WHO takes this opportunity to remind Member States that are Parties to the WHO Framework Convention of Tobacco Control (FCTC) of their obligations under the Convention. Heated tobacco products are tobacco products, meaning that the WHO FCTC fully applies to these products. (Decision FCTC/COP8(22)) Specifically, Article 13.4(a) obliges Parties, to prohibit "all forms of tobacco advertising, promotion and sponsorship that promote a tobacco product by any means that are false, misleading or deceptive or likely to create an erroneous impression about its characteristics, health effects, hazards or emissions."
WHO reiterates that reducing exposure to harmful chemicals in Heated Tobacco Products (HTPs) does not render them harmless, nor does it translate to reduced risk to human health. Indeed, some toxins are present at higher levels in HTP aerosols than in conventional cigarette smoke, and there are some additional toxins present in HTP aerosols that are not present in conventional cigarette smoke. The health implications of exposure to these are unknown.
On 7 July 2020, the US FDA authorized the marketing of a heated tobacco product, the IQOS Tobacco Heating System, under the Federal Food, Drug and Cosmetic Act. This Act requires pre-market authorization of new tobacco products before they can be placed on the US market.
The US FDA statement noted that, “Even with this action, these products are not safe nor “FDA approved“. The exposure modification orders also do not permit the company to make any other modified risk claims or any express or implied statements that convey or could mislead consumers into believing that the products are endorsed or approved by the FDA, or that the FDA deems the products to be safe for use by consumers.”
The US FDA authorization rejected claims that the use of the product is less harmful than another tobacco product or reduces risks to health. The FDA orders also require the company to monitor youth awareness and use of the products to help ensure that the marketing of the MRTPs does not have unintended consequences for youth use. The company must also keep the FDA apprised of efforts to prevent youth access and exposure.
Given that health may be affected by exposure to additional toxins when using HTPs, claims that HTPS reduce exposure to harmful chemicals relative to conventional cigarettes may be misleading.
Moreover, the relevant orders grant a temporary market authorization within the US and are based on factors specific to the US, which is not a Party to the WHO Framework Convention on Tobacco Control (WHO FCTC).
All tobacco products pose risks to health and WHO urges full implementation of the WHO FCTC. Rigorous implementation will support quit attempts and reduce initiation by non-users of tobacco products, especially the young. WHO recommends cessation of all tobacco use with interventions, such as brief advice from health professionals, national toll-free quit lines, nicotine replacement therapies and cessation interventions delivered via mobile text messaging.
WHO and the Stop TB Partnership’s New Diagnostics Working Group (NDWG) launched today a framework for the evaluation of new tests for tuberculosis infection. The document provides details on study design, populations, reference standards, sample size calculation and data analysis to guide the future development of these tests.
Approximately a quarter of the world’s population is estimated to be infected with Mycobacterium tuberculosis. Treatment of TB infection, also known as tuberculosis preventive treatment (TPT), aims to prevent the development of TB disease, and is one of the critical components to achieve the ambitious targets of the WHO End TB Strategy. At the United Nations High-level Meeting (UNHLM) on TB in 2018, countries committed to provide TPT to at least 30 million people in 2018-2022.
"We urgently need new tests for TB infection to expand access to TB preventive treatment for the millions in need, to stop the onset of disease, avert suffering and save lives," said Dr Tereza Kasaeva, Director, WHO Global TB Programme. "New tests with better operational characteristics which can be easily scaled up in the community are vital to overcome the current challenges of fragile supply lines, high cost, cold-chain requirements, uncertainty about quality-assurance, and appropriate laboratory infrastructure."
This framework for evaluation of new tests for the detection of TB infection has been produced to direct research and to facilitate a standardized evaluation, thus accelerating the adoption of the tests into global and national policy and subsequent scale-up. The document covers technical issues that should be considered when evaluating new tests for TB infection, such as evaluation of the safety of skin tests, costs to the health system and its users, preferred features and operational characteristics. It is intended for manufacturers of diagnostics, researchers, research funders, regulators, TB programme coordinators, civil society and other stakeholders.
"We will not be able to progress towards ending TB without reliable tests to confirm TB infection," said Dr Alberto Matteelli, University of Brescia, Italy and coordinator of the Task Force that prepared the framework document. "Although currently testing for TB infection is not always required before starting TPT, a positive test result will help direct TPT to those would benefit most from treatment and avoid unnecessary medication."
