Even though Brazil is a civil law country, the New Civil Procedure Code of 2015 has brought elements of common law jurisdictions to the Brazilian courts. Certain precedents rendered by the Supreme Court and the Superior Court of Justice – the country's highest courts for constitutional and federal law issues, respectively – are now binding on the lower courts.
The importance of clinical research for developing new treatments and discovering cures for diseases is indisputable. However, the degree to which patients benefit from participating in clinical trials and whether they should have post-trial access to experimental treatments are highly disputed, especially in Brazil, where free universal healthcare is a constitutional right. The House of Representatives is discussing clinical research and post-trial access as part of a new legislative bill.
One of the most influential moves in the healthcare sector is the recent development of point-of-care solutions. The main goal is to allow patients to get on-demand healthcare outside the hospital, mainly through medical devices and apps. Such technologies are likely to have a significant positive effect in the Brazilian public health system by making diagnostic testing accessible in areas where healthcare is hard to access.
The continuity of traditional healthcare models seems unlikely with the breakthrough of disruptive technologies. Historically, the healthcare sector has been slow to implement technological tools that have quickly transformed other areas of people's daily lives. However, a promising solution to address the interoperability, integrity and security challenges presented in the healthcare sector seems to be blockchain technology.
Advances in technology and the so-called 'fourth industrial revolution' continue to have an effect on society. For instance, telemedicine has rapidly developed and transformed the services provided by healthcare providers worldwide. Due to the expansion of telemedicine in Brazil, the Federal Council of Medicine intends to review and update Resolution 1643, which will hopefully attract new players to the market.
Brazil's complex and inefficient tax system is known worldwide. In addition to a heavy tax burden, the tax compliance costs that companies must bear in order to do business in the country are particularly high. This is also the case for the healthcare sector. However, there are specific cases of tax exemption, 0% tax rates and other exceptions which aim to reduce the final price of pharmaceutical products, devices and equipment. Several of these rules add to the complexity of Brazil's puzzling tax system.
Brazilian citizens will soon be able to test themselves for the HIV virus in their blood. The National Health Surveillance Agency recently approved the registration of the first HIV self-testing kit in the country, following the issuance of Resolution 52/2015. Brazil has joined other countries which have already approved the registration of an HIV self-testing kit to help to fight against undiagnosed people living with HIV.
The National Supplementary Health Agency recently issued a new normative instruction regulating the free flow of securities and allowing health insurers to request an annual prior authorisation in order to negotiate and use their assets as financial guarantees to obtain additional revenue. This measure is vital for the health insurance sector, as the use of financial guarantees for assets may play an important role in companies' fight against the existing political and economic situation in Brazil.
The Ministry of Health recently released a list of 52 strategic products for the National Unified Health System which are currently imported and which it believes should be manufactured by the national pharmaceutical industry. The Ministry of Health is seeking to encourage the transfer of the manufacturing of these products to Brazilian public and private pharmaceutical companies in order to reduce purchase costs, create more jobs and boost investments in the national pharmaceutical industry.
The Health Surveillance Agency (ANVISA) recently approved changes to its rules for using substances subject to special control in order to provide easier access to drugs containing cannabidiol and the first access to drugs containing tetrahydrocannabinol in Brazil. These two active principals derive from cannabis sativa and, until recently, their use was forbidden by ANVISA due to a lack of evidence of their positive effect in treating diseases.
The Supreme Court will soon decide whether the government will subsidise high-cost drugs, including where the Health Surveillance Agency has not approved their use. This issue is sensitive and has attracted widespread attention from stakeholders in the Brazilian healthcare system. Although the ruling is expected to bring an intermediary solution that has a smaller effect on public resources than the existing system, it may also abridge the rights of citizens.
The Health Surveillance Agency recently issued new rules regarding the transfer of marketing authorisations for certain products. Among other things, the rules enable the transfer of marketing authorisations and good practice certificates in transactions involving the sale and purchase of assets, without requiring the companies involved to complete a corporate transaction.