1. Context and Background
While AIDS has become a chronic disease in the West with much improved chances of survival, the needs of HIV-1 positive people and AIDS patients in the developing world are still neglected to an alarming degree. Until recently, the use of diagnostics, prevention methods, therapies based on well-established drug regimens of the West failed to reach patients apart from a tiny subpopulation. Recent global initiatives (e.g. “3x5” initiative of WHO, GFATM, the President’s Emergency Plan for AIDS Relief of the USA etc.) to introduce donated or cheap generic versions of Western medicines have changed the overall picture - the number of people receiving ARV therapy in developing countries is now 12.5%, which represents an enormous increase, but still a minute milestone given the extend of the pandemic. Although such positive developments and the push to dramatically increase the availability of treatment are under way, the estimated 5.1 million HIV-1 positive and AIDS patients that are still without protection show the emergency to increase access to treatment, at all levels. An estimated amount of 2 billion USD in sustained funding is needed to allow 2.1 million patients to gain access. The question of the sustainability of such funding remains wide open.
Therefore, innovative approaches to increase access to treatment through easily available and cheap medicines are needed. In 2004, several rounds of discussions with experts in the field, including two Workshops held at the ETH Zurich and one meeting with experts of the WHO were conducted by the EMF founders. Based on these discussions, they decided to create EMF as a non for profit foundation. The mission of EMF was defined as for the Research and Development (R&D) of safe, effective and affordable AIDS medicines and prevention modalities for the developing countries that can be locally produced at low cost.
The strategy is to identify natural products (NP) with anti-HIV-1 activity. Much like the discovery of Quinine from the bark of the “China Tree” (Chinona), the active substance or natural product (NP) used to combat Malaria, the strategy of EMF is to identify ingredients from nature (such as plants, seeds, fruits or bacteria) that could potentially help to combat the HIV/AIDS epidemic. The innovative and intriguing idea is to identify the genetic code in the NP that actively inhibits the HIV virus. Hence, EMF’s focus is on natural products, because only NP contain genes (chemical products do not contain genes). For that, plants, seeds, fruits or bacteria that contain such natural products will be identified.
How does the concept “from genes to drugs” translate in to reality?. After identification, the genes/gene clusters of the identified substance(s) active against HIV (“anti-HIV-1 activity”) will be transferred (through gene technology) to innocuous bacteria, yeast, fungi, plants, fruits or seeds that are not part of the major food chain and that have the capacity to multiply fast. These “multiplying vehicles” will then act as the mass-production instrument of the substance. Only locally available innocuous organisms will be chosen as production instruments (multiplying vehicles). This means locally available, simple technologies will be used and therefore the production cost will be negligible (annex 1: flow chart strategy).
After production, the active substances might be isolated and further refined to become regular formulations. Local pharmacies or (small) pharmaceutical companies might produce such powders, capsules or tablets based on drug substances. Other possible products might be directly edible fruits and seeds, aqueous extracts of plants, yoghurts, tofu cheese-like preparations, beer-like brews.
For details about the current portfolio see annex 2. The NPs that EMF is investigating will be – for a start - available from a Novartis stock.
The EMF efforts as presented are part of the early stages of the R&D line. They represent an innovative and risky basic research effort with the end goal to develop affordable and accessible HIV- drugs. Financing research with a potential to accelerate health development processes is part of operational strategies of SDC’s health policy. However, SDC’s Aids- and Health Policies emphasize a focus more on prevention and health promotion than treatment and care in its programme approaches. In this regard the commendable endeavours of EMF are not in line with these principles.
