Pharmaceutical CEOs
Pharmaceutical industry groups say the current draft of the World Health Organization’s pandemic treaty would leave the world less prepared for the next global outbreak.

CEOs from the world’s largest pharmaceutical companies issued a call to G7 leaders on Friday to oppose the inclusion of intellectual property rights waivers and pathogen benefit sharing in the World Health Organization’s (WHO) pandemic treaty. 

In meetings with Japanese Prime Minister and chair of next month’s G7 summit Fumio Kishida this week, a delegation of 24 CEOs from the industry group, the Biopharmaceutical Roundtable (BCR), argued that the current draft of the pandemic accord would make the world less prepared for the next pandemic by threatening IP rights and slowing the pace of pathogen sequence sharing.

The case made by BCR in its open letter is based on the vital if controversial role pharmaceutical companies have played in returning a sense of relative normalcy to day to day life since the height of the COVID-19 pandemic. 

“If we look back at the COVID-19 pandemic, I think it’s fair to say that the industry success in developing and scaling up vaccines, treatments, and test diagnostics at record speed was key to get our societies back and out of the pandemic,” said Jean-Christophe Tellier, BCR chairman and president of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). 

“[Protection of] intellectual property rights (IP) I think is one of the lessons from COVID-19.”

Global health and medicines access advocates have praised the strength of the WHO zero-draft in areas like IP waivers, which many believe would prevent a repeat of the limited and delayed access to life-saving drugs experienced by countries unable to afford the steep prices demanded by pharmaceutical companies at the onset of the COVID-19 pandemic. 

The topic is likely to be one of the key battle lines in treaty negotiations as the world tries to shape the lessons of the pandemic into what would be a historic achievement in the world of global health. 

“IP was never an issue for access in low and middle income countries,” Eli Lilly CEO David Ricks said in a press conference in Tokyo on Friday.  “As countries and multilateral organisations begin to advance future pandemic preparedness plans, it is critical that such frameworks prioritise and further strengthen the innovation ecosystem, which is built upon strong intellectual property, a vibrant private sector and fair value for innovation. 

“This is specifically what we have requested the G7 leaders to consider,” he said.  

Intellectual property protections must be absolute, industry says 

The idea that IP protections were essential to the record speed at which pharmaceutical companies got vaccines onto shelves is heavily contested. 

Industry groups like BCR and IFPMA say that without them, their incentive to innovate and invest in research and development is not sufficient to justify the costs. Since 2010, average research and development costs have risen 43% to almost $2 billion per drug. 

“We must prevent the weakening of the international IP protections that would result from unnecessary and misguided proposals to waive the TRIPS agreement for vaccines and therapeutics,” Ricks said. 

“While we strongly support the WHO as a partner and share its overall ambition to strengthen pandemic preparedness … through the WHO pandemic accord, there are concerning and troubling aspects of the zero-draft that would severely impact the ability of the private sector at large to provide leadership once again, if needed, in the areas where we did on COVID-19.”

The UN’s intellectual property agency has estimated the social benefits of COVID-19 vaccines at $70.5 trillion annually, nearly 900 times the estimated private sector revenues of $130.5 billion. 

“Almost two years of the COVID-19 vaccination programme … prevented 60 million deaths,” said WHO Executive Board member and International University of Health & Welfare president Yasuhiro Suzuki. “I would call [that] worth the money invested in the pharmaceutical sector.”

Pathogen benefit sharing will slow access to sequences 

Pathogen benefit sharing is another key point of contention in negotiations at the WHO. In its current form, the pandemic accord would allow countries sharing genetic sequences to seek financial compensation for uploading them to open databases. 

The first COVID-19 vaccine went into production just 66 days after the genome sequence was shared by Chinese scientists. Without that sequence, the development of vaccines would have been impossible. 

Pharmaceutical companies argue that providing a financial incentive for countries to share  critical genome sequences could result in a cost paid in thousands of lives should another pandemic arise. 

“Such approaches are more than likely to delay access to pathogens and the timely development of medical countermeasures in the event of a pandemic,” IFPMA Director General Thomas Cueni told Health Policy Watch. 

“Industry’s experience with the Nagoya Protocol has shown that a transactional approach is not compatible with rapidly accessing pathogens, particularly when rapid response is needed for epidemics and pandemics.”

Access to mifepristone, approved by the US FDA in 2000, has been restricted by a Texas judge.

The US Justice Department and Danco Laboratories, the manufacturer of the abortion pill mifepristone, turned to the country’s Supreme Court on Friday to overturn the limits set on access to the drug by lower courts.

This follows a partly unsuccessful appeal by the two parties for the stay of a ruling last week by Texas Judge Matthew Kacsmaryk that the US Food and Drug Administration (FDA) had erred in its approval of mifepristone.

A Fifth Circuit Court of Appeals ruling on 12 April only granted a partial stay of the Texas judgment, ruling that the statute of limitations bars challenges to the initial FDA approval of the drug in the year 2000.  However, the New Orleans-based Circuit Court of Appeals rolled back more recent FDA moves easing access to the pill. The Court of Appeals ruling thus limited access to mifepristone to women who are less than seven weeks’ pregnant (as opposed to 10 weeks) as well as limiting access to women who received in-person prescriptions, preventing women in states that have recently banned abortion to receive the pill in the post.  

These new limits will come into take effect on Saturday unless the Supreme Court issues a judgement before that.

