The Pharma Industry: An Ethical, Self-Regulated Sector

Throughout the world, the pharmaceutical industry is probably the most regulated sector, not only because of its relationship with health authorities given the highly specialized goods it produces and the services it provides, but also because of the impact these have on the well-being of society, its connection with patient associations, the medical establishment and healthcare providers, and the fact that it is a driving force for several other industrial sectors in any country.

The industry established in Mexico followed the international tendency toward self-regulation and, in 2005, the Ethics and Transparency Council of the Pharmaceutical Industry, CETIFARMA was founded as an autonomous organization that promotes and verifies the strict observance of and compliance with a code of ethics and various instruments of self-regulation and self-monitoring. Its main objective is to promote a reliable business practice within a framework of integrity and transparency that aims to improve healthcare and benefit patients. 

The board of CETIFARMA is formed by independent counselors who are not related to the industry, and are publicly recognized citizens because of their professional trajectories and moral excellence. They advise and conciliate in situations that may involve a conflict, by determining the appropriate course of action should a company file a complaint or denounce a violation of the code of ethics by another company. 

All the members of CANIFARMA must adhere to the mandate of CETIFARMA, which fosters an orderly development of the market through sound practices and strict compliance with the current legislation. This in turn promotes user confidence in pharmaceutical products by constantly providing reliable, complete, and timely information. The organization aims at avoiding conflict among the personal interests of patients, regulatory institutions, authorities and third parties. It encourages fair competition, respect to confidentiality, responsible prescribing, and combats self-prescription.

Along with the creation of the Council, the pharmaceutical industry developed its Code of Ethics, which both defines and serves the activity of the organization. It is noteworthy that it was the first industry in our country to issue such document, and that through it, all the pharma companies are held accountable to the same high standards of operation in the Mexican market, as opposed to others — mainly in Latin American countries — that rely on different codes for national and foreign companies. 

Every five years, the Code is revised and updated to respond to new challenges in the market, such as transparency in value transfers and research and collaboration with medical institutions and patient associations. There used to be a differentiation of areas in diverse documents, but as a result of the 2021 revision, all areas were integrated into the Code of Integrity, Ethics and Transparency of Health Care Suppliers (CIETEMIS), which brings together in a single document all the provisions and incorporates specific chapters on medical devices and other healthcare supplies, as well as on Contract Research Organizations (CROs).

Thus, the consolidation of the self-regulation system of the pharmaceutical industry has generated trust and conditions for service providers in different areas to implement it. The CIETEMIS was signed and adopted by companies that manufacture and market infant formulae in 2016, grouped in the respective Commission of the National Chamber of Milk Industries (CANILEC). In 2018, medical devices and healthcare supplies industry, which also belongs to CANIFARMA, as well as the Alliance of Contract Research Organizations of Mexico (ACROM)      also subscribed to the Code. The fact that industries closely related to the health sector voluntarily adopt the self-regulation system points at the dissemination of a culture of ethics and integrity that has permeated the health business environment.

As for its relationship with authorities, CETIFARMA has supported without restriction agreements issued by the Ministry of Health itself and through the Federal Commission for the Protection against Sanitary Risk (COFEPRIS), such as the Commitment to Transparency in the relationship among physicians, health care institutions and the pharmaceutical industry, promoted by the General Health Council, and the Agreement on self-regulation of health supplies and advertising ethics, signed with COFEPRIS in 2012 and updated in June 2018.

CETIFARMA also participates, together with CANIFARMA, in the Business Integrity Project, promoted by the United Nations Development Program (UNDP) in Mexico, the Liaison and Partnership Office of the United Nations and the Partnership Office of the United Nations Office on Drugs and Crime (UNODC), the US Agency for International Development (USAID) and the Ministry of Public Administration (SFP).

To sum up, under the oversight of CETIFARMA, the main surveillant of the application of the Code of Integrity, Ethics and Transparency of Health Care Suppliers is the industry itself, to      give certainty and guidance to authorities, patients, physicians and society at large.

Available at https://cetifarma.org.mx/wp-content/uploads/docs/docs/CIETEMIS-2021eng.pdf 

Available in Spanish at https://cetifarma.org.mx/wp-content/uploads/docs/docs/CIETEMIS-2021ratificado.pdf