Genetic
WIPO concludes General Assembly with agreement to negotiate new accord on genetic resources and traditional knowledge

Overcoming years of stalemate, the World Intellectual Property Organization (WIPO) agreed to negotiate a proposed treaty on genetic resources and related traditional knowledge (TK) that are key components in both traditional and new medicines.

Delegates to WIPO’s General Assembly decided that the negotiations both to begin the draft international instrument and to conclude the talks must occur no later than 2024.

The breakthrough is highly significant because talks over proposals to require patent applicants to declare their use of indigenous resources and knowledge, among other measures, have been languishing in a WIPO committee for decades.

Indigenous genetic resources, including plants, animals and microorganisms, and related “traditional knowledge” are scientifically valuable to life sciences research and have been the basis for many modern drugs, from artemisinin-based anti-malarials like Coartem® to anti-parasitics that treat onchocerciasis, known as river blindness.

In a meeting from 30 May to 3 June, the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources considered a draft working document, developed by WIPO’s secretariat.

It would have called for patent applicants to declare any such resources that are used in new patent applications to be registered in WIPO’s global registry, but the discussions were inconclusive.

Genetic resources
Delegates in discussions at the IGC

Negotiators would, however, now consider a mandatory “patent disclosure requirement” when patent applications are made for inventions that involve the use of genetic resources, along with addressing questions of access, use and benefit-sharing, according to a statement Friday.

WIPO says proponents of such a treaty argue it would “harmonize diverse national systems, foster the sustainable development of Indigenous and local communities, provide legal certainty and predictability for businesses, and improve the quality, effectiveness and transparency of the patent system.”

‘Difficult decisions’ on genetic resources

WIPO Director General Daren Tang hailed the breakthrough as an “important step” and said the UN agency’s secretariat would provide “full support” to delegates as they try to overcome the significant gaps that remain among nations over some of the key issues.

“Today is a triumph of multilateralism, of us as a General Assembly, moving together as a community to make a difference for people everywhere,”  Tang said. “Of course there are disagreements, there will be divergences. This is just the beginning of a whole new set of conversations.”

Tang described the proposed treaties as more than “mere pieces of paper” because they would provide concrete help to people around the world. WIPO acts as a global forum for intellectual property policy, services, information and cooperation.

Moldova’s UN Ambassador in Geneva, Tatiana Molcean, chaired the WIPO Assembly, which concluded Friday. Around 900 delegates from among WIPO’s 193 member nations attended the July 14-22 assembly.

Molcean said she was proud of the “difficult decisions” it made in agreeing to move ahead with the proposed treaties.

“After years of negotiations,” she tweeted, it was mere reverence to see, as Chair of #wipoGA, member states come together to take their negotiations towards a final resolution.” 

WIPO to streamline IP registration for designers

The WIPO Assembly also approved a decision to commence intergovernmental negotiations over a second proposed international legal accord on design law.

This is intended to offer designers  easier, faster and cheaper means of registering IP, and ensuring its recognition, in home markets and abroad, according to WIPO.

Work to simplify procedures for the IP protection of industrial designs was initiated in a WIPO standing committee on the law of trademarks, industrial designs and geographical Indications as far back as 2006.

The new accord, if approved, could also have implications for new health technologies, from diagnostics to cancer treatment.

Three years ago WIPO was part of a symposium with the World Health Organization and World Trade Organization on cutting-edge health technologies, such as gene editing therapies for cancer, that focused on ways of improving the international IP system to drive innovation and bring people needed therapies.

The proposed treaty on design law aims to eliminate bureaucratic red tape in ways that would particularly help smaller-scale designers in low- and medium-income countries who have less access to legal support for registering their designs overseas.

WIPO says data show the design industry accounts for 18% of employment and 13% of GDP in Europe, indicating the benefits such a treaty could have in developing economies where less or no similar data is available.

“The benefits of a vibrant design sector go far wider than GDP,” WIPO said. “Design can support efforts in education and sustainability, and can support community building.”

Image Credits: @Tatiana_Molcean, Photo: WIPO/Berrod.

Afghan women health workers.

The COVID-19 pandemic was a stress test for the health sector, which is one of the fastest growing economic sectors in the world, and also one of the largest employers of women. Women are 70% of the health and social care workforce and 90% of nurses but they are clustered into jobs that are lower paid, often unpaid, and given lower social status.                   

In a recent report by Women in Global Health, Subsidizing Global Health, we calculated that six million workers worldwide are in fact propping up health systems with their unpaid and grossly underpaid labor. This is cause for concern in the context of the WHO’s recent estimation that there is a projected shortfall of 10 million health workers by 2030.

Cause for further concern is the fact that though the default health worker may be female, women hold only 25% of senior decision-making roles in health and that pattern has continued in the pandemic.

In a previous survey by Women in Global Health, it was calculated that 85% of national COVID-19 task forces had majority male membership. Despite their exceptional contribution in responding to COVID-19, women do not have an equal place in decision-making in health systems and there is evidence that they have lost ground in health leadership and governance since the start of the pandemic. 

This is a loss to women, but also to health systems that lose out on the professional knowledge, talent and perspectives of the women who are experts in the health systems they largely deliver.

Women excluded throughout history 

While women have had roles in healing and birth, they were often excluded in the health sector.

If leadership jobs were awarded on merit, we would see more women leaders in the sector. Why then are women the minority of health leaders? History matters. For millennia women were traditional healers, makers of herbal remedies and birth attendants. 

Despite this, when medicine was formalized as a profession in Europe and North America, it was established by men as a profession for men, and women were formally excluded from training and practice.  

That practice spread throughout the world as modern medicine and medical schools were established, again excluding women. Women fought their way into medicine but in some countries, it took until the 1940s before the first woman was able to graduate and practice as a doctor. 

The barriers were very different for women in different countries, with women from minority races, ethnicities, castes and other disadvantaged social groups still fighting to overcome the gendered obstacles to entering medicine and higher status occupations such as surgery.  

Legacy of exclusion remains 

The legacy of the formal exclusion of women is reflected today in women’s place in the sector.  Even in countries where women first broke into medicine, the legacy remains. 

In the US, only 18% of hospital CEOs are women and only 17% are full Professors of Medicine. In Canada, 63%  of medical students are women, 41%of doctors but only 12% of Deans of Medicine. 

Women still face ‘glass ceilings’ in their career progression while the small minority of men in nursing are said to have ‘glass escalators’ that take them to the top quickly, leaving their women counterparts on the ground floor.

COVID-19 exposes gender inequity 

Women continue to work on the frontlines of the pandemic unprotected by vaccines.

COVID-19 has been a major shock to health systems, economies and societies. It has exposed the deep inequalities within and between countries. 

Although many people in high-income countries speak as though the pandemic is over, the Africa Centres for Disease Control reported in May 2022 that only 17%  of people in Africa were fully vaccinated. Significant numbers of health workers in Africa, mostly women, are still working on the pandemic frontlines unprotected by vaccines. 

A recent Women in Global Health report also noted that over six million women health workers are working unpaid or grossly underpaid.  A systemic shock as big as COVID-19 must prompt us all to consider the value of health and the value of the women who largely deliver health services.

We know how to close the gaps

In the health sector, a majority of health workers are women.

The gender gaps in leadership, pay and career progression in the health sector are wide, but we know how to close them. In some science, technology, engineering and mathematics (STEM) sectors the issue is to attract women into the sector. 

This is not the case in health since women are already the majority of health workers, especially in younger age groups. A study by the World Health Organization found that in 104 countries, the majority of doctors, nurses, midwives, pharmacists and dentists under 40 years of age were women. 

These trends show that women are keen to enter the health sector and their numbers are increasing everywhere. The gender imbalance in leadership clearly, however, will not just come into balance over time. 

‘Action, not evolution’ 

Women make up 75% of the global health workforce, but hold only 25% of senior positions.

It will take intentional action, not evolution, to ensure women have an equal place in health leadership.  We can enable women to succeed in leadership by focusing on four areas:

First, by building the legal and policy foundations for equality: Governments must create the legal foundation to enable women to engage equally with men at work. 

This will include laws to support women’s rights to equal pay and decent work, protection of women from violence and harassment at work and the removal of all barriers to women’s participation in work. Minimum wage legislation and support for collective bargaining will enable over six million women working unpaid and grossly underpaid in health systems, to enter formal labor market jobs where they can progress in their careers.  

Governments must enable girls to finish second education and more.

In many low-income countries, governments must enable girls to finish secondary education at the same rate as boys so they can enter tertiary education and professional training. Poverty and low levels of education limit women’s access to formal sector jobs in health. 

