Monopolizing clinical trial data: implications and trends.

Abstract

The 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. Box 1: TRIPS and TRIPS-Plus The TRIPS Agreement harmonizes standards for various types of intellectual property rights, such as copyrights, patents, and trademarks. TRIPS is an integral part of the WTO Agreements, which create binding obligations among WTO member countries. TRIPS is subject to the WTO's dispute settlement mechanism, which may—as a last resort—allow WTO member countries to apply trade sanctions against a noncompliant country. This is a powerful enforcement mechanism, especially vis-a-vis developing countries, which can usually ill afford to be faced with trade sanctions. Meanwhile, intellectual property protection that surpasses the standards and requirements of the TRIPS Agreement is often referred to as “TRIPS-plus.” There are many different TRIPS-plus provisions. For example, patent term extensions enable prolongation of the patent term beyond the 20 years required by TRIPS, under certain circumstances. Data exclusivity and “linkage” (see text) are other TRIPS-plus provisions. These TRIPS-plus provisions all delay or hamper generic competition. 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. Box 2: Patents, Registration, and Marketing of Medicines The pharmaceutical market is highly regulated. Two sets of laws and regulations play a crucial role in shaping this market: the intellectual property laws and the laws and regulations pertaining to drug registration. Intellectual property rights, especially patents, confer negative rights: if a particular medicine is under patent, the patent holder can prevent others from producing or selling (generic versions of) that medicine in the country concerned. But a patent does not give the patent holder the right to put that medicine on the market. In order to be allowed on the market, a medicine has to be registered by the national drug regulatory authority. Moreover, a patent applies to an invention, not to a medicine per se. Patents can be granted for instance for a new chemical entity, a production process, or a particular formulation. Thus, a single medicine can be covered by more than one patent. Some patents (notably those on the chemical entity) completely block generics. But in other cases it may be possible to produce a generic version without infringing the patent, e.g., a tablet would not infringe a patent that only covers liquid dosage forms.