The World Health Organization (WHO) has launched the largest global collection of publicly available disaggregated data on health inequality, which aims to empower public health officials to conduct more targeted responses to health threats. 

Composed of over 11 million data points, the Health Inequality Data Repository (HIDR) is the first open-source tool to allow for the tracking of health inequalities between population groups over time. 

“Disaggregated data – which show how health or other aspects of life are experienced by people of different ages, economic status, education levels, place of residence, sex, and other characteristics – are a vital part of advancing equity,” WHO said. “To achieve equity, we first need to know where inequalities are.”

The lack of precise data on health indicators has long been a major challenge for global health officials. Despite constant calls by WHO for countries to improve their data collection and reporting systems, disaggregated data is still not available for many dimensions of health inequality. Only half of the qualifying Sustainable Development Goals, for example, are tracked with disaggregated data. 

When data exists, it is most frequently broken down only by sex, and occasionally by age and place of residence, limiting the ability of health authorities to calibrate their policy responses to target those most in need of assistance. 

The HIDR data set contains statistics on over 2000 health indicators relating to the Sustainable Development Goals, COVID-19, immunization, reproductive, maternal and child health, infectious diseases like HIV, tuberculosis and malaria, and other health threats, broken down into 22 dimensions of inequality along demographic, socioeconomic and geographic lines. 

Armed with more precise information about which populations require the most help, global and national health officials can make more informed decisions, increasing the impact of often limited resources. 

“If we are truly committed to leaving no one behind, we must figure out who is being missed,” WHO Director-General Tedros Adhanom Ghebreyesus said. “The ability to direct services to those who need them the most is vital to advancing health equity and improving lives.”

Along with the launch of the database, WHO issued a call to governments to redouble their efforts to adopt routine health inequality monitoring and expand data collection capacities.

“Inequality analyses should be conducted regularly at the global, national and subnational levels,” the WHO said. “Inequality data can save lives by identifying who is left behind.”

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

Access to universal healthcare remains a global challenge and even more pressing in the African region. While African-based researchers, scientists and innovators have the capability to make significant contributions towards building homegrown solutions, the continent lacks adequate financial investment in innovative pharmaceutical research and development (R&D).

To achieve the African Union’s Agenda 2063 for a bold transformation of the continent, we need to take action now.  

Coming off the heels of the recent  African Innovation for Inclusive Healthcare webinar hosted by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the Holistic Drug Discovery and Development (H3D) Foundation, it is important to continue exploring how the African science and innovation community can be scaled up to capacitate the continent’s R&D to play a more effective role in responding to local health challenges. 

The webinar illustrated the successful drug development partnerships across the industry, government and academics in South Africa. 

Homegrown solutions should be at the heart of this ecosystem we want to build. We know that the continent’s public healthcare system and health innovation ecosystem face numerous challenges including limited access to medicines, competitive technologies, shortage of a critical mass of skilled personnel and inadequate funding. 

Underfunding

In 2006, African Union member states committed to spending 1% of their GDP on R&D. However, this is still not the case. African countries still vastly underfund their R&D efforts. According to a report from UNESCO, no country in Africa is spending 1% of its gross domestic product (GDP) on R&D, although spending on science has increased globally in the past five years. The report also highlights that while Africa has 16% of the world’s population, it only has 1.3% of the world’s researchers.

We’ve got our work cut out for us, but we have made some inroads. We’ve found that the best way to curb these problems is to build collaborations and strengthen existing capabilities. 

The Holistic Drug Discovery and Development (H3D) Centre, which I lead, provides avenues for research institutions to collaborate and work together to leverage our different capabilities and mobilise funding together. The past five years have taught us that we can transform and strengthen the capacity of historically disadvantaged institutions in South Africa and effectively expand the drug discovery community across the continent through partnerships and industry – and academic-led mentorship. 

At our webinar, I was pleased to hear Elizabeth V Mumbi Kigondu, Principal Research Scientist, Centre for Traditional Medicine and Drug Research at Kenya’s Medical Research Institute, say that this “will allow us to ensure that we have medicines and products coming from Africans and solve African health problems.”

Building on these partnership models, we recently partnered with the University of Limpopo and the University of Venda on tuberculosis (TB) research initiative to boost local TB research while also accelerating capacity development at these historically disadvantaged institutions.

Training scientists is one of the key tasks of H3D.

With these projects, H3D continues to address the challenges in capacity building by training local scientists – creating a steady stream of skilled scientists to generate African-led scientific knowledge while simultaneously closing the gaps in the local science and research sectors.  While building facilities is important, it is equally important to cultivate a skilled workforce to utilise these resources effectively.

