Recently, on 22 May 2019, through the judgment of RE 657.718 / MG, the Federal Supreme Court ruled that the State cannot be required to provide an experimental or unregistered drug with Anvisa, except in exceptional cases.
The trial began in 2016 and was finalized after lengthy discussions and debates between the ministers.
Synthetically, so decided the Supreme Court:
1) The State cannot be required to provide experimental medicines.
2) The absence of registration in Anvisa prevents, as a general rule, the supply of medication by court decision.
3) It is possible, exceptionally, the judicial grant of medicine without health registration, in case of unreasonable delay of Anvisa to consider the request (deadline longer than provided for in Law 13.411 / 2016), when three requirements are met:
I – the existence of an application for drug registration in Brazil, except in the case of orphan drugs for rare and ultra-rare diseases;
II – the existence of drug registration in renowned regulatory agencies abroad;
III – the inexistence of a therapeutic substitute registered in Brazil.
4) Actions that demand the supply of medicines without registration with Anvisa must necessarily be brought before the Federal Government.
The decision given by our Supreme Court has been right, and it is important to draw on this passage from Minister Luiz Roberto Barroso’s vote. On the one hand, extravagant or emotional decisions proliferate, condemning the Administration to the cost of unreasonable treatments – either because they are inaccessible or because they lack essentiality – as well as experimental or dubious drugs associated with alternative therapies.
Such statement of the minister could not be more correct.
There are numerous cases of court decisions that condemn the Union and often states and municipalities to provide unregistered and costly medicines. Such decisions often come with sentimental clamor rather than technical and legal grounds.
Obviously, no magistrate would like any citizen to die or suffer health deterioration due to the non-granting of a drug through a court decision.
However, authorizing the use of an unregistered and extremely expensive drug not only puts this person’s health at risk, but also the health of thousands of citizens who also depend on our already anemic Unified Health System.
Allocating the scarce resources of health in a few patients, so that they can use expensive treatments not registered by Anvisa, harms the other needy of SUS that often cannot obtain the most basic medicines or, at least, make medical appointments.
And at that point comes that old philosophical discussion, here is the issue of the allocation of scarce resources in the area of health, which involves the complex balance between the right to life and health of some versus the right to life and health. from many others.
According to the Ministry of Health, spending on expensive drugs in the last years of 2009 to 2018, were R$ 6 billion (USD 1.5 billion) to comply with court decisions.
The Federal Attorney General points out that, from 2007 to 2018, Union spending on the judicialization of health grew by 4,600%. Each year, the Federal Government even disburses R $ 1.5 billion (USD 375 million) with the purchase of judicialized products. Adding the spending of states and municipalities, the estimated value with these processes would reach R $ 7 billion (USD 1.75 million).
Yet, since these are unscheduled and often emergency demands, there is a major factor in these processes, the onerousness and difficulty in planning and control actions by public managers: planning, procurement of scale, control of Inventories, called price – cannot be used as a result of urgent court orders and tight deadlines, which ultimately lead to an increase in total costs for government health policies.
Thus, it is clear that in the ruling by the Federal Supreme Court, two points are exalted, the high cost that unregistered drugs bring to public coffers, as well as the uncertainty of their effectiveness and their side effects.