to the United Kingdom International Development Committee inquiry on the longer-term issues, implications of impact of coronavirus on developing countries around the world and the UK’s response
11 May 2020
Since the World Health Organization (WHO) declared the COVID-19 outbreak a pandemic on 11 March 2020, the number of cases has continued to rise at an accelerated pace. As of 10 May 2020, COVID-19 has been reported in 212 countries and territories around the world. More than 4.1 million cases have now been reported to WHO, and more than 280,000 people have lost their lives. During these extraordinary times, the global health community must stand together to find solutions to the several challenges posed by the pandemic to the health and wellbeing of people around the world.
Firstly, global health efforts to achieve the Sustainable Development Goals (SDGs) and other health targets (i.e. HIV/AIDS, Tuberculosis and Malaria) have been shaken by the COVID-19 pandemic. New challenges directly and indirectly related to the new coronavirus have impacted the implementation and delivery of projects globally. Unitaid will address such challenges and share mitigation actions that have been put in place to continue delivering against its commitments.
Secondly, to effectively address the COVID-19 pandemic, we need not only a vaccine but also reliable test, treat and track approaches that require new therapeutics, as well as better and faster diagnostics. These solutions need to work everywhere, including in countries with weak health systems and we need to ensure equitable access to new tools against COVID-19 for those in need, including health and community workers. Unitaid will also provide some insights into forward-looking work and considerations.
Founded by the governments of Brazil, Chile, France, Norway and the United Kingdom in 2006, Unitaid is a global health and development agency engaged in finding innovative solutions to global health challenges, including new ways to prevent, diagnose and treat diseases more quickly, cheaply and effectively, in low- and middle-income countries. Unitaid has been actively engaged in health innovations for low and middle-income countries since its inception in 2006. This work spans the introduction of new medicines, diagnostics and prevention tools for HIV, tuberculosis (TB) and malaria as well as co-infections such as hepatitis C and cervical cancer. The organization has deep experience to shepherd innovative health products across a rigorous pathway to generate evidence and impact data, navigate market barriers, and evaluate the most cost-effective delivery strategies - all with a focus on equity, affordability and scale. We work in partnership with key global health actors to roll out products at scale and with countries to integrate new approaches into national health systems.
Unitaid is working with its network of over 60 implementing partners to assess the impact of COVID-19 on on-going health initiatives in the field and to leverage its expertise to spur development and expand access to COVID-19 diagnosis, potential treatment and prevention relevant to low-resource settings.
Since 2006, the United Kingdom (UK) has provided over £ 500 million in funding to Unitaid and serves on its Executive Board, currently as Chair of the Policy and Strategy Committee (PSC) and a member of the Finance and Accountability Committee (FAC).
Since the emergence of COVID-19, Unitaid has been working closely with its grant implementers to ascertain, manage and mitigate the impact of the pandemic on its portfolio of projects. Among implementers and projects, a wide range of impacts are being reported, as detailed below. These challenges are common across implementers, demonstrating the range of potential impact of COVID-19 on UK-funded and multilateral development activities in the health sector. The long-term consequences of this could lead to delayed or reduced access to innovations intended to support the delivery of the Sustainable Development Goals for health.
In-country implementation challenges resulting in delays in delivering key outputs and potential challenges to ensure adequate project management and oversight. For example:
Temporary closures of health facilities/infrastructure - or repurposing of them to support the COVID-19 response - making it no longer possible for hospitals, clinics, laboratories and associated staff to carry out planned activities.
In new grants, specific challenges around early phase grant activities e.g. Recruitment of project staff delayed; site initiations and trainings postponed; delays in start-up in several countries due to inability to engage local officials/reprioritization of staff.
Postponed studies and delays in data collection, e.g. household surveys, drug resistance study sample collection and human subject research studies. Some clinical trial activities are also being temporarily halted, with potential loss of/delays in accrual of participants.
