Innovation & Marketing

Brazil's Best Counsel 2020 - Chapter Opening: Life Sciences

Partners Carlos Eduardo Eliziário, Gustavo de Freitas Morais and Rodrigo Augusto Oliveira Rocci co-authored the chapter opening for Life Sciences

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Life Sciences

 

 

The life sciences sector is profoun­dly affected by the high-speed trans­formations arising from technologi­cal development, so that regulatory authorities, companies and consul­tants must be prepared to deal with the upcoming challenges.

 

While the cycle for the develop­ment of new drugs may be hugely impacted by the large-scale use of algorithms which can review data collected from clinical trials, patient records and genetic profiles, the rise of breakthrough technologies such as gene therapy will likely disrupt the life sciences sector by offering customized treatments for patients.

 

Brazil’s National Agency of Health Surveillance (“ANVISA”) and the National Biosecurity Technical Commission (“CTNBio”) have already taken the first steps towar­ds the creation of a legal framework for advanced therapies, which en­compasses cellular therapy and genome editing, among others. In 2019, ANVISA issued regulations on the best practice for the use of human cells and clinical trials in­volving advanced therapies, and a public call for comments on a pro­posal for regulating the registra­tion of advanced therapy products is expected soon.

 

Under this new data-driven eco­nomy, the massive collection of pa­tient personal data will give rise to new concerns that must be well ana­lyzed and addressed by all players of the life sciences sector in Brazil, especially considering that we have a brand-new General Data Protec­tion Law (LGPD). Said law, among other things, created a set of stricter rules specifically for the collection and processing of personal data re­lated to healthcare.

 

Measures seeking to encourage cli­nical trials in the country, by redu­cing the barriers for ethical and re­gulatory approval and speeding up marketing authoriza­tion for new products, shall be considered a priority by regulators. In this regard, parti­cularly in the case of orphan drugs, ANVI­SA has recently appro­ved a new rule establishing special procedures for rare disease drugs (up to 65/100,000 individuals) and ultra-rare disease drugs (up to 1/50,000 individuals) regarding the approval of clinical trials, issuance of Good Manufacture Practice Cer­tificates and the granting of marke­ting authorizations.

 

Healthcare providers must also create mechanisms to incorpo­rate new therapies into the list of treatments and medical proce­dures provided by Brazil’s Univer­sal Healthcare System (“SUS”) and by the Private Healthcare System soon after these treatments receive proper regulatory authorizations in order to avoid the increase of the so-called judicialization of health in Brazil. For the incorporation re­view, it is highly recommended to provide the National Committee for the Incorporation of Health Technologies (“CONITEC”) with real-world pieces of evidence, in addition to clinical data, to prove the cost-effectiveness of new pro­ducts and treatments.

 

Even though the Brazilian Supreme Court has yet to issue a guiding de­cision on whether the Government should cover high-cost drugs for patients, it has already es­tablished that the Government should not pay for drugs not registered with ANVISA, except in the case of drugs for rare and ul­tra-rare diseases, provided that they are approved by renowned foreign regulatory authorities and there is no therapeutic equivalent appro­ved in Brazil. Those decisions are expected to put massive pressure on the federal budget, leading the Ministry of Health to seek for new purchase agreement models, such as value-based and risk-sharing agree­ments. A pilot project for the regu­lation of risk-sharing agreements involving a drug for rare diseases already incorporated into SUS has been recently published by the Mi­nistry of Health and will be imple­mented during 2019.

 

 

ABOUT THE AUTHORS

 

Carlos Eduardo Eliziário: Partner at Dannemann Siemsen, Carlos works as a transactional lawyer focusing on agreements involving the licensing of rights, technology transfer, franchises, retail networks, R&D agreements, corporate law, tax and intellectual property in general. Additional strength in issues related to digital law and data privacy.

 

E-mail: carlos.eduardo@dannemann.com.br  Phone: +55 11 2155-9506

 

Gustavo de Freitas Morais: Partner at Dannemann Siemsen. Extensive experience in litigation, intellectual property negotiations, industrial designs, technology transfer agreements, access to genetic resources as well as regulatory and life sciences matters. Expertly represents clients from such industries as the pharmaceutical, pesticide, biotechnology and chemical sectors.

 

E-mail: gustavo@dannemann.com.br  Phone: +55 11 2155-9527

 

Rodrigo Augusto Oliveira Rocci: Partner Rodrigo graduated from Mackenzie Presbyterian University School of Law and joined the firm in 2008 coming from an in-house experience at Sanofi. He has extensive experience representing leading companies from the pharmaceutical, food and healthcare industries in issues involving life sciences as well as intellectual property litigation and consultancy.

 

E-mail: rrocci@dannemann.com.br  Phone: +55 11 2155 9580

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