Launching today, the COVID-19 Law Lab initiative gathers and shares legal documents from over 190 countries across the world to help states establish and implement strong legal frameworks to manage the pandemic. The goal is to ensure that laws protect the health and wellbeing of individuals and communities and that they adhere to international human rights standards.
The new Lab (at www.COVIDLawLab.org) is a joint project of United Nations Development Programme (UNDP), the World Health Organization (WHO), the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the O’Neill Institute for National and Global Health Law at Georgetown University.
Well-designed laws can help build strong health systems; evaluate and approve safe and effective drugs and vaccines; and enforce actions to create healthier and safer public spaces and workplaces. Critically, they are key to effective implementation of the WHO International Health Regulations: surveillance; infection prevention and control; management of travel and trade; and implementation of measures to maintain essential health services.
“Laws and policies that are grounded in science, evidence and human rights can enable people to access health services, protect themselves from COVID-19 and live free from stigma, discrimination and violence,” says Achim Steiner, UNDP Administrator. “The COVID-19 Law Lab is an important tool for sharing good practices on laws and policies.”
The COVID-19 pandemic has seen a vast increase in urgent legislative action to control and reduce the pandemic.
“Strong legal frameworks are critical for national COVID-19 responses,” said Dr. Tedros Adhanom Ghebreyesus, WHO Director-General. “Laws that impact health often fall outside the health sector. As health is global, legal frameworks should be aligned with international commitments to respond to current and emerging public health risks. A strong foundation of law for health is more important now than ever before.”
However, laws that are poorly designed, implemented, or enforced can harm marginalized populations, entrench stigma and discrimination, and hinder efforts to end the pandemic.
“Harmful laws can exacerbate stigma and discrimination, infringe on people’s rights and undermine public health responses,” according to Winnie Byanyima, Executive Director of UNAIDS. “To ensure responses to the pandemic are effective, humane and sustainable, governments must use the law as a tool to uphold the human rights and dignity of people affected by COVID-19.”
The COVID-19 Law Lab is a database of laws that countries have implemented in response to the pandemic. It includes state of emergency declarations, quarantine measures, disease surveillance, legal measures relating to mask-wearing, social distancing, and access to medication and vaccines. The database will continue to grow as more countries and themes are added.
It will also feature research on different legal frameworks for COVID-19. These analyses will focus on the human rights impacts of public health laws and help countries identify best practices to guide their immediate responses to COVID-19 and socioeconomic recovery efforts once the pandemic is under control. It builds off the work of the UHC Legal Solutions Network, which was established to help countries achieve universal health coverage through the implementation of rights-based legal frameworks.
“We need to track and evaluate how laws and policies are being used during the Pandemic to understand what works,” said Dr. Matthew M. Kavanagh, faculty in Georgetown University’s Department of International Health. Katie Gottschalk, Executive Director of the O’Neill Institute for National and Global Health Law at Georgetown University Law Center added, “We must learn lessons from the early stage of pandemic policies to implement the most effective laws going forward – the COVID-19 Law Lab allows us to do just that.”
UNDP is the leading United Nations organization fighting to end the injustice of poverty, inequality, and climate change. Working with our broad network of experts and partners in 170 countries, we help nations to build integrated, lasting solutions for people and planet.
Learn more at undp.org or follow at @UNDP.
The World Health Organization provides global leadership in public health within the United Nations system. Founded in 1948, WHO works with 194 Member States, across six regions and from more than 150 offices, to promote health, keep the world safe and serve the vulnerable. Our goal for 2019-2023 is to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and provide a further billion people with better health and wellbeing. For updates on COVID-19 and public health advice to protect yourself from coronavirus, visit www.who.int and follow WHO on Twitter, Facebook, Instagram, LinkedIn, TikTok, Pinterest, Snapchat, YouTubeAbout UNAIDS
The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook, Twitter, Instagram and YouTube.
The O’Neill Institute, housed at Georgetown University, was established to create innovative solutions to the most pressing national and international health concerns, with the essential vision that the law has been, and will remain, a fundamental tool for solving critical health problems. The Georgetown University Department of International Health is home to scholarship in public health, economics, political science, and medicine. Georgetown’s Global Health Initiative serves as a university-wide platform for developing concrete solutions to the health challenges facing families and communities throughout the world. Read more at oneillinstitute.org and connect with us on Twitter and Facebook.
