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: email@example.com 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: firstname.lastname@example.org 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: email@example.com Phone: +55 11 2155 9580