Mexico Drug Sector Reforms Head for Senate

A series of major reforms to Mexico's General Health Law, which envisage tighter penalties against drug copying and so-called miracle products, is shortly to be sent to the country's Senate. It is hoped that the measures will receive final approval before the close of the current legislative session April 30.

US-based drugmaker Pfizer estimates Mexico's illegal pharmaceuticals industry at US$700mn per year, or roughly 10% of the total market. Treatments for cancers, HIV/AIDS, cardiovascular diseases and erectile dysfunction are among the most commonly copied. The majority of the trade is centred on Mexican states along the border with the US.

The main thrust of the reforms will be to increase penalties against illegal copying - reclassifying the production, distribution and sale of the products as a federal crime. Furthermore, the measures in their current form strengthen the authority of local drug regulator COFEPRIS, which will now be able to destroy bogus "miracle drugs," whereas earlier reforms only envisaged labelling changes.

If approved, Mexican industry sources believe that the new laws will allow the country to better clamp down on illegal pharmaceuticals, averting a similar state of affairs to that in Canada. Local groups claim that copy drugs from Singapore, Ecuador, China, Iran, Argentina, Thailand and South Africa have been able to penetrate the Canadian market, potentially exposing the US industry to a dual copy threat from both the country's northern and southern neighbours.

Nevertheless, the question of whether the reforms will win speedy legislative approval remains key. As Mexico approaches new presidential elections which have already proved highly controversial, many in the research-based industry will be anxious to ensure the reforms' approval before any change of administration.