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World Health Organization

Member States adopt the Global Strategy for TB Research and Innovation at 73rd World Health Assembly

WHO news - 4 hours 6 min ago

Member States have adopted the global strategy for TB research and innovation through an unprecedented written silence procedure of the 73rd session of the World Health Assembly (WHA) last week. The global strategy was developed to support efforts by governments and other partners to accelerate TB research and innovation, and to improve equitable access to the benefits of research in line with the commitments made in the WHO End TB Strategy, the Moscow Declaration to End TB and the political declaration of the United Nations high-level meeting on TB. The development of the strategy was requested by Member States during the 71st WHA with a view “to make further progress in enhancing cooperation and coordination in respect of tuberculosis research and development”.

Four major areas for action are highlighted in the strategy: creating an enabling environment for TB research and innovation; increasing financial investments in TB research and innovation; promoting and improving approaches to data sharing; and promoting equitable access to the benefits of research and innovation. In the spirit of fast-tracking efforts to end TB, a prerequisite for success is that all stakeholders make concerted efforts and collaborate. Hence, the strategy also makes the case for a unified and aligned response in which key national and international partners and affected communities support Member States by undertaking the investments and partnerships that are necessary for accelerating innovation. The primary audiences for the document are Member States, particularly ministries of health, science and technology, finance and education.

“Research and innovation are vital if we are to break the stronghold of TB - the world’s top infectious killer -that continues to claim millions of lives each year. This global strategy will guide Member States and other relevant stakeholders in translating political commitments on TB research and innovation into concrete action backed by investment, as an integral part of efforts to end TB” said Dr Tereza Kasaeva, Director of WHO’s Global TB Programme “We welcome this renewed commitment by Member States at a time where the COVID-19 pandemic has exposed many gaps in TB service provision that need to be addressed through innovation”.

Under the leadership of WHO, the strategy was developed during the past two years through a consultative process with Member States including managers of national tuberculosis programmes (NTPs) and other officials from within and beyond ministries of health such as ministries of science and technology; the WHO Strategic and Technical Advisory Group for Tuberculosis (STAG-TB); the WHO Global TB Research Task Force; representatives of civil society and affected communities; research funding institutions; and other stakeholders in TB research and innovation. The strategy has also benefited from an open web consultation, where extensive comments were received on a zero draft of the strategy.

The Assembly also passed a resolution requesting WHO to provide a report on the implementation of the strategy to WHA, biennially until 2030.  The resolution also called for the support of the scientific community, international partners and other relevant stakeholders to undertake research and innovation aligned to the needs of the countries most affected by TB; to strengthen public-private partnerships; and to facilitate knowledge sharing. Furthermore, it requested WHO to provide technical and strategic assistance to Member States in the implementation of the strategy.

“This resolution reflects Member States’ recognition of research and innovation as a key priority for ending TB, and their commitment to take concerted action to address unmet needs. It will help pave the way for the successful implementation of the strategy,” said Dr Matteo Zignol, a.i. Unit Head, Prevention, Care and Innovations at WHO’s Global TB Programme.

WHO at the virtual High-level Political Forum (HLPF) 2020

WHO news - 11 hours 10 min ago

The United Nations High-level Political Forum (HLPF), a mechanism that tracks and advances the implementation of the 2030 Agenda for Sustainable Development, was convened virtually due to the COVID-19 pandemic, on 7–16 July 2020, on the theme "Accelerated action and transformative pathways: realizing the decade of action and delivery for sustainable development ". Given the considerable impact of the pandemic on human health and the global economy, the Forum strongly focused on the potential impact of the pandemic on the implementation of the SDGs and the 2030 Agenda, and how the international community can respond and get back on track to achieving the sustainable development agenda. 