The pandemic has blighted the education of a generation of girls in some countries. We must create routes back into education for girls whose schooling has been interrupted.

Second, we must address the social norms and stereotypes that drive gendered segregation in the health workforce and place lower value on professions that are majority female. Gendered stereotypes of occupations and of leadership as a “man’s role” take hold long before people join the workforce. 

These stereotypes encourage men and women to enter different occupations in the health sector, with women typically entering nursing and more men entering surgery; and they also disadvantage women in leadership. 

A 2020 United Nations Development Program survey in 75 countries found around 50% of men and women believed men make better political leaders than women, while more than 40% felt that men made better business executives.  The same study found that bias against gender equality is rising, especially amongst younger men, with a backlash recorded in Sweden, India, South Africa and Romania. 

We must pay attention to the education of our young men and women if we are to build equal and strong societies as we emerge from the pandemic.

Women do not need to be fixed, they need to be supported and given opportunities to enter leadership roles.

Third, we must address workplace systems and organizational culture. Interventions in the past have focused on ‘fixing women’ by training them in self-esteem or self-presentation, on the assumption that women needed to change to compete with men. It is the workplace cultures and policies that exclude women that need to be fixed, not women. 

Women face systemic inequality, bias and the exercise of power that favors men for leadership roles. Quotas and targets for women in senior roles have proved highly effective at increasing women in leadership roles, even as an interim measure until parity is achieved. 

In addition, visible and accountable support by senior leaders of all genders and adopting an equal and family-friendly policy framework are essential to enabling women’s progression into leadership.

Fourth, we must enable women to achieve. Women do not need to be ‘fixed’ but they can be supported with measures including peer support and mentoring for women, developing formal and informal networks for women’s leadership and increasing the visibility of women’s leadership. 

Global networks, such as Women in Global Health, along with partnerships like Every Woman Every Child and the Partnership for Maternal, Newborn and Child Health, enable women to work together to share experiences and campaign together for change on a local and global scale.

New social contract for women in health 

The pandemic has exposed the weaknesses, inequalities and gender gaps in our health, social and economic systems.  A systemic shock as big as COVID-19 must prompt us all to consider the value of health and the value of the women who deliver health and care services. 

We cannot expect women to continue to support a system of gender inequality as we emerge from this pandemic. We are asking for a new social contract for women in health that closes the gender gaps, recognises their contribution and enables them to lead on an equal basis. 

This is not a marginal women’s issue, it is central to strong health systems and global health security, and it is everybody’s business.

Magda Robalo is the Global Managing Director of Women in Global Health and H.E. Kersti Kaljulaid is  Former President of Estonia and the UN Secretary-General’s Global Advocate for Every Woman Every Child

Image Credits: WHO, WHO Eastern Mediterranean Regional Office , PAHO/Sebastian Oliel, WHO Africa Region, Mass Communication Specialist 3rd Class Everett Allen/Flickr, Paul Hudson/Flickr, UN Women, World Health Summit , Kersti Kaljulaid/Twitter .

Intergovernmental Negotiating Body (INB) co-chair Precious Matsoso applauds delegates at the end of the meeting.

World Health Organization (WHO) member states have agreed that the future pandemic “treaty” currently being negotiated will be legally binding at the Intergovernmental Negotiating Body (INB) meeting that ended on Thursday – a day earlier than expected thanks to smooth negotiations.

The INB agreed that the treaty will be set up in terms of Article 19 of the WHO constitution, which enables the WHO’s highest decision-making forum, the World Health Assembly (WHA), to adopt “legally binding conventions or agreements” if agreed on by two-thirds of members to cover “any matter within the competence of the organization”. 

However, the INB did not close the door to including some “non-binding” clauses in the treaty as well as using Article 21 of the constitution “if appropriate”, which allows the WHO to adopt legally binding regulations.

WHO Director-General Dr Tedros Adhanom Ghebreyesus expressed satisfaction with the outcome of the INB meeting, the second since the body was agreed on last December.

“The legally binding instrument is very, very important, and that’s what you have decided and I am very glad to see that,” said Tedros.

“The legally binding principle is really key because this is the generation that has suffered and still suffering due to the pandemic. No generation can write this treaty or instrument or accord other than this generation, so that our children and the children of our children can  benefit and what happened over the last two to three years is not repeated in the future.”

‘Bitter pills’ to follow ‘honeymoon’

INB vice-chair, Thailand’s Viroj Tangcharoensathien, warns that negotiations ahead will be tough.

However, INB Bureau vice-chair Viroj Tangcharoensathien (Thailand) warned that the smooth running of the meeting marked the “honeymoon period”, and the tough challenge of negotiating the content of the treaty still lay ahead.

“We have achieved consensus on using Article 19 of the constitution as there was majority support to go that way, although we do not discard Article 21, and I feel that this is the honeymoon period and the honeymoon period will finish very quickly,” said Tangcharoensathien, warning of “bitter pills” at the next INB meeting scheduled for December.

“Based on the spirit and trust of INB in the Bureau and secretariat, I believe that we will be there by May 2024 and we will have achieved something substantial for the world because the world is waiting. Monkeypox is attacking us all the time and H5N1 [avian flu] is in the air,” he added.

The INB has until May 2024 to present a draft pandemic treaty to the WHA. Once it is passed, it will come into force for each Member State “in accordance with its constitutional processes”. This clause has only ever been used once – to adopt the Framework Convention on Tobacco Control, which contains both binding and non-binding clauses.

“The Health Assembly could adopt a legally binding instrument (under either Article 19 or 21 of the Constitution), and that instrument could contain both legally binding and non-legally binding provisions, with the non-binding provisions being, for example, recitals, principles, recommendations or aspirations,” according to a

According to a WHO explainer issued before the INB meeting, a legally binding instrument can contain “both legally binding and non-legally binding provisions, with the non-binding provisions being, for example, recitals, principles, recommendations or aspirations”, and this practice is “standard both in WHO and with other international instruments”.

Process ahead

In December 2021, WHO’s Member States decided at a WHA special session to establish the INB to draft an international instrument on pandemic prevention, preparedness and response.

The INB is expected to deliver a progress report to the 76th World Health Assembly in 2023 and submit its draft agreement to the WHA’s 77th meeting in May 2024.

The INB Bureau is comprised of co-chairs Roland Driece (Netherlands) and Precious Matsoso (South Africa), with vice-chairs Tovar da Silva Nunes(Brazil), Ahmed Soliman(Egypt), Kazuho Taguchi (Japan), and Thailand’s Viroj Tangcharoensathien, representing all WHO regions.

Between now and the end of October, the INB will conduct regional briefings and public hearings, which will result in a “zero draft” agreement to be presented to the next INB meeting on 5 December.

COVID-19 screening in Bangkok, Thailand.

WHO has issued stiff, dual warnings over a surging global rate of COVID infections alongside a still-expanding outbreak of Monkeypox.

The latter is set to be the focus of a discussion by a WHO Emergency Committee meeting Thursday, as the committee reconvenes to decide if a public health emergency should be declared over the virus outbreak, for which WHO has now confirmed almost 14,000 cases – more than double the 6,027 cases that had been reported as of 6 July.

who
Tedros Adhanom Ghebreyesus, WHO Director General

“In the past six weeks, the global weekly number of reported cases of COVID-19 has almost doubled,” Dr Tedros Adhanom Ghebreyesus also said, speaking at a WHO weekly press briefing Wednesday. He spoke on the eve of a second WHO Emergency Committee meeting that was set to convene, once more, to determine if Monkeypox should also be declared, like COVID, as a global health emergency.

“[COVID] deaths are also increasing, but for the moment, not as rapidly as cases. However, more cases means we can expect to see more hospitalizations and bears in the coming weeks. There are many sub lineages of the Omicron variant, most notably BA.5, which is the most transmissible variant detected yet.

“We have said consistently that this virus will continue to evolve and we must be ready for whatever it throws at us. That could be a new version of the variants we already know or something completely new. We know that for any future variant to become widespread, it must be more transmissible than previous variants. But we can’t know how deadly it will be. So all countries must be ready. Countries that have been dismantled some parts of the pandemic response systems are taking a huge risk,” Dr Tedros warned.

World will need new COVID vaccines

Woman receiving COVID-19 vaccine in Brazil.

While saying that “current vaccines remain highly effective against severe disease and death,” the WHO Director General also acknowledged that “we will need more vaccines that are better at protecting against infection” from the Omicron variant and subvariants of the SARS-CoV2 virus.

But he added that, “if and when we get those vaccines, we cannot afford the same horrific inequity that strained the rollout of vaccines last year.”

