Monopolizing Clinical Trial Data: Implications and Trends

T he Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement, Box 1) has to a large extent harmonized standards for intellectual property rights, including patents. For many countries, the TRIPS standards were higher than their previous standards. For example, TRIPS obliges countries to allow patenting of pharmaceuticals and imposes a minimum duration of 20 years for patents. Before TRIPS entered into force, a number of (developing) countries either did not grant patents for medicines, or had a shorter patent term. Since generic medicines can only be marketed in the absence of a patent or after its expiry, the implementation of TRIPS in those countries means it will take longer before generic versions of new medicines can enter the market. The TRIPS Agreement has therefore been criticized for its anticipated detrimental effect on access to medicines, especially in developing countries. But while much of the debate on TRIPS, intellectual property rights, and access to medicines has focused on patents (Box 2), largely outside the limelight the rather abstract notion of data exclusivity has quietly been introduced and promoted. Data exclusivity refers to the granting of exclusive rights over the data required for registration of pharmaceuticals, notably the clinical and preclinical trial data. Data exclusivity, too, can jeopardize access to medicines and negatively affect public health. This article tries to demystify the concept and implications of " data exclusivity, " and to provide an overview of current trends. It has at times been argued that a relatively obscure clause in the TRIPS Agreement—namely its Article 39.3— requires countries to implement data exclusivity [1,2]. However, careful reading of the article does not warrant this conclusion. Article 39.3 essentially demands that undisclosed registration data about new chemical entities be protected against unfair commercial use and against disclosure. Thus, in line with standard regulatory practice, authorities may not publish or share such data—though, importantly, TRIPS does not prevent disclosure when it is necessary to protect the public. Discussions about data exclusivity, however, gravitate around the interpretation of " unfair commercial use " of registration data. Before registering a pharmaceutical product and allowing it on the market, regulatory authorities verify its quality, safety, and effi cacy. In the case of a new medicine, safety and effi cacy are established via preclinical and clinical trials; hence submission of the trial data is an important prerequisite for registration. Meanwhile, in order to obtain marketing authorization …