FDAnews
www.fdanews.com/articles/70454-scant-hopes-for-regulatory-progress-in-venezuela

Scant Hopes for Regulatory Progress in Venezuela

March 30, 2005

While the international drug community continues to express its dissatisfaction at the level of patent protection in Venezuela, it should expect little in the way of reform in the short term. Much of this can be attributed not just to hostility from the Chavez government, but also to the lingering effects of the country's economic and political crisis in 2002.

Government policy was already focused on protecting its local industry prior to events of 2002. Subsequent events have only hardened its attitude, with growing importance being placed on local producers for healthcare provision. This is also reflected in the official priorities for intellectual property, with the stated opinion of the Venezuelan intellectual property agency, SAPI, being that patent considerations should not obstruct equitable access to medicines.

This rationale has already had significant negative effects for the research-based sector, as SAPI has removed US drug major Pfizer's local patent rights on its Viagra impotence treatment. As the lucrative drug can scarcely be said to be an essential medicine, there are suspicions that the move is symptomatic of a bias towards local producers, which will now be able to make cheap copies with less risk of official interference.

Government hostility to international patent rights has also been reflected in the judiciary, with attempts in the last year by the multinational sector to prevent the sale of about 20 copy products blocked by Venezuela's competition authority and the country's Supreme Court. Indeed, despite a marked upturn in economic conditions in recent months, these developments serve as a warning that any real improvement in patent policy is unlikely in the next few years.