The COVID-19 Law lab is a product of the UHC Legal Solutions Network is a collaboration between the World Health Organization (WHO), the United Nations Development Programme (UNDP), the Joint United Nations Programme on HIV and AIDS (UNAIDS), the Inter-Parliamentary Union (IPU), and the O’Neill Institute for National and Global Health Law at Georgetown University. The initiative aims to support countries to achieve universal health coverage by working with policymakers, civil society groups and other stakeholders to craft laws ensure that all people and communities have the right to access the promotive, preventive, curative, rehabilitative and palliative health services they need, of sufficient quality to be effective, while also ensuring that the use of these services does not expose the user to financial hardship.
World Health Organization Director-General Dr Tedros Adhanom Ghebreyesus today joined the leadership of Spain, paying homage to those who have lost their lives in the country due to COVID-19, saluting the heroic efforts of heath workers and praising the government’s resolute and robust response to reverse the virus’s transmission.
“It is with great respect that I join the King of Spain, the Prime Minister and the entire government of the country to pay tribute to the people who have fallen victim to COVID-19,” said Dr Tedros. “I extend my deepest condolences to the families of all people who have lost their lives due to this virus in Spain, and around the world.”
At one point, Spain was among the countries impacted most by COVID-19. At the outbreak’s peak, close to 10,000 new cases were reported in a single day in Spain. Since then, intensive efforts, led by robust surveillance, testing, contact tracing, treatment and isolation, have managed to suppress transmission.
Dr Tedros said this shift was due to the leadership shown by Spain and the strong resolve shown by the Spanish public to adhere to strict restrictions, including lockdowns, physical distancing and other critical measures to contain transmission. These efforts, combined, have successfully changed the course of the country’s outbreak.
Geneva/London, 15 July 2020 – Seventy-five countries have submitted expressions of interest to protect their populations and those of other nations through joining the COVAX Facility, a mechanism designed to guarantee rapid, fair and equitable access to COVID-19 vaccines worldwide.
The 75 countries, which would finance the vaccines from their own public finance budgets, partner with up to 90 lower-income countries that could be supported through voluntary donations to Gavi’s COVAX Advance Market Commitment (AMC). Together, this group of up to 165 countries represents more than 60% of the world’s population. Among the group are representatives from every continent and more than half of the world’s G20 economies.
“COVAX is the only truly global solution to the COVID-19 pandemic,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance. ““For the vast majority of countries, whether they can afford to pay for their own doses or require assistance, it means receiving a guaranteed share of doses and avoiding being pushed to the back of the queue, as we saw during the H1N1 pandemic a decade ago. Even for those countries that are able to secure their own agreements with vaccine manufacturers, this mechanism represents, through its world-leading portfolio of vaccine candidates, a means of reducing the risks associated with individual candidates failing to show efficacy or gain licensure.”
The COVAX Facility forms a key part of the COVAX pillar (COVAX) of the Access to COVID-19 Tools (ACT) Accelerator, a ground-breaking global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. COVAX is co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO, working in partnership with developed and developing country vaccine manufacturers. COVAX aims to accelerate the development and manufacture of COVID-19 vaccines, and to guarantee fair and equitable access for every country in the world.
It will achieve this by sharing the risks associated with vaccine development, investing in manufacturing upfront so vaccines can be deployed at scale as soon as they are proven successful, and pooling procurement and purchasing power to achieve sufficient volumes to end the acute phase of the pandemic by 2021.
“This early level of interest represents a tremendous vote of confidence in COVAX and our shared goal to protect people around the globe through the fair allocation of a COVID-19 vaccine,” said Dr Richard Hatchett, CEO of CEPI. “COVAX offers an innovative solution to the gravest public health crisis in living memory. It will speed up the availability of safe and effective vaccines through early investment in manufacturing capacity, and maximise the chances of success by backing a broad and diverse portfolio of vaccine candidates. Through COVAX our aspiration is to be able to vaccinate the most vulnerable 20% of the population of every country that participates, regardless of income level, by the end of 2021. Ensuring fair access is not only a matter of equity; it is the fastest way to end this pandemic”
The goal of COVAX is by the end of 2021 to deliver two billion doses of safe, effective vaccines that have passed regulatory approval and/or WHO prequalification. These vaccines will be delivered equally to all participating countries, proportional to their populations, initially prioritising healthcare workers then expanding to cover 20% of the population of participating countries. Further doses will then be made available based on country need, vulnerability and COVID-19 threat. The COVAX Facility will also maintain a buffer of doses for emergency and humanitarian use, including dealing with severe outbreaks before they spiral out of control.
