A special subcommittee of the Chamber of Deputies approved a report analyzing the use of experimental medications for the treatment of serious or rare diseases. The text, presented by governing party ally Leandre del Ponte (Partido Verde), authorizes the incorporation of medications not listed under the Universal Health Care System (Sistema Único de Salud or SUS) if their clinical efficacy in the treatment of rare diseases is confirmed by the initiating laboratory.

Currently, the inclusion of the medications under the SUS is the responsibility of the Ministry of Health, assisted by the National Committee for the Incorporation of Technology. Through this proposal, medications for the treatment of rare diseases could be offered within the public network, thereby eliminating the need for any review in the public sphere on product cost and benefit.

The text states that these medications will have an additional 5 years of exclusive market commercialization, in addition to the protection period provided by law for other medications. It also guarantees the right of clinical study volunteers to receive the product for free from the sponsoring laboratory as long as it is medically indicated.

The measure consists of a bill to amend health service regulations (Law N° 8.080/90) and the law that protects drug testing data (Law N° 10.603/02).

A long road

The collective body, which is linked to the congressional Social Security and Family Committee, was reinstated in May of this year. In 2016, the subcommittee summoned researchers to present on the current difficulties in the area of research development on new substances such as phosphoethanolamine, also known as the “cancer pill.”

Next steps

With the committee’s endorsement, the measure is now at the mercy of the floor of the Chamber of Deputies, which will be able to review and vote on the regulation before it is sent to the Senate so the legislative process can continue.