November 26, 2010
Mexico’s General Health Law was reformed on June 11 2009 in ways that will have an important impact on patent owners within the pharmaceutical and life sciences industries. The law was amended to include an article 222 bis, which defined biotechnological drugs, and allows for the approval of so-called biocomparables. The decree came into force on September 8, 2009, and the Ministry of Health had a 180-day period to issue all the specific regulations pertaining to the approval of these biocomparables.
Even though the 180-day period expired on March 8 2010, the regulations were still being reviewed, with input provided by both the Mexican Association of Pharmaceutical Research (AMIIF) and the National Association of Drug Manufacturers (ANAFAM).
COFEPRIS (the Mexican drugs regulatory authority) recently made the project of regulations available to the public, through the official website of the Federal Commission for Regulatory Improvement (COFEMER).
At this point, a 30-working day period is running for any interested party to provide comments to the project through COFEMER’s website, after which the project can be either published, or subjected to further analysis.
The main items in this project are:
Documents with comments have already been uploaded onto COFEMER’s official website.
These documents include an official communication from COFEMER to COFEPRIS (the authority which oversees approvals) referring to the regulatory impact that the provisions will have, which was made public on August 9 2010. COFEMER is requesting, among other things, the following:
This communication has been delivered by COFEPRIS which will have to make necessary justifications and adjustments to its proposal, before submitting it again to COFEMER. There is no specific deadline contemplated for this purpose. If modifications are made after the project is revised, a new 30-day period will be granted to the general public to provide comments.
The industry response
A second document contains a review carried out by the Mexican Association of Pharmaceutical Laboratories (AMELAF), with proposals for modifications to the project of regulations. Its proposals include the following:
Comments were also provided by the National Association of Drug Manufacturers (ANAFAM) and are also available to the public, with the following relevant items:
Another submission from an R&D based company highlights some issues that need to be corrected from a regulatory standpoint to adapt the document to the World Health Organization’s guidelines on evaluating similar biotherapeutic products.
In addition, AMIIF has filed a letter with COFEMER indicating that it is analyzing the project and will provide comments on the project in the coming weeks. These comments will most likely address both the technical and legal aspects of the issue, requesting that linkage, research exemptions and regulatory exclusivity are considered separately. AMIIF is expected to support the requirement to conduct pre-clinical and clinical trials locally when a drug will be manufactured in Mexico, without exception.
Until now, applications for both innovator and biocomparable drugs have been analysed and approved on a case-by-case basis, without a specific regulatory framework. This situation will continue until the regulations are finally passed.
From a legal standpoint, the main issue is that the project lacks a provision contemplating a regulatory exclusivity period, as compensation for the expenses incurred in pre-clinical trials, which will be mandatory to obtain an authorization for an innovator or reference biotechnologic drug.
The North America Free Trade Agreement (NAFTA), to which Mexico is a signatory, contains provisions contemplating a five-year minimum period after a drug containing a new chemical entity has been approved in which no other drug can be approved relying on the information contained in the innovator’s dossier.
Although the Treaty, which came into force in 1994, does not specifically mention biotechnology, the same rationale should apply when analyzing the regulatory framework that is now being established, in which an innovator will necessarily have to incur a great deal of expense to prove a drug’s safety and efficacy before COFEPRIS, regardless of whether or not a patent for the corresponding drug exists.
On the other hand, it is less expensive to prove the comparability of a follow-on biologic drug. This lack of balance when it comes to market entry can reduce incentives to innovate and bring new drugs and therapies to patients, unless an additional incentive is provided to the innovator.
Therefore, we consider that careful analysis of this issue should be made by Mexico’s authorities, so as to determine a proper time period for regulatory exclusivity after a reference or innovator drug has been approved, before a follow-on drug based on comparability tests is allowed.