innovation
Business leaders and experts from pharmaceutical companies across the world shared their experiences in voluntary licensing during the COVID-19 pandemic.

One of the most intense debates in the pandemic accord negotiations is over how to fast-track the development and equitable rollout of vaccines and medicines, with pharmaceutical companies insisting that any infringement on intellectual property (IP) rights will stifle innovation and that voluntary arrangements are the way forward.

A recent event to showcase voluntary licensing arrangements during the COVID-19 pandemic was organised by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA).

It brought a range of pharma companies and their licensees,  including MSD and licensee Dr Reddy’s Laboratories, Gilead and Ferozsons Laboratories, Pfizer and Biovac, and Johnson & Johnson and its licensee, Aspen Pharmacare.

The panellists expanded on how they voluntarily collaborated with each other and with governments across the world despite lockdowns and supply chain breakages  – in an evident rebuttal to their critics who have cast IP rights as a key barrier to more equitable medicines access, saying that IP sharing must be mandatory, not voluntary, in future crises. 

Expedited innovation – in difficult conditions 

Since the beginning of the COVID pandemic, a total of 59 vaccines and 44 therapeutics have been approved, said Rasmus Hansen, CEO and founder of the global health analytics firm Airfinity. 

In addition, 177 collaborations were created to manufacture and commercialise COVID-19 treatments, including 93 voluntary licensing agreements for COVID-19 treatments. Of the 93 voluntary licensing agreements, 84 are currently active, including 80 in developing countries. 

Innovation
Manufacturing agreements for therapeutics and vaccines were signed in parallel during the COVID-19 pandemic. (Source: Airfinity)

“What we are finding here is pretty much all of the manufacturing announcements involved some kind of collaboration,” Hansen remarked. “I remember we looked at the numbers week on week, and were really astonished to see the output coming from the manufacturers at that point.” 

Voluntary licensing facilitated swift action

The COVID-19 pandemic laid the existing inequity in access to vaccines and therapeutics threadbare. While high-income countries were able to enter into advance purchase agreements with big pharma companies long before the vaccines were ready, low and middle-income countries were forced to navigate arrangements for the local production of new vaccines and medicines that had been developed by the large pharma innovators. 

South Africa’s Aspen Pharmacare collaborated with Johnson & Johnson to manufacture its COVID-19 vaccine under the name “Aspenovax”, for instance, while Biovac partnered with Pfizer to manufacture mRNA vaccines. 

“The J&J vaccine was the one that was demonstrating the best prospects for Africa, given Africa’s idiosyncrasies, geographic supply chain and otherwise. We got into discussions with J&J and we were able to move very swiftly to concluding an agreement,” explained Stavros Nicolaou, Aspen’s group senior executive for strategic trade. 

Aspen was attractive to established companies, said Nicolaou,  because of its “strong track record and also a blueprint in the form of voluntary licensing and technology transfers that existed already” as well as two decades of experience.

The technology transfer was completed five and a half months after the agreement was signed in December 2021, which was “not an easy task given the severe lockdowns” at that stage.

“It’s not like J&J colleagues could jump on a plane and, and travel down south and inspect facilities and do audits,” Nicolaou pointed out, adding that Aspen staff worked 24/7 doing on-camera audits “to give certainty and assurance around quality, safety and efficacy of our manufacturing”.

Political complications

However, due to a lack of demand for COVID-19 vaccines as the pandemic evolved and the company getting caught in the middle of a political crossfire between Africa and Europe that delayed production, Aspen Pharmacare did not sell a single vial of the vaccine, as reported previously by Health Policy Watch. 

The political storm revolved around millions of J&J vaccines being produced in Aspen that were due for export to Europe at a time when only 7% of South Africans were vaccinated.

South Africa’s President Cyril Ramaphosa intervened, appealing to the Europe Commission head Ursula von der Leyen to prevent this and by September, European countries had agreed to return the J&J vaccines produced by Aspen for distribution in Africa.

“There was a standoff between Europe and the African Union in terms of where these vaccines would finally land,” Nicolaou explained at a previous webinar organised by Brown University. “And it took quite significant negotiating and eventually, an agreement was settled between the EU and Africa for some of these vaccines, initially 60% and eventually 90%, to be retained on the African continent.”

Therapeutics partnerships

Later in the pandemic, as therapeutics also came online, Indian firm Dr Reddy’s Laboratories entered into a licensing agreement with the US-based  MSD for the production of the antiviral drug molnupiravir, in January 2022. A Pakistani company, Ferozsons Laboratories Limited, also partnered with the US-based Gilead Sciences to manufacture Remdesivir. Both agreements were signed as voluntary licenses and as part of a long-term collaboration between these companies. 

Innovation
Vignesh Shivnath, director of business development alliance management at Dr Reddy’s Laboratories.

Despite bitter criticism that developing country markets still got access to such drugs much later and in far more limited quantities, the voluntary partnerships helped to build the capacity of firms in the global south to produce new forms of treatment, panelists said. 

For instance, early engagement and a bilateral partnership with MSD helped Dr Reddy’s Laboratories mobilise the materials needed to manufacture molnupiravir swiftly, said Vignesh Shivnath, the company’s director of business development alliance management. Dr Reddy’s Laboratories was one of eight generic manufacturers chosen by MSD for establishing bilateral manufacturing agreements.  

“The direct agreements with Gilead helped us to ramp up technology transfers, quality control and manufacturing roll-out at breakneck speed,” said Osman Khalid Waheed, CEO of Ferozsons Laboratories Limited, about his company’s partnership for the production of remdesivir in Pakistan.

Innovation
Osman Khalid Waheed, CEO of Ferozsons Laboratories Limited (left) and Hemal Shah, Director for Public Policy at Gilead.

“I think it was 6 May 2020, when Gilead first reached out to us, and within a week, we had an agreement. Within 12 weeks of that, we were able to start rolling out the product, and sharing information on production and quality control with our partners around the world,” said Waheed.

Under the looming shadow of the pandemic accord

Referring to the latest draft text of the pandemic accord, Thomas Cueni,  IFPMA Director-General, said that he is concerned that, should IP protections for innovative drugs and vaccines be weakened, there is a risk that more “unlicensed, substandard, low quality and counterfeit” drugs and vaccines might be produced in the next pandemic. 

