Priority medicines and the world
M.N. Graham Dukes
The initiative taken by the Government of the Netherlands in 2003 to develop a basis for a worldwide public health approach to the development of new medicines is welcome. Although new medicines have continued to enter the market during the half century in which public policies in this field have come to maturity, it is no secret that the development process has encountered grave problems and has been the subject of unresolved controversies. Of these, the most serious relates to the perceived divergence between the nature of the drugs reaching the market and the real health needs of populations. That divergence is evident even in Europe and the United States, where the research-based pharmaceutical industry is primarily established. Over six decades, there has been a series of true breakthroughs (such as the emergence of antibiotics to counter infection and several generations of new agents to treat cardiovascular or psychiatric disease); particularly in the last 20 years, however, far too many “new drugs” have been only insignificant variants on those already existing, and real breakthroughs have been virtually absent. This situation is serious enough in the industrialized world; the failure to make inroads on major disorders involving the people of developing countries is worse still.
The Priority Medicines Project, sparked by the Netherlands in the hope of bringing about real improvement, reflected the belief that research funding by the European Union could be a major tool to this end; it was therefore bound to be attuned to an important extent to the problem of western populations. From the start, however, the need for global progress was recognized, and the study was therefore entrusted to experts nominated by WHO and conducted under the Organization’s auspices. The report issued in November 2004 provides a distinguished analysis of the problems and advances important proposals to solve them (1).
An apparent conundrum which is tackled head-on relates to the common observation that, since new drugs emerge primarily from industrial research that is funded from sales and profits, companies will always be tempted to prioritize low-risk ventures aimed at a profitable market; these are much likely to involve the development of drugs of a familiar type for wealthy populations than the sort of costly innovative research that might produce true breakthroughs benefiting less wealthy parts of the world. As the report recognizes, such obstacles can be overcome if a multi-pronged programme of improvement is put in place. The public health sector does in fact have a substantial potential to influence the research process. For example, the volume of basic research carried out in public health institutions is considerable, often providing the foundation on which industry can create a useful new medicine. The public sector can also influence prices, enact helpful tax provisions and discourage some non-innovative activities (such as excessive advertising or exaggerated profits) so as to boost resources for industrial research of the most beneficial type. More directly, governments (or bodies such as the European Union) could fund certain types of research, notably in the field of antiviral agents, vaccines, drugs for neglected diseases and remedies for tobacco addiction. In parallel with these measures much can be done to reduce wastage of the results of innovation, for example by countering the reckless use of antibiotics which stimulates the emergence of resistant strains. Such approaches and others are well delineated in the report and backed by precise recommendations as to areas in which innovative medicinal research is most urgently needed and a discussion of the population subgroups (including women and children) who deserve more attention.
One must express some reservations as to those aspects of the report which seem to reflect a desire to compromise or too great an acceptance of industry’s self-proclaimed merits and potential. It is, for example, simply not true that it now costs US$ 800 million to develop a new drug; that figure is merely a poorly founded piece of industry-funded propaganda, which more authoritative authors have now thoroughly demolished (2); fortunately, the report does show some awareness of the estimate’s weakness. What is true is that the pharmaceutical industry, while repeatedly lambasting public regulation of its affairs, has in fact succeeded in adapting to such regulation where the needs of the population have rendered it necessary. It is hardly a secret that within the pharmaceutical industry some serious thinking is now going on as to the way in which it should reform if it is to serve the world’s population as well as it has traditionally served its shareholders.
The report on priority medicines does not present a full programme for action, but it provides for the first time a convincing picture of what needs to be done and the tools that can be applied. In the worst situation, a report like this may simply be lauded politely and then ignored. That would be tragic: this report is not an end in itself but a starting point for a programme of action which is now desperately needed.
Ref. No. 05-021618
- Priority medicines for Europe and the world. Department of Essential Drugs and Medicines policy. Geneva: World Health Organization; 2004. WHO document WHO/EDM/PAR/2004.7.
- Angell M. The truth about the drug companies. New York: Random House; 2004.