His comments signaled a shift in WHO’s stance on COVID vaccine composition.  Until very recently WHO had maintained that the existing vaccines, geared for the original SARS-CoV2 virus, should remain in place – for fear that retooling those vaccines now could interrupt the distribution of supplies that only recently began to reach many low- and middle income countries.

But science and industry have moved ahead – with regulatory authorities like the European Medicines Agency recently stating that they expect to be in a position to approve as early as September a new generation of “bivalent” vaccines developed by pharma manufactuers that also target the Omicron and its variants.

Monkeypox cases in more than 70 countries

Monkeypox rash

In terms of monkeypox, among the nearly 14,000 confirmed cases been reported to WHO until now from more than 70 countries and territories, just five deaths have been reported – all in Africa, said Dr Tedros.

That’s despite the fact that most cases of the disease, previously endemic only in central and west Africa, are now being reported form Europe where the infection transmitted by skin lesions, is be passed primarily among men who have sex with men.

“Although we’re seeing a declining trend in some countries, others are still seeing an increase, and six countries reported their first cases last week,” said Dr Tedros. Although he didn’t specify which countries first saw cases last week, he noted that: “some of these countries have much less access to diagnostics and vaccines, making the outbreak harder to track and harder to stop. WHO is validating, procuring and shipping tests multiple countries and will continue to provide support for expanded access to effective diagnostics.”

Tedros added that in reconvening Thursday, the International Health Regulations Emergency Committee on monkeypox would “review the latest data and to consider whether the outbreak constitutes a Public Health Emergency of International Concern (PHEIC), but “regardless of the committee’s recommendation, WHO will continue to do everything we can to support countries to stop transmission and save lives.

Mixed pattern of transmission in Europe and Africa

Rosamund Lewis, WHO’s technical lead on Monkeypox

Added Rosamund Lewis,  WHO’s technical lead on Monkeypox: “At the moment, we are seeing a very mixed pattern of transmission in some parts of the world, such as parts of Africa, Western Central Africa, but in other countries all around the world 99% of cases reported are among men.

“So it is men who are at risk right now. Not all men,” she added, however, noting that, “98% of those [cases] that are reported are among men who have sex with men, and primarily those who have multiple recent, anonymous or new partners.

“So it’s a question of really understanding what the risk is for an individual, what our individual risk of exposure, the choices we make,” she said.

Awareness-raising among LGBTI communities about prevention, testing and vaccines

Pride parade in Indianapolis, Indiana.

She added that WHO is working with representatives of affected communities, and with organizers of pride festivals and celebrations to raise awarenesss:

“These are all important celebrations of identity;  it is also very important that those venues and events and activities share information for people to protect themselves,” she said.

“Coverage of information in some of these events remains patchy.  Some event organizers and tools are sharing this information very broadly. And others may not be. We are urging all health authorities and all community organizers to engage with the affected communities.

“There are ways to protect oneself beyond simply being aware of the risk which is the most important – but also in terms of access to services, access to testing, finding out where tests are available and how they can best be taken, finding out where vaccines possibly may be available, and how they can best be accessed as well.

Added Mike Ryan, WHO executive director of Health Emergencies, “Like we said in COVID, don’t be the person to pass this disease and it doesn’t matter what group you’re in. If you have the lesions, get tested.

“If you can’t get tested, and you suspect that you have monkey pox don’t pass it around,” he said, adding:

“The community that’s currently being infected as one of the most engaged, powerful, responsible communities that we have, who have really worked so hard over many years to contain an even more deadly virus,” referring to HIV/AIDS.

“So we have full confidence that this community can and will engage very closely,” Ryan said.

Understanding of Monkeypox transmission drivers lacking

Monkeypox rash in a white male.

He added that, “we also need in the broader public health community is to keep an eye on other population subgroups, which we are doing.

“As we’ve said that before…this transmission is occurring and has been occurring in African countries and in particular zones over a large number of years. And we don’t fully understand  what’s driving transmission in those countries and there’s a lot more investigation to do and a lot more investments to be made in understanding that problem.

“Like with COVID, and with other pandemics, we’re destined to repeat these things if we don’t understand their origins, we don’t understand their drivers.

“So we have two jobs to do: We have to work very closely with the community that’s currently affected to ensure that they have the… knowledge to contain this disease, and that we keep an eye on and make sure that other population groups are not affected.

“And we [need to] work with countries that are affected with zoonotic transmission, and onward transmission,” he added, referring to the dozen or so central and west African countries where the disease has circulated for decades among wild animal populations, erupting sporadically in human communities as well, but usually in a more limited way than what is being seen today in Europe and other countries outside of Africa.

“And that’s one of the issues,” stressed Ryan.  “We have patterns of transmission in places like Ghana and Nigeria that actually aren’t purely zoonotic; there is human to human transmission that has occurred that does occur, not explosively, but it does occur in those environments. So we have a lot of knowledge to gain in the coming months. A lot of work to do, and a lot of investment to make both in the communities affected by this disease, but in the science of understanding this.”

Image Credits: Prachatai/Flickr, Health Policy Watch/Twitter, Agência Brasília/Flickr, ET Times Lifestyle/Twitter, Steve Baker/Flickr, Diverse Stock Photos .

pandemic
Loyce Pace speaking Wednesday 20 July with a small group of journalists at the US Mission in Geneva

The United States is open to drafting a pandemic accord that contains both legally binding and voluntary elements, according to Loyce Pace, assistant secretary for global affairs at the US Department of Health & Human Services.

Pace also told a small group of journalists Wednesday at the US Mission to the UN in Geneva that “the discussions are going quite well” on a broad scope of issues related to the prospective accord. Her comments coincided with a week-long meeting of the WHO’s Intergovernmental Negotiating Body (INB) in Geneva.

“I think we’re open as a US government to a mix of binding and non binding options as part of any final product. And really, in the end, we want to be a part of the solution,” Pace said.

The meeting came as delegates from WHO’s member nations met behind closed doors to decide whether a new pandemic agreement should take shape as a convention, agreement or regulation under the terms of two different articles of WHO’s Constitution.

If the accord is shaped under Article 19 of the Constitution, it would be a legally binding convention or agreement. It were done under Article  21, it would be a regulation – but that is the leastly likely choice since the International Health Regulations already exist and are being amended in a parallel process.

In either case, the new instrument could contain a mix of legally binding commitments and recommendations, according to a background paper prepared by WHO’s legal team, which is advising the INB negotiators.

The paper says the World Health Assembly could adopt a legally binding accord under Article 19 or 21 that contain both “legally binding and non-legally binding provisions, with the non-binding provisions being, for example, recitals, principles, recommendations or aspirations. This practice is, in fact, standard both in WHO and with other international instruments.”

Sharing pathogens genomic sequences in exchange for benefits 

Pace did not answer directly when asked to comment on details of the US position regarding developing country demands that the treaty include provisions that they should receive “benefits” for sharing of pathogens’ genomic data with drug development researchers.

At Tuesday’s public INB session, however, her colleague Colin McIff, deputy director of global affairs at the US Department of Health and Human Services, said access to pathogen sequences should not be linked to the promise of benefits from medicines produced in a “transactional way.”

“The sharing of benefits can be seen as a means to achieving equitable pandemic preparedness and response,” said McIff. “But our concern is that … if we continue to link access and benefits in a transactional way, that’s not really conducive to meeting public health needs, and improving pandemic preparedness.” 

Pharmaceutical companies were able to rapidly map out vaccines for the SARS-CoV2 virus because the virus sequence was shared early on by researchers via open platforms.

But that kind of free sharing could be curbed by the Convention on Biodiversity when it meets in December in Montreal.  The CBD is considering proposals to  explicitly incorporate reference to the sharing of pathogens genetic data or “information”  into the existing Nagoya Protocol on Access to Genetic Resources.

That would mean countries sharing the genetic sequence of a new or emerging pathogen could then demand they be compensated by pharma researchers that use the information to make new drugs or vaccines.

Tracking international agreements

Loyce Pace

“One of the things that we’re tracking is how other international agreements or dialogues are being brought into this process,” said Pace. “I think it’s important for the INB to acknowledge those various discussions, whether it is Nagoya, the WTO, or others. We have to be careful to keep those discussions in those places.”

The United States wants to focus the conversation in Geneva on the “core objectives around pandemic preparedness and response and ensure that it’s scoped appropriately to address the problem at hand,” Pace added, “not only around sharing of samples and information, but also about equitable access to innovations and other key priorities like one health and other issues that I know you’ve heard over the past couple of days.”

Additionally, the US is leading the charge on targeted revisions to the 2005 IHR rulebook that governs countries’ present-day responses to health emergencies. Those rules were widely criticized during the pandemic as slow and ineffective, prompting the World Health Assembly to agree in May to update them. 

