Research and innovation (R&I) play a key role in addressing some of our pressing societal challenges, for instance related to health, food and climate issues. This require R&I actors to rethink the way they can maximise the use of their knowledge assets in order to ensure societal impact.
In the past decades, a growing number of universities and public research organisations in the US introduced principles aiming to recognise the ethical and social responsibility surrounding the licensing of IP resulting from publicly funded research in their policies. More recently, socially responsible licensing principles and practices were included in the policies of some European universities and organisations.
Yet, the potential impact and benefits of these practices merit to be further explored in the European R&I landscape. Ethical considerations are key in an ecosystem where knowledge diffusion serves both economic and societal interests. Harnessing the full potential of the EU in a knowledge-based economy requires solid guidelines for responsible R&I practices to ensure that technological advancements align with societal values, contribute to the public good and therefore promote sustainable development goals (SDGs). As stressed in the recently published report ‘Much more than a market’, it is thanks to values such as openness, collaboration, and social innovation, that the EU will empower its citizens, strengthen its research capabilities, and secure its position as a global leader in the digital age.
Against this background, the Commission is taking action to foster the use of socially responsible practices by European universities and public research organisations with the aim to find a balance between commercialisation and societal impact in the valorisation of research results.
What is socially responsible licensing?
As recipients of public funding, universities and public research institutions have an ethical obligation to serve public interests, promote the public good and produce social benefits. In this context, the focus of these actors switched in recent years from exclusively performing research and teaching activities to contributing to economic, societal and environmental causes, as part of their so-called ‘third mission’.
Innovation and knowledge valorisation activities are essential to pursue this third mission. In particular, integrating socially responsible practices in intellectual assets management is key to widen access to innovation. Socially responsible licensing influences the way agreements are drafted to make sure that societal interests are taken into account in commercial activities. Examples of socially responsible licensing clauses include non-exclusive licensing of technologies with differential access or pricing for developing countries, the university’s right to require due diligence in downstream development, and the licensee’s obligation to exploit the invention for societal benefits and to be committed to ethical practices.
Pioneers of socially responsible licensing
In the 1960s, a medication named Stavudine was discovered by the Detroit Institute of Cancer Research as a treatment for patients fighting cancer. 20 years later, two researchers at Yale University funded by the US National Institutes of Health and the pharmaceutical company Bristol-Myers Squibb discovered a new use of Stavudine to treat HIV patients. Yale University obtained a patent for the HIV application of the medication and granted an exclusive license to Bristol-Myers Squibb. In 1994, the company started worldwide commercialisation of Stavudine with a uniform price. The cost of the medication (over 4.000 euros per year in 2001) made it hardly accessible for patients in developing countries such as South Africa.
The non-governmental organisation Médecins Sans Frontières declared the price of this essential medicine unsustainable and asked Yale University’s Board to waive the South African patent. The university however refused, claiming that this would break the exclusive license agreement with Bristol-Myers Squibb. Ultimately, strong public pressure pushed Yale to reconsider its licensing policy and the patent was waived in South Africa, allowing generic manufacturers to distribute the medicine at a much lower price.
Since then, Yale and other universities in the US such as Berkeley, Emory, and Harvard have developed different strategies to implement their socially responsible licensing policies. Originally and mainly applied in the fields of health and life sciences, these principles are increasingly recognised as a way to improve the accessibility of intellectual assets in different sectors such as plant breeding and food security.
Frontrunners in Europe
In Europe, socially responsible licensing policies have been introduced in a limited number of universities and public research organisations such as the University of Maastricht in 2015 and the Flemish Interuniversity Council (VLIR) in 2021. The Netherlands Federation of University Centres (NFU) is a leader in the field with its "Ten principles for Socially Responsible Licensing“ launched in 2019, followed by the publication of a toolkit to support negotiations of licensing agreements between universities or research institutes and companies. In these agreements, special attention is paid to societal objectives, like the effective availability of products and services licensed in a specific region or country to generate the greatest possible public benefit. The toolkit was created in collaboration with a broad range of public and private stakeholders including academic institutions, research organisations and companies to balance different expectations and interests.
In 2021, Wageningen University explored the application of socially responsible practices in the domain of agriculture and food production through the royalty-free licensing of patented CRISPR-Cas technology. CRISPR is a bacterial defence system against viruses to make plants more resistant to drought and diseases, ultimately helping to fight hunger around the world. The royalty-free licenses are only granted to gene-editing of plants for non-profit applications. Wageningen University’s patents are part of a patent pool and are available for exploitation by companies with commercial interests. This example shows how societal and commercial purposes can be combined.
Fostering socially responsible licensing in Europe to create further value for society: next steps
The Guiding Principles for Knowledge Valorisation identify socially responsible licensing as a way to valorise knowledge by considering societal needs and benefits besides traditional profit drivers. The Code of Practice on the management of intellectual assets recommends R&I actors to implement these practices. The importance of fostering the use of equitable and ethically responsible access to intellectual assets has also been highlighted in the context of the Mutual Learning Exercise (MLE) on Knowledge Valorisation, which engaged 18 countries striving to improve policies and public support for knowledge uptake and deployment.
The Commission decided to further investigate how to foster the implementation of socially responsible practices by universities and public research organisations. With this purpose, the Commission will encourage exchanges and discussions at EU level and plans to actively engage with a wide range of R&I stakeholders.
Important aspects to be reflected upon include aligning various interests at stake, boosting both economic and societal impact, applying this tool in a wide array of contexts and areas, as well as involving and fostering the motivation of heterogeneous actors for its implementation.
More information
Guiding Principles for Knowledge Valorisation and implementing Codes of Practice
Code of practice on the management of intellectual assets for knowledge valorisation
MLE Thematic report on intellectual assets management