Visitors to Brazil’s ubiquitous pharmacies – there seems to be one on each street corner of even the smallest town – will know that whatever the drug cited on their prescription, the sales assistant is likely to suggest a rival medication that “works much better.”
Often, packaging on the proposed substitute drug bears a yellow stripe and a bold yellow and red letter G for “Generics.”
In fact, local folklore has it the “rapaz da farmácia” is better-skilled at prescribing than the doctor, and knows his way around a pharmacopeia of drugs that have made their entrance since Brazil’s 1999 Generic Drug Law (Law 9787) was passed. Brazil was to follow standards recommended by the World Health Organization (WHO) and implemented in Europe, the US, and Canada.
While this too-vibrant entrepreneurial culture has now been partly tamed by regulation, it has helped Brazil’s thriving industry of generic or out-of-patent drugs, sales of which represent 25% of the overall market. Just how effective these drugs are, and how regulation has served the consumer, is now the subject of new research published in the Pan American Journal of Public Health.
The research shows that after just 20 years of market penetration, Brazil has the largest market for generics in Latin America. The “G” packaging is there to stay, although there have been conflicts between government, pharmaceutical companies, and consumers.
The first generic drugs were registered in the year 2000. At the same time, action was taken to encourage local firms to produce generics and to facilitate imports of key inputs. But it was not an easy start: a 2006 survey of eight Brazilian cities in which 55 health professionals were asked for their views. The results showed that 44% believed generic drugs were not as reliable as the originals and that, even among those who trusted generics, 17% did not prescribe them.
Today, however, physicians prescribing for patients in SUS, Brazil’s national health system, are required to use generic names. In the private sector, physicians are not bound by this rule and can prescribe by generic or branded drug name.
Despite their ubiquity, Brazil’s generic drugs haven’t been deeply researched. In an article published in Pan American Journal of Public Health, Elize Fonseca at the Education & Research Institute (INSPER) in São Paulo City and Ken Shadlen at the London School of Economics (LSE) present a case study on the regulation of generic drugs in Brazil and compare national approaches to promoting and regulating such medicines. The study was supported by FAPESP through its Young Investigators Grants.
The study stresses that the diverse factors and interests of both the public and private sectors shaped the design and implementation of the regulatory framework for generics in Brazil. Findings were based on empirical data collected between 2007 and 2015 from Brazilian government documents (such as generic drug regulation policy memos and official speeches) and more than 400 newspaper articles and scientific papers. This was supplemented by 60 interviews with regulators and government officials who had participated in designing and implementing Brazil’s generic drug policies.
The authors say four dimensions are crucial to evaluate generic drug regulation: equivalence, packaging, prescription, and substitution. Key questions included how the equivalence of generics to reference drugs is demonstrated, whether generics are allowed to display brand names on packaging, whether doctors can prescribe generics specifically, and whether pharmacists are authorized to substitute innovator products for generics.
“People often think the regulation of generics in Brazil is well established, but actually, it hasn’t been studied very much. We wanted to understand how and why Brazil opted for the regulation in force. It’s important to understand this because the regulatory framework governs a market with several key players, such as government, consumers, and pharmaceutical companies, and can extend or restrict access to medicines,” Fonseca told Agência FAPESP.
According to the authors, Brazil’s 1999 Generic Drug Law “was an opportunity to foster the use” of generic names (or Brazilian non-proprietary names) “as a prescription rule and improve the pharmacology requirements to register non-patent drugs”.
The authors also investigated whether there was any truth in those “this one works much better” claims made by so many salespersons in pharmacies. They asked the scientific question: “does a non-branded drug really work just as well as a branded one?” Bioequivalence means that the active ingredient of two drugs has the same rate and extent of absorption at the same dose and under the same conditions.
Today, Brazil has stringent requirements compared with those of other Latin American countries, the researchers write, pointing to a study by the Pan American Health Organization (PAHO) that found that no other national regulatory authority in the region required bioequivalence for so many drugs. Out of 86 drugs analyzed in Latin American countries, proof of bioequivalence was required for 51 in Brazil.
“Before Law 9787, local firms could copy reference drugs without submitting any proof of therapeutic equivalence,” Fonseca said. “The bioequivalence requirement forced various producers out of the market because they were unable to adapt to the new rules.”
Brazil’s federal health surveillance authority, ANVISA, created various instruments to assist local manufacturers, including a fast-track approval procedure for firms prepared to register generics.
ANVISA also provided continuous support to local firms and oversaw changes to their regulatory departments. As a result, Brazilian firms became expert at bioequivalence testing, which had previously had to be performed abroad. By 2009, 87.6% of such tests were carried out in Brazil.
The article “Promoting and regulating generic medicines: Brazil in comparative perspective” by Elize Massard da Fonseca and Kenneth Shadlen can be read at iris.paho.org/xmlui/handle/123456789/33835.
You can read an article by Brazilian journalist By Maria Fernanda Ziegler by clicking here.