New IP-sharing framework to accelerate R&D
The Access to Medicine Foundation has worked with BIO Ventures for Global Health (BVGH) to develop a framework for identifying which IP assets are most difficult for companies to share, yet most likely to speed up R&D of the medicines and vaccines needed by people living in low- and middle-income countries (LMICs).
Pharmaceutical R&D constantly leads to the generation of new intellectual property (IP), from clinical trial data to libraries of promising compounds. Not all IP assets generated by a company are used in their future R&D. When this happens, companies can choose instead to share them with other third-party researchers, under licensing agreements.
“Over the past 10 years, we have tracked how companies share their IP to accelerate R&D. We have identified the huge potential this has to bring newly developed products to people living in low- and middle-income countries. In 2018 we want to dive deeper into this analysis—to help guide companies towards making decisions about sharing their IP which are informed by global health considerations,” says Danny Edwards, Research Programme Manager for the Access to Medicine Index. “With this framework, companies now have a tool to strengthen their IP-sharing strategies.”
Sharing innovation to accelerate R&D
In the past, companies tended to invest in in-house R&D and ring-fence their knowledge and ideas, believing it to be the best way to protect and benefit economically from their IP. However, in today’s information-rich environment, some companies can benefit from a more open approach to innovation.
By sharing IP assets, the R&D process can speed up as third-party researchers can continue what companies have started. This can result in new medicines and vaccines for diseases that may be overlooked by the pharmaceutical companies due to e.g., commercial decisions. Since low- and middle-income markets offer different commercial market incentives relative to wealthier countries, IP sharing can support those who are working to develop new products that address the needs of LMIC populations.
A new framework to guide IP-sharing practices
Since 2008, the Access to Medicine Index has tracked how 20 of the largest R&D-based pharmaceutical companies share IP assets to accelerate product R&D for high-burden and priority diseases. The 2016 Index found that 14 out of 20 companies evaluated provided evidence of 32 instances in which they shared IP with research institutions or drug-discovery initiatives on terms that aim to support access to any resulting innovations in low- and middle-income countries. Most of this IP sharing aimed to accelerate R&D for HIV/AIDS, lower respiratory infections, malaria, tuberculosis and neglected tropical diseases.
In collaboration with BVGH—a non-profit organisation focused on R&D global health needs— the Access to Medicine Foundation has now developed a new framework for evaluating industry IP sharing agreements for R&D. The framework will be used for the first time as part of the 2018 Access to Medicine Index analysis allowing for a deepened analysis of companies’ activities in this area. The framework compares different IP-sharing agreements in terms of risk, effort and potential value to accelerating R&D. The Index analysis will publicly recognise, in its scoring system, companies that take the greatest efforts to share IP that has the greatest potential to accelerate R&D according to the needs of populations in low- and middle-income countries.
Companies can use the framework to improve their IP-sharing approaches by identifying assets that have potential to accelerate R&D for global health needs, where the company does not have plans to pursue such R&D internally. The framework can be used as a guide to illustrate how companies may be impacted when sharing a particular asset type: in terms of the efforts and costs associated with sharing it, and the value of the asset to the company. This information will enable companies to prioritise sharing assets that are most likely to benefit the recipient and accelerate R&D.
Identifying value and risks
The framework assesses 11 types of IP assets, all of which are valuable to product R&D for high-burden and priority diseases. The asset types are rated on a set of six criteria: 1) asset value to company; 2) risk to company; 3) effort for company; 4) asset value to researcher; 5) benefit to researcher; and 6) acceleration to market. Each asset type is given a weighting per criteria. The accumulated weights are used to place the asset type in one of three bands: assets in the ‘greatest’ category, for example, include those that pose a greater risk or effort to the company, but also have the greatest value to R&D that addresses global health needs.
“There are individuals within companies that may be aware of opportunities to support R&D for global health by sharing IP outside the company,” says Clarke Cole, Researcher for the Access to Medicine Index. “Strong alignment across company divisions, and the use of resources such as this framework, can help make this happen more often. Collaboration with organisations such as BVGH can also play an important role in supporting companies in this process.”
The results will be published in November as part of the 2018 Access to Medicine Index report.
This paper was co-authored by Clarke B. Cole, Researcher at the Access to Medicine Foundation and Katy Graef, Associate Director at BIO Ventures for Global Health.