The Global Alliance for Patient Access (GAfPA) is the international arm of the U.S. focused Alliance for Patient Access (AfPA), which works to improve patient access to approved therapies in countries around the world. An area of particular interest to the organization is Latin America where the Alliance is working to build bridges between countries like Colombia, Brazil and Argentina.
Amanda Conschafter, communications director for AfPA, spoke to Change Together about the Alliance’s activities in Latin America, how the region differs from the rest of the world and what still needs to be addressed.
What are the objectives of the Global Alliance for Patient Access?
We want policy decisions made on a regional and global level to be informed by both physicians and patient advocates, and to be favorable in terms of access to approved therapies, diagnostics and ideal care. We want healthcare decisions to be made between the physician and the patient, not by policies and bureaucrats removed from the situation.
What are the biggest issues in regard to patient access in Latin America?
Patient access to biologics and biosimilars is a prominent issue. One reason for this is indication extrapolation, i.e., when a biosimilar is cleared for use based on its similarity to an approved biological medication, despite not having been studied in that indication.
Drug naming is also an issue. The World Health Organization (WHO) has provided a template for how biologics and biosimilars should be named for consistency and safety, as well as making sure that prescribed drugs are those that patients actually get. Unfortunately, those guidelines haven’t been fully adopted by all countries in Latin America.
Finally, being heard is another issue in Latin America, for patient advocates at least. Many groups find it difficult to identify those who will listen to their voice and help drive policy change.
How is the Alliance addressing these issues?
We’ve focused our efforts on educating Latin American groups about the issue of drug naming, helping them understand the WHO’s guidance and why it’s important for them to adopt it.
We also organize events and provide educational materials through presentations and training courses. One recent example in Bogota saw 23 patient groups come together to develop core principles that will focus on moving the needle on biologic, biosimilar and policy issues.
At every event, we bring our experience in how to achieve meaningful change with policy makers. We advise groups on who to talk to, how to build a relationship with important bodies and show them that if they work together, a lot can be achieved.
What obstacles stand in the way of patient access to medicines being achieved in Latin America?
The lack of a centralized body like the European Union or a federal government is a big obstacle. There’s no regulating organization to push Argentina, for example, to sign off a policy or piece of legislation that’s been decided by Mexico.
Clearly there are also language barriers that can further complicate the issue, even between places like Brazil and Colombia where one country speaks Portuguese and the other speaks Spanish.
Which Latin American countries are leading meaningful change to patient access?
Colombia is an area that’s ready for attention along with Argentina, Mexico, Panama and Brazil. Argentina, Brazil and Colombia tend to garner more attention because of their size and economies and the fact that they are on the cusp of a more regulated system for treatment access.
Colombia’s treatment access route design is ideal, but not the way it’s used. Treatments often don’t go through the proper channels and certain steps can be missed because treatments can be approved by a minister of health without being approved by congress.
What advice would you give to patient advocacy groups in Latin America?
A lot of what we’re doing concerns building the infrastructure, identifying the patients and physicians who are interested in advocating and bringing them together so they can coordinate. Then we provide training and educational materials to help them advocate and impact policy.
Ultimately, you have to have a clear goal in mind at all stages. If you work together and address the key issues, you can get a lot done for people that are suffering with debilitating conditions so that patients can get safe access to the treatment options they need.