Juan Millán Soberanes
Director General
CETIFARMA
/
View from the Top

Prevention and Complience for the Health Industry

Wed, 09/05/2018 - 18:56

Q: As a self-regulatory authority, how does CETIFARMA contribute to Mexico’s healthcare?

A: The ethical principles that should lead the pharmaceutical sector are universal, as patients should receive the same treatment anywhere in the world. One of our main goals is to make sure that all volunteers are safe and that studies never incorporate vulnerable people. The core of any self- regulatory authority lies in prevention and compliance. The pharmaceutical industry produces goods that are essential for the population and it is necessary to guarantee that all the products comply with the highest production standards. This is even more important in the case of vaccinations. Vaccine manufacturers must ensure that Mexico’s vaccination rate stays between 90 and 95 percent as part of a federal effort to guarantee access to vaccines for all Mexicans.

Q: How would you describe CETIFARMA’s contribution in the development of safe medications?

A: CETIFARMA bases its actions on three axes. First, develop ethical codes for pharmaceutical companies to ensure that all products follow national and international quality standards. Second, CETIFARMA’s self-regulation system guarantees that the interactions of pharmaceutical employees with patient associations and medical institutions follow ethical principles. The third axis is monitoring compliance and notifying deviations to infringers so these can be corrected. If the deviation is not corrected, we impose sanctions. CETIFARMA’s role is to complement regulatory authorities, not to substitute them.

Q: How does CETIFARMA guarantee that its internal guidelines adhere to the current needs of the sector?

A: CETIFARMA is a Council of Ethics and Transparency that comprises eight independent members from the pharma industry and ensures that all its operations follow the organization’s code. CETIFARMA closely adheres to the principles of impartiality, zero conflicts of interest and constant interaction with authorities, medical institutions andbusinesses.In2007,wesignedaconsensusframework entitled Commiment for Transparency that brought together the will of the Ministry of Health, IMSS, ISSSTE, the 

National Academies of Medicine, Nursery and Pediatrics, the National Association of Private Hospitals, UNAM and IPN’s medical schools, the medical college, the pharmaceutical industry and CONBIOETICA.

Q: How will CETIFARMA’s alliance with ACROM influence the implementation of clinical trials in Mexico?

A: CROs manage clinical trials performed with both healthy and sick volunteers. For that reason, it is necessary to closely monitor them to identify any adverse effects. To do so, it was necessary to ensure that CROs adhere to the same ethical principles as pharmaceutical companies by following three strong standards of patient recruitment. First, ensure that volunteers are well-informed about the risks and benefits of participating in a clinical trial. Second, volunteers must sign their informed consent to participate in that clinical trial. Finally, the CROs should provide care to those patients who suffer any adverse effect during the trial. Alongside ACROM, we created a new best-practices code in February 2018 and CROs will provide us with information about their clinical trials. The standards we follow were created by the International Federation of the Pharmaceutical Manufacturers and Associations (IFPMA).

Q: What is CETIFARMA’s role in the development of national and international policies?

A: As part of the Asia-Pacific Economic Cooperation (APEC) forum, CETIFARMA has contributed to the generation of an ethics code for the region. We are also part of APEC’s working group, where we share our progress, challenges and solutions for the rest of Latin America.

The Director of CETIFARMA is the only Latin American member of the Ethics and Compliance Professionals (ETHICS) Forum based in France. This forum is in charge of improving systems for regulating ethics.