WHO recommends life-saving interleukin-6 receptor blockers for COVID-19 and urges producers to join efforts to rapidly increase access

6 Jul

The World Health Organization (WHO) has updated its patient care guidelines to include interleukin-6 receptor blockers, a class of medicines that are lifesaving in patients who are severely or critically ill with COVID-19, especially when administered alongside corticosteroids. 

These were the findings from a prospective and a living network meta-analysis initiated by WHO, the largest such analysis on the drugs to date. Data from over 10 000 patients enrolled in 27 clinical trials were considered. 

These are the first drugs found to be effective against COVID-19 since corticosteroids were recommended by WHO in September 2020. 

Patients severely or critically ill with COVID-19 often suffer from an overreaction of the immune system, which can be very harmful to the patient’s health. Interleukin-6 blocking drugs – tocilizumab and sarilumab – act to suppress this overreaction.  

The prospective and living network meta-analyses showed that in severely or critically ill patients, administering these drugs reduce the odds of death by 13%, compared to standard care. This means that there will be 15 fewer deaths per thousand patients, and as many as 28 fewer deaths for every thousand critically ill patients. The odds of mechanical ventilation among severe and critical patients are reduced by 28%, compared with standard care. This translates to 23 fewer patients out of a thousand needing mechanical ventilation. 

Clinical trial investigators in 28 countries shared data with WHO, including pre-publication data. Researchers worldwide compiled and analyzed the data. With the support of these critical partnerships, WHO has been able to issue a rapid and trustworthy recommendation for the use of interleukin-6 receptor blockers in severe and critical COVID-19 patients.

“These drugs offer hope for patients and families who are suffering from the devastating impact of severe and critical COVID-19. But IL-6 receptor blockers remain inaccessible and unaffordable for the majority of the world,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus.

“The inequitable distribution of vaccines means that people in low- and middle-income countries are most susceptible to severe forms of COVID-19. So, the greatest need for these drugs is in countries that currently have the least access. We must urgently change this.” 

To increase access and affordability of these life-saving products, WHO calls on manufacturers to reduce prices and make supplies available to low- and middle-income countries, especially where COVID-19 is surging. 

WHO also encourages companies to agree to transparent, non-exclusive voluntary licensing agreements using the C-TAP platform and the Medicines Patent Pool, or to waive exclusivity rights.

In addition, WHO has launched an expression of interest for prequalification of manufacturers of interleukin-6 receptor blockers. Prequalification of innovator and biosimilar products aims to expand the availability of quality-assured products and to increase access through market competition and reduce prices to meet urgent public health needs.

WHO pledges extensive commitments towards women’s empowerment and health

5 Jul

The World Health Organization announced multiple commitments to drive change for gender equality and the empowerment of women and girls in all their diversity at the Generation Equality Forum, held last week in Paris. The WHO commitments focused on ending gender-based violence; advancing sexual and reproductive health and rights; and supporting health workers as well as feminist movements and leadership. These commitments shape a progressive and transformative blueprint for advancing gender equality, health equity, human rights and the empowerment of women and girls globally.

The Forum, marking the twenty-fifth anniversary of the Beijing Declaration and Platform for Action on Women, came at a critical moment, with COVID-19 having exacerbated existing gender inequalities. WHO led in two key areas of the Forum: the Action Coalition on Gender-Based Violence (co-led with UN Women and other partners) and the Gender Equal Health and Care Workforce Initiative between France, Women in Global Health and WHO.

Recognizing the health sector has an important role to play in preventing and responding to gender-based violence against women and girls, WHO committed to:

WHO will partner with Wellspring, Ford Foundation, UN Women and the Government of the United Kingdom, in the launch of the Shared Agenda Advocacy Accelerator (the Accelerator) to advocate for increasing resources for preventing violence against women and girls. WHO will support the implementation of the International Labour Organization Convention No. 190 on Eliminating Violence and Harassment in the World of Work including by providing training to staff on a new internal policy, Preventing and Addressing Abusive Conduct. 

WHO also committed to investing in the evidence base for sexual and reproductive health and rights, including delivering comprehensive sexuality education outside school settings; improving access to quality and rights-based family planning in 14 middle-income countries ; supporting 25 countries in increasing adolescents’ access to and use of contraception; disseminating updated guidelines on safe abortion; and building knowledge among adolescents of their entitlements and ability to advocate for their needs. 

Together with UNFPA and UNICEF, WHO committed to work to end harmful practices like female genital mutilation and child, early and forced marriages. The health sector will be supported to end medicalization of female genital mutilation and provide quality health services to women and girls living with female genital mutilation and married girls.  

