africa cdc
Ahmed Ogwell Ouma, Africa CDC’s Acting Director (right) with WHO Director General Tedros Adhanom Ghebreyesus (left)

Africa CDC wants to be able to declare public health emergencies of continental security but the WHO warns this could be a risky move that could isolate African countries and create confusion regarding response.

The World Health Organization’s African Regional Office (WHO AFRO) has found itself explaining its disapproval of the Africa CDC’s quest for a mandate allowing it to be able to declare a “Public Health Emergency of Continental Security.”.

Last week, news broke that the WHO was mounting a drive to curtail Africa CDC’s ambitions to expand its powers – and particularly its request to African Union ministers of health to be empowered to declare a “Public Health Emergency of Continental Security”. 

The issue emerged as about 40 African Union health ministers convened in a meeting last week to discuss revisions to the statutes under which Africa CDC operates, which could give it more authority, including the power to declare regional or continent-wide health emergencies. 

At the meeting, 12 ministers reportedly supported WHO’s call to limit Africa CDC’s powers to declare such emergencies – which sources say  was a result of WHO’s lobbying of member states. The health ministers are due to reconvene again Tuesday to make a final recommendation on the amendments – which would eventually be placed before the AU Executive Council for a decision. 

In a statement, WHO’s African Region (AFRO) called for the assessment of the proposed policy’s benefits and risks to member states. It noted that while the policy change could reduce Africa’s dependence on others, it could also trigger more travel and trade restrictions and isolate the continent as occurred with the travel bans imposed by many countries in southern Africa after scientists there identified the emergence of the Omicron variant of the SARS CoV2 virus.

Arrivals to border control at London’s Heathrow Airport – quarantine rules were based on where they were vaccinated – and not the vaccine received.

“WHO believes a careful reflection on the interfacing between the declaration of a public health emergency of continental security and the global process would be of benefit,” WHO stated.

Speaking with Health Policy Watch Dr Abdou Salam Gueye, WHO AFRO’s Regional Emergency Director, added that creating a new type of emergency declaration at continental level, under the administration of Africa CDC rather than WHO, also could lead to confusion. And this he said could delay, rather than speeding up, countermeasures. 

At the same time he added, ““I believe that WHO is very open to discuss and see the best way to settle this issue.” 

Africa CDC’s acting director says more authority is justified 

Explaining why Africa CDC needs the mandate, Ahmed Ogwell Ouma, Africa CDC’s Acting Director, noted that African Union emergency response procedures – from recruiting response teams to medicines and vaccines procurement – cannot be activated without some kind of formal declaration of a public health emergency. 

“At the moment, that declaration of emergency is usually at two levels. First is at the national level. Governments are able to make that declaration that there is a public health emergency within their own borders. And beyond the borders, the WHO usually does that at the Geneva level,” Ouma said, speaking at an Africa CDC briefing last Thursday.

That, he noted, is the reason that AU policy organs are considering mandating Africa CDC to be able to declare regional public health emergencies within Africa, in order to ensure improved  continental health  security. 

Regional alert system doesn’t really exist

WHA President Dr Hiroki Nakatani of Japan applauds the decision of the 75th WHA to update the International Health Regulations.

Currently, WHO is only empowered under its International Health Regulations to declare public health emergencies at the global level and not at regional level.  

While there has been much criticism of this “binary” approach to the rules, it will take several more years to make amendments to the existing IHR, under a process that was just approved at last month’s 75th  World Health Assembly. 

And if there was to be a change in the existing yes-or-no alert system, the solution that has been most discussed is the addition of a global “yellow light” warning, rather than regional signals.  

Past history, however, has shown that it took considerable time for regional outbreaks in Africa to rank as sufficiently severe to warrant a global health alert. In the 2014-2016 Ebola outbreak in West Africa, a WHO public health emergency of international concern (PHEIC), was only declared in August 2018 – more than eight months after the first Ebola virus cases were reported in Guinea – and 6-8 months after the virus had already spread well into Liberia and Sierra Leone. 

In the case of the 2018 Ebola outbreak in the Democratic Republic of Congo,  there were 3 meetings of WHO’s Emergency Committee after the outbreak first began in May before a fourth meeting activated the PHEIC alarm in August 2018. Although considered a rapid response, in comparison to 2014, by that time the virus had already spread to Uganda, was threatening the borders of some 7 other states, and 1,700 people had already died.

Potential spillover of Ebola virus during the 2018-2020 outbreak to nine countries sharing borders with the Democratic Republic of Congo (Wadoum et al, 2021)

The experience underlines the importance of greater inter-African planning and cooperation on outbreak response, coordinated by Africa CDC, in the words of one retrospective study by a group of African and European researchers. 

Africa is split between two WHO regions

Another problem with WHO’s alert system is that within the global health agency,  responsibility for Africa is actually split between two WHO regional bodies – the AFRO region, which coordinates responses in sub-Saharan Africa and the Eastern Mediterranean Regional Office (EMRO). EMRO actually  includes seven African countries – Djibouti, Egypt, Libya, Morocco, Somalia, Sudan, and Tunisia – among its 21 member states and the occupied Palestinian territories, whose territories extend as far east as Afghanistan. 

While the split reflects the traditional cultural and political affiliations of north African with predominantly Muslim states elsewhere in the EMRO region – it also is artificial in terms of the ways in which diseases spread. 

But even if WHO were ever to be empowered to declare regional health emergencies, in the case of Africa,  such a declaration would automatically exclude Africa’s “EMRO” countries which might also be at risk. Or conversely, it would include EMRO countries even though the outbreak may not be relevant to Middle Eastern states  thousands of kilometers away.   

Africa CDC announcement would trigger faster response  

Africa CDC argues that if its request is granted by the AU Executive Council, there would be no change from the standpoint of WHO’s global alert system.  Ouma said emergency procedures would still be activated if WHO makes a pronouncement in Geneva for a public health emergency of international concern. 

But in addition, those procedures could also be triggered if Africa CDC were to make a pronouncement on a public health emergency of continental security – providing a more granular level of alert.

“Emergency set of procedures that will kick in are very similar,” he stressed.

He added that if and when the Africa CDC is eventually granted such authority by the African Union, the center would be able to focus on outbreaks that are largely endemic to Africa. And in that way, response will be faster and containment more effective.  

“We do not have to wait for a long time for a pronouncement to be made. That is our expectation indeed. And that is the expectation with the African Union. That is why this request has been made,” Ouma said.

WHO’s concerns

Preparation and disinfection of a house in Moto, Bikoro,
Equateur Province, after the discovery
of a confirmed Ebola case.

Dr Matshidiso Moeti, WHO AFRO’s Regional Director, told Health Policy Watch that WHO is not lobbying against the move among African ministers of health, who must render a decision. But rather  WHO aims to help them understand the pros and cons of outbreak declarations by different organizations and at different levels.  

“We would recommend that any decision made after this analysis lend itself to a rapid response, mobilization of resources – but also ensure that such declarations don’t then result in the type of isolation that we have seen in the past happen when countries are revealing information about outbreaks,” Moeti said.

Along with travel bans imposed on southern Africa following the identification of the Omicron variant, developed countries have frequently imposed travel advisories in the wake of African  national  outbreak  alerts.  For instance, the United States Centers for Disease Control imposed restrictions on incoming travelers from Guinea and DRC following Ebola outbreaks that involved only a handful of cases in each country.  Moeti expressed WHO’s interest in supporting its Member States and partners to think through such processes.

Aligning and streamlining WHO and Africa CDC efforts

Every year in fact, WHO responds to over 100 public health outbreak events of different sizes and different severity. Outbreaks at national level are declared by national government authorities.  But in the case of Africa or other developing regions, national outbreak announcements are closely coordinated with  WHO and those may also be greatly delayed – as was the case of the Malawi polio outbreak alert last February – which occurred three months after the polio case was first reported.  