“We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care,” said US Attorney General Merrick Garland in a statement. 

Garland added that the Justice Department “strongly disagrees” with the Fifth Circuit court’s decision to “deny in part our request for a stay pending appeal”. 

Court playing medical expert

US Vice-President Kamala Harris said in a statement that the appellate court decision “invalidates the scientific, independent judgment of the FDA about when and how a medicine is available to Americans”. 

Mifepristone, which was approved over 20 years ago, is also used to treat miscarriages,  endometriosis, fibroids and hyperglycemia.

“The Fifth Circuit’s decision – just like the district court’s– second-guesses the agency’s medical experts,” added Harris. “If this decision stands, no medication – from chemotherapy drugs, to asthma medicine, to blood pressure pills, to insulin – would be safe from attacks.

“This decision threatens the rights of Americans across the country, who can look in their medicine cabinets and find medication prescribed by a doctor because the FDA engaged in a process to determine the efficacy and safety of that medication.”

The Texas decision has already been contested by over 200 executives from pharmaceutical and biotech companies who this week released an open letter condemning Kacsmaryk’s “judicial activism”, while urging support for the “continued authority of the FDA to regulate new medicines.”

Harris described the mifepristone case as “the next step to a nationwide abortion ban”, adding that “our Administration will continue fighting to protect women’s health and the right to make decisions about one’s own body”.

However, the conservative-dominated Supreme Court has already struck down Roe v Wade, the case that legalised abortion in the US.

Florida governor Ron DeSantis signs the new law restricting abortion to under six weeks in his state.

Meanwhile, on Thursday night Florida Governor Ron DeSantis signed a bill banning abortion after six weeks, prohibiting telehealth for those seeking abortion and allocating $25 million annually to anti-abortion pregnancy centres.

“We are proud to support life and family in the state of Florida,” DeSantis said in statement. “I applaud the Legislature for passing the Heartbeat Protection Act that expands pro-life protections and provides additional resources for young mothers and families.”

The law won’t go into effect until the Florida Supreme Court rules on a challenge to the state’s current 15-week ban on abortion. However, this is unlikely to succeed as the supreme court is dominated by conservative judges.

Image Credits: State of Florida.

A doctor dispenses fexinidazole, the first-ever oral treatment for sleeping sickness, which was developed by DNDi.

When governments invest in drug research and development (R&D) with pharmaceutical companies, they should ensure upfront that these drugs are affordable and widely available – and a global pandemic accord needs to provide high-level guidance on how to do this.

This is the view of the Drugs for Neglected Diseases initiative (DNDi), a non-profit group that has led a series of successful drug development partnerships since it was set up 20 years ago to find new treatments for people living with neglected diseases.

“During COVID-19, some governments put conditions on their R&D funding but they either didn’t use them or didn’t put in place the right conditions. And then you have some governments who did not put in place any conditions in relation to affordability or technology transfer,” DNDi’s Director of Policy Advocacy, Michelle Childs, told Health Policy Watch.

Yet an intense crisis such as a pandemic is precisely when governments should use their investment as leverage to make sure that the products developed are affordable and accessible.

DNDi has developed 12 treatments to address neglected diseases including sleeping sickness (human African trypanosomiasis), visceral leishmaniasis, Chagas disease, malaria and hepatitis C together with a range of partners including pharmaceutical companies.

This week, it published a paper in which it shares both its lessons and agreement templates to ​​show how to ensure that investment in R&D results in innovation and equitable access.

“You have to have a deliberate strategy, backed up by conditions negotiated at the early stage of R&D,” says Childs, one of the paper’s co-authors.

“Leverage counts to achieve these conditions. You have to bring something to that discussion. We bring partnerships and some funding. But governments bring a lot of funding and they could tie it to conditions to ensure effective outcomes.”

Whether governments are prepared to use this leverage to ensure future pandemic products are affordable and accessible “is a key test of how serious countries are about implementing equity”, says Childs.

“In the context of the pandemic accord, this is something they could do with their money. It is a test of how serious they are about really changing outcomes and really operationalising equity and moving from talking about it to turning it into action.” 

Addressing IP

For DNDi,  a first step is to address intellectual property (IP), which can be a barrier to access and affordability and follow-on research.

“We try to develop drugs as public goods, and we want to ensure that we can share the research and the knowledge,” says Childs. “So we make it clear to any partner that we won’t enter into an agreement unless we find a way to deal with intellectual property, if it exists or if it’s created, that allows us both to develop the treatment and secondly, to make that treatment affordable and available .”

DNDi defines IP widely as “technology”, including both the standard IP rights such as patents and copyrights, as well as confidential know-how and results. 

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), which represents all the major pharma companies, has made it clear that IP rights are important for its members to safeguard their investments.

But some IFPMA members have entered into agreements with DNDi. The organisation’s success, says Childs,  is that it deals with IP and access from early on in negotiations with partners. Through these partnerships, DNDi has been instrumental in the development of 12 treatments for neglected diseases.

Sometimes DNDi owns the IP, which means it can use, share and publish it as it wishes. But sometimes the IP is owned by a partner, and DNDi obtains those rights through licences – but it ensures additional commitments by the partner to ensure equitable and affordable access and further research.

Leverage

Successful partnerships are the result of sharing, says Childs – from expertise and resources to risk.

DNDi enters negotiations with partners with its own expertise and some funding for the development “so we de-risk elements and lower some of the costs for example around clinical development”, she says. 