At a high-level event focusing on the Gender Equal Health and Care Workforce Initiative, WHO Director-General Dr Tedros Adhanom Ghebreyesus reiterated WHO’s commitment to advocating for decent and safe work conditions for all health and care workers, especially women. Several countries and organizations announced commitments towards the four pillars of the Initiative: gender equal leadership; equal pay; protection against sexual harassment and violence; decent and safe working conditions. The Gender Equal Health and Care Workforce Initiative will convene again during the United Nations General Assembly in September 2021.

WHO along with other UN agencies declared solidarity with and support to feminist movements and women human rights defenders, committing to expand an open, safe and inclusive civic space for their work. This commitment is closely linked to the UN Secretary-General's Call to Action for Human Rights and the recently published UN Guidance on Promoting and Protecting Civic Space. WHO will:

  • Update its gender policy, strategy and roadmap;
  • Open specific internship opportunities for individuals with feminist leadership experience;
  • Promote civil society participation in health systems, COVID-19 response and recovery activities;
  • Promote and encourage gender parity in World Health Assembly delegations, WHO panels and advisory groups; and
  • Facilitate menstrual hygiene and promote awareness.

WHO, as part of the Global Polio Eradication Initiative, also committed to  support countries to address gender-related barriers to polio vaccination, collect and analyse sex-disaggregated data to ensure girls and boys are reached equally, and to increase women’s meaningful participation and decision-making across all levels of the programme.

WHO has committed to accelerating and scaling up its efforts to prevent and respond to sexual exploitation, abuse and harassment. An organization-wide task team, headed by a Director reporting to the Director-General, will bring together WHO’s accountability functions that deal with these issues within WHO programmes and operations the field. The aim is to increase policy coherence, address gaps, and ensure that implementation of policy and procedures has sufficient impact to protect women, their families and communities.

There will be a priority focus on how allegations and cases are managed, and practical measures on how emergency and programmatic operations can safeguard people more effectively from sexual exploitation, abuse and harassment.

The Task Team will work with partners on the ground to empower communities to prevent and respond to sexual exploitation, abuse and harassment. They will also prioritize engagement with the UN systems, international partners and external experts to move this important work forward. Some of the activities currently being scaled up include awareness raising in communities; engaging female and male community focal points to empower women to be alert to and use community-based complaint mechanisms safely; and measures to strengthen survivor-based services for women through the health system and in the community.

 

New recommendations for screening and treatment to prevent cervical cancer

5 Jul

Logo of the HRP special programmeToo many women worldwide – particularly the poorest women – continue to die from cervical cancer; a disease which is both preventable and treatable. Today, WHO and HRP have launched a new guideline to help countries make faster progress, more equitably, on the screening and treatment of this devastating disease.

Ending suffering from cervical cancer

Last year, in 2020, more than half a million women contracted cervical cancer, and about 342 000 women died as a result – most in the poorest countries. Quick and accurate screening programmes are critical so that every woman with cervical disease gets the treatment she needs, and avoidable deaths are prevented.

WHO’s global strategy for cervical cancer elimination– endorsed by the World Health Assembly in 2020 –  calls for 70% of women globally to be screened regularly for cervical disease with a high-performance test, and for 90% of those needing it to receive appropriate treatment. Alongside vaccination of girls against the human papillomavirus (HPV), implementing this global strategy could prevent more than  62 million deaths from cervical cancer in the next 100 years.

Effective and accessible cervical screening and treatment programmes in every country are non-negotiable if we are going to end the unimaginable suffering caused by cervical cancer,” says Dr Princess Nono Simelela, Assistant Director-General for Strategic Programmatic Priorities: Cervical Cancer Elimination. “This new WHO guideline will guide public health investment in better diagnostic tools, stronger implementation processes and more acceptable options for screening to reach more women –  and save more lives.”

A shift in care

The new guideline include some important shifts in WHO’s recommended approaches to cervical screening. 

In particular, it recommends an HPV DNA based test as the preferred method, rather than visual inspection with acetic acid (VIA) or cytology (commonly known as a ‘Pap smear’), currently the most commonly used methods globally to detect pre-cancer lesions.

HPV-DNA testing detects high-risk strains of HPV which cause almost all cervical cancers. Unlike tests that rely on visual inspection, HPV-DNA testing is an objective diagnostic, leaving no space for interpretation of results.

Although the process for a healthcare provider obtaining a cervical sample is similar with both cytology or HPV DNA testing, HPV DNA testing is simpler, prevents more pre-cancers and cancer, and saves more lives than VIA or cytology. In addition, it is more cost-effective.

More access to commodities and self-sampling is another route to consider for reaching the global strategy target of 70% testing by 2030. 

WHO suggests that self-collected samples can be used when providing HPV DNA testing. Studies show that women often feel more comfortable taking their own samples, for instance in the comfort of their own home, rather than going to see a provider for screening. However, women need to receive appropriate support to feel confident in managing the process.

