Ethical Guidelines Support Industry Growth

Q: What is the main purpose of Cetifarma in the Mexican industry?

A: Over 10 years, we developed a self-organization plan linked to the compliance of the ethical and deontological codes. Cetifarma has incorporated as members not only pharmaceutical companies that produce chemical or natural medicines but also companies that manufacture medical devices. The decision to include medical devices manufacturers is related to non-infectious chronic diseases that affect Mexicans. For example, musculoskeletal system diseases are usually solved through the use of prosthesis or special devices. Cardiovascular diseases are also common among Mexicans, including hypertension. For this particular disease several medical devices have been designed, such as cardiac pacemakers and stents. The compliance of all our members with the ethical and deontological codes helps the industry to have a better communication process, respecting the patients’ needs.

Q: What are the main opportunities Cetifarma has detected in the Mexican Industry?

A: There are several opportunities we have detected that would allow us to strengthen our self-regulation system. Cetifarma needs to take concrete action to reinforce its relation with medical societies. We need to work closely with physicians to make sure they comply with a code of ethics so we can ensure the pharmaceutical industry supports the training of health professionals that act according to ethical guidelines. There needs to be an agreement between the pharmaceutical industry and the medical societies of private and public hospitals.

The pharmaceutical industry also needs to establish criteria, indicators and standards on what can be considered quality medical training and how to certify our training.

There is also a need to increase support for research and clinical trials. The pharmaceutical industry is committed to increasinginvestmentinthesetwofieldsinourcountry. Cetifarma needs to make sure that every clinical trial that is performed observes the ethical principles and guidelines that have been accepted worldwide. Pharmaceutical companies that perform human trials need to respect their patients’ autonomy and dignity. They also need to respect and comply with the decisions that ethics committees take regarding their procedures or products. Cetifarma works closely with the National Commission of Bioethics, the institution that approves the conformation of research ethics committees in the private and public sector.

Another issue requiring our attention is the promotion of a transparent culture within organizations. It is important that we make the effort to provide transparency on the interactions that take place between pharmaceutical enterprises and health professionals. Our objective is that by July 2017, individuals will be able to find reports on the companies’ websites regarding the support and investment they have given to medical societies, to continuous medical training of interactions and to research and clinical trials.

The strengthening of consensus with stakeholders is also a point that needs attention. In 2007 we signed a transparency agreement with the General Health Council. Signatories were the sanitary authorities, institutions that provide health services, national medicine academies of surgery and pediatrics, UNAM’s and IPN’s medical schools, the National Association of Private Hospitals and the National Medical School. This agreement allows a complementarity between authorities, professional health institutions and the pharmaceutical industry.

Another linking mechanism we are working on is an agreement on co-regulation between the pharmaceutical industry and the sanitary authorities. This agreement specifies that law abidance is tied to the compliance of ethical principles. The regulator entity must confirm the law is being followed and Cetifarma has the responsibility to confirm that ethical codes are being met. This agreement considers complementarity and information sharing between Cetifarma and the authorities.

Unfortunately, we have found that not every medical- related entity complies with the necessary guidelines. When these cases are detected we are forced to apply sanctions. In 2007 and 2009 we witnessed an important increase in controversies. The increase arose because those were the years that our conduct codes were updated to meet international standards. This particular situation led Big Pharma companies to make adjustments to comply with international codes. Part of our job is to work as a mediator when these situations arise between pharmaceutical enterprises.

The most important thing regarding the promotion of an ethics culture is the prevention of practices that do not comply with the codes. That is our mission: prevent through education and monitoring. For the monitoring task, we have developed alongside the companies’ compliance officers a monitoring focused on probable risks. For the model to work, the firms must identify the areas that are more prone of failing to meet the conduct code. Once they have been identified, the companies can take the necessary actions to prevent inappropriate conduct.

Q: What is the extent of Cetifarma’s participation in the international arena?

Q: Since 2006, Cetifarma is the only Latin American pharmaceutical association that has a seat at the IFPMA’s Code Compliance Network. On this compliance network are Big Pharma companies and self-regulation organisms, sharing experiences of the progress made in the obedience of conduct codes. Also, we were asked by the Ministry of Economy to participate in the drafting of ethical guidelines known as the Mexico City Principles, for the interaction of bio-pharmaceutical companies of the APEC region. Cetifarma is an active member of the working group of this region.

Cetifarma also is a member of a Latin American Compliance Group that allows us to share information between countries regarding challenges the pharmaceutical companies face in the region. The technical secretary of the IFPMA also participates in these meetings and shares information of the challenges that other regions in the world face. Our participation on international forums allows us to update constantly our practices and to improve them.

Q: What is the ethical discussion that took place in Mexico regarding the usage and production of biotechnological medicinal products?

A: The ethics discussion was focused on ensuring that the safety, quality and efficiency of biotechnological products are equivalent to those of the innovator. For this to happen, pharmaceutical companies that produce bio- similar products must comply with the necessary norms. Not only the legislative conditions must be met but also the ethical commitment of providing products with the same quality characteristics the sanitary authorities demanded from the branded product.

Unlike biochemical products, biotechnological medicines involve the usage of biological molecules, which have a less stable behavior than pharma chemicals. Therefore, the production process of biotechnological products must be controlled to ensure the quality and efficiency of these products. The patient’s safety must always be the final purpose. It is important to recognize the efforts made by the pharmaceutical industry, the medics, the authorities and organizations such as Cetifarma. Medicines in the Mexican market comply with safety and efficiency standards.