Fighting for the Common Interests of Pharmaceuticals
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Although pharmaceutical companies compete by nature, they all share common interests in many areas. Representing these interests is the raison-d’être of national and international organizations like the Latin American Federation of the Pharmaceutical Industry (FIFARMA).
“FIFARMA owes itself to the patients in Latin American and to its members. Our goal is to support them and help them to reach their goals in the most productive way,” says Luis Villalba, Executive Director of FIFARMA. “We are committed to the development of innovative therapies as all our members are heavily involved in innovation.” The association now comprises 21 members, including major pharmaceutical companies like Amgen, Astellas, BMS, Lily, Pfizer, Johnson & Johnson, Roche, MSD, Abbvie, Bayer, Novartis, Merck and Sanofi, as well as most pharmaceutical associations in Latin American countries including Argentina, Brazil, Colombia, Chile, Ecuador, Mexico, Peru, Central America (including part of the Caribbean) and Venezuela.
As a representative of the pharmaceutical sector, FIFARMA has a broad range of priorities, from fighting piracy, to promoting regulatory harmonization across Latin America, and works closely with the PAHO. The ultimate objective is to simplify the introduction of medicines and provide adequate access to innovation for all the population, which can be achieved by following the guidelines of other agencies. “Brazil, Mexico and Argentina have advanced regulatory agencies in the region and can be considered reference points in Latin America. If a product has been certified by any of these advanced agencies, it should be possible to introduce it in any other Latin American market.”
According to Villalba, Mexico has good regulations regarding pharmaceuticals and is taking clear measures to address enforcement. The problem the country is facing is the lack of access. “Local regulations specify that once a product is registered it still must undergo several more processes to be incorporated into the basic formularies of public health institutions.” Innovative medicines have high R&D costs, a situation that is even more complicated for orphan drugs, whose development costs are also high but for which the potential patient base is much smaller, which in turn increases final costs. FIFARMA seeks to work with authorities to simplify these processes for the benefit of patients, for instance, through the development of financing schemes. “We are greatly interested in the implementation of an outcome-based model where institutions pay for success cases instead of sold units. Some pioneers are introducing this financing model into Mexico but it is not yet popular.”
FIFARMA is also prioritizing pharmacovigilance and has launched a project called Vigilantia to strengthen its practice. “Pharmacovigilance needs to be highly proactive. While many Latin American countries have developed regulations concerning pharmacovigilance, there are significant reporting gaps considering the size of the population. The goal of Vigilantia is to increase awareness of the importance of pharmacovigilance for patients.” Villalba highlights several strategies, such as regular controls to provide medications and more follow-ups with patients. “The first step is to create awareness with doctors so they can communicate the importance of reporting side effects to their patients and to take note of these side effects. However, for doctors it is often time-consuming to keep track of this information because they are already extremely busy with other paperwork. Ideally, pharmacovigilance reports should be sent both to the manufacturer and to regulators.”
Villalba highlights the elimination of pirated medicines as another priority. “Falsified pharmaceuticals are the bane of the sector. They represent a huge burden for the population and for the pharmaceutical segment. In some countries, we estimate that the number of falsified products in circulation can reach up to 10 percent of the products.” To address this issue, FIFARMA adopted the Fight the Fakes initiative championed by IFPMA as it considers that existing efforts have not been sufficient. “We are fully convinced that this sector is not receiving enough attention from neither the authorities nor society. Our goal is to facilitate the work of the authorities in enforcing regulations and preventing these fake products from entering the sector.”