Supply-side challenges resulting in slowed product manufacturing, stockouts and delays in product development and registration. For example:
Challenges to procurement and supply chain activities, including delayed manufacturing in source countries, inability to complete product importation due to border restrictions, stockouts of products and anticipated wastage/expiry of existing products where clinical trial and service-delivery activities are slowed or temporarily halted.
Delays in product development work, e.g. implementation of field/laboratory studies.
De-prioritization of new product introduction.
Partner engagement slowdown resulting in challenges for driving scale up, creating demand, evidence dissemination and prioritization of innovation in future plans. For example:
Increasing requirements for in-country staff to telework with impacts on performance, particularly in low-bandwidth settings. Inability to travel within countries, necessitating cancellation of field visits to project sites.
▪Inability to hold group meetings in countries, requiring that a wide range of stakeholder meetings (e.g. meetings with ministry officials), seminars and trainings (e.g. protocol training), advocacy events (e.g. World TB Day) and high-level meetings be postponed. Cancellation of community engagement and community-based activities.
Delays in dissemination of results, key findings and postponement of other activities intended to support grant scalability and knowledge transfer to local authorities.
To mitigate these effects, on 19 March Unitaid issued guidance to implementers on active grant management during the pandemic to encourage grant implementers to take prompt action to mitigate the potential negative consequences of COVID-19 in Unitaid project countries, with particular attention to health worker protection, communication to affected communities and maintenance of essential services.
Importantly, Unitaid reassured implementers that it fully supports all reasonable measures to ensure the safety of staff implementing projects (such as the use of funds from current Unitaid project budgets to buy protective equipment) and the continuity of funding in the event that activities are delayed or interrupted.
Unitaid is closely monitoring the situation and making additional changes as needed to ensure programme continuity for the patients concerned. The impact is reported regularly to Unitaid’s Executive Board, where the UK is a member.
Unitaid is bringing its expertise in new product development, adaptation, scalability and access to mitigate the impact of COVID-19 in developing countries. Ultimately, the faster the global community can contain and efficiently address COVID-19, the faster the global health architecture will be able to continue its efforts towards the SDGs and other global health targets.
As a first response to the COVID-19 pandemic, Unitaid marshalled its expertise and partner network and redeployed a part of its investments to address immediate needs of those most vulnerable in the countries where it works. With a portfolio operating in front line health clinics in over 60 countries, Unitaid is contributing to global efforts to test innovative solutions and address knowledge gaps in the COVID-19 response that build on its existing diagnostic and treatment projects.
Unitaid has redeployed significant funding towards this effort, including by:
In addition to the above immediate activities, on 24 May 2020, Unitaid joined global health actors, private sector partners and other stakeholders in the launch of a global collaboration to accelerate the development, production and equitable access to new COVID-19 diagnostics, therapeutics and vaccines, the Access to COVID-19 Tools (ACT) Accelerator. Unitaid will co-convene the Therapeutics Partnership and will contribute its expertise to the diagnostics workstream, in coordination with global health stakeholders to support low-income countries. On 4 May 2020, the UK co-hosted the pledging conference to take forward the work envisioned under the ACT Accelerator.
Lessons Learned on Innovation, Access and Scalability of New Health Products in Low and Middle-Income Countries.
The early COVID-19 response has included intensive research, arranged in record time, and with historic collaboration across scientists, companies and institutions across the globe. New therapeutic options are urgently needed to protect healthcare workers and contacts of COVID-19 patients, and to treat people earlier in the course of the disease. But therapeutic options must be tested in real conditions, including in African settings, which are currently underrepresented in existing trials. A high number of trials are currently underway, and a scan of the pipeline reveals that some of these candidates have limitations preventing scaled use or impact in resource-limited settings, such as unacceptably high levels of toxicity, intravenous administration, cold chain requirements, or ability to treat severe stages of disease. For rapid, widespread use in low- and middle-income countries, therapeutics should have an excellent safety profile, oral administration, and approval for other indications. In our experience, these factors will need to be addressed from the start to end up with solutions that can be administered in low resource settings and weaker health systems. In addition, adequate production capacity and affordability of final products will also critical and needs to be considered early on.