The risk that new drugs and vaccines might enjoy weakened IP protections could also stymie investments in health tools that would be needed to confront the next pandemic, he warned. 

“In terms of the pandemic treaty, I have to admit, I’m deeply concerned that the zero-draft is potentially undermining innovation,” Cueni said. 

Member states of the World Health Organization (WHO) are currently in the process of negotiating a binding instrument for pandemic preparedness, prevention and response. 

At the  Intergovernmental Negotiating Body’s (INB) sessions this week in Geneva, African countries criticised the latest draft text, produced by a guiding body of six member states called the “Bureau”.  They called it “weak”, especially in matters concerning equity. 

“The African member states recognise the hard position that the bureau finds itself in trying to keep everyone at the negotiating table…

“However, it is unfortunate that, in that process, the core of what this instrument is supposed to address, namely equity, has been presented in a weakened or reduced format, especially in those articles that would result in a meaningful realization of equity,” Ethiopia said, on behalf of the 47 countries in Africa. 

Additional reporting by Kerry Cullinan.

Sudan
Violence erupted between a paramilitary group and the armed forces in Khartoum on 15 April 2023.

There have been 46 attacks on Sudan’s healthcare infrastructure during which eight people have been killed and 18 injured, and two-thirds of the hospitals in affected areas are closed as a result of the heightened attacks, the World Health Organization (WHO) said. 

Clashes erupted in mid-April in Khartoum between the country’s armed forces and a paramilitary group, Rapid Support Forces (RSF), headed by General Mohamed Hamdan Dagalo, currently deputy leader of the country’s Sovereign Council. The RSF appeared to attempt to stage a coup following conflict over the planned integration of the RSF into the Sudanese army.

“Overall, the greatest public health risks remain the ongoing violence resulting in trauma injuries, major disruptions to health care and repeated attacks on the health system, and poor access to clean water, sanitation and food, increasing the risk of malnutrition and water- and vector-borne diseases,” said the WHO in its first situation report on the conflict.

“According to the Preliminary Committee of Sudan Doctor’s Trade Union, 67% (60 out of 89) of all main hospitals in affected areas were out of service as of 31 May,” the report pointed out. 

“The 29 hospitals operating fully or partially (some providing emergency medical services only) are at risk of closure due to shortage of medical staff, supplies, water, and electricity.”

Among the healthcare assets compromised in the violence are the National Public Health Laboratory, and the Federal Ministry of Health’s National Medical Supply Funds Warehouse. 

Condemning the continued attacks on healthcare facilities, workers and assets, the WHO urged the parties in the conflict to uphold ceasefire agreements, in order to “guarantee the safety of humanitarians and safe passage of humanitarian aid in the country as well as protection of health workers and health facilities to ensure health facilities remain functional and accessible, and supplies are delivered without impediment so the population can receive the health care they need and deserve”.

Since 15 April, 866 people have been killed across the country, and over 6000 people have been injured. At least a million people had fled, including over 250,000 people who have taken refuge in neighboring countries. 

The WHO had earlier flagged the occupation of the National Public Health Laboratory, which housed a wide variety of chemical and biological materials, and disease pathogens, and added that it was conducting risk assessment around the situation. 

The agency added that the revised Sudan Humanitarian Response Plan (HRP) needs $2.6 billion to help the people in Sudan and that 24.7 million people were in need of humanitarian aid. WHO’s Contingency Fund for Emergencies (CFE) has released $3.6 million towards emergency response in the region, days after violence erupted. 

On 21 May, the RSF and the Sudanese military agreed to a seven-day ceasefire agreement in Jeddah to allow delivery of humanitarian aid to the affected people in Khartoum and regions torn by violence.  Although the warring parties agreed to extend the ceasefire by another five days, intense clashes were reported in Khartoum a day after the extension was agreed upon. 

Image Credits: UN Human Rights.

SIDS
(From left) Bente Mikkelsen, WHO; Health Ministers of Anguilla  Ellis Webster; Fiji (Ratu Lalabalavu) and Jamaica (Christopher Tufton); Katie Dain, NCD Alliance, Jumana Qamruddin, World Bank, and Kenneth Connell, Healthy Caribbean Coalition.

The burgeoning health issues of small island developing states – which are on the front lines of climate change, but also awash in handguns and ultra-processed food imports – is the focus of a high level ministerial meeting taking place in the Caribbean island of Barbados today and tomorrow. 

The SIDS Ministerial Conference on NCDs and Mental Health, co-sponsored by the World Health Organization, has brought together more than three dozen small island states that face not only climate precarity, but also globally high levels of hypertension and obesity as well as mental health disorders – in a complex web of issues that is both unique but also representative of broader global trends in unhealthy foods, environments and lifestyles.

The conference also represents a first attempt by WHO to more squarely confront what it calls the “commercial determinants of health” – such as the enormous dependence of small and isolated states on big food imports that are leading to more and more chronic diseases.

Barbados PM Mia Mottley laid out her Bridgetown agenda at COP 27

“We are not just the canaries in the mines for the climate crisis,” asserted Prime Minister Mia Amor Mottley at the opening session Tuesday evening.  She asserted that her “Bridgetown Agenda” for financial reform aimed at low- and middle-income countries was also critical to reforming development policies, agriculture and trade so as to allow SIDS countries to become more healthy, sustainable and self-sufficient.

“The world has to summon the political will to be able to put the structures in place that will allow us to be able to finance global public goods, not with short term capital. But with long term capital that makes sense. And that allows us to have the elbow room still to meet the other challenges that we face,” Mottley said.

Geographically remote and vulnerable to global markets

NCDs
Bente Mikkelsen, director of WHOs NCDs department.

“I think we really need to absorb the geographical remoteness, the domestic market and the diverse economies that is happening in the SIDS,” said Bente Mikkelsen, WHO’s head of noncommunicable diseases. 

“We have three threats coming together here, mental health,  NCDs and climate change,” she observed, “and also to add to the the experience from COVID-19 and the need for better preparedness.” 

She noted that small island states – scattered from the Pacific to the Caribbean – “are highly depending on international relationships” and that dependence has made them particularly vulnerable to cheap, ultra-processed food imports. 

“What you will see is a lot of nutrition related diseases in the SIDS countries… and we have already heard mention of the commercial  determinants of health,” she added. “The prevalence of hypertension exceeds 30% in all SIDS countries. The prevalence of diabetes is among the highest in the world. And very remarkably and very scary, I would say is the high obesity rates.” 