“The US is still focused on how we amend the existing International Health Regulations, which is a conversation happening outside of the intergovernmental negotiating body, but obviously involving many of the same players,” said Pace.

“The United States stands ready to be a part of solving the problem of pandemic preparedness and response problem. We weren’t quite there when it came to COVID-19. And we want to correct that collectively with other WHO member states.”

Civil society and private sector should have a seat at the INB table 

Another topic being discussed behind closed doors this week by the INB negotiators is a proposed expansion of the range of private sector and civil society groups that may observe and comment on the negotiations over the pandemic accords. 

Nearly 300 groups are already endorsed as “stakeholders” – including some civil society groups in “official relations” with WHO, as well as an additional layer of multilateral organizations including the African Union, International Monetary Fund, International Maritime Organization and International Civil Aviation Organization.

Pace, however, declined to elaborate on what criteria the US might endorse for choosing who else can join the table.

“The US has been pretty full throated about this, not just in the context of the INB, but just broadly with WHO,” she said. “We have to create space, not only for member states…including for small delegations, but also for civil society and the private sector, or other external stakeholders who need to be a part of this process.”

Asked whether those invited at the table would include a broader spectrum of civil society, e.g. environmental health groups, or more voices from big pharma and agri-business, Pace said only: “What remains to be seen is what the criteria will be or what the parameters or borders are.”

Commits to continuing US work on sexual and reproductive health rights 

Separately, Pace criticized the recent US Supreme Court ruling on abortion as one “which essentially struck down the constitutional right to abortion, safe and legal abortion for women in our country.”

But she said her department remains committed to promoting sexual and reproductive health rights for women worldwide, through its engagements with WHO, UNAIDS, UN Women and the UN Population Fund.

“Those partnerships remain strong. And that work still continues when it comes to sexual and reproductive health and rights,” she said, “alongside many other health priorities that lead us to accomplishing this end goal of universal health coverage.”

migrant
In March 2022, Ukrainians at the Lyiv train station fleeing the Russian invasion.

Dr Waheed Araian spent the first five years of his life hiding with his family in a cellar in Kabul from rockets and bombs.

“I came to the UK as a 15-year-old child refugee with no family support, hardly any education and about $100 in my pocket,” said Arian, now an emergency doctor in the UK’s National Health Service. “And that is just one story out of 1 billion.”

One billion people worldwide are refugees. And many of them are invisible to health systems lacking access to basic health services as well as to decent work, housing and food essential to good health, according to a first-ever WHO World Report on the Health of Refugees and Migrants, published Wednesday.

Speaking at a WHO press briefing, Arian, who was born in Kabul in the 1980s, during the Afghan civil war and Soviet invasion, vividly described the hunger, cold and illness that marked his childhood

Dr Waheed Arian speaking at WHO press briefing. 

We didn’t have much food, and many children, including ourselves, suffered from whooping cough. We didn’t have enough clothes,” he recalled. His parents finally decided to risk the dangerous, covert journey to Pakistan, traveling through rugged mountains astride horses and donkeys. They came under attack three times along the way. In a tented refugee camp  in Pakistan, he survived bouts of malaria and nearly died from tuberculosis. His family moved back to Kabul when there was relative calm again. But when war flared up again in the 1990s, his family sent him to the United Kingdom – where he vowed to study medicine. 

“My parents sent me away to the UK as a refugee. But I also came with hope to be able to life safely, to be able to study, to contribute,” he observed, “And that’s how it is with so many other refugees and immigrants across the globe.”

One in 8 people are migrants or refugees – only 1 in 3 countries offer full access to health services 

International migrants, refugees and asylum seekers (percentage of the total population), by WHO region, mid-2020

As many as 1-in-8 people worldwide are refugees or migrants. Despite the astonishing numbers, only about one-third of the countries surveyed by WHO offer refugees access to universal health coverage and primary health care services, according to the new report. 

“While many countries hosting refugees have policies allowing refugees to access health and social protection services, that access may be partial, entail prohibitive out-of-pocket expenditures and involve additional barriers, including distance to facilities, language and discrimination by providers,” the report says.

A multi-country survey of some 30,000 migrants and refugees conducted by WHO as part of the research found that some 37% of those people questioned said fear of deportation was a barrier to accessing health services, while close to 30% said they couldn’t pay the out-of pocket costs,” said Dr Santino Severoni, director of WHO’s Health and Migration Programme, at the briefing.

“The difficulty of navigating the health systems.. to identify where to go to receive suport, and access the service needed,” were other barriers identified along with a limited capacity of health care workers to respond to the special problems that refugees and migrants might present, Severoni said.

Along with those barriers, the report finds many countries have “policies and programmes that separate families, limit access to medical or social services, or condone or promote violence, discrimination, prolonged detention or illicit trafficking yield poor health.”

Working conditions – dirty, dangerous and demanding

Migrants and refugees also tend to occupy jobs at the lowest economic rungs of their host countries. WHO’s Director General Tedros Adhanom Ghebreyesus, speaking at the press launch, called them “3D jobs” which put migrants and refugees at a higher risk of occupational injuries. 

“Many migrant workers are engaged in the so-called ‘3D jobs – dirty, dangerous and demanding’ without adequate social and health protection or sufficient occupational health measures,” he said.

As a result, rates of work injuries are high even among migrants and refugees that manage to resettle, added Severoni, referring to WHO’s multi-country survey: “About 40% of the population which was surveyed and sampled, reported at least one injury related to their own conditions of employment.”

Mental health distress and self-harm rates also run high

International migrants, refugees and asylum seekers in the top three host countries, by WHO region, 2020

Some 22% of refugees who are directly touched by conflict also suffer from mental health distress. Not surprisingly, self-harm rates also are high.

Many refugees and migrants suffer from fear and abuse by traffickers during their migration, only to be subjected to forced confinement or legal limbo upon arriving at their destination. They also tend to suffer from being apart from family and friends, and from a lack of regular education or employment. 

“Often it’s due to many levels of traumas over many years,” Arian said of the risk factors he experienced first-hand and saw in others. “You are going through trauma by displacement, abandoning family members or loved ones, the social protective factors which are enhancing their mental well-being.”

Arian said many suffer “extensively” but receive no mental health screening or compassionate care, due to language and social factors. 

“In many cases they are put in detention centers or they go into hiding,” he said, citing additional political factors. “They live in extremely unkempt conditions. So it’s an accumulation of many factors.”

Environmental factors pose added health risks 

In the Colombia local authorities and humanitarian partners set up shelters and provided aid to people who had recently arrived from Venezuela.

The report details how many migrants and refugees face high out-of-pocket expenses to access health services that legal residents and citizens of their host country may get for free, even in some high-income countries. Those range from treatments for chronic diseases to sexual and reproductive health services. At the same time, a wide range of environmental factors also put them at greater risk.

That is particularly true when it comes to a lack of adequate housing or water and sanitation facilities, food insecurity, and poor air quality in neighborhoods with a preponderance of refugees and migrants. The report notes those factors are particularly prevalent in migrant settings across low-income Africa, the Middle East, and the Americas, though they also are present in higher-income Europe and Eurasia.

Housing for migrant workers, for example, often is inadequate even in high-income Asia, according to the report.

“In the WHO Western Pacific Region,” it says, “thousands of low-skilled migrant workers employed in the construction and marine industries, and in various other low-wage sectors in Singapore, live in dormitories – the largest of which have common and shared areas (e.g. recreational facilities, grocery stores and other services).

And these kinds of conditions have made migrant workers more vulnerable to infectious diseases, particularly COVID-19, the report notes from among many examples.

But the report also points to some favorable practices for refugees and migrants, such as public housing policies in Germany and Poland that allow some to qualify for below-market rental accommodations and other forms of support.

Most common reasons (%) for not accessing ANC services reported by Syrian refugees in Lebanon,
2015–2020

The report cites widespread issues with food insecurity among migrants, particularly in parts of Africa and WHO’s Eastern Mediterranean Region. It cites studies of refugees and migrants in Iran, Egypt, Libya South Africa, as well as Syrian, Sudanese, Somali and Yemeni refugees who have fled to Syria, Jordan, Lebanon and often may have to forego meals or reduce their food intake.  

“In the WHO Eastern Mediterranean Region, one fifth of refugees in Egypt could not meet their basic food needs, citing unemployment as a major barrier to food security,” the report notes. “And one-in-three migrants living in Libya reported inadequate food consumption.”

‘Almost invisible’ to health systems 

Do refugees and migrants have the same status as citizens in accessing government health services?
Information from 84 countries, 2018–2021

The report highlights a “fundamental knowledge gap” about migrant and refugee health, Dr Tedros said, insofar as these groups are often not tracked by national health systems or global health surveys. 

