TozziniFreire Advogados updates

Creating healthcare solutions with blockchain technology
TozziniFreire Advogados
  • Healthcare & Life Sciences
  • Brazil
  • November 08 2017

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.

Telemedicine and its effects on healthcare
TozziniFreire Advogados
  • Healthcare & Life Sciences
  • Brazil
  • September 06 2017

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.

Tax aspects of healthcare products
TozziniFreire Advogados
  • Healthcare & Life Sciences
  • Brazil
  • July 26 2017

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.

HIV self-testing kit now available
TozziniFreire Advogados
  • Healthcare & Life Sciences
  • Brazil
  • June 28 2017

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.

Health insurers now face less bureaucracy when negotiating their assets
TozziniFreire Advogados
  • Healthcare & Life Sciences
  • Brazil
  • May 24 2017

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.

Ministry of Health releases 52 priority products for technology transfer
TozziniFreire Advogados
  • Healthcare & Life Sciences
  • Brazil
  • March 15 2017

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.

Cannabidiol and tetrahydrocannabinol authorised for medical use in Brazil
TozziniFreire Advogados
  • Healthcare & Life Sciences
  • Brazil
  • February 01 2017

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.

Public healthcare system in spotlight
TozziniFreire Advogados
  • Healthcare & Life Sciences
  • Brazil
  • November 02 2016

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.

ANVISA publishes new rules for transferring marketing authorisations
TozziniFreire Advogados
  • Healthcare & Life Sciences
  • Brazil
  • September 28 2016

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.

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