Against lack of medicine, Brazil seeks to reduce dependence on imports of pharmaceutical ingredients

Brazil only produces 5% of these inputs, the rest (95%) is imported from China and India, according to Abiquifi (Brazilian Association of Pharmaceutical Inputs Industry). Until the end of the 1980s, the country produced 50% of the APIs consumed.

With the fall in tariff protections for imports of products in the early 1990s, Asian inputs began to be offered at very low prices and dominated the market, given the absence of policies to encourage the national pharmaceutical chemical industry.

The closing of borders in China and India during the pandemic, and, this year, the war in Ukraine and the rise in oil prices, have provoked a race of countries in search of alternatives to avoid future crises. Currently, the shortage of this raw material affects everything from the production of vaccines against monkeypox to essential medicines, such as antibiotics and pain relievers.

Last week, the visit of Nancy Pelosi, Speaker of the US House of Representatives, to Taiwan, reignited fears of a trade war between China and the United States. “This is extremely dangerous. An eventual geopolitical change leaves countries with their hair on end”, says Norberto Prestes, president of Abiquifi.

The United States, which also depends on API imports from Asian countries, announced that it will manufacture 180 molecules considered strategic to maintain production sovereignty and signaled that it is interested in partnerships with allied countries, including Brazil.

“The US needs to bring this production of APIs that they cannot control closer to them, to their neighbors, friends. Brazil has a good production capacity, it has good technicians, but it is necessary to reform the costs that it has today in the country”, says Nelson Mussolini, executive president of Sindusfarma (Pharmaceutical Products Industry Union).

Abiquifi has already delivered to the Ministries of Health and Science and Technology a survey of the 50 strategic molecules for public health in Brazil, based on a cut of private drug consumption, which represents 30% of the market. These include antibiotics, antihypertensives, and medications for the nervous and respiratory systems.

Now, according to Prestes, a second report will be made, based on SUS consumption, to define which are the priority inputs. “Based on this information, we will start to discuss a strategic plan, as was done in relation to fertilizers. [química fina] for fertilizer and pesticide is the same as for the medicine.”

The estimate is that it will be necessary to invest from R$ 2 billion to R$ 4 billion to expand API production in Brazil. “There are things that can be resolved more in the short term, like 3 years. Others will take 5, 10, 20 years. But this discussion cannot be postponed any longer.”

Another strategy has been a partnership between Brazilian companies and pharmaceutical companies in Argentina. According to Prestes, of the 350 inputs produced in both countries, only 20 are common to both. Among the proposals are joint production or technology transfer.

For Mussolini, from Sindusfarma, a tax reform and a review of the so-called “Brazil cost”, a set of structural, bureaucratic, labor and economic difficulties, are necessary for the country to arouse the interest of companies for the national production of API.

“If today you take out a loan to build a factory, before the money is deposited in your account you are already paying tax, the IOF. You pay tax before buying the first brick.”

Ricardo Pacheco, CEO of Cristália laboratory, explains that producing IFA in Brazil is much more challenging than manufacturing in China and India. “There are multiple issues, including regulatory issues, lack of investment, lack of lines of financing and the cost of importing equipment and research.

At Cristália, located in Itapira (SP), 68% of API production of the approximately 350 medicines available is produced in-house. The company has three pharmochemicals, one of which is oncology, and two biotechnology plants that produce biological APIs and final drugs.

“It was this consistent history that helped us guarantee the supply of Brazilian hospitals at the height of the pandemic”, he says. Production dates back to 1983, with the opening of the first factory.

The company has plans to expand production, but is not pursuing full self-sufficiency. “No pharmaceutical laboratory, in any country in the world, produces 100% of the inputs it needs. This also depends on specific vocations and raw materials”, says the executive.

In Pacheco’s opinion, it is necessary to create a legal framework that can provide legal certainty and stimulate the chemical industry in general. “The best way to do this is to promote articulation between universities, research centers, government agencies and the private productive sector.”

Marcelo Mansur, CEO of Nortec Química, the largest manufacturer of APIs in Latin America, with around 350 tons, says that Brazil needs to look at the health industrial complex, especially pharmochemicals, as a State policy, just as the China and India, which have invested on several fronts.

“At the moment of crisis, everyone talks, but when the crisis passes, everything returns to the question of price, which is understandable because [menor] price means [ampliar o] access. But the worst thing that can happen in health is lack. There are ways to equate these two issues, it goes through the nationalization of technologies.”

He reminds you that there are no quick answers in this sector. “You can’t build a factory in less than five years, you can’t register an API in less than two years. But it’s a discussion that has to be had in times of crisis and calm. [falta] intubation kit, but we are short of anti-flu, even saline for dialysis.”