The Lancet Global Health Journal recently published an article “The drug and vaccine landscape for neglected diseases (2000-11): a systematic assessment” discussing the current research and development ongoing in this area. They found 1,500 clinical trials were registered for neglected diseases which represents only 1% of all registered clinical trial activity. Of the 123 new products in development for neglected disease, more than half were vaccines or biological products. However, the article points out that 80 percent of neglected diseases have R&D gaps. In spite of these gaps, neglected-disease R&D has accelerated moving from 0.6-1.3 new products/year in 1975-1999 to 2.4 products per year in the 2000-2011 time frame.
Last year BIO Ventures for Global Health (BVGH) and the Biotechnology Industry Organization (BIO) produced the report “Bringing Innovation to Neglected Disease Research and Development” that proposed several solutions to help address this research and delivery neglected disease gap. The report suggested several solutions in a range of areas including increasing financial incentives, establishing links between relevant communities, and aligning regulatory bodies. However, the last proposed solution involved a key accelerator in R&D development often derided by the development community.
“Lack of ability to obtain or enforce intellectual property in both country of innovation and country of distribution creates great risk for the biotechnology companies considering neglected disease R&D. Biotechnology companies rely on strong patent rights to protect against the risk of early entry of generic competition which results in the loss of the large expense of innovation, obtaining regulatory approval, educating doctors, and distribution. Without clear intellectual property rights in neglected disease areas, biotechnology companies will look to other therapeutic areas with less risk.”
Neglected diseases represent a real humanitarian and market opportunity for countries like Brazil, China, Russia, and India. Expanding R&D into these diseases will not only advance their industrial policy goals but will also provide them with the opportunity to research, develop, run clinical trials, and provide their populations (who are uniquely targeted by neglected diseases) with new medicine.
As these countries understand the medical R&D reality before them, they will realize that anti-innovation policies like compulsory licenses are not sustainable. Only by investing in research and development, pursuing pro-innovation policies and using their low-cost research and manufacturing capabilities can they make a lasting contribution to humanity and, at the same time , deliver real health care systems that provide novel medicines to treat the neglected diseases plaguing their population.