“Secondly,  we aim for both affordable pricing and sustainability for the manufacturer in the definition of affordability in our licences, which is basically a cost-plus reasonable margin model. And we have a discussion with them about what is a reasonable margin in each case  – always subject to the condition that the treatment needs to be affordable for the places and the countries that need it,” she adds.

“We also work with the manufacturers and the countries to look at ways in which we can help them to optimise manufacturing processes to lower costs. ”

COVID mistakes

TRIPS Waiver protest in Indonesia. Civil society protested globally against the delay and limitations of the WTO TRIPS waiver for COVID-19 vaccines.

In contrast to a small outfit like DNDi, governments have far more resources – and thus leverage – in such negotiations. During COVID-19, governments – particularly the US and Europe – invested heavily in early drug development with pharmaceutical companies and the advance-purchase of goods, which both contributed to development costs.

But they either did not use or attach conditions to this investment to allow sharing of the technology or address affordability concerns and by the time COVID-19 vaccines were developed, there was a “late stage fire sale where everyone was scrambling for the products”, says Childs.

In preparation for the next pandemic, the pandemic accord currently being negotiated by World Health Organization (WHO) member states should contain an agreement for countries to apply such conditions to public funding to help countries in their negotiations with pharma and other partners and to ensure supply security and equitable access by retaining rights to share technologies when needed. 

Global coordination is needed

“There might be different partners and funders along the way from drug discovery to manufacturing and access,” adds Childs, so these conditions could guide the “handover of knowledge from one stage to another, as well as its transfer to different manufacturers in different regions”.

Mexico and Norway are currently championing the need for conditions to be placed on R&D  investment, she adds.

The WHO intergovernmental negotiating body (INB) currently negotiating the pandemic accord will need to decide what type of high-level conditions are put into the accord.

There are some hopeful signs in the zero-draft of the accord, which encourages countries to explore the terms and conditions of public financing on pandemic-related products, and whether obligations or requirements can be put on those products that are publicly funded.

But as those taking part in the INB stress at every meeting, “nothing is agreed on until everything is agreed”. It will be up to member states to ensure that public investment is tied to access and affordability.

Image Credits: Xavier Vahed/DNDi, Nur Sofi Iklima .

Bird flu
The World Health Organization said it considers the risk of the H3N8 virus spreading to be “low”.

A Chinese woman has become the world’s first person to die from the H3N8 strain of bird flu, the World Health Organization reported. No human-to-human transmission appears to have occurred, and the risk of the virus spreading is considered to be “low”, officials said.

The 56-year-old woman from China’s southern Guangdong province is the third person known to have been infected with H3N8 since the strain was first identified in North American waterbirds in 2002.

All three cases have been in China, where sporadic human infections with bird flu from exposure to infected poultry are common due to the country’s vast industrial and wild bird populations.

The first two non-fatal cases, both of which likely occurred from direct exposure to infected birds, were reported in April and May last year, the WHO said.

The deceased patient had pre-existing health conditions and had been in contact with live poultry and wild birds around her home. No one in close contact with her has shown any signs of illness.

Preliminary epidemiological investigations into the woman’s death by local health officials suggest that exposure to live poultry at a wet market is the likeliest source of the infection. Samples taken from the market she had visited before falling ill tested positive for influenza A(H3), according to environmental samples collected from the patient’s residence and the market.

“So far, no additional cases linked with this case, nor the previous cases, have been reported,” the WHO said. “The available epidemiological and virological information suggests that H3N8 avian influenza viruses do not have the capacity for sustained transmission among humans.”

Despite the lack of imminent risk, the UN health agency stressed the importance of “global surveillance to detect virological, epidemiological, and clinical changes associated with circulating influenza viruses.”

In February, the death of an 11-year-old girl in Cambodia from the H5N1 strain of avian influenza sparked worries that the virus had evolved to be able to spread in humans. Cambodian health officials have since confirmed no human-to-human transmission occurred.

“The threat is still very low for human-to-human transmission,” Cambodian National Influenza Center director Erik Karlsson said of the conclusions of the investigation into the case by local health authorities. “In terms of mutating into a transmissible virus, that’s quite a distant issue.”

All avian flu cases are detected and reported through the global severe acute respiratory infections surveillance system, which helps the world coordinate and keep track of new respiratory infections.

Image Credits: Roee Sherpnik .

A woman prepares for an HIV test in Uganda.

Ensuring that the HIV responses in countries receive full funding will not only lead to a 40% to 90% reduction in new infections but also result in substantial social and economic benefits, a new report launched by UNAIDS said. 

The socio-economic benefits countries with a fully financed HIV response will gain are higher educational outcomes, especially for young women and girls, eliminating gender inequalities and the development of human capital. 

“Urgent and collaborative action is needed to re-prioritise financing towards the HIV response,” the report states. “Without this commitment and decisive action, the response to HIV will continue to lag, threatening to widen pre-existing health and socio-economic inequalities— young women, children and other vulnerable populations will pay the highest price.”

Economist Impact, an evidence-based policy research organization, conducted a quantitative analysis across 13 countries in sub-Saharan Africa to arrive at these figures. The research and analysis was supported by UNAIDS.

The report, which was launched on Wednesday, compares two scenarios: one with 100% of the funding target set at the 2021 Political Declaration being met and the other with a “business as usual” (BAU) scenario in which the funding levels post-2021 are maintained as is.  

