MEXICAN GENERICS AND R&D GROW, BUT ILLEGAL SECTOR

Mexico has recently issued a law banning the advertising of 81 dubious so-called "miracle products," as hopes grow for a crackdown on bogus drugs in the country. Meanwhile, local industry groups have noted strong prospects for the generics and R&D sectors, but US associations continue to highlight problems with intellectual property and red tape in Mexico.

The new law against bogus drugs allows regulators to confiscate drugs where producers have claimed an unsubstantiated therapeutic value or that their product is an outright cure. It is also hoped that new mandatory bioequivalence laws will eventually force bogus drugs off the market -- making room for "true" generics, which currently account for just 4% of the market. Several producers of bogus drugs are already reported to have suspended manufacturing in advance of government inspections.

However, removing copy drugs from the market is proving a more challenging, longer-term aspiration. Legitimate manufacturers represented by local trade groups Canifarma, AMIIF and ANAFAM complain that the copy drug market is still intact, despite the new laws. The belief that copies are "crowding out" generics and confusing consumers is widespread. However, US trade groups point to a lack of co-ordination between Mexico's patent office INPI and drug regulators as the root of the problem.

These concerns aside, Mexico does offer significant scope for the research-based sector, especially as ethical prescription drugs dwarf all other sectors in terms of value. Local association AMIIF also claims that Mexico is one of the top ten clinical trial locations in the world, with trial activity growing by 25% in recent years.

Nevertheless, despite having the strongest data protection regime in Latin America and abundant "treatment naïve" volunteers, research professionals point out that while authorisation can take just three months in most European countries, a permit in Mexico can take up to nine months to arrive.