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Life Sciences in Brazil

Contributors:

Henderson Furst

Guilherme Gieron Fonseca e Silva

Daniel Kenzo Sato Mir

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It is an honor to, once again, present Chambers readers, with news of the Life Sciences sector in Brazil. From April 2021 to now, a lot has happened, and starting where we left off in 2021, COVID-19 has represented suffering for all humanity, while a lot has been tested and learned. The health sector has been able to design new strategies and public policies, quickly understanding what works and what does not, improving health practices and standards in general.

Due to Covid 19, the Life Sciences Sector - produced health products and developed health care practices - remained on the stage of the mainstream press, involving all government agencies in the country. The Legislative, Executive, and even the Judiciary worked actively to meet the demands - many of which already existed - that this new reality brought into light.

Anvisa's regulatory review

Despite the extraordinary regulatory requirements imposed by the pandemic, Anvisa concluded, in March 2022, the review and consolidation of normative acts as determined by Decree nº 10,139/2019. The review aimed to eliminate ambiguities, repetitions, and obsolescence: it was carried out in five (5) stages, which led to the evaluation of more than 1200 normative acts.

Decree No. 10,139/2019 also provided a last step, aimed at identifying and consolidating normative acts that require in-depth review that may imply changes in merit: this is undoubtedly the most challenging phase of the regulatory review project, whose deadline is scheduled for August 2022.

In April 2022, during the congress “The Future of State Regulation”, organized by the Brazil-Europe Integration Forum in Lisbon, one of the Directors of ANVISA presented what the agency considers the “future of health regulation”: the accelerated development health technologies impose the existence of a global administrative law aimed at the development of regulatory instruments that effectively deal with the complexity of the phenomena experienced by the community of nations.

The agency recognizes, externally, the evolution of the global regulatory landscape, and celebrates regulatory convergence among agencies around the world as never before.

Obviously, Anvisa's active participation as a member of the Management Committee of the International Council for Harmonization of Technical Requirements for Pharmaceutical Products for Human Use (ICH), for which it was re-elected in mid 2021, makes this mission a tangible reality.

Internally, Anvisa's attention is focused on the standardization and harmonization of health surveillance practices in the federative system: according to Law 8080/1990, health surveillance is a concurrent competence of the Federal Government and the States and Municipalities. The (hopefully) claim to standardize the activities and practices of all government agencies involved in health surveillance actions, in a country whose territory has continental proportions, is an immense challenge, but celebrated by the Regulated Sector, which suffers the impact of non-uniformity practices, depending on where its activities are located.

Telemedicine and Telehealth

As mentioned in our previous article, telemedicine has become a point of attention for the community involved with health technologies. During the pandemic, telemedicine was an exponent for ensuring patient access in an agile and effective way.

In Brazil, Law 13.989/2020 authorized the use of telemedicine only while the Public Health Emergency of National Importance (ESPIN) caused by Covid19 lasts. With the end of ESPIN, declared by the Ministry of Health in April 2022, telemedicine would return to the previous narrow regulatory level, given by the Federal Council of Medicine (CFM), and if nothing was done, the practice would no longer have normative support.

The Chamber of Deputies, then, hastened to re-regulate the issue and approved Bill 1998/2022, which expands the concept for the practice of telehealth and establishes the parameters of remote care for all forms of provision of healthcare services.

The aforementioned bill is now awaiting approval at the Senate and is expected to be approved by the end of this year.

The CFM also updated, according to its competence, its regulations on the subject, as provided in Resolution 2,314/2022, which specifically defined and regulated telemedicine, and the acts and procedures performed by doctors or under their responsibility.

The regulatory movement, either by the Brazilian parliament or by the CFM, is a relief for companies that have developed and dedicated themselves to providing telemedicine services during the pandemic: with the next law and the newly edited regulation, these providers will be able to develop quickly and vigorously, with legal certainty.

Cannabis

Medical cannabis has gained prominence in recent years. However, the normative basis that regulates the matter in Brazil is completely anachronistic, as it dates back to the period in which cannabis use was repressed by criminal norms aimed at combating the trade and consumption of psychotropic drugs. Much prejudice surrounds the issue, despite the fact that the Anti-Drug Law itself authorizes the Federal Government to regulate planting and manufacturing for medicinal and scientific purposes.

But science imposed itself, and due to the popular movement of those who need products based of cannabis for health treatment, the matter is evolving considerably, although still at a very slow pace.

In consecutive decisions, the Judiciary recognized the State's failure to regulate the issue and started to authorize, on a case-by-case basis, the domestic cultivation of cannabis for extracting cannabidiol oil (CBD), first by patients or family members and then by patient associations.

