MAPGuideⓇ: Equitable Access Toolkit
Implementing Access Objectives through R&D Partnerships and Agreements
The Role of Partnerships in Equitable Access
Achieving equitable access to a healthcare intervention usually requires cooperation, coordination and partnerships between multiple organizations at different stages of the R&D and commercialization process. These partnerships may take the form of informal, ongoing dialogue, or they may be established as written, but non-binding, statements of intent through a memorandum of understanding (MoU), or they may be governed by a formal contract or agreement.
Why Formal Agreements Matter
Unlike informal relationships, formal agreements establish the specific rights and obligations each party has accepted to achieve partnership objectives. They also provide mechanisms to manage, enforce, and if necessary, terminate those requirements.
The diagram below outlines some of the key types of agreement that commonly govern the research, development, and commercialization of medical products.
Expand the boxes below for details of the role of each agreement type in facilitating equitable access
Purpose: The primary purpose of an R&D funding agreement is for one party to provide funds to another party to support the development and/or manufacturing of a medical product. R&D funding agreements can cover a number of different financing structures, including grants and investments, and they can support different stages of the R&D and commercialization process.
Role in facilitating equitable access: Partnerships with R&D funders can provide the financing that innovators, developers and manufacturers need to develop products with limited commercial potential, or to undertake activities needed to broaden access to a product (e.g., additional clinical trials, new formulations, tech transfer to additional manufacturers, product registration). In exchange for funding, R&D funding agreements can require funding recipients to make equitable access commitments for the funded product.
Typical partners: Organizations typically involved in these agreements include:
- Funders: philanthropic funders, intermediary funders, impact investors, multilateral funders, government agencies.
- Funding recipients: academic institutions, non-profit research organizations, product development partnerships (PDPs), biotechs, big pharma, generics manufacturers.
Purpose: R&D collaboration agreements are used to enable two or more parties to work together on the development of a medical product. These agreements may begin during early-stage discovery or R&D, but can provide for continued collaboration through to commercialization if the R&D activities are successful. The parties to an R&D collaboration agreement usually share their intellectual property for the purpose of joint research and/or product development. Parties to a collaboration agreement may also contribute funding or provide in-kind contributions such as access to expertise or resources.
Role in facilitating equitable access: Collaboration agreements can be used as a structure through which commercially-oriented and access-oriented organizations share their respective resources to develop a medical product with the goal of making it promptly affordable and available for all patients that need it. In some cases, the collaboration agreements establish different rights and responsibilities for the parties in different markets or territories, allowing a commercial partner to pursue profit-making objectives in some markets while ensuring that there is a mechanism to support equitable access for under-served populations.
Typical partners: Organizations typically involved in these agreements include academic institutions, non-profit research organizations, government research agencies, PDPs, biotechs, big pharma.
Purpose: The primary purpose of a license agreement is the grant of rights from an intellectual property (IP) owner (licensor) to a third party (licensee) to allow the licensee to use the licensor’s IP for specified purposes. The rights granted under a license agreement usually relate to IP protected by patent rights, but they sometimes also include a transfer of related know-how or materials, and may therefore have some elements in common with a technology transfer agreement and/or an MTA.
License agreements may be used at different stages of the product R&D process. “Upstream” licensing generally refers to licenses for early-stage technologies that have not been developed into a medical product. “Downstream” licensing generally refers to licensing for a product that is in late-stage clinical trials or is already approved for use.
Role in facilitating equitable access: License agreements are a tool for enabling the development, manufacturing and commercialization of medical products to meet the needs of underserved populations. Upstream licenses may be used to support the development of innovations for unmet medical needs, whereas downstream licenses can allow the manufacturing of affordable generic medicines or biosimilars in sufficient quantities to meet the needs of lower-income markets.
Licensors may grant licenses solely for the purpose of facilitating equitable access (for example, by working with organizations such as the Medicines Patent Pool, or with PDPs), or they may grant more commercially-oriented licenses that include equitable access commitments.
Typical partners: Organizations typically involved in these agreements include:
- Licensors: academic institutions, non-profit research organizations, government research agencies, biotechs, big pharma
- Licensees: non-profit research organizations, PDPs, biotechs, big pharma, patent pools, generics manufacturers
Purpose: Technology transfer agreements govern the terms of transferring data, materials, documentation, and knowledge from one party to another for the purposes of development and/or manufacture of a medical product. These agreements may include detailed technology transfer plans and success criteria setting out the steps to be taken to complete the transfer. Since technology transfer agreements relate to the use of a party’s IP, they often have elements in common with license agreements.
