COVID-19 and the TRIPS Regulation on the Disclosure of Clinical Trial Data

Worldwide, scientists are conducting clinical trials on potential vaccines and treatments against COVID-19. Many of these drugs are already in the market for other diseases and, according to the University of Liverpool, could be produced for even $1 a day per patient. Some are off-patent and could be manufactured as ‘generic’ or ‘similar’ versions, like chloroquine and hydroxychloroquine. However, others, like antivirals and receptor inhibitors, are proprietary, and patent protection, combined with limited supplies, could increase their prices (see here and here). 

If any of the medicines and vaccines is to prove effective, availability and affordability will be as much part of the treatment as the medicine itself, in particular to avoid that drugs that are fundamentally cheap be off-limits for poorer patients. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is one of the main conventional instruments to establish a minimum level of protection of intellectual property rights and to ensure that such rights do not constitute barriers to legitimate trade. It has relevant flexibilities, associated with:

• Article 31 and Compulsory licensing (see more here),
• Article 6 and the exhaustion of intellectual property rights (more here),
• Research exception and the Bolar provision (here), as well as other exceptions conferred in Article 30, along with flexibilities related to the patentability criteria. 

These provisions are reinforced by the Doha Declaration on the TRIPS Agreement and Public Health, which recognises that the members of the World Trade Organization (WTO) can make the most of the flexibilities of the TRIPS Agreement to promote their public health policies in challenging circumstances. 

Along with such instruments of intellectual property comes a rather neglected (albeit important) aspect of competition law enshrined in Article 39.3 of the TRIPS Agreement. It requires member states to offer effective protection against unfair commercial use of the data required by governments to authorise the marketing of a pharmaceutical product. The main rationale of the clause is to limit the chances of competitors free riding on the data package produced by the originator to prove the efficacy and non-toxicity of the drug (see here). It can, though, provide an additional period of market exclusivity which, according to the OECD, may postpone the market entry of the generic drug for a period between 5 to 12 years, even in the absence of patent protection.

One of the main controversies among WTO members relates to the modes of implementation of the protection set in the clause. The Article explicitly refers to the protection against disclosure, and the protection against unfair commercial use, but does not elaborate on what they mean. Also, the WTO dispute settlement mechanisms have not issued a decision on the interpretative margins available to member states (see here), what results in different national rules and legislation, which can be classified as (i) simple unfair competition rule; (ii) the duty to pay for data access; and (iii) exclusivity rights in the use of the data and in market access (see here and here).

In the US, for instance, tests submitted to the Food and Drug Administration (FDA) are protected by data exclusivity. The exclusivity of the use of the new tests is guaranteed for a period of three years, which means that third parties can claim the approval of the generic version of the first use after the five years of protection. US bilateral agreements with Australia, Bahrain, Jordan and South Korea also mention the protection of a new therapeutic indication; and in the European Union, there is the possibility of granting the extension of market exclusivity for another year, present one or more new therapeutic applications, before the end of the eight-year period of exclusivity of the test dossier.

Proponents of the exclusivity model typically argue that it rewards the creation of standardized and better data, in a manner separate from patent protection (see Mercurio). Still, the doctrine diverges on whether such logic is appropriate for the approval of a new mode of use of a known drug, and if the use of undisclosed clinical data for public interest, or by public authorities and publicly-funded labs, would violate the protection against unfair commercial use.

Strauch and Michaelis are among those who suggest that the agreement offers protection against the ‘commercial use’, meaning the use made by the entities that compete with the originator and not by the public administrator. Consequently, there would be no need of protection in situations which are not commercial in nature. That is the case, for example, of sanitary authorities which refer to the first registrant’s data to grant anticipated marketing approval to subsequent applicant but impede the competitor to commercialize the product before the term of protection expires. Carvalho also gives the example of a governmental agency which relays the originator’s data to the registration of the generic product under the exclusive purpose of granting marketing approval for exporting it to other countries. While such conduct would have a clear commercial impact, its effects are verified in another territory, outside of the reach of the national data protection. 

Article 39.3 also establishes an exception, whenever it is ‘necessary to protect the public’. Following Article 31 of the Vienna Convention on the Law of Treaties, 1969, this provision should be interpreted in accordance with the ordinary meaning given to its term, providing policymakers a great margin to consider what is needed to protect the public against the pandemic. The Doha Declaration equally underscores that the TRIPS Agreement ‘can and should be interpreted and implemented’ in such way that it supports the national endeavours ‘to protect public health and, in particular, to promote access to medicines for all’. Additionally, Article 5(c) confirms that member states have ‘the right to determine what constitutes a national emergency or other circumstances of extreme urgency’ (emphasis added). If the Doha Declaration has some impact on the meaning of Article 39.3, that impact necessarily means that it should be interpreted and implemented in a manner supportive to the protection of public health and to the access to medicines for all. 

In essence, in this particular context of a worldwide emergency, access to clinical trial data serves pressing public health needs and helps combat the outbreak in an efficient and transparent way, in line with the flexibilities conferred by Article 39.3. If applied as a means of ensuring equitable and universal access by those in need to future vaccines and treatments for COVID-19, it can be a relevant policy tool to: (a) avoid the conduct of similar experiments or its repetition; (b) expedite the production of essential generic medicines; (c) enhance the trust and confidence of the public; (d) encourage companies and institutions to improve the design, conduct, and oversight of clinical trials; and (e) allow the medical community to choose the most effective therapies and learn about available experimental drugs or vaccines (see here).

Vanessa Sant’Anna is a PhD candidate in Interdisciplinary International Studies (IIS) at joint program of the University of Vienna and the Diplomatic Academy of Vienna, as well as a career diplomat of the Ministry of External Relations of Brazil. She holds a LLM in Diplomacy by Instituto Rio Branco and has in her diplomatic duties has worked as Deputy-General Coordinator of Economic Organizations, Deputy-Chief of the Division of Tax and Financial Co-operation, as well as Deputy-Head of Human Rights. She has served in both the Embassy of Brazil in the Kingdom of the Netherlands and the Embassy of Brazil in the Slovak Republic.

Image: Sam Whitney/Getty/Wired.

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