 

WHO actively participated in the Forum, by contributing to the background materials and agenda for four of the six official thematic sessions (Advancing human well-being; Ending hunger and achieving food security for all; Protecting the planet and building resilience; Sharing economic benefits) as well as in the virtual special events, side events and the Voluntary National Reviews (VNRs).  The 47 countries that presented VNRs, echoed the need to undertake substantial measures to contain the spread of COVID-19 and to ensure the proper functioning, preparedness and strengthening of health systems.

 

The eight WHO co-sponsored side events, focused on UHC and investing in health; tobacco control, COVID-19 and children; global strategy to leave no one behind during the COVID-19 pandemic; COVID-19 vaccines, Nutrition, as well as education in time of COVID-19, among others.

 

WHO’s main side event, co-hosted by Dr. Nata Menabde of the WHO office at the UN, focused on Investing in Health: the Key to Building Back Better from COVID-19 and Accelerating Progress for UHC and Sustainable Development, was organized in collaboration with the Group of Friends of UHC and Global Health and UHC2030. It addressed the extent to which COVID-19 has endangered global health and human security, threatening the progress made on the SDGs, as well as best practices and lessons learned to help accelerate response and recovery. Dr. Tedrosaddressed the meeting in a video message, urging leaders to fulfil the commitments made in the UHC Political Declaration to build back better, accelerate action to achieve the SDGs, and leave no one behind.

 

WHO was also represented by Mr. Stewart Simonson, Head of the WHO Office at the UN, at a side event on “Education and the Trying Times of COVID-19”, organized by theMission of the State of Qatar to the UN. He highlighted the vulnerability of children and young people due to the health and socioeconomic impacts resulting from the pandemic and stressed the need for national health system reform to be led by a strong multi-sectoral and whole-of-government approach.

 

The WHO VNR lab event cosponsored by the Financing for Sustainable Development Office of UNDESA and UHC2030, featuring Dr. Agnes Soucat, Director of Health Systems Governance and Financing at WHO, raised awareness of the health financing gaps as well as showcased solutions to financing health systems and build on lessons learned from COVID-19.

 

WHO also participated in thevirtualSDG Media Zone focusing on sustainability, solidarity and solutions, as the pillars for recovering back better. Dr Bruce Aylward, Epidemiologist and Senior Advisor to the WHO Director-General, highlighted the importance of vaccines in the global response efforts to COVID-19 and the crucial need for equitable access to them, once they become available.

 

Prior to officially concluding the Forum, the ECOSOC President, unveiled new UN stamps which pay tribute to frontline workers in the pandemic. Proceeds from an added surcharge will go directly to the COVID-19 Solidarity Response Fund to support the WHO and partners.

Plane carrying WHO trauma and surgical supplies arrives in Beirut, Lebanon

WHO news - 07.08.2020

A plane carrying 20 tonnes of WHO health supplies has landed in Beirut, Lebanon, to support the treatment of patients injured by the massive blast that occurred in the city on 4 August. The supplies will cover 1000 trauma interventions and 1000 surgical interventions for people suffering from injuries and burns resulting from the blast.

The shipment was airlifted from WHO’s logistics hub in Dubai earlier this afternoon using a plane donated by the Government of the United Arab Emirates, a key WHO partner in health emergency response.

“Our hearts and prayers are with all those affected by this tragic event as we continue our mission to serve all people in Lebanon with life-saving and essential health care services. We are working closely with national health authorities, health partners and hospitals treating the wounded to identify additional needs and ensure immediate support,” said WHO Representative in Lebanon Dr Iman Shankiti.

As a result of the blast, 3 hospitals in Beirut are now non-functional and 2 hospitals are partially damaged, leaving a critical gap in hospital bed capacity. Injured patients are being transferred to hospitals across the country, as far as south Saida and north Tripoli, and many facilities are overwhelmed. WHO will distribute the supplies to priority hospitals across Lebanon receiving and treating injured patients.

This latest emergency comes in the context of recent civil unrest, a major economic crisis, COVID-19 outbreak and heavy refugee burden. The legendary resilience of the Lebanese people has rarely been so severely tested. Ensuring that there is continuity of the response to COVID-19 – including targeting the most vulnerable for assistance – is a priority for both the Ministry of Public Health and WHO.

