posted on 06/20/2022 07:01
(credit: Carlos Vieira/CB/DAPress)
By Nelson Mussolini – executive president 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 that appears, 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, sanitary and ethical problems. Law 14,313, of 2022, which deals with the processes of incorporation of technologies into the SUS and on the use by the public system “of medicines whose indication for use is different from that approved in the Anvisa registry”, is a true attack against the SUS, Anvisa and, consequently, public health.
To be used on a large scale, a drug needs, in Brazil and in the world, to be extensively tested in clinical research that proves its safety, efficacy and quality for the indicated therapeutic treatments. Once these studies are approved, which are often extremely expensive, the product receives the registration requested by the pharmaceutical industry that developed it and can be offered to the population, for use according to the indications described in the package insert.
It is in this context that the medicines offered by the SUS are inserted. These are products for broad consumption, which must necessarily follow the general guidelines for use provided for 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 body, is always restricted and determined. Therefore, creating a rule in the SUS that allows the use of medicines for diseases not approved in the product registration with Anvisa represents a serious threat to collective health.
When, after extensive phases of clinical research, pharmaceutical companies obtain approval for a drug and launch it on the market, the next step is to permanently monitor the use of this product by the consumer, 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 monitor the correct application of the products and the reports of side effects; and, in serious cases, suspend distribution to protect the population, as has happened in the past.
Having adopted the rule of allowing the SUS to offer medicines with an indication for use not approved by Anvisa, who would be responsible for monitoring the off-label use of the products? There is also the issue of legal liability. Who would be held responsible for the use of an off-label drug in the SUS in the event of a serious adverse event? Would it be the SUS technicians who approved its off-label use? Obviously, the drug developer cannot be held responsible, as the company obtained approval only for the therapeutic indications that appear in the registration dossier and package inserts and always warns that the product must be used only in accordance with the health registration and guidance. doctor.
Finally, it is necessary to consider how much the indication of off-label use of medicines in the SUS affronts medical practice and weakens patient care. When a doctor decides to indicate to his client a drug not formally approved by Anvisa for the treatment he is prescribing, he proceeds according to his conviction, clinical experience, medical ethics, in particular situations and based on the etiology of the disease, with full knowledge of the patient’s health conditions.
This is an exclusive competence of the physician, which does not apply to the State and its institutions, nor can it be contemplated by a generic and unrestricted rule. It should be noted that the pharmaceutical industry does not want its products to be dispensed in any way. 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 are still facing, proved the competence and relevance of our Unified Health System and Anvisa, which, by technical criteria, based on science, guided the population on what could or could not be 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 adopted for diseases that do not have medicines registered with Anvisa and after extensive debate with society. If there is a therapeutic solution duly approved by the regulatory body, there is no plausible reason to put SUS users and public health at risk, even if minimal.