Speaking in May at a pre-World Health Assembly briefing  Gueye noted that as with so many other issues in Africa’s health system, there is need for improved coordination between WHO and African members states generally.

Open Briefing to 75th WHA: Left to Right: Priti Patnaik, Agnes Soucat of the French Development Agency and WHO’s Abdou Salam Gueye discuss the global architecture for health emergencies response.

“We need several Africa CDCs in order to tackle those issues,” said Gueye, speaking metaphorically about the need for more resources overall. “What we need is just to have a coordination mechanism where what needs to be done will be clarified, and also people will work together in a complementary manner,” Gueye said. 

Gueye said he had recently visited Addis Ababa, Ethiopia’s capital city, where he discussed with colleagues at the Africa CDC ways to improve collaboration.

“We said what we want to do and they said what they want to do,” he related, suggesting a more formal coordinating mechanism could also be useful. “We could complement each other at any point and there is a place for an additional organization to work together. We need better streamlining in order to know what the other is doing and where we can really put our force together and succeed.”

Elaine Ruth Fletcher contributed to this story.

Image Credits: Ahmed Ogwell/Twitter , @HeathrowAirport/capt_saini, Wadoum et al, 2021, Journal of Risk Management and Healthcare Policy, WHO/Junior D. Kannah, Benoit Varenne , Badur et al (2019).

MC12 Chairman Timur Suleimenov gavels the end of the closing session with WTO Director General Ngozi Okonjo-Iweala early Friday morning.

Limited IP waiver text says WTO members “will decide” on inclusion of COVID-19 tests and treatments within six months. 

The World Trade Organization’s first ministerial conference in four and a half years reached agreement early Friday morning on what officials described as “an unprecedented outcome” of six agreements, including a deal to curb some fishing subsidies that deplete ocean stocks, a limited waiver of WTO’s intellectual property protections on COVID-19 vaccines and a humanitarian food security measure – all of which will have wide-ranging impacts on global public health.

In a tactical victory for medicines access advocates, WTO members agreed to insert a clause in the final text on the IP waiver for COVID-19 vaccines stating that “no later than six months from the date of this decision, members will decide on its extension to cover the production and supply of COVID-19 diagnostics and therapeutics.”

While there is now a global surplus of vaccines making the waiver in existing IP for the jabs almost meaningless, any future decision to extend the waiver of certain IP protections to COVID-19 tests and treatments — which are much easier to produce and also still in very short supply in many countries — could be more impactful.   

Two overnight sessions before white smoke emerged 

WTO’s director-general, Ngozi Okonjo-Iweala, presides over the 12th Ministerial Conference (MC12)

WTO’s marathon talks involving more than 100 trade ministers lasted a day and a half longer than planned and included two sleepless nights. Kazakh politician Timur Suleimenov, who chaired the conference, said it “feels like a very long and gruelling marathon” but he was happy to show that the WTO can deliver and address some of the global challenges.

“We actually needed to showcase to the world that multilateralism is alive, and the rules-based system is alive,” said Suleimenov, a deputy chief of staff to Kazakhstan’s president, at a closing press conference. “We did need an extra day — actually two — to prove to the critics that they were wrong, and I think we did a little more than that. And I think we have reached a remarkable outcome.”

The six decisions and ministerial declarations were endorsed and accepted by all of WTO’s 164 member nations, he said, paving the way for WTO “to be ready for future crises.” The long-fought deal to curb fishing subsidies for fishing of over-exploited species and on the high seas, he said, is “a unique and unprecedented accomplishment” that will help deal with the global food crisis. “We have a successful, and some would call it maybe, historical conclusion,” he added.

WTO’s director-general, Nigerian-American economist Ngozi Okonjo-Iweala, said she was exhausted, since “we haven’t slept for two nights, we were here throughout,” but the conference had produced “an unprecedented outcome” that would have “very tangible results” for citizens worldwide.

Agreement on agricultural measures elude members

Protests Wednesday, 15 June, outside of the World Trade Organization against existing WTO rules that developing countries say unerasonably limit public food stockholding

She said the only major area in which WTO member nations were not able to agree was a draft decision on agricultural reform  — where developed country opposition to  developing country demands for an easing of WTO rules around public stockpiling of vital food supplies eventually foiled a comprehensive deal.

However, the final draft of a ministerial declaration on food insecurity reaffirmed the importance of improving ”  the functioning and longterm resilience of global markets for food and agriculture, including cereals, fertilizers, and other agriculture production inputs,” considering specific needs of developing and  net food-importing developing countries.”  The agreement also acknowledged that “adequate food stocks can contribute to the realization of Members’ domestic food security objectives,” although it encouraged members with available surplus stocks to release them
on international markets.

Even so, the six other deals may go a long way to restoring WTO’s credibility as a vital global institution. Its last ministerial conference in December 2017 at Buenos Aires failed to clinch a single deal. And, in 2019, WTO’s appellate body for settling trade disputes virtually ground to a halt due to U.S. opposition to refilling judges on its bench. A former World Bank managing director and Nigerian foreign minister, Okonjo-Iweala took the helm of the WTO last year and was resolved to restore the global trade body’s relevance.

“I want to say how delighted I am and excited that we’ve been able to prove that the WTO can deliver, and deliver multilateral outcomes. When I started this job, I mean, the expectations of the WTO were not very high, to be kind about it,” she said. “But today we’ve shown that the WTO can produce outcomes, and multilateral outcomes like that. So we were expecting one or two deliverables … and we got six.” Since WTO operates by consensus, any single nation can block a deal.

“It was not an easy process, an easy road,” Okonjo-Iweala added, laughing. There were a lot of bumps, just like I predicted. It was like a roller coaster. But in the end, we got there.”

Harmful fisheries subsidies — not the full deal but… 

Commercial fishing boat

She called the deals “very, very substantive outcomes,” including the TRIPS vaccines waiver and a companion declaration on WTO’s pandemic response; a declaration to exempt World Food Programme purchases from export restrictions; and the decision to curb environmentally harmful fishing subsidies that cap 21 years of negotiations on subsidies that experts say have enabled big rigs to plunder the high seas far from home countries, driving a depletion of 30% of the world’s fish stocks. 

 “Although it is not the full package,” she said of the fishing subsidies deal, rather than keep disagreeing “we were able to say, ‘Okay, where do we all agree on?’ … That is stage one,” Okonjo-Iweala said.

Notably, the final agreement still prohibits subsidies to fishing of stocks on the high seas that are not managed by regional bodies, the International Institute for Sustainable Development said in a statement. It prohibits subsidies for vessels and operators engaged in illegal, unreported, or unregulated (IUU) fishing, and it establishes new rules for subsidies for the fishing of stocks that are already over-exploited – requiring countries to rebuild the stocks “to a biologically sustainable level” if it continues to subsidize such fishing. And the treaty contains certain flexibilities for developing country WTO members, known as special and differential treatment.

WTO members also agreed to continue negotiations on issues that fell by the wayside in the draft text, with an eye to an agreement by MC13 to “achieve achieve a comprehensive agreement on fisheries subsidies, including through further disciplines on certain forms of fisheries subsidies that contribute to overcapacity and overfishing.” Developing countries led by India had protested a broader curtailment of subsidies, including for fuel, at this stage, saying it would harm artisinal fishermen – who also may fish up to 100 nautical miles offshore – although critics said the India also was more concerned with protecting its industrial fishing fleets.

Agreement matters

Buying fish from a vendor at Gosa Market, Abuja, Nigeria

However imperfect, the agreement is a turning point after 20 years of negotiations over the subsidies at a time when 90% of the world’s fisheries are fully exploited or dangrously depleted, according to the FAO, threatening global food security – and a protein source upon which one-third of the world’s population relies.

“This agreement matters because it will require governments to think critically about their subsidy policies and how they interact with efforts to manage natural resources sustainably,” said Alice Tipping, who leads IISD’s program on sustainable trade and fisheries subsidies. 