“Refugees and migrants are virtually absent from global surveys and health data, making these vulnerable groups almost invisible in the design of health systems and services,” he said, adding this makes “these vulnerable groups almost invisible in the design of health systems and services.”

Appeal to politicians and advocates 

A child is screened for malnutrition at a health centre in Abu Shouk IDP camp in North Darfur.

Dr Tedros appealed to policymakers and civil society to both close the data gaps and begin considering refugees and migrants more holistically in health services planning. 

“We hope government will use this report to develop evidence employment policies and actions and we hope advocates will use it in their efforts to call for inclusive health systems,” he said.

WHO is calling on governments and organizations that work with refugees and migrants to work together and to evolve, through participatory governance, to a point where the data includes them, Dr Tedros said. WHO also wants to prioritize them in research, he said, and to include them in social and financial protections that allow them to gain better access to health systems worldwide.

“It’s a matter for the political leaders in every country to make a decision to show political commitment to address the barriers that refugees and migrants are facing,” said Tedros. “This is a political issue and the political leaders should address it. If that’s addressed.”

Today’s host could be tomorrow’s refugee  

WHO Thailand health officials and volunteers visit a Burmese migrant worker and her child in her dormitory in Thailand to talk about how to stay safe from COVID-19.

But addressing migrant and refugee health issues also are human and moral obligations in all societies, most of which are built upon previous generations of migration and refugee waves, Tedros added.

“Movement is tradition or it’s in our DNA. We have been moving  for millennia,” he said. “And even countries who prided themselves of not having any refugees because of conflict or other problems, are now becoming major contributors of refugees and migrants.”

Image Credits: WHO / Ploy Phutpheng, WHO / Kasia Strek, WHO, WHO / PAHO / Karen Gonzalez, WHO / Lindsay Mackenzie.

Professor Kelly Chibale, founder and director of the Holistic Drug Discovery and Development (H3D) Centre at the University of Cape Town (UCT) in South Africa.

COVID-19 exposed Africa’s vulnerabilities and its urgent need for local innovation and drug development. Leading African scientist KELLY CHIBALE discusses some of the key challenges.

Improving scientific skills in Africa and stemming the continent’s brain drain weigh heavily on Professor Kelly Chibale’s mind, particularly as COVID-19 pandemic has damaged fragile health systems and reversed hard-fought gains against a range of infectious diseases.

Professor of organic chemistry at the University of Cape Town, Chibale runs one of the continent’s most innovative medicine discovery and development laboratories, the Holistic Drug Discovery and Development Centre – H3D. But there are many barriers to success – ranging from a lack of skills and resources to antiquated regulatory requirements, and Afro-pessimism.

Major global supply chain disruptions during the first two years of the COVID-19 pandemic exposed the dearth of African innovation and how some initiatives from the global North were unsuited to the South – such as vaccines that needed ultra-cold storage.

Lack of opportunities

“It’s really important to tap into local innovators to get homegrown solutions,” says Chibale.  “But the Achilles heel of the continent is a lack of skills. 

“You can have technology transferred from a pharmaceutical company today, but it’s a new technology, which means you have to upskill people and we don’t have a critical mass of people that are skilled. It’s really painful because every single African country, after gaining independence, quite rightly invested heavily in training nationals but today, we are still talking about a critical shortage of skills.”

The “brain drain” of skilled Africans is driven by a range of issues, he contends, but at its heart is a lack of opportunities.

Chibale favours on-the-job training so that people can put into practice what they are learning, but adds that this also requires the capacity to absorb newly trained people – and this is often where the wheels fall off.

He gives the example of international clinical trials that require a high level of skills and organisation. But once they are over, everything is simply packed away.

“There is no pipeline of projects coming through, which means you’re going to lose the skills that you’ve gained. You’re going to lose continuity, you’re going to lose the infrastructure, you’re going to lose the technologies and you’re going to lose the people.”

Stemming these losses requires African organisations and governments to step up as partners, not mere participants.

“Skills development programmes have to be locally led. If they’re driven from New York or Geneva or wherever often these will end up being in silos and duplicating other programmes.”

Stepping up as partners

Kelly Chibale (centre) honoured for his research work at a Medicines for Malaria 20th anniversary event in 2019.

If African institutions and governments step up as partners and “co-create” projects with funders, these will have a better chance of success.

African governments could, for example, have policies that mandate that products need to have locally manufactured components and give incentives to local manufacturers and prioritise ordering from them.

In addition, African countries could require clinical data about how effective medical products are on local populations, as Japan and China do, before they approve medical products.

“Tremendous credit to the government of South Africa, for example, for the way they’ve come to the party with all in all our partnerships,” says Chibale.  “For every dollar we get from the Bill Melinda Gates Foundation, we get a dollar from the South African government.

“But it’s not all about the money. You can incentivise business by having an attractive regulatory framework where companies know that if they submit data, they’ll get a yes or no within a predictable period.”

However, Chibale concedes that some African countries simply lack the infrastructure to do some of the work, while fostering and retaining scientific talent is not the only factor in the equation.

 “In South Africa, we’ve developed infrastructure to a point where we can order reagents and chemicals very quickly to do drug discovery. But we worked with colleagues in other parts of Africa, and had to order the reagents for them. But then we couldn’t even ship the reagents because their customs make it so hard to even receive a donation. We are sometimes our own worst enemies with assistance.”

African Medicines Agency game-changer

Chibale is enthusiastic about the African Medicines Agency (AMA), which is due to be headquartered in Rwanda, according to the announcement made just this week.

African Union Selects Rwanda to Host African Medicines Agency, Grants Africa CDC Autonomous Status

As a former board member of South Africa’s regulatory authority, Chibale understands how important a strong and nimble regulator is to R&D.

“COVID has really highlighted the importance of having a competent regulatory authority in Africa that can facilitate regulatory harmonisation, and timely approve and monitor products.

“Having the African Medicines Agency will be a significant step forward. What bedevilled access to vaccines on the continent is that we didn’t really have a harmonised regulatory environment or even procurement at the continental level. This is really going to increase access to products because we have a unified way of doing things.”

AMA will also be crucial in managing continental clinical trials.

“If you don’t approve clinical trials quick enough, your population is not going to benefit from participating in trials that will make sure that the vaccines or therapeutics are optimised for your population,” says Chibale. 

“There’s also a business case to be made. Clinical trials create jobs, and research and development can be promoted across the whole value chain when we know that we can harmonise the environment.  Some Phase 3 trials have to be done in multiple countries. If you don’t have a harmonised regulatory environment, each country is going to do its own thing and hold up the other countries.”

Afro-pessimism

One of the hardest barriers to local innovation is Afro-pessimism:

“This might sound like I’m being funny, but it really is true. People almost don’t trust if the innovation is made in Africa. We need to take pride in what is locally produced and be deliberately supportive of local producers. People almost want to trust something that’s come from overseas and yet many of those products are not really tested on a bigger population in Africa.”

Image Credits: Kerry Cullinan, E Fletcher/HP-Watch.

pandemic

Should the corporate sector be allowed to engage in negotiations around the new binding instrument on pandemic prevention, preparedness and response that is being developed by World Health Organization member states? This week’s closed-door debate by WHO member states to decide who should get a seat around the table risks opening a Pandora’s box of vested interests. 

Twenty years ago the WHO Tobacco Convention (FCTC) initiative, the first treaty negotiated at the WHO in response to the globalization of the tobacco epidemic, set very clear ground rules. Governments included a specific statement that tobacco companies should neither participate in the negotiations of the convention nor in national tobacco policy-setting. 

Yesterday, some of the leading member state delegates gathered in Geneva for a week of deliberations on a first working draft text for a new legal instrument to govern global pandemic preparedness and response, steered by the International Negotiating Body (INB) nonchalantly hinted that business actors are welcome. Advocating for an all of society approach in the drafting process, the European Union, the USA and the United Kingdom, among others, trumpeted the need for the participation of corporate entities in the treaty’s early formulation and vision. 

The issue of which non-state actors can interact formally on the INB negotiations – beyond those already in official relations with WHO – is due to be discussed in detail this week on the basis of a short-list already submitted to member states in March outlining “proposed modalities of engagement for relevant stakeholders.” 

This list already recognizes a new and wider range of international and multilateral groups with direct corporate interests, in addition to the existing “non-state actors in official relations with WHO”.

Some 220 non-state actors already holding the coveted status of “official relations with WHO” include the International Federation of Pharmaceutical Manufacturers and Associations, as well as  agro-business foundations such as CropLife International, and private sector outliers, such as the International Air Transport Association, and the World Plumbing Council. 