She called for stronger regulatory measures, such as higher taxes on unhealthy foods, along with measures “supporting the healthy forms of trade” that incentivize local production and imports of healthier alternatives.  

Economic and commercial drivers of health in the spotlight

NCDS – primarily cardiovascular diseases, cancer, diabetes and chronic respiratory diseases – cause 74% of premature deaths in the world (before the age of 70), including 8 million deaths linked to unhealthy diets, points out a WHO briefing paper on the intertwined challenges of climate change and NCDs in the small island nations, published at the start of the conference.

“The NCD epidemic has grown earlier and faster in SIDS than elsewhere in the world due to commercial influences and trade challenges, which undermine access to fresh, nutritional food,” the brief points out.

Now, climate change is making things even trends worse:

“Heat-related mortality from NCDs such as cardiovascular and kidney diseases in SIDS is projected to increase with higher temperatures. The elderly, children, pregnant women, outdoor workers, the poor and marginalized and people living with NCDs and obesity are among the worst affected,” the paper points out.

Not only that, but  “damage to crops and livestock from rising sea levels and extreme weather events and reduced fish catches because of higher ocean temperatures and acidity,” could increase food insecurity as well as the already heavy reliance on unhealthy imported foods.

Another WHO “discussion” paper on the economic drivers of the NCD epidemic in the SIDS provides further detail on how food imports have swamped the SIDS, which tend to be debt-ridden and vulnerable trading partners.

“Obesity rates in SIDS continue to increase, in part due to the over-availability, widespread marketing, reliance and entrenchment of importing foods and non-alcoholic beverages that are high in saturated fatty acids, trans-fatty acids, free sugars and/or sodium, and typically highly processed (HFSS foods), and their relatively high consumption,” the WHO paper notes.

“Five of the top 10 countries with the highest overweight and obesity rates in the world in 2016, and seven of the 10 countries with the highest rates of diabetes, are Pacific Island countries and areas.” Over 60% of adults in the Caribbean, and up to 80% in some Pacific Island states are obese, the paper adds, referring to the two regions that together, comprise most small island developing states.

Colonialism, climate change and unsustainable fishing combined

NCD
Shifts from traditional diets based on local fresh foods to ultraprocessed imported foods is one of the main reasons behind the rise of NCDs.

It wasn’t always that way. Traditional diets were fibre-rich, with plenty of seasonal fruits, legumes, nuts, seeds and other indigenous plants, the WHO notes. But current obesity trends are being driven by a “change in the diets of local populations from traditional, locally grown staples to imported, energy-dense, HFSS foods and beverages.

“This shift away from agricultural production has been shaped by economic and commercial factors… , including the colonial legacy of land ownership and land division, land loss and pressures, as well as increasing migration and urbanization,” states the WHO paper on economic determinants. “It is also impacted by climate change and increasing droughts within the countries, as well as prohibitive inter-SIDS trade provision and shipping costs and other barriers, when compared to importing food internationally.

“As noted in a regional UN Conference on Trade and Development (UNCTAD) meeting, fishing remains a mainstay of economic activity, but remains challenged by issues such as illegal fishing. Unsustainable fishing or fishing insufficiently regulated to protect local fisheries and local consumption has direct impacts on health, as depleted stocks require island fishermen to work longer hours, farther from shore, in less safe conditions.”

“In contrast to the urban populations, people in rural areas of Pacific SIDS have a more varied diet which is more likely to meet WHO recommendations of consuming more than 400 grams of non-starchy fruits and vegetables daily,” the paper notes.  Government policies are historically weak: “In 2021, only 13 of the 38 Member States SIDS had food based dietary guidelines (FBDGs) to inform and guide policy work along the food system, and no FBDGs explicitly incorporated environmental sustainability elements.”

 

Reducing taxes and duties on fresh foods and promoting healthy school lunches

SIDS
Christopher Tufton, Minister of Health and Wellness, Jamaica

“I anticipate that in a few years time, we’re going to see premature mortality increase and it’s going to have a negative impact, I believe on the labor force and on the quality of life,” said Christopher Tufton – Minister of Health and Wellness, of Jamaica in a panel discussion on Wednesday. “What do we need to reduce this trend?  I think we have to target all stakeholders and not just the converted.. From an economic modeling perspective and from a quality of life perspective. 

“Particularly in terms of nutrition, we are import-dependent,” he noted, asking “how do we impact the global commodity chains to influence behavioural change?”  Schools offer one point of focus, Tufton said.

“We are starting at the level of schools to influence behavioural change..We are pursuing nutrition policy  because our children are our future. They’re a captive audience,” Tufton.  Another panel member Ellis Webster, Minister of Health of Anguilla, agreed that school feeding programmes are a good starting point.

A key aim of the conference is to consolidate SIDS inputs into a upcoming high level UN meeting on Universal Health Coverage,  scheduled for September, WHO says.  Traditionally, NCDs and mental health have been poorly represented within countries’ UHC plans, with inadequate attention to prevention as well as to diagnosis and treatment.

The conference also follows on from the SIDS High-level technical meeting on NCDs and mental health held in January 2023, where representatives from SIDS countries discussed the progress and challenges to meet the Sustainable Development Goal 3.4 related to NCDs and mental health.

An outcome document to be issued at the close of the conference aims to reafirm SIDS political commitments to putting NCDs and mental health front and center, stimulating both increased domestic action and more international cooperation.

Image Credits: WHO.

Rwanda’s health minister, Sabin Nsanzimana (centre) receives the AMA Host Agreement from the AU.

The African Medicine Agency (AMA) came a small step closer to reality over the weekend when Rwanda signed a Host Country Agreement with the African Union (AU) Commission.

The AMA will serve as a continental body that provides regulatory leadership on medicines, enabling a harmonized regulatory system on the continent – but it has still to be ratified by most of Africa’s powerhouses.

At the signing ceremony, Rwandan Health Minister Sabin Nsanzimana said that the AMA will build confidence in the quality of health products, promote cooperation and mutual recognition in regulatory decisions and facilitate the movement of health products on the African continent.

Thomas Cueni, Director-General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) recently described the AMA as “a bit of a mess” because it had not yet been ratified by Africa’s most powerful nations, including Nigeria, Ethiopia and South Africa.

