MAPGuideⓇ
Equitable Access Toolkit
Introduction to Equitable Access Plans
What is an access plan?
An equitable access plan describes the activities to be undertaken as part of the R&D and commercialization process to address barriers to, and support the achievement of, equitable access to a healthcare intervention.
An equitable access plan can be attached as an annex to an agreement, and, where relevant, should expand on access commitments made through the provisions in the body of an agreement by providing details of the specific actions that a partner will take to fulfil those commitments, as well as the timelines for doing so.
What does an access plan look like?
As with agreement provisions, there is no one-size-fits-all template for an access plan; the elements included in an access plan will depend on what is appropriate for a particular product. Plans are also likely to evolve over time, with revisions made and more details added as the product moves towards commercialization.
Below is an outline of some potential components of an access plan, with an indication of details that may be added at different stages of product development.
In addition to addressing a partner’s actions to facilitate equitable access, access plans should consider the broader ecosystem needed to enable access to the end product, recognizing that a single project between two organizations is unlikely to be able to address all potential barriers to access. This approach enables organizations to contextualise their activities within a wider end-to-end access roadmap, and consider the future funding requirements and development partnerships needed to be able to fulfil access commitments, as well as identifying where other stakeholders should be responsible for parallel and/or future activities to facilitate access to an end product.
Access plan obligations in agreements
Agreement provisions related to the development and implementation of access plans can address elements including:
- The timeline for establishing a plan;
- Review and update mechanisms for the plan as more information becomes available about the product over time;
- Requirements to share the plan with third parties to support coordinated action to facilitate access; and
- Continuity and enforcement mechanisms to ensure that access plan obligations are diligently pursued and remain attached to the product throughout the development process.
Timeline
Initial access plans should ideally be established early in the development process so that equitable access goals for the product are integrated into product development plans from the outset.
Deferring access planning to a later stage risks the need to undertake unanticipated additional development activities, resulting in an inefficient use of funding and resources. For example, developers may need to adjust manufacturing processes to support product affordability, develop new product formulations to meet appropriateness requirements, or conduct additional clinical trials or adjust trial design to meet product registration requirements in different markets.
Early establishment of access plans also allows for early identification of the need to engage with additional stakeholders that may be responsible, and/or have access to funding, for different aspects of the access pathway. Earlier engagement and forward planning can help to minimize disruptions or delays in the development and commercialization process beyond the scope of a single funding agreement, therefore reducing the risk of delayed access to the end product.
Review and update mechanisms
Access plans should not be static, they should be ‘living’ documents that evolve alongside product development and commercialization plans as more information becomes available about the characteristics, manufacturing costs, and likely regulatory and procurement pathways for the product.
Regular review and update mechanisms can be included in agreements by:
- Defining trigger events or development milestones (for example, the end of or entry into a clinical trial phase) for the addition of specific details into the access plan;
- Integrating reporting on the implementation of access plans into progress reporting requirements; and
- Including oversight of the access plan in the responsibilities of a governance body such as a joint steering committee or specialist equitable access advisory committee.
Opportunities to engage with relevant experts through advisory committees or another consultation mechanism may be particularly valuable for smaller and early-stage companies who may have limited in-house capacity for, and experience with, the full range of potential barriers to access that need to be considered as part of an access plan.
Transparency
As described above, the parties to a single agreement are unlikely to have the capacity and expertise required to address all of the potential barriers to access to an end product. Sharing an access plan either publicly or with a defined group of relevant stakeholders provides opportunities for coordination with those that can fill capacity, funding and knowledge gaps to facilitate progress of the product along the access pathway, as well as enabling timely uptake of, and access to, an end product.
Some agreements provide for the development of both confidential and public versions of an access plan in order to manage concerns regarding the disclosure of commercially sensitive information.
Examples from the MAPGuide
Funding Agreements
The [Developer] will work with the [Funder] to develop (by the time of completion of Phase II clinical trials) and execute a manufacturing and supply plan that will enable to be met the reasonably expected demand in Developing Countries for any Products. […] The manufacturing and supply plan could involve the use of manufacturing partners and support from donors, and the specific level and allocation of funding responsibilities in such plan will be decided as mutually agreed in good faith in writing by the parties based on a fair allocation of the expected benefits between Developing Countries and developed countries.
Source: taken from a strategic relationship agreement between the Bill & Melinda Gates Foundation (Funder) and Arsanis (Developer) made in connection with an USD $8 million investment by the Foundation to support a Staphylococcus aureus antibody development program. Partner types: philanthropic funder, industry; Product type: neonatal sepsis mAb; Development stage at signature: discovery. Read in context.
