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Event
body:

Access to controlled medicines in humanitarian emergencies remains constrained

Recognizing World Humanitarian Day 2021, the International Narcotics Control Board (INCB), the United Nations Office on Drugs and Crime (UNODC) and the World Health Organization (WHO) once again call on governments to facilitate access to medicines containing controlled substances in emergency settings, including during pandemics and the increasing number of climate-related disasters.

The theme of World Humanitarian Day 2021 acknowledged the impact of climate-related emergencies. Over 7,348 disasters have been reporting in the last two decades of which 40% are now estimated to be climate-related according to United Nations reports. The impact of their increasing number combined with the persistent COVID-19 pandemic creates a complex landscape for ensuring access to controlled medicines in emergencies.

A year after an  earlier joint statement, unprecedented trade restrictions, shortages of medicines, surges in infections and new variants of SARS-CoV-2 compound the problems related to maintaining supply of controlled medicines, according to WHO and the World Trade Organization.

The problem of access to controlled medicines in emergencies

There is an increase in demand for controlled medicines in emergency responses. Since the beginning of the COVID-19 pandemic, WHO has identified over 20 medicines with global-level shortages, including four that contain controlled substances that are used in intensive care units for treatment of severe cases of COVID-19. Internationally controlled medicines such as morphine, diazepam and midazolam listed as WHO essential medicines, are vital for the management of pain, palliative care, surgical care and anesthesia, and treatment of drug-use disorders, mental health and neurological conditions.

Shortages impact countries of all income levels. Low- and middle-income countries (LMIC) are often disproportionately impacted by shortages--partly related to their relative purchasing power in international medicines markets and partly because specialized systems to manage controlled medicines do not always accommodate sufficient exceptions for emergencies.

Urgent action is needed to ensure that national systems improve access to controlled medicines for people affected by emergencies, including pandemics, and climate-related disasters.

Action by governments and the international community

WHO guidelines on controlled medicines in emergencies outline simplified control measures for the cross-border trade of controlled medicines during humanitarian emergencies. They have been adapted into operational terms in the Inter-Agency Emergency Health Kit guidance. These guidelines and others have been in place for many years but are not consistently or effectively used by all countries.

In the current global landscape, it is of paramount importance that relevant authorities in exporting and importing countries exercise and apply the flexibilities described in these guidelines in several key areas, such as:

  • Amendments, waivers or new provisions that allow for greater flexibility in the use of control measures on controlled medicines during emergencies;
  • Enhanced partnerships, including reliance on relevant humanitarian agencies to carry out certain activities on behalf of governments;
  • Flexibilities that would ensure safe, timely and appropriate use of controlled medicines in emergencies, including provisional and long-term solutions.

Collaboration towards solutions

Interagency collaboration is critically important in our race against the climate crisis and humanitarian emergencies. On World Humanitarian Day, humanitarian personnel deserve our support and we honor and recognize their efforts. For those who have lost their lives working for humanitarian causes, we remember and honour the spirit of everything they have done. Our collective best effort is essential to facilitate the timely supply of controlled medicines for those in need during humanitarian crises.

Resource documents

Best practice guidance and international experience can be useful in interim national guidance as well as necessary changes to legislation. The following provide examples of from UN agencies and other useful information:

 



Access to controlled medicines in humanitarian emergencies remains constrained

Recognizing World Humanitarian Day 2021, the International Narcotics Control Board (INCB), the United Nations Office on Drugs and Crime (UNODC) and the World Health Organization (WHO) once again call on governments to facilitate access to medicines containing controlled substances in emergency settings, including during pandemics and the increasing number of climate-related disasters.

The theme of World Humanitarian Day 2021 acknowledged the impact of climate-related emergencies. Over 7,348 disasters have been reporting in the last two decades of which 40% are now estimated to be climate-related according to United Nations reports. The impact of their increasing number combined with the persistent COVID-19 pandemic creates a complex landscape for ensuring access to controlled medicines in emergencies.