However, in late May, South Africa’s Parliamentary Health Portfolio Committee recommended that the country’s parliament ratifies the AMA Treaty. The issue had been tabled in Parliament in mid-May and referred to the committee for further discussion. 

In its presentation to the committee, the South African Department of Health highlighted that the AMA would add value to the country and the continents by, amongst other things, reducing the prevalence of substandard and falsified medicines and vaccines, providing a consistent voice on regulatory issues, pool expertise from across the continent and ensure regulatory harmonisation and convergence on standards, and guidelines for quality, safety, and efficacy.

The issue will now be put to a vote in that country’s Parliament.

Dr Seth Berkley, CEO of Gavi (left) and Marie-Ange Saraka-Yao, Managing Director for Resource Mobilisation, Private Sector Partnerships and Innovative Finance (right).

International vaccine alliance Gavi is on track to immunize 300 million more children by 2025 despite setbacks caused by the COVID-19 pandemic, it announced on Tuesday.

“Despite the huge strain placed on countries’ health systems by the COVID-19 pandemic, we’re on or ahead of schedule on eight of the 11 key commitments that we made for the period 2021 to 2025. These include efforts to immunize a further 300 million children, prevent between seven to eight million future deaths, and unlock $80 to $100 million in economic benefits,” said Gavi CEO Dr Seth Berkley 

The alliance released its mid-term review report that tracks the progress of its goals for the 2021-2025 period. Every year Gavi provides vaccines to protect nearly half of all children on the planet. 

The report coincides with a meeting of world leaders in Spain’s capital of Madrid for the Global Vaccine Impact Conference, where they are discussing the lessons from the COVID-19 vaccine access platform, COVAX, which was co-led by Gavi.

Improving Africa’s manufacturing capacity is a long-term goal

In the coming years, countries in Africa have pledged to improve vaccine manufacturing capacity as COVID-19 exposed their vulnerability. 

While Gavi expressed confidence in the continent’s ability to scale up, it tempered expectations by adding that this was likely to be a long-term process.

“This is a long road. It is important to acknowledge that it takes time,” said Marie-Ange Saraka-Yao, Gavi’s Managing Director for Resource Mobilisation, Private Sector Partnerships and Innovative Finance. “A lot of pieces have come into play,” 

Gavi also said it is working to ensure there is enough advance procurement so that manufacturers can produce vaccines at scale while keeping the cost low.

Gavi played a key role in improving vaccine access during COVID-19 in 92 countries.

Neonatal deaths, weak malaria vaccines are challenges

Gavi flagged neonates’ deaths, the low efficacy of malaria vaccines and climate change as key challenges.

While there has been considerable progress in reducing childhood deaths, deaths of neonates (babies in the first 28 days of life) remain high.

“The RTS,S vaccine which is the first malaria vaccine, had an efficacy rate of 39%. Now that may sound low, but given how prevalent malaria is, for every 200 children vaccinated, you save one life. So, in terms of impact, this vaccine is really important,” Berkley said.

Climate change is compounding challenges. As rainfall patterns change, droughts become more frequent and intense, and food insecurity is expected to rise.

“In my country, where climate change and displacement are making it harder, not easier, to deliver health services – vaccines are an essential way to manage outbreaks and save lives,” said Dr Abdelmadjid Abderahim, Minister of Public Health and Prevention in Chad.

 Countries returning to pre-pandemic vaccination

While Gavi has presented an optimistic picture, a number of countries reported their post-pandemic struggles less optimistically at the recently concluded World Health Assembly weren’t so optimistic, including the re-emergence of polio cases in Pakistan and Afghanistan, after the pandemic disrupted routine vaccinations.

Gavi said nearly 57 low- and middle-income countries are on track to return to pre-pandemic level of routine immunization. 

“According to the data we’re seeing from countries, we believe there are encouraging signs that resilient health systems in the now 57 Gavi implementing countries are having some success in recovering following the pandemic,” Berkley said.

The cases of several other women facing similar charges are working their way through UK courts. Another woman is set to stand trial later this year.

There have been calls for abortion law reforms in the UK after a woman was sentenced to 28 months in prison on Monday for carrying out an abortion after the legal term limit.

The 44-year-old mother of three was sentenced under a law passed in 1861 that carries a maximum penalty of life imprisonment, sparking calls for immediate legal reform across the political spectrum.

Abortion was legalised in the United Kingdom in 1967, and is legal up to 24 weeks, while any procedure after the 10-week mark must be carried out in a clinic or hospital.

However, in this case, Carla Foster procured abortion pills by misrepresenting the term of her pregnancy during a COVID-19 lockdown when access to abortion pills was relaxed.

She claimed that she was seven weeks’ pregnant whereas doctors concluded Foster’s foetus was between 32-34 weeks old at the time of her abortion. This means it had a strong chance of survival if it had been born in a medical facility.

However, the British Pregnancy Advisory Service (BPAS), the abortion care provider Foster misled about the term of her pregnancy to acquire the abortion pills, said it was “shocked and appalled” that the case had led to criminal charges, adding: “No woman can ever go through this again.”

“We are now seeing a mother of three prosecuted under laws that do not exist in the same way in any other country,” BPAS chief executive Clare Murphy told the BBC.

A law passed nearly two centuries ago applies in cases where a woman intentionally causes an abortion after the 24-week limit. Foster was initially charged with “child destruction” under the 1929 Infant Life Preservation Act, which she denied. She later plead guilty to charges under the Offences Against the Person Act passed in 1861.

The 162-year-old law states that women in the United Kingdom who use “unlawfully administered” medications to induce an abortion can be kept “in penal servitude for life”.

With another woman set to stand trial later this year,  lawmakers say action must be taken before another criminal prosecution occurs.

“Society has moved on, healthcare has moved on, and I think parliament has a role now to look at reforming our abortion laws,” said Labour MP Dame Diana Johnson, who has previously tried to repeal the 1861 act with a backbench bill.

“Removing the criminal law is a very sensible, reasonable step, but it’s not to deregulate abortion care and who can provide it.”

Mifepristone, the medication Foster used to terminate her pregnancy, is also at the centre of court battles in the United States as states seek to outlaw abortion pills following the repeal of Roe v. Wade.

Caroline Nokes, a conservative MP who chairs the Common Women and Equalities Committee told the BBC that parliament should “decide in the 21st century whether we should be relying on legislation that is centuries old”.