The U.S.-based Pew Charitable Trusts said the fishing subsidies deal will help curtail overfishing and improve ocean health by creating a global framework to limit subsidies for illegal, unreported, and unregulated fishing. “This is a turning point in addressing one of the key drivers of global overfishing,” said Isabel Jarrett, who manages Pew’s campaign against fishing subsidies.

“Now, WTO members need to bring the treaty into force as swiftly as possible and implement it in good faith,” she said. “Recognizing that there are still outstanding issues for WTO members to discuss, we were pleased to see them commit to recommending further rules on harmful fisheries subsidies at the next ministerial conference.”

India’s trade delegation also had been blocking agreements on the fishing subsidies, but India’s Commerce Minister Sri Piyush Goyal seemed to hint it was a negotiating tactic when he told reporters on the fifth day of negotiations that his delegation still believed the conference “will turn out to be one of the most successful ministerials that the WTO has seen in a long time.”

Partial IP waiver criticized on all fronts 

Protest in Indonesia against the delay in WTO’s approval of a TRIPS waiver for COVID-19 vaccines.

The long delayed deal on a partial IP waiver for COVID-19 vaccines aims to ease rules under which developing countries can produce and export biosimilar (generic) versions of vaccines, without permission from patent holders. It passed after last-minute input from the United States and China, Okonjo-Iweala said. 

Presumably, the United States had to agree to the clause providing for negotiations over tests and treatments in six months time; until now, it had only agreed for the waiver on vaccines — much to the chagrin of vaccine advocates.  

As one of the world’s biggest vaccine exporters, China also had to agree to waiver language that implicitly excludes it from the IP exemption.  A footnote in the agreement says developing countries that can make COVID-19 vaccines “are encouraged to make a binding commitment not to avail themselves of this decision. Such binding commitments include statements made by eligible Members to the General Council, such as those made at the General Council meeting on 10 May 2022, and will be recorded by the Council for TRIPS and will be compiled and published publicly on the WTO website.”

China, which exported more than 10% of the world’s COVID-19 vaccines in 2021, had explicitly said in the General Council proceedings that it would not avail itself of the waiver, but it objected to language explicitly excluding large developing country exporters.   

The temporary waiver, overrides some existing WTO “TRIPS” protections on intellectual property, enabling developing countries to produce and export COVID-19 vaccines without a license from the patent-holder, under somewhat relaxed terms.

Final IP waiver deal denounced by co-sponsor India and pharma industry 

WTO
Press briefing Wednesday in Geneva by civil society opposed to the WTO draft text on an IP waiver for COVID vaccines with UN AIDS Executive Director Winnie Byanyima (second from right)

But unlike the deal on fisheries subsidies, there was no celebration over the final IP waiver text – which is limited in scope as well as carrying a number of new conditions that many original advocates described as potentially dangerous precedents. The text came in for immediate criticism by the the pharma industry as well as by India, one of the original co-sponsors of the waiver initiative. 

Pharma industry leaders share a “deep disappointment with the decision taken to adopt a TRIPS waiver, despite intellectual property (IP) not being a barrier to vaccine scale-up and wide acknowledgement of vaccines surplus,” the Geneva-based International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) said in a statement.

Médecins Sans Frontières (MSF) described it as a “devastating global failure”, while Ellen t’Hoen, of Medicines, Law and Policy said it was “no longer a TRIPS waiver in the sense it was proposed by South Africa and India in October 2020.”  Although she acknowledged that the new measure “may make the issuing of a compulsory licence easy and swift and will help the few countries that currently do not have workable compulsory licensing mechanisms.”

Jamie Love, of Knowledge Ecology International said that “while the text is not expected to impact COVID-19 vaccine equity much or at all, there are some silver linings.” He named those as the: “shorter and more usable” requirements for notifying WTO of vaccines produced under the waiver for export, as well as the waiver of any limitation on imports by countries with no manufacturing capacity of their own.

“If the decision is extended to therapeutics in six months, it may be much more value, given the supply constraints on therapeutics and the much better regulatory pathway,” he added.

India meanwhile said that the long-delayed agreement on the vaccine IP waiver had lost its relevance in light of the vaccine oversupply. “What we are getting is completely half-baked and it will not allow us to make any vaccines,” India’s Goyal said in a statement posted earlier this week on his ministry’s website. “It’s just too late. There is no demand for vaccines anymore.”

He said, however, that his nation hopes the measure will lead to a broader deal a half-year from now: “Our hope and desire was that this will be the beginning and in 6 months they will decide over the therapeutics and the diagnostics.”

Elaine Ruth Fletcher contributed to the reporting and writing of this story. 

Image Credits: @ITforChange, World Trade Organization, Michael Casmir, Pierce Mill Media, Nur Sofi Iklima , MSF Access .

mental health
Prevalence of anxiety and depressive disorders increased during the first year of the pandemic.

In the largest review of the world’s mental health services since 2001, the World Health Organization Friday called for far greater investments in mental health as part of primary health care systems and a transformation of attitudes and approaches to protect mental health and provide care for people in need.

The report’s executive summary, ‘Transforming mental health for all’, calls for governments to develop more affordable, community-based mental health services, integrated into broader primary health care systems – with greater attention to human rights, quality care and freedom from stigma and discrimination. 

The report finds that on average, countries dedicate less than 2% of their health care budgets to mental health. More than 70% of mental health expenditure in middle-income
countries still goes towards psychiatric hospitals – as compared to more preventive and community-centered approaches. And around half the world’s population lives in countries where there is just one psychiatrist to serve 200 000 or more people – reflecting the dire imbalance in services available at all in low- and middle-income countries.

“Everyone’s life touches someone with a mental health condition. Good mental health translates to good physical health and this new report makes a compelling case for change,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. 

The report also showcases examples of good practice, drawing upon the advice and lived experiences of people with mental health conditions – to demonstrate how change can be achieved. 

Mental health – under treated and under-resourced 

The global prevalence of mental disorders in 2019. Anxiety and depressive disorders were the most prevalent.

Mental health conditions remain widespread, under treated, and desperately under-resourced, the report relates.

About one in eight people in the world live with a mental disorder, with anxiety and depressive disorders the most common in 2019. The number of people with one or both of these disorders went up by more than 25% in the first year of the pandemic alone, as mental health worsened worldwide.

Stigma, discrimination, and human rights violations have globally impacted people with mental health conditions and care systems everywhere. Additionally, only a small fraction of people in need are able to access effective and affordable mental health care, with gaps in service found especially in low-income countries. Globally, some 71% of people experiencing psychosis do not even receive mental health services. 

These statistics and others featured in the report highlight an urgent need to reshape both the environments and systems that influence and care for people’s mental health. 

More multi sectoral investment in mental health would not only advance public health and curtail frequent human rights violations of people with mental health conditions, but it would enable socioeconomic development through the better integation of people experiencing mental health issues into society and workplaces, the report says. 

“The inextricable links between mental health and public health, human rights and socioeconomic development mean that transforming policy and practice in mental health can deliver real, substantive benefits for individuals, communities and countries everywhere,” said Tedros. 

Progress has proven change is possible, but it is still ‘business as usual’ 

Mental health remains under-resourced, with only 2% of health budgets going towards mental health, and focusing on psychiatric hospitals as opposed to community health care.

Despite progress in mental health achieved over the decade, 2 out of 3 dollars of scarce government spending on mental health remains focused on stand-alone psychiatric hospitals rather than community-based mental health services where people are best served, the report states: 

“For most of the world, the approach to mental health care remains very much business as usual.” 

Countries need to accelerate implementation of WHO mental health action plan 

Stakeholders must invest in transforming the environment that influences mental health.

The report urges all countries to accelerate their implementation of WHO’s Comprehensive mental health action plan 2013 – 2020, which was adopted by the World Health Assembly in May 2013. 