“The COVID-19 pandemic, like every health crisis, also presents us with opportunities,” said Dr Soumya Swaminathan, WHO Chief Scientist. “A vaccine that is affordable and accessible to all will help us address systemic health inequalities. We need all countries to support COVAX to achieve this goal and bring an end to the acute phase of the pandemic.”
The success of these efforts will ultimately depend on securing enough funding from governments and commitments from vaccine manufacturers to participate at a scale large enough to deliver a global solution. The formal expressions of interest submitted are non-binding; the COVAX pillar will now begin a process of consultation with all 165 countries, with countries funding vaccines through their own domestic budgets being required to provide an upfront payment and a commitment to purchase doses by the end of August to secure involvement in the COVAX Facility.
Significant progress has been achieved by the COVAX partners to date, with seven of the nine candidate vaccines supported by CEPI already in clinical trials. A memorandum of understanding with AstraZeneca also commits them to supply 300 million doses of COVID-19 vaccines to COVAX.
In addition, in June Gavi launched the COVAX Advance Market Commitment (AMC), a financing instrument aimed at incentivising vaccine manufacturers to produce sufficient quantities of eventual COVID-19 vaccines to ensure access for developing countries. The AMC has already raised close to US$ 600 million against an initial target of US$ 2 billion from high income donors as well as the private sector. The Gavi Alliance will also work with the developing countries to assure readiness of supply and cold chain and training to reach high risk groups.
Notes to editors
The countries submitting expressions of interest include Argentina, Armenia, Brazil, Canada, Czech Republic, Estonia, Finland, Iceland, Ireland, Israel, Japan, Kuwait, Luxembourg, Mauritius, Mexico, Monaco, Montenegro, New Zealand, North Macedonia, Norway, Portugal, Qatar, Republic of Korea, San Marino, Saudi Arabia, Switzerland, United Arab Emirates and the United Kingdom.
In addition to the 75 potentially self-financing countries that have submitted Expressions of Interest in the COVAX Facility, 20 Gavi COVAX AMC-eligible countries have also voluntarily submitted Expressions of Interest.
The proposed list of 90 AMC-eligible countries includes existing Gavi-supported countries, former Gavi-supported countries and IDA-eligible small economies. The full list is subject to approval by the Gavi Board and will be released once approved.
About Gavi, the Vaccine Alliance
Gavi, the Vaccine Alliance is a public-private partnership that helps vaccinate half the world’s children against some of the world’s deadliest diseases. Since its inception in 2000, Gavi has helped to immunise a whole generation – over 760 million children – and prevented more than 13 million deaths, helping to halve child mortality in 73 developing countries. Gavi also plays a key role in improving global health security by supporting health systems as well as funding global stockpiles for Ebola, cholera, meningitis and yellow fever vaccines. After two decades of progress, Gavi is now focused on protecting the next generation and reaching the unvaccinated children still being left behind, employing innovative finance and the latest technology – from drones to biometrics – to save millions more lives, prevent outbreaks before they can spread and help countries on the road to self-sufficiency. Learn more at www.gavi.org and connect with us on Facebook and Twitter.
The Vaccine Alliance brings together developing country and donor governments, the World Health Organization, UNICEF, the World Bank, the vaccine industry, technical agencies, civil society, the Bill & Melinda Gates Foundation and other private sector partners. View the full list of donor governments and other leading organizations that fund Gavi’s work here.
CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated nine partnerships to develop vaccines against the novel coronavirus. The programmes are leveraging rapid response platforms already supported by CEPI as well as new partnerships.
Before the emergence of COVID-19, CEPI’s priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).
The World Health Organization provides global leadership in public health within the United Nations system. Founded in 1948, WHO works with 194 Member States, across six regions and from more than 150 offices, to promote health, keep the world safe and serve the vulnerable. Our goal for 2019-2023 is to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and provide a further billion people with better health and wellbeing.