Orfenix welcomes a recently published report of the Medicines Patent Pool, in partnership with Boston Consulting Group, shows how voluntary licensing brings both improved access to medicines, in particular in low and middle-income countries and economic benefits to the companies doing the out-licensing.[1] The report highlights that the benefits for companies go beyond the increase in revenue and include cost savings. Moreover, the report shows that this kind of socially responsible licensing benefits enables reaching more patients than the licensor could without licensing, as the licensees are able to reach patients that are otherwise out of reach.
The Medicines Patent Pool (MPP) is a public health organisation, supported by the United Nations, is dedicated to enhancing access to and promoting the development of life-saving medications for low- and middle-income countries. The MPP’s work is not done in isolation but in collaboration with civil society, governments, international organisations, industry, patient groups, and other stakeholders. This collaborative approach is at the heart of its mission to prioritize and license essential medicines, thereby fostering the production of generics and the creation of new formulations.[2]
Until recently, the MPP focused mainly on supporting the out-licensing of existing products to achieve its goals. However, it now also looks into attaining its goals in early stage technology, i.e. before the product is on the market. This includes, for example, the pre-clinical and clinical development in startup companies. As licensing may play a crucial role, albeit to the company, instead of by the company, the MPP is well placed to use its expertise to improve the eventual access. To execute this approach, MPP looks to universities and other public research organisations to include language along these lines in its licenses.
As we in Orfenix know, early planning for access within the development process is not just important; it’s vital for addressing potential barriers to access for the final product. This proactive planning and preparation provides more time to develop and implement effective solutions, reassuring all stakeholders about the thoroughness of the process. Such proactive planning dovetails with licensor goals and benefits licensees. Attaching the access plan obligation to the licensed product itself helps avoid the limitations of focusing solely on a single patent. The plan links the access to a product as a whole and not just the licensed patent, as more traditional university technology transfer tends to do in anti-shelving clauses.
Health technology development is increasingly complex, with patent rights under a license often representing just a fraction of the finished, commercialised product. This product may incorporate other third-party patents and frequently relies on the innovator’s proprietary intellectual property, such as manufacturing know-how. Therefore, requiring an access strategy for the product(s) ensures comprehensive access, regardless of how patent rights are utilised in the invention. This comprehensive approach to access planning aims for outcomes instead of inputs while doing justice to the complexities of development.
This approach is fully in line with Orfenix’s commitment to access to medicines, not only for low- and middle-income countries. The commitment to work for equitable access to medicine does not start once a product is successfully developed. The commitment to consciously work towards this objective has to be made far earlier. It impacts the development as such, for example, the type of partner you pick or the obligations you enter into. Of course, socially responsible licensing only achieves its aims if the product gets developed, but this does not require the company to aim for profit maximization. Orfenix’s projects show that there are plenty of partners, from industry and from university, that can work effectively together to bring products to the market within the framework of improving the effective availability of medicines, as set by socially responsible licensing.
The Dutch academic medical centres (i.e. university hospitals) jointly agreed on principles to improve the effective availability of products based on publicly funded research in 2019.[3] They have since built on those principles to provide a suite of tools to facilitate hospitals negotiating for licenses with companies.[4] The key takeaway of these rules is the overarching focus on the effective availability of the products or services based on the expertise and research of universities. This emphasis is perfectly aligned with the initiative of the MPP. It highlights how early access planning as an integral part of licenses granted by universities fits with the goals and aims of the Dutch academic medical centres but most likely with universities and university hospitals globally.
The MPP’s initiative has already impacted the U.S. Government’s policy in the context of federally funded research. The National Institutes of Health (NIH) announced in May that it is set to introduce a new policy within its Intramural Research Program (IRP) to enhance access to products derived from taxpayer-funded inventions. The NIH is currently seeking public input on this draft policy, along with the proposed language for license agreements that integrate patient access considerations into the commercialisation process for NIH-owned inventions.[5] We at Orfenix hope that the Dutch government agencies involved in research funding such as NOW and ZonMW, and the EU Horizon programs will follow suit and also include the access plan as part of their commitment to socially responsible licensing.
[1] https://medicinespatentpool.org/news-publications-post/voluntary-licensing-right-for-health-smart-for-business-report
[2] https://medicinespatentpool.org/
[3] https://www.nfu.nl/sites/default/files/2020-08/19.4511_Ten_principles_for_Socially_Responsible_Licensing_v19-12-2019.pdf
[4] https://www.nfu.nl/sites/default/files/2023-08/Factsheet_Toolkit_Socially_Responsible_Licensing%20Toolkit_230823.pdf
[5] https://public-inspection.federalregister.gov/2024-11188.pdf
