Pharmaceutical companies are encouraged to research neglected diseases with what are called “push” or “pull” programs. Instituting such programs requires policy makers to consider how to distribute resources in a way that is both fair and efficient.
Neglected diseases, also referred to as “forgotten” diseases, are infectious diseases that affect the world’s most vulnerable populations. While many of these infections are due to otherwise preventable parasites, a good number have no available cures. Neglected diseases are quite prevalent in poorer countries in tropical climates. Such environmental conditions, combined with poor sanitation and unsafe drinking water, are conducive to exposing humans to a variety of new and varied pathogens. Examples of neglected diseases include Nodding Syndrome (NS), scabies, yaws, sleeping sickness, and Chagas disease.
Because neglected diseases are rarely found in the developed world, there is often difficulty with generating the needed interest and investment for researching their cures. Even if a disease is prevalent in a population, if the demanding market cannot pay for the research and/or cures, there is little incentive for research and development (R&D) teams to address the issue.
In an effort to encourage R&D exploration into neglected diseases, policy makers have created both “push” and “pull” programs. Push programs directly impact the cost of the research process by providing incentives such as research grants, tax breaks, or fast-tracking the approval process. By contrast, pull programs provide indirect incentives that reward the final products of research. Examples of pull program include guaranteeing market exclusivity for the products of research results, receiving priority in the FDA review process, and granting transferable patent exclusivity.
Though most will agree that neglected diseases ought to receive their fair-share of attention from the research community, the specifics of doling out resources and giving special treatments are still a matter of debate. Economists tend to prefer pull programs because they reward only the final, successful products from expensive and labor-intensive research efforts. In the specific context of neglected disease drug discovery, pull programs would most likely come in the form of advanced purchase commitments.
However push programs are also important for encouraging R&D support for neglected disease research. In particular, basic research benefits greatly from push programs. Basic research is the type of research that is conducted for the purposes of knowledge expansion (e.g. “How does the chemical profile of a cancer cell differ from a normal cell?”). By contrast, applied research seeks to discover solutions to real-world problems (e.g. “Can we create a drug that exclusively attacks cells of a particular chemical profile?”). Because basic research seeks to produce answers and ideas instead of profitable products, basic researchers do not stand to gain anything from pull programs. Rather, they must rely on push programs.
Most agree that the issue of push vs. pull programs is context specific and that the optimal solution will vary from case to case. Consequently, “hybrid” programs have been popularized as a way to combine both push and pull incentive packages. Perhaps the most famous hybrid program was set into place by the Orphan Drug legislations. The 1983 Orphan Drug Act includes a seven-year market exclusivity agreement (a pull incentive), tax credits, grant programs, and FDA advice counseling (push incentives).
The issue of how to create optimal incentive programs to encourage neglected disease research is a matter of great importance for science policy-makers. Both researchers and individuals afflicted with neglected diseases will no doubt be interested in how profit-minded pharmaceutical companies are given incentives to research less prominent diseases.
By Sarah Takushi
Bill and Melinda Gates Foundation