All 194 WHO Member States had signed up for the plan, which commits them to global targets for transforming mental health. 

“Every country has ample opportunity to make meaningful progress towards better mental health for its population,” said Dévora Kestel, Director of WHO’s Mental Health and Substance Use Department, director of WHO’s Department of Mental Health and Substance Use. 

The report makes several recommendations for action, grouped into ‘three paths to transformation’ that focus on shifting attitudes to mental health, addressing risks to mental health and strengthening systems of care for mental health. They are:

  1. Deepen the value and commitment we give to mental health. This includes stepping up investments in mental health, not just by securing appropriate funds and human resources to meet mental health needs, but also through committed leadership and evidence-based policies and practices. 
  2. Reshape the environments that influence mental health, including homes, communities, schools, workplaces, healthcare services, natural environments. This includes implementing concrete actions to improve environments for mental health such as stepping up action against intimate partner violence and abuse and neglect of children and older people. 
  3. Strengthen mental health care by changing where, how, and by whom mental health care is received. This can be done by shifting away from custodial care in psychiatric hospitals to building community-based networks of interconnected services that are integrated in general health care; community mental health services; and services beyond the health sector. 
The vicious cycle between poverty and mental ill-health exacerbates mental health conditions

Concluded Kestel: “Whether developing stronger mental health policies and laws, covering mental health in insurance schemes, developing or strengthening community mental health services or integrating mental health into general health care, schools, and prisons, the many examples in this report show that the strategic changes can make a big difference.”

Image Credits: AMSA/Flickr, WHO.

Dr Ahmed Ogwell Ouma, Africa CDC’s acting director, asserts the continent should be top priority for smallpox vaccine doses that protext against monkeypox.

Rich countries are rushing to get doses – but African countries say they should get the vaccines first for a disease endemic to the continent. 

A plan by the World Health Organization (WHO) to create a vaccine sharing mechanism that will attempt to provide equitable access to vaccines effective against monkeypox disease will only be acceptable if the sharing of vaccine doses begins in Africa – where the disease burden is highest, says Dr. Ahmed Ogwell Ouma, Acting Director of the Africa Centres for Disease Control and Prevention (Africa CDC).

Ouma told Health Policy Watch on Thursday that while the Africa CDC supports making the vaccines available, they should be distributed first where the disease is endemic:

“When the smallpox vaccines are released to address monkeypox, it should start here in Africa where burden is larger, the risk is higher and the geographical spread is also known,” Ouma said.

Nine countries in west and central Africa are endemic zones for the zoonotic disease – with 1597 cases – 1488 suspected and 109 laboratory-confirmed- since the beginning of 2022.  A total of 66 deaths have been reported by Africa CDC – although WHO recently put the death toll at 72.

Either way, that is a case fatality ratio (CFR) of  4.1% or more on the continent, including all suspected cases. Some studies have shown Monkeypox mortality rates as high as 10% in the Democratic Republic of Congo – where the most virulent clade of the virus is in circulation.  

Meanwhile, another 1900 Monkeypox cases of the less virulent West African clade have been reported in Europe, the Americas, the Middle East as well as two African countries outside of the endemic zone; no deaths have so far been reported (see graphic below). 

WHO planning ‘fair’ monkeypox vaccine allocation system – will rich countries adhere? 

WHO’s Director General Dr Tedros Adhanom Ghebreyesus said this week that the agency would develop an allocation system to fairly distribute Monkeypox vaccines to targeted groups at risk. 

It is “essential that vaccines are available equitably wherever needed. To that end, WHO is working closely with our Member States and partners to develop a mechanism for fair access to vaccines and treatments,” Tedros told journalists at a Tuesday press conference. 

However, the worry is that rich countries may snap up a limited supply of available vaccines – while strategies to target African countries where the virus is endemic lag behind – much as COVID vaccinations in Africa did. 

WHO’s European Regional Director Dr Hans Kluge, also alluded to those concerns at a press conference on Wednesday. 

As rich countries rush to secure monkeypox vaccines, African countries that have been living with the disease for decades risk being ignored, Kluge warned. 

“Targeted vaccination, either before or after exposure to the virus, can benefit contacts of patients, including health-care workers. Yet, we are already seeing a rush in some quarters to acquire and stockpile these,” Kluge said.

“Once again, a ‘me first’ approach could lead to damaging consequences down the road, if we do not employ a genuinely collaborative and far-thinking approach. I beseech governments to tackle monkeypox without repeating the mistakes of the pandemic – and keeping equity at the heart of all we do,” Kluge said.

The irony is that targeting monkeypox in countries where it is endemic would likely be a more effective strategy, in public health terms, experts also have warned.  

“Whatever vaccination happens in Europe, that is not going to solve the problem,” Francois Balloux, an infectious disease expert at University College London, told the Associated Press.

Smallpox vaccines are thought to be about 85% effective against monkeypox, according to WHO. One vaccine against monkeypox exists, but so far it is only approved in Canada and the United States.

Monkeypox is also spreading in Africa, albeit slowly

Africa CDC and WHO confirmed that the new wave of monkeypox also now appears to be spreading outside of Africa’s endemic zone, with fresh cases reported in Ghana and Morocco — two countries where it is not typically seen. 

As of Thursday, Africa CDC had recorded 1597 cases of monkeypox — 1488 suspected and 109 laboratory-confirmed. A total of 66 deaths have been reported. That is a case fatality ratio (CFR) of  4.1% including all suspected cases. 

Matshidiso Moeti, WHO African Regional Director

Dr Matshidiso Moeti, WHO’s Africa director, meanwhile said that monkeypox cases have now been confirmed this year in eight African countries – including Morocco and Ghana where there had been no previous reports. 

While some 1536 suspected cases have been reported in Africa since the beginning of this year, there are now also 36 confirmed cases in Nigeria, 10 in the Democratic Republic of the Congo, eight in the Central African Republic, as well as 5 cases in Ghana,  3 in Cameroon and 2 in the Republic of Congo, and 1 in Morocco. Additionally, Ethiopia, Guinea Liberia, Mozambique, Sierra Leone, Sudan and Uganda, all countries with no previous incidents, have also now reported suspected cases, according to WHO AFRO. 

Africa CDC classifies Monkeypox risk as moderate.

Not a single dose of vaccine available in Africa 

Despite the public alarm, Africa CDC classified Africa’s monkeypox risk as moderate and urged countries to put their emergency operation centers on alert while also calling for the prioritization of a “One Health” approach to controlling predominantly animal sources of the disease.

And despite Africa’s long history with the disease, Oumam told Health Policy Watch the continent does not have a single dose of smallpox vaccine available on the continent to fight the disease.

So African CDC’s recommendations right  now are focused on the use of non-pharmaceutical methods, such as sharing information and raising public awareness among health workers.

“Our core response to monkeypox is non-pharmaceutical activities where we engage with the public. We give them information on what they need to do to protect themselves, and also increase the index of suspicion of our health workers so that they’re able to pick out any possible case as early as possible, isolate them and provide them with the management that they need,” Ouma told Health Policy Watch.

Developing vaccines to protect Africans could have prevented outbreak 

Meanwhile, Professor Emmanuel Nakoune, acting director of the Institut Pasteur in Bangui, Central African Republic, attributed the current disease outbreak to a global decision to stop smallpox vaccination following its eradication. If this hadn’t been done, he said, monkeypox outbreaks would have been preventable.

“So it means that this is a virus that was there all along, but it was controlled by the smallpox vaccination because those two viruses are from the same family. So what we could have done, perhaps, was to anticipate and prevent the propagation of monkeypox — was to recognize that it is a public health issue in Africa,” Nakoune said.

Public health officials should have anticipated and developed vaccines that could protect the African population, considering the index case in the latest outbreak was an imported case that may have been prevented if there had been the development of vaccines, and attempts were made to contain monkeypox.

