Regulating Generic Drugs in South America: the Case of Mexico
By Moeller IP Advisors
Last month, the Federal Economic Competition Commission (Cofece) of Mexico released a report stating that major pharmaceutical industries did not face substantial competition from generic drugs in the Mexican market because of regulatory delays and issues.
How does the Mexican law regulate generics? What sorts of issues does a company face when trying to introduce a generic drug to Mexico?
The issue with Generics
According to the Cofece report, generic pharmaceuticals seem to make their way particularly slowly in the Mexican market. On average it may take more than two years between the expiration of a patent and the launch into the market of the first generic drug: in the United States, the launch is almost immediate, while in the European Union it is around seven months. Moreover, two years after the entry of the first generic, the penetration of generic drugs reaches only 21.4% of the market, against the 89% of the United States or 74% of Canada.
The Health Registration Procedure for Generic Drugs in Mexico
In order to market a drug in Mexico, a company should apply for a health registration that certifies the efficacy, safety and quality of the drug. It is issued by the Mexican Commission for Health Risks (Cofepris).
Cofepris grants the health registration to generics if they contain the same amount of the active ingredient and have the pharmaceutical form of the “original”. Cofepris also checks that the pharmacopeial specifications, dissolution profiles or bioavailability are equivalent to the original.
Cofepris has a maximum term of 180 days to conclude the procedure; the term is cut in half if the application is accompanied by a favorable technical report issued by a third party authorized by the Ministry of Health.
However, the reality is different: the average time for concluding the procedure is usually 347 days, and 214 days in case of a pre-assessment by an authorized third party.
It has to be noted that unlike in most countries, the Cofepris certification lasts only five years.
The Linkage System
The Mexican law also introduced a linkage system. The system should make sure that no generic pharmaceuticals are marketed until the patent is pending on the drug of reference, in order to protect the rights of the patent holder.
In particular, Article167-bis of the Rules of Health Suppliers states that, once having received the application for registering a new drug, the Cofepris should “ask the technical cooperation of the Mexican Industrial Property Institute so that the latter determines at the latest of ten working days after receipt of the request, if current patent rights are breached.”
At the same time, Article 47 bis of the Mexican Industrial Property Act establishes that the Mexican Industrial Property Institute (IMPI) “shall publish in the Gazette, and will make available to the public a listing of products which shall be subject matter of industrial protection according to the substance or active ingredient” and specify the validity of the corresponding patent. Thus, the list includes the trade name, the pharmaceutical identity, the patent number and the expiring date.
Because of the publications of the list, the company that aims at introducing the generic on the market can check if all the patents on the original drug have expired in relation to the ingredients, the formulation and the use of that drug for a specific disease.