Recommendations respond to the link between HPV and HIV

Women who are immunocompromised, such as those living with HIV, are particularly vulnerable to cervical disease; they are more likely to have persistent HPV infections and more rapid progression to pre-cancer and cancer. This results in a six-fold higher risk of cervical cancer among women living with HIV.

In recognition of this, the new guideline include recommendations which are specific for women living with HIV. This includes using an HPV DNA primary screening test followed by a triage test if results are positive for HPV, to evaluate the results for risk of cervical cancer and need for treatment. The global recommendations also advise that screening start at an earlier age (25 years of age) than for the general population of women (30 years of age). Women living with HIV also need to be retested after a shorter time interval following a positive test and following treatment than women without HIV. 

With these new guidelines, we must leverage the platforms already developed for HIV care and treatment to better integrate cervical cancer screening and treatment to meet the health needs and rights of the diverse group of women living with HIV to increase access, improve coverage, and save lives” Dr. Meg Doherty, Director, WHO Department of Global HIV, Hepatitis and Sexually Transmitted Infections Programmes.

Every intervention counts to eliminate cervical cancer

Data showing where countries around the world currently stand in relation to their burden of cervical cancer and coverage for screening and treatment, are due to be published by the end of 2021. These country profiles can help ministries of health identify where their programmes need strengthening and measure progress towards the 2030 targets.

For a cervical cancer prevention and control programme to have impact, strengthening patient retention and ensuring rapid treatment of women who screen positive for HPV or cervical pre-cancer is a fundamental priority.

Cost-effectiveness of screening tests is important for scaling up programmes, but other aspects of the public health approach to eliminating cervical cancer are also vital,” said Dr Nathalie Broutet, WHO Department of Sexual and Reproductive Health and Research and HRP. “What matters most is the coherence of every country’s programme in ensuring the continuum of care: that all women have access to screening, health care providers are informed in a timely manner about the results of the screening test and can in turn share this information with their client, and that women can access appropriate treatment or referral if needed.” 

WHO calls for all women to ensure they get regular cervical cancer screening tests in line with the recommendations of their local health authority.

Summary recommendation for the general population of women

Summary recommendation for women living with HIV

WHO suggests using either of the following strategies for cervical cancer prevention:

  • HPV DNA detection in a screen-and-treat approach starting at the age of 30 years with regular screening every 5 to 10 years.
  • HPV DNA detection in a screen, triage and treat approach starting at the age of 30 years with regular screening every 5 to 10 years.

WHO suggests using the following strategy for cervical cancer prevention among women living with HIV:

  • HPV DNA detection in a screen, triage and treat approach starting at the age of 25 with regular screening every 3 to 5 years.

 

Table

 

Joint COVAX Statement on the Equal Recognition of Vaccines

1 Jul

COVAX was built on the principle of equitable access to COVID-19 vaccines to protect the health of people all across the globe. That means protecting their lives and livelihoods, including their ability to travel and conduct trade. As travel and other possibilities begin to open up in some parts of the world, COVAX urges all regional, national and local government authorities to recognise as fully vaccinated all people who have received COVID-19 vaccines that have been deemed safe and effective by the World Health Organization and/or the 11 Stringent Regulatory Authorities (SRAs) approved for COVID-19 vaccines, when making decisions on who is able to travel or attend events.

Any measure that only allows people protected by a subset of WHO-approved vaccines to benefit from the re-opening of travel into and with that region would effectively create a two-tier system, further widening the global vaccine divide and exacerbating the inequities we have already seen in the distribution of COVID-19 vaccines. It would negatively impact the growth of economies that are already suffering the most.

Such moves are already undermining confidence in life-saving vaccines that have already been shown to be safe and effective, affecting uptake of vaccines and potentially putting billions of people at risk. At a time when the world is trying to resume trade, commerce and travel, this is counter-effective, both in spirit and outcome.

COVAX commends countries that have already shown commitment to equity as well as safety by accepting travelers protected by all vaccines validated by WHO Emergency Use Listing (EUL) and/or the 11 Stringent Regulatory Authorities (SRAs) approved for COVID-19 vaccines. We call on other nations and regions to do the same.  

 

Notes to editors

About COVAX

COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, is co-convened by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance Gavi) and the World Health Organization (WHO) – working in partnership with UNICEF as key implementing partner, developed and developing country vaccine manufacturers, the World Bank, and others. It is the only global initiative that is working with governments and manufacturers to ensure COVID-19 vaccines are available worldwide to both higher-income and lower-income countries.

CEPI’s role in COVAX

CEPI is leading on the COVAX vaccine research and development portfolio, investing in R&D across a variety of promising candidates, with the goal to support development of three safe and effective vaccines which can be made available to countries participating in the COVAX Facility. As part of this work, CEPI has secured first right of refusal to potentially over one billion doses for the COVAX Facility to a number of candidates, and made strategic investments in vaccine manufacturing, which includes reserving capacity to manufacture doses of COVAX vaccines at a network of facilities, and securing glass vials to hold 2 billion doses of vaccine. CEPI is also investing in the ‘next generation’ of vaccine candidates, which will give the world additional options to control COVID-19 in the future.

