1. We, the G7 Health Ministers met in Oxford, UK, and virtually, on 3 and 4 June 2021, to reaffirm the importance of international collaboration on health, in the context of a significant global crisis.
2. We are meeting amid the COVID-19 pandemic, which continues to have a devastating impact on lives, livelihoods and economies across the world. We remember the lives that have been lost to the pandemic, both directly and through broader impacts on health, health service provision and inequalities. We recognise that the pandemic has left no one untouched: that it has impacted not only physical health but also mental health and social wellbeing; that people young and old have been kept apart and that economic damage has been widespread. The impact of the pandemic has been a gendered one and has disproportionately affected many different populations experiencing marginalisation and vulnerability within and among countries, in addition to women and girls.
3. We recognise the immense and continuing contribution and commitment of health and care workers, working tirelessly on the frontline to look after the sick and protect the well. We recognise the importance of reducing the public health and personal risks for them while they are doing their job protecting and serving affected populations. In this, the International Year of Health and Care Workers, we thank them for their dedicated work in helping the world fight this pandemic, as well as providing broader care. We commend the commitment and innovation of governments, scientists, researchers, manufacturers and clinical trial participants in enabling the identification, testing, production and rollout of safe and effective COVID-19 social and medical countermeasures and the individuals throughout the world who have taken steps to reduce the spread and decrease the impact of COVID-19.
4. We as G7 Health Ministers have a major part to play, nationally, regionally and globally, in overcoming and fully recovering from the pandemic; in planning and delivering healthier, resilient and more sustainable and inclusive recovery strategies; and ensuring that we learn lessons for the future, including taking further concrete action this year that captures the political will to build back better and strengthen global health security and systems for the future. We welcome the discussion at the G20 Global Health Summit and support the Rome Declaration to improve preparedness for and response to health emergencies.
5. We commit to continue to support science-based responses to COVID-19, and to promote high quality, interdisciplinary research and development that is not limited to medical countermeasures. Our renewed efforts to improve pandemic preparedness need to anticipate that a future health threat may differ in its origins, patterns, nature and impact from this pandemic and previous health threats. Our reflections, learnings and solutions must take an intersectoral, whole of society approach, planning for the unexpected future while taking into account the known past. Our efforts to improve preparedness need to take into account the growing pandemic of antimicrobial resistance (AMR) with clear leadership, bold science-based actions and a One Health approach.
6. We fully support the World Health Organization (WHO) and the crucial leadership, convening and coordination role it plays in global health, in strengthening multilateral cooperation and in steering the world’s preparation and response to public health emergencies, especially at this difficult time. We also recognise that there is a need to strengthen and support the ongoing reforms of WHO at the centre of a stronger and more effective global health architecture, to ensure it remains fit for evolving challenges, including with the continued strong support and involvement of its member states and non-state actors including civil society. We also stress the importance of an appropriately, sustainably and predictably funded WHO to enable it to fulfil its vital role. We recognise that improving the way WHO is financed is essential if the organisation is going to play the leadership role we all want to see.
7. We emphasise the importance of promoting and monitoring equitable global access to safe, effective, quality and affordable vaccines, therapeutics and diagnostics. We affirm support for all existing pillars of the Access to COVID-19 Tools Accelerator (ACT-A), including its COVAX facility. We are committed to addressing the financing needs in global health to support the research, development, manufacturing, and equitable distribution of safe and effective COVID-19 diagnostics, therapeutics and vaccines. We note the intention to conduct a comprehensive strategic review as a basis for a possible adaptation and extension of its mandate to the end of 2022. We commit to supporting COVAX financially, including by encouraging pledges to the facility, including at the COVAX AMC Summit, disbursing as soon as possible, providing in-kind contributions, and coordinating with and using COVAX, which is the key mechanism for global sharing of vaccines to supplement its own direct procurement, to enable the rapid equitable deployment of vaccines. In this regard, we welcome the outcome of the COVAX Advance Market Commitment Summit co-hosted by Japan and Gavi on 2 June. We emphasise our support for global sharing of safe, effective, quality and affordable vaccine doses including working with COVAX when domestic situations permit. We affirm our support for efforts to strengthen supply chains and boost and diversify global vaccine manufacturing capacity, including for the materials needed to produce vaccines, including by sharing risks, and welcome the vaccines technology transfer hub launched by WHO. We recall in this regard the Charter for Equitable Access to COVID-19 Tools and welcome the commitments made in the G7 Foreign and Development Ministers’ equitable access and collaboration statement.
