New drugs, vaccines, and diagnostics are desperately needed for millions that suffer from infectious diseases in developing
countries. The challenges of meeting this need are endless, but leaders at the Biotechnology Industry Organization (BIO) and
BIO Ventures for
New drugs, vaccines, and diagnostics are desperately needed for millions that suffer from infectious diseases in developing
countries. The challenges of meeting this need are endless, but leaders at the Biotechnology Industry Organization (BIO) and
BIO Ventures for Global Health are optimistic.
"The fact is, that while challenges are tremendous, they are not insurmountable," said Lila Feisee, BIO's vice-president for
global intellectual property policy. "The goal of getting products to the people who need them is a shared goal. It's the
approach that varies, and respect for each approach is crucial in order to have progress in this area."
BIO is taking a few approaches of its own. In May 2010, the organization developed a policy statement to educate its members
about how they can improve access to medicines outside of their own borders. One approach encourages companies to use creative
strategies when entering into license agreements with commercial and noncommercial entities for their inventions. Examples
of creative strategies would include considering licensees in the developing world as well as facilitating sublicensing agreements
and incentives that are designed to improve access to drugs in the developing world. Another approach highlights the importance
of working to identify compounds or technologies that can have useful application in the developing world, rather than focusing
only on research and development of drugs only for the broader marketplace.
BIO is also educating its members about the whole picture, so to speak, with regard to increasing access to drugs in the developing
world. Says Feisee, "The greatest challenges in improving health outcomes in the developing world are not related to the availability
of health products, though clearly more can be done in this area, but are related in large measure to the lack of adequate
infrastructure (e.g., trained personnel, roads and hospitals, and legal and regulatory policies) and distribution capability
in the developing world. It is not simply enough to make or manufacture a product. There are many products both on and off
patent that are available for many existing developing world diseases. But in many instances, the products cannot get to where
they are most needed due to inadequate roads and delivery systems, or when they do reach their destination, there is no way
of monitoring their uptake due to the lack of trained healthcare professionals or consistently available clinics or hospitals."
She notes that local governments and NGOs are the best entities to handle these types of infrastructure problems, and that
they can also encourage early-stage research domestically. The global biotech industry can be of assistance in helping to
develop medicines that require little or no follow up monitoring (e.g., single dosage formulations, sustained release formulations),
or products that are temperature-stable, says Feisee. "Several of our companies are already working to address some of these
types of concerns.... Agricultural biotechnology companies, for example, are helping to increase food security and nutrition
throughout the world, and BIO's industrial and environmental companies are working on developing new ways to purify water
and clean the environment."
BIO also has been working with BIO Ventures for Global Health, which was spun out of BIO in 2004 with the help of a Gates
Foundation grant. BVGH's mission is to save lives by accelerating the development of novel drugs, vaccines, and diagnostics
coming from the biotechnology industry to address the unmet medical needs of the developing world. According to BVGH's CEO
Melinda Moree, "People want to help other people—the desire is there to help save the lives of people in poor countries."
Although the desire is there, the financial incentives are harder to find. According to Moree, "It's mostly poor people who
suffer from these diseases and there is little market to drive the investment needed. This lack of commercial incentive has
resulted in a very slow pace of drug development for these diseases."
BVGH has been heavily involved in the implementation of FDA's Priority Review Voucher (PRV) Program, which creates an incentive
for investment in the development of new drugs and vaccines for neglected tropical diseases, such as malaria, tuberculosis,
and intestinal worms. The agency grants a PRV to the sponsor of a newly approved drug or vaccine for these diseases. The voucher
applies to accelerate the review of any other drug. A voucher can save a company several months of FDA review time, which
for a blockbuster product could be worth up to hundreds of millions of dollars.
This resource savings is important especially because recent economic times have led to a shortage of investments in new
medical treatments. A way to correct this market failure, according to BVGH, is to reduce the risk companies face both by
providing additional information to illuminate market demand, and by providing new incentives to motivate investment in global
health. BVGH is developing a pay-for-success prize to address these needs. Countries and donors have to work together to prioritize
and