Gavi’s role in COVAX

Gavi leads on procurement and delivery at scale for COVAX: designing and managing the COVAX Facility and the Gavi COVAX AMC and working with its traditional Alliance partners UNICEF and WHO, along with governments, on country readiness and delivery. As part of this role, Gavi hosts the Office of the COVAX Facility to coordinate the operation and governance of the mechanism as a whole, holds financial and legal relationships with 193 Facility participants, and manages the COVAX Facility deals portfolio: negotiating advance purchase agreements with manufacturers of promising vaccine candidates to secure doses on behalf of all COVAX Facility participants. Gavi also coordinates design, operationalisation and fundraising for the Gavi COVAX AMC, the mechanism that provides access to donor-funded doses of vaccine to 92 lower-income economies. As part of this work, Gavi provides funding and oversight for UNICEF procurement and delivery of vaccines to all AMC participants – operationalising the advance purchase agreements between Gavi and manufacturers – as well as support for partners’ and governments work on readiness and delivery. This includes tailored support to governments, UNICEF, WHO and other partners for cold chain equipment, technical assistance, syringes, vehicles, and other aspects of the vastly complex logistical operation for delivery. Gavi also co-designed, raises funds for and supports the operationalisation of the AMC’s no fault compensation mechanism as well as the COVAX Humanitarian Buffer.

WHO’s role in COVAX

WHO has multiple roles within COVAX: It provides normative guidance on vaccine policy, regulation, safety, R&D, allocation, and country readiness and delivery. Its Strategic Advisory Group of Experts (SAGE) on Immunization develops evidence-based immunization policy recommendations. Its Emergency Use Listing (EUL) / prequalification programmes ensure harmonized review and authorization across member states. It provides global coordination and member state support on vaccine safety monitoring. It developed the target product profiles for COVID-19 vaccines and provides R&D technical coordination. WHO leads, together with UNICEF, the Country Readiness and Delivery workstream, which provides support to countries as they prepare to receive and administer vaccines. Along with Gavi and numerous other partners working at the global, regional, and country-level, the CRD workstream provides tools, guidance, monitoring, and on the ground technical assistance for the planning and roll-out of the vaccines. Along with COVAX partners, WHO has developed a no-fault compensation scheme as part of the time-limited indemnification and liability commitments

UNICEF’s role in COVAX

UNICEF is leveraging its experience as the largest single vaccine buyer in the world and working with manufacturers and partners on the procurement of COVID-19 vaccine doses, as well as freight, logistics and storage. UNICEF already procures more than 2 billion doses of vaccines annually for routine immunisation and outbreak response on behalf of nearly 100 countries. In collaboration with the PAHO Revolving Fund, UNICEF is leading efforts to procure and supply doses of COVID-19 vaccines for COVAX. In addition, UNICEF, Gavi and WHO are working with governments around the clock to ensure that countries are ready to receive the vaccines, with appropriate cold chain equipment in place and health workers trained to dispense them. UNICEF is also playing a lead role in efforts to foster trust in vaccines, delivering vaccine confidence communications and tracking and addressing misinformation around the world.

About ACT-Accelerator

The Access to COVID-19 Tools ACT-Accelerator, is a new, ground-breaking global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. It was set up in response to a call from G20 leaders in March and launched by the WHO, European Commission, France and The Bill & Melinda Gates Foundation in April 2020.

The ACT-Accelerator is not a decision-making body or a new organisation, but works to speed up collaborative efforts among existing organisations to end the pandemic. It is a framework for collaboration that has been designed to bring key players around the table with the goal of ending the pandemic as quickly as possible through the accelerated development, equitable allocation, and scaled up delivery of tests, treatments and vaccines, thereby protecting health systems and restoring societies and economies in the near term. It draws on the experience of leading global health organisations which are tackling the world’s toughest health challenges, and who, by working together, are able to unlock new and more ambitious results against COVID-19. Its members share a commitment to ensure all people have access to all the tools needed to defeat COVID-19 and to work with unprecedented levels of partnership to achieve it.

The ACT-Accelerator has four areas of work: diagnostics, therapeutics, vaccines and the health system connector. Cross-cutting all of these is the workstream on Access & Allocation.