8. We also recognise the importance of vaccine confidence, and the severe risk posed by misinformation and disinformation about the importance, safety and effectiveness of vaccines on the acceptance and uptake of COVID-19 vaccines and other vaccines around the world. We commit to build confidence in science and provide timely, clear, coherent communication from different levels of government. We note the work of the Global Vaccine Confidence Campaign led by the G7 Presidency, and the Global Vaccine Confidence Summit on 2 June 2021.
9. We strongly support the One Health approach, recognising that human, animal, plant and environmental health are interlinked. We welcome efforts by WHO, the Food and Agriculture Organization of the United Nations (FAO), the World Organisation for Animal Health (OIE) and the United Nations Environment Programme (UNEP) to cooperate and make the One Health approach central to their work. We welcome the establishment of the One Health High Level Expert Panel (OHHLEP) by WHO, FAO, OIE and UNEP and encourage further close coordination and collaboration including full integration of environmental and ecosystem work. This is crucial in order to improve the international system’s ability to prevent, detect, report and respond to current and future health threats, including by promoting transparency and facilitating the rapid sharing of data, samples and information, both internationally and across sectors. As health ministers, we will continue to work with environment, agriculture and other relevant ministers recognising the links between the health of humans and animals (both domestic and wildlife), biodiversity conservation, ecosystems and climate change, and the need to protect human health including through food and water safety and security, as well as from hazardous chemicals and air, water and soil pollution and contamination. Looking ahead to the 26th UN Climate Change Conference of the Parties and the 15th meeting of the Conference of the Parties to the Convention on Biological Diversity, we acknowledge the important relationship between health, the environment and climate change, including the role the health sector plays in building health system resilience and contributing to sustainability.
10. We reaffirm our commitment to achieving Universal Health Coverage (UHC) and the other health-related United Nations (UN) Sustainable Development Goals and targets; to strengthening health systems; reducing inequalities; and improving human well-being and socio-economic development. We remain committed to an inclusive and sustainable recovery that upholds human rights, including the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. The pandemic has slowed progress to deliver UHC and exacerbated existing inequalities, particularly for women and girls and vulnerable and marginalised groups. We note with concern the disruption to life-saving essential services, including for nutrition, water security, sanitation, and hygiene; safe delivery; family planning; life-course immunisations; endemic infectious diseases; and non-communicable diseases, including mental health and cancer care. We affirm our commitment to sexual and reproductive health and rights of all persons and to promoting safe and respectful maternal health, new-born health and child health - free from discrimination, coercion, exploitation and violence. The pandemic has also reiterated the need to ensure safe and healthy working conditions. We therefore support the consideration to recognise safe and healthy working conditions as a fundamental principle and right at work at the International Labour Organisation (ILO).
11. The pandemic highlights the need to take a broader and longer-term view of public health, including the need for a greater focus on healthier populations for enhanced resilience to future pandemics. At least one quarter of the global burden of death and disease is already directly attributable to environmental factors with clear implications for our ability to achieve UHC. Furthermore, linkages between environmental factors, health outcomes and infectious diseases such as COVID-19 are increasingly being established. Building back better must include a ‘health in all policies’ approach that remains grounded in equity and addresses the social, environmental and economic determinants of health. We also recognise the importance of infectious disease prevention and control, including water security, sanitation and hygiene, to the fight against COVID-19 and in advancing our broader global health security and health system strengthening objectives.
12. The pandemic has particularly affected women and girls in a number of ways because of existing and persistent gender inequalities and unequal power relationships in societies: it has seen an intensification of gender based violence (GBV), including violence against women and girls globally that we all need to act to tackle; particular impacts of reduced access to services; as well as disproportionate impacts on women as informal, including unpaid, caregivers and income providers for their families. Women also constitute the majority of the health and social care workforce, particularly in nursing and midwifery. We should maintain a strong focus on gender equality and the empowerment of all women and girls to achieve the goals of the UN Agenda 2030 and Sustainable Development Goal 5 as we continue to combat this pandemic and through our recovery, promoting their important role as agents of change and leaders in our societies, including in the health sector.