The key to driving health innovation in Africa is in strengthening human resources through science mentorship. As a J&J Satellite Centre for Global Health Discovery, H3D has partnered with the company to harness the best scientific talent in Africa and to mentor them in boosting H3D’s antimicrobial resistance (AMR) drug discovery portfolio, which will eventually attract more projects and investments. These mentorship programmes foster a culture of innovation and entrepreneurship that encourages the development of new technologies, products and services.

Having highlighted the importance of partnerships and collaborations in African R&D innovation, it is equally crucial to discuss the role of financial investment in this sector as it provides access to resources that drive R&D, technology transfer and entrepreneurship. 

Manufacturing active pharmaceutical ingredients

H3D has recently been granted funding from the United States Agency for International Development (USAID) to boost medicines manufacturing in Sub-Saharan Africa. The fund through MATRIX will support a pilot project that will evaluate innovative technology for the cost-effective manufacturing of active pharmaceutical ingredients (APIs) in South Africa.

While the South African pharmaceutical formulation industry is well developed and produces more than half the final pharmaceutical product consumed locally, the country does not have the capacity to synthesise and manufacture APIs. 

To address this challenge, H3D has partnered with an international group of scientists and a local API manufacturing company, Chemical Process Technologies (CPT) Pharma, to develop a creative approach that, if successful, could revolutionise the manufacturing of medicines in South Africa, and the rest of the continent.

This collaboration will facilitate both technology transfer and on-the-job skills development and forms a crucial role in seeding new industrial development that is so critical for absorbing the abundant labour force available in South Africa.

While there is no silver bullet, these are perhaps valuable lessons for the types of health innovations that the continent can produce when vested interests are aligned towards the same goals, particularly considering Africa’s longstanding manufacturing scarcity and the urgent need to scale up R&D efforts.

With continued funding and support for African science, research, and development innovation, Africa’s capacity for R&D and innovation will increase and this will drive progress in achieving quality healthcare for all.

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

 

Image Credits: Kerry Cullinan.

Naomi Burke-Shyne, executive director of Harm Reduction International

Fifty years into the world “war on drugs”, the drugs are winning. Global levels of drug use and production, as well as drug-related deaths and incarcerations, are at all-time highs.

Leading proponents of drug-policy reform who have gathered at the International Harm Reduction Conference in Melbourne this week say the evidence is in that it is time for the world to adopt a new approach. 

“The irony of the profound failure of the war on drugs is that it has actually driven the illicit production of more and more substances and has led to more toxic drug supply,” said Naomi Burke-Shyne, executive director of Harm Reduction International, the UK-based drug-policy justice NGO that convened the conference. 

“In order to save lives, we must offer overdose prevention and supervised space for people injecting drugs; together with pill testing to understand the potency, adulteration or toxicity of a substance,” she said. 

Helen Clark, chair of the Global Commission and Drug Policy and former prime minister of New Zealand, called the war on drugs “a complete failure”.

“The war on drugs is completely counterproductive. It has failed, and we need to try new approaches,” she told the conference. “Drug use continues to grow around the world, millions of people are imprisoned for drug possession and millions more are unnecessarily contracting HIV and hepatitis C because of lack of access to effective harm reduction measures.”

“Human beings have been using substances, for whatever reason, for thousands of years,” Clarke said. “We’re not dealing with new issues here. We’re dealing with totally inappropriate and wrong ways of tackling them.”

Drug overdose in the US continues to climb despite the ‘war on drugs’.

Supervised injection centers work

People who inject drugs in medically supervised settings are less likely to overdose, share needles, report emergency room visits, or develop abscesses when compared to people without access to such facilities, according to a new study presented to the conference on Tuesday by researchers from the French Institute of Health and Medical Research (INSERM). 

The 12-month study is the first-ever controlled trial on the efficacy and impacts of medically supervised injection rooms, which are hygienic facilities where people struggling with addiction can inject drugs under the watchful eye of medical staff. These facilities are government-operated, stocked with drug-testing kits and overdose-prevention medications like naloxone, and allow patients to access other health services like mental health support, blood tests and essential primary care.

“People can get tested for hepatitis and get started on treatment within two hours, there are sexual reproductive health services for women, lawyers dropping around, housing officers,” Burke-Shyne said.  “Yes, the space has drug consumption, but I think that really underplays how important the holistic approach to supporting vulnerable communities is.”

