Philanthropic and non-profit funders generally have an access-oriented mission, which is often reflected in equitable or global access policies or statements. Some of the elements included in policies published by philanthropic and non-profit funders are:

• The funder’s definition of equitable access for the products, data and other results arising from its funding;
• How the funder views its role in facilitating equitable access and how it will collaborate with other stakeholders; and
• The funder’s approach to incorporating equitable access obligations into its funding agreements, and its expectations of the actions to be taken by funding recipients. Expectations outlined in published policies include:
  • Development of access plans or strategies;
  • Prompt and broad dissemination of data, results & publications (sometimes detailed further in an open access policy);
  • Appropriate management of intellectual property (IP) rights to support equitable access; and
  • Commitments to support timely availability of funded products in sufficient quantities and at affordable prices.

Product Development Partnerships (PDPs) are usually formed specifically for the purpose of facilitating equitable access to medical products to prevent, treat and/or diagnose one or more diseases. The actions that a PDP will take to achieve these objectives are often set out in access and/or IP policies. Some of the elements included in policies published by PDPs are:

• Objectives for medical products to be affordable, available, appropriate, and adopted (sometimes referred to as the 3As or 4As approach).
• The PDP’s strategic priorities for facilitating equitable access, often taking an end-to-end approach, incorporating product development activities, as well as advocacy work, and a range of activities to support demand generation, sustainability, stewardship and product adoption.
• How the PDP will collaborate with partners and other stakeholders as part of its approach to access; and
• The PDP’s approach to generating and licensing intellectual property rights, including expectations for license agreements to include obligations consistent with the PDP’s equitable access objectives.

Academic institutions often receive public or philanthropic funding, and have a mission to achieve public benefit from the results of their research. As part of this commitment to creating public benefit, academic institutions may have policies on facilitating equitable access to their healthcare innovations.

Access-oriented policies published by academic institutions are often referred to as “socially responsible licensing” (SRL) policies, reflecting the fact that the translation of early-stage academic innovations into medical products often takes place through license agreements. Some of the commitments made in access-related policies or statements from academic institutions include:

• Publication and dissemination of research;
• Using appropriate IP management and protection strategies to facilitate equitable access;
• Supporting the development of technologies for diseases that disproportionately impact developing countries;
• Negotiating licensing agreement provisions intended to facilitate equitable access, such as non-exclusive or limited exclusivity license grants, reservations of rights for humanitarian purposes, waiving royalty requirements, and requiring licensees to submit an affordable access plan; and
• Consideration of societal impact as a metric of success for technology transfer offices, alongside more traditional economic measures.

Government agencies may provide funding and/or licenses to government-owned innovations to other organizations for the development of medical products. These agencies may have policies, or be governed by legislation, that reflect their responsibility to make the results of tax-payer funded research accessible to the public. Approaches to access-related policies or legislative requirements can vary substantially by country, but they often focus on affordability and availability for citizens of the relevant country rather than wider equitable access considerations.

National policies may evolve in the future, particularly as governments look to implement the provisions of the WHO Pandemic Agreement, which includes a requirement for the development and implementation of policies on the inclusion of provisions in public funding agreements that promote timely and equitable access to pandemic-health related products.

An example of a government agency policy with a broader approach to access is the U.S. NIH’s Access Planning Policy, which requires applicants for commercialization licenses to submit an access plan. The access plan is defined as the licensee’s “strategy to support broad access to a licensed product for the U.S. population, and it can include, as applicable, strategies through the lens of promoting equitable access for underserved communities in the U.S. and for populations in low- and lower-middle-income countries.”

For-profit companies including big pharma and biotechs often publish policies, strategies or statements setting out their approach to access to medicines. These statements are sometimes linked to the company’s corporate social responsibility principles or sustainability initiatives. Access to medicines statements may include elements such as:

• The company’s position on intellectual property including:
  • Its rationale for filing patents;
  • Commitments not to file or not to enforce patents in certain countries;
  • Participation in initiatives such as IP Principles for Advancing Cures and Therapies (IP PACT) and Pat-INFORMED (Patent Information Initiative for Medicines);
  • Support for TRIPS Flexibilities; and/or
  • Engagement in licensing activities, including through organizations such as MPP.
• Affordable pricing principles such as tiered pricing structures, and patient assistance and access to healthcare programs;
• Participation in product donation programs;
• A commitment to working with partners to support access;
• The company’s role in conducting R&D to provide innovative solutions for unmet medical needs;
• Commitments to an early, structured, and sustainable approach to access planning, including early consideration of access and the development of access pathways; and
• Approaches to clinical trials including evidence generation, diversity, making products available in all countries where the company conducts clinical trials, and continued cost-free access to a drug for clinical trial participants until it is available on the market.