13. We therefore commit to take the following strategic actions as G7 Health Ministers across 4 areas:
- global health security
- antimicrobial resistance
- clinical trials
- digital health
Global health security
14. The COVID-19 pandemic has made clear the urgent need for a more resilient, coherent and strengthened global health security architecture – in terms of our ability to better anticipate, prevent, detect and prepare effectively for health threats. We need to act swiftly and decisively at the start of an outbreak to harness and share information, data and samples and continue to do so transparently as it develops; and to coordinate an effective global response, on both human and animal health and interconnected topics such as travel and trade. We encourage new public health guidance in consultation with national and relevant international organisations on international travel by sea or air, including cruise ships. We support an expert-driven, transparent, and independent process for the next phase of the WHO-convened COVID-19 origins study, and for expeditiously investigating future outbreaks of unknown origin.
15. We need to ensure we are better prepared domestically for future health security threats and that we support and learn from the efforts of other countries in this regard. Working with finance ministers, including through efforts by the G20, we will take further action on innovative sustainable financing approaches, including to improve international coordination and accountability between global health and finance policy makers for strengthening and maintaining country preparedness and lessening the gap in health security funding through mobilisation of domestic and external resources. We welcome efforts to improve monitoring and evaluation mechanisms to help countries better assess their public health capabilities, including the efforts to review and update the tools and processes under the auspices of WHO and for accountability and oversight. We will invest in enhancing approaches for biosafety and biosecurity, as they relate to the core capacities of the International Health Regulations (2005) (IHR) and contribute to global health security, to reduce avoidable biological risks.
16. We affirm the central role of WHO for preparedness and response to health emergencies and we are committed to strengthening WHO’s role in this regard. We highlight the importance of improved implementation of and compliance with the IHR. We also support initiatives such as the Global Health Security Agenda and the Global Health Security Initiative in support of the central coordination role of WHO and emphasise the need to establish more effective and efficient triggers that enable swift response to emerging infectious disease threats. We commend the work of the Independent Panel for Pandemic Preparedness and Response, the IHR Review Committee and Independent Oversight and Advisory Committee for the WHO Health Emergencies Programme (IOAC) who recently reported at the 74th World Health Assembly (WHA) in May 2021. We urge rapid follow up of the recommendations, particularly around improved global surveillance, strengthening country accountability for IHR compliance, an exploration of a periodic peer review model, and ensuring WHO is sustainably financed. We encourage further consideration of an improved alert system that promotes early warning and triggers timely action on the back of the IHR Review Committee recommendations around alerts.
17. We emphasise the need for ongoing political commitment at the highest levels to support pandemic preparedness beyond the current pandemic. We welcome the upcoming special session of the WHA to consider the benefits of developing a WHO convention, agreement or other international instrument on pandemic preparedness and response. We encourage all countries to engage constructively in this process to foster a step change in international collaboration.
18. We emphasise the need for more immediate action to strengthen capacities for preventative measures at the human-animal interface, as well as surveillance of potential disease outbreaks, and in particular zoonotic diseases in humans and animals (including from wildlife, domestic and livestock and aquatic animal species) and antimicrobial resistance. The COVID-19 pandemic has brought into sharp relief the need to understand the complexity of the drivers of human health emergencies; to strengthen our horizon scanning for new health threats; and to ensure we quickly have more complete, clearer and better integrated information on which to act, bearing in mind the understanding that the health of humans, animals, plants and their shared environment are inextricably linked. We commend the contribution that relevant organisations, especially WHO, OIE, FAO and UNEP and other existing agencies and networks have made to improve our understanding and response to the current pandemic and future health threats. But we need to do better. This means making the One Health approach, which also incorporates climate change, conservation and sustainable use of biodiversity, central to our thinking on health security and future resilience including by supporting global and local cross-sectoral actors in geographic settings vulnerable to the emergence and spread of pandemic threats. We need to make better use of advances in our ability to collect, analyse, use and share human, animal, plant and environment health data and enable faster collaboration in order to anticipate, assess the risk of and respond to health security threats. This interconnectedness needs to capture formal and informal information, data and sample sharing, including accessing multisectoral surveillance from human, animal, plant, food, climatic and aquatic health chains.