The study compared the behaviour of people who injected drugs in the supervised injection sites in Paris and Strasbourg to users in Bordeaux and Marseille, where no centers exist. In addition to the benefits to health and overdose reduction, the study found that people with access to supervised injection services were also far less likely to inject in public spaces or commit crimes.

Today, 16 countries around the world officially operate medically supervised injection rooms. These include the Netherlands, the United States, Canada, Australia and Switzerland – which pioneered the approach by legalizing prescription heroin in 1994.

 Results from a control study at New York City’s new supervised injection site are expected by the end of June.

 “Medically supervised injection rooms, the medicine naloxone to reverse overdoses, and drug checking technology work,” Burke-Shyne said. “They are public health no-brainers.”

Fentanyl fears multiply 

As the consequences of the push by Purdue Pharma to mainstream the prescription of high doses of the opiate pain-medication, Oxycontin, continues to ravage the United States, a new lethal drug has taken over: fentanyl.

The synthetic opiate, which is up to 50 times stronger than heroin and 100 times stronger than morphine, was identified in 66% of US drug overdose deaths in 2021. The growing inflitration of fentanyl in the country’s drug supply has resulted in many users unintentionally taking the drug – with deadly consequences.   

In New York City, where drug overdose deaths have nearly tripled since 2015, only 18% of people who inject drugs reported intentional fentanyl use, yet over 80% tested urine-positive for fentanyl, according to new toxicology data presented by researchers from the University of New York (NYU) on Tuesday.

Fentanyl is used by cartels and drug-smuggling networks to cheapen their up-front costs for heroin, which is more expensive to produce. Cutting heroin with fentanyl greatly increases their profit margins at the cost of heightened danger for users unaware their supply is mixed with a far more potent drug.

Drug-testing facilities, such as medically supervised injection rooms, can greatly reduce people’s risk of overdosing by providing clarity on the composition of the drugs they are injecting.  Intentional use of fentanyl was associated with more severe substance use disorders, high drug use frequency, and recent overdoses, the study found.  

“No one should die of an overdose,” Burke-Shyne said. “Drug consumption rooms should be accessible; they should be where people need them. It’s that simple.”

More than 1,500 people die from opiate overdoses every week in the United States. In the year leading up to March 2022, a staggering 110,366 people lost their lives to drug overdoses – nearly 20 times the per capita death rate of the European Union.

Needle-borne diseases are critically underfunded 

Medical advances in recent years have made hepatitis C highly treatable. While the medications are affordable in most low- and middle-income countries, chronic underinvestment in hepatitis C and harm prevention programmes have handicapped efforts to eradicate the disease. 

On Tuesday, UNITAID announced a $31 million commitment to prevent hepatitis C in high-risk populations like people who inject drugs and people in prisons. The investment represents a 20% increase in global harm prevention efforts, which UNITAID said will also assist health systems in curbing the transmission of other blood-borne diseases like HIV. 

While people who inject drugs make up just 10% of the world’s 58 million people infected with hepatitis-C, injecting drugs contribute to 43% of new infections. Eighty percent of people infected with hepatitis-C live in low- and middle-income countries. 

Criminalisation has long been a hallmark of the war on drugs, but advocates say the practice of confining high-risk populations to prisons actually multiplies the risk of infection. 

Criminalising drug use “only serves to overpopulate the prison services and the risks, therefore, multiply,” said Kgalema Motlanthe, former president of South Africa and a commissioner at the Global Commission on Drug Policy. “Those who are literally sleeping over each other in prisons that are overcrowded end up really being exposed to more risks.”

Jason Grebeley, head of the University of New South Wales’ Hepatitis C and Drug Use Group, added that the health benefits of decriminalisation are often overlooked. 

“It’s really critical that we think about the fact that decriminalisation could actually play a major role in reducing a range of harms for people who inject drugs,” he said. 

Image Credits: Conor Ashleigh/Harm Reduction International.

WHO
Dr Tedros Adhanom Ghebreyesus, director-general of the WHO.

Two weeks after a Texas judge stirred controversy by banning a popular US abortion pill, WHO’s Director General has explicitly re-affirmed the organization’s support for abortion rights, stating that “women should always have the right to choose when it comes to their bodies and their health”. 

Dr Tedros Adhanom Ghebreyesus’ comments came just a day before the US Supreme Court is set to decide whether to suspend the judge’s ruling and maintain full access to the abortion drug, mifepristone, while the case is appealed. The case will be the court’s most significant consideration of abortion rights since its landmark ruling last June overturning the 1973 decision of Roe v. Wade, guaranteeing abortion rights nationally.

