Brazil Introduces New Measures To Tackle ‘Judicialization’ Of Access To Medicines
Executive Summary
Brazil has announced new measures to try to deal with the costly problem of patients pursuing access to medicines through the courts.
A new digital platform will help Brazilian judges access clinical evaluations of medicines and other technologies to help them decide whether to grant access sought through legal proceedings.
The platform, announced on 19 August, is a joint initiative of the National Council of Justice (CNJ), the health ministry and the Hospital Israelita Albert Einstein.
Lawsuits brought by patients to access medicines and other health technologies are something of a fixture in Brazil. This is because the Brazilian constitution gives all citizens the basic right to health care but without stipulating how this works in practice or establishing any limits on the provision of health care.
The number of cases has been increasing over recent years, as has public spending on the cases and the medicines involved. The federal health ministry said in 2017 it had spent some R$4.5bn ($1.4bn) on complying with court orders to supply medicines and other health products over seven years, and that spending soared between 2010 and 2016. (Also see "Brazil Sets Sights On Biogen’s Spinraza For First Risk Sharing Deal" - Pink Sheet, 28 Feb, 2019.)
To help manage the problem, the new digital platform will help judges access advice from health professionals to decide whether the case in question is urgent. If it is deemed to be urgent, specialists nominated by Hospital Israelita Albert Einstein will assess whether access to the medicine or technology should be granted. This “critical evaluation” reviews the “appropriateness of adopting a treatment according to the principles of effectiveness, efficacy, efficiency and safety of the prescribed medicine or procedure,” says the CNJ.
The advice will be stored on the digital platform and will be available for other judges to consult should they be presented with similar cases.
Rare disease treatments have formed a large portion of the drugs accessed through the courts and have Included Biogen’s Spinraza (nusinersen) for spinal muscular atrophy. Following an assessment by Brazil’s health technology appraisal body CONITEC announced in April, the drug is now available on the national health system, the SUS, at specialist centers through a risk sharing deal.