Dr. Margaret Chan, Director-General of the World Health Organization (WHO) commented on the main issues affecting medical innovation during her opening remarks at a recently held joint WHO, World Intellectual Property Organization, and World Trade Organization technical symposium.
She stated, “The central problem is that the current system of incentives and rewards for product innovation is driven by market forces and not by global health priorities. When treating the poor in countries with diseases, the need to use a new product may be very necessary, but the market fails to do this because of the limited capacity for the poor in developing countries to pay”.
The result is that there is a great mismatch between products that can have a major impact on global health and what is actually on the market or in the pipeline. There is also a mismatch between products that turn the biggest profit and products that save the most lives in poor countries.
Dr. Chen summed up some of the other problems such as:
- Current procedures for drug discovery and the development of new medicines is inefficient as companies and universities jealously guard their data and rarely share data so much work is duplicated
- Governments are struggling to create incentives for innovation because of the need to control health expenditures
- Innovation in the pharmaceutical industry has declined in market shaped by cost-containment measures, stringent regulatory requirements, and complex diseases that are not really understood
- New patents are used, sometimes for “me too” drugs, and sometimes through the evergreening of existing products and therefore the discovery of new entities with breakthrough therapeutic potential continues to decline
- Health and medical professionals everywhere are running out of first-line antibiotics, and in several cases, second-line antibiotics are not available with few replacements in the pipeline
- Progressively higher and higher prices are another universal concern that points to the need to change business models but it also raises some fundamental ethical issues
- Costs for many new medical products are becoming unsustainable for even the wealthiest countries in the world
As explained by Dr. Chen, “During recent negotiations, WHO Member States weren’t willing to provide mandatory financial contributions to a global research and development fund. Instead calls are being made to make better use of what already exists.”
Countries are re-examining existing systems that shape the market and these systems need to be adjusted to operate as incentives for innovations. Other mechanisms such as direct grants to companies, awarding milestone and end prizes, and initiating patent pools are also being explored.
Public-private partnerships for product development are increasingly accepted as a viable way to bring badly needed new products to market. The Meningitis Vaccine Project (MVP) a partnership between PATH and WHO has proven to be a good example.
The goal for MVP was to develop, test, introduce, and provide for the widespread use of conjugate meningococcal vaccines. As a result of this collaborative research project, the number of meningitis cases in Africa’s meningitis belt are at the lowest level in ten years. This decrease is due to the introduction of MenAfriVac® developed by the collaborative efforts used in working on the MVP.
Dr. Chen emphasized, “It’s encouraging that more countries are using health technology assessments when decisions are needed on pricing and reimbursement.” She added “In addition, better use of existing EHRs are proving to be more valuable in obtaining the much needed data on safety and effectiveness of medicines. In fact, the EHRs have proven to be more helpful than even some clinical trials and introducing stricter regulations in dealing with safety and effectiveness issues.”