Speaking at a Tuesday press briefing, Dr Tedros Adhanom Ghebreyesus also called on Afghanistan’s Taliban regime to reconsider their ban on Afghan women working with UN agencies to deliver vital health services.

Echoing a recent statement by UN Secretary General Antonio Guterres that the ban is a “violation of the fundamental human rights of women”, Tedros said: “Female staff members and health workers are essential for delivering lifesaving and services to those in need. I call on the Taliban to rethink a decision that will massively reduce access to health services and only harm the Afghan people”.  

On 4 April, 2023, Taliban banned women from working in UN offices in Afghanistan. UN officials have initiated a period of operational review in Afghanistan till 5 May, 2023 and have reportedly warned that the organization may choose to halt all operations in the country if the ban is not rescinded. The Taliban move follows on a December 2022 decision banning women from working in NGOs across Afghanistan.

DG articulates longstanding WHO abortion rights policy

In commenting on the US abortion controversy, now before the US Supreme Court, Tedros protested attempts by politicians and courts to curtail women’s right to access safe abortions.  

“WHO is concerned that the right of women to access safe abortion services, including through use of medical abortion medicines, are being limited by legislators and or courts. To be clear on WHO’s position, women should always have the right to choose when it comes to their bodies and their health,” Tedros said. 

“Restricting access to abortion does not reduce the number of procedures and only drives women and girls towards unsafe ones and also death. Ultimately, access to safe abortion is healthcare that saves lives.” 

Tedros was, in fact, repeating a longstanding WHO position on abortion rights, which is articulated on its Health Topics page, which states:

“Ensuring that women and girls have access to abortion care that is evidence-based – which includes being safe, respectful and non-discriminatory – is fundamental to meeting the Sustainable Development Goals (SDGs) relating to good health and well-being (SDG3) and gender equality (SDG5).”

Even so, it was the first time in several years that the WHO DG had taken such an explicitly public position on the charged issue. Far milder language supporting women’s right to access sexual and reproductive health services was often hotly opposed by the previous US administration of President Donald Trump in a number of UN fora, including the World Health Assembly, because it was presumed to include abortion services.

Response to controversy sweeping the United States

WHO’s statement came in response to a ruling by the Texas US Northern District Judge Matthew Kacsmaryk on 7 April that the Food and Drug Administration (FDA) had erred by approving the abortion pill, mifepristone, suspending the initial FDA approval of the drug more than two decades ago, as well as a number of regulatory amendments made since that eased access.  

Kacsmaryk‘s  ruling not only threw into question the legal status of the pill used for 54% of US abortions, but also the longstanding authority of the FDA to determine what drugs are safe and authorized to use – or not – nationwide.  Only hours later, Judge Thomas Rice of the U.S. Eastern District in the state of Washington, issued an opposing ruling, ordered the Food and Drug Administration to preserve access to mifepristone in the 17 states and the District of Columbia which had sued to protect access to the drug.

Then on 12 April, 2023, a partial stay was granted on Kacsmaryk‘s ruling by the Fifth Circuit Court of Apeals after the drug’s manufacturer Danco Laboratories, the FDA and the US Department of Health and Human Services (HHS) appealed. The partial stay allowed mifepristone to be available to women pregnant for seven weeks or less, but only with a doctor’s prescription delivered in person. That was in contrast to more recent FDA rulings that women can safely use the drug in pregnancies up to ten weeks, and may also access the drug via the post.   

On 14 April, 2023, the Supreme Court issued a temporary hold on the original decision until 19 April, 2023; the Court is preparing to  reconsider the Texas court’s ruling, at the request of the US HHS for an emergency intervention. 

16 confirmed, 23 probable Marburg cases

Meanwhile, the number of cases of Marburg virus disease in Equatorial Guinea has increased to 16 confirmed and 23 more probable cases with 11 deaths, WHO officials also reported at the briefing. 

That’s more triple the number of confirmed and probable cases that were last reported on 30 March,when Equatorial Guinea announced a total of 13 people had been infected.  Two more people have also succumbed to the disease, bringing the death count to 11 since the outbreak began in February. 

Bata, a port city in Equatorial Guinea’s Litoral district, is the most affected area with nine cases, WHO officials said at the briefing. 

But they pushed back on reporters’ suggestions that travel restrictions might be necessary to contain disease spread.

“It’s not the time for travel restrictions. It has not helped the world. It just harms those countries who are doing the right thing, struggling [against] these macroeconomic challenges the whole world is facing,” said Dr Abdi Rahman Mahamud, director of WHO’s Alert and Response Coordination Department. 