A year after an  earlier joint statement, unprecedented trade restrictions, shortages of medicines, surges in infections and new variants of SARS-CoV-2 compound the problems related to maintaining supply of controlled medicines, according to WHO and the World Trade Organization.

The problem of access to controlled medicines in emergencies

There is an increase in demand for controlled medicines in emergency responses. Since the beginning of the COVID-19 pandemic, WHO has identified over 20 medicines with global-level shortages, including four that contain controlled substances that are used in intensive care units for treatment of severe cases of COVID-19. Internationally controlled medicines such as morphine, diazepam and midazolam listed as WHO essential medicines, are vital for the management of pain, palliative care, surgical care and anesthesia, and treatment of drug-use disorders, mental health and neurological conditions.

Shortages impact countries of all income levels. Low- and middle-income countries (LMIC) are often disproportionately impacted by shortages--partly related to their relative purchasing power in international medicines markets and partly because specialized systems to manage controlled medicines do not always accommodate sufficient exceptions for emergencies.

Urgent action is needed to ensure that national systems improve access to controlled medicines for people affected by emergencies, including pandemics, and climate-related disasters.

Action by governments and the international community

WHO guidelines on controlled medicines in emergencies outline simplified control measures for the cross-border trade of controlled medicines during humanitarian emergencies. They have been adapted into operational terms in the Inter-Agency Emergency Health Kit guidance. These guidelines and others have been in place for many years but are not consistently or effectively used by all countries.

In the current global landscape, it is of paramount importance that relevant authorities in exporting and importing countries exercise and apply the flexibilities described in these guidelines in several key areas, such as:

  • Amendments, waivers or new provisions that allow for greater flexibility in the use of control measures on controlled medicines during emergencies;
  • Enhanced partnerships, including reliance on relevant humanitarian agencies to carry out certain activities on behalf of governments;
  • Flexibilities that would ensure safe, timely and appropriate use of controlled medicines in emergencies, including provisional and long-term solutions.

Collaboration towards solutions

Interagency collaboration is critically important in our race against the climate crisis and humanitarian emergencies. On World Humanitarian Day, humanitarian personnel deserve our support and we honor and recognize their efforts. For those who have lost their lives working for humanitarian causes, we remember and honour the spirit of everything they have done. Our collective best effort is essential to facilitate the timely supply of controlled medicines for those in need during humanitarian crises.

Resource documents

Best practice guidance and international experience can be useful in interim national guidance as well as necessary changes to legislation. The following provide examples of from UN agencies and other useful information:

 

subject: INCB, UNODC and WHO Joint Statement on Access to Controlled Medicines in Emergencies
Event
body:

Twelve months ago, the world came together to support COVAX, a multilateral initiative aimed at guaranteeing global access to life-saving COVID-19 vaccines.

With the support of the international community, COVAX immediately began securing financing, entering into negotiations with vaccine developers and manufacturers and addressing the host of technical and operational challenges associated with rolling out the largest and most complex vaccination programme in history.

COVAX has already achieved significant progress: more than US$10 billion has been raised; legally-binding commitments for up to 4.5 billion doses of vaccine; 240 million doses have been delivered to 139 countries in just six months.

Yet the global picture of access to COVID-19 vaccines is unacceptable. Only 20% of people in low- and lower-middle-income countries have received a first dose of vaccine compared to 80% in high- and upper-middle income countries.

In the critical months during which COVAX was created, signed on participants, pooled demand, and raised enough money to make advance purchases of vaccines, much of the early global supply had already been bought by wealthy nations. Today, COVAX's ability to protect the most vulnerable people in the world continues to be hampered by export bans, the prioritisation of bilateral deals by manufacturers and countries, ongoing challenges in scaling up production by some key producers, and delays in filing for regulatory approval.

According to its latest Supply Forecast, COVAX expects to have access to 1.425 billion doses of vaccine in 2021, in the most likely scenario and in the absence of urgent action by producers and high-coverage countries to prioritize COVAX. Of these doses, approximately 1.2 billion will be available for the lower income economies participating in the COVAX Advance Market Commitment (AMC). This is enough to protect 20% of the population, or 40% of all adults, in all 92 AMC economies with the exception of India. Over 200 million doses will be allocated to self-financing participants. The key COVAX milestone of two billion doses released for delivery is now expected to be reached in the first quarter of 2022.

