Global Insight Perspective | |
Significance | The Mexican drug regulator has unveiled plans to re-certify the safety and efficacy of 2,000 medicines as part of efforts to purge the market of poor-quality copies. |
Implications | The drive is unlikely to succeed fully while COFEPRIS remains under-resourced and regulations are unfit for purpose. The research and development (R&D)-based firms Takeda and Lilly have recently found it very difficult to remove illicit copies from the market. |
Outlook | COFEPRIS is likely to miss its target of purging the market of so-called “similar” medicines by 2010, and the government’s policy objectives are unlikely to be met. |
The Best Laid Plans
The Mexican drug regulator COFEPRIS has announced plans to greatly increase the pace at which poor-quality, non-equivalent generics known as ”similares” are removed from the market. The agency hopes to re-register 2,000 pharmaceutical presentations in the fourth quarter of this year, in an effort to verify each product’s bioequivalence to the reference product, its quality and status in patent law. By 2010, COFEPRIS expects to re-register a grand total of 10,000 products, with the number of presentations on the market set to shrink by a third as low-quality drugs are removed from circulation. Moreover, from 2010 onwards sanitary registrations will become renewable every five years—a change that is expected to lead to the removal of a large number of older products that have inferior efficacy profiles to newer drugs.
Unfortunately, this burst of regulatory energy has yet to be accompanied either by clear enabling legislation or the development of an adequate testing infrastructure. The domestic manufacturers’ association AMELAF is sceptical of the new re-registration drive’s chances of finishing on time, adding that there are only 22 test labs in the country and that just 11 are formally accredited to carry out the full range of tests necessary to gauge product quality. The group also notes that there is no specific legislation that sets out exactly how pharmaceutical firms should go about re-registering their products. Moreover, it is estimated that the agency typically takes as long as 10 months to review a sanitary registration. These concerns have been echoed among lawmakers. The government-aligned secretary of the lower house’s Congressional Health Committee, Antonio Muñoz Serrano, recently commented that Mexican law is failing to keep pace with technological changes and the urgent need for modern health regulations. For good measure, Muñoz Serrano added the somewhat dubious claim that so-called ”similar” medicines can cause leukaemia and anaemia.
Patent Infringement Goes Unpunished
Aside from the question of product quality, there are lingering concerns over the enforceability of intellectual property legislation with regard to medicines in Mexico. According to the Reforma newspaper, the research-based firms Takeda and Eli Lilly have had little success in getting a patent-infringing copy of their oral antidiabetic Zactos/Actos (pioglitazone) removed from the market. In July 2006, the national patent office IMPI ordered the Mexican firm RIMSA to remove its combination product Diaberil (pioglitazone plus glimepiride) from sale and pay Takeda and Lilly a fine of 24 million Mexican pesos (US$2.2 million). Lilly has commented that the compensation offered is completely inadequate, in view of the fact that the original product turns over some 200 million pesos (US$18 million) per year in Mexico.
Nevertheless, Diaberil remains on sale pending a decision on the patent by a judge; worse still, RIMSA has since launched a second pioglitazone product, Diabamet (pioglitazone plus metformin). Reforma reports that COFEPRIS has refused to comply with a ruling from the patent office that Diabamet should be removed from the market. Indeed, even as a decision approaches on Diaberil, RIMSA has already moved to launch a new formulation of pioglitazone plus glimepiride. This suggests that in the case of this particular patented molecule at least, the cycle of copying and resulting litigation is set to continue for a very long time indeed.
Outlook and Implications
As well as illustrating that COFEPRIS remains hamstrung by its slow-moving registration process, the recent case also throws the agency’s commitment to removing patent-infringing products into question. This is not entirely unsurprising, as a lack of formal co-ordination between the patent office and the drug regulator is a longstanding concern of research-based pharmaceutical firms operating in Mexico. However, at a time when Mexico is set to liberalise the entry of foreign generic products and is looking to attract investment in clinical trials, recent regulatory activity leaves much to be desired from innovator firms’ point of view. Furthermore, if the government’s policy aim is to create a well-regulated drug market where a clear line is drawn between safe, effective generics and innovative products, recent developments are not encouraging by any conventional yardstick.
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