A Brazilian Method to Trust Generic Drugs and Increase Their Use

    Generics have special packaging in Brazil - Photo by ABr

    A new methodology that can be used to compare generic drug regulations between countries can help scale up the use of life-saving medicines by easing the way to legislation and prescription, according to a recent report.

    By clarifying the traits of generic drugs and the constraints to using them the new methodology can help overcome persisting mistrust over their widespread use by doctors, lawmakers, public officials and others who shape relevant policies.

    “Promoting the use of generic drugs can constitute a core instrument for countries’ national pharmaceutical policies, one that reduces drug expenditure while expanding health care access”, write the authors in the report, published in the Pan American Journal of Public Health.

    Experts are currently lacking a roadmap that would allow them to determine what aspects of the generic drugs policy should be evaluated and compared, says Elize Fonseca, a researcher at the Teaching and Research Institute of São Paulo, and co-author of the research, in an interview with Brazil’s research foundation FAPESP.

    The study focuses on Brazil — the main Latin American market for generic drugs — but the methodology can be used to compare regulations between other countries.

    “Currently, each country has a different type of regulation, which at the end creates a trade barrier. But by answering four key questions [about biological equivalence with branded drugs, packing, prescription and replacement] we [the user of the methodology] can arrive to a better understanding of regulation in every country”, Fonseca explains.

    Comparing legislation helps by unveiling the reasons behind governments’ legal stance on generics, for example. And it can pave the way to consistent rules so these drugs are more easily traded between countries.

    In the case of Brazil, the methodology detected a number of conflicts of interest between government, pharmaceutical companies and consumers. This is because drug regulation “is a technical issue, but also political”, according to Fonseca.

    For instance, only a quarter of all medicines sold in Brazilian drug stores are generics, even though the country has strongly supported their manufacture and prescription since 1999. Pharmaceutical companies still promote and advertise branded medicines as superior to generics in many countries.

    In addition, while the Brazilian health system requires doctors to prescribe medicines according to their generic name, a 2006 study cited in the report found that 44 per cent of health professionals across eight cities said generic drugs are not reliable enough — a sign of mistrust. Among those who did trust their effectiveness, 17 per cent did not prescribe them.

    The research is based on government data collected between 2007 and 2015. It is also based on a review of more than 400 science papers and journalistic articles, complemented by interviews with 60 officials and regulatory authorities that took part in the drafting and implementation of generic drugs policies in the country.

    The researchers also analyzed bio-equivalence, a measure of whether generic and branded medicines have the same compounds and formulation.

    “Before the generics law was passed [1999], the pharmaceuticals industry in Brazil could copy drugs without an obligation to show evidence of their therapeutic equivalence,” says Fonseca.

    “After [the law] demanding bio-equivalence, several producers were unable to adapt to the new legal requirements and their products were pulled out the market.” She points out that “competitiveness is key” in the pharmaceuticals sector “in order to get lower prices”.

    To avoid a rise in prices, since 2000 the National Health Surveillance Agency (ANVISA) created a range of support tools that manufacturers of generics can use to register their products and support local enterprises that sell them.

    ANVISA also promoted capacity building so that bio-equivalence tests take place in the country rather than abroad. Currently, 88 per cent of these tests are done in Brazil, and regulations in this area are more stringent than in other Latin American countries, according to the research.

    Next the authors plan to conduct a case-by-case analysis of how generics regulation works in Chile, Colombia, Argentina and Mexico.

    This article was originally published by SciDev.Net

    Tags:

    • Show Comments (0)

    Your email address will not be published. Required fields are marked *

    comment *

    • name *

    • email *

    • website *

    Ads

    You May Also Like

    In Brazil, Diplomas Don’t Open Doors for Women

    Gender equality in Brazilian science is increasing up to doctorate level but few women ...

    Indians at Paraná's FUNASA

    Brazil Inaction Brings Malaria and Tuberculosis Back to Indian Population

    The recent occupations of public buildings by Brazilian Indians are reactions to the ineffectiveness ...

    In Brazil, Private and Public Researchers Join Hands at Last

    The Brazilian President Luiz Inácio Lula da Silva took steps earlier this month to ...

    Roaming the Brazilian Amazon in Search of the Flying Monkey

    The saki, or “flying monkey,” a mid-sized South American primate, gets its nickname from ...

    Brazil’s Plans to Help Those Without Health Insurance

    Brazil’s Ministry of Health plans to expand four programs designed to improve care for ...

    Brazilian Amazon Gets Help from Science

    Brazilian Amazon Gets Help from Science Brazilians scientists have been discussing ways of reducing ...

    Abimo stand from Brazil

    Brazil Expecting US$ 20 Million from Middle East Medical Fair

    Brazil's Association of the Manufacturers of Medical and Dental Products (Abimo), estimates that the ...

    Health center

    Hypochondriacs They Are Not! 77% of Brazilians Call Selves Healthy or Very Healthy

    IBGE, the Brazilian bureau of statistics, has just released the 2008 edition of its ...

    Lack of sanitation in Brazil's favelas is common -

    Basic Sanitation Might Be Coming Soon to a Big Favela in Rio

    Brazilian authorities have taken the first step towards providing basic sanitation to more than ...