Beyond Borders: Global biotechnology report 2010

Commission (CTNBio) — determine the
bio-safety of GM products and regulate
stem cell research and commercialization.
Conflicting rules and the lack of a
consolidated industrial policy have created
challenges for companies operating in the
country. Complex regulatory procedures
have also often led to long delays in gaining
product approval. However, the Government
has recently made efforts to streamline
the regulatory process to make it more
efficient and investor-friendly, with most of
the policy improvements centered on the
GM crop industry. In 2008, for instance, the
Government gave CTNBio final authority on
all approvals of GM products, addressing the
overlapping functions of NBSC and CTNBio.
Progress has also been made in addressing
the protection of intellectual property
(IP) rights related to biotechnology. The
Government is evaluating an option to grant
IP protection for biological material, but
only for Brazilian researchers. The Brazilian
Parliament is also considering a proposal
to eliminate the use of secondary or
polymorph-related patents on various drug
substances to strengthen the IP protection
environment in the country.
Outlook
Brazil’s biotechnology industry has
evolved considerably during the last
decade and is fostering the formation
of innovation-focused biotechnology
companies. The sector is being boosted by
major Government initiatives, such as the
Biotechnology Development Policy (PDB)
and a 10-year, US$4.0 billion biotechnology
development program. Brazil has been
attracting considerable foreign investment,
and domestic companies are strengthening
their research and manufacturing
capabilities while enhancing their marketing
strength in foreign markets. However, the
country’s infrastructure and regulatory
processes are still evolving, and continued
focus will be required to maintain growth.
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