“With the emergence of new challenges due to the latest devastating event, the United Nations in Lebanon and partners have been mobilized to provide immediate humanitarian assistance to the Lebanese people in support of the Government’s response to this tragedy. We are in this together, and we are committed to supporting Lebanon in this very difficult time,” said Dr Najat Rochdi, UN Resident Coordinator in Lebanon.

 

73rd World Health Assembly Decisions

WHO news - 07.08.2020

The Member States of the World Health Organization (WHO) have adopted a number of decisions to advance global public health that had been proposed to the 73rd World Health Assembly in May 2020, via a "Written Silence Procedure".

The proposals relate to: strengthening global immunization efforts; cervical cancer prevention and control; a global strategy for tuberculosis research and innovation; eye care - including preventing vision impairment and blindness; strengthening efforts on food safety, a global strategy and plan of action on public health, innovation and intellectual property; a decade of healthy ageing; and influenza preparedness.

Strengthening global immunization efforts to leave no one behind

The Immunization Agenda 2030 strategic proposal envisions a world where everyone, everywhere, at every age, fully benefits from vaccines to improve health and well-being. The key goal is to extend the benefits of vaccines to everyone, everywhere. The strategy is people-centric, led by countries, implemented through broad partnerships and driven by data. It systematically applies these 4 core principles across a set of key priorities, highlighting that immunization is an investment for the future, creating a healthier, safer and more prosperous world for all. 

Vaccines are available to prevent more than 20 life-threatening diseases, helping people of all ages live longer, healthier lives. Immunization currently prevents well over 3 million deaths every year from diseases like diphtheria, tetanus, pertussis, influenza and measles; yet far too many people around the world – including nearly 20 million infants each year – have insufficient access to vaccines.

Cervical cancer prevention and control

The WHO global strategy to accelerate the elimination of cervical cancer as a public health problem establishes goals and targets for 2020 to 2030. It focuses on 3 key pillars: prevention through HPV vaccination; screening and treatment of pre-cancerous lesions; and management of invasive cervical cancer, including access to palliative care. All pillars must be pursued collectively to reach elimination.

To eliminate cervical cancer, all countries must reach (and maintain) an incidence below 4 per 100 000 women-years.  To get on the path to elimination, the strategy urges all countries to achieve the following targets by 2030: 90% of girls fully vaccinated (by 15 years of age); 70% coverage of screening with a high-performance test (once by the age of 35 and again by 45 years); and 90% of women who are identified with cervical disease receive treatment (90% of women with pre-cancer treated; 90% of women with invasive cancer managed). Achieving the 90-70-90 targets will yield impact on 2 fronts: we will see reductions in incidence and in mortality.  By 2030, the median cervical cancer incidence rate would fall by 10%, setting the world on the path to avert 70 million cases in the century.

Cervical cancer currently kills more than 300 000 women each year. The fourth most common cancer among women globally, its burden is greatest in low- and middle-income countries, where access to public health services is limited.

Tuberculosis research and innovation

The global strategy for TB research and innovation was developed to support efforts by governments and other partners to accelerate progress and to improve equitable access to the benefits of research in line with the commitments made in the WHO End TB Strategy, the Moscow Declaration to End TB and the political declaration of the United Nations high-level meeting on TB

It highlights 4 major areas for action are highlighted in the strategy: creating an enabling environment for TB research and innovation; increasing financial investments in TB research and innovation; promoting and improving approaches to data sharing; and promoting equitable access to the benefits of research and innovation. The strategy also makes the case for a unified and aligned response in which key partners and affected communities support Member States by undertaking the investments and partnerships that are necessary for accelerating innovation.

The resolution requests WHO to report biennially, until 2030, on the implementation of the strategy.  The resolution calls for the support of the scientific community, international partners and other relevant stakeholders to undertake research and innovation aligned with the needs of the countries most affected by TB; to strengthen public-private partnerships; and to facilitate knowledge sharing. Furthermore, it calls on WHO to provide technical and strategic assistance to Member States in the implementation of the strategy.