 

First Meeting of the Task Force on COVID-19 Vaccines, Therapeutics and Diagnostics for Developing Countries

30 Jun

The Heads of the World Bank Group, International Monetary Fund, World Health Organization, and World Trade Organization today convened for the first meeting of the Task Force on COVID-19 Vaccines, Therapeutics and Diagnostics for Developing Countries. They issued the following joint statement:

“As many countries are struggling with new variants and a third wave of COVID-19 infections, accelerating access to vaccines becomes even more critical to ending the pandemic everywhere and achieving broad-based growth. We are deeply concerned about the limited vaccines, therapeutics, diagnostics, and support for deliveries available to developing countries. Urgent action is needed now to arrest the rising human toll due to the pandemic, and to halt further divergence in the economic recovery between advanced economies and the rest.

We have formed a Task Force, as a “war room” to help track, coordinate and advance delivery of COVID-19 health tools to developing countries and to mobilize relevant stakeholders and national leaders to remove critical roadblocks—in support of the priorities set out by World Bank Group, IMF, WHO, and WTO including in the joint statements of June 1 and June 3, and in the IMF staff’s $50 billion proposal.

At today’s first meeting, we discussed the urgency of increasing supplies of vaccines, therapeutics, and diagnostics for developing countries. We also looked at practical and effective ways to track, coordinate and advance delivery of COVID-19 vaccines to developing countries.

As an urgent first step, we are calling on G20 countries to (1) embrace the target of at least 40 percent in every country by end-2021, and at least 60 percent by the first half of 2022, (2) share more vaccine doses now, including by ensuring at least  1 billion doses are shared with developing countries in 2021 starting immediately, (3) provide financing, including grants and concessional financing, to close the residual gaps, including for the ACT-Accelerator, and (4) remove all barriers to export of inputs and finished vaccines, and other barriers to supply chain operations.

In addition, to enhance transparency we agreed to compile data on dose requests (by type and quantity), contracts, deliveries (including through donations), and deployments of COVID-19 vaccines to low and middle-income countries—and make it available as part of a shared country-level dashboard. We also agreed to take steps to address hesitancy, and to coordinate efforts to address gaps in readiness, so countries are positioned to receive, deploy and administer vaccines.” 

Joint Statement by the Heads of the World Bank Group, International Monetary Fund, World Health Organization, and World Trade Organization on the First Meeting of the Task Force on COVID-19 Vaccines, Therapeutics and Diagnostics for Developing Countries

30 Jun

The Heads of the World Bank Group, International Monetary Fund, World Health Organization, and World Trade Organization today convened for the first meeting of the Task Force on COVID-19 Vaccines, Therapeutics and Diagnostics for Developing Countries. They issued the following joint statement:

“As many countries are struggling with new variants and a third wave of COVID-19 infections, accelerating access to vaccines becomes even more critical to ending the pandemic everywhere and achieving broad-based growth. We are deeply concerned about the limited vaccines, therapeutics, diagnostics, and support for deliveries available to developing countries. Urgent action is needed now to arrest the rising human toll due to the pandemic, and to halt further divergence in the economic recovery between advanced economies and the rest.

We have formed a Task Force, as a “war room” to help track, coordinate and advance delivery of COVID-19 health tools to developing countries and to mobilize relevant stakeholders and national leaders to remove critical roadblocks—in support of the priorities set out by World Bank Group, IMF, WHO, and WTO including in the joint statements of June 1 and June 3, and in the IMF staff’s $50 billion proposal.

At today’s first meeting, we discussed the urgency of increasing supplies of vaccines, therapeutics, and diagnostics for developing countries. We also looked at practical and effective ways to track, coordinate and advance delivery of COVID-19 vaccines to developing countries.

As an urgent first step, we are calling on G20 countries to (1) embrace the target of at least 40 percent in every country by end-2021, and at least 60 percent by the first half of 2022, (2) share more vaccine doses now, including by ensuring at least  1 billion doses are shared with developing countries in 2021 starting immediately, (3) provide financing, including grants and concessional financing, to close the residual gaps, including for the ACT-Accelerator, and (4) remove all barriers to export of inputs and finished vaccines, and other barriers to supply chain operations.

In addition, to enhance transparency we agreed to compile data on dose requests (by type and quantity), contracts, deliveries (including through donations), and deployments of COVID-19 vaccines to low and middle-income countries—and make it available as part of a shared country-level dashboard. We also agreed to take steps to address hesitancy, and to coordinate efforts to address gaps in readiness, so countries are positioned to receive, deploy and administer vaccines.” 

WHO and Global Fund Sign Cooperation Agreement to Scale Up HIV, TB and Malaria Interventions and Strengthen Health Systems

30 Jun

The World Health Organization and the Global Fund to Fight AIDS, Tuberculosis and Malaria signed a cooperation and financing agreement to implement 10 strategic initiatives to accelerate the end of AIDS, tuberculosis and malaria as epidemics and strengthen systems for health. This new agreement, which will cover the 2021-2023 implementation period, aims to address some of the persistent challenges that impede progress against the three diseases and protect hard-won gains from new pandemics like COVID-19.

