MAPGuideⓇ
Equitable Access Toolkit
Incorporating Equitable Access Considerations for Clinical Trials into License Agreements
Approaches to designing, executing, and sharing data from clinical trials can play an important role in achieving timely and equitable access to a final product. Depending on the scope of activities under a license or collaboration agreement, it may be appropriate for the agreement to include clinical trial-related provisions reflecting best practice approaches for facilitating equitable access, such as:
The registration of clinical trials, and the reporting of both positive and negative results, in a publicly available clinical trial registry;
Open access publication of clinical trial results;
Rapid sharing of clinical trial results during health emergencies;
Compliance with good clinical practice guidelines;
Timely and meaningful community engagement throughout the clinical trial process;
Recruitment of diverse and inclusive clinical trial populations;
Use of clinical trial sites in LMICs to support faster regulatory reviews for markets where a funded product may be most needed;
Making clinical trial results available to the Ministry of Health in the country in which a trial is conducted;
Providing a funded product to third parties at an affordable price for clinical trials; and
Planning for post-trial access to the product for patients participating in the clinical trial.
License and collaboration agreements may address the above considerations through specific agreement provisions and/or as part of a product development or access plan established under the agreement. These requirements may also be passed-through from a party’s obligations under funding agreements related to the licensed product or technology.
Clinical trial-related provisions may also provide for licensor or collaboration partner oversight of clinical trial design and execution through rights to review and comment on clinical trial protocols, and/or other governance and reporting mechanisms under the agreement.
Examples from the MAPGuide
[Funder] has the right, but not the obligation, to create a committee of experts to advise [Funder]/[Licensee]/[Licensor], as applicable, on clinical trials and expanded access with respect to SRA Development Candidates and SRA Products (the “[Funder] Clinical Trials Advisory Committee”). Such [Funder] Clinical Trials Advisory Committee shall consist of such individuals as [Funder] may designate, but shall include [**]. The [Funder] Clinical Trials Advisory Committee shall have, as one (1) of its principal mandates, the responsibility of balancing (i) the rapid and efficient development and commercialization of SRA Development Candidates and SRA Products for the benefit of all potential patients in the SRA Field and (ii) the appropriateness, based on available safety and efficacy information with respect to such SRA Development Candidates and SRA Products, of providing access to such SRA Development Candidates and SRA Products to individual patients via the extension protocols or expanded access programs further described in Sections [x] Such [Funder] Clinical Trials Advisory Committee may establish its own procedures for meetings and decision-making.
[Funder] has the right, but not the obligation, to assist with patient recruitment for any SRA Company Clinical Trial involving [disease] patients by (i) referring to [Licensee] (or, at [Licensee]’s request, referring directly to any clinical investigator at a clinical trial site for the applicable clinical trial) up to [**] [disease] patients meeting the enrollment criteria for the applicable clinical trial and identified by [Funder] or its designee, and/or (ii) proposing up to [**] clinical trial sites with access to appropriate patient populations for such clinical trial. […]
Each time that [Licensee] commences the drafting of a clinical trial protocol for a SRA Development Candidate or SRA Product, and at reasonable times thereafter, [Licensee] will discuss with [Funder] [Licensee]’s plans for making such SRA Development Candidate or SRA Product available to participants in such clinical trial after the completion of such trial. […]
Source: taken from a license and collaboration agreement between the Roche (Licensee), PTC Therapeutics (Licensor), and the Spinal Muscular Atrophy Foundation (Funder), which builds on initial development work under a sponsored research agreement (“SRA”) between PTC and the Foundation. Partner types: industry, non-profit research institution; Product type: SMA treatment (Evrysdi/Risdiplam); Development stage at signature: preclinical. Read in context.
The [Licensee] will provide [Licensor] with a copy of any proposed Protocol amendments and shall not implement any Protocol amendments until such amendments are submitted by [Licensor] to the FDA. [Licensor], as the holder of the IND, shall be responsible for submitting any Protocol amendments to the FDA. The [Licensee] will consult [Licensor] concerning any provisions of the Protocol or Protocol amendments which may deviate from or fail to meet the standards of the ICH Harmonised Tripartite Guideline for Good Clinical Practice or which affect the Product. Such provisions will only be included with [Licensor]’s agreement. […]
The [Licensee] will require all Investigators to sign agreements requiring them to comply with the ICH Guidelines for Good Clinical Practice as required by the Protocol. […]
Source: taken from a license and collaboration agreement between the UK Medical Research Council (Licensee) and Indevus (Licensor). Partner types: industry, non-profit research institution; Product type: microbicide for the prevention of HIV infection; Development stage at signature: phase 3 clinical trial. Read in context.
[Commercial Partner] will manufacture and make available to [Non-Profit Partner] samples of CAMB in such quantities as shall be necessary for [Non-Profit Partner] to conduct its activities under the R&D Plan. Such samples will be subject to the provisions of Section [x – material transfer] below and sold by [Commercial Partner] to [Non-Profit Partner] at a price to be agreed between the Parties once agreement on clinical trial protocols have been reached by the JRC. [Non-Profit Partner] and [Commercial Partner] management will base the cost of clinical trial materials on the cost of the raw materials necessary for the production of CAMB and agree to a reasonable and sufficient additional cost to cover [Commercial Partner]’s internal costs or the costs of using an external manufacturer.
Source: taken from a research collaboration agreement between DNDi (Non-Profit Partner) and BDSI (Commercial Partner). Partner types: industry, non-profit research institution; Product type: treatment of African Human Trypanosomiasis , Chagas disease, and Visceral & Cutaneous Leishmaniasis (CAMB); Development stage at signature: pre-clinical. Read in context.
How will other stakeholders support clinical trial conduct to facilitate equitable access, for example by supporting clinical trial sites.
Will the clinical trial strategy be developed further as part of the access plan for the licensed product?
How do clinical trial provisions align with other provisions in the agreement intended to support response to health emergencies?
How do requirements for registration and reporting of clinical trial results align with other publication obligations under the agreement?
How does the clinical trial strategy align with the licensee’s regulatory and product registration commitments for the funded product?
How will the governance mechanisms under the agreement provide oversight over clinical trial conduct?
What clinical trial-related information will be incorporated into reporting obligations under the agreement?
This toolkit has been built based on the data in the MAPGuide and the GHIAA team’s experience of negotiating and implementing agreements. We intend that the toolkit will evolve and expand over time based on input from MAPGuide users and availability of new agreements showing examples of alternative approaches. We welcome ongoing constructive dialogue around these materials and encourage you to contact us or fill in our feedback survey to share your thoughts, questions and suggestions.