Role in facilitating equitable access: Like license agreements, technology transfer agreements are a tool for enabling the manufacturing and commercialization of medical products, often generic medicines, at volumes and prices that meet the needs of lower-income markets. Technology transfer can also have impacts beyond facilitating access to a specific product as it can support LMIC-based manufacturers in developing skills and experience that can be leveraged in the future, therefore strengthening capacity for local and regional manufacturing to meet LMIC needs.
Typical partners: Organizations typically involved in these agreements include:
- Transferors: academic institutions, non-profit research organizations, government research agencies, biotechs, big pharma
- Transfer recipients: non-profit research organizations, PDPs, biotechs, big pharma, patent pools, generics manufacturers, state-owned enterprises (SOEs)
Purpose: The primary purpose of material transfer agreements (MTAs) is to govern the sharing of materials (e.g., cell lines, compounds, pathogen samples) from one party to another. MTAs are often used to enable an organization to undertake discovery work or evaluate materials to assess their potential for further development, although they can also be used at later stages of development, potentially combined with license and/or technology transfer agreements.
Role in facilitating equitable access: Some MTAs include benefit-sharing provisions, which require the materials recipient to make equitable access-related contributions in recognition of the value of the materials for the subsequent development of profit-making products or other assets. Benefit-sharing provisions may include the donation of a specified volume of products, reserving a certain volume of products for sale to a specified entity at an affordable price, and/or entering into license and technology transfer agreements with manufacturers serving lower-income markets.
Some examples of this approach include the Standard Material Transfer Agreements under the WHO Pandemic Influenza Preparedness (PIP) Framework and the proposed PABS Annex to the WHO Pandemic Agreement.
Typical partners: Organizations typically involved in these agreements include:
- Transferors: academic institutions, non-profit research organizations, government research agencies, biotechs, big pharma
- Recipients: non-profit research organizations, PDPs, biotechs, big pharma
Purpose: Advance purchase agreements are generally used to incentivise the development and manufacture of medical products, particularly those that have limited or uncertain markets. The developer or manufacturer receives a level of certainty over purchase volumes and future revenues, provided that the product receives marketing authorization, while the other party receives access to the approved product, potentially at an agreed price. These agreements may also include advance payments to the developer or manufacturer to support the investments required to bring the product to market.
Role in facilitating equitable access: Advance purchase agreements can take the form of volume and/or pricing guarantee agreements, which are market shaping mechanisms used to incentivize product development and manufacture to meet the needs of lower-income markets. Other forms of advance purchase agreement that are not solely intended to address lower-income markets can also include equitable access provisions in exchange for the upfront investment and guarantees provided by the purchaser.
Typical partners: Organizations typically involved in these agreements include:
- Purchaser/guarantors: national procurement agencies, multilateral procurement agencies, innovative finance organizations
- Guarantee recipients: product developers and manufacturers
Purpose: Procurement agreements govern the terms and conditions under which one party purchases a medical product from another party, usually in exchange for a financial consideration. The products purchased under these agreements have usually already received marketing authorization in the country or countries covered under the agreement.
Role in facilitating equitable access: Procurement agreements support the availability of medical products for national healthcare systems and patients. Product developers and manufacturers can support equitable access through commitments to enter into procurement agreements with national or multilateral agencies that are purchasing the product for use in lower-income markets on reasonable terms, including affordable pricing.
Typical partners: Organizations typically involved in these agreements are national or multilateral procurement agencies, and product developers or manufacturers.
Purpose: Distribution agreements underpin the movement of medical products from a manufacturer to public and private healthcare entities such as hospitals and pharmacies.
Role in facilitating equitable access: Distribution agreements play a critical role in ensuring that products can reach patients, including those in remote and hard to reach areas. Distribution agreements can also support product uptake and sustainability, for example agreements related to the distribution of diagnostics may include maintenance and warranty obligations.
Typical partners: Organizations typically involved in these agreements include wholesale distributors, and product developers or manufacturers.
Connections between agreements
Successful development, commercialization, and patient access to a single medical product may rely on more than one of each of the types of agreements in the diagram. For example, funding may be needed from different funders to support different activities, and licenses may be needed for multiple different technologies. In addition, it is likely that multiple other supporting agreements will be required, such as those securing raw materials supplies, clinical research services, and expert consultancy support.
The complete set of agreements underpinning a product forms a complex web of rights and obligations – including equitable access commitments – which need to work together, and which may impact one another. For example, funding agreements for early-stage R&D can include equitable access obligations that must be passed through to future partners. This can impact future license and technology transfer agreements, as well as who receives supplies of the final product.
What are the key considerations for developing and negotiating access provisions for R&D agreements?
What types of agreements are needed to support end-to-end access?
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.