19. The COVID-19 pandemic has intensified awareness and discussion of the importance of One Health approaches. Mainstreaming One Health approaches will require stronger leadership. We believe that the Tripartite Plus organisations (WHO, FAO, OIE and UNEP) should be at the heart of this work, including through strengthening and further integrating surveillance and analysis to gather intelligence from human health, animal health, food and agriculture and environment ecosystems and to investigate the links between human, animal and environmental health. We welcome and encourage this work. We recognise the need to ensure complementarity and to avoid duplication across the global health security architecture. We appreciate initiatives such as the OHHLEP, PREZODE and the establishment of the WHO Hub for Pandemic and Epidemic Intelligence. We also welcome WHO’s commitment to work with expert partners and countries to develop an advanced International Pathogen Surveillance Network. We strongly encourage the Tripartite Plus to conduct a comprehensive One Health intelligence scoping study to identify potential opportunities for further technical harmonisation of their systems. This collaboration on One Health intelligence will inform how the Tripartite Plus One Health intelligence mechanisms can contribute to the other emerging initiatives. We request that the Tripartite Plus report on progress with this important work to the G7 and OHHLEP before the end of the year and consider how this can best be shared with the Tripartite Plus governing bodies.
20. We support the commitment made by climate and environment ministers to establish the International Zoonoses Community of Experts on a voluntary basis. We commit to working more closely together with our climate and environment ministers on the One Health agenda, proactively sharing information, samples and data. We will continue to work towards ensuring the resilience of our health surveillance systems through sharing best practices, building capacity and improving technology domestically and internationally, particularly with our development partners.
21. While we all work to strengthen our own systems, we also recall the 2015 and 2016 commitments to support low and middle-income countries (LMICs) with implementing the IHR and strengthening health systems. We welcome the conclusions of the G7 Carbis Bay progress report that the G7 has made significant progress on these commitments to strengthen health systems, preparedness and resilience in LMICs, and that the G7 have supported the vast majority of the 76 target countries to strengthen capacity on IHR. We also welcome the report’s findings of sustained G7 funding and support for health systems strengthening, advancing UHC, and supporting emergency response. Even still, further sustained action is needed.
22. We recognise the need for greater coordination of public health support, health financing, health security and capacity building efforts as well as mutual learning with LMICs, including the specific challenges facing fragile and conflicted affected states, among G7 partners and institutions. This work should be tailored to regional and country contexts and owned by and responsive to the needs and capabilities of countries and regions. We are committed to improving coordination at a regional and country level and deepening engagement and collaboration with necessary institutions to ensure alignment with regional needs. We also commit to strengthening coordination with development ministers and between health and development agencies within our countries. We need to continue supporting the Global Polio Eradication Initiative whose surveillance capacity and ability to reach vulnerable communities are critical in many countries to prevent and respond to pandemics.
23. With many countries struggling to respond to the COVID-19 pandemic, we also recognise the immense threat posed by the evolution of this virus and other pathogens. Scientific capabilities, including pathogen genomics, have a vital part to play in detecting, analysing and assessing the risks, and tracking the emergence, spread and evolution of SARS-CoV-2 and other pathogens around the globe. We are committed to strengthening our own capabilities in this field and to strengthening these capabilities in other countries. We note the UK’s offer to provide SARS-CoV-2 genomic sequencing and analytical support to countries with limited capability, through the New Variant Assessment Platform, as part of a focused global effort to strengthen surveillance of potential variants of concern. This supports the larger global risk monitoring and assessment framework WHO has established to track SARS-CoV-2 variants around the world. We will collaborate with each other as envisioned under the IHR and with relevant international organisations urgently to improve global surveillance for COVID-19, by strengthening viral genomics, and the timely sharing of data which can inform the development of new vaccines, therapeutics and diagnostics. This effort will also build capacity to sequence genomes of other health threats to detect them as they emerge and will be used to enhance global pathogen surveillance and information exchange.
