Brazil's Best Counsel 2021 - Chapter Opening: Life Sciences
The life sciences sector has been profoundly affected by the high-speed transformations arising from technological developments, as such, regulatory authorities, companies and industry consultants must be prepared to face the upcoming sectoral challenges.
While the cycle for developing of new drugs may be significantly 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 to patients. Brazil’s National Agency of Health Surveillance (ANVISA), with the contribution of the National Biosecurity Technical Commission (CTNBio), has created a legal framework for advanced therapies, which encompasses cellular therapy and genome editing, among others (Ordinance 338/2020).
Under this new data-driven economy, the massive collection of personal patient data will give rise to new concerns which must be carefully analyzed and addressed by all players of the life sciences sector in Brazil, especially in light of the recently enacted General Data Protection Law (LGPD). Said law, among other things, established a stricter set of 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 cases per 100,000 individuals) and ultra-rare disease drugs (up to 1 case per 50,000 individuals) regarding the approval of clinical trials, the 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. With regards to incorporation, 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.
Very recently, the Brazilian Supreme Court (STF) issued a guiding decision on whether the Federal Government should cover high-cost drugs for patients and established that the Government should not pay for drugs which are not registered before 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. This decision is expected to put a massive strain on the federal budget, leading the Ministry of Health to seek new purchase agreement models, such as value-based and risk-sharing agreements. In 2019, a pilot project for the regulation of risk-sharing agreements involving a drug for rare diseases already incorporated into SUS was published by the Ministry of Health. However, the Brazilian press recently reported that the Ministry of Health suspended the agreement, alleging that it would be inviable. Even though that conclusion has not yet been confirmed by the Ministry of Health, mainly because its focus is firmly set on fighting the Covid-19 pandemic, the early termination of the first risk-sharing agreement executed in the country could jeopardize future risk-sharing agreements for high-cost drugs.
ABOUT THE AUTHORS
Carlos Eduardo Eliziario is a partner at Dannemann Siemsen. Mr Eliziario 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. He is well known for his strength in issues related to digital law and data privacy.
Rodrigo Augusto Oliveira Rocci is a partner which holds a Bachelor of Laws from Universidade Presbiteriana Mackenzie and joined the firm in 2008 coming from an in-house experience at Sanofi. Mr. Rocci 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.
Caio Ribeiro Bueno Brandão is an associate who joined Dannemann Siemsen in 2007. With a Bachelor of Laws from Universidade Presbiteriana Mackenzie and currently studying towards a postgraduate degree in Intellectual Property at the same institution, Mr. Brandão is recognized for his knowledge of litigation and civil procedure matters having acted in several cases involving national and international companies in the pharmaceutical, food and health sectors.
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