Date Published: February 6, 2015
Publisher: Public Library of Science
Author(s): Christine Årdal, John-Arne Røttingen, Matthew H. Todd.
Greater investment is required in developing new drugs and vaccines against malaria in order to eradicate malaria. These precious funds must be carefully managed to achieve the greatest impact. We evaluate existing efforts to discover and develop new drugs and vaccines for malaria to determine how best malaria R&D can benefit from an enhanced open source approach and how such a business model may operate. We assess research articles, patents, clinical trials and conducted a smaller survey among malaria researchers. Our results demonstrate that the public and philanthropic sectors are financing and performing the majority of malaria drug/vaccine discovery and development, but are then restricting access through patents, ‘closed’ publications and hidden away physical specimens. This makes little sense since it is also the public and philanthropic sector that purchases the drugs and vaccines. We recommend that a more “open source” approach is taken by making the entire value chain more efficient through greater transparency which may lead to more extensive collaborations. This can, for example, be achieved by empowering an existing organization like the Medicines for Malaria Venture (MMV) to act as a clearing house for malaria-related data. The malaria researchers that we surveyed indicated that they would utilize such registry data to increase collaboration. Finally, we question the utility of publicly or philanthropically funded patents for malaria medicines, where little to no profits are available. Malaria R&D benefits from a publicly and philanthropically funded architecture, which starts with academic research institutions, product development partnerships, commercialization assistance through UNITAID and finally procurement through mechanisms like The Global Fund to Fight AIDS, Tuberculosis and Malaria and the U.S.’ President’s Malaria Initiative. We believe that a fresh look should be taken at the cost/benefit of patents particularly related to new malaria medicines and consider alternative incentives, like WHO prequalification.
Malaria is an ancient, global scourge that continues to plague the world today. Up until the mid-19th century it was endemic in most countries, placing 90% of the world’s population at risk . The Centers for Disease Control and Prevention was established in 1946 to combat malaria in the U.S. . By the 1960s North America and Europe had been declared malaria free by the World Health Organization (WHO) .
We have classified organizations simply as either industry or non-industry. Industry is any for-profit company. Non-industry includes academic institutions, governments, non-profit research institutes, foundations, and product development partnerships (since their funding is largely public or philanthropic).
We present our results by phase of the pharmaceutical value chain, i.e. early stage drug and vaccine discovery, late stage drug and vaccine discovery and clinical trials. Our results are summarized in Table 2.
This quote by Barret aptly describes the general perception of pharmaceutical innovation. However, in the case of malaria, both systems (government expenditure and patents) are being used concurrently by the not-for-profit sector. As we have demonstrated, public and philanthropic sectors are financing and performing malaria drug/vaccine discovery and development, and then restricting access through patents, ‘closed’ publications requiring journal fees and hidden away physical specimens, and, then finally also purchasing the end product, the antimalarials and related technologies. The Affordable Medicines Facility for malaria (AMFm), financed by UNITAID and The Global Fund to Fight AIDS, Tuberculosis and Malaria, disbursed co-payments for medicines distributed through the private sector of more than US$ 140 million in 2012 . The U.S.’ President’s Malaria Initiative procured about 4.5 million malaria treatments for pregnant women and 72 million ACT treatments in 2012 . The not-for-profit sector needs to attempt to get better value for its money. One way may be through a more open source business model given that most of the value chain is publicly and philanthropically funded. We outline such a model.
We have evaluated existing efforts to discover and develop new drugs and vaccines for malaria to determine whether malaria R&D would benefit from an open source approach and how such a business model may operate. Our results demonstrate that mainly the public and philanthropic sectors are financing and performing malaria drug/vaccine discovery and development, but then restricting access to the research outputs through patents, journal fees and hidden away physical specimens. This makes little sense since it is the same public and philanthropic sector that purchases the drugs and vaccines. We recommend that a more “open source” approach is taken by making the entire value chain more efficient through greater transparency which may then lead to further collaboration.