“A few countries have screening, which has some rationale, and we received the update on that, but it’s not the time for travel restrictions,” he added, saying that “WHO is very clear” in its opposition.  

Mahamud added that Equatorial Guinea has also learnt a lot from its COVID-19 experience and has established a “good, robust” response to the Marburg outbreak. 

–Updated on 20.4.2023 to correct the name of the Texas judge who on 7 April issued the original ruling suspending use of mifepristone to US Northern District Judge Matthew Kacsmaryk; On the same day. US District Court Judge Thomas Rice, of the US Eastern District Court in the State of Washington, issued the contradictory ruling to preserve access in 17 other states and Washington DC. 

Medical technologist Candice Snyders preparing samples for analysis at the BMRI facility in South Africa

CAPE TOWN – The most advanced biomedical research centre on the African continent has opened in South Africa, boasting state-of-the-art research and training facilities.

Stellenbosch University’s Biomedical Research Institute (BMRI) houses over 500 researchers who are examining the genetic and biomolecular basis for diseases afflicting Africans – including Professor Tuilo De Oliveira, renowned for decoding the COVID-19 variant, Omicron.

De Oliveira’s Centre for Epidemic Response and Innovation (CERI) is one of only two specialised genomic facilities on the African continent, the other being Christian Happi’s African Centre of Excellence for Genomics of Infectious Diseases at Redeemer’s University in Nigeria. 

“Our mandate on the continent from the Africa CDC is to support other African countries with identifying and characterising pathogens, and we do that – dozens and dozens of pathogens, many of them that you may not have ever heard,” De Oliveira told the media launch.

“For example, we sent a team to Malawi last week to help characterise their explosive cholera outbreak. We have a team going to Mozambique to do a similar thing. We also  receive samples from other countries in Africa and produce genomes that can better characterise the pathogens because if you can characterise the pathogen, you can develop the diagnostics, you can develop the therapeutics and you can develop a vaccine.”

Aside from providing genomic sequencing for 26 African countries in the past year, CERI has had is running an African genomics Africa fellowship, and has trained 320 fellows so far to take the technology back to their own countries. 

Prof Tulio De Oliveira, who decoded Omicron, has a research unit at BMRI.

De Oliveira is one of only 20 scientists represented on the World Health Organisation’s virus evolution committee that helps to guide the global response to new virus threats as they evolve. 

“Unfortunately, that’s what viruses do – evolve. We saw that with COVID evolving a lot. We see how HIV evolved to generate drug resistance. We are now very worried about the evolution of the the avian pathogenic strain of H5N1 that’s decimating the bird populations around the world,” says De Oliveira. “Pathogens don’t respect borders.”

The BMRI cost around $66-million, was financed primarily by the university itself, and took four years to build as the pandemic slowed construction, said vice-dean Professor Nico Gey van Pittius.

“Fifty percent of the African continent is under the age of 25. We want to capacitate the future scientists. This is where the future Nobel Laureates will come from,” said van Pittius.

Fingerprick TB test

Prof Novel Chegou

For Professor Novel Chegou, who has spent 18 years at the university from when he was an honours student to his current position as a professor in molecular biology and human genetics, the beauty of the facility is that it enables conversations between scientists in different disciplines.

“This building was designed with collaboration in mind. It’s easy to collaborate. I can go and talk to the microbiology people. I can track down Tulio and bounce some ideas off him. There are all these top scientists. If you’re a younger person, you’re not really limited to work with with your supervisor,” says Chegou.

In contrast, in the past scientists were crammed four people to an office, even if you were a full professor, Chegou remembers.

One of the most exciting prospects for BMRI is the fingerprick blood test for tuberculosis that Chegou and his team are testing in clinical trials – something that has developed as a result of a “huge collaborative effort”, he adds.

Tuberculosis is the most common – and deadliest – infectious disease in South Africa, but testing for it isn’t that easy, particularly if it is outside the lungs.

Another exciting initiative is a project examining how an active ingredient in turmeric called curcumin might play a role in mitigating Parkinson’s Disease.

Prof Soraya Bardien

“Around one percent of the global population over the age of 60 suffers from Parkinson’s Disease,” says Professor Soraya Bardien, who heads the only research project on the disease in the country.

“Unfortunately, the prevalence in South Africa is not known because studies have been done on that. What is known is that Parkinson’s is the fastest growing neurological disorder worldwide,” adds Bardien.