Strikingly, only a few environmental health NGOs, notably the International Society of Doctors for Environment (ISDE), are recognized by WHO. None of the global environmental advocacy groups, such as Health Care Without Harm, the Global Climate and Health Alliance, or the Wildlife Conservation Society’s health programme, have been accredited so far – despite efforts to win a seat at the table.   

Expanding INB stakeholders list – who will win the prize? 

WHO member states at the INB meeting taking place 18-22 July 2022 in Geneva

WHO member states are now set to expand the list of stakeholders in the INB negotiations even further, adding an as yet-to-be defined list of new actors as a proposed Annex E of the current list of recognized groups. This Annex E , effectively, is a blank check for the entry of still-more vested interests to the INB talks.  

Astonishingly, the WHO member state discussion and decision on these added non-state actors will be held behind closed doors – away from media scrutiny and without much possibility for intervention by existing CSOs.  

So will even more powerful pharma, agri-business and other vested interests be invited to join the talks, while environmental actors concerned with One Health issues critical to pandemic prevention, remain locked out of the room? 

The risks of this are high. And it is a looming question critical to the future direction of the talks. 

Post-democratic complacency sweeping public institutions 

The issues at stake here are but one more reflection of the post-democratic complacency sweeping across state and multilateral institutions, gradually transforming the relationship between public institutions and the corporate world. 

This is not happening only at the WHO. The global multilateral arena is visibly occupied by imaginations of sustainable development that maximize new market futures through the tropes of inclusiveness, transparency and innovation. 

In the context of the WHO, the proposed modalities for engagement for relevant stakeholders do not in fact propose any safeguards against corporate political interference in the pandemic treaty and its making. 

In fact, they pave the way to an ever-increasing range of entities to gain a foothold of status  with the organization – beyond the pharma and agribusiness interests, like CropLife International, already in recognized WHO relations.

Pervasiveness of pharma groups in disguise 

Pharma continues to grow in global health.

In the meantime, the dominance of pharma continues to grow, unregulated. 

We are referring here to the powerful public and private partnerships created by the philanthropic sector – mostly the Bill and Melinda Gates Foundation – over the last two decades, including groups such as Gavi The Vaccine Alliance, The Global Fund, and Coalition for Epidemic Preparedness Innovations (CEPI).  

During the pandemic, these Gates-funded hybrid organizations collaborated in the creation of a new ‘super public-private partnership’ the Act Accelerator (ACT-A), and its vaccine component, COVAX. This new structure was tasked with orchestrating the international response to the COVID pandemic – with governments’ complacent consent.   

Legally, these institutions constitute largely inaccessible jurisdictions of private foundations deeply inhabited by corporate logics, interests and staff. Although a “transition” of the Act-A and COVAX functions back to Gavi and its partners was recently announced, it remains to be seen if and how this prototype architecture of the early phases of pandemic crisis will give rise to new ‘super’ entities or functions, as part of the WHO pandemic legal accord. 

A COVAX vaccine delivery prepared for shipment in April 2021

Several relevant stakeholders are advocating in support of this scenario. Whatever the future holds, during the recent pandemic we were confronted with a text-book example of global health privatization that ran counter to the obvious need for a strong public sector role in countering the crisis. 

So it should be no surprise that, despite early warnings, the INB continues to sideline concerns from civil society about the ambitions of the private sector in the tailoring of the treaty – as well as the need for more transparent discussions about who should be recognized as stakeholders, based on WHO constitutional principles.

Protecting from vested interests? 

While member states hold free-wheeling, closed-door discussions this Thursday and Friday, about their final list of INB stakeholders, the task of watchdog will pass to the WHO Secretariat and its legal team – also tasked with protecting the world’s public health agency from undue corporate capture along the lines of the Framework of Engagement with Non-State Actors (FENSA), approved by the World Health Assembly in 2016.  

How can WHO, the sole international institution mandated to achieve the highest possible standard of health for everyone on this planet, protect an in-house treaty–making process, and the negotiated norms on future pandemics, from the viral  influence of vested interests in their corporate and philanthropic variants? 

How will WHO member states safeguard this complex process from the power strategies that corporate lobbyists commonly exercise in the multilateral arena – in line with their mandate as duty bearers vis a vis the right to health? 

Big Pharma and Big Food are not Big Tobacco? 

Testing bio-pesticides in a Moroccan fruit orchard – alternatives yet to be taking up at scale by agribusiness worldwide.

The reluctance, when not outright opposition, to consider strict safeguards against corporate interference in managing future pandemics may be founded on one simple assumption: Big Pharma and Big Food are not  ‘Big Tobacco’. Pharmaceutical corporations save lives. Agribusiness provides food supplies. Tobacco corporations destroy health and lives. But this premise is profoundly mistaken and neglects three important facts wholesale. 

Firstly: pharmaceutical and agribusiness corporations, like any corporation, including tobacco, are primarily – and indeed statutorily – geared to profit-making. This is a reality that can, and indeed often does, produce tricky contradictions with policy-making purposed to improving the health of the largest public possible. 

The fact that COVID-19 vaccines were not initially made accessible to millions of people globally to protect the intellectual property rights of pharmaceutical corporations is a particularly germaine example of this. Pharma’s animal health branches, together with agri-business, are meanwhile making gigantic profits from the sale of antibiotics dedicated to the intensive production of livestock and pesticides that spur antimicrobial resistance and the risks of new pathogen emergence

Secondly: the pharmaceutical industry, like tobacco, has a troubling track record of market abuses and violations of international law that seriously undermined public health. Just a taste, to remind pandemic treaty negotiators? From Pfizer to AstraZeneca, some of the world’s largest vaccine manufacturers have paid hundreds of millions to billions of dollars to settle lawsuits on claims ranging from bribery and fraud to off-label drug promotion. In February, four leading pharma firms, including Johnson & Johnson agreed in US courts to pay out $26 billion on claims that their business practices fueled the opioid epidemic, which has caused rampant addiction, suffering, and death. Do we seriously want to treat entities like this as “partners” in crafting the vision and implementation of a pandemic treaty, after Covid-19?

The tobacco industry continues to expand, with one of the world’s largest cigarette manufacturers owning a stake in COVID vaccine manufacturer Medicago.

Thirdly: the officially stigmatized tobacco industry is not giving up and expanding its reach into the pharma sector, now under the cover of the response to the COVID-19 pandemic. Tobacco industry interests in pharmaceutical corporations are widespread and growing, with corporations even holding intellectual property rights to life-saving vaccines and treatments.

One of the world’s largest cigarette manufacturers, Philip Morris International (PMI), owns a significant stake in COVID vaccine manufacturer Medicago. To make matters worse, the Canadian government, in contravention of the WHO FCTC, has partnered with PMI to produce the Medicago Inc. vaccine. This sparked a public outcry; Canada was not only violating its international commitments but deepening one epidemic through its response to another.

British American Tobacco (BAT), another global tobacco actor, has likewise been involved in supporting development of a COVID vaccine through a subsidiary, Kentucky BioProcessing (KBP). Thanks to the WHO FCTC, approval for global distribution of these vaccines will be premised on Big Tobacco divesting from these ventures.

Big Food and Agribusiness also threaten treaty’s integrity 

Antimicrobial resistance resulting from increasing use of antibiotics in farming and particularly livestock production has been described as a ‘silent pandemic’.

In the aftermath of the pandemic, Big Tech, Big Food, Big Agribusiness are increasingly jumping on the expanding market of global health products as well as the supply chain risks management.  

The intersection of these powerful interests – which promote spiraling use of antibiotics and pesticides in unsustainable methods of farming and intensive livestock production – ultimately threatens a balanced, reality-based approach to AMR and One Health in the INB negotiations. 

Yet, while many member states this week have underlined AMR as the silent pandemic that calls for One Health as the vital approach to pandemic prevention, others have questioned whether these issues are getting too much emphasis, saying that One Health is not well understood and lies outside of the range of WHO’s usual mandates. 

Given the growing systemic pandemic risks associated with unsustainable food chains and biodiversity destruction, focusing almost exclusively on surveillance and pharmaceutical solutions for the pandemic response iterates the disease-specific reductionistic approach that industry has thrived on for the last two decades. This must change in the pandemic treaty discussion.  

But  while there are active CSO groups, recognized by WHO, advocating for medicines access issues, as already noted, hardly any planetary health players are to be seen  in the pandemic negotiations, to pose cogent counter-arguments and perspectives on the human-animal-environment interface that One Health addresses.