24. The COVID-19 pandemic has brought into stark focus the impact a novel and initially untreatable infectious disease can have on humanity to maintain and extend the efficacy of existing and emerging antimicrobials in treating infectious diseases. We reiterate the need for ongoing education and reinforced stewardship of the use of antimicrobials, including avoiding their use where there is no science-based evidence of effectiveness. The pandemic also highlighted the importance of infection prevention and control (IPC) measures to tackle AMR, targeting both healthcare-associated and community-associated infections. We will seek to build on the advances and investments made in these, broader IPC measures and other measures such as supply-chain strengthening that have been integral to the COVID-19 response, but we must act strongly and across disciplines if we are to curb the silent pandemic of antimicrobial resistance. We recognise the importance of the research and development in new and innovative antimicrobials as well as alternatives to antimicrobials; vaccines, diagnostics and other countermeasures; and the need to take bolder steps to mitigate, minimise and contain the risk of AMR as part of our plans to Build Back Better, taking a One Health approach.
25. We acknowledge the research findings on incentives provided by the Global AMR R&D Hub and the lessons from activities, including the UK, US and Germany’s novel reimbursement projects and mechanisms. We appreciate the work of initiatives including the Global Antibiotic Research and Development Partnership (GARDP), Biomedical Advanced Research and Development Authority (BARDA) Late-Stage Development Support, the Combating Antibiotic-Resistant Bacteria Accelerator (CARB-X), the Replenishing and Enabling the Pipeline for Anti-Infective Resistance (REPAIR) Impact Fund, the Innovative Medicines Initiative (IMI) antimicrobial resistance accelerator and the nascent industry-led AMR Action Fund to support the development and approval of much-needed innovative antimicrobial therapeutics. We note the ambitions of the EU’s 2020 Pharmaceutical Strategy for Europe which will support new business approaches with regard to the development and market access of antimicrobials. We appreciate the SECURE initiative to develop proposals for a new international antibiotic pooled procurement scheme. We also recognise that these initiatives alone will not solve the lack of incentives.
26. We note the discussions being held by the G7 finance track this year to explore concrete market incentives options to bring new antimicrobials (in particular antibiotic therapeutics) to market and help ensure security of their supply. Together, we will seek to overcome the economic barriers to an endurable supply of antimicrobial products and to ensure sustainable innovation in antimicrobial R&D while encouraging appropriate provisions for stewardship, diversity and security of supply chains, environmental protection in manufacturing and disposal, and global access. To achieve this, we will bring together health and finance officials, along with representatives from our other ministries and agencies as appropriate.
27. We recognise the need to value antimicrobials in a way which takes account of the positive impacts they bring to healthcare systems and wider society, in addition to benefiting individual patients. Acknowledging their wider importance could help incentivise much-needed innovation while ensuring access and good stewardship. We will develop a set of shared valuation principles, based on public health needs and taking into account the WHO priority pathogen list, that could subsequently be applied to new and existing antimicrobial products by G7 countries on a voluntary basis. Based on these shared principles, we will work together with industry and other key stakeholders to consider options that would incentivise the development of and access to both novel and existing antimicrobial products and that could be adapted to our different systems. Once agreed, we will encourage others including WHO, as well as large international drug purchasers such as UNICEF and the Global Fund, to consider how these shared principles for antimicrobial products could be applied more widely.
28. We acknowledge the pressures on complex global drug supply-chains and the notable threat to healthcare systems posed by antibacterial shortages, exacerbated during the pandemic. We note the impact that an insecure global supply of quality-assured antimicrobials can have on patient outcomes, increasing healthcare costs and the development of drug resistance. Further work is also required on how we could return to clinical use some older, but clinically useful, antimicrobials no longer manufactured or marketed due in part to lack of commercial viability.