Recognizing its important role in the regulation and inspection of the subject, Anvisa started to authorize the emergency importation of cannabis-based medicines by patients and, more recently, granted the registration, manufacture, and dispensation, upon medical prescription, of cannabis-based medicines in Brazilian territory. Until the writing of this article, sixteen (16) drugs were registered by Anvisa for manufacture and sale in Brazil.

The production of the IFA is not yet authorized, but the National Congress is working, on an urgency basis, on a bill to fully regulate the matter. It is expected that with the enactment of the law, the medical cannabis and hemp market will gain importance for its range of medicinal and industrial applications.

Trends and developments - Topics to follow

(i) Clinical trials

A bill that regulates scientific research with human beings in Brazil is being analyzed at the National Congress. Regulations on scientific research with human beings have existed since 1996, when the National Health Council (CNS) created the National Council for Ethics in Research (CONEP), which established guidelines and made the approval of research protocols by Research Ethics Committees mandatory to carry out or to participate in research with living beings.

Obviously, the topic caused repercussions during the pandemic, and since then, a Bill of Law has been in analysis on an urgent basis in order to establish, in the legal system, the structure of ethics in research. One of the points of attention for the Life Sciences Sector, for which clinical research is a very relevant topic, concerns the regulation of the protection of sensitive data of research subjects, especially regarding international exchanges of data in multicentric research, the possibility of remote monitoring and conducting remote research (virtual clinical trials).

(ii) Advanced and Gene Therapies

In the beginning of 2020, Anvisa approved the regulation that established the minimum requirements for product registration of advanced and gene therapies. Advanced and gene therapies are a special categories of innovative drugs developed from biotechnology, which, respectively (a) use human cells and genes with the objective of meeting therapeutic and quality of life demands related to rare diseases and those diseases without therapeutic alternatives (advanced therapies); or that (b) use recombinant nucleic acid, which may have the objective of regulating, repairing, replacing, adding or deleting a genetic sequence and/or modifying the expression of a human gene, with a therapeutic, preventive or diagnostic result (gene therapy).

The first advanced therapy product was approved in 2020. In 2022, two (2) new products were approved: one with CAR-T cells for the treatment of hematological cancer and is part of a new generation of personalized immunotherapies against cancer, based on the collection and genetic modification of the patients' own immune cells. The other approved product is for the treatment of multiple myeloma, based on T cells modified to express chimeric antigen receptors. The approval of the products by Anvisa took a similar time as that spent by the Food and Drug Administration - FDA and the Committee for Medicinal Products for Human Use - CHMP of the European Medicines Agency - EMA.

With a robust regulatory framework and a qualified technical staff, Anvisa is prepared to approve new therapies that represent a new course in medicine for the treatment of increasingly complex diseases and therapies.

The Future of Health: Robotic Medicine, Artificial Intelligence and Metaverse

In March 2022, the Brazilian Federal Council of Medicine regulated a new medical procedure using robotic platforms. The robot-assisted surgery is a minimally invasive surgical procedure, for the treatment of diseases, which has its efficacy and safety proven. Due to the telemedicine regulation, a significant increase in this type of procedure is expected.

A bill to regulate Artificial Intelligence (AI) in Brazil is being discussed at the National Congress, which aims to establish a regulatory framework and enable advances in the use of AI tools in various sectors, including life sciences. The use of AI in the life science field is intriguing and challenging, as there are concerns about the legal and ethical limits related to the use of these tools to replace health professionals, including for diagnoses. The challenge lies in fostering innovation and at the same time preserving human autonomy and security, promoting human well-being, as well as ensuring transparency and accountability criteria for all the players and agents. The material already existing in the European Union and published by the World Health Organization should contribute as a source of inspiration for the design of the AI regulatory framework in Brazil.

If AI matters were not challenging enough, it seems that the next trend to be discussed will be health in the metaverse. After COVID, augmented reality (AR) or virtual reality (VR) found a new (critical) systematic application in health and in the practice of medicine. Health care professionals using augmented reality to operate on patients (e.g., holograms to visualize people and equipment) and using virtual reality to create spaces for patient treatment and to put in place various types of therapies, raise hard questions for legislators, governmental authorities and for the private sector: “What jurisdiction and applicable laws shall apply?” “Are there conflicts of rules?” “What are the parties liabilities?” and “What privacy regulation should be followed?”. Undoubtedly, many very complex legal issues will demand our attention in the coming years.

Editor’s note: Kestener & Vieira Sociedade de Advogados is a high-end boutique featuring in Band 1 in Chambers’ Life Sciences ranking. Leading partner Beatriz Kestener, who has been ranked in Band 1 since 2011, is a major force in the market and a key figure advising on matters before Brazil’s regulators and sanitary authorities. She co-authors the overview above with partners Henderson Furst, Guilherme Gieron Fonseca e Silva and Daniel Kenzo Sato Mir.