“This is not something that has been debated in any great detail for many years now,” Nokes said. “And cases like this, although tragic and thankfully very rare, throw into sharp relief that we are relying on legislation that is very out of date. It makes a case for the parliament to start looking at this issue in detail.”

A spokesperson for British Prime Minister Rushi Sunak said he was “not aware” of any plans to change the current approach to abortion.

“Our laws, as they stand, balance a woman’s right to access safe and legal abortions with the rights of an unborn child,” he said.

Asked to respond to the government’s statement on Sky News, veteran Labour MP Stella Creasy said it is “a bit worrying” that “the government does not even know that abortion is not legal in this country”.

“What many of us are worried about is that this could be the start of many more prosecutions and an attempt to chill a woman’s right to choose in the country,” Creasy said, noting that the cases of several other women facing similar charges to Foster are currently passing through UK courts. “Abortion is not a criminal matter, it’s a healthcare matter.”

Abortion is hotly contested in many parts of the world. While access to abortion has been eased in Colombia and Mexico in recent years, many US states have either banned abortions entirely or reduced the time in which women are able to get abortions. Florida, for example, recently made it illegal for a woman to get an abortion after six weeks of pregnancy when many women are not yet aware that they are pregnant.

Image Credits: Wei-te Wong.

Futures Without Violence’s Leila Milani (left) and Ruxana Jina, Director of the Data Impact Programme at Vital Strategies.

It took years – and much data-crunching – before the US government was persuaded that measuring women’s security is an important way to assess the security of where she lives – her city, state and country.

Most governments lack the data to make this calculation. Gender-based violence (GBV) is notoriously under-reported, and officials often have little idea about the extent or nature of GBV in their countries. 

Yet one-in-three women will experience physical or sexual in their lives, according to the World Health Organization (WHO).

While GBV can involve physical, sexual and psychological abuse by intimate partners and non-partners, as well as the sexual abuse of girls and trafficking of women for sex, its most common form is the abuse of women by intimate male partners, according to Fatima Marinho, Principal Technical Advisor at Vital Strategies.

A global health organisation that helps governments to strengthen their public health systems, Vital Strategies asserts that investment in data is “a missing component of interventions to end gender-based violence”.

“Most of the women who experience gender-based violence don’t experience [swift justice],” says Ruxana Jina, Director of the Data Impact Programme at Vital Strategies.

“It’s often intimate partners. It’s often at home. It’s often underreported, and it’s only through the data that we get the true story. Data unmasks the truth. It tells us the true story around the true burden.” 

Jina has worked to unmask GBV and femicide in a range of countries including India and South Africa, and some of the findings have been jarring.

Mumbai’s high burden of homicide and suicide

An autopsy-based analysis of the bodies of 1,467 Mumbai women, girls and non-binary people found that 12,3% of the dead – 181 women – had an “underlying history or indication of GBV”. This was deduced from the autopsy reports themselves, victims’ statements (if they were still alive when they reached the hospital), police reports and relatives.

Two-thirds of victims were married and the perpetrators were either husbands or intimate partners (61%) or family members (39%).

An extraordinarily high percentage of those 181 people with a history of violence died from suicide (86), with 10 dying from homicide and the remainder dying from accidents.

However, the study highlighted critical data gaps, such as the absence of a standardized data collection tool with respect to GBV in autopsies, which means that socio-demographic factors for the victim were missing. 

Another Mumbai-based data project involved monitoring and evaluating 12 hospital-based Dilaasa Centres, one-stop crisis centres that the city’s public health department has set up to provide medical services for GBV survivors and link them to the police and social services.

“The data wasn’t standardised,” Jina told a VitalTalks panel in New York last week.

The centres also didn’t measure outcomes, such as whether the women accessing services were having better health outcomes or better social protection, and whether more cases were being prosecuted. 

But working with government officials and people working in the centres, a Vital Strategies team was able to help to develop a monitoring and evaluation framework with standardised indicators.

“That’s been very important because it not only helps the government officials in Mumbai to ensure that the services that they offering are of high quality, it’s actually addressing the needs of the woman,” said Jina.

“These types of data on one-stop centres can help provide information on the effectiveness of the service delivery model that can help inform global recommendations and guide other countries decide on the organization of their services.”

Identifying vulnerable women in Brazil

Márcia Lima, National Secretary of Policies for Affirmative Action and Overcoming Racism in the Ministry of Racial Equality in Brazil.

Márcia Lima is the National Secretary of Policies for Affirmative Action and Overcoming Racism in the Ministry of Racial Equality in Brazil.

“It’s impossible to think about public policies without evidence,” said Lima. “Public policy based on evidence is the most effective way to improve social problems.”

However, Lima said that it was very hard to collect accurate GBV data because of “a culture of silence across all groups”.

In 2022, Vital Strategies developed an analytical method to estimate the burden of GBV in Brazil, finding that almost one-in-five women over 18 had experienced violence, while the same ratio of school girls had been abused.

The data also enabled researchers to develop a profile of who was most vulnerable to GBV. Race (black and brown women), age (between 14 and 39) and partners’ use of alcohol were key risk factors, said Marinho.

A sub-national data collection project shed more light on racial disparities, finding that black women are more likely than white women to be subjected to sexual and physical violence and that homicide rates for black and brown women have worsened but improved for white women.

“We can’t face GBV without addressing racism,” Lima told VitalTalks.

Data collection in a Brazilian city, Goiania, found that women who had been assisted for GBV were three times more likely to die by suicide. 

“We also analysed the public health data to identify missed opportunities for health services in addressing violence and predictors of femicide and all in all types of domestic violence,” said Marinho.

Fatima Marinho, Principal Technical Advisor at Vital Strategies

Grabbing the attention of policy-makers

Leila Milani, a Program Director with Futures Without Violence, said that it was important to “grab the attention of those who can make a difference – those who can put the funds into place to support more data to support more programming”.

She credits Dr Valerie Hudson, Professor of International Affairs at Texas A&M University, for ensuring that the US government took the security status of women more seriously.

“She looked at all the data points – 20 years’ worth of data points – that made the case for the link between the security of women and security of states, and for the first time, it got the attention of those who needed to pay attention,” said Milani. 

“She made the point that, where you see inequality and violence against women, that’s a  number one indicator of insecurity.”

