Policy Recommendation
The UN Sustainable Development Goals, which support the implementation of universal health coverage by 2030, recognise that more equitable and timely access to health interventions such as medicines, vaccines, diagnostics and therapies is an important driver of good health and improved lives. In the words of the World Health Organisation, universal health coverage can only be achieved when there is affordable access to safe, effective and quality medicines and health products. Recent years have seen significant progress, made through collaboration between different actors and using various mechanisms and business models. Cambridge Enterprise (CE), supported by the University of Cambridge, wishes to play its role.
Cambridge Enterprise licences anticipate that licensees, upon achieving the first regulatory approval for a new medicine, will discuss and where possible agree a plan to support affordable access for the licensed product(s) in low and middle income countries, such as through licensing or partnerships including with non-profit organisations, with strategies and timelines.
Background
CE annually receives a Freedom of Information Act request from WhatDoTheyKnow for the CE/University policy on affordable access, including the original legal language for clauses related to the policy. Recently CE has been approached by several groups, including ‘Universities Allied for Essential Medicines’ and ‘Global University Venturing’, enquiring about equitable access clauses in our healthcare licences, to make medicines available in lower income countries. This policy has been developed in response to the increasing demand for such licensing terms, including from research funders, and the importance CE and the University of Cambridge places on supporting access to affordable medicines.
Analysis
Approaches taken by other universities range from the University of Oxford with a general “as far as is practicable” policy, to UCLA that publishes its full discussion document and language incorporated into its licence agreements to biopharma innovations (see references below).
We recommend the policy at the outset of this document but would not publish our licence language. There is a risk that the requirement for an Affordable Access Plan may not be acceptable to CE licensees, although UCLA have used similar language in its licences since 2020. Issues will most likely be raised by the company that ultimately markets a drug (probably a sub-licensee). Medicines Patent Pool (MPP), a significant player and advisor in the area that makes medicines available in lower income countries, are not aware of an Affordable Access Plan being completed to date.
The policy generally aligns with the approach published by the Wellcome Trust, a major healthcare funder, and MPP guidelines that both relate to Low and Middle Income Countries (LMICs, as determined by the World Bank Group). Whilst countries such as Brazil and China are currently LMICs, the template legal language allows a licensee to decide (with CE’s agreement) that an Affordable Access Plan is not needed or infeasible in any specific LMIC.
References
University of Oxford: Access to essential medicines in the developing world
UCLA Considers Underserved Populations When Licensing Medical Research Discoveries
Medicines Patent Pool: Affordable Access Plan Provision
Wellcome’s approach to equitable access to healthcare interventions
World Bank Group classifications by income level for 2024-2025
Appendix
“Affordable Access Plan”:
means the Licensee’s and/or its Sub-Licensees’ plans (including strategies and timelines) agreed with CE reasonably intended to support affordable access in LMICs, such as through licensing or partnerships including with non-profit organisations.
“LMIC”:
means Low and Middle Income Countries as defined from time to time by the World Bank Group.
“Regulatory Authority Approval”:
means approval given by any federal, national, multinational, state, county, city, provincial, or local regulatory agency, department, bureau or other governmental entity with authority over the marketing, commercialization, manufacture or sale of a pharmaceutical product in the Territory, including the FDA in the United States, the EMA in the EU and the MHRA in the United Kingdom.
Affordable access plan
(a) The Licensee shall notify CE within [1][3] months of the first Regulatory Authority Approval.
(b) Within 3 months of receiving the first Regulatory Authority Approval of a Licensed Product, the Licensee will [use reasonable endeavours to] provide CE with either:
(i) a draft Affordable Access Plan; or
(ii) a written explanation as to why such an Affordable Access Plan is not needed or infeasible in one or more LMICs.
(c) In the case of clause (b)(ii), the Licensee agrees to discuss such reasoning with CE in good faith within one (1) month thereafter and, if following such initial discussion, CE concludes that an Affordable Access Plan is reasonable and desired, the Licensee agrees to [use all reasonable endeavours] provide CE a draft Affordable Access Plan within three (3) months of such initial discussion.
(d) The parties shall use reasonable endeavours to agree the Affordable Access Plan within 3 months of the Licensee providing such plan to CE in accordance with clause (b) or (c).
(e) To the extent such Affordable Access Plan includes Confidential Information, the Licensee will also provide a non-confidential version or statement of such Affordable Access Plan that CE can make available to third parties:
(i) specifying the LMICs in which the Licensee does and does not intend to commercialise the Licensed Products; and
(ii) setting out the Licensee’s and its Sub-Licensees’ plans (including strategies and timelines) reasonably intended to support affordable access in LMICs, such as through licensing or partnerships including with non-profit organisations.
The Licensee agrees to discuss in good faith the status, progress and implementation of the Affordable Access Plan on each Anniversary and following such discussion CE and the Licensee may amend the Affordable Access Plan by mutual consent.