“This report comes at a critical time with evidence that should act as a catalyst for political decisions to ensure full HIV funding, that will have substantial social and economic outcomes,” Winnie Byanyima, the executive director of UNAIDS, said in a press release. 

“It will put African countries on a path towards building more resilient healthcare systems and be better prepared for future pandemics.”

Fully financing the HIV response could lead to a 40%-90% reduction in the number of new infections compared with the figures if countries resort to the BAU approach. In countries like Mozambique and South Africa, where the HIV burden is high, this would mean a reduction in the number of new cases by 810,000 and 1.35 million respectively by 2030. 

Increased access to education

This gain will also impact young women, girls and people belonging to other vulnerable groups. “ For example, our findings show that if the full funding targets for HIV are met in South Africa, the female population aged 15-19 could account for almost 15% of the total reduction in new HIV infections between 2022 and 2030, despite making up less than 5% of the total population,” the report explains. 

Reduced mortality rates in people living with AIDS due to higher investment in HIV response will lead to a reduction in the number of children orphaned by AIDS. This will translate into higher enrolment rates and attendance in schools. 

“For example, a reduction of approximately 722,000 orphans relative to BAU is estimated in Mozambique in 2030 when full funding targets for HIV are met…We estimate an additional 87,000 children enrolled in school in Mozambique in a single year,” according to the report.

This could also lead to a decrease in the gender gap in access to education. If HIV response is fully funded in South Africa, the number of boys enrolled in secondary school in 2030 could increase by 23,000 and the number of girls enrolled in secondary school could increase by 27,000. 

Positive shift in human capital

Fully financing the HIV response brings with it a positive change in human capital development, according to the report. 

With a robust, dynamic HIV response, countries can reduce mortality rates among their working population, especially among those aged between 34 and 60 years. 

“In Mozambique, for example, the size of this cohort could be an estimated 2.4% larger under a full funding scenario, in contrast to the total population that is 0.9% larger under this same scenario. These changing population dynamics associated with investing in the HIV response give rise to greater economic opportunities by enabling growth in the workforce.”

The economic gains resulting from a well-funded HIV response could run into billions of dollars when compared with the BAU approach. 

“Our analysis finds that the GDP of South Africa, which has the highest burden of disease of the countries studied, could be 2.8% higher (equivalent to US$17bn) than BAU funding levels in 2030 if HIV funding targets are met,” the report points out.  

The 2021-Political declaration

In 2021, the UN member-states adopted a declaration to reduce the number of new HIV infections per year to under 370,000 and AIDS-related deaths to 250,000 by 2025. The member-states also committed to end pediatric AIDS, eliminate discrimination related to HIV and provide HIV treatments to 34 million people by 2025. 

Achieving these numbers would translate into preventing 3.6 million new HIV infections and 1.7 million AIDS-related deaths by 2030. 

Image Credits: 2011, Sokomoto Photography for International AIDS Vaccine Initiative (IAVI).

Survivors of sexual violence participating in job training in the Democratic Republic of Congo.

KIGOMA, Tanzania – Mary Akile is still harbouring emotional suffering four years after a rape attack that inflicted both physical pain and untold mental anguish.

“I still remember how the attackers invaded my house and raped me, one after another,” says Akile, her voice cracking as she recalled the harrowing ordeal during April 2019 at Kabindi village, North Kivu Province in the Democratic Republic of Congo (DRC).

The 47-year-old mother of three, who is now living in Tanzania’s western Kigoma region, is amongst many DRC rape survivors who have suffered the horrors of war.

For decades, women and girls in the war-torn country have experienced sexual violence including rape, which has caused a myriad of problems including physical injuries, long-term psychological trauma, broken families, socio-economic exclusion and stigma.

Conflict-related sexual violence is considered a gross violation of human rights with devastating mental health consequences for the victims, medical experts said.

According to a study published in Jama, women who reported sexual assault were more likely to experience depression and twice as likely to have elevated anxiety and sleeping problems.

Scanty data  

While cumulative statistics of rape incidents in the DRC are hard to find, in 2020 the United Nations Organisation Stabilization Mission in DRC (MONUSCO) documented at least 1053 cases affecting 675 women, 370 girls, three men and five boys.

Although fear and shame engulfing communities in central and sub-Sahara Africa have for years forced rape survivors to keep mum, many of them are now publicly sharing their stories as they desperately try to unravel the emotional harm they’ve been harbouring for far too long.

This is partly thanks to reparative justice, a new paradigm for repairing emotional harm and preventing it from happening again that is premised on the need for reparations to be provided to victims.

“I feel relieved to publicly tell my story. A heavy burden has been lifted off my head, ”Akile said as she brushed a strand of dreadlocks off her face.

Rape has been used as a weapon of war by armed groups in the DRC to terrorise women and girls, forcing them to flee the country, Akile said.

The perpetrators of sexual violence are seldom punished so their victims are denied justice and don’t get compensation to rebuild their lives.

“Ever since I move to Tanzania, I feel safe and I don’t want to go back to Congo,” said Akile who designs and sells African Batik fabrics popularly known as Vitenge to eke out a living.

Mary Akile (left) a sexual violence survivor, designs batik fabric at her new home in Kigoma Tanzania

Impact on survivors

As part of its global initiative to enhance access to reparations for survivors of conflict-related sexual violence, Global Survivors Fund (GSF), a Swiss-based humanitarian organisation, is working with grassroots organisations in DRC and Guinea to support the healing process of the victims.

