A new project that stimulates the development of affordable and effective drug regimens to treat tuberculosis (TB) is catching notice in policy circles.
The “3P Project” is based upon the three aims of the project, namely “pulling funding, pooling data and intellectual property and pushing funding” for the research and development of TB treatment, Grania Brigden, 3P Project Lead, told Intellectual Property Watch in a recent interview.
The 3P Project plans to distribute monetary prizes and grants for research and development of new treatment for TB, Brigden said. The intellectual property and the data resulting from the R&D will be pooled together and made available via licences, and the final costs of the medicines will be delinked from the costs of R&D, she said.
The underlying idea of the 3P Project originates from the Open Access Campaign of Médecins Sans Frontières (MSF – Doctors Without Borders), Brigden said.
The 3P Project is still in the development phase, according to Brigden. Nonprofit group International Union Against Tuberculosis and Lung Disease (Union) – with offices in various regions in the world – will host the secretariat of the 3P Project. There will be a close collaboration between the 3P Project, based in Geneva, and other organisations such as MSF and the Medicines Patent Pool (MPP) in order to avoid duplication of work, Brigden added.
The launch of the 3P Project is planned during the Global Ministerial Conference on TB from 16-17 November in Moscow. The event is especially relevant due to high number of TB cases in Russia.
Tuberculosis and R&D
Investment in research and development for TB – the world’s most deadly infectious disease – has been decreasing, even as the number of TB patients continues to increase, according to Brigden. It is not the science, but the lack of investment that prevents the development of a better treatment for TB, she said.
The market for TB treatment is failing, and the pipeline for new TB drugs is really weak, she said, adding that TB cannot be cured with one drug.
TB primarily occurs in the vulnerable groups of middle and low-middle income countries. Brazil, Russia, India and China – the BRIC countries – bear the highest burden of TB, but they do not invest as much in the R&D for TB treatment as countries with a lower burden, said Brigden. The 3P Project is talking with several governments about how the project could work for them, Brigden added.
There is a clear political will to do something about TB, Brigden said, adding that governments are starting to prioritise TB. And a clear link has been established between TB and antimicrobial resistance, she said. This changing landscape offers a unique environment for the launch of the 3P Project, said Brigden, who noted that the UN General Assembly High-Level Meeting on TB takes place in 2018.
The current treatment of drugs-resistant TB takes two years and entails painful daily injections for at least six months and a high number of tablets with several serious side-effects, according to Brigden.
TB is a global disease and it is in everyone’s interest to find a better treatment to cure, she said. The ultimate aim of the 3P Project is to find within 10 years a tuberculosis regimen that works “for everyone and everywhere” and cures TB patients in one month or less, Brigden said.
The 3P Project offers a unique opportunity to move from a conceptual discussion on delinkage and failure in the market of TB treatment to an actual operationalisation, Brigden said.
The objective is to change the incentives for research for TB treatment by fostering partnerships, offering prizes and grants and pooling intellectual property and data together on a worldwide scale.
The monetary prizes granted by the 3P Project constitute rewards for the investment made by developers before phase 1 of the clinical trials, Brigden said. Different criteria will be established as conditions to receive a prize.
Developers will be required to transfer the IP and data related to TB to the pool after they win a prize, Brigden said. The drug compound and the related data will be made available by licence agreements governed by MPP, which has the necessary experience, Brigden said. The developer can continue to develop the TB drug and apply for grants after receiving the prize from 3P, she said. And the developers can keep the IP for all other purposes than TB.
The awarding of the prizes will not be linked to specific deadlines, but applications for prizes will always be possible, Brigden said. The aim of the 3P Project is to give two or three prizes a year, and there is an element of competition as no multiple prizes will be given for the same kinds of drug compounds, she said.
Data and IP Pooling
The pooling of data and IP aims at ensuring open collaborative research to ensure fair licensing for competitive production of the final products, according to the MSF website. Pooling of drug compounds is particularly important because TB cannot be cured by only one drug, Brigden said. The data from the clinical trials will be shared, irrespective of whether the outcome of the clinical trials was positive. Data sharing will facilitate the development of a better understanding of TB, she said.
Developers who get through the first phase of the clinical trials can apply for grants. Grants, the so-called pull mechanisms, provide upfront financing for developers for their R&D activities during the clinical trials. The grants allow developers to carry out the clinical trials without the need to invest their own money, Brigden said.
Brigden underlined that there will be no link between the market price of the medicine and the R&D costs. The profit percentage of the developer of the final drug will be defined in discussion between the developers and the 3P Project.
The aim is to establish “a real open” format for everyone to participate, according to Brigden. The grants and prizes will also be open to academic institutions and pharmaceutical companies.
The licence agreements will entail the obligation for the licensee who wants to have access to make the drugs available in highly affected countries such as Myanmar and Burkina Faso in order to gain access to the market in BRIC countries, Brigden said. This obligation ensures that the product becomes available “in the right way for everyone and everywhere,” she said.