Call for agencies and consultants: medicines regulation in Latin America

Understanding the regulation and provision of multiple sclerosis disease modifying therapies in Latin America

Multiple Sclerosis International Federation (MSIF) is seeking the support of an agency or consultant to carry out a scoping exercise to increase our knowledge and understanding of the regulation and provision of multiple sclerosis (MS) treatments in the Latin America region. The work will be used by MSIF to develop a strategy to improve the regulation of disease modifying therapies (DMTs) in Latin America and improve access to information by people with MS and their healthcare professionals, ultimately to increase access to safe and effective DMTs in Latin America. For the purpose of this document ‘treatments’ refers to ‘DMTs’.

Agency/consultancy brief: Please download here

Deadline for applications: 11th August 2018

Budget: Maximum £20,000 including travel and expenses

Timeline: Maximum six months, starting from August/September (please indicate expected timeframe needed)

Background: The right treatment at the right time can help people with MS take control of their condition and live independently. However, it is critical that people with MS are prescribed safe and effective treatments that are made available based on suitable clinical evidence, with appropriate pharmacovigilance in place. Health is a human right and providing adequate services and treatment is essential to meeting this right.

There are a number of licensed, innovative DMTs available in Latin America. There are also a number of off-patent, repurposed, biosimilar and generic options in the pipeline or currently available. Provided that generics and biosimilars have the right clinical data to support their use, they can allow a health system to have access to treatments that are significantly cheaper.

Producing good quality biosimilars is more complex than producing generics due to the inherent properties of the biological drug. Biosimilars therefore require through bioequivalent studies, including clinical trials to demonstrate safety and efficacy. In Latin America, some biosimilars have not been fully assessed for their safety and efficacy, posing a potential risk that they are of poor quality. In some areas this is despite regulation dictating that these studies are required for approval.

As a federation of MS organisations all united in our commitment to improve the lives of people affected by MS across the world, MSIF wants to better understand the scale of the problem in Latin America, with a view to using our collective influence to address it. We expect there to be lessons learnt and applied to our work elsewhere around the globe.