Kang, Hyo Yoon

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Not Much of a WaiverHyo Yoon Kang 2022-03-18T14:59:03Seventeen months after South Africa and India initiated the TRIPS waiver proposal,the negotiating “quad” (South Africa, India, US and the EU) is reported to havereached a compromise at the WTO. The text of the proposal was leaked this week.From a legal perspective, the outcome of the compromise is more muddled andconfusing than clarifying, although it claims its aim to be the latter. As it presentlystands, the text is not so much a waiver of TRIPS obligations than a modificationof existing obligations and conditions of exemptions around patents, as well as anintroduction of additional requirements.What the draft text coversThe leaked text is a draft, and it is not clear if this is a final version which will bepresented to the WTO General Council for approval. My reading is based on theshort document that has been published here. It is also reproduced on the NGO KEIwebsite.The draft text only mentions two issues of the TRIPS: patents and data exclusivityin regulatory data. It refers to Art. 28 (1) of the TRIPS which specifies the rightsconferred by a patent and to Art. 31 and 31bis that specify the conditions forcompulsory license which does not require the authorisation of the patent rightholder. It also mentions exclusive treatment of pharmaceutical data by some TRIPSmember states which have data exclusivity provisions in place in their respectivedomestic jurisdictions (Art. 39 (3)). The compromise excludes any discussionor waiving of copyright, trade marks, know-how and other kinds of confidentialinformation. The compromise applies only to vaccines, but not to therapeutics anddiagnostics against Covid-19.The leaked text on patentsThe passages in the leaked text which pertain to Art. 31 TRIPS are moreclarifications and complications to existing law than waivers. On the one hand, itwaives Art. 31(f) which imposes restrictions on exports under compulsory license toless than half of a country’s domestic production. The text keeps 31 (h) requirementof determination of adequate remuneration intact.The leaked text introduces an additional requirement of all applicable patents to beidentified as part of compulsory license authorised under Art. 31(a). This is a newcumbersome requirement that did not exist before for the grant of a compulsorylicense. It is not clear if “applicable patents” include unpublished patent application.It does not clarify the level of search that the list is supposed to be based on, forexample, a freedom to operate search or a basic search.- 1 -Overall, it would be difficult to describe these ideas as “waivers”, or even“clarifications”. They complicate an already cumbersome Art. 31 and Art. 31bis morethan they waive.The leaked text on confidential information andregulatory dataThe document mentions TRIPS Art. 39 (3) which concerns the treatment ofregulatory data in pharmaceutical and agricultural chemical products and theirexclusivity. Art. 39 (3) does not relate to existing patents. A company can have dataexclusivity of various lengths of time in different domestic and regional jurisdictionsseparately from patent rights.The leaked text states: “Nothing in Article 39.3 of the Agreement shall preventa Member from taking measures necessary to enable the effectiveness of anyauthorization issued as per this Decision.”Art. 39 (3) already contains a public interest clause which provides defence againstthe disclosure of protected data “where necessary to protect the public”. It isnot clear why Art. 39 (3) is mentioned at all in the leaked text because it is onlyrelevant for jurisdictions that have a high level of data exclusivity in place, suchas US and EU. But these countries would not be included in the proposed waivercompromise proposal in any case, because it would only cover self-declareddeveloping countries, and even amongst those, be restricted to countries that haveexported less than 10% of global vaccines doses in 2021. It would require a closeranalysis, but it is likely that very few countries would be affected by Art. 39 (3) in thecategory of waiver applicable countries as carved out in the leaked document. Theconfirmation of public interest exception that already exists in Art. 39 (3) says little inaddition about its relation to free trade agreements and investment treaties.The issue of data exclusivity – from a legal point of view – is not necessarilyconnected to patents or to the practical and legal technical challenge to devise novelways to mandate know-how and technology transfer, as Olga Gurgula had explored.The leaked text offers no mechanism or a mandate to share the data available ata regulatory agency outside one’s jurisdiction for making vaccines — the alreadyexisting public interest provision in Art. 39 (3) is not elaborated or expanded towardsnon-domestic publics. For example, there is no mechanism by which a genericmanufacturer in India could access European regulatory data. The mention of Art. 39(3) in the leaked text adds nothing new to what already is within the TRIPS.The leaked text does not mention Art. 39 (1) and (2) which are about undisclosedinformation more broadly and incorporate the provisions of the Berne ConventionArt. 