Department for International Trade Guest Blog: An Introduction to the Brazilian HealthTech Market
With the recent signing of the ABHI and ABIMED MOU (ABIMED - Brazilian Association of Importers of Medical and Hospital Equipment, Products and Supplies) and, lamentably, the pandemic situation in Brazil hitting the UK headlines, perhaps now it is more important than ever to shine a different light on what is a dynamic market for UK HealthTech.
Brazil: An Overview
Although this may seem obvious, it is vital to point out from the offset that Brazil is massive in terms of landmass and population size. The Brazilian Report[i] claims that ‘all the countries in the European Union could fit inside Brazil’s borders twice over. Combined, Brazil’s 27 states are bigger than the contiguous United States.’ Accordingly, Brazil has the largest healthcare market in Latin America, valued at £181 billion in 2019, and forecast to be worth £212 billion by 2023[ii], supporting its 212 million population. The Brazilian private healthcare market is the world’s second largest by population size and much of the public health system relies on private providers.
Using 2019 as a more typical year, Brazil’s universal public health system, Sistema Único de Saúde (SUS), modelled after UK´s NHS, was responsible for 44%% of healthcare expenditure, with the private sector accounting for 56%[iii]. Of the population, 76% of Brazilians depend solely on SUS, while 24% have access to private insurance companies[iv] which is commonly provided by employers. Key private providers are health insurance companies, with the biggest players in the market being: UnitedHealth Group (Amil), NotreDame Intermédica, Unimed, SulAmérica and Bradesco Saúde.
Since the establishment of SUS in 1988, the country has witnessed significant improvements in the quality of life and health of its citizens, with the average life expectancy reaching 79.3 years for women and 72.1 for men[v]. As in many countries, an ageing population and increasing prevalence of non-communicable diseases (such as cancer, diabetes, cardiovascular and neuropsychiatric conditions) are presenting challenges to the sector and to the wider economy. These factors require significant investment in terms of healthcare services, of which ABHI members may provide. Such as the promotion of preventive actions; the strengthening of primary care; home care and imports of medical devices. In this sub-sector, orthopaedic items and implants, pacemakers and prosthesis, lead the field in imports in terms of volume. Whereas electrocardiogram, endoscopy and X-ray/MRI machines lead in terms of value, which are key areas for UK industry. Since 2012, the value of imported medical devices, materials and support equipment in Brazil has been much higher than that of exports. The Economic Bulletin of the Brazilian Alliance of Innovative Health Industry (ABIIS) also shows that Brazil imported a total of US$6.2bi in medical devices in 2020 (which was 12.9% higher than in 2019)[vi], although an exceptional year, it shows the continuation of the trend. The Brazilian Government and the private sector are also increasingly looking to new and upcoming technologies, such as genomics and advanced therapies.
The acquisition of technologies (including digital health solutions and pharmaceutical) is of growing importance. The broader trend of high cell phone usage in Brazil reveals a sophisticated market. A recent report from App Annie shows that the number of mobile health apps downloaded by Brazilians in 2020 grew 45% in comparison to the year before; with the global average being 30%.[vii]
São Paulo: A Closer Focus
Huge however, is not unsurmountable and it can be helpful to think about Brazil (and indeed wider Latin America) through the lens of cities. The cities in Brazil are certainly not small fry - please don’t think that this is reducing the potential market - refining is a more accurate reflection.
São Paulo, Brazil’s principal business city contributes 31% of Brazil’s GDP which is greater than entire economies like Belgium and Singapore[viii]. It has a population of over 12 million people and is a centre of excellence for higher education, including Universidade de São Paulo (or USPE as it is known locally, when sounding out the acronym in English). Together with the fact that the country’s leading hospitals are based in the city, this makes it an important base to consider for HealthTech providers. It’s not only HealthTech companies that should see São Paulo as a hotspot; a recently published city ranking for FintTech companies[ix] listed São Paulo as the fourth most important city globally - pipped to the post only by San Francisco, London and New York. All in all, this makes a for a buoyant tech ecosystem.