On 25 May, the US released the country’s first-ever national plan to end gender-based violence, that Futures Without Violence helped to inform, said Milani.

The plan recognises GBV as “a public safety and public health crisis, affecting urban, suburban, rural, and Tribal communities in the United States” and that it is “experienced by individuals of all backgrounds and can occur across the life course”.

“We’ve had the Violence Against Women Act, which has funded a lot of the shelters and programming and training, but we’ve never had an actual plan. Many countries have already implemented plans, but the US had not stepped up to that obligation,” she added.

“One of its pillars is a commitment to increase the collection of data and research.”

WHO global estimates on gender-based violence, 2022.

Data for the future

“I often think about the data in terms of the root causes,” says Jina. “ Who are the people who are affected? Are there specific risk factors that we could be addressing? How do we then identify the best interventions? It’s one thing saying we have a problem, how are we acting on that problem? Then we need to evaluate that intervention to see if it is actually  making a difference.”

Lima called for “more the participation of civil society to the pressure government to create more and more information. Data is knowledge. Knowledge is power.”

Sharon Kim-Gibbons, Vital’s Vice-president of Public Health Programs, concluded the VitalTalk by asserting that data can play a key role in ending GBV – “but it’s a highly conditional”.

“Is the data complete? Is it accurate? Is it consistent? I think we’d also say that you have to ask the right women the right questions because the risk is not equal,” said Kim-Gibbons.

“We need national country-level surveys but also small qualitative focus groups. Public health is so complex. We all try to be as predictive and analytic as possible, but [understanding] is often so nuanced between cultural and social factors.”

INB co-chairs Roland Driece and Precious Matsoso

The African region of the World Health Organization (WHO) has condemned the weakening of equity clauses in latest draft of the pandemic accord and called for this week’s negotiations to focus on principles and key areas of concern rather than the detailed text.

The 47 WHO Africa group countries made their submission at the resumption of the Intergovernmental Negotiation Body (INB) meeting in Geneva on Monday. 

“The African member states recognise the hard position that the bureau finds itself in trying to keep everyone at the negotiating table,” said Ethiopia on behalf of Africa.

“However, it is unfortunate that, in that process, the core of what this instrument is supposed to address, namely equity, has been presented in a weakened or reduced format, especially in those articles that would result in a meaningful realisation of equity.”

Ethiopia representing the African region.

It described the draft (being referred to as WHO CA+) as “going backwards” on equity from the zero-draft. A key criticism of the current draft is that it does not propose any legal obligations to ensure that all countries have equitable access to pandemic-related products such as vaccines, tests and therapeutics.

Africa wants legally binding commitments on the transfer of technologies, know-how and intellectual property rights; capacity-building for local manufacturing to address pandemics; technical and financial support, and the establishment of a “comprehensive access and benefit sharing (ABS) mechanism” for pandemic pathogens.

In its statement in support of Africa’s call for stronger equity clauses, South Africa added “rebuilding or strengthening health systems” and “the use of IP rights and TRIPS waivers” to strengthen countries’ pandemic prevention, preparedness and response.

A new alliance of countries calling itself the Group on Equity stressed the need for “concrete provisions that effectively operationalise equity”.

Presented by the Philippines, the group cuts across WHO regions and includes China, India, Brazil, South Africa, Bangladesh, Colombia, Indonesia, Malaysia, Mexico, Pakistan and Thailand.

A group of Latin American countries represented by Colombia also supported Africa and the Equity Group’s call for strengthened equity clauses, declaring the need for “a practical and relevant instrument not simply a document filled with good intentions”.

Meanwhile, Brazil said that it is “essential that any measure related to sharing of pathogens be accompanied by the benefits that arise from their use in a unified system”, and warned that the inclusion of “so many measures” related to One Health might dilute the focus.

“It is urgent to have a fully agreed upon definition of pandemic and the method for declaring it, with clearly stated criteria, in order to be able to better grasp the scope of the instrument,” added Brazil.

Rising INB tension 

The INB Bureau has recommended that the current negotiations, in closed sessions until 16 June, should focus on “substantive issues” at this stage as the parties are still too far apart for text-based negotiations.

This approach had wide support, including from the European Union, which stressed that an “increased level of mutual understanding will be the best way to enable us to assess where we may concur and where we can move closer to each other”.

The EU called for a focus on “Chapter Two provisions and, of course, on equity issues”. Chapter Two is the guts of the draft and is home to virtually all the contentious clauses related to equity, covering all the key issues flagged by the Africa group.

Opening Monday’s INB meeting, co-chair Roland Driece said that tension was growing in the body, which he described as a “sign of maturity” as issues of conflicts became more evident.

With only 10 months left to fulfil its mandate, “time is pressing, and the text on the table is getting more concrete all the time,” said Driece, adding that six INB meetings remained in this time.

“We can feel that the tension is rising. I can feel it, where in the beginning everybody was kind and positive and you feel that people are now asking questions….  I take that as a sign of maturity, maturity in our process, and maturity of what we are doing. And it is only normal that we enter a stage where we are more critical of what we write down, more critical of what we might agree upon.”

Echoing Driece, co-chair Precious Matsoso added: “We have the best of our times laughing but it seems we’re getting now into the most difficult part where our strength will be tested.” 

Matsoso also explained to member states the gruelling process that the Bureau had gone through to formulate the latest draft, distilling all member state suggestions – amounting to 208 pages – into the 43-page draft.

After the open session of the INB, member states have moved into “drafting group” closed sessions until 16 June. 

The closed sessions continue to distress civil society organisations, which believe negotiations should be open.

Expressing concerns about participation and transparency, Health Action International said that the “secret meetings” sent the “wrong message”.

“We have serious reservations on how some topics are being addressed or, rather, discarded in these discussions; most notably the issue of health-oriented IP management as a substantive part of improving access to health technologies and contribute to a robust human rights-based approach that will harness international efforts for the attainment of universal equitable access,” added HAI’s Jaume Vidal during the session in which non-state actors were able to make their contributions.

somalia
Worried families gather outside the beachfront hotel in the Somali capital Mogadishu awaiting the return of their relatives.

A staff member of the World Health Organization (WHO) in Somalia was among the 16 civilians killed in a terrorist attack on a hotel in the capital Mogadishu on Friday night, the WHO confirmed.