With regard to testing, access to effective tests to confirm COVID-19 diagnosis remains a challenge worldwide. Low- and middle-income countries, in particular, are likely to face continued constraints to effective diagnosis of COVID-19 for several reasons: resource-intensive diagnostic approaches, high demand in high-income countries, delays in implementation of testing, long turnaround times for test results, leading to loss to follow up of patients, and uncertain quality and reliability of tests on the market. In addition, the early COVID-19 response has deployed molecular diagnostic tests, newly available from established manufacturers. However, limitations – notably finite supply coupled with high demand in high-income countries as well as cost – mean additional approaches are needed, especially for low- and middle-income countries.
Rapid diagnostic tests could stem the pandemic, with significant global impact. In particular, antigen-based tests may offer a simpler and faster way to identify those infected. This could enable surveillance, contact tracing, reduced transmission, and initiation of early treatment, when available. Antigen-based tests could play a major role in tackling COVID-19 with widespread deployment of among healthcare workers, in COVID-19 hotspots, or among people returning to work as lockdown restrictions are eased. Of manufacturers developing antigen-based tests, some may be reluctant to invest resources in the absence of clear market signals, such as a target product profile, policy, and forecasted demand. In sum, new testing options are required for an adequate global response to COVID-19 – but targeted work must ensure that new tests are available, fit-for-purpose, affordable and accessible.
On equitable access, lessons learned from the HIV response underline the need to ensure that lifesaving treatments must be made available to those in need across the globe and that access considerations must be front and centre in the product development phase. As the scientific research for COVID-19 treatment and technologies is evolving rapidly and intensifying thanks to a historic collaboration, the global community needs to anticipate and agree on conditions to ensure access (quality/price/volume). Given the volumes at stake, the required quantities are unlikely to be produced by a sole company to meet the demand. In this context, clear access principles should be set up front. Considering the need for public resources to develop such key products, contractual arrangements on IP rights should be negotiated with companies involved in R&D and production, with cost plus principles and transfers of technology to ensure production capacity can be maximized as rapidly it can be.
Over the last nearly fifteen years, Unitaid has supported the Medicines Patent Pool (MPP) to work closely with industry -- originator companies and generic manufacturers -- in negotiating voluntary licensing of essential medicines, including for HIV, TB and malaria. The result has been that over 90% of people living with HIV in developing countries are taking treatments covered by the MPP. Overall, this model has supplied over 11 billion does of treatments for infectious diseases, saving the global community over US$ 1.4 billion.
To ensure that medicines, tests and tools for COVID-19 are available and affordable in all countries without a time lag, Unitaid, together with the Medicines Patent Pool, is offering this expertise and lessons learned to the WHO and the global community, to support broad access to new medicines and treatments developed for covid-19. These efforts should build on the lessons learned and successful tool from the HIV, TB and malaria epidemics.
Unitaid is committed to bring this experience and lessons learned to its work and that of partners under the ACT Accelerator.
Innovations to develop not only a vaccine but also better treatments and improved diagnostics will be essential to global efforts to combat covid-19 and to restarting and sustaining the global economy. These innovations will need to be adapted to work in a range of situations, including in low resource settings. Accelerating the development, manufacture, and broad distribution of these products will not happen automatically. UK support to the Global Coronavirus Response has been and will continue to be essential in developing the vaccines, medicines and diagnostics required to confront this pandemic. The COVID-19 pandemic has highlighted in stark terms the importance of strengthening health systems and striving towards universal health care. Alongside the work on COVID-19, we must protect the public health gains made over the last 20 years in HIV, TB, malaria, reducing maternal and child mortality and remain on track to reach the Sustainable Developments Goals.