by Markus Spiske, Pexels