Pharmaceutical research and development (R & D) is one of the best examples of human ingenuity, attracting vast funding and deploying the most advanced technologies. Over the past century, it has enabled unprecedented advances for human health. Yet the pharmaceutical R & D system is struggling to keep up with society’s medical needs. More and better medicines are desperately needed at a time of global ageing and expanding populations, with new challenges such as antibiotic resistance on the horizon and many tropical infectious diseases still in need of adequate pharmaceutical solutions.
A new paper published today by the Oxford Martin School calls for ‘open science’ approaches to drug discovery and offers ways forward that would transform how the medical challenges of this century could be addressed more efficiently.
‘A New Pharmaceutical Commons: Transforming Drug Discovery ’, written by Professor Chas Bountra, Dr Wen Hwa Lee, and Dr Javier Lezaun, highlights the limits of traditional R&D models focussed on secrecy and the protection of Intellectual Property (IP) rights, and offers a set of recommendations for strengthening pre-competitive and open source practices that can accelerate the race for cures to the world’s most harmful diseases.
Professor Chas Bountra, Co-Director of the Oxford Martin Programme on Affordable Medicines and Chief Scientist at the Structural Genomics Consortium, said:
“The pharmaceutical industry has made enormous strides in the production of potential therapies and medicines. But even today, close to 90% of candidate drugs that enter Phase 1 trials fail to make it to the market place. This is a system beset by duplication of effort and hence wastage of resources. No one lab or institution can do this on its own. We must urgently pool resources and expertise, minimise duplication, explore new drug targets, biomarkers, and technologies in order to generate new, effective, and more affordable drugs for patients more quickly.”
The new paper calls for the adoption of ‘open science’ principles that would allow for a less restrictive approach to the sharing of pharmaceutical tools and data, and would re-define the role of IP in pharmaceutical R&D. It also gives examples of where this is already working successfully.
“There has been a great deal of successful experimentation with the application of pre-competitive and open source approaches to drug discovery, not least here at Oxford with the Structural Genomics Consortium, which has shown how corporate pharmaceutical resources can be pooled and used to produce IP-free science” says co-author Dr Javier Lezaun at the Institute for Science, Innovation and Society.
Dr Wen Hwa Lee expands on this;
“Recent healthcare advances have been challenging what is becoming an obsolete way of working, in search of a more efficient configuration. At the centre of this soul-searching and restructuring is the matter of trust and cooperation which can be best established through open science and transparent frameworks.”
Although there is no simple one-size-fits-all solution to the challenges of the drug discovery process, the authors argue that open source R&D has the potential to have a significant impact. The paper outlines a number of recommendations aimed at enlarging and strengthening this crucial component of the drug discovery ecosystem.
- Calls on governments to provide tax incentives for pre-competitive and open source research, for example by introducing a lower tax rate on profits obtained from IP-free innovations, or to facilitate the placing of patented innovations in free-access platforms.
- Recommends that regulatory agencies introduce specific designation for products developed through open science collaborations, with reduced fees and fast-tracked review of technical data.
- Suggests that pharmaceutical companies develop new evaluative metrics to better capture the value of open science research, and create schemes that allow researchers to contribute a percentage of their time to open science drug discovery initiatives.
- Proposes within academia a shift away from patent- and intellectual property-centric measures of performance.
- Advocates that research funding bodies increase investment in open science drug discovery initiatives, developing specific funding programmes to kick-start these efforts and place the supporting infrastructures on more sustainable footing.