Regulatory highlights: digital health in Brazil during Covid-19 outbreak

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Ana Cândida Sammarco

ana.sammarco@mattosfilho.com.br

Mattos Filho Advogados, São Paulo

Nathalia Cassone Buozo

nathalia.buozo@mattosfilho.com.br

Mattos Filho Advogados, São Paulo

Caroline Alves Pires de Aguiar

caroline.aguiar@mattosfilho.com.br

Mattos Filho Advogados, São Paulo

Introduction

Uncertainty is a word that has recently been considerably used and is an ongoing feeling during this first semester of 2020. After all, it was hard to imagine that humanity would live a pandemic in the current moment. In the blink of an eye, countries had to act around the clock to contain the spread of Covid-19. And they did not have a handbook explaining how.

On 30 January 2020 the World Health Organization (WHO) declared the new coronavirus outbreak as a public health emergency of international concern. A few days after, the Brazilian Ministry of Health enacted Ordinance No. 188/2020,[1] which states that Covid-19 is also a public health emergency of national concern. On 7 February 2020, Federal Law No. 13,979/2020[2] was enacted by the Brazilian President to establish measures for the combat of Covid-19 in Brazil, such as quarantine and social isolation.

Almost 20 days after this declaration, the Brazilian Government issued a notice informing that the first case of infection by Covid-19 was confirmed.[3] On 11 March 2020 the new coronavirus was declared a pandemic by the WHO.[4]

Many countries, including Brazil, started to straighten their protective measures. A social and economic transformation normally triggers the necessity of implementation of new norms or amendment of old ones, even more when this transformation comes in the form of an emergency. The uncertainties behind this pandemic instigated the need for action to seek certainty or at least safety.

In this context, our article comprises a summary of the regulatory highlights related to digital health in Brazil, which were driven by this pandemic scenario, such as: telemedicine; medical prescriptions and medical certificates in digital form; and remote sale and home delivery of medicines subject to special control.

Regulatory highlights

In a scenario of social isolation and quarantine, the Ministry of Health together with authorities associated to the health sector in Brazil, such as the National Health Surveillance Agency (ANVISA), the National Supplementary Health Agency (ANS) and Professional Councils, established the following measures.

Telemedicine

Up to Covid-19 outbreak, the provision of medical services through telemedicine was regulated by the Federal Council of Medicine (CFM),[5] which authorised its use for medical assistance limited to situations of urgency or emergency.

To reduce the circulation of people exposed to Covid-19 and to decrease the number of face-to-face consultations in healthcare facilities, CFM has, on a temporary basis, allowed the use of telemedicine in broader situations apart from urgency or emergency cases.[6]

In this regard, CFM determines that a physician is required to inform the patient of all limitations on the use of telehealth, including the impossibility of performing a physical examination during the consultation. Furthermore, Ordinance No. 467/2020[7] from the Ministry of Health gives general guidance on the practice of telemedicine and indicates procedures which shall be adopted by healthcare professionals.

In addition to CFM’s regulation, the Brazilian Congress enacted Federal Law No. 13,989/2020, which authorises the use of telemedicine as long as the crisis originated by Covid-19 persists. It is noteworthy that the concept of ‘crisis originated by Covid-19’ is very broad. On one hand, it is possible to argue that the time frame would be the public health emergency of national concern. On the other hand, Covid-19 originated an internal crisis way beyond the health emergency.

The use of telemedicine was also authorised by ANVISA in connection with clinical trial procedures,[8] especially in relation to patient monitoring. Lastly, even though there was not a formal amendment to ANS regulation to expressly include telemedicine as a mandatory service, ANS clarified that telemedicine services are of mandatory coverage for private health insurances, since such services are encompassed by the modality of medical consultation.[9]

Medical prescriptions and medical certificates in digital form

In the context of telemedicine services, physicians might also remotely issue medical prescriptions and medical certificates by means of a digital signature, which shall be recognised by the Brazilian national digital certification system (ICP).[10] To assure the security of the information and the interoperability between physician, patient and pharmacist, CFM, the Federal Council of Pharmacy (CFF) and the National Institute of Information Technology developed a digital platform named as Electronic Prescription Platform.

Although ICP was established long before in 2001[11] and CFM has already confirmed the authenticity and validity of electronic documents signed by means of ICP,[12] only with the recent authorisation to use telemedicine on a broader context, the subject became a trending topic.

ANVISA also confirmed that the dispensing of medicines subject to special control by pharmacies through electronic medical prescriptions with ICP is possible, provided that: (i) such medicines are classified as antimicrobial medicines (ie, not comprising for example thalidomide and retinoids for systemic use); and (ii) before the dispensing of the medicines, the pharmacist conducts an authenticity and validity assessment of the electronic medical prescription.[13]

Lastly, ANS clarified that it is mandatory for health insurance plans to accept medical requests remotely issued by means of an electronic document.[14] This was a relevant measure to enable in practice the use and functional applicability of medical prescriptions and medical certificates in digital form.

Remote sale and home delivery of medicines

ANVISA authorised the remote sale and the home delivery of medicines on a temporary basis, subject to special control by pharmacies.[15] The online sale of medicines was already allowed in Brazil, but only for over-the-counter medicines.[16]

However, it is important to highlight that the pharmacy shall, as a first step, collect the medical prescription and, after the assessment of the document by the pharmacist, the medicine (subject to special control) might be delivered to the patient’s home. So, it is not a simple online sale. It includes a confirmation by the pharmacy before delivering the medicine.

Final considerations

Before Covid-19 outbreak, it is possible to say that the use of technology as a tool to provide healthcare services was more restricted, given the concern of jeopardising the physician–patient relationship, as well as the concern of encouraging the indiscriminate use of medicines.

However, the pandemic brought uncertainty and the need to act fast and search for new solutions. The key challenge was to find a way to provide healthcare services without compromising the protective measures enacted by the government. Digital health is being used as an important tool to simultaneously accomplish these goals.

The regulations analysed above indicate a great step forward in the Brazilian healthcare sector. Although they have been established on a temporary basis, it is possible to analyse their effect on the healthcare industry.

It is a great opportunity for governmental authorities, players from the industry and society in general to learn what works in practice and what should be improved. Thus, if and when these regulations are transformed into permanent legislation, they can be drafted and decided, taking into consideration the practical experience already witnessed during the Covid-19 period.