Pharmaceutical Industry: 5 Key points for its operation in Mexico.

Pharmaceutical Industry: 5 Key points for its operation in Mexico.

In our country, pharmaceutical and health regulation has evolved with the participation of various actors such as the Ministry of Health (“Secretaría de Salud”) and the Federal Commission for the Protection against Health Risks (“Comisión Federal para la Protección contra Riesgos Sanitarios”).

In a contextual way, we must understand that pharmaceutical regulation has as its main objective the safe and effective use of Medicines;  available when needed; that there are no barriers to access them; that the expense is optimal (including the adequate use by mexican citizens); as well as promoting the introduction to the market of new therapeutic alternatives.

Health regulation in our country is in charge of the Federal Commission for the Protection against Sanitary Risks (hereinafter “COFEPRIS”) which is a decentralized body of the Ministry of Health. COFEPRIS, whose constitution and entry into operation dates from 2001, has powers in matters of regulation, control and health promotion, under the terms of the General Health Law and other applicable legislation.

Throughout these years, the regulation imposed by COFEPRIS has been relevant and defining for the pharmaceutical industry as well as for the food industry in our country, since modifications have been made in the following areas: (i) Renewals of Health Records; (ii) the elimination of the plant requirement; (iii) policies to promote generic medicines; (iv) the Certificate of Good Manufacturing Practices; and (v) recognition by international organizations such as the Pan American Health Organization and the World Health Organization.

However, it is important to mention that pharmaceutical industries and retail pharmacies nationwide should consider having an agenda in terms of health compliance to comply with the obligations, permits, licenses and authorizations established by law and that are required by COFEPRIS, and thus avoid falling into breaches of the provision and be the object of closure of the establishments and administrative fines, in accordance with the above mention we believe it is important to follow these recommendations.

  1. Maintain an order in the compliance documentation of the pharmaceutical industry, example. Health Licenses, Notice of Operation, Permits and Authorizations issued by the Health Authority.
  2. File in a timely manner the requests for Registries, Health Licenses and Notices before COFEPRIS, in order to perform the necessary functions for the operation of the Industry.
  3. Train personnel for the management and sale of Controlled Drugs in compliance with the provisions established by the General Health Law and COFEPRIS.
  4. Conduct periodic audits of the necessary and mandatory compliance documentation in accordance with the General Health Law for the operation and function of the Industry, in order to detect anomalies or unforeseen events and correct themselves before receiving an administrative sanction or Closure by COFEPRIS.
  5. Comply with the provisions stipulated by the General Health Law and by the ordinance and requirements by the COFEPRIS.
Why a Personal Data Protection Law?

Why a Personal Data Protection Law?

The Federal Law on the Protection of Personal Data held by Individuals (LFPDPPP) has already been in force in our country for a while and after analyzing its application it is my perception that there is still a great lack of knowledge about the subject of the law by the individuals and therefore many obligations emanating from it that individuals are not aware of their compliance by the mere fact of ignorance of it. A recurring question among professionals and companies forced to comply with it is ¿why and for what was this new law issued?

It is common among individuals that when a law like this comes into force is perceived as an increase in the regulatory burden that exists on said company or professional, although it is sometimes considered as a burden, I differ from that perspective since a good protection of personal data and compliance with the law can benefit the core business in the interconnected world we live in.

The right to privacy already existed among the first generation, who protected closed correspondence, prohibited the intervention of communications and deprivation of documents without a judicial mandate. However, the development of technology and its potential to accumulate and process personal information motivated international organizations to analyze and resolve the issue of personal data protection and privacy rights. In order to be in agreement with the international organizations in 2009, our Constitution was reformed, in order to regulate the protection of personal data and to establish the rights to access, rectify and cancel personal data, as well as the opposition to its treatment.

The main objective of the Law is the protection of personal data held by individuals, with the purpose of regulating their legitimate, controlled and informed treatment, in order to guarantee the privacy and the right to self-determination of persons.

However, the need to regulate the collection, exploitation and flow of personal information is obvious in an era in which personal data is an asset with which commercial agreements are carried out and on which business models are built, and in which the means for their processing have increasing capacity and lower cost. The challenge of the law is that such regulation be effective for people whose data they seek to protect, but also efficient, so as not to hinder the development of new business.

In conclusion, the constitutional reforms and the creation of the Law on the protection of personal data are due to international trends in the area of data protection and right to privacy, but also to the global economic sense of protecting the personal assets of different companies or businesses and in our country the law came to stay and to be fulfilled by individuals, so I believe that instead of being seen as a regulatory burden, it should be seen as an investment in the development of the business, which will generate confidence in the client, employees and will improve the business of the company.