(2002; 77 pages) [Spanish]
The use by health authorities and competitors of test data which must be submitted to obtain marketing approval of pharmaceutical (and agrochemical) products has been subject to specific regulations in several jurisdictions. Some developed countries, notably the U.S. and EU, have established data protection regulations based on the exclusive use of such data by the originator company. In other countries, however, off-patent generic products can be approved by relying on the data available to health authorities or by reference to a prior registration either domestic or in third countries. In all cases, the physical and chemical similarity (or essential similarity) with the registered product must be demonstrated.
The TRIPS Agreement has obliged WTO Member countries to treat test data as a component of "intellectual property". However, the rationale for test data protection is the investment made in data production, rather than their creative or inventive content.
Article 39.3 of the TRIPS Agreement requires data protection against disclosure and "unfair commercial use". Article 39.3 develops Article 10bis of the Paris Convention; that is, it requires the protection of data against dishonest commercial practices.
The non-disclosure obligation admits exceptions where necessary to protect the public, and in other cases where measures are adopted to ensure that the information is not used in an unfair commercial manner. Considerable room has been left to Members for defining the grounds for the application of these exceptions.
In implementing the obligation to protect against unfair commercial use, the Member States can determine, in accordance with their own values and practices, the standards demarcating dishonest commercial practices. Further, the TRIPS Agreement has deferred to Members the determination of the legal means to be used in order to make such protection effective. Hence, Members may opt for means of protection against unfair commercial use which allow for the approval of "similar" products without the use of the data or relying on them. Members may also opt, but are not obliged to, grant "TRIPS-plus" protection on the basis of data exclusivity, as some countries currently do.
In making such choices, policymakers will have to weigh the protection of the interests of originator companies against the importance of creating a competitive environment in order to increase access to medicines that are outside patent protection. From a public health perspective, the introduction of TRIPS-plus standards does not seem the best approach for developing countries.
In sum, developing countries should carefully consider the scope of regulations on approval of pharmaceutical products. Such regulations should be enacted with a pro-competitive intent, in a manner that maximizes legitimate competition and access to drugs, while respecting the legitimate interests of the originators of data in accordance with the standards of protection established by the TRIPS Agreement.