The president of CETIFARMA, the council created by the pharmaceutical industry in Mexico for ethics and transparency, discusses the tireless effort it has made to professionalize the compliance function in the industry as well as the growing importance of transparency and ethics in its relation with physicians and patients.
Mexico is at the forefront of the pharmaceutical industry with regard to self-regulation. Why is it the case that Mexico is more advanced than other countries in this area?
There are two major aspects that explain why Mexico is in a better position in the implementation of self-regulating schemes compared to other key pharmaceutical markets in Latin America. First, thanks to the creation of CETIFARMA as an autonomous self-regulatory body by the national chamber of the pharmaceutical industry. Second, in contrast to the rest of Latin America where there are separate chambers for local and global companies, in Mexico the national chamber includes both local and global companies.
Mexican companies are very aware of the fact that if they don’t implement self-regulating schemes, increasing governmental regulation will be imposed. There is a certain ebb and flow to this issue due to the fact that there are governmental officials who believe in self-regulation, and others who do not. It is an issue that is constantly being questioned and discussed.
What have been CETIFARMA’s priorities over the past two years?
Our main focus has been on professionalizing the compliance function. We are in a constant dialogue with compliance officers to implement our ethics codes and, together with them, to improve these instruments. We organize four meetings per year and currently we are working with seven task groups responsible of developing materials and designing workshops for the rest of their colleagues.
In the past we’ve focused on promoting ethical issues, now we are working towards a broader and more comprehensive transparency program with all stakeholders involved. This year we are implementing a monitoring program to assess the companies’ compliance in the continuous medical education activities they sponsor.
How are companies implementing the compliance aspect, and do you see any differences between large multinationals that are more used to having a compliance office, and local or national Mexican companies?
Generally speaking the industry has made important efforts to implement compliance strategies. Even though global companies have had compliance officers for a longer period of time, there is no significant difference between them and local companies.
At the end of July 2014, CETIFARMA was the co-sponsor of the Latin American Pharma Compliance Congress. What were the main topics of this congress?
One of the most discussed topics was the trend towards an increasing disclosure of payments of the pharmaceutical industry to health care professionals (HCPs) and the ways in which it will impact and be implemented in Mexico. The problem with regard to the relationship between physicians and the industry is the lack of an institutional framework with common objectives. We are working towards a closer relationship with HCPs via the National Academy of Medicine, which created a specific committee for this purpose, the Council of Ethics and Transparency of Physicians in Relation to the Pharma Industry (CETREMI in Spanish).
Another topic that was addressed is the interaction of the industry with patient organizations. It is a very complex issue, which is much more developed in Europe and North America, but is rapidly gaining importance in Mexico.
How do you think this will change in the future, what steps are being taken to amend this?
If we consider that it is a very sensitive political issue, significant changes are not likely to happen in the near future. In Mexico we don’t have an institution with enough authority and credibility to enforce mandatory measures that could apply to the different stakeholders related to the pharmaceutical industry. For example, even though the National Academy of Medicine has the moral recognition to make proposals, it does not have the faculty to go beyond these.
What are your professional plans for the future in CETIFARMA?
Transparency is our challenge and our main goal. Transparency is one of the best ways to build and sustain trust among the different actors related to the Industry: pharma companies, patient organization, HCPs, authorities and society as a whole. In this scenario, our role is very difficult because we are in the middle of everything and everyone. If we open our operation and decision making processes to public scrutiny, we avoid speculations and opacity.
Today in some sectors of society the pharmaceutical industry does not have a good image. Even though this perception is in part justified by the behavior of some companies, it is also true this image is not representative of the industry as a whole. The industry has contributed significantly to social progress, and this negative image is not fair. Until now the Industry has not been able to communicate its positive contributions to society. In this sense the role of CETIFARMA is to promote ethical compliance and transparency, as a means to help improve its image within society, as ell as to act as a communication vehicle between the industry, the authorities and the different stakeholders involved, in order to ensure the safety and wellbeing of patients.
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