The attack by al-Qaeda affiliate al-Shabaab targeted the Pearl Beach Hotel and Restaurant, an upscale location on Lido beach often frequented by high-ranking government officials and foreign diplomats.

The militants’ siege lasted over 10 hours before local security forces regained control of the hotel, killing seven attackers. Ten civilians were injured while 84 were successfully evacuated during the attack, according to a statement by Mogadishu police.

The WHO staffer killed in the attack was identified as Nasra Hassan, a 27-year-old female Somali national. Hassan joined the WHO country office in Somalia to support the agency’s drought emergency response operations in the southern region of Jubaland.

“We condemn in the strongest terms this heinous attack on a hotel that claimed so many lives, including the precious life of one of our dearest colleagues, Nasra,” Dr Malik Mamunur, WHO representative in Somalia said. “We condemn all attacks on innocent civilians and humanitarian workers and express our deepest condolences to the family members of all those who were killed in this attack.”

Around 1.1 million Somalis have been displaced by droughts since January 2021. Last year, as many as 43,000 people died as a result of the record droughts sweeping the country. Half of them were under the age of five, according to a report by the Somali government and the United Nations agencies.

The hotel attack occurred just a week after the bodies of 54 Ugandan peacekeepers were found dead at a military base 130km from the capital. The increase in al-Shabaab attacks across the country in 2022 resulted in the deadliest year for Somali civilians since 2017, UN Secretary-General Antonio Guterres told the security council in February.

Despite the unrest, WHO said it remains committed to working with the Somali government and local partners to address ongoing health needs and emergencies across Somalia.

“WHO is committed to continuing efforts to preserve health and respond to emergencies in Somalia,” the organization said in a statement, adding that the safety of WHO staff is a “paramount factor in ensuring ongoing life-saving response operations”.

Al-Shabaab held permanent positions in Mogadishu until 2011 and continues to control vast areas of rural territory across the country. While its militants have been pushed out of Somalia’s major cities and towns, they continue to mount irregular attacks on civilian and military targets.

WHO has delivered around $5 million of medical supplies in the past year. This aid is focused on essential health and nutrition care for Somalis affected by the extreme drought and food insecurity sweeping the wider Horn of Africa.

The extreme droughts in the Horn of Africa are considered a “grade 3” emergency by WHO, the organization’s highest alert level. Other “grade 3” crises include the humanitarian situation in Afghanistan and the ongoing conflicts in Ukraine, Yemen, Ethiopia and Syria.

About 3.5 million children under five were vaccinated against polio, measles, and cholera or protected against malnutrition under WHO programmes in 2021. The UN health agency has also worked with federal and state ministries of health across Somalia to establish a medical supply chain that can reach the most vulnerable people in the country.

“Being a health professional and working in a resource-starved and geographically challenged health system in a conflict zone, WHO supplies are proving to be a lifeline for millions,” Dr Yusuf Omar Mohamed, head of pharmaceuticals and supply chains at the Somali Ministry of Health said of WHO’s operations in the country. “Everyone wondered how a medical supply chain could work in Somalia, but I believe WHO has shown it to the world that if there is a resolve to serve humanity, obstacles can be turned into opportunities.”

Image Credits: Said Yusuf Warsame, AMISOM.

emerging outbreaks
From far left: Dr Nathalie Strub-Wourgaft, moderator, Dr Dimié Ogoina, Dr Jean-Jacques Muyembe, Dr Marie Jaspard, Dr Mimi Darko.

More R&D into already known emerging disease threats, from Mpox to Lassa fever would go a long way to both bolster developing countries’ preparedness as well as protecting the world, experts argue.

Member state negotiations resume next week over a draft WHO convention on pandemic prevention, preparedness and response – which is supposed to be ready by the May 2024 World Health Assembly. 

While parties prepare to debate the latest draft text published, distilled from a 208 page “compilation draft” of 34 different country and regional proposals, the lessons learned from recent or ongoing outbreaks can  provide concrete insights on how to make the world better prepared.

A group of high level experts from Africa, Europe, the Middle East and Latin America provided their insights at a recent seminar on “How Can Global Action Really Meet Local Needs in Emerging Outbreaks, hosted by the Graduate Institute’s Global Health Centre on the margins of the recent World Health Assembly.  

The event was co-sponsored by the International Geneva Global Health Platform, and PANTHER Health, an NGO dedicated to supporting rapid responses to emerging infectious diseases in Africa.

Insights from Mpox, Lassa fever are indications of preparedness 

Bernhards Ogutu, Chief Research Officer, of the Kenya Medical Research Institute (KEMRI).

Speaking at the event, Bernhards Ogutu, Chief Research Officer of the Kenya Medical Research Institute (KEMRI), said insights from current Mpox, Lassa fever and other “endemic pandemics in the south” are among the best indications of countries’ current level of preparedness for future outbreaks.

“Even when we think there are no pandemics there’s lots of them that we need to address and possibly need to see how well to do this as we get prepared for the next pandemic,” Ogutu said.

The INB text echoes the importance of research and development. Article 9 of the current draft states that: 

“The Parties shall cooperate to build, strengthen and sustain capacities and institutions for research and development for pandemic-related products, particularly in developing countries, including for related clinical trials and information-sharing through open science approaches for rapid sharing of scientific findings and research results.”

More research in endemic countries is needed

But those high notes of ambition are far from today’s reality said Jean-Jacques Muyembe-Tamfun, director of the Democratic Republic of Congo’s Institut National de la Recherche Biomédicale. He noted, for instance, that more research in endemic countries on the connection between smallpox and Mpox could have contributed to the more rapid roll out of countermeasures when the Mpox global health emergency hit countries worldwide last year. 

With knowledge about how the smallpox vaccine provides some protection against Mpox, more adequate research a decade ago into Mpox vaccines and treatments could have informed better policy guidance on priority countermeasures and target groups for their use, during the recent emergency. This might have yielded recommendations for continued smallpox vaccination in countries where Mpox is endemic, he suggested.

Instead, when the emergency hit, it was unclear how wide a net needed to be cast with the vaccines, which turned out to be in short supply, and were rarely put to use.  As for medicines, just one small study in the Central African Republic of the new treatment, Tecovirimat (TPOXX™), was only just beginning when the virus emerged.

