Preliminary thoughts on a program for Essential Health Research
James Love
January 6, 1999
Essential Health Research and the Market
In matters concerning public health, intellectual property rights are a means and not an end. Patents and other types of intellectual property rights are mechanisms to promote research. They are not the only mechanisms to promote research. Public spending on research and mandatory reinvestment requirements are other mechanisms, for example.
There are many possible areas for medical research. The priority given various research projects will depend upon the framework. For example, in a market driven system with strong forms of intellectual property rights for invention, one would expect investments targeted at projects with the greatest rate of return. This might include projects that are important from a public health point of view, such as the development of products or marketable technologies that treat important public health problems. But it will also include other projects, that are less essential.
Market incentives will also drive investments into areas that have some value to society, but which would not be considered the highest priority from a public health perspective. For example, considerable private investments are spent on baldness remedies or “me too” drugs that do not represent important advances in therapeutic value.
To better appreciate the limits of market incentives, it is useful to think about some of the areas where market incentives are insufficient. Here are just a few:
- Diseases that primarily afflict the poor, such as Malaria, which kills 5 percent of all Sub-Saharan children, Chagas’ Disease, a terrible illness that afflicts 1 to 2 million poor persons in South America, and many other topical illnesses.
- Research on appropriate technologies, methods of delivery and compliance.
- Adverse affects of drugs.
- Impact of the environment or diet or health.
- Demographic and Epidemiological research,
- Vaccines
- Basic research.
A program for Essential Health Research
The World Health Organization has a very important program on Essential Drugs. This program focuses on the rational use of pharmacueticals, given limited resources. The WHO essential drugs program, and the many variations of this program by national governments, public health organizations, or even private sector health maintenance organiations, typically address the issue of how an existing body of medical technology can be used. The emphasis is on access, and proper use of drugs.
A program on essential medical research would address a different set of issues. Clearly one would want to identify areas of research that are essential, and to discuss the setting of priorities. But for this to be meaningful, there should also be an identification of the mechansims and means to pay for the research program.
As indicated above, three important mechanisms for funding medical research are:
- The assignment of private rights for the commerical use of research,
- Public (or donor) funding of research, and
- The requirement that pharmaceutical companies and other health care providers “reinvest” a percent of revenues into health research.
The approaches in 1-3 can also be combined in any number of ways.
Implications of the Essential Health Research approach
A program that seeks to promote an Essential Health Research (EHR) agenda would have several important implications. These come to mind.
- By definition, if you have essential health research, you would also have non-essential (or at least less essential) research.
- There would be an explicit assumption that resources are scarce, and that national health care expenditures were not infinite. Policy makers would be asked to justify research incentives on economic grounds, and to consider alternatives.
- Programs like the US Orphan Drug Act, which has no means test and which does not link rewards to invention or investment, would be very difficult to justify.
- There would also be an assumption that the public’s access to “essential” medical research would be important. Competing alternative mechanisms to fund EHR might have quite different consequences for access to the technology. This would be a factor in choosing the best mechanism.
- An EHR approach would be appropriate for the development of a “burden sharing” approach to trade agreements. Given the non-equivalancy of health research (more or less essential), new standards and metrics would be developed to determine how important a country’s contribution would be to global medical research. As noted above, the concept of “essential” health research and the recognition that access is related to sense that reseach is the “essential,” would influence the choice of mechanisms for funding medical research, as well as the research agenda itself.