During the World Economic Forum 2023 in Davos, specialists discussing the topic of health unanimously indicated that “the past three years of the Covid-19 pandemic have exposed vulnerabilities in healthcare systems around the world and highlighted the dangers of inequalities in care – not only creating global health risks, but also causing knock-on effects on geopolitical tensions and economic risks.” They continued by stating that “from the security impacts of mass migration to the closure of societies that affect people's ability to work, and the health consequences of climate-related disasters, recent years have demonstrated that health is linked to the stability and prosperity of countries”. These same experts also defend the “4th Industrial Revolution Technology” as the ideal way to boost sustainability goals in the industry, in addition to cooperation and data exchange across borders.
In the spirit of optimism, below is what we have been seeing in Brazil.
“I can safely say that the health sector in the country has positioned itself beyond the minimum standards of compliance, incorporating safe technological means into its day-to-day life, whether from a purely institutional perspective, or from a market point of view, as a way of remaining competitive, resisting disproportionate disruption – seen, for example, in China –, and moreover, gaining the sympathy of foreign capital” – said Bruna.
This new market framework is called by experts in the field “Life Science 4.0.”, which considers a revolutionary process of changes in the paradigms that guide health from the increasing insertion of digital media, data and technologies in the care of patients’, consumers’ and business partners’ related processes.
Such nuances indicate that companies operating in this field through disruptive business models shall therefore explore the opportunities that technology offers behind their products and services with great caution. This is, in fact, a major pole of legal concern, especially in this new era of computerization and monetization of data.
In summary, 2022 was a year marked by a series of changes to the health industry, in response to the constant and increasingly expressive popular demand for products and services in line with the new technologies available on the market. This can be seen, for example, in the new regulatory framework for software as medical devices and the respective regulation rules; the use of data-driven tools in clinical research and quantum computing processes; the exponential growth of femtechs and solutions in the digital therapeutics field; the creation of digital package leaflet for medicines; the new rules for framing, labelling, microbiology and regularization procedures for cosmetics, personal care products and perfumes; the new regulatory frameworks for the labelling of drugs and warning phrases for substances, therapeutic classes and control lists on inserts and packages; the new public consultation on the modernization of the regulatory framework for food and packaging, and the long-awaited approval of the bill that finally regulates telehealth in Brazil.
It is apparent that, more than ever, the Brazilian National Health Surveillance Agency (in Portuguese, “Agência Nacional de Vigilância Sanitária” or simply “Anvisa”) is committed to the implementation of regulatory harmonization and convergence measures, recognized as the international technical alignment movement that takes into account the best practices of the industry and internationally legitimized principles and standards in the regulatory processes, as well as the application or adaptation of technically justified local regulatory requirements.
In this regard, emphasis shall be placed on encouraging the strategy of regulatory trust ("regulatory reliance"), commonly identified as taking benefit from equivalent assessments already carried out by trusted regulators, foreign regulatory authorities or international entities that have regulatory practices aligned with those of Anvisa (the so-called "Equivalent Foreign Regulatory Authorities", or simply "AREEs" in Portuguese). This practice has been defended by the agency as a mechanism able to provide (i) agility to the evaluation of requests for registration and/or regularization of health products and services, especially with regard to their quality, safety and efficacy standards, as well as (ii) access in the event of a public health emergency.
Furthermore, the recent election of Luiz Inácio Lula da Silva (Lula) to the presidency of Brazil for the years 2023 to 2026 brought news for the management of the Brazilian National Ministry of Health, now assumed by Nísia Trindade – the first woman to head the Ministry.
In her inauguration speech, in summary, the minister (i) defended science and the dialogue with the scientific community, (ii) stated that measures that “offend science, human rights, sexual and reproductive rights and that transformed several positions of the ministry of health into a conservative and denialist agenda” will be revoked, (iii) highlighted the importance of strengthening local production and the Health Economic-Industrial Complex (HEIC), especially in order to encourage the country's autonomy in the production of pharmaceuticals and immunizations, as well as increasing child and adult vaccination coverage, (iv) ensured the restructuring of the National Committee for Health Technology Incorporation (in Portuguese, “Conitec”), (v) and also created a new Secretariat for Information and Digital Health, which shall focus on implementing the Digital Health Strategy for Brazil 2020-2028 (in Portuguese, “ESD28”), as well as the initiatives that make up the “Conecte SUS Program”, such as the National Healthcare Data Network (in Portuguese, “RNDS”) and “Informatiza APS”.
In fact, some measures have already been taken by the Ministry of Health recently assumed by Nísia Trindade: this last Monday (16), six ordinances and technical notes were revoked – among them, a rule that made it difficult to have a legal abortion (in the case of rape), and a technical note authorizing the prescription of chloroquine and hydroxychloroquine in the treatment of Covid-19.
When considering the recent sanction of Law n. 14,510/22, which finally regulates telehealth definitively in the country, the expectation is that other subjects related to Digital Health will be even more debated and encouraged, as is the case of digital prescriptions and remote diagnostic tests (Point-of-Care Testings – PoCTs), as well as remote requests for medication dispensing.
It is undeniable that we live in times of profound transformation in the global and national health sector, with the emergence of increasingly advanced technologies capable of revolutionizing the market, as well as the access to high-class products, services, and therapies.
This is also expected in relation to the long-awaited revision of norms related to the cultivation, import, commercialization, prescription, dispensation and therapeutic use of Cannabis and its derivative products for medicinal purposes, whose industry already configures an economic and social success around the world – the estimate is that the segment will reach a global gain of US$ 105 billion by 2026, according to research carried out by Prohibition Partners, with the Latin American region responsible for US$ 824 million of the US$ 55.3 billion estimated for the world market of cannabis in the year 2024 .
In the transactional field, 2022 was a relatively quiet year for the healthcare industry. In any case, a series of natural factors, added to the maturity of the regulatory system in the country, signal a return to normality levels in 2023. This resumption, in large part – and as already expected, due to what was exposed above – will be driven by the advance in the reliability of the “digital”, implying the greater use of data-oriented tools to better offer personalized solutions to the recipients of goods or services. In addition, the investigation of cell and genetic therapies, which move the entire life cycle of this industry, also make up the investment niche of biopharmas and biotechs that already make use of AI, big data, machine learning, quantum computing, automation, IoMT etc., and present themselves as a sure lever of their respective solution portfolios.
Innovation, then, is really the big next thing in the world.
Lastly – but not least –, as well spoken during the preparation of the World Economic Forum 2023 in Davos, the health of the planet depends on human health, so the life cycle of a considerable part of the flow of investments seen around the world, sooner or later, will bump into the health sector – and Brazil, more than ever, is on the right track to take advantage of that.
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This article describes the current thinking at Campos Mello Advogados on these topics and should not be viewed as a legal opinion.