Protection of Pharmaceutical Data - Mexico
The developed and developing countries have taken important steps towards harmonized protection of data exclusivity rights. Recently, Canada amended the Food and Drug regulations concerning data protection in order to offer better defences to innovator laboratories. India has also taken measures to secure R&D for new drugs by including data exclusivity protection rights in its legal system.
Although the protection offered by the Mexican legislation is designed to comply with treaties such as the Trade-Related Aspects of Intellectual Property Rights (TRIPs) Agreement or the North American Free Trade Agreement (NAFTA), such protection does not adequately defend the regulatory data or provide effective means of enforcement due to the divergences between the partial disclosure system of other countries and the non-disclosure system adopted by Mexico. Data exclusivity rights mentioned in the Mexican Industrial Property Law (MIPL) states that the regulatory data is protected according to international treaties, while the Health Supplies Regulations (HSR) establishes that the regulatory data for drugs containing new chemical entities will be protected by means of non-disclosure. However, following issues must be kept in mind while implementing an adequate data protection in order to promote innovation by the governments of the countries:
Social consequences:- Human rights and access to healthcare has been on the approval list of IP agreements. It includes access to medicines for which government of developing countries will have to focus their attention on building an appropriatge health insurance system. Notwithstanding this, these governments will also have to offer an adequate IP protection to secure patent and data exclusivity rights for the innovator laboratories as well as makers of generics to provide quality low-cost drugs by the end of the protection period. Although Mexican legislation regarding data exclusivity is designed to comply with the provision of international treaties, it provides an IP legal framework that is not harmonized with those of other countries.
Reliance on the protected information:- In order to obtain a marketing authorization for a drug or a crop protection agrochemical containing a new chemical entity, the innovator laboratory is required to file substantial informatio9n to prove the new drug's safety and efficacy or the agrochemical's biological efficacy and human, animal and environmental safety. Since for obtaining such information may take five to 10 years, Article 39.3 of the TRIPs Agreement forbids the use of the information filed by innovator laboratories before the competent authorities in an unfair commercial manner, subject to different interpretations by any country's authority when litigation arises. However, in order to avoid similar misinterpretations by the Mexican tribunals, it would be necessary to implement an adequate data exclusivity legal framework.
Non-disclosure:- Maxican Law and Regulations provide protection to the regulatory data by means of confidentiality and non-disclosure of information. However, the downside of this protection is the fact that a dossier might be illegally used to request a market authorization by a generic laboratory arguing that the information was developed by the claimant. The dossier may be taken from countries with partial disclosure policies or corporate infiltration. Therefore, innovator laboratories may not be interested in maintaining such a regulatory data as confidential if, instead of non-disclosure, appropriate measures against the use of that information in an unfair manner are available.
Data exclusivity:- Since the Mexican legal framework regarding data exclusivity does not contemplate a term of protection for this data, the adoption of amendments similar to those implemented by the Canadian government will block any kind of unfair commercial use including the reliance issue and will set a period of time for the duration of the protection. Such amendments will also have to address the non-disclosure protection of regulatory data. In this regard, it will be necessary for Mexico to implement a partial disclosure system which may offer reasonable protection for the innovatory laboratories. The partial disclosure system will harmonize data exclusivity protection with Mexico's commercial partners and will provide several benefits for the makers of generics, since relevant information would be available during the filing period after the end of the protection.
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