posted on 20-06-2022 07:01
(credit: Carlos Vieira/CB/DAPress)
By Nelson Mussolini – Executive Chairman of the Pharmaceutical Industry Union (Sindusfarma) and Member of the National Health Council (CNS)
Complex situations do not have simplistic solutions. Behind the common sense and pragmatism emerging, the proposal to use drugs for therapeutic indications not approved by the National Health Surveillance Agency (Anvisa) in the Unified Health System (SUS) hides some serious legal, hygienic and ethical problems. Law 14,313 of 2022, which deals with the processes of incorporation of technologies in the SUS and on the use by the public system “of drugs whose indication for use is different from that approved in the Anvisa registry”, is a real attack on the SUS, Anvisa and therefore public health.
To be widely used, a drug must undergo extensive testing, in Brazil and in the world, in clinical trials demonstrating safety, efficacy and quality for its indicated therapeutic treatments. Once these studies are approved, which are often extremely expensive, the product will receive the registration requested by the pharmaceutical industry that developed it and can be offered to the public for use according to the indications described in the package insert.
It is in this context that the medicines offered by the SUS are introduced. These are products for wide consumption, which must necessarily follow the general guidelines for use stated in the package inserts approved by Anvisa. Contrary to this principle, the off-label therapeutic indication, which is not included in the package insert approved by the regulatory agency, is always limited and determined. Therefore, creating a rule in the SUS that allows the use of drugs for diseases that are not approved in the product registration with Anvisa poses a serious threat to the collective health.
When pharmaceutical companies, after extensive phases of clinical research, obtain approval for a drug and bring it to market, the next step is to continuously monitor the use of this product by consumers to confirm its original safety, efficacy and quality. . This process is called pharmacovigilance and involves a large network of centers and professionals and investments of millions of reais per year to check the correct application of the products and the reports of side effects; and, in severe cases, suspend distribution to protect the population, as has been done in the past.
Now that he has passed the rule that the SUS may offer medicines with an indication for use not approved by Anvisa, who would be responsible for overseeing the off-label use of the products? There is also the issue of legal liability. Who would be held responsible for using an off-label drug in the SUS in the event of a serious adverse event? Would it be the SUS technicians who approved the off-label use? It is clear that the drug developer cannot be held responsible, as the company has only received approval for the therapeutic indications that appear in the registration dossier and package inserts and always warns that the product should only be used in accordance with health registration and guidelines. doctor.
Finally, consideration should be given to the extent to which the indication of off-label use of drugs in the SUS offends medical practice and weakens patient care. When a doctor decides to prescribe to his client a medicine that has not been formally approved by Anvisa for the treatment he is prescribing, he will act according to his convictions, clinical experience, medical ethics, in certain situations and based on the etiology of the illness, with full knowledge of the patient’s state of health.
This is an exclusive jurisdiction of the physician, which does not apply to the State and its institutions, nor can it be envisaged by a general and unrestricted rule. It should be noted that in no way does the pharmaceutical industry want its products to be dispensed. The ethics followed by the companies is that these products are used in accordance with Anvisa’s rules.
The Sars-CoV-2 pandemic, which we continue to face, proved the competence and relevance of our Unified Health System and Anvisa, which guided the population on what could or could not be done, based on technical criteria, based on science. used. in the fight against covid-19.
And even if the aforementioned ethical, health and legal barriers were overcome, this law would only make sense if off-label use were passed for diseases for which no drugs are registered with Anvisa and after extensive debate with society. If there is a therapeutic solution that has been duly approved by the regulatory body, there is no plausible reason to endanger SUS users and public health, even if it is minimal.