Argentina: Need for new test data legislation

Taking into account the benefits of test data protection, several Latin American countries have integrated proper data protection measures into their national legislation.

During the negotiations over Article 39.3 of the TRIPs Agreement, such long-term benefits to the health of the citizens of all member countries of the World Trade Organization that would result from adequate test data protection enforced by governments were expressly recognised.

As an example of such benefits we can mention that in developed countries (for example, in the United States) the data protection rights and marketing exclusivity granted by the Orphan Drug Act have resulted in a dramatic increase in the number of orphan drugs available to the public.

In the case of developing countries a serious problem is the lack of pharmaceutical products used to treat conditions or diseases that are not normally found in developed countries or when a disease affects only a reduced group of patients in developed countries, but a large number in developing countries. In this situation, the potential markets in developed countries would not always be enough to encourage the spending required for research and testing of such medicines.

Adequate test data protection in both developed and developing countries will create the proper incentives through the creation of a larger market of consumers.

Notwithstanding these benefits, Argentina's legislation (Law 24,766 – the Confidentiality Law, Executive Order 150/92) fails to provide effective protection against unfair commercial use or unauthorised disclosure of test and other data generated to obtain marketing approval for pharmaceutical products.

The enactment of new legislation consistent with the TRIPs Agreement would improve the health and standard of living as new and better medications would be available to the general population.

Daniel R Zuccherino

Obligado & CiaParaguay 610, 17th FloorC1057AAH, Buenos Aires, ArgentinaTel: +54 11 4114 1100Fax: +54 11 4311 5675admin@obligado.com.arwww.obligado.com