Contribution of Dr Bernard Pécoul, Médecins Sans Frontières (MSF) Okinawa International Conference on Infectious Diseases: 7-8 December 2000
Bernard Pécoul’s speech at the Okinawa conference. Presented Drugs for Neglected Diseases Working Group recommendations, including defining a needs-driven research agenda for drugs for neglected diseases, promoting technology transfer, etc.
Thank you for giving me the opportunity to speak today on the important issue of research and development.
There has been enormous private investment in drug research over the last quarter century. Of the 1,223 new chemical entities approved during this time, 379 were true therapeutic innovations. Out of these, only 11 were for tropical diseases.
Here are the 11 tropical disease drugs (slide 3). Most were the result of veterinary research (5) or military research. Only a few were specifically for tropical diseases.
It is also important to note that today, some of these drugs are out of reach for many patients because production has been abandoned or they are too expensive. For example, eflornithine, which is used to treat sleeping sickness, is no longer produced by Aventis. The production of nifurtimox by Bayer was uncertain until just recently. Other drugs are priced at levels that make them inaccessible to most people who need them.
It is clear that R&D for tropical diseases has ground to a standstill.
As you can see from this graph (slide 4), the pharmaceutical market has been rapidly expanding in North America and Europe. The North American drug market has gone from just under 80 billion dollars in 1993 to more than 160 billion projected for 2002. North America makes up 5% of the world's population.
In comparison, the market in Africa and Asia has remained the same, while the population has doubled. Today, Africa and Asia make up 72% of the world's population.
The size of the market seems to be closely linked to the size of the R&D budget.
Pharmaceutical companies spend billions on R&D for the diseases of concern to industrialised countries. In contrast, the budget for product development for the Tropical Disease Research programme, which is a common programme of WHO, the World Bank and UNDP, has averaged just 10 million dollars per year during the last decade. The numbers speak for themselves.
The evidence indicates that most of the world's population is left out of the picture when new medicines or vaccines are developed. R&D activities are responding less and less to the real clinical needs of the developing world. This is a crisis that must not continue.
But now we have to ask: who is responsible for the solution?
Is it the pharmaceutical industry? Roy Vagelos, former head of Merck, had a point when he said: "it is a social problem that we are faced with, and we cannot ask industry to solve it."
It is essential that the pharmaceutical industry contribute to the search for solutions. But we cannot rely on industry alone to solve the crisis, or to set the rules of the game.
While one could blame the lack of R&D on "market failure," we also point the finger squarely at "public health failure."
Political leadership is crucial for ensuring that research and development does not only serve the needs of the wealthy.
We are encouraged by the G8 communiqué from last July, as well as by the recent communication from the European commission. Both are going in the right direction by pushing for research for global public goods.
But what are the next steps we should take now?
One year ago, we set up the independent "Drugs for neglected diseases" working group, which my colleague described earlier this morning. Its goal is to identify strategies to promote the development of new, effective, safe, affordable, and easy-to-use drugs. Based on the findings of the working group, we make the following six recommendations:
1) Define a clear, need-driven research agenda for new medicines including vaccines. This will assist policy makers, funding agencies, and the research community in setting the right priorities to address the needs of developing countries. This agenda will drive a coordinated effort to develop 10 to 20 new drugs over the next 10 years, with an estimated cost of $500 million to $2 billion. This amount is not beyond the reach of our societies.
2) Promote the transfer of technology. This will ensure more autonomy for developing countries to address their specific concerns, and may ensure lower prices through public involvement or generic production. It is a warrant for a sustainable response.
3) Find diverse funding sources for the development of medicines, including money from governments in the North and South, NGOs, and foundations.
4) Create mechanisms to drive needed research in the private sector. For example, governments could demand that a small percentage of profits go towards developing essential medicines for neglected diseases.
5) Secure the market
- When the disease is only prevalent in developing countries, we may need to rely on a fully subsidised system
- When the disease impacts both rich and poor countries, we should implement an equity pricing system
6) Negotiate an international treaty to ensure R&D for neglected diseases. This treaty should promote the search for medicines and vaccines that are effective and easy to use, and must ensure their affordability. It should address quality, efficacy, and safety standards. It should correct the current imbalance between rights and obligations under the present international treaties and agreements, such as TRIPS. It should guarantee that drugs for neglected diseases will be considered global public goods and address the relevant intellectual property issues.
Because we recognise that public backing is the essential precursor of political will, in the coming year, MSF will dedicate itself to raising public support for these recommendations.
Today, Médecins Sans Frontières calls on all actors responsible for the R&D standstill to begin addressing the crisis now. We all know that research and development is a long process – we cannot afford to wait.
Thank you for your attention.