torresigner /
3 June 2018AmericasAnna Arroyo and Fernando Granados

Keeping quiet on clinical trials

Several queries have been raised regarding the precise manner in which Mexico brings protection to one of the elements that involves more effort, time and money in the commercialisation of new chemical and biological molecules with therapeutic application: the invaluable clinical data. For most pharma companies, it is not quite clear how prepared the Mexican Law is to offer data exclusivity.

The Federal Commission for Protection against Health Risks (COFEPRIS), which approves new drugs for marketing in Mexico, has been recognised as a National Regulatory Agency Level IV for drugs and vaccines by the PanAmerican Health Organisation since 2012 and 2014 respectively, becoming the first Latin American regulatory agency to obtain both acknowledgements.

Due to these recognitions, health registrations obtained in Mexico are valid in other Latin American countries such as Chile, Colombia, Panamá, Costa Rica, Ecuador, Belize and El Salvador, which means requesting a health registration in Mexico has become more attractive for pharmaceutical companies aiming to have a strong presence in Latin America.

Nonetheless, some companies have reservations when it comes to clinical data exclusivity and the solidity of its enforcement, particularly for biological products, given that in Mexico data exclusivity is available only when the corresponding health registration application is filed, and the Mexican Industrial Property Law does not dictate a specific period of time for data exclusivity.

How did we get here?

In 2009, Mexican legislation underwent a critical reform on the subject of biological products when article 222 bis was included in the General Health Law; the article introduced the terms “biotechnological drug” and “biocomparable” and rejected the terms “biological product” and “biosimilar”.

Later, in 2012, COFEPRIS issued an official communication dictating the guidelines for data exclusivity which stated that this type of protection would exclusively apply to new chemical entities; biotechnological drugs were not explicitly mentioned. But ever since, data exclusivity has been provided for both new chemical entities and biotech drugs. No further distinctions between these two classes of pharmaceuticals have been attempted.

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