Regulatory Frameworks
Before taking any other steps, UK HealthTech companies must take into account the local regulatory framework. All medical and healthcare products must be approved by the Brazilian health surveillance agency, ANVISA, before they can be sold in Brazil and only companies established in the country can apply for product registration. This means that working with a local partner from the beginning is essential. A local partner will be able to navigate this field with more agility and be able to support you with the relevant documentation in Brazilian Portuguese. The enhanced collaboration established by ABHI and ABIMED can certainly benefit you as a member in making those connections, alongside the MoU’s focus on collaboration regarding global regulations and environmental sustainability.
It is no secret that Brazil is known to have a complex regulatory system, however ANVISA has been moving towards regulatory convergence and at the end of 2020 its affiliation to PIC/S was officially finalised, making it easier for non-Brazilian companies to do business in Brazil. Recent advances around IP protection are also providing a safer environment for foreign technologies to enter the market.
ANVISA has implemented procedures established by the International Medical Device Regulation Forum (IMDRF). IMDRF member countries created the Medical Device Single Audit Program (MDSAP), which enables manufacturers of health products to hire audit bodies recognised under the programme to conduct GMP audits that address the regulatory requirements of participating authorities (these are Brazil, Australia, Canada, USA and Japan). ANVISA continually updates the list of approved auditing organisations that are able to conduct these certifications and it is worth keeping a check on its website.
To reduce bureaucracy, ANVISA allows the transfer of registration of products among companies. Furthermore, products considered as essential to the public health system may be eligible for an expedited registration process, although some patience is still required.
Other government organisations involved in the regulation and introduction of new medical products are the National Institute of Metrology, Quality and Technology (INMETRO for its initials in Portuguese) and the executive agency responsible for overseeing compliance of quality and safety standards is the National Commission for Incorporation of Technologies in SUS (CONITEC, again with the acronym in Portuguese). The latter incorporates new medical technologies into the public health system, which will be of particular relevance to ABHI members.
Interested to Learn More?
With cities that are more like small nation states, and complex frameworks, Brazil at once seems full of opportunity and a little bit daunting. An important point to bear in mind, is that this is the same for your competitors, once in Brazil, UK companies can expect to have long-term and fruitful partnerships. ABHI’s close ties with the Department for International Trade is a fundamental relationship that can help you reach that point, or throughout your journey. If you are looking for more information, support in entering the local market, which events to attend (when we can do that again!) - contact the team at: dit.latac@mobile.trade.gov.uk for you to be welcomed or que seja bem-vindo no Brasil.
Department for International Trade
Useful Links
DIT-LATAC Roadshow 2021- Healthcare session
Digital Brochure: UK COVID-19 solutions and offer for Latin America and the Caribbean (LATAC) - if you would like your business to be featured in this listing please complete your details here.
Major healthcare events in Brazil:
- Hospitalar – The largest medical trade show in Latin America, organised by Informa Markets
- CONAHP – Organised by the Brazilian Association of Private Hospitals
- BIO LATAM – Organised by BIO Industry Association and BioMinas
- Jornada Paulista de Radiologia – Organised by the Brazilian Society of Radiology
- Congresso Internacional de Odontologia – Organised by the Sao Paulo Association of Dental Surgeons
- Medical Fair Brasil
[i] https://brazilian.report/society/2018/11/22/size-how-big-brazil-territory/ accessed 27/07/21
[ii] Infomoney (2019)
[iii] https://www.anahp.com.br/dados-do-setor/ (accessed 09/08/2021)
[iv] Saúde Business (2021)
[v] IBGE (2020)
[vi] https://abiis.org.br/deficit-da-balanca-comercial-do-setor-de-dispositivos-medicos-fecha-2020-em-125-e-consumo-interno-tem-queda-de-15-mesmo-com-a-pandemia/ (accessed 09/08/2021)
[vii] https://www.cnnbrasil.com.br/tecnologia/2021/03/19/relatorio-download-de-apps-de-saude-no-brasil-cresce-mais-do-que-media-mundial (accessed 09/08/2021)
[viii] https://www.en.investe.sp.gov.br/why-sao-paulo/ accessed 27/07/21
[ix] https://findexable.com/ accessed 27/07/21