10bis regarding the fair treatment of commercially valuable information. TRIPSArt. 39 (1) and (2) need to be understood in the broader contexts of the meaningsof fair or unfair competition and confidential commercial information and tradesecrets. There is nothing in the current draft compromise text which indicates that39 (1) and (2) could be waived on grounds of countervailing public interest. This is amissed opportunity. For example, in the UK jurisprudence of confidential information,- 2 -different public interests need to be weighed when determining the desirabilityof confidentiality in relation to that of disclosure (Attorney-General v GuardianNewspapers Ltd (No 2) (‘Spycatcher’): HL 13 Oct 1988).ContextThe compromise draft text on India and South Africa’s TRIPS waiver proposalarrives after seventeen months of failure to come to a decision in the midst of aglobal pandemic. The intensity of the debate about global vaccine supply anddistribution may have waned amidst Russia’s invasion of Ukraine. The problem ofvaccine inequity however persists. According to Our World in Data, as of 17 March2022, only 14.1% of people in low-income countries have received one dose ofvaccination. The majority of high-income countries have administered more boosterdoses than first doses had been administered in low-income countries in the lastseven months, as the Financial Times reported a few days ago. It is also worthrecalling the sense of urgency and uncertainty when vaccines were in short supplyin Europe and North America. The race for vaccines was exacerbated by developedcountries engaging in vaccine nationalism. Together with my colleagues, we set outin detail arguments in favour of a comprehensive TRIPS waiver in May 2021, afterthe US swung behind the waiver proposal albeit with a more limited scope. Over180 IP law experts have expressed their support for the TRIPS waiver initiative inan open letter in July 2021. The long wait for this week’s announcement after anestimated pandemic death toll of 18 million lives is concerning for the negotiations onintellectual property in negotiations towards the WHO Pandemic Treaty.Civil society organisations, such as KEI, MSF and Oxfam, have condemned thelimitation of this draft compromise text to vaccines and patents only. The only clearbenefit of the text is that it will enable the WHO mRNA hub and its regional traininghubs to operate without the fear of patent litigation from Moderna and provide legalclarity to build production of WHO mRNA vaccine in waiver-applicable countries.The wisdom of setting a precedent of carving out the geographical limitation of thewaiver is also questionable (footnote 1 of the document). If encouraging competition,scaling up production and equitable access to vaccines are the purpose of thewaiver discussion, it makes little sense to leave out China and Brazil which havesignificant manufacturing capacities. China does not qualify under the 10% of 2021vaccine export criterion as it has exported a significant amount of its vaccines at atime when developed countries were exporting none or very little. There may wellbe other trade considerations in play, and Geneva Health Files reported that Chinamay have agreed to this exclusion. It is not clear if Brazil still has the status of adeveloping country. If not, it would not be included in the waiver-eligible category ofcountries. The publics in Europe and US would also benefit from more knowledge-sharing which would encourage more innovation, competition and transparency.- 3 -ConclusionThe WTO waiver discussion has been the testing ground for re-assessing theskewed balance between public and private interests within the TRIPS structure.In light of future pandemics, it is concerning that this rather lacking text is the resultof a seventeen months wait in a global pandemic that have resulted in 18 milliondeaths and which have shown the developed nations which have opposed thetemporary waiving of TRIPS obligations also failing to supply and support lower andmiddle income nations with vaccines, necessary equipment and medicines. Thecompromise text resembles the EU position in the waiver negotiations.This pandemic is not yet over. The opportunity to draft a more streamlined andpracticable text is still there and should not be missed, also for the sake of beingbetter prepared for the next global pandemic.- 4 -

Not Much of a Waiver

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Not Much of a Waiver

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