In 2019, a total of 1.4 million people died from tuberculosis and an estimated 409,000 people died from malaria. In 2020, 690,000 people died from AIDS-related illnesses.

Through the new agreement, the strategic initiatives seek to:

  • Expand TB preventive treatment for people living with HIV in 9 countries across Africa;
  • Strengthen efforts to provide differentiated HIV service delivery;
  • Accelerate efforts to find people with TB missed by health systems in 20 countries;
  • Accelerate introduction of innovation for multi-drug resistant TB treatment through regional operational research in Eastern and Central Europe;
  • Support 26 countries and territories to eliminate malaria by 2025;
  • Improve country data collection and use to develop evidence-informed policy;
  • Foster the rapid uptake of service delivery innovations with South to South Learning;
  • Improve quality of care;
  • Encourage rapid uptake of procurement and supply chain management innovation; and
  • Increase program sustainability, facilitate the transition to domestic financing and improve program efficiency.


WHO and the Global Fund have a long and successful partnership working together to scale up HIV, TB and malaria interventions and strengthen health systems in many countries. Through focused efforts and catalytic investments, this collaboration has contributed to significantly reduce the disease burdens of HIV, TB and malaria worldwide, saving millions of lives since 2002.

“The COVID-19 pandemic, more than ever, reinforces the need to strengthen our partnership to achieve our shared goals of ending the epidemics,” said Dr Mubashar Sheikh, Director, Deputy Director-General’s Office, WHO. “This agreement supports countries to develop more effective responses to the HIV, tuberculosis and malaria epidemics and build the resilient health systems they need to reach the most vulnerable.”

“Together, WHO and the Global Fund have proven to be a powerful force that builds on strong in-country support and regional presence, technical leadership and financial resources to strengthen systems for health and accelerate the end of AIDS, TB and malaria as epidemics,” said Michael Byrne, Head of Technical Advice and Partnerships at the Global Fund. “This new agreement will help overcome the multiple challenges caused by the COVID-19 pandemic, safeguard and expand HIV, TB and malaria programs.”

 

 

 

WHO issues first global report on Artificial Intelligence (AI) in health and six guiding principles for its design and use

28 Jun

Artificial Intelligence (AI) holds great promise for improving the delivery of healthcare and medicine worldwide, but only if ethics and human rights are put at the heart of its design, deployment, and use, according to new WHO guidance published today.

The report, Ethics and governance of artificial intelligence for health, is the result of 2 years of consultations held by a panel of international experts appointed by WHO.

“Like all new technology, artificial intelligence holds enormous potential for improving the health of millions of people around the world, but like all technology it can also be misused and cause harm,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “This important new report provides a valuable guide for countries on how to maximize the benefits of AI, while minimizing its risks and avoiding its pitfalls.”

Artificial intelligence can be, and in some wealthy countries is already being used to improve the speed and accuracy of diagnosis and screening for diseases; to assist with clinical care; strengthen health research and drug development, and support diverse public health interventions, such as disease surveillance, outbreak response, and health systems management.

AI could also empower patients to take greater control of their own health care and better understand their evolving needs. It could also enable resource-poor countries and rural communities, where patients often have restricted access to health-care workers or medical professionals, to bridge gaps in access to health services.

However, WHO’s new report cautions against overestimating the benefits of AI for health, especially when this occurs at the expense of core investments and strategies required to achieve universal health coverage.

It also points out that opportunities are linked to challenges and risks, including unethical collection and use of health data; biases encoded in algorithms, and risks of AI to patient safety, cybersecurity, and the environment.      

For example, while private and public sector investment in the development and deployment of AI is critical, the unregulated use of AI could subordinate the rights and interests of patients and communities to the powerful commercial interests of technology companies or the interests of governments in surveillance and social control.

The report also emphasizes that systems trained primarily on data collected from individuals in high-income countries may not perform well for individuals in low- and middle-income settings.

AI systems should therefore be carefully designed to reflect the diversity of socio-economic and health-care settings. They should be accompanied by training in digital skills, community engagement and awareness-raising, especially for millions of healthcare workers who will require digital literacy or retraining if their roles and functions are automated, and who must contend with machines that could challenge the decision-making and autonomy of providers and patients.

Ultimately, guided by existing laws and human rights obligations, and new laws and policies that enshrine ethical principles, governments, providers, and designers must work together to address ethics and human rights concerns at every stage of an AI technology’s design, development, and deployment. 

 

Six principles to ensure AI works for the public interest in all countries

To limit the risks and maximize the opportunities intrinsic to the use of AI for health, WHO provides the following principles as the basis for AI regulation and governance:

Protecting human autonomy: In the context of health care, this means that humans should remain in control of health-care systems and medical decisions; privacy and confidentiality should be protected, and patients must give valid informed consent through appropriate legal frameworks for data protection.

