Description: A package of incentives to encourage the creation of a one-month Tuberculosis (TB) regimen which is affordable for all.
Start date: Proposed in 2015.
Status: Proposed (seeking funding to launch in 2017).
The 3P project is a project to increase the creation of and access to TB drugs. Specifically, it aims to create a one-month TB regimen which is affordable for everyone.1
The project seeks decouple the cost of R&D from the price of the ensuing treatment, through prizes, grants and the pooling of intellectual property (pull, push, pool).
The precise mechanism envisaged is that companies will apply to the 3P
Project for either a prize or a grant. They will then be asked to pool their data, and be considered firstly by a scientific committee and then a steering committee, which will decide whether to allocate the prize or grant. It also envisages that all drugs developed using 3P funding will join the Medicines Patent Pool (MPP).
The 3P Project is run by a consortium of anti-TB organisations, led by the International Union Against Tuberculosis and Lung Disease (IUATLD). Médecins Sans Frontières (MSF) were instrumental in starting the project.
Scope: The 3P Project focuses on TB, and would impact all areas of R&D in this area.
Access: Via a patent pool, the 3P Project would increase competition and lower prices. Licensing agreements would be made with conditions of affordability and scope of provision.
Innovation: Incentives are not directly linked to health impacts.
Efficiency: It is not clear how costly the 3P Project would be to run. The 3P Project would be partially market-based, as the patent pool would create competition in manufacture and sales.
Governability: Given the variety of mechanisms involved, it is likely that the 3P Project would need substantial governance. The prize mechanism will also require price setting and product specification, which are difficult to do correctly. The selection process would need to be robust against political interference (which might be a less grave concern as the project is administered by Non-Governmental Organisations (NGOs).
Political Feasibility: As the 3P Project coexists alongside patents, this makes it easier to implement. It also has the backing of a wide range of NGOs.
As a composite project, the 3P Project contains elements of many other proposals.
Both the Fund for research in Neglected Tropical Diseases (FRiND)and the 3P Project share the idea of raising funds which are disbursed for the late-stage creation of neglected drugs on condition of affordability. The 3P Project has a more composite mechanism and a more targeted disease area than FRiND.
The 3P Project is composite and disease focused, like the Chagas Disease Prize Fund. It too would involve both a patent pool and prizes for specific products. The 3P Project also envisages direct funding of research, which is not part of the Chagas Disease Prize Fund. The Tuberculosis Prize proposal is essentially the same as the Chagas Disease Prize Fund.
The Health Product Research and Development Fund is a mixed proposal, and as such might look something like the 3P Project. Both proposals would disburse funds in a variety of ways. A key difference is that the 3P Project is TB specific, whereas the Health Product Research and Development Fund targets all Type II and III diseases.
The WHO global consortium is also a mixed proposal like the 3P Project, but targeting antibiotics.
The 3P Project envisages direct funding of research. Selection would be based on scientific assessment. This is similar to Product Development Partnerships (PDPs).
The 3P Project includes a requirement to pool information. This is comparable to The Pool for Open Innovation against Neglected Tropical Diseases and Medical Innovation Prize Fund (MIPF).2
The 3P Project would incorporate a patent pool.3 If FRiND operated a system of license exclusivity for FRiND, then it too would become a patent pool.
Stakeholders on board:
Core members of the Steering Group: TB Alliance (TBA), Médecins Sans Frontières (MSF), the Stop TB Partnership (STBP), The South African Medical Research Council (SAMRC), the International Union Against TB and Lung Disease (The Union), the Medicines Patent Pool (MPP), the Critical Path Institute (C-PATH) and an individual nominated by civil society groups (CS).
The WHO’s Global TB Programme sits as a permanent observer to the Steering Committee.
The 3P Project was presented to the World Economic Forum on Africa in May 2017.4
Reasons that such a regimen has so far not been developed commercially, in addition to the poverty of many TB sufferers, are that:
There are high risks and costs to testing multiple drugs and combination treatments.
Consequently, companies have focused on drugs rather than regimen.
There are also pipeline problems in progressing drugs to late-stage trials.5
This suggests that a proposal that incentivises the creation of non-commercially viable drugs might have a particularly strong effect on diseases which require multiple treatments, and on improving pipelines.
The proposal: “THE 3P PROJECT. Better TB Treatment. Faster,” 2016. https://www.msfaccess.org/sites/default/files/TB_briefing_3P-2016_EN.pdf.
The proposal summarised: “THE 3P PROJECT. Better TB Treatment. Faster.Factsheet,” 2016. https://ec.europa.eu/research/health/pdf/hpforum/6b_ghpforum_brussels_2016-12_3p-project_factsheet.pdf.
News and comment:
”‘3P Project’ WHO Bulletin Editorial Emphasises Urgent Need for R&D Funding Innovation.” The Union. Accessed July 7, 2017. http://www.theunion.org/news-centre/news/3p-project-who-bulletin-editorial-emphasises-urgent-need-for-rd-innovation.
“Fundraiser – 3P Project at Switzerland.” Accessed July 7, 2017. https://uncareer.net/vacancy/fundraiser-3p-project-86568.
“The 3P Project: A New Approach to Developing Better Treatments for TB.” Accessed July 7, 2017. http://www.msfaccess.org/spotlight-on/3p-project-new-approach-developing-better-treatments-tb.
“The Union Presents ‘3P Project’ to World Economic Forum on Africa.” The Union. Accessed July 7, 2017. http://www.theunion.org/news-centre/news/the-union-presents-3p-project-to-world-economic-forum-on-africa.
Grania Brigden, José Luis Castro, Lucica Ditiu, Glenda Gray, Debra Hanna, Marcus Low, Malebona Precious Matsoso, et al. “Tuberculosis and Antimicrobial Resistance – New Models of Research and Development Needed.” Bulletin of the World Health Organ 95 (2017): 317.