In October of 2020, 9 months into the pandemic, fearing conflicts over intellectual property (IP) related to medical measures to fight the pandemic, India and South Africa proposed at the World Trade Organization’s Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) a temporary waiver of certain provisions of the TRIPS Agreement for the duration of the pandemic. The WTO Members have so far failed to make any meaningful progress.
In mid-March 2022, a draft decision text – cobbled together by the European Union, South Africa, India and the United States – became available. The draft contains many of the characteristics of the EU proposal of October 2021 which, at the time, we assessed as ‘meaningless’. WTO Members are currently mulling over the draft agreement and pressure is mounting for them to sign up for it. Some have hailed this text as a breakthrough, including WTO Director General Okonjo-Iweala, who called it “a major step forward”.
But many have questioned its limited scope (only on vaccines, not therapeutics), as well as additional requirements which make it ill suited to the size of the response needed (see, for example, here, here and here.) IP rights holders also seemed dissatisfied, as is generally the case when patents are pointed out to be a barrier to medicines access.
Here is ML&P’s take.
The draft agreement proposes a 3 or 5-year limited waiver of some TRIPS requirements related to compulsory licensing and aims at increasing supplies of Covid-19 vaccines to developing countries through the use of compulsory licences. The waiver can only be used by “eligible members”, which are defined as developing countries which “exported less than 10 percent of world exports of COVID-19 vaccine doses in 2021”. This would exclude China according to the IMF tracker.
The draft agreement is therefore very far from the original waiver proposal, which aimed at providing manufacturers of any Covid-19 technology the freedom to manufacture, without fear of legal actions as a result of patent infringement. Under this draft agreement, manufacturers of Covid-19 vaccines will remain dependent on case by case Government decisions and the status quo is maintained for manufacturers of other Covid-19 technologies.
While the text aims to clarify TRIPS Article 31, which outlines under what parameters a patented technology can be used without permission of the patent holder, and waive some of its limitations, it does only the bare minimum and creates some troublesome precedents. Think tank Knowledge Ecology International has pointed out, for example, that the new requirement to list all relevant patents can present a challenge as patent landscapes are rarely straightforward. For a complex technology like a vaccine, there can be interlocking patents from a variety of different rights holders, and some key patents are often hard to link to relevant products.
Paragraph 2 of the draft agreement intends to clarify and facilitate the use of TRIPS Article 31 as it says that Members may issue compulsory licences (CL) through any type of instrument, “whether or not a Member has a compulsory licence regime in place”. However, TRIPS does not prescribe what type of instrument should be used to issue CL and in other fields of infectious disease, issuing compulsory licences and government use decisions in a variety of ways, is a longstanding practice. See our TRIPS Flexibilities Database for details. So in practice this provision provides no additional flexibility.
Paragraph 3(a) intends to clarify or provide a waiver to TRIPS Article 31(a) rather creates some uncertainty in that it states that Members “may issue a single authorization” covering several patents related to a COVID-19 vaccine but also states that “the authorization shall list all patents covered”, which is not a requirement of TRIPS Article 31(a) now and is very difficult to do.
Paragraph 3(b) only repeats TRIPS Article 31b without adding any clarification. TRIPS Article 31b waives the obligation of Members to have prior negotiations with the right holder in the case of a national emergency or other circumstances of extreme urgency. Para 3b of the waiver is only clarifying that Covid-19 constitutes an emergency, which so far has not been questioned by anyone.
Paragraph 3(c) may be the only true new waiver of this text, in that it waives the restriction of TRIPS Article 31(f) which limits exports under compulsory licences by prescribing that a CL should be predominantly for the domestic market. This limitation has been subject to years of discussion after the adoption of the Doha Declaration on TRIPS and Public Health in 2001, and led to an amendment of the TRIPS Agreement in 2017 See: special-compulsory-licences-for-export-of-medicines and here.
This paragraph clarifies that Members “may allow any proportion” of the CL to be exported. Exports are however limited to developing countries only. This means that the existing restriction on some HICs to import from a CL issued under TRIPS Article 31 (bis) remains and that EU countries without manufacturing capacity remain forced to source Covid-19 vaccines from the patent holders.
