[Guest post] The TRIPS Waiver Debate: Why, and where to from here?

The discussion surrounding the suspension of IP rights in the COVID-19 vaccines has become increasingly heated over the past few months and weeks. The IPKat is delighted to host a guest opinion on the so called ‘TRIPS waiver’ by Prof Daniel Gervais (Vanderbilt University).

Here’s what Prof Gervais writes:

The TRIPS Waiver Debate: Why, and where to from here?

by Daniel Gervais*

While Merpel got her vaccine ...

I have been asked many times what I make of the debates about the TRIPS waiver. I had decided not to comment, especially on social media where it seems to be 50 shades of black and white. After listening to the “for” and “against” debate in the European Parliament, however, I decided to put a few thoughts on paper (well, on the screen) because for or against the waiver strikes me as the wrong debate.

First, it is not a matter of being for or against *the* waiver. In the end, there is likely to be *a* waiver, with specific provisions about, inter alia (think of it as turning three knobs): (a) which rights are waived; (b) for which purpose and (c) for which period of time. It is possible that the WTO will actually vote on this waiver, though WTO practice would more typically look for a text-based consensus, turning the three knobs (and finding other knobs to turn) until everyone can agree—if at all possible. But whatever the outcome of that debate, it is unlikely fully to address four key issues concerning the effectiveness of the waiver, nor does it directly answer deeper questions about the future of pharmaceutical research.

First on my list of issues: which relevant patent applications have been published? As the pandemic is not quite 18 months old and patent applications are typically published 18 months after filing, one would have to see which patents are likely to be issued, and then whether they contain all the information necessary to produce the vaccines. Though patent law requires disclosure, patent applicants have many creative ways of not disclosing everything. Hence, a waiver may not be sufficient. This does not mean it is not necessary. The point is simply that getting the actual know how is a barrier that the waiver may not solve. Some of those opposed to the waiver in the EU parliamentary debate emphasised the importance of the transfer of know-how. They are correct though again it does not lead to the conclusion that the waiver must be opposed. As I see it, those are related but different questions. The actual questions to answer about the (patent) waiver is what patents are “in the way”, and whether those patents contain all the necessary information for a third party to manufacture the vaccines. This question can only be answered once the relevant patent applications are publicly available. This should be possible, as some very recent pre-pandemic applications concerning mRNA vaccines for coronaviruses (not SARS-Cov-2) have not only been published but already granted (for example Moderna’s US patent 10,933,127 B2, issued March 2021).

One might also ask whether voluntary licenses (presumably with know-how transfer) are or will be available. In that context, some observers who know the inner workings of the WTO have suggested that the push for the waiver may be a way to get leverage in discussion between governments and pharmaceutical companies.

My second issue is: what idle capacity exists? Production capacity is necessary for third party manufacturers (and then people) to benefit from the waiver. It looks like this capacity exists, as Teva, among others, seems ready willing and able to produce vaccines. As far as I can see (and I may well be wrong), precise idle capacity had not been well documented until fairly recently.

The third issue is the murky interface between patent rights and rights in data submitted to governments for drug approval purposes (“data exclusivity”). How those rights are granted affects what portion of clinical test data are made public, among other things. Basically, pharmaceutical companies benefit from two separate layers of legal protection on a newly approved patented pharmaceutical. It may be time to create more structured links between the two forms of protection. I suggested one approach here. The waiver may of course include the limited data protection provision in TRIPS article 39.

The fourth issue is crucial: is the waiver is actually necessary? Here, I suggest that one should distinguish two forms of necessity: doctrinal and normative. The latter emerges forcefully in current debates, which have been used to send signals about perceived deficiencies in global drug development and the need for reform. I return to this below. The answer to the former (whether a waiver is doctrinally necessary) is, as I see it, debatable for three reasons.

... Others are afraid of needles

First, TRIPS articles 31 and 31bis already provide for compulsory licensing in two different sets of circumstances. Essentially, under 31 such a license is used predominately for domestic use (assuming, therefore, the existence of domestic manufacturing capacity). 31bis is meant to allow exports to countries without manufacturing capacity. The effectiveness of any compulsory license is subject to the same aforementioned caveats as the waiver in terms of know-how transfer.

Second, there are a number of cases in WTO jurisprudence where panels and the Appellate Body have interpreted WTO rules rather flexibly when a public health measure was challenged as clashing with a WTO commitment (EC-Asbestos and Australia-Tobacco Plain Packaging, to name just two). In the plain packaging case, the flexibility was supported by references to TRIPS articles 7 and 8 and the 2001 Declaration of the TRIPS Agreement and Public Health. I am finishing an article on this point and cannot explain all the details here but, to summarise a complex set of interpretive issues, it strikes me as unlikely that a panel (or the Appellate Body if and when it resumes its operations) would find against a WTO Member in the context of this pandemic. Indeed, this shift in WTO dispute-settlement approaches may reflect a broader shift in the very ethos of the WTO. In 1995, that ethos (like that of the GATT before) was trade liberalisation. Now, it is about something else, or something more, a change I described using the label “pluralism” in the latest edition of my TRIPS book. Ambassador Tai (USTR) seems to agree, not about the label as much as the need to move away from a strict ethos of trade liberalisation.

Third, and relatedly, it is unlikely that a case against a Member using TRIPS flexibilities to fight the pandemic would be filed in the first place. That said, the doctrinal force of the waiver is that it provides more certainty about the latter two reasons.

The deeper question alluded to above is whether the current vaccine research and development model in many major jurisdictions (basically using public funds to do “basic” research and then letting market forces backed by exclusive rights decide what gets brought to market) needs to be re-examined. There is a role for market-based incentives, but in certain cases (also in areas such as tropical and orphan diseases) they have not worked particularly well to ensure equitable access. A concerted, publicly funded global effort to produce (perhaps in publicly funded labs) certain products may need to be explored further, as do alternative funding sources (foundations, etc). This reasoning can apply to other diseases as well. Much work has been done on this issue, but much work remains to be done. Whether the World Health Organization (WHO) can conduct an orchestra of nations here, and which nations will be willing to play in that orchestra, remains to be seen. It is essential to consider in that context that, while some of the countries without domestic vaccine manufacturing capacity that were caught off guard by supply chain disruptions in the early days of this pandemic have started developing “national” manufacturing capacity (eg Canada), not all nations can do so.

The world’s answer to COVID-19 provides a fresh set of key data, some good (rapid vaccine development), some bad (inequality of access) to fuel future conversations about optimal vaccine/emergency pandemic response R&D models. If there is one good thing that can come out of this global ordeal, it is that we are now having this conversation in earnest.

* The views expressed are the author’s own.