29. We recognise the need to work together across the G7, with industry and other relevant economies to strengthen supply-chain resilience through a broader and more geographically diverse, quality-assured manufacturing base. We will take a risk-based approach and acknowledge that this requires more transparency and a deeper understanding of where our antimicrobials and their ingredients come from. We task our G7 human and veterinary medicines regulatory and other relevant authorities to work with policy makers, industry and other relevant stakeholders on recommendations to map and to strengthen antibiotic supply-chains, taking account of commercial sensitivities.
30. Alongside climate and environment ministers, we recognise that the release of antimicrobials into the environment can select for antimicrobial resistance and have an impact on human, animal and environmental health. We also note that heavy metals and biocides potentially have an impact on AMR and human, animal and environmental health. We underline the importance of a One Health approach in tackling AMR and call on all governments to promptly implement measures for the sound management and reduction of inappropriate use of antimicrobials. In this context, we note the potential role that soil microorganisms may play in the fight against AMR. We call on the UNEP, in collaboration with the Tripartite organisations, to strengthen the evidence base on the contamination, mechanisms, causes and impacts of AMR emerging and spreading in the environment as mandated at the United Nations Environment Assembly 3. We commit to work in close collaboration with governments and relevant parties such as medicines regulators where independent of government, and agriculture, academia, industry, the Tripartite on AMR and UNEP to develop and implement long-term, sustainable solutions to this issue. We note with concern that there are currently no international standards on safe concentrations of antimicrobials released into the environment from, among other things, pharmaceutical manufacturing, healthcare facility effluent, agriculture and aquaculture. We also acknowledge the work of the AMR Industry Alliance in this regard. We commit to accumulate knowledge on antimicrobial resistance in the environment.
31. We will work with G7 Environment Ministers, the AMR Industry Alliance, academia and other relevant parties to agree standards as a baseline and explore a joint pathway to action for their mainstreaming. We will consider privileging the purchase and/or reimbursement of antibiotics manufactured according to these agreed standards without disrupting fragile supply chains and taking account of the differences in our healthcare systems. We call upon WHO to accelerate the adoption of changes to relevant Good Manufacturing Practice (GMP) guidance sections applicable to waste and wastewater from antimicrobial production and for industry to take these standards into account as part of their Environmental, Social and Corporate Governance responsibilities.
32. The COVID-19 pandemic has highlighted the need for even greater international collaboration and coordination to enable the swift and equitable set up and implementation of scientifically rigorous, adequately powered therapeutic and vaccines clinical trials during this pandemic and for future pandemic responses, to facilitate rapid availability of safe, effective and high quality medical countermeasures while protecting trial participants’ safety and rights and based on good clinical practice.
33. We acknowledge the work of governments, industry, academia, competent regulatory authorities and agencies, international organisations and initiatives, and others during this pandemic to research, develop, test, produce and deploy safe and effective vaccines, therapeutics, diagnostics and other medical products faster than ever before. We acknowledge existing regulatory frameworks and practices such as good clinical practices and the work of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). We will work together to continue improving this process in future while ensuring the highest standards of ethics, safety, efficacy and quality.
We support the G7 Therapeutics and Vaccines Clinical Trials Charter, which sets out our shared principles to accelerate the speed with which clinical trials generate robust evidence and their findings can be implemented in this and future pandemics. We emphasise the need to facilitate the rapid generation of compelling clinical evidence through randomised controlled trials of potential therapeutics and vaccines that are adequately powered, robustly designed, consistent with good ethical and good clinical practice principles, and where appropriate, comparable. This would enable timely and decisive action on the findings and support public health and clinical decisions. Greater transparency, collaboration and coordination will speed up the generation and sharing of robust evidence and data and facilitate its swift implementation. Reducing the time to deployment for safe and effective therapeutics and vaccines, while maintaining rigorous scientific and patient safety standards, will help bring this pandemic to an end and ensure our systems are strong, resilient and ready for future health threats; ultimately saving lives. We support greater collaboration in large scale international trials which enable a greater diversity of trial participants, avoid unnecessary duplication of efforts and produce clinical evidence that is generalisable to a larger number of populations and places. This includes more rapidly pursuing the specific needs reflective of the diversity of all population groups including children and pregnant people; and ensuring citizen engagement to strengthen confidence in science. We acknowledge the valuable and essential leadership and coordination of WHO, stringent regulatory authorities and other international organisations and seek to support and work with them, through existing mechanisms where possible, to implement the principles set out in the charter. We also encourage other governments, the private sector, philanthropic organisations, academia and other relevant organisations to commit to the principles and actions of the charter. We want to see rapid implementation of the Charter in our own systems and will work to do so.