Box: The Waiver and the mRNA Technology Transfer Hubs
One practical effect the current draft agreement may have relates to the WHO mRNA technology transfer hub. The objective of the WHO hub is to build capacity in low- and middle-income countries to produce mRNA vaccines through a centre of excellence and training (the mRNA vaccine technology hub). The hub is located at Afrigen, Cape Town, South Africa, and will work with a network of technology recipients (spokes) in low- and middle-income countries. In September 2021, the Pan-American Health Organization (PAHO) announced agreements with two centres to establish regional mRNA manufacturer spokes – in Brazil, with the Bio-Manguinhos Institute of Technology on Immunobiologicals at the Oswaldo Cruz Foundation, and in Argentina with Sinergium Biotech.
The South African hub uses publicly available information about Moderna’s Covid-19 vaccine to replicate the technology. This technology was chosen because Moderna had publicly stated in March 2020 that it would not enforce patent rights during the pandemic. Recently, Moderna announced it expanded this earlier commitment to never enforce Covid-19 patents in the Gavi COVAX advanced market commitment (AMC) for 92 low- and middle-income countries.
However, it also announced that in non-AMC 92 countries, where it considers “vaccine supply is no longer a barrier to access”, it expects those using Moderna-patented technologies to respect its IP or to enter into a licence agreement on commercially reasonable terms. Brazil, Argentina and other non-AMC countries could therefore potentially use the proposed waiver as a leverage to negotiate reasonable terms to continue to use Moderna’s patented technology.
Paragraph 3e refers to the WHO guidelines for Non-Voluntary Use of a Patent on Medical Technologies published in 2005, as a useful reference for determining what should be an adequate remuneration in accordance with the requirements set out in TRIPS Article 31h (which requires that patent holders be compensated in the case of a CL). While this is useful, referring to a 17 year old document is hardly the kind of decisive and innovative measure one would need from the WTO in the face of a global pandemic. Indeed, countries, for example Ecuador, have used the WHO guidelines when issuing CLs medicines patents in the past. See for details: http://tripsflexibilities.medicineslawandpolicy.org.
Paragraph 4 of the proposed solution clarifies that provisions of TRIPS Article 39.3 on the protection of pharmaceutical test data, which some Members have implemented as data exclusivity, should not hamper the effective use of CL to increase access to Covid-19 vaccines in the eligible countries. This could potentially be a helpful clarification and it is noteworthy that some national laws such as in Chile, Colombia, and Malaysia already contain a data exclusivity waiver in case of CL . This provision, however, should not be confined to ‘the eligible countries’ alone. For example, the absence of a data exclusivity waiver in the EU pharmaceutical regulation was also identified as a barrier to the effective use of CL by the chair of the Dutch Commission on Compulsory Licensing in his report of June 2020.
The last sentence of the draft solution instructs Members to decide on the extension of this decision to the production and distribution of Covid-19 diagnostics and therapeutics within 6 months. This is potentially significant. It is, however, not clear why such a decision should be postponed since therapeutics have become available. Recently approved Covid-19 therapeutics have been licensed to the Medicines Patent Pool. If this extension is approved, developing countries excluded from the MPP licence should be able to issue CLs to manufacture, import or export affordable generics versions of Covid-19 antivirals with less political pressure. However the notification obligation contained in paragraph 5 will raise concerns among Members, in particular because issuing a CL under article 31 has not before been subject to a notification obligation. Based on past experience it is fair to say that such a notification may provoke political and trade pressures to abandon the CL.
The draft agreement reaffirms the existing right of developing countries, except China, to issue a CL to manufacture, import or export Covid-19 vaccines. This is a right that under TRIPS all WTO Members have, so one could say that this draft introduces limitations to the use of a CL by identifying a list of eligible countries. All the while, the draft agreement fails to address the elephant in the room, namely: ensuring that know-how related to vaccine technology is shared in order to enable timely production of quality assured products.
In conclusion, a pandemic TRIPS waiver needs to offer significantly more options to WTO Members than they have currently under TRIPS to deal with IP challenges to access and manufacture pandemic counter measures. This draft agreement does not meet that test. It risks being hailed as a diplomatic victory in Geneva but with little practical consequences elsewhere.