The GSF was launched in October 2019 by Nobel Laureates Dr Denis Mukwege and Nadia Murad. Mukwege is a renowned Congolese gynaecologist who has treated hundreds of rape survivors in DRC, while Murad, who was kidnapped by ISIS in Iraq, is a leading advocate for survivors of genocide and sexual violence.

GSF’s mission is to enhance access to reparations for survivors of conflict-related sexual violence around the globe, mainly by providing “interim reparative measures in situations where states or other parties are unable or unwilling to meet their responsibilities”.

In DRC, the initiative works in more than 60 villages in north and south Kivu and the central Kasai region. More than 1,093 survivors of conflict-related sexual violence have received financial compensation, vocational training, and medical and psychological care, GSF officials said.

The conflict in the mineral-rich eastern DRC, where over 120 armed groups are jostling for natural resources, has triggered a spiral of violence that has killed thousands of people and displaced many others including women and children.

Following an individual assessment, the identified survivors within the scope of our project in DRC and Guinea, received medical treatment, surgeries but also individual and physical therapies, as well as family therapies, when needed, according to  GSF.

Reparations are measures taken to address human rights violations by acknowledging the damage caused, recognising the dignity of the victims and trying to restore hope for the future.

While survivors of sexual violence usually need urgent help to rebuild their lives, the pathway to official reparation takes a long time, GSF officials said.

To mitigate the suffering, the charity and its partners are providing a number of interim reparative measures, including therapy, to transform the lives of the survivors.

Many survivors of sexual violence in DRC and Guinea live in constant fear due to the violent behaviour of the military and insecurity. But with multiple reparative measures, remarkable changes are happening and many survivors have seen a glimmer of hope that they can turn their lives around. 

A visit by Health Policy Watch to eastern DRC showed survivors of sexual violence reporting improved physical and mental health along with increased financial status and a sense of justice.

“Before, I didn’t even dare approach people to talk about what happened to me at the stadium. Thanks to the therapy, today I can talk about what happened to me. This is also the case for most of my friends,” said one survivor who preferred anonymity.

More confident

Before this initiative survivors complained that sexual violence had affected their health and social status but they are now feeling more confident thanks to the improvement in their mental and physical health.    

A study conducted by the Netherlands Institute for the Study of Crime and Law Enforcement to understand perceived changes to the quality of life of the survivors of conflict-related sexual violence in Guinea and the  DRC after they had received support from non-governmental organisations in their process of healing show their quality of life and social status within the family and community improved.

The study which examined the emotional and social-economic wellbeing of survivors and their families shows reparative measures have had a positive impact on the well-being of survivors.

According to the study, the individual and group psychological therapies in Guinea have helped survivors to regain trust in their loved ones and are now willing to tell them about their ordeals.

Panellists taking at the UN in Geneva discuss the human rights situation in Congo

Global campaign

Global women’s rights movements have been waging a fierce battle for recognition and care of rape victims in war-ravaged nations. Governments, the United Nations and humanitarian organisations have been struggling to provide post-rape care including post-exposure prophylaxis against HIV transmission within 72 hours of the rape, and emergency contraception within 120 hours while conducting physical examinations on the victims.

But due to limited capacity, public health institutions usually focus on the immediate needs of rape survivors and are unable to help those struggling with the longer-term health impact of rape, especially depression, anxiety or post-traumatic stress disorder.

DRC rape survivors who lack access to mental health care complain that they are being ignored. In North Kivu, for example, sexual violence survivors feel haunted by the trauma and struggle to provide for their families, yet they hardly get badly needed care for mental health.

“I sometimes wake up in the middle of the night screaming and have scary nightmares,” said Akile. “I wish I would meet my attackers face-to-face and let  them apologise to me, that would bring a perfect relief.”     

Long-term health problems

As a public health threat affecting women and girls worldwide, sexual violence has placed survivors at risk of unintended pregnancy, unsafe abortion, sexually transmitted diseases and long-term psychological trauma, experts said.

Sylvia Kaaya, professor of psychiatry at Tanzania’s Muhimbili University of Health and Allied Sciences told Health Policy Watch that survivors of sexual violence are likely to experience post-traumatic stress disorder and recurring reproductive, gastrointestinal, cardiovascular and sexual health problems.

“During trauma, the body releases cortisol to avoid pain and inflammation, and it raises blood sugar to help the victim free from danger. However, when these physical responses persist, they may cause health problems,” she said.

Sexual abuse, notably rape, may also produce gynaecological trauma including genital injury and fistula that cause complications during childbirth. 

While timely access to clinical care is essential to prevent adverse consequences of sexual violence, experts say survivors have repeatedly been traumatised due to negative attitudes amongst healthcare providers. 

A global review of healthcare-based interventions for survivors of sexual violence shows a lack of clinical competency and prevalent negative attitudes of healthcare providers in Africa often results in poor quality of health services.

Nobel Laureate Mukwege has famously summed up the sad situation for women in his country by saying that: “In conflict zones, battles take place on women’s bodies.”

But for Akile, the root cause of this status quo is male chauvinism. “I feel sorry for fellow women in my country who cannot change this situation,” she said.

Image Credits: Alexis Huguet, Kizito Makoye.

Members of the WHO Working Group on Sustainable Finance hammer out the final agreement on increasing member state contributions in 2022, Germany’s Björn Kümmel on far left.