Integrated people centred eye care

A new World Health Assembly resolution focuses on the need to integrate people-centred eye care services into health systems. The first ever WHO report on vision (published in 2019) predicts a substantial increase in the number of people with eye conditions and vision impairment in the coming years. The resolution highlights 4 key strategies for Member States to improve access to services and reduce inequities.  The first is to better engage people and communities by raising awareness of the importance of early identification of eye conditions and simplifying access to care for underserved populations. The second is to strengthen eye care in primary health care so people can access services closer to their homes. The third is to improve coordination of eyecare services with other health services and with other sectors such as education and labour. The final recommendation is to integrate eye care into national health strategic plans and universal health coverage schemes. Member States recalled that preventing and addressing vision impairment not only improves quality of life for patients, it also enables them to remain economically productive.

Strengthening efforts on Food Safety 

A new resolution urges Member States to apply a “One Health” approach that promotes the sustainability and availability of safe, sufficient and nutritious food for all populations. Recognizing food safety threats, including foodborne antimicrobial resistance and climate change, the resolution also calls upon Member States to invest in national food safety systems and innovations, and to share timely data and evidence on foodborne disease outbreaks and hazards to the International Network of Food Safety Authorities (INFOSAN).

The Secretariat is requested to update the Global strategy for food safety to address current and emerging challenges and incorporate new technologies and innovative strategies for strengthening food safety systems. It also calls on the WHO Director-General to strengthen the Organization’s leadership in the Codex Alimentarius Commission and INFOSAN, and produce updated foodborne disease estimates by 2025. 

Around the world, an estimated 600 million - almost 1 in 10 people – fall ill after eating contaminated food each year, resulting in 420 000 deaths and the loss of 33 million healthy life years (DALYs). The burden of disease falls disproportionately on the most vulnerable, especially children and those living in developing countries.

Global strategy and plan of action on public health, innovation and intellectual property

The Global strategy and plan of action on public health, innovation and intellectual property urges Member States to reinforce implementation in line with the recommendations of an overall programme review panel. The decision also calls on Member States to further discuss, in informal consultations to be convened by the Director-General, the recommendations of the review panel on promoting and monitoring transparency of medicines prices and actions to prevent shortages. The decision emphasizes the necessity to allocate resources for WHO Secretariat implementation and further requests the Director-General to submit a report on progress made in implementing the decision to the Seventy-fourth World Health Assembly in 2021, through the Executive Board.

Decade of Healthy Ageing

Member States endorsed a proposal for a Decade of Healthy Ageing 2020–2030 and asked the Director-General to report back on progress on its implementation every 3 years during the Decade. The Health Assembly also asked the Director-General to transmit this decision to the Secretary-General of the United Nations for consideration of the proposal for the Decade by the United Nations General Assembly.

Populations around the world are ageing at a faster pace than in the past and this demographic transition will have an impact on almost all aspects of society. Already, there are more than 1 billion people aged 60 years or older, with most living in low- and middle-income countries. Many do not have access to even the basic resources necessary for a life of meaning and dignity. Many others confront multiple barriers that prevent their full participation in society.

The Decade of Healthy Ageing is an opportunity to bring together governments, civil society, international agencies, academia, the media, and the private sector for ten years of concerted, catalytic and collaborative action to improve the lives of older people, their families, and the communities in which they live.

Influenza Preparedness

Member States requested the Secretariat to continue its support for WHO’s Global Influenza Strategy 2019–2030. They also requested the promotion of synergies, where relevant and appropriate, with the International Health Regulations (2005), implementation of national plans for influenza preparedness and response, and immunization programmes. The Secretariat is requested to report back on progress through the Executive Board to the 75th World Health Assembly.