In addition to working closely with participating governments to ensure the conditions are in place on the ground to facilitate successful rollout of vaccines, COVAX and its partners call on donors and manufacturers to recommit their support, and prevent further delays to equitable access by ensuring the following:

  • Manufacturers deliver to COVAX in accordance with firm commitments and provide transparency on timelines for availability to COVAX to allow countries to plan in advance. 
  • Where countries are ahead of COVAX in manufacturer queues, and already have achieved high coverage, to give up their place in the queue to COVAX so that its participants can access the doses already secured via supply contracts and deliver vaccines to where they are needed most.​
  • Expand, accelerate, and systematize dose donations from countries that are already well advanced in their vaccination programmes. This includes ensuring doses are available in larger and more predictable volumes, with longer shelf lives – reducing the burden on countries trying to prepare for deliveries.

 As the COVID-19 pandemic continues to claim lives, destroy livelihoods and stunt economic recovery, we continue to emphasise that no one is safe until everyone is safe. There is only one way to end the pandemic and prevent the emergence of new and stubborn variants and that is by working together.

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.

 



Twelve months ago, the world came together to support COVAX, a multilateral initiative aimed at guaranteeing global access to life-saving COVID-19 vaccines.

With the support of the international community, COVAX immediately began securing financing, entering into negotiations with vaccine developers and manufacturers and addressing the host of technical and operational challenges associated with rolling out the largest and most complex vaccination programme in history.

COVAX has already achieved significant progress: more than US$10 billion has been raised; legally-binding commitments for up to 4.5 billion doses of vaccine; 240 million doses have been delivered to 139 countries in just six months.

Yet the global picture of access to COVID-19 vaccines is unacceptable. Only 20% of people in low- and lower-middle-income countries have received a first dose of vaccine compared to 80% in high- and upper-middle income countries.

In the critical months during which COVAX was created, signed on participants, pooled demand, and raised enough money to make advance purchases of vaccines, much of the early global supply had already been bought by wealthy nations. Today, COVAX's ability to protect the most vulnerable people in the world continues to be hampered by export bans, the prioritisation of bilateral deals by manufacturers and countries, ongoing challenges in scaling up production by some key producers, and delays in filing for regulatory approval.

According to its latest Supply Forecast, COVAX expects to have access to 1.425 billion doses of vaccine in 2021, in the most likely scenario and in the absence of urgent action by producers and high-coverage countries to prioritize COVAX. Of these doses, approximately 1.2 billion will be available for the lower income economies participating in the COVAX Advance Market Commitment (AMC). This is enough to protect 20% of the population, or 40% of all adults, in all 92 AMC economies with the exception of India. Over 200 million doses will be allocated to self-financing participants. The key COVAX milestone of two billion doses released for delivery is now expected to be reached in the first quarter of 2022.

In addition to working closely with participating governments to ensure the conditions are in place on the ground to facilitate successful rollout of vaccines, COVAX and its partners call on donors and manufacturers to recommit their support, and prevent further delays to equitable access by ensuring the following:

  • Manufacturers deliver to COVAX in accordance with firm commitments and provide transparency on timelines for availability to COVAX to allow countries to plan in advance. 
  • Where countries are ahead of COVAX in manufacturer queues, and already have achieved high coverage, to give up their place in the queue to COVAX so that its participants can access the doses already secured via supply contracts and deliver vaccines to where they are needed most.​
  • Expand, accelerate, and systematize dose donations from countries that are already well advanced in their vaccination programmes. This includes ensuring doses are available in larger and more predictable volumes, with longer shelf lives – reducing the burden on countries trying to prepare for deliveries.

 As the COVID-19 pandemic continues to claim lives, destroy livelihoods and stunt economic recovery, we continue to emphasise that no one is safe until everyone is safe. There is only one way to end the pandemic and prevent the emergence of new and stubborn variants and that is by working together.

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.

 

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