Encouraging donors that make voluntary contributions to the World Health Organization’s (WHO) budget to enable these to be flexibly allocated rather than ringfenced for specific programmes might be more effective to “resolve the structural defect of WHO’s funding model than periodically calling for more assessed contributions from member states”.

This is according to a new paper published in the BMJ, which reveals that 88% of WHO’s biennial programme budget comes from “voluntary contributions” – almost 10% higher than the four-fifths that the organisation claims on its website.

WHO gets its money from two main sources – the assessed contributions (ACs) of member states, which are flexible, and voluntary contributions (VCs) from member states and non-state actors that are “overwhelmingly earmarked” for specific programmes and projects.

“While ACs remain at their mid-1990s levels because of the zero growth policies of the 1980s and 1990s, VCs have increased over the last decade from 75% to 88%,” the UK-based authors note, based on WHO figures from between 2010 and 2021.

Researchers Obichukwu Iwunna, Jonathan Kennedy and Andrew Harmer note that, as voluntary contributions are earmarked for donor-specified programmes and projects, “there are concerns that this trend has diverted focus away from WHO’s strategic priorities, made coordination and attaining coherence more difficult, undermined WHO’s democratic structures and given undue power to a handful of wealthy donors”.

“Surprisingly, the share of voluntary contributions provided by upper middle-income countries was consistently less than the share by lower-middle-income countries. Furthermore, in terms of their share of voluntary contributions, we found that upper middle-income countries contributed the least proportion of their gross national income to WHO.”

“Conversely, ACs have fallen gradually, from 25% of WHO’s biennial programme pudget in the 2010–11 biennium to 12% in 2020–21. As a percentage of WHO’s total revenue, VCs to the General Fund constituted 60% in 2010–11, increasing to 84% in 2020–21.”

The researchers urge the Agile Member States Task Group on Strengthening WHO’s Budgetary, Programmatic and Financing Governance to “broaden its focus on VCs to include research to better understand why donors prefer to voluntarily fund WHO”, focusing on “the incentives that determine donor support for specified and flexible voluntary contributions”.

Image Credits: Germany's UN Mission in Geneva .

Pro-abortion demonstrators in the US

Hundreds of executives from US pharmaceutical and biotech companies have condemned as “judicial activism” last Friday’s ruling by a US District judge in Texas that the Food and Drug Administration (FDA) had erred by approving the abortion pill, mifepristone.

The FDA, US Department of Justice and the drug manufacturer, Danco Laboratories have opposed the ruling, which will now be heard by the US Court of Appeals for the Fifth Circuit.

In court papers filed on Monday, the US government and Danco asked the appeal court for a decision by Thursday and the court has asked the groups opposed to mifepristone’s approval to respond to the government by midnight Tuesday.

Meanwhile, on April 7, just hours after the Texas ruling, another US District Court Judge Thomas Rice, ruled in the state of Washington that the FDA must ensure that mifepristone is available in 17 states and the District of Columbia, which had immediately sued to preserve access to the drug. 

If there is disagreement at the US Appeals Court, where the contradictory rulings are now headed, the matter will go to the US Supreme Court, which is dominated by anti-abortion judges.

Texas judge Matthew Kacsmaryk’s original ruling banning the drug was based on a legal claim brought by a number of anti-abortion groups led by the Alliance Defending Freedom (ADF); the groups claimed that the FDA had “improperly approved” mifepristone more than two decades ago. ADF is also the faith-based litigator group that also succeeded in the appeal to the US Surpeme Court to overturn the 1973 Roe v Wade ruling on 24 June 2022 – a ruling that upended 50 years of US abortion rights protection at the federal level.  

The Trump-appointed Kacsmaryk is renowned for his conservative views. While working for the conservative Christian legal organisation, First Liberty Institute, between 2014 and 2019, he also argued against a Washington law mandating pharmacies to provide contraceptives.

“Justice Kacsmaryk’s act of judicial interference has set a precedent for diminishing the FDA’s authority over drug approvals, and in doing so, creates uncertainty for the entire biopharma industry,” according to the biopharma executives in an open letter published on Monday.

“If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone,” they add. 

Meanwhile, US Health Secretary Xavier Becerra told PBS that the decision was “reckless”, and that the Biden administration  would fight to ensure that women had access to the medication.

“We intend to do everything to make sure it’s available to them not just in a week, but moving forward, period, because mifepristone is one of the safest and most effective medicines that we have seen over the last 20 years to help women with their health care, especially abortion care,” Becerra said.

“If a judge decides to substitute his preference, his personal opinion for that of scientists and medical professionals, what drug isn’t subject to some kind of legal challenge?” he added.

Mifepristone, together with misoprostol, is used in 60% of abortions within the first 10 weeks of pregnancy.

It has also become the only abortion method for women living in US states such as Alabama, Mississippi and Texas, where abortions are outlawed but women are able to purchase the drugs online from other states.

Several states such as Washington, California, Connecticut and Massachusetts have started stockpiling mifepristone pills to ensure access if the Texas decision stands, according to Stat News.

Should the ruling stand, women in states where abortion is still legal will have to undergo medical abortions that are riskier and more costly.

Image Credits: Gayatri Malhotra/ Unsplash.

WHO

Seventy-five years ago on Friday – World Health Day – the World Health Organization’s (WHO) founding constitution became the first document to formally recognize health as a human right. Three-quarters of a century later, a WHO battered by the COVID-19 pandemic is juggling how to adapt to new health threats with achieving its most basic mission: public health for all. 

“Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity,” reads the opening passage of the 1948 constitution, still in effect to this day. 

“The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition.”

Nearly 80 million people died in the two world wars in the years leading up to the establishment of WHO. Many lives were lost not from bullets or mortar shells, but from famine and disease. 

The wars, like the COVID-19 pandemic, touched all corners of the world, creating a sense of shared destiny that led to the establishment of the United Nations and its agencies to safeguard the world from another global conflict.

“In the beginning [of the pandemic], the entire world faced the same uncertain threat — and same uncertain future. That feeling of shared fate was the reason the WHO was founded 75 years ago, as countries were rebuilding after the collective trauma of World War II,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “It’s why the authors of the WHO’s constitution affirmed both that health is a human right, and that the health of all people is fundamental to peace and security.”

Two decades later, the world agreed to the WHO’s International Health Regulations, a framework for cooperation on preparedness and response to health threats that has defined the landscape of international global health ever since. 

In 1978, in the mountains of present-day Kazakhstan, the world upped its health ambitions by ratifying the Alma-Ata declaration, whose slogan set a deadline for the end of the millennium for what remains the WHO’s key unfulfilled ambition: “Health for all”. 

The finish line is far out of sight despite decades of progress

WHO
The First World Health Assembly opened in the Palais des Nations, Geneva, on 24 June, 1948, with 53 of the Organization’s 55 Member States represented, as well as nine countries not yet members.

The goal of universal health coverage remains as distant as ever, but remarkable progress has been made in the WHO’s lifetime. 

Life expectancy globally has increased from 46 to 73 years, with the biggest gains found in the world’s poorest countries. Smallpox, a scourge on humankind for thousands of years, has been eradicated. Polio is not far behind, with cases falling by 99.9% since the 1980s. 

While the HIV and TB epidemics stubbornly fight on, they are significantly diminished. HIV and TB diagnoses that once equalled a death sentence are now treatable. 

Maternal mortality has fallen by a third and child mortality has been cut in half. Significant progress has also been made against a series of neglected diseases like river blindness, sleeping sickness, leishmaniasis, and many others. 

“The WHO can’t claim sole credit for these successes – the very nature of what we do involves working with partners to support countries as they implement policies and programs that drive change,” Tedros said. “But it’s difficult to imagine the world would have seen the same improvements in health had the WHO not existed.” 

But for every problem solved, five more remain in their place.

The eradication of smallpox from the world was certified by the Global Commission, an independent panel of scientists drawn from 19 nations, in December 1979 at WHO Headquarters in Geneva.

Progress against TB and malaria has stalled. Noncommunicable diseases like cardiovascular disease, diabetes and cancers now account for 70% of all deaths globally. 

The efficacy of life-saving antimicrobials pioneered in the mid-1950s are under threat due to over-use and unregulated use in sectors like agriculture and pharmaceuticals. 

Climate change is ushering in a new era of health threats intertwined with pollution and natural disasters. Air pollution kills nearly seven million people every year.

Access to health services remains vastly unequal between and within countries. Since 2000, access to essential services has increased significantly, but at least half the world’s population still lacks access to one or more services like family planning, basic sanitation or access to a health worker. 

“Often this is because of where people live, their gender, their age, or who they are,” said Tedros. “They are people living in poverty, refugees and migrants, people with disabilities, unique minorities or other marginalized groups.”

WHO estimates the world will face a shortage of some 10 million health and care workers by 2030. The most serious shortages will be in the poorest countries as skilled workers migrate to higher paying jobs in rich nations.  

The number of people facing financial hardship due to out-of-pocket health expenses increased by a third to almost two billion people in 2017. 

COVID-19 – along with exposing deadly flaws in global pandemic response systems – disrupted health services and economies, further increasing the number of people unable to afford to treat their health needs.

“The world needs the WHO now more than ever,” Tedros said.

Paycheck to paycheck: expectations of WHO outgrow a stagnant budget

WHO
Over time, countries have ceded their roles in funding the WHO to private charities with specific health objectives, leaving the organization with less money to focus on its core mission.

Few people outside global health circles realize that the WHO operates on a shoestring budget. The organization tasked with bringing about universal health coverage for all does not even have one dollar for each of the world’s eight billion people.

For 2023, its adjusted budget is just $7.5 billion. The world’s largest economy, the United States, contributed just $680,000 – approximately 0.00000292% of its GDP.

In contrast to its budget, expectations of the WHO have grown over the decades. It effectively operates as a second health ministry in many of the world’s most impoverished regions, financing primary-care clinics, quarterbacking emergency and routine vaccine programmes, and providing medical training and guidance to local health authorities and staff.

The increased frequency of natural disasters driven by climate change have also forced WHO to take on new responsibilities as an emergency responder, providing things like sanitation services, essential medical supplies and staff support in affected countries and difficult to reach regions like northwestern Syria. 

After the earthquakes struck, WHO Director-General Tedros Adhanom Ghebreyesus (centre) became the first top UN official to visit northwestern Syria since the start of its civil war over a decade ago.

In the last year alone, WHO teams responded to over 70 global health emergencies, including the return of Ebola in Uganda, cholera outbreaks in over two dozen countries and the Mpox epidemic. 