“Unfortunately, this wasn’t done and today, we have to live with this. Once again, we are learning a lesson that when there are new diseases which happen wherever, anywhere, it’s very important that efforts be made to find solutions and prevent these diseases from taking root all over the world,” he said.

Similarly, Dr Peter Fonjungo, director of the U.S. Centers for Disease Control and Prevention’s efforts in the Democratic Republic of the Congo, recommended more preparedness and  lab surveillance. 

“This really helps us in early detection, and also in infection prevention control,” he said, “especially for those healthcare workers so that we can limit the spread of this virus.”

WHO’s mapping availability of vaccine supplies 

In a statement, WHO’s headquarters told Health Policy Watch that its plans for the doses will involve working closely with its member states and partners to determine what kind of coordination mechanism would work best to ensure fair access to vaccines and treatments. 

“We are currently mapping the availability of current supplies and planned production, the needs, support countries with information and advice so they are ready to use the vaccines, and a fair allocation approach based on need,” a WHO spokesperson said. 

However, regulatory, legal, operational, technical and other issues would first have to be clarified before a vaccine sharing program can be set up, the global health body says.

As in the COVID pandemic, it’s already clear that rich countries won’t wait for those processes to take unilateral action.

According to the pharma company Bavarian Nordic, the United States has recently ordered the equivalent of 13 million doses of its JYNNEOS®smallpox vaccine, the only FDA-approved vaccine against monkeypox, in addition to 1.4 million doses already stockpiled.  Bavarian Nordic, has a production capacity of only about 40 million doses annually.

An antiviral agent known as tecovirimat that was developed for smallpox also was licensed by the European Medical Association (EMA) for monkeypox in 2022, based on data in animal and human studies. However, Tecovirimat is not yet widely available, according to an analysis by the global health analytics firm Airfinity.

c-tap
C-TAP aims to expand access to COVID-19 technologies and health products.

A new sublicense agreement for a COVID-19 antibody test has been announced Thursday by the Medicines Patent Pool (MPP) on behalf of the World Health Organization’s COVID-19 Technology Access Pool (C-TAP) and South African company Biotech Africa. 

The new agreement builds on the first non-exclusive licensing agreement announced by WHO and MPP last year with Spain’s National Research Council (CSIC). The sublicense allows Biotech to manufacture and commercialize CSIC’s COVID-19 serological test worldwide. The test effectively checks for the presence of SARS-CoV-2 antibodies developed in response to COVID-19 infection or to a vaccine. 

Both WHO and Biotech welcomed the agreement, which will cover all related patents and biological material needed to manufacture the test. Additionally, the license will be royalty-free for low- and middle-income countries and will remain valid until the patent expires. 

“The most effective way to get – and keep – ahead of COVID-19 is to keep testing,” said WHO Director General Dr Tedros Adhanom Ghebreyesus. 

“This new agreement means we can take advantage of untapped manufacturing capacity so more people in more countries can have easier access to affordable diagnostics.”

“The signing of this agreement emphasizes [Biotech Africa’s] ongoing goal to support diagnostic needs around the world,” said Jenny Leslie, Biotech Africa Chief Operations Officer. 

2nd year anniversary of C-TAP comes with challenges and need to incentivize private sector 

Medicines Patent Pool Executive Director Charles Gore

The agreement was announced by the World Health Organization on the second anniversary of the launch of C-TAP – which aims to be a pool for the open-licensing of COVID treatment, vaccine and test technologies. 

C-TAP was launched in 2020 by WHO’s Dr Tedros and the President of Costa Rica with the aim to pool technologies that would boost manufacturing capacity in developing countries, and also expand access to COVID-19 health products. 

The pool mechanism stood empty for nearly a year until Spain announced in November 2021 it would partner with C-TAP over the antibody technology.  In March 2022, C-TAP received a boost from an announcement by the US National Institutes of Health (NIH) that it would share a number of COVID technologies for which it holds the patents.

Celebrating the second anniversary during a virtual event Thursday, MPP Executive Director Charles Gore acknowledged both the challenges C-TAP has experienced in its two years and the potential for more partnerships to be made in the future. 

“Two years on, to be frank, we’ve made progress, but it’s been slow,” he said. 

Gore pointed to the need to find more ways of incentivizing the private sector to share patents.

“It’s unrealistic to expect for-profit organizations to change into philanthropies overnight. We need to think about how to incentivize the sharing of patents and know-how, and how to put that into practice.” 

“Access should not need a pandemic to put it at the top of the health agenda. But now that it has happened, we must at least make the most of this opportunity. And that’s for COVID-19 now, but critically also for the future,” concluded Gore.  

Image Credits: Marco Verch/Flickr.

A health worker explains her child’s symptoms to a mother in a Guinea health centre

On the Day of the African Child, Medicines for Malaria Venture (MMV) reflects on what 10 years of seasonal malaria chemoprevention has meant for young children in the Sahel, and how to protect more children going forward.

Malaria, a disease that is both a cause and consequence of poverty, has plagued endemic-country health systems, economies and people — especially children — for millennia.

The Day of the African Child is an opportunity to celebrate 10 years of seasonal malaria chemoprevention (SMC) and to draw attention to the fact that, despite the progress made against the disease, children in sub-Saharan Africa still bear the majority of the global burden.

The World Health Organization (WHO) first recommended SMC in 2012 to protect eligible children in Africa’s Sahel region, where malaria transmission is at its highest during the rainy season. The importance of this is underscored by the fact that six out of 10 countries targeted by WHO’s ‘high burden to high impact’ initiative are located in this region.

When administered to this population of children in this geographic region, the intervention has been shown to be highly effective, providing up to 88% protection against malaria within the first 28 days after its administration and reducing hospital admissions by up to 39%.

Modelling estimates also suggest that the intervention could curb roughly 21 million malaria cases and prevent 100,000 child deaths each year, if successfully delivered to at-risk populations. National malaria control programmes (NMCPs) have therefore been quick to include SMC in their strategic plans and deliver it year-on-year.

To administer SMC, children aged three to 59 months receive one dose of sulfadoxine-pyrimethamine with three doses of amodiaquine (SPAQ) 3 days a month. Previously, this was recommended for up to four months; however, WHO’s new guidelines recommend SMC for the “peak malaria transmission season”, regardless of length.

SMC use has expanded rapidly since its introduction. In 2012, several thousand children in two countries received SMC. In 2021, about 44 million children in 13 countries benefited. The growing number of children receiving SMC required greater supply security and more pharmaceutical suppliers.

Fosun Pharma’s subsidiary, Guilin Pharmaceuticals, with MMV’s support, developed a SPAQ tablet that was prequalified by WHO in 2014. Results from the first SMC trials showed that the intervention would be more effective if the medicines were palatable and easily dissolved in water, reducing the likelihood that children would spit them out.

Consequently, Guilin developed a child-friendly version of SPAQ that was prequalified by WHO in 2018. MMV and S-Kant, funded by UNITAID, developed another dispersible version of SPAQ that was WHO prequalified in 2021. Since 2014, over 700 million treatment courses of SPAQ have been distributed.

Relieving pressure on health systems and economies

A local health center during coronavirus.

Currently, the malaria burden in sub-Saharan Africa is an impediment to reaching Sustainable Development Goal 3 (Ensure healthy lives and promote well-being for all at all ages), and more specifically, Target 3.3 (End the epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases and combat hepatitis, water-borne diseases and other communicable diseases).

SMC is a low-cost intervention that contributes to reducing the burden on health systems in terms of cost of malaria diagnosis, treatment and in-patient admissions. In fact, a 2021 analysis in seven countries revealed that implementing SMC saved health systems approximately USD 66 million and increased economic productivity by USD 43 million, contributing to Goal 8 (Decent work and economic growth).

This is also significant for families who pay out of pocket for malaria diagnosis and treatment: 13% of the global malaria budget came from out-of-pocket expenditure; much higher than with other priority diseases in sub-Saharan Africa such as HIV/AIDS, where out-of-pocket expenditure represented just under 5% of global spend.

