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Ana Cândida Sammarco

Mattos Filho Advogados, São Paulo

ana.sammarco@mattosfilho.com.br

 

Nathalia Cassone Buozo

Mattos Filho Advogados, São Paulo

nathalia.buozo@mattosfilho.com.br

 

Caroline Alves Pires de Aguiar

Mattos Filho Advogados, São Paulo

caroline.aguiar@mattosfilho.com.br

 

The word‘uncertainty’ has been frequently used to sum up the general feeling during the first half of 2020. At the beginning of the year, it was hard to imagine that humanity would be living through a pandemic in the current moment. However, in the blink of an eye, countries had to act around the clock to contain the spread of Covid-19 with no explanatory handbook.

On 30 January 2020, the World Health Organization (WHO) declared the novel coronavirus outbreak as a public health emergency of international concern. A few days later, the Brazilian Ministry of Health enacted Ordinance No. 188/2020,[1] which stated that Covid-19 was a public health emergency of national concern. On 7 February, 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 Covid-19 infection was confirmed.[3] On 11 March 2020 the novel coronavirus was declared a pandemic by the WHO.[4]

Many countries, including Brazil, started to increase their protective measures, resulting in  social and economic transformation. This triggered the implementation of new norms and amendment of old ones to provide some level of certainty or safety. This article summarises the regulatory highlights related to digital health in Brazil that were driven by the pandemic scenario of social isolation and quarantine, 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

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

Until the Covid-19 outbreak, the provision of medical services through telemedicine was regulated by the Federal Council of Medicine (CFM),[5] which limited its use to medical assistance in 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 temporarily allowed the use of telemedicine in a wider range of situations.[6]

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 must 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 can be argued that the timeframe should be related to the public health emergency. On the other hand, Covid-19 has sparked an internal crisis which extends 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. 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 insurance, since such services are encompassed by the modality of medical consultation.[9]

Medical prescriptions and medical certificates in digital form

Physicians may also remotely issue medical prescriptions and medical certificates by means of a digital signature recognised by the Brazilian national digital certification system (ICP).[10] CFM, the Federal Council of Pharmacy (CFF) and the National Institute of Information Technology has developed a digital platform called the Electronic Prescription Platform to assure the security of the information and the interoperability between physician, patient and pharmacist.

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

ANVISA also confirmed that the dispensing of medicines subject to special control by pharmacies through electronic medical prescriptions with ICP is possible, provided that:

• such medicines are classified as antimicrobial medicines (for example, not comprising thalidomide and retinoids for systemic use); and
• the pharmacist conducts an authenticity and validity assessment of the electronic medical prescription before dispensing the medicines.[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 measure enables 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 subject to special control by pharmacies on a temporary basis.[15] The online sale of medicines was already allowed in Brazil, but only for over-the-counter medicines.[16]

It is not a simple online sale. It is important to highlight that the pharmacy must collect the medical prescription and, after the assessment of the document by the pharmacist, the medicine subject to special control must be delivered to the patient’s home.

Final considerations

Before the Covid-19 outbreak, the use of technology as a tool to provide healthcare services was more restricted, given concerns over jeopardising the physician–patient relationship and encouraging the indiscriminate use of medicines.

However, the pandemic brought uncertainty, the need to act fast and to 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 accomplish these goals.

Although he regulations highlighted above have been established on a temporary basis, their effect on the healthcare industry is significant. They are a great step forward for the Brazilian healthcare sector. They provide an opportunity for governmental authorities, players from the industry and society in general to learn what works in practice and what should be improved.

If or when these regulations are transformed into permanent legislation, the drafting can be informed by the practical experiences of the Covid-19 crisis.