News

Brazilian court to rule on access to medicines

BMJ 2016; 355 doi: http://dx.doi.org/10.1136/bmj.i5533 (Published 12 October 2016) Cite this as: BMJ 2016;355:i5533
  1. Claudia Collucci
  1. Sao Paulo

The Supreme Federal Court of Brazil will decide whether states should provide access to high cost drugs that are not listed on the public health system—Sistema Único de Saúde (SUS). Applications for access to these drugs are usually made based on the right of every Brazilian to health.

The court is looking at two specific cases. The first, from 2007, is from the government of Rio Grande do Norte, which is appealing against an application from a patient for sildenafil (Viagra). The second case, from 2008, involves a patient with chronic kidney disease from Minas Gerais who is appealing against a decision by the state not to fund cinacalcet (Mimpara), which is not licensed in Brazil.

The judgments in these two cases are likely to set a precedent for other lawsuits. If the appeals are rejected, patients may find it harder to access drugs that are restricted in Brazil.

Over the past few years Brazil has faced an explosion in the number of lawsuits from people claiming that the government has failed to fulfil demands for drugs and treatment. In Sao Paulo state, for example, the number of lawsuits nearly doubled in the past five years from 9385 in 2010 to 18 045 last year.

Data from the Brazilian Ministry of Health have shown that federal spending on lawsuits rose from $38m (£31m; €34m) in 2010 to $340m in 2015. The government pays both parties’ legal fees.

Grace Mendonça, the country’s attorney general, said, “The judgments are often injunctions that can end up completely destabilising the system.” She said that the government had no obligation to provide “everything to everyone” but to provide “everything to everyone that is available on the SUS.”

Patients who expect favourable decisions from the court are exerting increasing pressure. Six of the 10 most commonly used drugs for patients with serious and rare diseases are not on the SUS list and are accessible only through legal action. These drugs include eculizumab for people on dialysis and galsulfase and idursulfase to treat metabolic disorders.

Sergio Sampaio, president of the Associação Brasileira de Assistência a Mucoviscidose, an association for patients with cystic fibrosis, said that the court’s decision could affect patients with rare diseases. “Depending on the result, many patients who are receiving drugs because of lawsuits could stop getting them.”

The trial, which started two weeks ago, was suspended last week after a minister asked for more time to examine the cases. No date has yet been set for the trial’s resumption.

Some commentators have said that the current model of litigation is worsening the country’s already pronounced health inequities. The model is characterised by a prevalence of individual claims and a high success rate for the litigant—over 80%. Most of those bringing the lawsuits live in the most affluent areas of the country and are represented by private lawyers whose fees are beyond the reach of most of the population.

Luis Roberto Barroso, minister of the Supreme Federal Court, said that the courts should intervene only in extreme situations. “The judiciary is not the appropriate forum for the definition of public health policies,” he said.

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