Aligning with the INB’s draft text on supporting research in developing countries, Muyembe argued that his country remains critical for clinical trials on Mpox, the findings of which could help in developing tools that would protect the rest of the world against the new variants of an old disease. 

“DRC is the most affected country. We will not lack cases of Mpox to continue our studies and clinical trials in the field,” he said.

‘No regrets’ funding

A look inside the drafting process of the INB.

Funding has always been a subject of debate in global health and the INB’s June negotiations are no exception. In the working document, financing was captured in Article 19 and it describes sustainable financial resources as playing an important role in achieving the objective of the instrument. It pegged financing as the primary financial responsibility of national governments in protecting and promoting the health of their populations. 

The parties, however, are yet to agree on whether to include a proposed Paragraph 6 in Article 19 on Financing, stating that funding models “would take into account national financial capacity and capabilities.” Two options are being considered, one which would elaborate the principle in detail – and one which would not reference it at all:

Option 19.A6. The Parties agree that the funding models for pandemic prevention, preparedness and response need to take into account national financial capacity and capabilities, and to this extent shall: (a) establish programmes that convert debt repayment into pandemic prevention, preparedness, response and recovery investments in health, to be attained under individually negotiated “debt swap” agreements; and (b) commit to expanding partnerships with development finance institutions for providing additional funding to developing countries, through prioritized debt relief, debt restructuring and the provision of grants rather than loans that will guarantee that programmes protect essential health and related spending from encroachment, as well as to take advantage of the economic benefits of frontloading finance for prevention and preparedness or support investments. 

Option 19.B: not to include a paragraph.

At the Graduate School event, Veronika von Messling, Director-General for Life Sciences at the German Federal Ministry of Education and Research also stressed the importance of a ‘no regrets’ funding approach that permits flexible use of both national resources and donor-based funding that allows recipients to dynamically adapt plans in times of crisis. She described this as essential to long-term capacity strengthening in low and middle income countries.

“These are central elements for a global pandemic preparedness and response,” she said. “Continuous investment in national and international initiatives even before a pandemic. underline the importance of acting not only in times of crisis, but also in between.”

The formidable INB task ahead 

Members of the drafting group preparing for the upcoming INB meeting.

The Intergovernmental Negotiating Body (INB) will resume in its fifth meeting on the draft accord next week. 

The INB is the name of the group that is drafting and negotiating the WHO “convention, agreement or other international instrument on pandemic prevention, preparedness and response,” with a view to its adoption under Article 19 of the WHO Constitution, which allows the World Health Assembly to adopt “legally binding conventions or agreements” by a two-thirds vote. It is open to all Member States and Associate Members (and regional economic integration organizations)

From 12 June, the board, starting with Member States and followed by relevant stakeholders, will provide general comments on the Bureau’s most recent draft text, published on 2 June. At the 76th World Health Assembly, the INB said it has made progress in developing a framework for the accord, although negotiations are expected to continue steadily until May 2024. 

One Health – a key principle of the accord – or not?    

Excerpt from the briefing of the INB bureau drafting notes shared with member states earlier this month.

In a briefing last week, the “Bureau” of six member states guiding the negotiations, provided a mapping of the draft text and its proposed amendments by member states, reflecting the many choices still to be made.  

Those range from semantic choices between “but” or “and”, to the critical question of whether “One Health” will be included as a fundamental principle of the accord. Other challenges include how prescriptive to be regarding tasks that parties would fulfil, particularly with regard to prevention and surveillance. For instance, word choices like “are encouraged to” suggest voluntary action while “shall” conveys a mandatory meaning. 

While there appears to be agreement on referencing the importance of strengthening R&D and information sharing about research agendas and plans in the text, changes are being proposed to the section on preparedness monitoring and functional reviews (Article 8). Some member states oppose the establishment of a peer review mechanism for monitoring preparedness in which countries would review the plans and performances of other member states.

While there appears to be agreement on references in the text to the healthcare workforce, changes are being proposed to the section on preparedness monitoring, with some member states opposing the establishment of a peer review mechanism for monitoring preparedness, whereby countries themselves would review the preparedness plans and performance of other member states. 

The review instrument, fashioned on a similar mechanism used by the Human Rights Council, is called the “Universal Health and Preparedness Review’. It has already been piloted on a voluntary basis by some member states.

For the preparedness review and about 16 other controversial provisions touch on sensitive topics from the inclusion of “One Health” as a key accord principle (Article 8) to the sharing of genetic sequence data in exchange for rights to the benefits from drugs and vaccines developed (Article 12), the bureau draft contains 2-3 options for each key paragraph to allow member states to choose a direction.

For the more controversial provisions of the accord, which touch on sensitive topics ranging from the sharing of genetic sequence data to notification requirements during emergencies, the “Bureau” draft contains 2-3 options for each of about 16 key paragraphs – so that member states can concretely choose a direction.

Two options are presented for principle 8. Option 8.A: One Health – Multisectoral and transdisciplinary actions should recognize the interconnection between people, animals, plants and their shared environment, for which a coherent, integrated and unifying approach should be strengthened and applied with the aim of sustainably balancing and optimizing the health of people, animals and ecosystems, including through, but not limited to, by giving attention to the prevention of epidemics due to pathogens that are resistant to antimicrobial agents and zoonotic diseases. 

Option 8.B: not to include as a principle.

The journey ahead

Following the June meeting, the INB will host its sixth meeting in July 2023. Further meetings or drafting group sessions could be held in September, November, and December. The board is expected to submit its outcome for consideration by the 77th World Health Assembly in May 2024.

The six members of the INB Bureau include Ms Precious Matsoso (South Africa), former Director General of the National Health Department of South Africa and INB Bureau co-chair, representing Africa and Mr Roland Driece (Netherlands) Director of International Affairs at the Ministry of Health, Welfare and Sport, and INB Bureau co-chair, representing Europe. 

Other members are Ambassador Tovar da Silva Nunes (Brazil) Permanent Representative of Brazil to the UN in Geneva, representing the Americas; Dr Viroj Tangcharoensathien (Thailand) Advisor to the Ministry of Public Health, representing South-East Asia; Mr Ahmed Salama Soliman (Egypt) representing the Eastern Mediterranean region; and Mr Kazuho Taguchi (Japan) representing the Western Pacific region.

The full panel on how global action can meet local needs in emerging outbreaks can be viewed here.

  • Additional reporting by Elaine Fletcher.