Integrating SMC and other health interventions

Seasonal malaria chemoprevention has saved thousands of lives of children under the age of five.

Combining SMC with interventions such as malaria community case management (CCM), long-lasting insecticidal net distribution and malnutrition interventions has enabled health systems to optimize staff time and reach children who otherwise may not have been reached.

Even with limited resources, through CCM, countries have trained and supported community health workers who provide services for multiple illnesses such as malaria, pneumonia and diarrhoea for sick children and families with limited access to case management at health facilities.

In 2021, WHO approved the RTS,S vaccine for children in areas with moderate to high Plasmodium falciparum malaria. While the vaccine is a useful addition to the malaria control toolbox, its efficacy (around 36%) falls short of being a silver bullet. Encouragingly, recently reported studies have shown that when the vaccine is combined with SMC, the efficacy in preventing malaria is significantly greater for each intervention alone – providing a belt-and-braces approach to better protect young children at risk of malaria.

The introduction of innovations like digital tools, which are replacing paper-based data collection and management systems in SMC campaigns in Benin, the Gambia, Ghana and Nigeria, has also helped better manage and improve data quality. Enhancing the integration of digital systems will contribute to stronger data management systems that can provide evidence for informing policy decisions and boosting programme effectiveness.

Initiatives such as the European & Developing Countries Clinical Trials Partnership-funded OPT-SMC project are also building NMCP staff’s capacity to better implement SMC and improve data monitoring, evaluation and management in all 13 implementing countries.

Overcoming new challenges and finding ways forward

Boys drink water from rehabilitated wells by AMISOM in EL-Ma’an, Bal’ad District of HirShabelle State.

Now that protection of children under 5 in the Sahel is improving, there is evidence of seasonal malaria shifting to older children. Projects in Senegal have shown that SMC is effective in five- to 10-year-olds. Consequently, the SMC-Impact project, financed by the Korea International Cooperation Agency’s Global Disease Eradication Fund, will pilot expanding SMC to older children in the Gambia and Niger.

While the numerous benefits of SMC for communities and economies are evident, children in parts of Southern and East Africa with seasonal malaria are not yet benefiting from the intervention due to anticipated lack of efficacy due to high levels of resistance to SP and AQ, which have precluded large-scale implementation.

However, preliminary results from pilots conducted with SPAQ in Eastern and Southern Africa show positive results. Additionally, the updated WHO guidelines for malaria chemoprevention suggest that any antimalarial combination that is different from those used for first-line treatment can be used for SMC. Thus, larger-scale implementation of SMC can be anticipated in Africa in the coming years.

Despite proven benefits, the future of SMC is uncertain, as malaria budgets continue to be under threat due to growing health and national security challenges facing both donor and SMC-implementing countries. Africa’s growing population, which is expected to triple by 2100, will require protection against malaria.

In addition to saving lives, protection against life-threatening diseases like malaria will bring significant productivity and economic benefits. Increased financing and national stewardship for SMC are non-negotiable if countries want to keep populations healthy and generate national economic savings.

Although there are challenges to reaching all at-risk children, it is important not to overlook the work that has been — and continues to be — undertaken by NMCPs, researchers, healthcare workers and caregivers to save children’s lives over the past 10 years. The impact of SMC has been remarkable, and in the decade ahead, it will likely increase the impact it can deliver as restrictions on geography and targeted age ranges are relaxed.

Dr Abena Poku-Awuku is an Advocacy Manager at Medicines for Malaria Venture. Dr André-Marie Tchouatieu is a Director of Access and Product Management at Medicines for Malaria Venture.

Image Credits: Medicines for Malaria Venture, USAID.

The World Trade Organization (WTO) is extending its 12th Ministerial Conference (MC12) for a fifth day, buying time for delegates to negotiate some tough deals in five main areas: the pandemic response, COVID-19 vaccines, fishing subsidies, food shortages and agriculture.

The long-delayed ministerial conference, which opened on Sunday and was originally planned to close on Wednesday evening, is now scheduled to last until Thursday afternoon as pressure has built for the WTO to show real results from the meeting, the first in five years. 

“It requires that we work harder and work nights, whatever it takes to be able to do it,” said the WTO’s director-general, Ngozi Okonjo-Iweala. Progress is being made but it needs a little more work and more time. The not-so-good news is that we are running out of time, so I think it is really time for ministers to make the requisite decisions that need to be made.”

Civil society calls on WTO ministers to reject current IP waiver text

Press briefing Wednesday in Geneva by civil society groups opposed to the WTO’s draft text on an IP waiver for COVID vaccines with UN AIDS Executive Director Winnie Byanyima (second from right).

Meanwhile, a wave of opposition was building to the terms of a proposed waiver of parts of the 1995 TRIPS Agreement, a major intellectual property agreement. The proposed waiver has been one of the draft WTO decisions deemed to have the best chances of gaining consensus approval this week. Its aim is to make it easier for developing countries to produce and export generic versions of COVID-19 vaccines.

Some 150 civil society groups delivered a letter to WTO trade ministers calling on them to include tests and treatments in the waiver terms, along with vaccines, and to remove a complex series of limitations on the export, import and potential re-exportation by third-party countries of any generic products manufactured under the waiver.

“I call on all countries to step up and think about what this waiver is meant to do,” said Winnie Byanyima, executive director of UNAIDS, at a press conference convened by civil society groups Wednesday. She called on WTO members to ensure the waiver would “cover all forms of intellectual property rules, not just narrow patent-related restrictions on exports; [and] address tests and life-saving treatments today.  Don’t kick the can down the road.” The virtual broadcast of the press conference was cut short abruptly by a hack of the WTO’s zoom line.

WTO spokesperson Daniel Pruzin indicated the deals closest to being completed were the “WTO response of the pandemic” – a so-called ‘trade and health declaration’’ to reduce trade barriers for essential medicines and the active pharmaceutical ingredients they contain – and the limited waiver of patent rights on COVID-19 vaccines to boost their availability among developing countries.

“We’re still optimistic of getting some outcomes from this conference,” Pruzin told reporters on Tuesday night. “Everything’s extremely fluid at the moment.”

He said Okonjo-Iweala believes some of the negotiations are “really close” to coming to fruition, and delegates “just need more decision-making that will allow us to go over the line.”

Convergence on exemption of World Food Programme purchases 

WTO
A family feed their cows straw from the roof of their home in Adadle in the Somali region of Ethiopia.

There also seemed to be momentum behind efforts to lift or ease export restrictions on food and to exempt World Food Program (WFP) humanitarian purchases from export restrictions.

The potential deals with the biggest remaining sticking points appeared to be over a ministerial declaration on other aspects of trade and security – as well as a draft decision to eliminate environmentally harmful fisheries subsidies, including subsidies for long-distance fishing that critics say contributes to a dangerous depletion of fish stocks and other ocean resources. 

WTO operates by consensus decision-making, so a single member’s veto can doom an agreement. India, in particular, has opposed aspects of the draft agreement on harmful fisheries subsidies, claiming they could affect artisanal fishermen. While there is some merit to those concerns, Indian environmental advocates point out that most of India’s fuel and other fisheries subsidies already go to large fleets working farther offshore.

[See related story: https://healthpolicy-watch.news/wto-opens-with-cautious-optimism-but-civil-society-protests-lockout/]

India’s Commerce Minister Piyush Goyal told delegates that “the exemption from [WTO] disciplines for the low income, or resource-poor or livelihood fishing, particularly again for those nations not involved in long-distance fishing up to our EEZ, i.e. 200 nautical miles, is highly essential to provide socio-economic security to these vulnerable communities,” according to a statement posted online by India’s Ministry of Commerce & Industry.

On the brighter side, a draft declaration on intensified action on food safety measures to enhance food security and limit pathogen spread in the international trade context seemed to be set for member approval.