“Our research focus is twofold. One, we work on the genetic causes of the disease and we use genetic and genomic approaches to identify cases in South African individuals with Parkinson’s disease. And then secondly, we use therapeutic approaches on curcumin.” While results are “years away”, curcumin has proven to be a “powerful antioxidant” acting against cell death in the laboratory.

Another pressing problem is the rise of cardiovascular and metabolic diseases in South Africa, which are projected to rise exponentially over the next few decades.

Prof Faadiel Essop

“There’s a paucity of work that we’ve studied our own populations,” says Professor Faadiel Essop heads the Centre for Cardio-metabolic Research in Africa (CARMA). 

But one of his concerns is how cardio-metabolic diseases are interacting with HIV. Souh Africa has the largest HIV burden globally, and people with the virus are living longer but also developing cardio-metabolic diseases related to a host of factors including diet and the side effects of antiretroviral drugs. 

CARMA is conducting a longitudinal study of people living with HIV in a community called Worcester examining contributing factors to cardio-metabolic diseases, such as changes in the bad cholesterol (LDL), obesity, smoking, and the side effects of ARVs.

Virtual reality

The Biomedical Research Institute was launched this week in Cape Tpwn.

During a tour of BMRI, teams of neurosurgeon registrars are doing simulated laparoscopic neck surgeries on cadavers while supervised by Professor Ian Vlok in the SunSkill facility, a specialist facility for training surgeons.

In the psychiatry laboratory, students hope that they will be able to treat post-traumatic stress disorder, using virtual reality to understand how stress hormone cortisol is released and whether they can find a way to stop this.

The largest biosafety level three laboratory enables research on a wide variety of pathogens, while a biorepository can store 3.5 million samples in temperatures of -80 degrees C.

Bioinformatics students are coding, a staff member is packing away bones.

“The investment in the BMRI will allow significant human capacity development through training some of the best students from the continent and exposing them to extensive national and international research networks,” says Medical Dean Professor Elmi Muller.

“The BMRI will be a game changer for healthcare in Africa and is true evidence of using breakthrough science to improve lives.”

 

Image Credits: Kerry Cullinan, Stellenbosch University.

WHO's New Leadership Team

Nearly a year after his appointment to a second term as WHO’s Director General, Tedros Adhanom Ghebreyesus has finished a revamp of his senior leadership team –  keeping key loyalists in place, while adding new faces that are a clear nod to powerful member states such as China, France and Japan. 

But the new team members come with a mixed bag of experience – and some have hardly any experience at all in the areas to which they have been appointed, WHO insiders were quick to say in reaction to the new appointments.  

The new appointees include Dr Ailan Li, a Chinese national and head of WHO’s Cambodia office, as Assistant Director-General for WHO’s ‘Healthier Populations’ cluster which covers the increasingly critical areas of climate change, pollution, healthy lifestyles and nutrition. 

Dr Yukiko Nakatani, currently deputy director in Japan’s Ministry of Health, will become Assistant Director-General for Access to Medicines and Health Products, a politically charged area of work marked by oft-highly charged battles between pharma companies and medicines access groups over drugs costs and IP rights. 

Another new appointment is Dr Jérôme Salomon, a French national, as Assistant Director-General for Universal Health Coverage, Communicable and Non-communicable Diseases.  Of the three, Salomon has the most extensive global public health experience, including stints on the WHO Emergencies Committee; as a director at Institut Pasteur in Paris, and as a  full professor at the Simone Veil Medical School, Paris.  

Significant to the success of the pandemic treaty negotiations is the appointment of Catherina Boehme, formerly chef de cabinet, as ADG of External Relations and Governance. In that role, Boehme will represent WHO in critical negotiations between WHO member states over the proposed treaty, as well as other processes, such as reform of the existing International Health Regulations.  As a German national who also previously served as chief medical officer at the Geneva-based Foundation for Innovative New Diagnostics (FIND), before becoming its CEO, she brings with her both deep speciality expertise as well as an understanding of member state pressures and needs – both in high income and developing countries.

Trusted advisor Aylward gets new role

Dr Bruce Aylward has been a key member of Tedros’s inner circle throughout his tenure as Director General.

Meanwhile, Bruce Aylward, a longtime Tedros senior advisor, was appointed Assistant Director-General of the Universal Health Coverage, Life Course Division – where he will “drive the organization’s agenda to transform primary health care as central to universal health coverage, as well as overseeing WHO’s work on health systems, immunization and reproductive, maternal and child health,” according to a WHO press release Monday announcing the new team.