Mexico’s feat against rabies through cross-sectoral collaboration is possible in other countries

WHO news - 07.08.2020
Mexico is, so far, the only country validated by the World Health Organization (WHO) for having eliminated dog-mediated human rabies as a public health problem. To encourage countries that have implemented elimination programmes as recommended by WHO and the Organisation for Animal Health (OIE), international procedures have been developed jointly by WHO and OIE, following a One Health approach. The procedures involve several steps in the preparation, submission and review of a dossier.

WHO Information Notice for Users of Medical Devices 2020/3

WHO news - 07.08.2020

Date: 7 August 2020

Subject: Substandard/Falsified medical devices and personal protective equipment (PPE) used in the context of the COVID-19 pandemic

WHO-identifier: 2020/3, version 1

Type of action: Advice to users of medical devices and PPE used for prevention, treatment and care for COVID-19.

Attention: Users of medical devices and PPE[1], procurement entities and customs officials, national programme managers and their implementing partners, laboratories, ministry of health and national regulatory authorities for medical devices and PPE.

Purpose: To advise on actions to be taken to identify and prevent circulation of substandard/falsified medical devices and PPE for COVID-19.  

Description of the problem:

WHO continues to be made aware of circulation of substandard/falsified medical devices and PPE for prevention of COVID-19 and in the treatment and case management of people with COVID-19.

WHO uses the following definitions:

  • Substandard, also called "out of specification", are authorized medical devices that fail to meet either their quality or safety performance specifications.
  • Falsified medical device that deliberately/fraudulently misrepresent their identity, composition or source.
  • Unregistered/unlicensed medical devices that have not undergone evaluation and/or approval by the national regulatory authority for the market in which they are marketed/distributed or used, subject to permitted conditions under national regulation and legislation.


Any adverse event or product problem for a medical device may reveal that a product is substandard or falsified.  

Advice on action to be taken by buyers/donors of medical devices and PPE for COVID-19:

  1. Purchase products that have been authorized/approved/listed by the responsible institution: the national regulatory authority (NRA) or any other institution that has the mandate to oversee quality, safety and performance of such medical devices and PPE in your country.
  2. Review registration status by checking your NRA’s website for lists/databases of authorized/approved/listed products, and list of withdrawn/non-approved products. If such information is not publicly available on their websites, communication with your NRA is encouraged.
  3. Ensure donated medical devices and PPE are registered (see WHO guidelines).
  4. Purchase products from the legal manufacturer, or their designated economic operator (agent, distributor, supplier, authorized representative).
  5. Request from the manufacturer if any obsolescence plans are in place.

Advice on action to be taken by users of medical devices and PPE for COVID-19:

  1. Follow guidance from WHO on appropriate use of medical devices for COVID-19 T and use technical specifications provided by WHO or the final user to select the appropriate, safe and qualified medical device.
  2. Avoid purchasing medical devices online from an unknown source.
  3. Request a copy of the certificate of safety and performance depending on the functionality of the product from the manufacturer for each lot/serial number of product.
  4. Cross-reference the labelling of product received against your NRA’s authorization/approval/listing letter and labelling on your NRA’s website and the manufacturer’s website.
  5. Conduct incoming inspection for certain categories of medical devices.
  6. Read the instructions for use to understand the intended use of the product and taking note of any limitations.
  7. Ascertain, within reasonable doubt, that the product is genuine. Contact WHO, if in doubt[2].
  8. Run all required calibration and preventive maintenance procedures as instructed by the manufacturer in their instructions for use and operation manuals.
  9. Report any product problems and/or adverse events as complaints to the manufacturer as soon as you become aware using a complaint form and copy to WHO and your NRA. The contact details for the manufacturer can be found in both primary and secondary packaging materials and instructions for use.