Image Credits: MSF Access , Michael Tewelde / World food Programme.

Russia’s ongoing refusal to let Ukranian grain lift its blockade of Black Sea ports is causing a global food crisis and has led to allegations that the country is weaponizing” the world’s food supply.

Over the weekend, Ukrainian President Volodymyr Zelenskyy warned that the world will face a “severe food crisis” as Russia’s war continues in his country. 

“The world will face an acute and severe food crisis and famine,” he said, virtually addressing 575 delegates from 40 countries at the Shangri-La dialogue in Singapore, Asia’s top defense conference.

At the beginning of June, Senegalese President Macky Sall and chair of the African Union Chair, announced that Russia had told him it was ready to allow Ukrainian grain exports.

Last week, Sall urged Ukraine to de-mine waters around its Odessa port to ease much needed grain exports from the war-torn country on the basis that Russia has said it will not attack the ports – something Ukraine is not ready to believe.

Meanwhile, there are various reports that Russia has been stealing grain from some of the ports and selling it elsewhere, but this has been denied by Russia.

Ukraine and Russia produced 30% of the world’s grain. 

Russia has also seized wheat, bombed silos and many railways, with Ukrainian Ministry of Foreign Affairs spokesperson Oleg Nikolenko noting that “Russia’s appetite was growing” as it destroyed the second biggest grain terminal in Ukraine on 7 June.

“The food [crisis] touches Asia, Europe and Africa. Russia has blocked the Black Sea. Prices are rising. Russia is violating international law,” Zelenskyy added, following his remarks at the dialogue. 

Ukraine has asked Europe for temporary storage in an effort to secure the next harvest, with Deputy Agriculture Minister Markian Dmytrasevych highlighting that Russian occupation in the south and east has reduced the country’s grain storage capacity by 15 million tons, in a tweet from the Ukrainian Kyiv Independent. 

As reported by Reuters, Russia’s foreign minister Sergei Lavrov has said that it is Ukraine’s responsibility to solve the problems of resuming grain shipments, adding that Moscow has fulfilled its necessary commitments. 

Africa feels the pressure of food shortage 

food shortage
As the impact of drought worsens, growing risk of famine in Somalia, in combination with hiked food prices from the Ukrainian food shortage. 
Some 4.5 million Somalis are directly affected by the drought, and about 700,000 people have been displaced.

Africa already acutely feels the ripple effects of the war in Ukraine.

A combination of drought in the Horn of Africa and hiked food and fuel prices have left poor families out of reach of food, in addition to killing crops and livestock. North Africa and the Middle East have already experienced a 70-80% increase in the price of wheat, a staple food in this region. 

Both the United Nations and the US have addressed the resounding impact of the global food crisis.

“The Kremlin needs to realize that it is exporting starvation and suffering well beyond Ukraine’s borders, with countries in Africa that are experiencing an outsized share of the pain,” said Antony Blinken, US Secretary of State, in his remarks during a 6 June roundtable discussion on food security. 

“The prices in the world are going up. We see in some countries up to 17 percent of inflation. We see shortages of food in many parts of the world, especially in the Sahel of Africa, the Horn of Africa and other populous countries that depend on wheat as a staple food,” said Amin Awad, UN crisis coordinator, to Rosemary Barton Live. 

“If the world does not widen its gaze from the war in Ukraine and act immediately, an explosion of child death is about to happen in the Horn of Africa,” Rania Dagash, deputy regional director of UNICEF, told a briefing.

About 49 million people are at risk of falling into famine conditions in the months ahead, according to a Hunger Hotspots report published last week by the UN Food and Agriculture Organization (FAO) and World Food program. 

“The war in Ukraine has exerted an upward pressure on already elevated food prices, with major effects on acute food insecurity,” the report reads. 

For the Horn of Africa in particular, the Somali peninsula has 386,000 children in urgent need of treatment for life-threatening malnutrition, up from the 340,000 children who needed treatment in 2011, a year when famine killed hundreds of thousands of people. 

Somalia is “on the brink of devastating and widespread hunger, starvation and death,” warned Dagash. 

“[This is a] perfect storm for famine if action is not taken now.”

Image Credits: Joseph C. Okechukwu/Twitter , UN-Water/Twitter .

WTO Director-General Dr Ngozi Okonjo-Iweala at the opening of the 12th WTO Ministerial Council

After nearly 18 months of debate, World Trade Organization (WTO) members now appear likely to approve a limited waiver of patent rights on COVID-19 vaccines in their closing session on Wednesday. 

But if the current draft text is approved as it stands, it may be a pyrrhic victory for the medicines access groups that fought for months for a broad waiver of intellectual property (IP) rights on medicines, tests and vaccines, first proposed by India and South Africa in October 2020.  

Those civil society advocates are nervously eyeing the draft waiver’s provisions, which they fear could even set a bad precedent for future accords – a precedent worse than the limits currently contained in the WTO’s Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). 

TRIPS sets out a global set of rules under which countries may break patent protections and issue “compulsory licenses” for urgently needed health products without risk of a formal complaint of trade violations being lodged at WTO.     

“I think we’d arguably rather walk away,” said Jamie Love, director of Knowledge Ecology International, at a press briefing on Tuesday.  “And I think there’s some in pharma that would prefer that too” he added, referring to the longstanding opposition by pharmaceutical groups to the waiver proposal. 

Scope: limited only to vaccines 

The biggest criticism from civil society about the decision likely to be adopted Wednesday is that the waiver is limited to COVID-19 vaccines, now in surplus, while omitting reference to tests and treatments where access is often more uneven.  

Potentially, the waiver’s provisions could be extended in the future to tests and treatments, but text explicitly stating that remained in brackets as negotiations over the final details continued Tuesday evening.   

Speaking at a WHO press briefing Tuesday, WHO’s Director-General Dr Tedros Adhanom Ghebreyesus echoed the civil society frustrations about the dramatically pared-down scope of the waiver text.

“As I have said many times, the TRIPS waiver was created for use in emergencies. So if not now, then when?  I hope countries will come to an agreement on a waiver not just for vaccines, but for diagnostics and therapeutics as well,” said Tedros. 

Worries about new legal precedents 

Civil society groups demonstrate outside embassies of the United States, United Kingdom, Australia, Canada, Brazil, and other countries which oppose a temporary WTO patent waiver on COVID-19 health products.

But other nuances in the near-final waiver text are even more of a concern for the civil society legal experts who follow WTO closely.  

Love and medicines access activist Ellen t’Hoen of Medicines, Law and Policy, described their concerns in a press briefing Tuesday. In particular they noted: 

  • Contrary to existing WTO TRIPS exceptions, only  “developing countries”  can take advantage of the new COVID vaccine waiver formula to import vaccines, potentially excluding lower-middle or middle-income countries that don’t have that status at WTO.   
  • The waiver formula is likely to limit, either explicitly or implicitly, those countries that can export vaccines under a compulsory license to producers with less than 10% of the world’s COVID vaccine export capacity.  In particular, that would exclude China, one of the world’s biggest exporters of medicines and vaccines.  

Those two provisions worry advocates for the precedents they could set. Even under the imperfect system of WTO’s existing TRIPS rules, any country – developed or developing – may opt to manufacture a health product under a compulsory license for urgent public health purposes. And any country may export their products – even if that export is sharply curtailed by a host of bureaucratic rules around packaging and notification to WTO, enshrined in a famous 2005 TRIPS amendment, known as 31 bis.    

What’s good about the waiver?

The one potential “improvement” in the waiver language, medicines access advocates say, is that reference to those “notification” requirements, as required under 31 bis have been streamlined somewhat.

Whereas under the existing rules, countries producing and exporting a health product under a compulsory license have to notify WTO officially of its moves ahead of time, the language in the IP waiver for COVID-19 vaccines states that such notification may take place “as soon as possible after the adoption of the measure.”

