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Brazil's biotech firms: From imitators to innovators in health-related products

  • several monoclonal antibodies for cancer treatment (Recepta Biopharma, of So Paulo);
  • a recombinant protein for treating melanoma as well as anti-hypertensive and an analgesic peptide both isolated from snake venom (COINFAR, of So Paulo); and
  • fetal, neonatal and adult stem cell therapies for cardiac disease, type I diabetes and neonatal hypoxia (Cryopraxis, Rio de Janeiro).

Barriers to development

Major challenges include:

  • A patent regime in desperate need of reform

    The Brazilian patent office can take over seven years to process patent applications for drug candidates. Brazilian law prohibits patenting some important biotechnologies, such as recombinant versions of proteins found in nature. Some companies are also concerned that once a pharmaceutical product has been approved by the patent office, ANVISA (the national regulatory agency that approves health products, among other activities) can withhold approval on grounds such as eventual public access issues.

  • Regulatory issues

    The main regulatory roadblock highlighted by both public and private sector interviewees is the lack of practical experience in product development and manufacturing on the part of ANVISA regulators. Other commonly cited stumbling blocks include long delays in the ethics approval process for clinical trials as well as biosafety and biodiversity regulations.

  • Human resources

    Although Brazil has been successful in raising the overall level of biotech expertise, there is evidence of a disconnect between the output of existing training programs and the actual needs of the health biotech sector. Lack of sufficiently specialized and targeted training programs and the "academic model" of university preparation are limiting the supply of appropriately-trained personnel. An additional challenge for private industry, especially SMEs, is their inability to match or exceed the incen

Contact: Terry Collins
Program on Life Sciences, Ethics and Policy,McLaughlin-Rotman Centre for Global Health

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