Trends in animal antimicrobial sales correspond with growing AMR hotspots – ETH Switzerland

Rhetoric aside, this means that the final outcome, whether its a treaty, convention or other legal instrument, may end up lacking any meaningful teeth to address the systemic determinants of zoonotic spillover events – related to unsustainable development, unhealthy and unsafe food production, and anthropogenic colonization of ecosystems. The WHO Secretariat and the INB will be dragged into merely enabling yet another new and splendid round of private-sector driven biomedical solutions.

The INB must set convincing and transparent criteria 

WHO delegates should not forget that, if they are serious about being inclusive, credible ground rules need to be created to bring transparency and order to today’s unregulated scene where conflict of interest policies render the multilateral landscape a confusing free-riding space. 

Since the WHO Secretariat and the INB point to the FCTC as their model for treaty-making, they should be mindful that the FCTC’s success has been largely attributed to member states’  precedent-setting controls against corporate manipulation. 

The INB must set convincing and transparent criteria to ensure that those negotiating, observing negotiations, and subsequently implementing the new treaty, convention or other legal instrument do not have conflicts of interest. Declaring those conflicts is not enough, if we are to build trust.

Negotiators should ensure any and all consultations with vested industries in developing the pandemic accord are publicly and immediately disclosed. This helps guard against self-serving industry influence over public health policy or the perception thereof.  

The COVID-19 pandemic has illustrated the centrality of universal public health systems in the management of a pandemic, and the inapplicability of market rules and principles in handling such an immense crisis in each country. We do not want to see future pandemics, and the global agreement supposed to prevent and respond to them, pave the way to new modes of exploitative health care marketization. Humanist ideals in global justice cannot be used to enhance the very practices that subvert it. 

It’s important that these and other strict guideposts be adopted for success. This will require less lip service be paid to the FCTC and more meaningful consultation with those WHO officials and civil society organizations intimately familiar with the Convention. There’s a lot to learn from that process that is relevant to the current one.

The success of the treaty and global pandemic response depends on it. Public health practitioners and human rights advocates the world over recognize as much. We implore the INB and the WHO delegates to do the same. 

Ashka Naik

Ashka Naik serves as the Research Director at Corporate Accountability, leading strategic research and equity-centered analysis of corporate power across issues, from public health to food systems. She is also pursuing her doctorate at the University of Massachusetts, where she explores the intersectionality of food security, women’s empowerment, and neoliberalism. 

Nicoletta Dentico

Nicoletta Dentico, journalist and writer, serves as Director of the Global Health Justice Program at the Society for International Development (SID). She is co-chair of the CSO independent platform Geneva Global Health Hub (G2H2). 

 

Image Credits: Jernej Furman/Flickr, Max Pixel, WHO, FAO, Chris Vaughan, Flickr: Paul van de Velde, Van Boeckel et al, ETH Zurich.

genomics inb
Precious Matsuso, moderator for the July 2022 INB talks on a pandemic treaty, convention or other legal instrument.

The question of whether pathogens’ genomic sequences should be shared freely – or in exchange for a clear benefit – as well as the role ‘One Health’ should play in any new Pandemic Convention or legal accord were key points of emerging dispute among member states on Day 2 of the Intergovernmental Board Meeting (INB). 

Those debates, aired publicly in the first two days of the week-long meeting that aims to draw the broad outlines of a pandemic treaty, offered a good taste of the rough road ahead. 

In sharp contrast, Wednesday and Thursday are set to be closed-door sessions. There, in private, member states will make two critical decisions. 

They will decide on the legal position of the new accord under the WHO Constitution – which in turn will reflect how legally binding the agreement really will be; 

They will also decide if the negotiations should be thrown open to an as yet undefined list of more civil society and private sector groups – beyond the nearly 300 entities already recognized as “stakeholders” in the talks.  

Genomics – a hot spot

Colin McIff, Deputy Director of Global Affairs in the Office of Health and Human Services, US delegate

On the genomics issue, the United States delegate Colin McIff fired off the opening shots in what is sure to be a prolonged and painful debate, saying that countries’ agreement to grant access to pathogen sequences, should not be addressed in a “transactional way” – hinged to promises of sharing benefits from the medicines or vaccines that are later produced. 

The US concern has been echoed for months by pharmaceutical companies as well – which were able to rapidly map out vaccines for the SARS-CoV2 virus because the virus sequence was shared early on. 

However, that free tap of information could be turned off if the December meeting of the parties to the Convention on Biodiversity opts to includes “genetic information” into its existing  Nagoya Protocol on Access to Genetic Resources – initially developed to protect countries IP on indigenous plant and animal species from uncontrolled development – but now being applied to pathogens as well. 

“The sharing of benefits can be seen as a means to achieving equitable pandemic preparedness and response,” said McIff. “But our concern is that … if we continue to link access and benefits in a transactional way, that’s not really conducive to meeting public health needs, and improving pandemic preparedness.” 

The US position was quickly countered by a wide range of developing countries, including Indonesia, Malaysia and the African group of 47 countries.  

‘Fair, equitable and timely access and benefit sharing’ 

“Fair, equitable and timely access and benefit sharing is an important provision as we have clearly seen the benefits of genetic sequence sharing, like the Nipah virus, that provided a valuable contribution to the development of mRNA technology,” said Malaysia’s delegate to the talks. “Hence, we propose to strengthen this concept [in the text]….  which reads ‘measures to ensure access to pathogens and genomic sequence information as well as fair and equitable sharing of benefits arising from the utilization of pathogens and genomic sequence information to one or more standardized real time platforms available to all parties.’’

Namibia, meanwhile stressed that as long as the benefit sharing mechanism is defined up front and automatically, it would not hinder rapid pathogen sharing, saying:

“The instrument should be balanced, inclusive, global, effective and legally binding, respecting the sovereign rights of states to control access to their genetic resources and ensuring fair and equitable sharing of benefits arising from the utilization of genetic resources. 

“We also note that providing timely access to pathogens is absolutely fundamental to PPR [pandemic preparedness and response] and we therefore consider that regular upfront benefit sharing by the pharmaceutical industry from their current ongoing uses of pathogens is required to ensure that timely access to new and emerging pathogens is provided. 

“In this regard, we stress that providing access to pathogens by showing genetic sequence data must be treated as equivalent to access provided through sharing biological samples, and must therefore trigger the same benefit sharing obligations on strengthening and sustaining health systems resilience and capacities.” 

‘One Health’ not mature enough – environmental health beyond WHO’s competence 

Researcher explores evidence around the wildlife-trade- pandemic nexus

Strikingly, Namibia and other African and developing country member states expressed reluctance to incorporating so-called “One Health” concepts deeply into the new legal instrument, saying that the term has not been well defined, and 

“Regarding the emphasis some member states and regional groups have placed on the One Health approach Namibia is of the view that that this concept is not yet mature enough for it to have a central role in the instrument,  seeing as we have about 22 months until May 2024. There may indeed be further discussions and the relevance spaces in that time on One Health that may bring us to position to support its inclusion with the primacy that is being proposed.

“The issue for us is that the concept does not enjoy international consensus and has not been discussed sufficiently by member states for them to have ownership on it. As it stands, we have very grave concerns. 

“”We also think there is an overemphasis on AMR [antimicrobial resistance] and not enough consideration on food safety, for instance,” the Namibian delegate continued.. 

“Furthermore, we see animal, plant and environmental health as being beyond the competence of the WHO and that they should be thoroughly considered in the appropriate international organizations by their member states before being brought together at a global level and included as a central pillar of the instrument we are discussing.”

Canada, EU and others say One Health Should be Central

one health
EU delegate at INB meeting.

Those viewpoints, also echoed by Kenya, Botswana and South Africa, contrasted sharply with statements by Canada, the European Union and other developed countries about the centrality One Health approaches should play in the new accord – to prevent the spillover of  zoonotic diseases into human communities and food chains. 

The United States took a middle-of-road view, with Colin McIff, Deputy Director of Global Affairs in the Office of Health and Human Services, saying,  “On One Health. We recognize the critical role that One Health plays in preventing future pandemics. We would appreciate further member state discussions with input from non governmental stakeholders to understand the specific commitments being sought from member states that will make a meaningful difference in advancing pandemic prepared prevention preparedness and response. 

“For example, we imagine that additional discussions are needed on how to improve interoperability of [human and environmentally-based] bio-surveillance and reporting systems, the role of non governmental stakeholders; measures that would help prevent and detect pandemics and reduce opportunities for zoonotic spillover, and how the WHO instrument will relate to other key actors such as FAO OIE [World Organization for Animal Health) and UNEP.”

Civil society calls for pandemic treaty that won’t ‘waste their time’

Medicus Mundi International

Civil society groups attending the public INB session, meanwhile, reiterated the need for a substantive, meaningful pandemic treaty –  that strengthens transparency, funding and equity for marginalized groups in the global health landscape. 

