AGREEMENT FOR TRANSPARENCY The Case of Mexico Juan F. Millán S CETIFARMA, Second International Pharmaceutical Regulatory and Compliance Congress May 28 - 29, 2008 Paris, France

AGREEMENT FOR TRANSPARENCY Background Conceived as self regulation to promote cooperation between HCP, the pharmaceutical industry, medical academies and healthcare institutions (public and private). Participants: the stakeholders involved in the provision of the healthcare, research, development, production and dispensation of medicines. Experience without precedent in Mexico. Compliance of governmental institutions is reinforced by the support of Mexico's President as witness in the signature of the agreement (24.10.08). Leadership of the General Council of the Health System, agency responsible of regulating and supervising healthcare provision in the country.

Participating Institutions National Academies of Medicine, Surgery and Pediatrics National Chamber of the Pharmaceutical Industry Council of Ethics and Transparency of the Pharmaceutical Industry National Committee of Bio-Ethics Mexican Medical Association Private Hospital Associations Medical Schools General Council of the Health System Health Ministry National Health and Social Security Systems

Objective To establish a consensual framework of principles and actions in order to promote ethical and transparent relations between the pharmaceutical industry, physicians, and healthcare institutions.

Assumptions Relations between the pharmaceutical industry and HCP should focus on product’s safety, treatment efficiency and financial protection of the patient. Cooperation between HCP and the pharmaceutical industry has been essential in promoting the development and appropriate use of medicines. The relation between these groups must be regulated by ethical principles, a humanistic approach to patients, accuracy, professional independence, transparency, cooperation and social responsibility. Liberty to prescribe is related to HCP responsibility and competence; the use of therapeutic means is decided after considering their scientific value, efficacy and suitability, without disregarding the cost-benefit for the patient.

Scope The agreement defines basic principles for the interaction between the medical profession and the industry in four areas, including specific conduct guidelines for each of them. Promotion and information of authorized medicines The industry has the right to promote its products among HCP, respecting the clinician’s independence to define treatment. The content of promotional materials must be accurate, precise and truthful.

Scope II. Training and continuing education for HCP sponsored by the pharmaceutical industry Sponsorship of academic events by the industry is acceptable, provided these have a clear educational purpose. Continuing education programs, events to up-date and disseminate scientific information must be endorsed by academic institutions. Accepting financial support for educational events, does not oblige doctors to prescribe medicines from the sponsoring company. Educational or promotional materials will clearly specify the objective of the event .

III. Studies and clinical research Scope III. Studies and clinical research Cooperation between the industry and HCP has been of primary importance in the development of new products and pharmaco-epidemiological research. Studies on clinical research have to be submitted to research and ethics committees for their authorization by the Federal Commission for the Protection from Sanitary Risks. Research committees are responsible of verifying that protocols are based on updated information and that the procedures proposed are viable. Ethics committees protect the rights and safety of the participants in studies, as well as the ethical perspective of the protocols.

Scope IV. Appropriate use of medicines and respect for medical prescription Patient interests must be protected from the time of prescription until it is filled, respecting physician’s therapeutic instructions. HCP will promote patients adherence to medical prescription and treatment.

Follow-up Committee The General Council of the Health System established a Follow-up Committee to promote the implementation and dissemination of the agreement; responsible of: Receiving and analyzing complaints relating to the infringement of the agreement, and issuing the corresponding resolutions. Proposing preventive and corrective measures. In the case of controversies, CETIFARMA acts as mediator between the pharmaceutical industry, HCP and institutions. Disseminating the agreement and recommendations among public and private institutions of the National Health System.

Current Status Theme Advances I. Promotion and information of authorized medicines All companies (180) have signed their adherence to the Code of Pharmaceutical Marketing Practices. There is a more effective surveillance of the content of promotional material, in order to avoid misleading information and enhance compliance with the local laws and regulations. There is a compromise to erradicate the provision of not permitted financial benefits or benefits-in-kind to HCP and sanitary institutions. Increased control and accountability of medical samples provided to HCP’s. Promotion of reports on adverse reactions. Closer contact with medical associations via the exchange of information and colaboration agreements.

Current Status Theme Advances II. Training and continuing education for HCP sponsored by the pharmaceutical industry To obtain sponsorships, Medical Associations have to submit their anual academic programs, indicating: topic, objetives, audience, venues and amounts required. In order to be sponsored, CETIFARMA has defined that 80% of the program of the event must be allocated to scientific/educational issues. Medical Associations have been informed of the conditions regarding hospitality. III.Studies and clinical research The company’s representatives must ensure that clinical studies adhere to national and international ethical research principles and protocols. Promotion of informed consent of participants in clinical research studies.

Current Status Theme Advances IV. Appropriate use of medicines and respect for medical prescription Contact with the Pharmacy’s Association to explain the importance of: respecting medical prescription. containning the preassure to substitute a prescribed medicine with alternative products. Work closely with the Sanitary Authorityand medical associations to promote adherence of patients to treatments.