New G7 clinical trials charter to bolster global health defences

Health ministers from some of the world’s largest democracies have committed to a new international agreement making it easier and quicker to share results from vaccine and therapeutic trials to tackle COVID-19 and prevent future health threats.

Following the conclusion of the UK-hosted, in-person G7 Health Ministers’ meeting in Oxford, a Therapeutics and Vaccines Clinical Trials Charter will be rapidly implemented. This will help deliver high-quality, reliable and comparable evidence from international clinical trials to speed up access to approved treatments and vaccines, benefiting people in the UK and globally.

This will include stronger collaboration in large-scale international trials to enable greater diversity of participants, including pregnant people and children. The charter will also help to avoid unnecessary duplication of efforts, more quickly eliminate medicines that do not work, and produce robust clinical evidence that can be extrapolated to a larger number of populations and places to save more lives.

The agreement follows news that industry leaders are joining forces to step up collective efforts to save lives from diseases and tackle global pandemics, with a new commitment to protect against future pandemic threats and slash time to develop and deploy new diagnostics, therapeutics and vaccines to just 100 days.

Health and Social Care Secretary Matt Hancock said:

It has been a huge pleasure to host the G7 Health Ministers meeting this week and I want to thank everyone who has taken part.

The landmark agreements we’ve reached in Oxford – which has been at the heart of the global response – show our commitment, not just to getting through the COVID-19 crisis, but also to make we’re better prepared for future threats.

It contains a series of measures to make us all safer by improving clinical trials, quicker and wider access to safe vaccines, better use of data, more accurate health surveillance tools and greater collaboration between countries.

We are determined that, working together, we will beat this virus and build back better.

Following G7 ministerial discussions, the sharing of new disease data to agreed standards, focused pandemic surveillance systems and measures to improve the security of antibiotic supply chains will all play central roles in preventing and combatting health emergencies for decades to come.

There will be a thorough assessment of the international health security surveillance operations currently in place to ensure they meet the demands of a highly connected world and keep pace with advances in technology. This collaborative approach will support work to identify potential health threats across human, animal, plant and environmental ecosystems so we can act swiftly to prevent diseases spreading and save lives.

Industry, government and other stakeholders will consider together how best to incentivise the development and supply of new and existing antimicrobial treatment products, including new antibiotics, to ensure modern medicine remains one step ahead of drug resistance

The key agreements that have been made by G7 countries are below.

Clinical trials

Agreement of rapid implementation of a G7 Therapeutics and Vaccines Clinical Trials charter, which sets out shared principles to accelerate the speed with which clinical trials generate robust evidence to enable timely and decisive action on the findings and support public health and clinical decisions.

Stronger collaboration in large-scale international trials to enable greater diversity of participants, including pregnant people and children, avoid unnecessary duplication of efforts and produce clinical evidence that is generalisable to a larger number of populations and places.

Digital health

The need to work together to develop international standards and recommended practices for the creation, use, and mutual recognition of testing and vaccination certificates across countries that rely on safe, effective, and rigorously reviewed vaccines. This includes working to ensure that processes and national certification policies do not disadvantage certain groups of people, including participants in vaccine clinical trials. There is a commitment to work as G7 countries towards a process of mutual acceptance of COVID-19 certificates.

Work to agree standardised minimum datasets for patients’ health information, to enable patients to share their health information with healthcare providers in different countries, where they choose to do so.

Work to develop an internationally agreed process for clinical evaluation of AI algorithms used in health, such as to diagnose health conditions from images. This will help enable healthcare providers to access AI algorithms developed in other G7 countries.

Global health security

The need for better co-ordination and collaboration across complex systems – key drivers of a strengthened One Health approach towards global health security surveillance. The collaboration on One Health intelligence will provide an interim report by the end of 2021 on how the WHO, FAO, OIE and UNEP can collectively deliver consistent, reliable and comprehensive data on emerging human, animal, plant and environmental health treats.

Collaboration to improve global surveillance for COVID-19, including data which can inform the prevention, detection and response to global health threats. This effort will also build capacity to sequence genomes of other health threats to detect them as they emerge.

Affirmation of the central role of the World Health Organization (WHO) for preparation and response to health emergencies and the G7 are committed to strengthening WHO’s role, stressing the importance of ensuring a sustainably financed WHO.

A commitment to share vaccine doses with developing countries through COVAX when domestic situations permit to accelerate and supplement vaccines purchased directly by COVAX to enable the rapid equitable deployment of vaccines across the world.

Antimicrobial resistance (AMR)

Development of principles that assess the value of innovation in, access to and good stewardship of novel antibiotics, with a view to these being applied to new incentive mechanisms.

As part of a One Health approach, a commitment to work with environment ministries, industry and regulators to develop and recognise standards to limit levels of antimicrobial manufacturing waste that are released into the environment.

The need to work together with industry and other partners to better understand antimicrobial supply chains, which will enable steps to be taken in the future to reduce drug shortages and supply insecurity.

Recognition of the novel valuation, reimbursement and procurement projects that are emerging in G7 economies, including in the UK, as well as the new international antibiotic pooled procurement scheme being developed by WHO, Unicef, the Global Antibiotic Research and Development Partnership (GARDP) and the Clinton Health Access Initiative.