Brazil has an universal healthcare system established by the Federal Constitution,1 according to which the State must provide all citizens with access to healthcare by devising and putting in place economic and welfare policies targeted at reducing the risk of illnesses of all sorts, while also ensuring unbiased access to public actions and services for promotion, protection and recovery of health.
In the public sector, healthcare is delivered by a regionalised and hierarchical system, named Unified System of Health (SUS), organised in accordance with the following principles:
- universalisation, which secures healthcare to the entire population regardless of economic condition, social status, bond or contribution payment, or any other condition;
- comprehensiveness, which secures access to a whole set of preventive and curative healthcare actions and services at all levels of complexity, in an ongoing and articulated manner between the Federal Government, states and municipalities; and
- decentralisation, which guarantees the allocation of funds and responsibilities between the Federal Government, states, Federal District and municipalities in light of epidemiological, populational, territorial and administrative organization characteristics, with a view to ensuring comprehensive and effective care to the population, considering local needs
The State's healthcare obligations are developed within the SUS by the Ministry of Health (MOH), in the federal sphere, and by the respective healthcare offices at state and municipal levels.
The SUS is funded by the social security budget and by the Federal Government, states, Federal District and municipalities' funds, among others. Private entities may freely participate in healthcare and supplement the SUS when public funds are not sufficient to guarantee health cover to everyone in a certain region.
The SUS is tasked, among others, with:
- implementing public health surveillance, comprehensive therapeutic (and pharmaceutical) care, epidemiological surveillance, and occupational health actions;
- participating in the formulation and enforcement of basic sanitation policies and actions;
- organising and training healthcare personnel;
- acting in food and nutritional surveillance;
- cooperating with environment protection, including the labour environment;
- formulating policies on medications, equipment, immunobiologicals and other healthcare-sensitive inputs, also participating in their production and control;
- overseeing healthcare-sensitive services, products and services;
- overseeing and inspecting food, water and beverages for human consumption;
- participating in the control and inspection of production, transportation, storage, safekeeping and use of psychoactive, toxic and radioactive substances and products;
- fostering scientific and technological developments in the healthcare industry;
- devising and enforcing a policy on blood and blood derivatives.
Comprehensive therapeutic care, however, has long taken centre stage in discussions over the role of the State in responding to its power-duty concerning health matters, the more so because of the hefty sums incurred by the SUS to provide a whole plethora of medications and treatment, no matter how complex, to meet individual or collective needs and demands.
Under the Organic Health Law2, comprehensive therapeutic care consists both in dispensing healthcare medications and products and in offering therapeutic (home, outpatient and inpatient) care.
Within the context of its therapeutic care duties, the SUS will only provide those medications and products envisaged in a Clinical Protocol and Therapeutic Directive (PCDT) approved by the MOH for the corresponding illness.
The PCDT sets out criteria to be followed by the SUS managers in terms of diagnosis of an illness or disorder; treatment, medications or products to be prescribed at all stages of the illness or disorder in point, as well as those otherwise adopted if the first-option medication, product or treatment results in diminished efficacy, growing intolerance or a relevant adverse reaction; recommended use; clinical control mechanisms; and follow-up and ascertainment of therapeutic results.
In the absence of a PCDT, the prescription must necessarily follow the list of medications certified by the SUS, such as the List of Essential Medications (RENAME).
A healthcare product, medication or procedure is only added to the PCDT or to the list of SUS-certified procedures after being first incorporated by the MOH.
The incorporation process of new medications, products and procedures by the SUS, as well as the creation or change of a PCDT, may be initiated by any interested party upon specific application to the Executive Office of the National Committee on Incorporation of Technologies (CONITEC).
The CONITEC is a standing technical body that assists the MOH on its decisions to incorporate, remove or change new medications, products and procedures, as well as on the preparation or revision of a PCDT, based on the following guidelines:
- promoting the universal and comprehensive access to healthcare actions within the SUS based on the best technical and scientific knowledge available at the time;
- protecting citizens in health promotion, prevention and care actions by ensuring a safe and secure process for incorporation of technologies by the SUS;
- incorporating technologies in reliance on reasoned criteria and efficacy, effectiveness and efficiency standards vis-à-vis the healthcare needs; and
- incorporating technologies that are relevant for citizens and for the healthcare system alike, based on their cost-effectiveness.
The CONITEC is tasked – after due process, which comprises the opening of a public consultation with regard to an application for incorporation – with recommending the incorporation of medications, products and procedures by the SUS as well as the creation or change of a PCDT to the MOH's Science, Technology and Strategic Inputs Office (SCTIE) for a decision, which must in turn be published in the Official Gazette of the Federal Executive.
The SUS does not provide any clinical and surgical products, procedures or medications that are at experimental stage or else lack in authorization from or registration with the National Public Health Agency (ANVISA).
Under the regulation, the incorporation process of medications, products and procedures by the SUS must be completed within 180 days (extendable for a further 90 days) from filing of the corresponding application. The PCDT may be prepared concurrently with assessment of the proposed technology incorporation by the CONITEC, or later on (via separate application).
Considering the operational procedures for availability of healthcare products and medications by the SUS, the regulation grants to MOH a 180-days period from publication of the green-light to incorporation of medications and products (or from the PCDT) to make such approved technologies available at the SUS.
These operational procedures include, among others, the process for product acquisition by healthcare authorities for availability at the SUS.
In Brazil, acquisition by the public administration must generally be preceded by a public bidding process intended to ensure the best conditions for the public administration while also allowing interested parties to submit their bids on equal conditions.
Specific formalities apply to the bidding process within the periods prescribed by laws to that end, to wit: preparing and opening and bidding notice (edital); calling interested parties to tender; receiving bids; and selecting and awarding the winning bidder; and signing the corresponding agreement.
If the intended item cannot be replaced with another of the same type, at the same quantity or of the same quality (for instance, in case of patented drugs or new biologic drugs), the bidding process may then be waived. Nonetheless, the public administration must follow its internal procedures, before execution of the contract, to ensure that the contracting has satisfied legal and regulatory requirements.
This procurement process, coupled with matters of logistics and availability of medications at public drugstores, basic healthcare units or high-cost drug pharmacies, must be carried through so that the corresponding medication may be available no later than 180 days from publication of the green-light to incorporation of healthcare technologies, or from the PCDT, thus enabling the State to ensure comprehensive therapeutic care to citizens.
- Article 196
- Law 8,080 of 1990