Brazil: access and reimbursement of medicines in the public market

Paulo Rosito

Souto Correa, São Paulo

paulo.rosito@soutocorrea.com.br

Matheus Montecasciano

Souto Correa, São Paulo

matheus.montecasciano@soutocorrea.com.br

Anderson Ribeiro

Souto Correa, São Paulo

anderson.ribeiro@soutocorrea.com.br

This article intends to briefly describe:  

• how the Brazilian legislative framework regulates the incorporation of new pharmaceutical products into the Brazilian public healthcare system (Sistema Único de Saúde or SUS), commonly known as ‘reimbursement’ in other international jurisdictions;
• which public authorities are involved;
• what the ‘judicialisation’ phenomenon is; and
• the importance of strategic legal support throughout the process of incorporation.

The intention is not to cover all different aspects of the public market or the incorporation process, but to summarise some information for a non-familiarised person.

Some background information is essential to understand the economic Brazilian healthcare regulatory system.

Who is the payor for medicines in Brazil?

1. For over-the-counter products, payment is made by the patient out of pocket.
2. In general, patients pay out of pocket for prescription products sold at pharmacies; the government pays for them in some therapeutic areas.[1]
3. Hospital products are usually paid either by the patient’s health management organisation (HMO) or by SUS in the case of public hospitals.
4. SUS will also pay for some other specialty products (eg, rare diseases) if such products are incorporated into SUS (ie, reimbursed).

In Brazil, around 28.5 per cent of the population has access to HMO coverage. SUS solely covers the remainder, which is funded at federal, state, and city levels and is managed by a ‘three-party committee’.

What is the legislative framework for incorporating a new product into SUS?

As per industry standards, pharmaceutical products are subject to stringent regulations under Brazilian law.

According to Law 6,360/1976, pharmaceutical products must get marketing authorisation from the Brazilian health regulatory agency, Anvisa. The main requirements for registration are proof of safety, efficacy and quality.

After Anvisa’s marketing authorisation, pharmaceuticals must approve their maximum market prices before the Drug Market Regulation Chamber (CMED). Thereafter, the product is ready to be legally commercialised in the Brazilian market.

Traditionally, this is the moment when companies would start thinking about an incorporation strategy, which would be taken to the National Commission for the Incorporation of Technologies (CONITEC), a health technology assessment (HTA) body within the flowchart of the Ministry of Health (MoH).

Within its legal remit, set forth by Law 12,401/2011, CONITEC serves as the body that, after a lengthy and technical procedure, renders a non-binding opinion to the MoH, which will ultimately decide whether a given product should be reimbursed. CONITEC’s recommendations are issued based on (1) scientific evidence regarding the efficacy and safety of drugs, (2) effectiveness, and (3) economic evaluation of the drugs to be incorporated from the perspective of the public healthcare system.

What is the ‘judicialisation’ phenomenon and where does it come from?

As per Article 196 of the Brazilian Federal Constitution of 1988, health is a right of all and a duty of the state (constitutional right). This constitutional right and SUS were regulated by Federal Law 8,080/1990, which establishes ‘pharmaceutical assistance‘ as one of many actions to be implemented by the Brazilian state.

Considering the constitutional right and the legislation, during the early 2000s, patients who could not afford pharmaceutical products started filing lawsuits against the government to have access to such medicines.

The authorities literally belittled these lawsuits. During the 2010s, when high-cost rare disease drugs were launched and patients started getting injunctions in their favour to gain access to these high-cost drugs, authorities became concerned due to budgetary reasons.

Another factor in the increasing number of patient lawsuits was that CONITEC was not only slow in reviewing new technologies – and often patients do not have time to wait –but also set up criteria that would make a favourable recommendation for reimbursement nearly impossible.

The evolving case law on judicialisation

Considering that the lawsuits aiming for access and payment for pharmaceuticals were brought to the judiciary, and the constitutional nature of the ‘health right’, many leading cases ended up at the Brazilian Supreme Court (STF). Historically, STF made the following decisions:

1. May 2019: it is not mandatory for the state to pay for experimental products not approved by Anvisa, except if there is an undue delay by the agency, the product is already approved by renowned agencies in the world, and there is no therapeutic substitute available in SUS. Note: rare disease drugs entail a broader exception, as the drug does not even need to be subject of a submission.
2. September 2024: it is not mandatory for the state to pay for products that are approved by Anvisa but are not incorporated into SUS, except for cases in which the patient is able to demonstrate all of the following requirements:
   1. there was a denial to the patient’s request to have the product before a state pharmacy;
   2. there is not an incorporation procedure before CONITEC or, if the incorporation was denied, this decision must be illegal;
   3. lack of a therapeutic alternative available in SUS;
   4. evidence-based medicine supporting the prescription;
   5. clinical necessity of the product; and
   6. financial incapacity of the patient to pay for the product.

In addition to the decision taken in September 2024, the Brazilian Supreme Court has also ruled on which state level (federal, state or city) will pay for the expenses by purchasing judicialised products and some other procedural aspects of the lawsuits.

The recent decision from September 2024 is generating doubts about its implementation, its impact on the feasibility of enforcing the constitutional right to health, and how it will impact future decisions pertaining to products’ lifecycle and market entry strategies.

Key takeaways

Brazilian public access to medicines is not only regulated by different laws and regulations, but there is a huge component of court decisions that all stakeholders must observe.

Brazilian access professionals are often resorting to their legal teams to seek support in having strategic discussions due to the Supreme Court decisions. These legal teams will necessarily play an even more strategic role in the companies’ business by providing critical advice that may represent access to the companies’ products sooner rather than later (or not).