Since formal notifications of any kind to WTO typically take place at ministerial level, it can slow down exports immensely, Love noted.  “You can’t just talk to the Minister of Health, for example.

“You’re going to have to talk to the Minister of Trade. They’re going to go to the Foreign Affairs Minister if it’s  a WTO notification. 

“It may just be an email. But that email doesn’t just zip out the door. I mean, anytime that the WTO is invoked, it’s a high level of coordination within multiple government departments, including people with very different political views on things. 

“Often this involves four cabinet-level ministers in the exporting country and another four in the importing country.  So say you’re trying to run a business and you’re trying to get like maybe four Cabinet members in two different countries every time you change your order to sign off on something and notify the WTO. Not an easy process.

“And they [the trade and foreign affairs ministers] have counterparts in the United States, in Europe, for example, that they care about and they have relations with, and that just opens up and multiplies the areas for bilateral pressure, or maybe just inaction. 

Ellen t’Hoen

Waiver doesn’t enable know-how sharing

Another oft-stated goal, at least indirectly, of the waiver measure, was to stimulate local manufacturing in countries that lacked means to buy vaccines abroad as well as the political or financial capacity to strike investment deals with major pharma companies on local production.  

Those gaps were most evident in African countries that were almost entirely shut out of the first months of vaccine roll-out after India banned exports of AstraZeneca’s COVID vaccines produced by Indian generic companies during the height of its pandemic, the sole supplier of vaccines for the global COVAX platform.

Perhaps it was partly as a result of political pressure around the waiver, that major pharma companies like Moderna and Pfizer eventually reached out voluntarily to strike a range of new deals with African manufacturers on COVID vaccine production. 

But pharma groups always maintained that the waiver could not compel vital sharing of know-how or even generate “one more dose” of vaccines.  

While Love and other access advocates still believe that the initial proposal for a broad-based waiver on all COVID health products, affecting not only patents but also trade secrets and know-how, could have triggered more transformational changes, they now are grudgingly in agreement with the idea that the WTO decision, as it stands now, will have little real impact. 

“If you want the vaccine, you need a certain level of collaboration, a sharing of that technology,” said t’Hoen. “WHO has tried to facilitate that through the technology access pool… But it’s much more important to have that know-how in the public domain at an earlier stage, so that it can be managed much earlier.”

The limited waiver process has snowballed, and will likely be carried forward Wednesday largely by ministers who need to show a political result out of the WTO, which critics have accused of being more and more irrelevant anyway. 

Meanwhile, Love and his allies are setting sights on new initiatives and formulas to shake up the trade body, one being a “public goods” platform where countries could commit under existing WTO rules to ensure that its public funding for new health-related R&D contains formulas for open-licensing of resulting medicines or vaccines innovations – or at the least, the open publication of trial results and research findings. 

A new WTO initiative on public goods

“I hope the WTO will walk away from the train wreck that this is and start working on the global good agreements,” said t’Hoen. 

“We hope that between now and the next ministerial..  more than one government will table a text on an agreement with the WTO on public goods,” added Love, noting that such an agreement could be modelled on the existing WTO “General Agreement on Trade and Services”. 

Trade-related “public goods” pledges made under the proposed mechanism would be binding, make use of the existing WTO dispute resolution processes, and could also be used to promote “public goods” well beyond medicines – from trade measures that advance climate mitigation or biodiversity to food security and refugee relief.  

“We think this would be a good project for the WTO… It would change the culture of the WTO and it would be a service to the public … It would get governments to sponsor and mobilize public goods, to put them on their agenda. 

At the same time he admits that, in terms of the IP waiver battle, he frames it as a chapter that may be closing for now, for better or worse: 

“I think that it has been overstated what the effect of the WTO rules are. The WTO doesn’t grant patents or enforce patents. If it disappeared tomorrow, it wouldn’t change any existing IP granted under national law, bilateral or regional agreements,” said Love.

 

Image Credits: Samy Rakotoniaina/MSH, Jay Louvion/ WTO, Tadeau Andre/MSF .

Monkeypox lesions

Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization (WHO), has called a meeting of the emergency committee for next Thursday to discuss whether monkeypox should be declared a public health emergency.

This follows the spread of the disease in at least 32 new countries outside of the nine African countries where it is endemic, with 1,600 confirmed cases and a further 1,500 suspected cases reported to the WHO.

“The global outbreak of monkeypox is clearly unusual and concerning. It’s for that reason that I have decided to convene the Emergency Committee under the International Health Regulations next week to assess whether this outbreak represents a public health emergency of international concern,” Tedros told a media briefing on Tuesday.

The WHO has described the identification of over 1,200 confirmed cases of monkeypox in just over three weeks as “an unprecedented event”.

There have been 72 deaths reported this year, all in endemic countries, although the WHO is investigating a possible monkeypox death in Brazil.

“While in the current outbreak most but not all initially reported cases from four WHO regions are among persons who self-identify as men who have sex with men, it is expected that other cases will continue to occur in different population groups,” according to WHO’s vaccine and immunization guidance on monkeypox published on Tuesday.

Renaming monkeypox?

Dr Rosamund Lewis, WHO technical lead on monkeypox

The WHO is also discussing changing the name of monkeypox and its clades, currently known as the Central Africa and West Africa clades.

The WHO is also in discussion with member states about “equitable access” to the smallpox vaccine for monkeypox.

However, WHO monkeypox technical lead Dr Rosamund Lewis warned that while some smallpox vaccines may be protective against monkeypox, a lot of the data is old or relates to animal studies.

“There was not a lot of clinical data and so WHO is calling on countries to work together to collaborate in the use of these vaccines, and to use standard research protocols with standard data collection tools so that we can learn about the effectiveness of vaccines as they are deployed in this situation,” said Lewis.

The WHO does not advocate mass vaccinations but says rather that decisions around immunization with smallpox or monkeypox vaccines should be made on a case-by-case basis through “clinical decision-making, based on a joint assessment of risks and benefits” between a health care provider and a patient.

“Control of monkeypox outbreaks primarily relies on public health measures including surveillance, contact-tracing, isolation and care of patients,” according to the WHO guidelines.

A recent two-day scientific meeting on monkeypox convened by the WHO identified a number of research priorities including whether the disease is spread by people who are asymptomatic and whether those vaccinated against smallpox have lifelong immunity to monkeypox.

Grade three emergency in Horn of Africa

Drought-affected livestock walking to a river in Adadle district in the Somali region of Ethiopia.

The WHO has declared a “grade three emergency” – the highest level possible – in the Horn of Africa, “where the worst drought in 40 years has pushed over 30 million people in eight countries into acute food insecurity,” Tedros said. 

Among the affected countries – Djibouti, Eritrea, Ethiopia, Kenya, Somalia, South Sudan, Sudan and Uganda – an estimated 7.5 million people have left their homes in search of food and water.

‘A grade three emergency means that we are on coordinating the response across all three levels of the organisation: country offices, regional offices and headquarters,” said Tedros. “Our priorities are supporting countries to find outbreaks and to make sure people have access to the essential health services they need.”

Last week, UNICEF reported the 2022 March-May rainy season was “likely to be the driest on record, killing livestock and crops, displacing populations, increasing the risk of disease and malnutrition, and pushing children and families to the brink of death or destitution.”

“Communities are taking extreme measures to survive, with thousands of children and families leaving their homes in pure desperation in search of water, food, and pasture, requiring a collective response by all humanitarian partners,” said UNICEF. “This is a water crisis and more than 8.5 million people, including 4.2 million children, are facing dire water shortages in the region.”

Tedros said there were severe implications for public health.

“Malnourishment can have a lifelong impact on health and makes people increasingly vulnerable to disease,” he said. “Severely malnourished children are nine times more likely to die of this, such as cholera and measles.”

Image Credits: Tessa Davis/Twitter , Michael Tewelde / World Food Program.