Article 39(3) TRIPS : understanding the obligations, exploiting the flexibilities

Abstract

A pharmaceutical is authorised into a market only after a drug sponsor has proven its safety and efficacy before a specialised state agency, usually by providing evidence of clinical experimentation on several hundreds of subjects. According to several estimates, drug testing lasts several years and amounts to several hundreds millions of USD dollars. However, generic companies do not need to re-conduct clinical trials to gain authorisation for their bio-equivalent products. This is because if the two drugs are equivalent, either the safety of the second compound is de facto established by the first authorisation, or in any case the pharmaceutical agency is already in possession of all the relevant information to evaluate the candidature of the generic. The opportunity of letting competitors utilise originators’ trials to gain approval for their bio-equivalent drugs was heatedly debated during the negotiations that led to the establishment of the treaty on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and were dealt with in Article 39(3) of the Agreement. The provision stipulates that: “Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use”. Unfortunately, more than twenty years after the formation of the treaty, the legal meaning of the provision remains highly debated among scholars and WTO members. In detail, it is still controversial whether the provision mandates for some sort of protection against regulatory reliance or if it simply forbids otherwise unlawful behaviours as industrial espionage, data theft or misappropriation. Moreover, it remains unclear which boundaries the provision poses on Member States rights to disclose regulatory information to the public. The present dissertation investigates the obligations imposed by Article 39(3) TRIPS on WTO parties and aims at overcoming the academic disagreement on the topic. By reassessing the relevant literature, and by combining old and new arguments, it argues that Article 39(3) does address regulatory reliance practices. In an on original approach, the dissertation also elucidates the amount of protection necessary to comply with the provision and its effect on developing countries pharmaceutical policies. However, it also emphasises that the impact of the provision on developing countries pharmaceutical policies is greatly mitigated by the flexibility left to WTO members to approve generic drugs by referring to prior foreign authorisations. The dissertation also elucidates the limits within which regulatory agencies are allowed to disclose regulatory dossiers to the public. After having analysed the obligations imposed by the provision, the dissertation looks at another contentious topic: the TRIPS consistency of public health safeguards that stretch the wording of the provision to achieve important policy goals. This analysis is carried out on the belief that, in the process of implementation of international treaties, obligations and flexibilities are but the two sides of the same matter. Indeed, while the former expression refers to what measures WTO members are required to implement to comply with a specific provision, the latter describes the leeway left to parties to meet their obligations through different options and solutions. The dissertation defends the TRIPS consistency of several Article 39(3) flexibilities necessary to achieve important public health goals, such as reducing international drug-lag, preventing evergreening practices, fostering disclosure of clinical dossiers and safeguarding compulsory licensing.