Wellcome’s approach to equitable access to healthcare interventions

Editor’s Note:
We include the full text of this important commitment to helping assure access to healthcare interventions released by Wellcome Trust. We anticipate that it could – and should – inform commitments and reporting by other funders, development organizations and commercial entities.
 
Wellcome’s approach to equitable access to healthcare interventions
This statement outlines Wellcome’s approach to maximising access to healthcare interventions for people worldwide, with a focus on low- and middle-income countries (LMICs).
27 March 2018
The statement covers our approach within our funding and policy work, and will guide us when considering new ideas and opportunities.

It is intentionally high level – more detail on implementation is provided in complementary policy papers and contractual mechanisms.

Context
The UN Sustainable Development Goals (opens in a new tab), 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.

Currently, access to healthcare is not equitable. According to the World Health Organization, 30 per cent of the world’s population, and over 50 per cent of the population in parts of Africa and Asia, do not have regular access to essential medicines. Around 2 billion people lack access to life-changing medicines and other interventions.

Recent years have seen significant progress, made through collaboration between different actors and using various mechanisms and business models. These include equitable pricing, more flexible approaches to intellectual property (IP), product development partnerships, increased donor funding, more efficient procurement, and effective advocacy by civil society. They have significantly increased the range of interventions available and the number of people who can access them.

However, there is much more to do. The barriers to equitable access are many and varied. They include inadequate healthcare systems, lack of infrastructure, funding gaps, pricing practices, and sub-optimal regulatory and procurement processes. IP is also a barrier if rights are not secured and managed in a manner that enables equitable access. To overcome these barriers, stakeholders must be committed to action and working together.

Wellcome will lead efforts to deliver equitable access. It is our mission and obligation to maximise the public benefit delivered from our funding. This will only be achieved if the interventions we fund reach those who need them.
 
Our role
Wellcome already makes an important contribution to access. We spend around £1 billion each year supporting some 14,000 researchers in over 70 countries to advance ideas, drive reform and support innovation to improve health. We also partner with others to fund new approaches. These include CEPI (opens in a new tab) (the Coalition for Epidemic Preparedness Innovations), which finances and coordinates the development of new vaccines to prevent and contain infectious disease epidemics, and CARB-X (opens in a new tab), which aims to accelerate the development of new antimicrobials.

We will do more through our funding, advocacy and direct activities. Across the public and private sectors, and in civil society, we will work with others where they have greater expertise or impact, for example in healthcare infrastructure and funding. Our approach will be applied globally across Wellcome’s activities, but with a focus on initiatives that will particularly benefit vulnerable populations in LMICs.

We recognise that levels of access, barriers and the rate of change possible will vary significantly between different countries and regions. So, we will adopt approaches tailored to specific diseases, technologies and geographies.

To accelerate equitable access, we will work throughout the product development life cycle – from discovery, development and manufacturing to the scaling up of health interventions and health systems. This will ensure that interventions are fit for purpose for different settings and available for different populations to purchase and use.

Our principles
To broaden vulnerable populations’ access to new and existing high-quality interventions, products whose development we support must be affordable, appropriate, adapted and available, particularly in LMICs.

We will achieve this through four key principles:

  1. Support sustainable access and innovation

:: To improve global health, we must improve existing interventions and find new ones that address unmet needs, and then provide timely access to them. Our policies and processes will support innovation and access, to ensure both can be secured on a long-term, sustainable basis.
:: To enable the development of new interventions for vulnerable populations, we will ensure that our funding conditions incentivise needs-based research and support a vibrant global research environment, including in LMICs.
: We will work with producers, policy makers and procurers to encourage approaches to registration, quality of medicines, pricing and use of IP that incentivise innovation and increase timely access.

  1. Foster collaboration and partnership

:: Sustainable innovation and access requires different mechanisms and cooperation between a range of stakeholders. We will collaborate with others to explore and generate new ideas and funding models.
:: When we collaborate, we will make clear our expectation that the products that we fund will be affordable and quickly accessible. We will expect our partners to share this commitment and help deliver it through different approaches.

