07 Aug 2013, BioSpectrum Bureau , BioSpectrum
Singapore: The World Health Organization (WHO) has emphasized 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. Furthermore, there is a serious mismatch between products that rake in the biggest profits and products that save the most lives in poor countries.
Speaking at a technical symposium on medical innovation in Geneva, Dr Margaret Chan, director general, WHO, highlights that current procedures for drug discovery and the development of new medicines are inefficient. Companies and universities jealously guard their data, sharing is rare, and much work is duplicated.
"In the pharmaceutical industry, innovation has declined in a market that is shaped by cost-containment measures, stringent regulatory requirements, and complex and poorly understood diseases. New patents are issued, sometimes for 'me-too' drugs, often through the ever-greening of existing products. But the discovery of new entities with breakthrough therapeutic potential continues to decline," Dr Chan said.
Healthcare and medical professionals are running out of first-line antibiotics and, in several cases, second-line antibiotics as well. Few replacements are in the pipeline. This trend strongly suggests that the world is moving towards a post-antibiotic era, in which common infections will once again kill.
Dr Chan raised questions in the symposium that, "Should the need for innovation and appropriate incentives be driven by a spirit of social solidarity? Or should the price of a new medicine be based on what the market is willing to pay? This leads quickly to the argument that no price can be placed on a human life. If human life has value, no price for saving a life can be judged too high. This argument, in turn, leads quickly to the reality. The costs of many new medical products are becoming unsustainable for even the wealthiest countries in the world."
Last year, the US Food and Drug Administration approved 12 drugs for various cancer indications. Of these 12, 11 were priced above US$ 100 000 per patient per year. This price is unaffordable, for most patients, most health budgets, and most insurance companies.
"These are problems for all countries, not just the developing world. I can assure you, after more than two decades of efforts, there are no easy solutions. Everyone agrees that discovery and innovation must be rewarded. Most also agree on the need to deconstruct the costs of R&D and divorce these costs from the eventual price of the product. Ways of doing so are being explored. But divorce always costs money. New sources of financing must also be found."
Dr. Chan suggested that public-private partnerships for product development are increasingly accepted as a viable way to bring badly needed new products to market.
"Drug regulatory authorities have expressed their willingness to be involved in the stimulation of innovation. Some argue for adaptive approaches to market authorization, whereby the single transition from non-approval to approval is replaced by a series of approval stages as new evidence emerges and is subsequently evaluated, Dr, Chan said.