Access-Oriented Licensing: A Path to Affordable Health Technologies for All

The briefing note by WHO and UNDP advocates for access-oriented technology licensing to ensure equitable access to health technologies, emphasizing reduced royalties, transparency, and broad territorial rights. It provides practical guidance to align innovation with public health goals, particularly in underserved regions.

The briefing note on access-oriented technology licensing, jointly produced by the World Health Organization (WHO) and the United Nations Development Programme (UNDP), highlights the crucial role of technology licensing in ensuring equitable access to health technologies. With contributions from leading experts, including Professor Frederick Abbott and representatives from WHO, UNDP, and the Medicines Patent Pool, the document emphasizes the need for licensing models that prioritize public health over profit maximization. Rooted in WHO’s Global Strategy on Public Health, Innovation, and Intellectual Property and UNDP’s HIV and Health Strategy, this guide advocates for licensing approaches that can bridge the gap between technological innovation and its accessibility, particularly in low- and middle-income countries.

Technology Licensing: A Catalyst for Equitable Access

Technology licensing underpins the research, development, production, and distribution of critical health technologies, including vaccines, diagnostics, and therapeutics. By creating the legal framework for transferring intellectual property (IP) such as patents, trade secrets, and trademarks, licenses facilitate the sharing of innovation and technical expertise between parties. This process, often referred to as technology transfer, enables the commercialization and distribution of health products, ensuring that technological advances benefit wider populations. The briefing note underscores that access-oriented licensing, which may include reduced or waived royalty fees, is particularly critical for fostering affordability and availability of health products in underserved regions. These agreements balance financial sustainability for licensors with the imperative of public health equity.

Prioritizing Public Health Over Profit

A distinguishing feature of access-oriented licensing is its focus on societal benefits rather than maximizing financial returns. Unlike conventional profit-driven licensing, access-oriented agreements are designed to reduce barriers to affordability. This may involve lower royalties, geographic flexibility, or provisions that allow the use of regulatory data to expedite product approvals. The note also explores the potential of open-source licensing, which is increasingly relevant in health technologies. Borrowed from the software sector, open-source licenses make IP freely available under certain conditions, such as mandating that any improvements or adaptations to the technology be shared in the same way. This approach fosters collaboration and ensures that innovation remains accessible to all.

Addressing Challenges in Licensing Agreements

The document identifies common challenges in technology licensing and offers guidance on overcoming them. Geographical limitations, field-of-use restrictions, and exclusivity clauses can hinder the widespread adoption of health technologies. While exclusivity may be necessary to attract investment in some contexts, the authors argue that access-oriented agreements should aim to minimize such constraints. For instance, licensing agreements should permit the production and distribution of products in regions where the patent holder does not enforce rights or where governments have issued compulsory licenses to address urgent public health needs. By avoiding unnecessary limitations, licensing agreements can support the production and delivery of health products to the populations that need them most.

The note also highlights the importance of transparency and fairness in agreements. Provisions related to royalties, pricing, and grant-back obligations should align with public health objectives, ensuring that agreements foster both affordability and sustainability. Additionally, licensees should be allowed to develop and improve upon licensed technologies without burdensome conditions, encouraging innovation and adaptation to local needs.

Practical Guidance for Negotiating Access-Oriented Licenses

To support stakeholders in drafting effective access-oriented licenses, the briefing note provides a comprehensive checklist of critical elements to include in agreements. These elements cover IP rights, royalties, regulatory approvals, transparency requirements, and dispute resolution mechanisms. For instance, agreements should specify the territorial scope of licensing rights, aiming for the broadest possible reach to maximize access. Pricing terms should ensure that reduced royalty rates result in affordable pricing for end users. Regulatory approval provisions should address access to necessary data and cooperation between licensors and licensees to expedite market entry.

The checklist also emphasizes systemic issues like the role of compulsory licensing under the TRIPS Agreement in addressing public health emergencies. Governments may issue compulsory licenses without the consent of patent holders to meet urgent health needs. The briefing stresses the flexibility allowed under international law for such measures, particularly in cases of national emergencies or non-commercial public use. It further calls for transparency in licensing agreements, advocating for the disclosure of commissions and fees and the publication of essential terms to build trust and accountability.

Bridging Innovation and Access

WHO and UNDP present this briefing note as both a policy guide and a practical toolkit for advancing global health equity. By championing access-oriented licensing, the organizations aim to ensure that technological advancements benefit all populations, especially those in resource-limited settings. The document emphasizes that public health must take precedence over financial gain in regions where affordability remains a major barrier to healthcare.

Access-oriented licensing models provide a framework to harmonize innovation with social justice, fostering affordable and equitable access to life-saving health technologies. Through this approach, WHO and UNDP reaffirm their commitment to improving health outcomes worldwide and leaving no one behind. By integrating practical guidance with broader policy considerations, the briefing note offers actionable recommendations to bridge the gap between innovation and accessibility, advancing a global health agenda centered on equity and inclusion.