Aylward had previously led the DG’s “Transformation” initiative which sought to revamp the organization’s internal structure until the COVID pandemic shifted his attention to health emergencies, where he participated in the first visit by senior WHO leaders to China at the outset of the pandemic in February 2020, and later led WHO’s work on the multi-agency Access to COVID-19 Tools Accelerator (ACT-A) Hub, including the creation of the COVAX vaccine facility. 

“In his new role, Dr Aylward will drive the Organization’s agenda to transform primary health care as central to universal health coverage, as well as overseeing WHO’s work on health systems, immunization and reproductive, maternal and child health,” said Tedros’ announcement. Aylward holds a medical degree and a master’s degree in public health.

Previously announced additions to the senior management team include Jeremy Farrar, former head of Wellcome Trust, as new Chief Scientist. Farrar, a noted epidemiologist who also played a key leadership role in the global public health response to COVID, is probably the most high-profile public health personality to join the WHO senior team. He replaces Indian national Soumya Swaminathan.  

Disappointment in healthier population cluster 

Dr Ailan Li has been head of WHO’s Cambodian office since July 2019.

There was, meanwhile, disappointment in WHO’s internal ranks over the appointment of Li to the Healthier Populations cluster.  With a background primarily in emergencies and emerging infectious diseases, it is an area of work that will be entirely new to her professionally.  

“Clearly she has no experience in this area of work at all,” said one WHO staff member. Another insider who previously worked with her in the Western Pacific region described Li as a “micro-manager” who had performed a primarily political role until now as head of the Cambodia WHO office.

While it is common for the DG to give influential WHO member states a seat around the leadership table, previous Chinese appointees, such as Ren Minghui, also had significant public health careers alongside their political assignments and gained wide respect during their time in Geneva.  Minghui, a former ADG of WHO’s Universal Health Coverage cluster until recently, is now a director general at the Chinese Ministry of Health. 

Dr Yukiko Nakatani (middle) will become Assistant Director-General for Access to Medicines and Health Products in May.

Meanwhile, Nakatani, appointed ADG in the Access to Medicines cluster, is regarded as a largely unknown quantity by Geneva observers of the complex set of issues circling around that topic – which range from the high cost of cancer drugs to issues around the transparency of clinical trial data and prices paid by countries for bulk medicines purchases. 

A paediatrician by training, Nakatani has worked on topics such as medical device reimbursement and price-setting regimes during her time at Japan’s Ministry of Health – sometimes defending policies that raised the ire of industry.  

During her two years as a WHO technical officer, she also co-authored a number of papers on assistive technologies.  But she appears to lack the rich policy background of her predecessor, the Brazilian Dr Mariângela Simão, in the area of medicines access. Prior to arriving at WHO, Simão was a senior official at UNAIDS and in Brazil’s Ministry of Health, where she led successful negotiations with pharma companies to lower the price of HIV medicines.   

Appointments of trusted associates a Tedros hallmark  

Dr Mike Ryan alongside Tedros on a visit to areas of northwestern Syria affected by the February earthquakes.

Only a handful of senior officials who served in the first five years of Tedros tenure, remain in the new leadership team. Those include  Dr Hanan Balkhy, a Saudi Arabian national, as Assistant Director-General for Antimicrobial Resistance (AMR), where she is leading a multi-sectoral collaboration with the Food and Agriculture Organization, the World Organization for Animal Health, and the United Nations Environment Programme, to enhance prevention of AMR through better management of animal and environmental drivers.

Prior to joining WHO, Dr Balkhy, a paediatrician, was Executive Director for Infection Prevention and Control at Saudi Arabia’s Ministry of National Guard. 

Other long-serving staff include Mike Ryan, Executive Director of Health Emergencies, and Samira Asma, head of Data, Analytics and Delivery for Impact (DDI).   

Ryan, a respected emergencies specialist, was the public WHO face of the global COVID response. But he also demonstrated intense loyalty to Tedros echoing his statements on controversial WHO positions, such as opposition to public masking in the early days of the pandemic.  

Asma is considered a close Tedros confidante. Her management of DDI has been controversial internally insofar as she lacks the health statistics, measurement and monitoring of her predecessor, Ties Boerma, now a professor at the University of Manitoba. As the head of WHO’s former department covering health metrics and monitoring, he wielded huge influence and authority in both the strategic direction and implementation of WHO’s work.  

Triple Billion targets – a movable goalpost 

Dr Samira Asma is considered one of Tedros’s closest confidantes by WHO insiders.

Asma is also tasked with showing progress on WHO’s ‘Triple Billion’ targets for achieving access to universal health coverage, improved health emergencies’ response, and healthier lifestyles and environments for three billion people worldwide by 2023. 