“The relevance of the substantive elements of the pandemic treaty will finally determine if all of us currently take part of a historic process, or if you just waste our time with the compilation of an uninspirational and encyclopedic document,” said the delegate from advocacy group Medicus Mundi International.

“[A document] that will not change any realities, that will keep people sick, keep health systems vulnerable, and keep national health authorities depending on national charity, instead of having the needs for caring for the health and wellbeing of their people.”

Transparency for R&D and clinical trial costs 

Knowledge Ecology International (KEI) called for an item on transparency to be included, specifically for R&D and clinical trial costs, as well as information on the research itself and the outcomes.

The medicines access advocacy group also proposed measures to incentivize persons or entities to openly share access to biological data, resources, and know-how as a public good, and also noted a need to fund such research in the first place.

“[We would also like to see] measures for norms for the funding of R&D by national governments that provide flexibility in terms of methods, management and control, funding consistent with transparency and best incentives to collaborate,” said KEI’s director, Jamie Love. 

Thorny question of private sector participation 

Another issue of concern is the role the private sector may play in negotiations over, and governance of, the pandemic agreement, Love added.  

“The United States made this mention of including other actors, including the private sector in the conversation. And I think from our point of view, we would have concerns if you had drug companies, vaccine manufacturers, and people that manufacture diagnostic tests involved in the governance in different ways. Because of the conflicts of interest they present. And so I wanted to flag that.” 

He also protested against the outsized influence wielded by the Gates Foundation in debates over technology sharing and intellectual property rights – which are also emerging as thorny points in the INB deliberations.  

“If you look at the Global Fund, or UNITAID, some committees created by the World Bank, Gavi and CEPI, you see, the Gates Foundation playing the central role in all these institutions as the largest non-actor state and sometimes the largest discretionary funder, period, to the WHO.    

“And yet, they play a controversial role, particularly on the issues of sharing of technology and technology transfer and intellectual property rights. And so I just don’t know if it’s helpful to have one institution run by you know, one guy or you know, his family or whatever, you know, having an excessive amount of influence on these decisions. 

“We’re more comfortable with, with something that did not give, for example, the Gates Foundation or its surrogates a role in the governance.” 

IFPMA offers to set aside fixed amounts of pandemic products in ‘real-time’ for poor countries  

James Anderson, IFMPA Executive Director for Global Health

As one solution to ongoing controversies over IP rights and, related to that, equitable access to medicines and vaccines,  International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) pledged to set aside an “allocation of real-time production of vaccines, treatments and diagnostics for priority populations in lower income countries and take measures to make them available and affordable”.

The IFPMA’s  ‘Berlin Declaration’ unveiled at Tuesday’s INB meeting, aims to overcome the huge inequities seen during the COVID crisis by rich countries’ pre-purchase and stockpiling of vaccines and health products – before poorer countries could get in line.   

See related story here:

Big Pharma Offers to Reserve Pandemic Products for Poorer Countries in Future – Albeit With Prerequisites

The joint declaration by major pharma innovators – Biopharmaceutical Industry Vision for Equitable Access in Pandemics – 

However, this commitment will only succeed “if other stakeholders also play their parts,” said IFPMA’s James Anderson, executive director for global health. The declaration calls upon the G7 and G20 to contribute more to strengthening health systems in low- and middle-income countries so they can absorb new health products.  

“Without robust plans to deliver pandemic vaccines, treatments, or diagnostics, and ongoing care to populations in all countries,” said Anderson, “attempts to improve equity will not succeed.” 

Equity must be prioritized 

Women in Global Health delegate Shubha Nagesh

Other groups, such as Women in Global Health and Sightsavers highlighted the need for equity in the treaty for marginalized groups.

“Too often women from the global south are marginalized in health leadership,” Shubha Nagesh, the delegate from Women in Global Health. “Women have made an exceptional contribution during COVID-19, but are often clustered into lower or unpaid roles with reduced status.”

Sightsavers strongly supported the right to health and human rights, with an emphasis on equity, to be embedded in the treaty, particularly for individuals and groups disproportionately at risk, including persons with disabilities and those in vulnerable situations. 

“To achieve equity, instruments should really affirm human rights obligations to those that are at higher risks from pandemics,” said Sightsavers’ delegate.

Image Credits: Wildlife Conservation Society, Wildlife Conservation Society .

Major pharmaceutical companies have offered to reserve a “real-time allocation” of vaccines and treatments upfront for “priority populations in lower-income countries” in future pandemics – providing the G7 and G20 also help low-income countries finance and make effective use of the products.

Launching its Berlin Declaration on Tuesday, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) acknowledged that there has been an inequitable distribution of COVID-19 products, which it attributed to “inadequate financing mechanisms upfront and a lack of country readiness”.

It calls for  “strong, fully funded international procurement mechanisms”  for pandemic vaccines, therapeutics and diagnostics (VTD) for lower-income countries that can forecast demand and sign advanced purchase agreements with industry early in a pandemic. 

“Each company will take measures, in partnership with governments, to help ensure that authorized pandemic vaccines and treatments are available and affordable in countries of all income levels, including via donations, not-for-profit supply, voluntary licenses or equity-based tiered pricing based on countries’ needs and capabilities, or any other innovative mechanism as during COVID-19,” according to the IFPMA.

Stronger health systems

However, a “prerequisite” for the success of more equitable access rests on improving health systems in lower-income countries to ensure that they “are better prepared to absorb and deliver vaccines and treatments”  – and the willingness of high-income countries to “provide the necessary political and financial support” to achieve this, says the IFPMA. 

The IFPMA also says that the success of its declaration depends on “a strong innovation ecosystem, grounded in intellectual property rights, and the removal of trade and regulatory barriers to export”.

“Intellectual property rights should be respected since society depends on them to stimulate innovation and the scale-up of supply,” according to the declaration, which has been named “Berlin” in recognition of Germany’s leadership role as President of the G7.

The pharmaceutical industry has lobbied vehemently against any relaxation of IP rights for COVID-19 products, putting it at loggerheads with health activists and a number of governments in low and middle-income countries.

Better protected

The IFPMA’s future pandemic preparedness plan, which it aims to sell to world leaders in upcoming meetings, is based on “innovation, manufacturing scale-up, and planning ahead for equitable access”.

“With all stakeholders collaborating and playing their part, we can make sure that the efforts, investments, learnings and losses seen during COVID-19 are not in vain, but rather help shape a future where everyone is better protected from the threat of pandemics,” said Thomas Cueni, Director General of IFPMA.

“Our proposal is just a first step along the way to what I believe has the potential to be a transformational solution for future pandemics.” 

The declaration commits pharma to three key issues:

  • working with regulators and other stakeholders to establish streamlined approaches to develop and deliver new quality, safe and effective vaccines and treatments even faster in the future;
  • supporting collaborations, a geographically diverse sustainable manufacturing footprint and mechanisms for rapidly scaling-up supply in a future pandemic; 
  • planning ahead to ensure equitable access and delivery of pandemic products, including identifying priority groups such as health workers and high-risk individuals, who “should be vaccinated first, regardless of the country they live in”.

“We will build on existing manufacturing partnerships, business-to-business agreements set up in advance, ongoing capability development and voluntary licensing and/ or early, voluntary technology transfer where this will facilitate rather than impede scale up and global supply,” says the IFPMA. 

It also appealed to governments to commit to unrestricted trade, no export bans across the vaccine-treatments-diagnostics supply chain and expedited processes for import and export during a pandemic.

 Pharma proposes to work with G7 and G20 on a joint solution for better access to vaccines and treatments around the world for future pandemics 

Jean-Christophe Tellier, IFPMA President and CEO of UCB, said “we applaud Germany’s leadership of the G7’s pandemic response and trust that our declaration is seen by world leaders as a practical proposal to build greater equitable access into future pandemic response. 

“For this potentially life-saving concept to become reality, we will need to work with G7, and later this year in Bali with G20 to flesh out how to make it work. The reward if successful will help shape a future where everyone has a chance to be better protected from the threat of pandemics from the outset, no matter where they live.”

José Manuel Barroso, Gavi chair and co-chair of COVAX, the global COVID vaccine access platform, applauded the IFPMA and industry leaders for “seizing the initiative”. 

“We saw effective innovation and manufacturing scaling up with this pandemic; but we also saw the challenges we had to overcome to get the vaccines to all those who needed them,” said Barroso.

“The industry’s commitment to reserve part of production of vaccines and treatments at real time for vulnerable populations in low-income countries provides an opportunity to work together strategically to forge a new social contract. I hope that political leaders will do their part and engage with industry on how to make this work.”

Image Credits: Glsun Mall/ Unsplash.