Innovative biotechnical medicines have been and continue to be developed and investigated as an alternative to traditional chemically-based medications and have been used to prevent, treat, and detect certain ailments such as cancer, diabetes, and cystic fibrosis.[2] They differ from commonly-used chemical medicines in that they are derived from a biological source, a living organism. Due to this fact, the development and reproduction of biotechnical medicines are far more complex and difficult to achieve.[3] As such, they cannot be treated in the same manner as chemical medicines in terms of production and distribution. Additionally, their development and distribution need to be carefully regulated and structured to ensure safety and efficiency.[4]

The World Health Organization (WHO) created regulations for biotechnical medicines on an international level, setting the stage for individual countries to establish their own laws. Although these regulations are recognized internationally, they do not necessarily reflect the realities or the nuances present in all countries globally. Given that biotechnical medicines affect different ethnicities in different ways (e.g., a medication that helps prevent diabetes in Asian populations could have adverse effects in people of Caucasian descent and vice versa[5]), each nation must create laws, regulations, and standards specific to their population in order to guarantee the safety and efficiency of the medications for their populations.[6] Nations such as the United States, Canada, Japan, Europe, and more recently Mexico, have created structures to regulate biotechnical products.[7]^,[8]^,[9] However, this is not the case with many countries in the Americas.

Although biotechnical medicines are becoming increasingly available in Latin America, structures have not been established by many countries to ensure an adequate standard for the medications.[10] To address this need in the Americas, PAHEF, in partnership with Edelman and funding from Roche, initially established the Safe Biotech Initiative in Mexico to inform physicians, medical professionals, and patients about the advancements and benefits of biotechnology in the field of medicine. As part of this initiative, an advisory group, consisting of in-country established experts in the fields of medicine and medicinal law, was created to participate in and promote the educational campaign by holding informative workshops all over the nation, creating networking opportunities, and developing resources and tools to increase medical practitioners’ and patients’ knowledge of biotechnical medicines. PAHEF was proud to contribute to this dialog between providers, experts, and patient groups related to this initiative that were brought to fruition in October 2011, when the Mexican Congress passed the first regulations for biotechnical medicines; one of the first in Latin America.[11]

Due to the success of the activities in Mexico, while taking advantage of other Latin American nations’ timely development of regulations, PAHEF and its partners expanded the program regionally. In early December 2011, PAHEF led a two-day workshop entitled Similar Bio Therapeutic Products: Science and Regulations in Mexico City. Workshop participants included regulatory authorities and representatives from the ministries of health of Brazil, Colombia, Costa Rica, El Salvador, Guatemala, Mexico, Panama, Peru, Uruguay, and Venezuela. The workshop was inaugurated by Dr. Simón Kawa, the National Commissioner for Bioethics of the Mexican Secretary of Health, and Dr. Roberto Mendoza, the Commissioner of Sanitary Authorization of the Mexican Federal Commission of Protection against Health Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS), who provided their support of the biotechnical initiative and emphasized the importance of educating regulatory authorities on this topic.

The workshop provided an overview to biosimilar products and highlighted WHO guidelines and regulations, and regulations from several regions including the European Union, Canada, and Japan. PAHO’s Pan American Network for Drug Regulatory Harmonization also presented on the experiences of the regulatory authorities in the region. These presentations, case studies, best practices, lessons learned, and overall guidance provided a unique context for biotechnical medicine regulations, and information and materials for the Latin American participants to use to help their nations in the formulation of biotechnical regulations that are best suited to their realities. The representatives also shared experiences and current issues on the regulations in place or the development of new regulations, many of which are not exclusive to that particular country. The participants agreed that although the WHO, the European Union, and United States regulations were helpful, they did not particularly address some of the challenges faced in Latin America, such as the lack of resources to perform vast case studies or clinical trials and access to medical attention. A representative of the advisory committee of the Safe Biotech Initiative in Mexico, Dr. Gilberto Castañeda of the Center of Investigation and Advanced Studies at the National Polytechnic Institute (Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional), reiterated this point by stating, “Latin America does not have the economies of scale like the United States or European Union. We have economies of what is available and this is something that the current [international] regulations have been unable to address. PAHEF, with this workshop, has addressed the differences and gave tools to move forward with our individual countries’ regulations.”

The workshop also created a platform for peer support among the regulatory authorities and ministries of health throughout Latin America. Through this networking opportunity, the participants have begun dialoguing about this important topic. To further this discussion and ensure that it is continued beyond the workshop, PAHEF plans to create an online forum designed for the initial pool of participants to aid each other and share important information. The participants also asked for additional biotechnical workshops to educate other key players developing regulations. PAHEF is planning a similar workshop focusing exclusively on case studies and will include activities simulating the approval process of biotechnical medicines.