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.

Since the Mexican Constitution considers international treaties as the same level as federal laws, the Mexican Congress was prompted to amend, in 1994, some laws to adjust them to the conditions stated in the North American Free Trade Agreement (NAFTA). The amendments included the addition of article 86 bis into the Industrial Property Law, which states that “information regarding safety and efficacy of pharmaceutical and agricultural products that make use of new chemical components shall be protected under the terms of the international treaties to which Mexico is part”.

For Mexico, the main international agreements considering data exclusivity are TRIPS, in article 39(3), and NAFTA, in articles 1771.5 and 1771.6, which state that “… the party shall protect against disclosure of the data related to safety and effectiveness of the product, where the origination of such data involves considerable effort, … no person other than the person that submitted them may, without the latter’s permission, rely on such data during a reasonable period of time after their submission, which shall normally mean not less than five years from the date on which the party granted approval to the person that produced the data for approval to market its product”.

There is no doubt that the provisions as set forth in TRIPS and NAFTA regarding data exclusivity have been useful during these last decades, but Mexico is reaching a point where data exclusivity will become a key tool for pharmaceutical companies to consider.

Are changes to be expected?

The current data exclusivity landscape could change sooner than expected, since negotiations for new NAFTA regulations are currently in process. US, Canadian, and Mexican trade negotiators have concluded the seventh round of negotiations in Mexico City. However, IP provisions remain unsolved, and a revision regarding data exclusivity seems mandatory in the remaining negotiations.

Finally, seeing that an amendment to the Industrial Property Law defining the scope of rights and terms of data exclusivity in Mexico looks quite unlikely, pharma companies with data exclusivity concerns should look out for any future NAFTA resolutions on this matter.

Anna Arroyo is an associate at Uhthoff Gómez Vega & Uhthoff. Her practice areas include chemistry, pharmaceuticals and biotechnology. She can be contacted at: aarroyo@uhthoff.com.mx

Fernando Granados is an associate at Uhthoff Gómez Vega & Uhthoff. His practice areas include chemistry, pharmacy and biotechnology. He can be contacted at: fgranados@uhthoff.com.mx