Promoting human well-being and safety and the public interest. The designers of AI technologies should satisfy regulatory requirements for safety, accuracy and efficacy for well-defined use cases or indications. Measures of quality control in practice and quality improvement in the use of AI must be available.

Ensuring transparency, explainability and intelligibility. Transparency requires that sufficient information be published or documented before the design or deployment of an AI technology. Such information must be easily accessible and facilitate meaningful public consultation and debate on how the technology is designed and how it should or should not be used.

Fostering responsibility and accountability. Although AI technologies perform specific tasks, it is the responsibility of stakeholders to ensure that they are used under appropriate conditions and by appropriately trained people. Effective mechanisms should be available for questioning and for redress for individuals and groups that are adversely affected by decisions based on algorithms.

Ensuring inclusiveness and equity. Inclusiveness requires that AI for health be designed to encourage the widest possible equitable use and access, irrespective of age, sex, gender, income, race, ethnicity, sexual orientation, ability or other characteristics protected under human rights codes.

Promoting AI that is responsive and sustainable. Designers, developers and users should continuously and transparently assess AI applications during actual use to determine whether AI responds adequately and appropriately to expectations and requirements. AI systems should also be designed to minimize their environmental consequences and increase energy efficiency. Governments and companies should address anticipated disruptions in the workplace, including training for health-care workers to adapt to the use of AI systems, and potential job losses due to use of automated systems.         

These principles will guide future WHO work to support efforts to ensure that the full potential of AI for healthcare and public health will be used for the benefits of all.

At Local Production Forum, WHO and partners highlight key steps to improve access to health technologies

25 Jun

The first WHO World Local Production Forum ended today after five days of discussions centered on promoting quality and sustainable local production to improve access to medicines and other health technologies.

  • Delegates from over 100 countries, international partners, civil society groups, industry associations, and major investors joined WHO, WTO, UNIDO, UNICEF and UNCTAD to highlight the challenges facing local production and the steps required to address them, as well as the range of opportunities for the sector. 

Looking ahead, the Forum will provide a platform to drive forward efforts to support and enhance local production of health products in low- and middle-income countries.

Forum conclusions, recommendations and next steps

Increasing manufacturing capacity for global security - The COVID-19 pandemic has highlighted the importance of local manufacturing as a key component of pandemic response by reducing reliance on global markets and imported products.

Vaccine production was a central theme at the Forum, as were the role of new technologies and generation of flexible manufacturing strategies to develop sustained production capacity in low- and middle-income countries.

Technology transfer and licensing were seen as key to scaling up production. Sharing intellectual property and know-how will be essential, along with facilitation of voluntary licensing and effective technology transfer. It will also be vital to create a favourable environment for technology transfer. Key elements will include good governance; a skilled workforce; good access to market information and careful assessment of local capacity to receive and absorb the transferred technology.

Governmentsrole is key in creating an enabling political environment and a supportive business eco-system. Such efforts must be coordinated with relevant stakeholders at national, regional and global levels.

National regulators and local manufacturers can drive quality-compliant local production and facilitate faster access to health technologies during pandemics and beyond.  To do that, they need continued training, support and resources.

Low access to capital is a key limiting factor for local manufacturers in low- and middle-income countries. The greater interest expressed by key development banks and other financial institutions towards investing in the sector indicates improvement in this area, whilst the need to develop strong investment cases, including demonstration of a long term economically viable business case, were highlighted as key components of successful manufacturing projects.

A mechanism to stimulate industry engagement was recommended for strengthened collaboration with and among industry bodies with the aim of transferring priority technologies to low- and middle-income countries.

A strategic advisory group should be established by WHO in collaboration with Member States and partners to address current and future global challenges and trends in local production and technology transfer.

The next Forum will be held in The Netherlands as announced by Deputy Prime Minister and Minister of Health, Welfare and Sport, Hugo De Jonge. The Local Production Forum is now established as a long-term mechanism to promote dialogue and decision-making to strengthen local manufacturing capacity and move towards the shared goal of universal access to health technologies.

 

From 30 million cases to zero: China is certified malaria-free by WHO

25 Jun

Following a 70-year effort, China has been awarded a malaria-free certification from WHO – a notable feat for a country that reported 30 million cases of the disease annually in the 1940s.

“Today we congratulate the people of China on ridding the country of malaria,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Their success was hard-earned and came only after decades of targeted and sustained action. With this announcement, China joins the growing number of countries that are showing the world that a malaria-free future is a viable goal.”

China is the first country in the WHO Western Pacific Region to be awarded a malaria-free certification in more than 3 decades. Other countries in the region that have achieved this status include Australia (1981), Singapore (1982) and Brunei Darussalam (1987).

