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HOMOLOGATION Under the REMD, COFEPRIS must grant


authorisation for the sale of a medical device within 30 days of the application, unless the application is unclear or incomplete, in which case, the term will be restarted from the date on which the applicant provides the missing information requested by COFEPRIS. If COFEPRIS does not respond within 30 days, the application is deemed to have been tacitly approved.


Tere are clear differences between the regulatory processes in Mexico, Canada and the US. Nonetheless, the REMD states that COFEPRIS undertook the necessary actions to ensure that US and Canadian laws and regulations, and the tests and inspections carried out by the US Food and Drug Administration and Health Canada “adequately comply with the objectives of the [Mexican] Regulation on Health Products”.


Te REMD does not specify what ‘actions’ were undertaken by COFEPRIS. Te resolution contains only a general comparison of registration requirements in the US, Canada and Mexico. Te resolution only emphasises that COFEPRIS may revoke or cancel sanitary registrations for medical devices and, if necessary, order their seizure or recall.


Legal remedy of REMD


Proponents of homologation argue that the reciprocal recognition of equivalence leads to greater efficiency. However, the REMD is not reciprocal. Moreover, it is not based on NAFTA.


Tere are provisions regarding public health and the sale of pharmaceuticals in agreements that form the legal framework of the WTO, including TRIPS, GATT, the Agreement on Sanitary and Phytosanitary Measures, the Agreement on Technical Barriers to Trade and the General Agreement on Trade in Services. All of these agreements allow member states to adopt measures to prevent health hazards. However, the language of the agreements is ambiguous: they do not specify the level of risk to public health required to justify regulation, the level of proof required to establish the existence of a risk or the means by which risks to public health are to be balanced against the negative effects of trade barriers.


In short, the regulation of pharmaceuticals under the WTO framework remains in its infancy. Tus, efforts at harmonisation or homologation should proceed on a bilateral (or multilateral)


and reciprocal basis. Te resolutions published by COFEPRIS are unilateral and non-reciprocal. Mexican manufacturers of medical devices must continue to meet all requirements established by COFEPRIS for the approval of their products, and the approval of their products by COFEPRIS will count for nothing when they seek approval in the US or Canada.


Te REMD is being challenged in the courts. Te plaintiffs have argued that the resolution deprives Mexican manufacturers of their constitutional right to equal protection of the law. In addition, it has been argued that Article 161 bis should be struck down because it exceeds the regulatory power granted to the president under the Mexican constitution. Te resolutions have also been challenged on the ground that COFEPRIS did not follow the public consultation process outlined in the Federal Law of Administrative Procedure.


Conclusions


Redundant legislation is costly and inefficient. However, poorly designed unilateral homologation schemes confer unfair advantages on foreign manufacturers.


74 Life Sciences Intellectual Property Review 2011


www.worldipreview.com


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