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  • Brazil biotech 'held back' by regulatory barriers


Brazil has the "building blocks" for an innovative health biotechnology sector, but is held back by regulatory barriers and poor coordination between the public and private sectors, say the authors of a new study.

The authors, from the McLaughlin-Rotman Centre for Global Health (MRC), based at the University Health Network and the University of Toronto, Canada, used case studies from 19 domestically-owned private biotechnology companies and four public sector research institutions to draw their conclusions, published last week in the June issue of Nature Biotechnology.

It is the third study the MRC have conducted on biotechnology in developing countries. Studies on China (see Regulations 'hinder' China biotech investment) and India have already been carried out.

Development of products like vaccines, medicines and diagnostic kits has made considerable progress in Brazilian companies in recent years, the authors found.

Products have been developed to deal with local health problems often ignored by larger international pharmaceutical companies — including malaria, Chagas disease and dengue — and neglected markets such as small laboratories and rural settings.

But barriers remain, say the authors. For example, it can take seven years to process patent applications, and there are often long delays in the ethics approval process for clinical trials.

"One of the things that became more prominent in the Brazil paper was the interface between the public and the private sector," co-author Peter Singer, interim director of the MRC, told SciDev.Net. He says that the government has focused mostly on the public sector as a source of health products, and now, it's time to increase support to the role of the private sector in health.

In addition, few companies export products, or carry out any truly collaborative international partnerships. "Brazilian companies are still focused on the Brazilian market, but they are now starting to pay attention to international markets," says co-author Rahim Rezaie.

The researchers make recommendations for Brazil, including improving the performance and transparency of government regulatory bodies; promoting international collaboration and export; and supporting innovative startup firms.

Wim Degrave, a senior scientist at the Oswaldo Cruz Foundation, one of the Brazilian institutes included in MRC's study, says that expertise on patent issues in public research institutions should be strengthened.

He adds that while not much of the development of health products in Brazil is innovative at the moment, gaining revenue from non-innovative products and establishing large-scale production enables companies to concentrate on the research and development of new products.

Link to full paper in Nature Biotechnology


Nature Biotechnology 26, 627 (2008)

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