“Congratulations to China on eliminating malaria,” said Dr Takeshi Kasai, Regional Director, WHO Western Pacific Regional Office. “China’s tireless effort to achieve this important milestone demonstrates how strong political commitment and strengthening national health systems can result in eliminating a disease that once was a major public health problem. China’s achievement takes us one step closer towards the vision of a malaria-free Western Pacific Region.”

Globally, 40 countries and territories have been granted a malaria-free certification from WHO – including, most recently, El Salvador (2021), Algeria (2019), Argentina (2019), Paraguay (2018) and Uzbekistan (2018).

China’s elimination journey

Beginning in the 1950s, health authorities in China worked to locate and stop the spread of malaria by providing preventive antimalarial medicines for people at risk of the disease as well as treatment for those who had fallen ill. The country also made a major effort to reduce mosquito breeding grounds and stepped up the use of insecticide spraying in homes in some areas.

In 1967, the Chinese Government launched the “523 Project” – a nation-wide research programme aimed at finding new treatments for malaria. This effort, involving more than 500 scientists from 60 institutions, led to the discovery in the 1970s of artemisinin – the core compound of artemisinin-based combination therapies (ACTs), the most effective antimalarial drugs available today.

“Over many decades, China’s ability to think outside the box served the country well in its own response to malaria, and also had a significant ripple effect globally,” notes Dr Pedro Alonso, Director of the WHO Global Malaria Programme. “The Government and its people were always searching for new and innovative ways to accelerate the pace of progress towards elimination.”

In the 1980s, China was one of the first countries in the world to extensively test the use of insecticide-treated nets (ITNs) for the prevention of malaria, well before nets were recommended by WHO for malaria control. By 1988, more than 2.4 million nets had been distributed nation-wide. The use of such nets led to substantial reductions in malaria incidence in the areas where they were deployed.   

By the end of 1990, the number of malaria cases in China had plummeted to 117 000, and deaths were reduced by 95%. With support from the Global Fund to Fight AIDS, Tuberculosis and Malaria, beginning in 2003, China stepped up training, staffing, laboratory equipment, medicines and mosquito control, an effort that led to a further reduction in cases; within 10 years, the number of cases had fallen to about 5000 annually.

In 2020, after reporting 4 consecutive years of zero indigenous cases, China applied for an official WHO certification of malaria elimination. Members of the independent Malaria Elimination Certification Panel travelled to China in May 2021 to verify the country’s malaria-free status as well as its programme to prevent re-establishment of the disease.

Keys to success

China provides a basic public health service package for its residents free of charge. As part of this package, all people in China have access to affordable services for the diagnosis and treatment of malaria, regardless of legal or financial status.

Effective multi-sector collaboration was also key to success. In 2010, 13 ministries in China – including those representing health, education, finance, research and science, development, public security, the army, police, commerce, industry and information technology, customs, media and tourism – joined forces to end malaria nationwide.

In recent years, the country further reduced its malaria caseload through a strict adherence to the timelines of the “1-3-7” strategy. The “1” signifies the one-day deadline for health facilities to report a malaria diagnosis; by the end of day 3, health authorities are required to confirm a case and determine the risk of spread; and, within 7 days, appropriate measures must be taken to prevent further spread of the disease.

Keeping malaria at bay

The risk of imported cases of malaria remains a key concern, particularly in southern Yunnan Province, which borders 3 malaria-endemic countries: Lao People’s Democratic Republic, Myanmar and Viet Nam. China also faces the challenge of imported cases among Chinese nationals returning from sub-Saharan Africa and other malaria-endemic regions.

To prevent re-establishment of the disease, the country has stepped up its malaria surveillance in at-risk zones and has engaged actively in regional malaria control initiatives. Throughout the COVID-19 pandemic, China has maintained trainings for health providers through an online platform and held virtual meetings for the exchange of information on malaria case investigations, among other topics.

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Note to the editor

WHO malaria-free certification

Certification of malaria elimination is the official recognition by WHO of a country’s malaria-free status. WHO grants the certification when a country has demonstrated –with rigorous, credible evidence – that the chain of indigenous malaria transmission by Anopheles mosquitoes has been interrupted nationwide for at least the past three consecutive years.  A country must also demonstrate the capacity to prevent the re-establishment of transmission.

The final decision on awarding a malaria-free certification rests with the WHO Director-General, based on a recommendation by the independent Malaria Elimination Certification Panel (MECP). For more on WHO’s malaria-free certification process, visit this link.

Virtual forum: “From 30 million cases to zero:  China creates a malaria-free future”

On 2 July, representatives from China’s National Health Commission and frontline health workers will join malaria programme managers from other regions, WHO experts and global partners in a virtual forum to share reflections and perspectives on China’s malaria elimination journey. Discussions will be in English with simultaneous interpretation provided in Chinese, French and Spanish. To register for the webinar, visit this link.