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 .

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 .