How the Judicialization of healthcare in Brazil is affecting patients

Now that the Paralympic games have come and gone in Brazil, some of these athletes, along with millions of other victims of rare diseases, face daunting physical, legal and emotional endeavors in their day to day lives.

The current obstacles patients have to hurdle now are brought forth by policy, such as the ongoing ordeal when trying to acquire medication in Brazil’s public health care system.

If somebody is in serious need of medication, the only way he or she can take initiative is by filing a court order so the government will have to provide the medication. But this presents a new obstacle. Time.

Cristiane Vitor, a Rio native, witnessed firsthand the struggles this causes for her son, Washington. He is a patient with Pompe disease, a disorder caused by the buildup of glycogen in the body's cells, according to the Genetics Home Reference of the U.S. National Library of Medicine. Washington is still waiting to receive his medication.

Associations and patients affected by rare diseases are protesting for their constitutional right of supplied medication by the public health care system (SUS). The Supreme Court is deciding whether SUS needs to supply these medications because they are so expensive or not manufactured in Brazil.

Washington has not been able to receive his medication since May.

“I cannot get it from the Secretary of Health in Rio,” Cristiane said. “I stopped going directly to the public health clinic because the physicians would not even consider prescribing the medication because of the price.”

This can be physically taxing for Washington. “He needs to sometimes use a wheelchair or stay seated for many hours,” Christiane said. “He feels that his whole body is heavy.”

Martins mentioned that even though Vitor can obtain the medication with a court order, it can take months or even a year to receive the medication. Even then, that only solves the problem temporarily.

“When Washington’s medication ends,” said Dr. Sandra Martins, a physiatrist who has specialized in medicine and rehabilitation for more than 30 years. “They have to start a whole new process instead of buying the medication in bulk. And that generates lots of anxiety in patients and relatives.”

Martins sees many patients who are afflicted with diseases ranging from cerebral palsy, to diseases that affect neurological and neuromuscular development.

“Many patients start filing there cases in court to obtain these drugs or treatment,” said Martins. “But because of the economic crisis in Brazil, they realize that there are lots of cases filed in court demanding the payment for these treatments.”

This leads to many patients in the public health care system not knowing when they could be receiving their medication, just like Washington.

The anxiety has now led to protests all across the country with the help of various associations affiliated with rare diseases.

Clara Migowski, the president of the Association of Muscular Dystrophy, said this is because the medications may no longer be provided for public healthcare patients at all.

“In the case that the Supreme Court decides that the government is not mandated to dispense medication that has not been cleared by the ANVISA,” she said. “Any further requests or appeals in courts will be denied because the Supreme Court has decided that medications not approved ANVISA or that are not in the public health formulary, will not be paid with public money.”

According to Migowski, the process for ANVISA can take up to three years to approve a drug. With a rare disease like Duchenne muscular dystrophy being degenerative, a wait of three years can mean death for these patients.

“Right now the decision has been postponed because one of the ministers has asked to look at the case to make a better decision,” said Migowski. “I see that just as a legal maneuver to wait until all of the media attention dies down to resume the hearing of the process.”

Martins, Migowski and many others said the best course of action is to continue actively protesting at the time of court decisions and notifying the public of this situation. They also want to keep the discussion live on the internet to reach their goal of one million signatures.

Martins has witnessed innovations in medicine for these rare diseases appear in her profession throughout the years. “These drugs have worldwide recognition,” Martins said. “As a physician knowing these medications are available, it is my obligation to notify patients that there is a treatment for the condition.”

Martins mentioned that these drugs are approved by the FDA and other drug agencies in Europe. The patients have to sue the state health agency in court to make them pay and obtain the medication. So the patients can import these medications. Some of these medications may have been approved by ANVISA. But there are some peculiar guidelines to approve these “orphan drugs.”

“For instance, they (ANVISA) require that the medication be tested with at least 30 patients over the period of a year,” Martins said. “But the problem is some of these diseases are so rare that only 30 people in the world have this diagnosis. So this is an unrealistic expectation, which condemns the patients to not receive a medication that could save their lives.”

Martins said the deciding factor for this case is to bring public awareness to the problem so many of her patients can gain access to life-saving medication. She has strength in numbers being a volunteer physician for Rio’s Association for Muscular Dystrophy.

But if the court does not rule in the favor of the patients, the only way they will be able to battle these temporary diseases is through symptom relief, according to Migowski.

Migokwsi related this situation to someone with pneumonia, as a less severe example. “They are going to cough,” Migowski said. “So it’s like giving a patient only cough syrup when they also need an antibiotic.”

Many patients are literally in a race against the progression of their disease. And Migowksi mentioned the prognosis does not look good if they do not take legal action.

“There are an estimated three million patients with rare diseases in Brazil,” said Migowski. The patients have support in numbers with associations for many of these rare diseases.

Martins said there are 23 associations involved protesting against cutting off funding for these medications.

“We have been filing requests in court,” said Martins. “A letter of medical necessity stating that the treatment was essential for the patient’s survival.”

Martins says that in the case for Duchene’s, mechanical ventilators are used to support the weakened muscles used for breathing. But there is no equipment to help support the weakened muscles of the heart.

“It’s essential that they get the medication so they won’t die,” Martins said. “There are some other diseases that give a similar situation, like mental diseases. And these medications can sometimes stall and even revert these diseases.”