The Triple Billion targets were the centerpiece of Tedros’ strategic direction in his first five years of office.

In Monday’s announcement, the DG recalled them once more, saying that the reformed senior leadership team aims to: “accelerate progress on implementation of WHO’s 13th General Programme of Work (GPW13), and achievement of its “triple billion” targets and the health-related Sustainable Development Goals.”

But critics say that the targets are a moveable goalpost – a useful public relations tool but targets for which it is virtually impossible to demonstrate concrete, measurable progress, in the ways outlined by WHO’s 13th Programme of Work (2019-2023).   

Disappointment among senior civil servants 

There was also some disappointment that none of the senior WHO staff that had been serving as interim Assistant Director Generals received final appointments to Tedros management team, with the exception of Aylward. 

Influential member states like the United States had earlier expressed some hopes that the promotion of more senior WHO staff through the ranks to senior leadership positions could help convey a stronger sense of professionalism and accountability within the organization’s ranks. 

Instead, four senior staff who had briefly served as interim ADG’s were summarily dismissed by Tedros with little more than a ‘thank you’ conveyed via an internal note sent out to WHO staff simultaneously to Monday’s announcements.

Observed one WHO scientist, “I think our organization needs a very clear and honest agenda first of all. We need strong technical competency, less political mumbo jumbo, and honesty and accountability; this is what we have lost over time.” 

-Updated on Tuesday, 18 April 2023

Image Credits: Guilhem Vellut, DFID, WHO, Japan MoH, WHO.

Vials of Pfizer´s COVID-19 vaccine. COVID vaccines mostly reached in or around the regions they were produced, a WHO report finds.

A South African group that promotes anti-Semitic conspiracy theories claims to have issued a high court application to challenge the authorisation of the Pfizer COVID-19 vaccine by the country’s health minister and regulatory authority – but the health department has not been served with any legal papers.

In a recent publicity drive, the Freedom Alliance of South Africa (FASA) released papers it claims to have lodged in the country’s high court calling the authorisation of Pfizer’s COVID-19 vaccine “unlawful”, and naming the South African health minister, regulatory authority SA Health Products Regulatory Authority (SAHPRA) and Pfizer amongst its respondents.

But South African health department spokesperson Foster Mohale said that while the department had heard of the case “we have not received court papers on this matter”.

Meanwhile, Willis Angira, Pfizer’s external communications manager for East and Southern Africa declined to comment saying: “Unfortunately we cannot comment on ongoing legal proceedings”.

The 736-page “court documents” also have no court number or stamp indicating that they have actually been lodged in court.

FASA appears to be part of the international anti-vaccine movement, and cites as supporters of their case a number of outspoken critics of COVID-19 vaccines such as UK cardiologist Dr Aseem Malhotra, Prof Norman Fenton, Jessica Rose and Dr James Thorp.

Bizarre conspiracies

FASA promotes a range of extreme conspiracy theories on its website, including that the world is run by Freemasons who “sold their souls to satanic Jewish bankers”, and together they orchestrate wars, “conspire for world domination” and “subvert the West”.

They have also published articles on their website claiming that the COVID-19 vaccines contain artificial intelligence “synbio” aimed at “transforming humanity to Human version 2.0”, and that these react to WiFi and 4G, and assemble microchips in people’s bloodstreams.

FASA’s Telegram channel makes claims about vaccines making you magnetic or emitting Bluetooth signals, and bizarre 5G conspiracy theories about streetlights.

In the section on international partners, FASA includes the logo of Save the Children, but a spokesperson for that organisation said that “we are in no way associated with FASA – this is not a campaign that we support”.

Despite its logo appearing on the group’s website, Save the Children has no links with the anti-vaccine group in South Africa.

International vaccine court challenges

Meanwhile, in the US, renowned anti-vaxxer Robert F Kennedy Jr and his organisation, the Children’s Health Defense, are suing a number of news organizations fighting misinformation, including the BBC, Washington Post, Associated Press and Reuters.

They claim that these outlets have censored “alternative COVID narratives”, and that they have been “censored, de-monetized, demoted, throttled, shadow-banned, and/or excluded entirely from platforms like Facebook, YouTube, Twitter, Instagram, and Linked-In.”

Kennedy’s group has opted to bring the case in the jurisdiction of ultra-conservative Texas judge Matthew Kacsmaryk, who recently ruled that the US Food and Drug Administration (FDA) had erred by authorising abortion pill mifepristone.

Image Credits: Photo by Mat Napo on Unsplash.

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 .