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Doing Business in Brazil: Political and economic landscape

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Changes to Legislation of the Brazilian Public Healthcare System (SUS) Bring Hope to Patients

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One of the greatest Brazilian achievements is undoubtedly the Brazilian Public Healthcare System (SUS). Provided for by Article 196 of the 1988 Brazilian Constitution, it establishes that health is a right for all and a duty of the State, and guarantees to every Brazilian access to public health, regardless of payment to the Brazilian Social-Security Administration (INSS).

It is important to highlight that, even though the service provided by the public health system is at times lacking, especially in some regions of the country, there are countries in which those who cannot pay do not have any kind of access to medicines or clinical or hospital treatments, thus are left to agonize in their illness or even dying.

Considering that SUS comprises a complex mechanism of patient support, one of its most important points (and also perhaps the most controversial) is the incorporation of new technologies, especially new drugs.

While technology progresses and advances in genetics, biology, and immunotherapy are developed, there is controversy regarding the cost of these new drugs, especially those aimed at rare diseases, that is, those affecting a relatively small group of patients. As a result, in order to have a return for the huge investments made in clinical research, pharmaceutical companies are forced to significantly increase the price of such drugs, as their purchase will be restricted to a very small group of patients and its cost cannot be diluted. Rare diseases are those considered as those affecting up to 65 people in every 100,000 individuals, that is, 1.3 people for every 2,000 individuals. The exact number of rare diseases is unknown but estimated to be between 6,000 and 8,000 different types worldwide.

As the budget allocated to SUS is finite and annually approved, it is common for authorities to refuse requests for supplying medicines not incorporated into SUS by means of the National Committee for Health Technology Incorporation (Conitec), stressing their high cost or lack of approval by the Brazilian FDA (Anvisa). This leads to a relatively common phenomenon in Brazil, which is the judicialization of health when patients rely on the judiciary branch to guarantee the government's duty, regardless of whether the drug is incorporated or not into SUS by Conitec.

Although the judiciary branch is favorable to requests for supplying drugs, even if not incorporated, there has always been reluctance to make SUS supply a drug not approved or not indicated by Anvisa.

However, the publication of Statute 14,313 of March 21, 2022, which changed provisions of the Statute that created SUS, Statute #8080of September 19, 1990, brings hope to patients by introducing the following:

1. The methodologies used in the comparative economic evaluation of benefits and costs in regard to already incorporated technologies, including with regard to home care, outpatient care, or hospital care, when applicable, will be provided in regulations and widely applied, including in regard to indicators and parameters of cost-effectiveness used in combination with other criteria.

2. The process of incorporating, excluding, or changing new drugs, products, and procedures by SUS, as well as establishing or changing clinical protocols or therapeutic guidelines will follow random distribution, respecting the specialization and technical competence required for analyzing the matter.

3. The process of incorporating, excluding or changing new drugs, products, and procedures by SUS, as well as establishing or changing clinical protocols or therapeutic guidelines will depend on the public availability of procedural acts.

4. In every instance of SUS management, the following are prohibited: (i) payment or reimbursement of drugs, products, and experimental clinical or surgical procedures, or use unauthorized by ANVISA, and (ii) the release, payment or reimbursement of national or imported drugs and products without registration with ANVISA. However, there are the following exceptions: (i) drugs and products in which the indication for use differs from that approved in Anvisa's registration, provided that its use has been recommended by Conitec, demonstrating scientific evidence on efficacy, accuracy, effectiveness, and safety, and that it is standardized in protocols established by the Ministry of Health and (ii) drugs and products recommended by Conitec and acquired by means of international multilateral organizations for use in public health programs of the Ministry of Health and entities related thereto.

As seen above, the aforementioned law brought innovations to transparency, but what really stood out was the possibility of having  SUS bear with the costs of purchasing drugs in which the indication for use differs from that approved in Anvisa's registration, provided that its use has been recommended by Conitec, that is, off label drugs.

Such a measure may be an advance and hope for a wide range of patients, as there are drugs that, due to their initial studies, are only approved for one indication, when indeed their effectiveness includes other indications not yet approved. Take for example an oncological drug, initially approved solely for post-chemotherapy use, but which proves to be extremely efficient for pre-chemotherapy use and that could contribute to quality of life, survival, and perhaps even avoid the death of a patient.

The question that arises is whether ethical and scientific precepts will prevail over the economic or political interests inherent to the discourse.

Be that as it may, the aforementioned statute is a ray of hope to many patients who will be able to access treatment as a result of such changes.

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