The Global Access Coordinator, who shall initially be [Name] (or another person mutually agreeable to the [Developer] and [Funder]), will lead the [Developer’s] efforts to market the Products to Global Health Purchasers in Target Countries and to ensure overall customer success in Target Countries, in accordance with a plan to be prepared by the Global Access Committee on or prior to [date – 3 months after effective date] (the “Global Access Plan”). The activities of the Global Access Coordinator, which activities shall be consistent with the Global Access Plan, shall be overseen jointly by the [Developer]’s senior management and the Global Access Committee.
Source: taken from a global health agreement between the AXA Prime Impact Master Fund (Funder/Investor) and Revelation Biosciences (Developer) made in connection with a USD $4 million preferred stock purchase agreement. Partner types: impact investor, industry; Product type: allergic rhinitis therapeutic & diagnostic; Development stage at signature: early stage development. Read in context.
When its Product enters Phase III trials (or Phase IIb trials, if they are intended as the pivotal trials to support registration, or otherwise, when the [Developer] is preparing a Product that is not a therapeutic or preventative for First Approval as defined in Section [x]), the [Developer] shall create and provide to [Funder] within ninety (90) days, a plan reasonably describing how it intends to meet the above stewardship and access obligations for the Product, (the “Stewardship and Access Plan”). The Stewardship and Access Plan shall not include confidential business information and shall include:
(i) Strategy to support access and stewardship (e.g. proposed reliable production with sufficient capacity, supply systems, the broad approach to product labelling, and the broad approach to ensure economic barriers to access are as low as reasonably possible);
(ii) Identifying obstacles and constraints to access and stewardship;
(iii) Exploitation strategy for Project IP Rights, including whether it is planned for the Project IP Rights to be transferred to a third party;
(iv) Strategy to ensure marketing approvals are received for key territories in a timely manner; and
(v) Strategy for monitoring effectiveness of access and stewardship, including proposed metrics to measure success.
The [Developer] shall update the Stewardship and Access Plan and provide it to [Funder] when the Product is first approved by any of the FDA, EMA (or national authorities), or Japan’s PMDA (the “First Approval”). After First Approval, the Stewardship and Access Plan shall be updated if there are significant market or product changes, or if events so require. The [Developer] shall use best reasonable efforts to comply with its Plan at all times.
The Stewardship and Access Plan will be a non-confidential document and the Stewardship and Access Plan held on file after First Approval will be publicly posted on the [Funder] website.
Source: taken from the CARB-X (Funder) portfolio company agreement template with subrecipients (Developer). Partner types: non-profit funder, industry/non-profit research organizations/academic institutions; Product type: innovative therapeutics, preventatives and rapid diagnostics targeting drug-resistant bacteria; Development stage at signature: early stage development. Read in context.
The initial plan to support such Equitable Access commitment is set out in Annex E (the “Equitable Access Plan”); and the Equitable Access Plan shall be reviewed by the JMAG and/or the Equitable Access Group after it is established in accordance with Clause [x] no less than every [***] and shall take into account, as applicable, changes in COGs over time, production yield and volume and production economics. The Equitable Access Plan shall be updated throughout the Term to reflect such reviews or as otherwise agreed between the Parties. A significantly more detailed Equitable Access Plan shall be agreed promptly after the Equitable Access Group is established. Each Partner will keep [Funder] fully and regularly informed of its adherence to the Equitable Access Plan and its progress, or lack thereof, in meeting its objectives.
The Equitable Access Plan shall include a commitment from the Partners to negotiate future purchase, allocation and supply commitments in respect of the Project Vaccine(s), with purchasers in LMICs and UMICs, including with relevant international public health stakeholders such as Gavi, UNICEF and the Pan American Health Organisation.
Source: taken from a USD $38.4 million funding agreement between CEPI (Funder) and the University of Oxford and Barinthus Biotherapeutics (Developers). Partner types: non-profit funder, industry/academic institution; Product type: MERS vaccine; Development stage at signature: early stage development. Read in context.
