New resolution


Despite having a full-coverage public healthcare system, Brazil is the third largest market for private healthcare insurance in the world, with approximately 42.5 million registered individuals. The poor quality of the public service, the long waits that patients endure and the limitations on drugs offered by the government all serve to fuel the private market.

Private healthcare insurance providers are regulated by the government through the National Agency of Supplemental Health (ANS) and must comply, among other things, with the minimum standards set forth by the legislation.

Although the public healthcare system provides patients with several drugs made in Brazil for free, both within and outside hospitals, until recently private healthcare insurance providers were limited to providing drugs needed during hospitalisation, and only where the insurance covered such care (Article12(II)(b) of Federal Law 9,656/98). However, since January 2014 this situation has changed.

New resolution

On October 21 2013 the ANS enacted Normative Resolution 338, which established that as from January 2 2014, all private healthcare insurance must cover 37 oncological oral drugs for the home treatment of several types of cancer, including chronic myeloid leukaemia and breast, kidney, intestine, stomach, lung, ovarian, pancreatic and central nervous system cancers.(1)

According to the ANS, the main advantage of this mandatory coverage is that patients will be able to receive treatment at home, without needing to go to a clinic or hospital, thereby diminishing risks to health. The inclusion of drugs for the treatment of patients outside hospitals in the list of mandatory coverage is unprecedented. Furthermore, it is possible that new drugs will be added to this list (eg, those for the treatment of pulmonary chronic obstructive disease and hepatitis C), as the change to mandatory coverage was made by an internal ruling of the ANS and required no new law or significant change to the legislation.

The procedure for delivering these drugs to patients is defined by each private healthcare insurance provider. It is possible for the insurance provider to buy all medicines to be distributed directly to patients. Alternatively, the insurance provider can reimburse the patient for the costs of the drug or the patient can buy the medicine from pharmacies affiliated to the insurance provider by filling out a form. Further developments in this new market are expected in 2014.

The implementation of Normative Resolution 338 will have a further impact on the pharmaceutical industry. While physicians in the public healthcare system are forced to prescribe by international non-proprietary name only, the legislation on the ability to exchange drugs is followed by all in the private sector. This creates opportunities to recoup market share based on actual physicians' prescriptions. The procedure will also assist patients in finding substantial drugs in Brazil.

For further information on this topic please contact Otto B Licks, Laura Carvalho, Rodrigo Massafera or Ricardo Campello at Licks Advogados by telephone (+55 21 3550 3700), fax (+55 21 3550 3777) or email ([email protected], [email protected], [email protected] or [email protected]). The Licks Advogados website can be accessed at


(1) The list of the 37 drugs initially covered can be found at