The Pharma Letter: Brazilian pharma offers high standards and strong partnerships, but reforms and investment needed

Website: The Pharma Letter

Journalist: Angel Galindo

Brazil’s pharmaceutical industry is the largest in Latin America and currently the seventh biggest in the world though, according to projections from IQVIA, it could be in fifth position in 2023.

As the largest pharmaceutical hub in the region, the country maintains strong commercial ties with other Latin American countries, as well as Asian nations.

Indeed, large Brazilian pharma companies operate in most countries in South America – in some cases, even with local drug manufacturing. At the same time, large Asian drugmakers operate in Brazil and, in the biosimilar segment, some Brazilian and Asian companies have technology transfer agreements.

Conditions 'conducive to innovation'

Certain factors explain Brazil’s privileged situation, explained Nelson Mussolini (pictured above), executive president of the Sindusfarma trade association, talking to The Pharma Letter’s Latin American correspondent.

Firstly, he pointed out that the pharmaceutical industry in Brazil follows the high-quality standards practiced in the world’s leading markets. This allows medicines manufactured in Brazil to be exported to all continents.

Also, with more than 210 million inhabitants, the country is the ninth largest economy in the world and its consumer market has not yet reached maturity, offering ample opportunities, especially in the area of health.

From medium- and long-term perspectives, Brazil’s demographic and socioeconomic foundations are favorable: a large population, an increasing number of older people and a tendency to expand access to medicines and medical treatments in the public and private healthcare systems.

These conditions are conducive to innovation and a fast pace of business, focused on the launch of new products. This leads to the development of a flourishing pharma industry that operates in Brazil, said Mr Mussolini.

Pandemic challenges

This year, despite the coronavirus pandemic, Brazilian pharma markets have been strong, and they have not felt the consequences of this global health emergency.

Mr Mussolini said this was related to the agility and competence with which the pharmaceutical industry in Brazil dealt with the international crisis in the supply of active pharmaceutical ingredients and raw materials, along with rising transportation costs, notably air freight.

In the same way, the monitoring of the world situation, correct management of stock levels, the ability to make adjustments in production lines and the regulatory agility of Brazil’s health surveillance agency, ANVISA, avoided supply problems and are guaranteeing the healthcare system and population access to the medicines they need.

Another helpful factor has been the world’s leading pharma companies having a presence in Brazil, and these firms having well-established links with industry in Brazil.

During the pandemic, these relationships became even stronger, with numerous technological and commercial partnerships being signed due to the worldwide race for development, manufacture and distribution of vaccines and medicines to fight the virus.

Great challenges for 2021

In 2020, the Brazilian pharmaceutical industry is expected to grow around 6% and, next year, the growth rate is projected to be around 8%.

One of the challenges ahead, according to Mr Mussolini, is the need to modernize the sector’s regulatory pricing framework by improving the market’s economic regulation model. The issues involved in this include price control, the tax burden, incorporation of new technologies in the health system, and agility in the approval of patents, among others.

Mr Mussolini believes that perhaps the biggest challenge of all is the review of drug price control.

“The rigid and outdated pricing model often inhibits the launch of innovative products or forces the withdrawal of traditional and often essential products by imposing values that hinder their production and commercialization,” he said.

Previous governments have promised to modernize the price-fixing rule and its amendments, which have been in effect since 2003, but no measures have been implemented. Currently, Jair Bolsonaro’s government is studying a new price rule for drugs with incremental innovation.
“We hope that this action shall get off the ground and help Brazilians’ health,” Mr Mussolini said.

In search of new medicines

The pharmaceutical industry in Brazil is actively participating in clinical research into coronavirus vaccines. At the same time, other vaccines and treatments are in the initial research and development (R&D) phase in Brazil.

In a broader scenario, the pharmaceutical industry in Brazil is advancing R&D into medicines in the country. And, overcoming a long period of mistrust, universities are becoming industry partners in this effort, something that gives Mr Mussolini hope.

The pharma industry is one of the segments that invests the most in R&D in Brazil, but in terms of spending on drug research and development, Brazil massively lags the OECD average, meaning more investment is needed.

“Investment in pharmaceutical industry R&D occupies the fifth position in Brazil, behind the segments of transport, computing and electronics, chemical products and vehicles,” Mr Mussolini said.