To further define Your Global Access commitments, You are required to complete a Global Access Strategy and any other Global Access activities and documentation listed in the Reporting & Payment Schedule. The Global Access Strategy should address the following concepts with respect to all Funded Developments: (a) identification of Background Technology at the outset of the Project and any Funded Developments created during the Project and specific strategies to ensure access to such Funded Developments and Background Technology; (b) agreements and/or procedures for transfers of materials and data among Project Collaborators or third parties relevant to the Project; (c) reporting processes for the creation of Funded Developments to both the Project management team and to the Foundation as well as the publishing and dissemination of the knowledge and information gained from the Project; (d) strategies to secure, manage and allocate intellectual property rights associated with the Funded Developments or Background Technology in a way that ensures Global Access while providing incentives for future potential private sector participation; and (e) anticipated development, commercialization and sustainability strategies during and after the Project to ensure that Global Access can be met.
Source: taken from a USD $9.3 million grant agreement between the Bill & Melinda Gates Foundation (Funder) and Arsanis (Developer). Partner types: philanthropic funder, industry; Product type: RSV mAb; Development stage at signature: preclinical. Read in context.
License Agreements
Some academic and research institutions include an “Affordable Access Plan” provision in their license agreements. Some institutions have collaborated with the Medicines Patent Pool to develop these provisions.
Exact language varies between institutions and agreements, but they commonly include requirements for the licensee to:
- Deliver an affordable access plan within a specified period of time after FDA or other stringent regulatory authority approval, or alternatively provide a written explanation as to why a plan is not required or not feasible;
- Identify the LMICs in which it does not intend to commercialize the license product (the “Non-Commercialized Territory”);
- Set out strategies and timelines intended to support affordable access in LMICs and Non-Commercialized Territories, such as through licensing or partnerships;
- Provide a non-confidential version of the access plan that can be made available to third parties; and
- Participate in progress discussions to which the licensor may invite a “designated entity.”
Examples of Affordable Access Plan provisions include:
The Access and Implementation Plan will be drawn up in good faith at a high–level at the beginning of the Development and Distribution Program and will be developed by the Parties in more detail at a later stage.
[…]
The Regulatory Strategy (including timelines and milestones) for the registration of the Product shall be defined by the Parties, following the high‐level Access and Implementation Plan. Upon agreement on the Regulatory Strategy for a country, the Parties shall jointly establish a detailed Access and Implementation Plan for such country to ensure availability of the Product through public and private distribution channels in the Territory on an Affordable Basis.
Source: taken from DNDi’s template Development Collaboration and License Agreement. Partner types: PDP, industry/academic institutions; Product type: treatments for neglected diseases; Development stage at signature: template intended for use from Phase 1 clinical trials through to proof of concept in humans. Read in context.
Within six (6) months of the Effective Date or such longer period as may otherwise be agreed in writing (including by email), the Parties shall agree a detailed Manufacturing and Supply Plan for the supply of the Drug Product through the JSC. The Manufacturing and Supply Plan shall be based on the following principles:
the Parties shall develop a detailed forecasting, supply, access and implementation plan for the supply of the Drug Product and define related operational supply chain management processes to ensure availability and access of the Drug Product in the Field with the consultation, as appropriate, of one or more funding agencies or partners, e.g., the World Health Organisation; […]
Source: taken from a collaboration agreement between Entasis Therapeutics and GARDP. Partner types: PDP, industry; Product type: gonorrhea treatment (zoliflodacin); Development stage at signature: Phase III clinical trials. Read in context.
The Sublicensee shall use its best efforts to achieve the Manufacturing and Manufacturing Approval objectives and specific target dates set out in the Sublicense Access Plan in furtherance of the Access and Stewardship Objectives.
Should the Sublicensee not achieve any of the objectives set out in the Sublicense Access Plan by the corresponding target dates, the Parties shall consult in good faith to discuss the situation, the causes of any such delays, and possible actions to minimize the delay and/or prevent future delays. If requested by [Licensor], the Parties shall discuss and agree an access action plan to remedy the situation (each an “Access Action Plan”), and the Sublicensee shall diligently and in good faith implement the Access Action Plan.
Source: taken from a sublicense agreement between GARDP (Licensor) and Orchid Pharma (Sublicensee) related to a head license between GARDP and Shionogi. Partner types: PDP, industry; Product type: antibiotic (cefiderocol); Development stage at signature: FDA and EMA marketing approval. Read in context.
Funding agreements
License agreements
What actions can the funder take if the funded partner does not or cannot make progress against the access plan?
What actions can the licensor take if the licensee does not meet its access plan obligations?
How can the funder monitor the funded partner’s progress against the access plan?
How can the licensor monitor the licensee’s progress against the access plan?
What is the mechanism for periodic review and update of the access plan?
What is the mechanism for periodic review and update of the access plan?
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.