Uncertainty prevails in Brazil over fate of reimbursement for spinal muscular atrophy dug Spinraza (nusinersen), and whether it will become available on the Brazilian Public Health System (SUS).
In response to concerns about its cost, the company has proposed an expense-ceiling model in which the government pays for the projected figures of 300 patients, with the company absorbing the cost of any additional patients.
However the health ministry’s Secretary of Science, Technology and Strategic Inputs, Marco Fireman, reportedly claimed the Ministry was preparing to issue a compulsory licence for the product (allowing the country to produce the product without the agreement of the company).
Compulsory licensing is allowed under the World Trade Organisation’s Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS), in order to allow Less Developed Countries to have access to medicines despite their high commercial cost, or to allow production during national emergencies. Brazil has only ever previously invoked this power with regards to high-cost medication to mitigate the spread of HIV/AIDS, not for an orphan drug.
Following the comments, Health Minister Gilberto Occhi stepped in to clarify that the Ministry is planning no such step, saying it was “out of the question” given the legal complexities it would raise. However he reiterated that the company’s pricing (even with its proposed expense-ceiling model proposal) was not affordable for the country.