Chronic patients report difficulties accessing medication.

Brasilia 247 - Waiting up to eight hours in line to pick up medication is synonymous with maintaining treatment for her 4-year-old son, says homemaker Ana Paula Lobato. Little Davi, who requires special care, has a congenital disease affecting his heart and lungs, causing him to live in a kind of Intensive Care Unit (ICU) in his own home. Bosentan, used to treat pulmonary arterial hypertension, is provided free of charge by the Federal District Government every month to the child and can cost up to R$ 4,3 for a single box of the medication.

Today (8), the date on which the National Day of Struggle for Medicines is remembered, Ana Paula and other chronic patients report difficulties in accessing medicines, in addition to the frequent shortages in the stock of high-cost pharmacies in the DF.

“There are situations where I come here and can’t find the medicine, I have to come back and face a four- to eight-hour wait in line to get it. This wait is immense, exhausting, but I’m still grateful to have access to this medicine for my son considering the current situation in the country,” says Ana Paula.

For Vanuza Ferreira, the situation is similar. For two decades, the civil servant has depended on the medication distribution policy to ensure the health of her son, a 21-year-old pharmacy student. Mario Albert has cystic fibrosis, a chronic genetic disease that mainly affects the lungs, pancreas, and digestive system. Monthly, Mario Albert's mother faces a kilometer-long queue to receive a set of seven medications estimated by Vanuza to cost R$ 9.

“It wouldn’t be feasible to treat my son without this kind of assistance; with the medication, he has a normal life. When I can’t find the medicine, I have to turn to the cystic fibrosis association I belong to. We always help each other when there’s a shortage of medication. I don’t mind waiting in line; the medicine means my son’s life, and despite delays, we never run out.” 

According to the Health Department of the Federal District Government, the Specialized Component Pharmacies (High Cost) provide 200 medications. Currently, 58 of these medications are out of stock, but according to the agency, "all have purchase processes underway."

Professor Margareth Lima has severe psoriasis, an autoimmune skin disease characterized by patches, primarily located near the hairline, elbows, and knees. To treat the disease, she continuously uses the injectable medication etanercept. The cost of a box, averaging R$ 9.621,40, is prohibitive for the professor's budget.

“Every month is a struggle. They've already made changes to the pharmacy's service, but the waiting time is still very long. I see very sick people and elderly people arriving at 6:30 am to get a service number, which only starts at 8 am. Nowadays, the employees even let us know in the queue if they have the medication or if it's out of stock, which saves us a lot of time. It takes a long time, but the service is good, and I prefer to face the queue and leave with medication in hand than to go without treatment,” says the teacher.

In the two pharmacies (Asa Sul and Ceilândia), approximately 30 chronically ill patients are treated. Every day, from 8 am to 17 pm, more than a thousand patients are seen, at an average of 50 people per hour.

Pharmaceutical products
According to the Ministry of Health, the supply of medicines in the Unified Health System (SUS) is organized into three components that make up the Pharmaceutical Assistance Financing Block - Basic, Strategic and Specialized, in addition to the Popular Pharmacy Program. According to the Ministry, R$ 15,9 billion was allocated last year for the acquisition, transfer of resources and distribution of medicines in Brazilian states and municipalities.

A list defines the medications that should meet the priority health needs of the population within the SUS (Brazilian Unified Health System). The 2017 National List of Essential Medicines (Rename) includes 869 items, compared to 842 in the 2014 edition. It also defines the responsibility for acquisition and distribution for each entity within the SUS (state, municipality, and federal government).

In the last publication of the list, in August of this year, the ministry announced the inclusion of medications such as dolutegravir, for the treatment of HIV infection, and rivastigmine, a transdermal patch used to treat patients with mild to moderately severe dementia. Alzheimer.

Judicialization
Many chronically ill patients resort to the courts when they lack access to or the means to obtain medications necessary for their treatment. According to the Ministry of Health, the impact of court orders on the ministry's budget is growing. In seven years, the federal government spent R$ 4,5 billion to comply with court orders for the purchase of medications, equipment, diets, nutritional supplements, expenses related to surgeries, hospitalizations, and court deposits, an increase of 1.010% between 2010 and 2016.

"In 2016, the figure reached R$ 1,3 billion, with the purchase of the ten most expensive medications to meet court demands costing the Ministry of Health almost R$ 1,1 billion, representing 90% of the total expenses for the 790 items purchased in 2016," the ministry informed in a statement.

According to a study by the Federal Audit Court (TCU) released in August, the federal government's spending on health-related lawsuits in 2015 totaled R$ 1 billion, an increase of over 1.300% in seven years. The provision of medications, some unregistered with the Unified Health System (SUS), accounts for 80% of these lawsuits. The Court also detected instances of fraud aimed at obtaining undue benefits.

Drug registration
Responsible for registering medications throughout the country, the National Health Surveillance Agency (Anvisa) follows a rigorous process, often questioned for the length of time it takes for a product to be analyzed. To be manufactured and sold in the country, medications need registration granted by the agency.

In 2016, the agency received 8.697 petitions for registration, post-registration amendment, and renewal of registration for biological products, medicines (referring to the subject analysis codes), changes to package inserts and labels of medicines, and authorizations for clinical research.

According to the regulatory agency, the total registration time for these products varies and is composed of three phases: the waiting time, the time Anvisa takes to analyze the applications, and the company's time, related to fulfilling Anvisa's requirements, that is, the time needed for the company to present supplementary technical information about the product to support the decision. The agency does not establish deadlines, but registration usually takes years to be granted.