WHO also had boots on the ground to meet health needs in the conflicts in Ethiopia, Syria, Ukraine, and Yemen, and sent aid and staff to assist people hit by the floods in Pakistan and severe droughts in the Sahel and Horn of Africa. 

And not all funding given to WHO is created equal. Over 80% of the organization’s budget consists of “voluntary contributions”, which donors designate to be spent on specific initiatives like fighting HIV or malaria. This leaves under a fifth of the WHO’s already miniscule budget to be spent flexibly on its core mission of supporting public health. 

This lack of agency in the WHO’s ability to direct funding has become increasingly acute due to the rise of influential private charities like the Bill & Melinda Gates foundation and Gavi, the vaccine alliance. Between them, they account for 15% of the WHO’s budget, all of which is earmarked for specific projects dictated by the charities.

The voluntary nature of these contributions also makes them unpredictable, creating serious budgeting challenges for some of the WHO’s most essential responsibilities.  

“Much of the WHO’s work doesn’t make headlines,” Tedros said. “We bring experts together to distill the best science into treatment guidelines on which many countries rely. We set global standards like the International Classification of Diseases. We name pharmaceutical substances, monitor disease patterns, and provide technical advice to more than 150 countries on strengthening their health systems.

“Much of it is unglamorous, painstaking, and slow-moving work,” he said. “But it makes a huge difference.”

The Pandemic Treaty: towards a new approach to global health 

The WHO’s next chapter is prearing the world for the next pandemic, with member states currently negotiating a pandemic accord that aims to address the many weaknesses exposed by COVID-19 – the most glaring being equitable access to medicines and vaccines.

Vaccine hoarding by wealthy nations during COVID-19 was a sharp reminder of an earlier epidemic of HIV, when poorer countries only got access to life-saving antiretroviral medication to a decade after wealthier countries.

The WHO has proposed that it gets 20% of “pandemic products” manufactured during the next pandemic – including medicine, vaccine and protective equipment. It will then allocate this to poorer countries. 

There are huge differences in opinion and approach amongst member states, with these negotiations being the biggest challenge facing the WHO in recent times.

However, Tedros remains optimistic that member states will choose the right way forward.

“The WHO belongs not to those of us who work for it, but to the nations and people of the world who created it 75 years ago, with a vision for a healthier, safer, fairer world,” Tedros said. “Our vision remains unchanged: The highest possible standard of health for all people.”

Image Credits: US Mission Geneva, WHO, WHO.

Pamela Hamamoto, lead US negotiator on the WHO pandemic accord.

International NGOs and activists have called out the US for siding with China to exclude the public from seeing drafts of the pandemic accord as it is being negotiated by World Health Organization (WHO) member states.

“The attempt to create a veil of secrecy now surrounding the substantive and technical text-based negotiations on the WHO pandemic treaty sets a dangerous precedent for norm-setting at the multilateral level,” the group says in a letter sent on Wednesday to the US Secretary of Health & Human Services, Xavier Becerra, and Secretary of State Antony Blinken.

Excluding the public “undermines trust in the process at a time when attacks on the WHO and on the pandemic accord are increasing”, according to the letter signatories, which include Health Action International (HAI), Knowledge Ecology International (KEI), Oxfam America, People’s Vaccine Alliance (PVA), Public Citizen and STOPAIDS. 

“No one doubts the ability of industry lobbyists to obtain access to the negotiating text documents, creating an information and influence asymmetry that is inappropriate for public health norm-setting,” they added.

China and US opposition

The letter arises from China and US opposition to a proposal by the European Union (EU) that “all inputs and additions to the zero draft should be available to all stakeholders”, which was made during the fourth meeting of the WHO’s Intergovernmental Negotiating Body (INB) that is thrashing out the accord.

However, China insisted that the marked-up version of the pandemic treaty zero draft should be circulated only to “drafting group participants”, and this was backed by the US.

US Ambassador Pamela Hamamoto stated: “I think at this stage, I have some concern about sharing the draft to all stakeholders given where we are in the process and so I just want to be careful about that and certainly if we are sharing it with all stakeholders [we] would support removing the attribution of member states.”

In contrast to the INB process, negotiations at the World Intellectual Property Organization (WIPO) are public, and observers can access the draft texts under discussion, including those with member-state attributions, the signatories pointed out.

Extended deadline for textual submissions

INB co-chair Precious Matsoso closing the 5th INB meeting.

Meanwhile, the fifth INB meeting concluded on Thursday evening with a brief public report indicating that the deadline for member states’ textual submissions has been extended from 14 to 22 April.

The INB Bureau has undertaken to get a compilation report of the submissions back to states a month later, by 22 May, with a report on the process due to be made to the World Health Assembly, which also starts on 21 May.

The next meeting of the INB’s drafting group is from 12 to 16  June, and the sixth INB meeting is set for 17-21 July.

Concluding INB5, co-chair Precious Matsoso thanked delegates for their hard work.

“We’re really grateful for this level of commitment and and the trust you’ve bestowed upon the Secretariat in the bureau,” said Matsoso.

“It’s very tight and it’s very difficult, and it will get even more difficult as we progress,” she warned.

“But we surely will do our best and hope that we can produce a product that we’ll all be proud of and that will make this world feel safer. Ten years from now, we must look back and say we made the right decisions.

The closing session, which was open to the public, was over in a few minutes after delegates agreed to the meeting report that was shown on screen. The key decisions are captured below.

Image Credits: E Fletcher/Health Policy Watch .