Posted on 06/20/2022 07:01
(loan: Carlos Vieira / CB / DAPress)
By Nelson Mussolini – executive president of the Pharmaceutical Industry Union (Sindusfarma) and a member of the National Health Council (CNS)
Difficult situations do not have a simple solution. Behind common sense and apparent pragmatism, the proposal to use medication for medical symptoms that has not been approved by the National Health Monitoring Agency (Anvisa) in the United Nations Health System (SUS) hides some serious legal, hygiene and ethical problems . Law 14,313, 2022, which deals with technological integration processes in SUS and on the use of a public system “of drugs whose indication of use is different from that approved in the Anvisa registry”, is a real attack on SUS , Anvisa and, therefore, public health.
In order to be used in large quantities, the drug needs, in Brazil and around the world, to be thoroughly tested in clinical research that proves its safety, effectiveness and quality for the treatment shown. Once these studies are approved, which are often very expensive, the product receives registration requested by the pharmaceutical industry that manufactured it and can be made available to the population, for use according to the indications described in the packaging package.
It is in this context that the drugs provided by SUS are included. These are widely used products, which must follow the general usage guidelines provided in Anvisa package packaging approved. Contrary to this principle, an unmarked medical indication, which is not included in the package approved by the regulatory agency, is always blocked and determined. Thus, enacting legislation in SUS that allows the use of drugs for diseases that are not approved in the product registry by Anvisa represents a serious threat to collective health.
While, after many phases of medical research, pharmaceutical companies obtain the approval of the drug and launch it on the market, the next step is to permanently monitor the use of this product by consumers, to ensure its original safety, effectiveness and quality. This process is called pharmacovigilance and involves a large network of facilities and specialists with an investment of millions of reais per year to monitor the proper use of products and side effects reports; and, in extreme cases, suspend supply to protect the population, as has happened in the past.
After passing a law allowing SUS to provide prescription drugs that have not been approved by Anvisa, who would be responsible for monitoring the use of unlabeled products? There is also the issue of legal liability. Who will be responsible for the use of unregistered drugs in SUS in the event of a serious incident? Are SUS technicians authorizing its use outside the label? Obviously, the pharmacist is not responsible, as the company obtained approval for only the medical indications that appear on the registration and packaging label and always warns that the product must be used in accordance with the registration and health guidelines only.
Finally, it is important to consider to what extent the indication for the use of unregistered drugs in SUS undermines medical practice and impairs patient care. When a doctor decides to show his client a drug that has not been officially approved by Anvisa for the treatment he prescribes, he proceeds according to his beliefs, clinical experience, medical ethics, in certain circumstances and based on the etiology of the disease. knowledge of the patient’s state of health.
This is a unique ability of the physician, which does not apply to the Government and its institutions, nor can it be complied with by a general and unambiguous principle. It should be noted that the pharmaceutical industry does not want its products to be released in any way. The code of conduct for companies is that these products are used in accordance with Anvisa rules.
The Sars-CoV-2 epidemic, which we are still facing, confirmed the competence and importance of our Unity Health System and Anvisa, which, by technical criteria, according to science, guided the population on what could or could not be used. used. the fight against covid-19.
And even if the aforementioned moral, health and legal restrictions were removed, this law would be meaningful only if non-label use was passed on diseases that do not have drugs registered with Anvisa and after extensive discussion with the community. If there is a medical solution properly approved by the regulatory body, there is no acceptable reason to put SUS users and public health at risk, even if it is small.