Adverse events may be:

  • Death of the patient, end-user or any other person occurred or may have occurred
  • Death of the patient, end-user or any other person occurred or may have occurred

 

 

 

 

 

 

 

 

 

 

Product problems may be:

  • Packaging – damaged, defective, suspect tampered
  • Labelling – insufficient instructions for use, illegible
  • Sampling – device does not collect/transfer specimen
  • Liquid – leak, splash
  • Mechanical – misalignment, jam
  • Electrical – unable to charge, power loss or fluctuation
  • Data – capture, display, or storage affecting product     functionality
  • Software – network, program, algorithm, or security affecting product functionality
  • Environmental – noise, temperature, humidity/moisture, fungal/bacterial growth, or dust affecting product functionality
  • Failure to calibrate
  • Increased rate of invalid or unreturnable test results
  • Obviously incorrect, inadequate or imprecise result or readings
  • Unable to obtain reading

 

 

 

Advice for action to be taken by national regulators of medical devices and PPE for COVID-19:
  1. Assess products (full assessment or through reliance/recognition mechanisms) and share approval/authorization/listing on your website or any other platform which is accessible to stakeholders. Ensure such assessment is conducted before issuance of import permit for non-domestically manufactured product.  
  2. Conduct inspection of imported products in collaboration with customs officials at the point of entry to detect substandard/falsified devices and products. The following information can be checked; import certificate issued by the NRA, certificate of analysis (translated) which needs to be compared with the imported products. Physical examination of products including labelling information and details of the importer (authorized representatives or approved suppliers), matching of product details with certificate of analysis, evidence of tampering of labels, language, product description such as size, shape, colour, product code and batch, cracks, abrasion, erosion, breaks and seal integrity.
  3. Collect samples for further investigation if there is any suspicion about the product and take appropriate regulatory actions such as quarantine and testing.
  4. Ensure that users are aware that they should report any adverse event and product problems to the manufacturer.  
  5. Post field safety notices issued by manufacturers for medical devices and PPE supplied within your jurisdiction on your website.
  6. Exchange information with other regulators if your market surveillance detects product problems or adverse events. 

 

Note: For many jurisdictions, emergency use/approval mechanisms have been put in place for certain medical devices. These products should be the subject of increased monitoring by device users for adverse events and product problems.


[1] WHO previously published a WHO Information Notice for Users for falsified in vitro diagnostics (IVDs) used to diagnose COVID-19, seeWHO Information for Users n°2/2020.

Some PPE elements are classified as medical devices in some jurisdictions.

[2] Contact for further information: Anita SANDS, Regulation and Safety, e-mail: sandsa@who.int

 

Call for Expression of Interest in Advocacy Reference Group

PMNCH is leading a partnership effort to address the impact of COVID-19 on the health and rights of women, children and adolescents. A joint Call to Action aims to mobilize more than 1,000 PMNCH partners and to engage new constituencies in a campaign to advocate for continued access to essential and quality care for sexual, reproductive, maternal, newborn, child and adolescent health and the need to invest in and strengthen primary healthcare systems. More information is here.

We are forming an Advocacy Reference Group to serve as a sounding board and to facilitate the exchange of information and build supportive networks among partners engaged in advocacy and communication strategies for women's, children's and adolescents' health.

New Science Council to be established

WHO news - 06.08.2020

As a science-based institution, WHO is always striving to be at the forefront of scientific progress and its potential to improve health for all. A new WHO Science Council comprising international experts from a broad range of disciplines will support WHO in interpreting cutting-edge scientific and medical knowledge, as well as the latest advances in technology.

The Science Division’s Research for Health department will facilitate the Council’s work in advising on WHO’s top science, research, and innovation priorities, focusing on areas of greatest urgency and identifying the biggest gaps in evidence. The Council’s recommendations will be given to the Director-General as part of an expansion of the scope of the science underpinning WHO’s public health work.

New global health challenges are increasingly accompanied by rapid advances in science and  technology, including solutions that arise in nonmedical fields and which employ innovative techniques. In accordance with WHO’s directing and coordinating role in health, the Organization is seeking advice from the Science Council on state-of-the-art evidence-based responses to health challenges.

The terms of reference for the Science Council, along with information on the call for nominations, are here. 

 

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