Last Thursday (2 June, 2022), Marcelo Queiroga – president of the Brazilian Society of Cardiology and current Minister of Health – approved the Ordinance aimed at regulating telehealth in the country.

Telehealth comprises all types of digital medical care, including primary care appointments, digital therapeutics, diagnosis, e-health patient monitoring, health wireless applications, transmission of image medical reports, medical care education, and many more.

The Ordinance is in force nationwide and sets the health regulatory rules for the rendering of healthcare services through the interrelated fields of telecommunication technologies, such as mobile health, digital health, health IT, etc.

By nature of the shifting virtual interaction surrounding the subject matter, the Telehealth Ordinance’s main goal is to set a standard that is as high as a physical face-to-face for this new healthcare delivery model. Moreover, it is also much in line with the recent Resolution No. 2.314/2022, issued by the Brazilian Federal Council of Medicine (in Portuguese, “Conselho Federal de Medicina” or simply “CFM”),  which regulates telemedicine. Likewise, key take-outs relates to (i) the health professional freedom and independence regarding the decision on whether or not to use telehealth – including the first medical appointment or an medical intervention; (ii) the ICF of the patient or his/her legal representative; and (iii) no need of further HCP’s enrollments before other jurisdictions’ councils when the HCP provides only telehealth outside the territory in which they are listed.

Although there is no definitive number that encapsulates what the digital therapeutics market is worth right now, its value can be estimated from a variety of sources.

The practice of telehealth has several pilot projects throughout Brazil. The Brazilian Ministry of Health has already invested more than R$ 126 million in 50 projects around 22 Brazilian states. Recently published research demonstrated that the telehealth project initiative expanded access to quality patient care, especially to regions and underserved populations that need it the most. For example, in the northern region of Brazil, more than 120 ambulatories dedicated to telehealth have already been put into operation, all in connection with Basic Health Units (“UBS”), Local Units and Indigenous Health Homes in several municipalities.

In view of the end of the ESPIN in April 2022, in addition to the recent regulation issued by the CFM two weeks ago and now the Anvisa’s Telehealth Ordinance, the expectation of an imminent development in the law on the subject matter hereof becomes undisputable in the country (i.e., although still pending approval in the Senate – Bill n° 1988/2020).

In the last eighteen months, significant steps have been taken to define clearer criteria for the still early-stage idea of Digital Health in the country – and most of those are already strongly accepted by most of the market players. All of them have the primary objective of facilitating (i) the continuity and development of the entire supply chain of products and services associated with digital therapeutics, as well as (ii) the ability to enter and expand upon the domestic market. And this arises from the fact that the new regulations bring clarity, legitimacy and safety to the practice of telehealth and telemedicine in Brazil, providing a market with countless and valuable opportunities for domestic and foreign investment. Plus, the Telehealth is a welcome solution to the large Brazilian population, as this is also going to increase quality and effectiveness of the healthcare system.

“The side effect of this ‘under construction’ regulatory environment is in a way the raw material for the advancement of the industry. This will force the operator (which includes biotech, pharmaceutical and medical device companies to healthcare providers) to carefully assess their capabilities and the best moment in time and model to enter into these previously unexplored business scenarios. To illustrate, I refer to one of the questions that usually resonates abroad nowadays – ‘Monetization and commercialization: Do we partner up, acquire or license?’. There is a clear net benefit, but also a few downsides. So, in Brazil, what will be the answer?”

This growth inevitably drives healthcare consumerism, so the pursuit of disruptive and revenue-generating opportunities should be – and, for some, has already been – a point of great attention.

CMA info

This article describes the current thinking at Campos Mello Advogados on these topics and should not be viewed as a legal opinion.

Campos Mello Advogados is a Brazilian law firm which has worked in cooperation with DLA Piper LLP across the globe since 2010.