  1. Be flexible and pragmatic

:: Our approach to achieving broader global access will be proportionate and tailored. We will take into account the nature of each award and awardee, the stage of development and potential future health benefits.
:: We will work with awardees to agree specific, proportionate and equitable access commitments that are appropriate for them and the stage of development of the intervention. This will ensure that any contractual obligations fairly reward the awardee as well as optimise access.
:: We do not believe that a one-size-fits-all model is the best way to achieve progress. It will be important to adopt different models and approaches for different product areas and geographies.
:: We want to make existing interventions more usable and accessible in LMICs. As well as supporting innovation to do this, we will seek to replicate existing successes and embed good practice, such as generic entry and patent pooling.

  1. Promote transparency to support innovation and access to products

:: We support the appropriate sharing of information to encourage innovation and broaden equitable, timely access. This will create a better shared understanding of the relationship between the costs of research and development, the price of products and appropriate levels of return.
:: We expect our researchers to manage research outputs in a way that will achieve the greatest health benefit. They should make outputs, including software, products and materials, widely available and should publish in open-access journals. This will ensure that other researchers can verify the work and build on it to advance knowledge and make health improvements. Products that emerge directly from research supported by Wellcome should similarly achieve the greatest health benefit.
:: We will share information about the status of product registration, the impact of products (such as the amount of product delivered or number of people benefitting) and other non-sensitive elements of the agreements and access plans agreed between Wellcome and the organisations we fund.
:: We will maintain the confidentiality of information that, if released, could disincentivise potential partners and deter innovation. This could include the cost structure of the interventions we fund and specific access provisions set in award agreements.
: We will report annually on the implementation of this approach and its outputs and impacts.

Our approach
We will use a range of tools to promote equitable and timely access, tailored to the nature of the funding, products and organisations involved.

Contractual mechanisms
Contractual mechanisms will be used on a case-by-case basis for those we fund and may include:
:: Requesting or requiring that awardees have an appropriate and proportionate global access plan that covers registration targets, plans to meet demand, flexible approaches to IP and other strategies that reflect ability to pay and ensure that economic barriers to access are low.
:: Tailored revenue-sharing arrangements to reward organisations that help deliver our access ambitions.
:: Stewardship plans outlining how to achieve the optimal use of an intervention, including, for example, how to avoid the misuse, overuse or abuse of antimicrobials and pain medicines.

Appropriate application of IP
:: To improve health and support the sustainability of projects we fund, the management of IP rights by the awardholder should incentivise innovation and support equitable access to it, being clear that different settings require different approaches.
:: IP management will not preclude the ability to secure commercial rewards. Awardees may receive private benefit from exploiting Wellcome-funded IP, provided that health improvement remains the primary outcome and as long as the benefit is necessary, reasonable and proportionate, in line with UK charity law.
:: We will respect our awardees’ and third parties’ IP rights, which we expect to be applied appropriately to deliver public health benefit. If we believe that IP developed using Wellcome funding is being used in a way that restricts health benefit, then we will work with the rights holder to ensure that the relevant IP is used appropriately. This might include not seeking or enforcing patents in low-income countries, voluntary licensing with broad geographic scope in middle-income countries, and patent pooling. In exceptional circumstances, such as IP being shelved or not taken forward for any reason, we will consider accessing the unexploited IP to deliver benefit in unserved countries.

Advocacy
:: We will be an active advocate for global innovation and access. We will develop policies, convene and participate in meetings and workshops, lead studies and collaborate with others. We will encourage other stakeholders to adopt holistic approaches to deliver access globally and to build global norms and systems that address that goal.

Conclusion
Too many people around the world lack access to essential medical interventions and knowledge. The approach outlined in this statement will allow Wellcome to maximise the impact of our funding, partnerships and policy work to increase timely equitable access and contribute to the goal of universal health coverage.

We will support research that delivers improvements in health and healthcare delivery. We are committed to enabling everyone, particularly vulnerable populations in LMICs, to have access to the life-changing benefits research delivers.

What this means for researchers we fund
We already expect our researchers to manage their research outputs in a way that will achieve the greatest health benefit. This means making outputs widely available and publishing in open access journals.
We set out what access good practice looks like for most of our grantholders in our intellectual property and patenting, Consent and revenue sharing agreement [DOC 165KB], and open access policies.
For Innovator Awards, we negotiate specific access conditions on a case-by-case basis.