34. We recognise the importance of digital health solutions in transforming healthcare including but not limited to in response to pandemics. In order to derive maximum benefit from advances in digital health, we need to have data governance, system security, privacy, regulatory and data protection standards in place according to national and regional contexts. This includes ensuring that digital health solutions are inclusive, comprehensive and equitable. The ability for digital healthcare systems to work together seamlessly using common and open standards is critical to the safe, effective and efficient use of technology in health and care. At present, there is significant variability within and across nations with respect to how computable health data is represented and used for healthcare and in the standards used for patients’ health data.
35. We support countries and territories in developing their own digital health policy in line with WHO guidance towards comprehensive digital health systems that protect privacy and equity of health care access. We support the development of and the building upon existing open health data standards, open-source software tools and related infrastructure so that international investments made remain accessible and adaptable to changing requirements.
36. The COVID-19 pandemic has also provided specific cases where the ability to share and validate health data internationally is crucial to supporting the development of health policy, delivery of care, and regulatory and surveillance activities, as well as the power of data intensive technologies on common purposes and in a defined secured framework, such as the European Health Data Space or the Global Partnership on Artificial Intelligence. These actions could be implemented and leveraged among the G7 and other partners, cognizant of varying statutory or regulatory paradigms.
37. We commit to work towards adopting a standardised minimum health dataset for patients’ health information, including through the International Patient Summary (IPS) standard, with the shared objectives of facilitating health interoperability within and between countries, developing internationally shared principles for enabling patient access to health data, based on the principle of informed explicit consent or patient permission and in keeping with countries’ and regional existing legislative frameworks; and facilitating and promoting the use of open standards for international health data to encourage the widest possible adoption of standards and greater interoperability. To achieve this goal, we will work with the Global Digital Health Partnership (GDHP) as they are already advancing IPS efforts.
38. One significant area that would benefit from interoperability of health systems and data is around testing data and vaccination records for COVID-19 and potentially other diseases. We recognise that there is a need for multilateral collaboration on a standards-based, minimum data set for COVID-19 testing and vaccination verification that can be used internationally as necessary. We should work within existing WHO processes to develop international standards and recommended practices for the creation, use, and mutual acceptance of testing results and vaccination certificates across countries. Vaccines must be safe, effective and rigorously reviewed. We should work to ensure that processes and national certification policies do not disadvantage certain groups of people, while retaining effective controls on the potential transmission of variants of concern and variants of interest. This includes working to ensure that participants in vaccine clinical trials are not disadvantaged. We acknowledge the efforts of the EU to establish digital COVID certificates to facilitate the safe free movement of travellers. The usage of vaccination certificates should be based on the latest scientific evidence and the current epidemiological situation. We are committed to work as G7 countries towards a process of mutual acceptance of COVID-19 certificates.
39. We acknowledge that governance of artificial intelligence (AI) systems in the health sector must be strengthened in order to keep pace with technology development. There is currently no international consensus on clinical evaluation standards for health AI algorithms, making it challenging for them to be used in different countries. We welcome the work of WHO and the Global Digital Health Partnership to call for the development and international recognition of a framework for the clinical evaluation of health AI based on the democratic values we share as G7 nations, and our shared commitment to responsible AI as set out in the Organisation for Economic Co-operation and Development (OECD) principles on AI. We recognise the importance of this work for aligning regulatory requirements for AI-enabled software as a medical device being spearheaded by the International Medical Device Regulators Forum, regional and country specific regulatory bodies.
40. We commit to work together, in close coordination with other international initiatives, to define and develop a shared understanding of phases for how we clinically evaluate health AI algorithms and develop and share best practices for benchmarking the suitability of a health AI algorithm developed in one G7 country for potential deployment in another. As the suitability of health AI algorithms depends on strong governance based on clear values and ethics, we further commit to work together to integrate such considerations into best practices.