By Juan Serrano --
Following up on the note for future regulations to approve biotechnological drugs in Mexico (see "Mexico to Issue Regulations for Approval of 'Biocomparable' Drugs"), documents with comments have been uploaded to the official website of the Federal Commission for Regulatory Improvement (COFEMER).
The first of these documents is 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, amongst other things, the following:
- A justification for the elimination of the 3-year period in the Roche-Bolar-like research exemption in order to verify compliance of provisions in the Industrial Property Law.
- Justification for each requirement to approve biocomparable drugs.
- Additional information on cost impacts that the new regulations will have on industry participants.
- Additional information on reductions of public health expenditures derived from the regulations.
This communication has been delivered by COFEPRIS which will have to make the necessary justifications and adjustments to its proposal, before submitting anew to COFEMER. There is no specific deadline contemplated for this purpose. After the project is revised, if modifications are made, a new 30-day period will be granted to the general public to provide comments.
The second document contains a review by the Mexican Association of Pharmaceutical Laboratories (AMELAF) with a proposal for modifications to the project of regulations. In this proposal, the main items are the following:
- Concerning the Roche-Bolar-like exemption, AMELAF is proposing to change the wording in order for linkage review by COFEPRIS to be made only in regards to the first "molecule" (active ingredient) patent, which would be applicable both to biotech and chemical drugs. This goes directly against the decision by the Mexican Supreme Court, which interpreted linkage regulations to include patents covering pharmaceutical formulations as well (see "Mexican Supreme Court Decides on Broad Interpretation of Linkage Regulations"). This specific proposal is very likely to be contended by AMIIF, and/or individual patent holders.
- AMELAF is also proposing to make most regulatory requirements for the approval of a biocomparable drug subject to the discretion of the Ministry of Health on a case by case basis. The current project contains mandatory pre-clinical and clinical trials, pharmacodinamics studies, immunity response studies in animals and in vivo studies. The proposal by AMELAF is to make all of these requirements applicable "if necessary."
Whereas this proposal could have some merit in order to avoid studies that would prove to be unnecessary for specific drugs, it should be allowed only if a correlating provision providing for regulatory exclusivity is passed, in order to maintain a balance between the innovators making the initial studies and subsequent market entrants. No such provision is contained in the project.
- Additionally, AMELAF is proposing that the term for COFEPRIS to approve a biotech drug be reduced from 235 to 180 working days, and that, if that term expires without a response, then the application is understood as granted. This last item is not likely to be approved, as it could result in the authorization of drugs without full review of the applications by the corresponding authority, which might generate sanitary risks.
A copy of the two documents mentioned in this article can be found here.
Juan Serrano is an attorney with Olivares & Cia in Mexico City and frequent contributor to Patent Docs. He can be contacted at [email protected].
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