covid-19
The results of a controversial “human challenge” study challenged the assumption that the contagiousness of a person is correlated to the severity of their symptoms.

Since the beginning of the SARS-CoV-2 pandemic, the popular assumption was that people displaying severe symptons were also the most contagious. But new data from a controversial Imperial College London study published on Tuesday found the two participants that were the biggest “superspreaders” of the virus both displayed only minor symptoms. 

“How symptomatic a person is has often been assumed to indicate their contagiousness,” said the authors of the ‘challenge’ study, published in The Lancet.  The study, involving healthy volunteers who were deliberately infected with COVID at a time when no vaccine or treatments existed, found that the severity of symptoms experienced by the volunteers “did not influence the extent of viral emissions.” 

At the time of its launch in 2021, one leading expert called it “dumb and dangerous“, in an interview with Health Policy Watch.

But the data collected from the 34-person study paid off.  There was no direct relationship between symptom severity and viral load among the 18 volunteers who went on to develop COVID, and were monitored for two weeks from a hospital bed. The variability is something the researchers suggested may be attributable to the diversity of physiological factors such as breathing mechanics or mucous acidity. 

“It’s that variability among humans that has made this virus so difficult to control,” Monica Gandhi, an infectious-diseases expert at the University of California told Nature, in a review of the findings.    

Ethics and risk

The study’s findings are as provocative as its design. The trial is a “human challenge” study, in which researchers deliberately infected participants with COVID-19 in what is known as a “human challenge” study. The ethics of infecting healthy, young participants with a potentially life-changing and potentially deadly virus – regardless of scientific upside – are fiercely contested.

When the Imperial College study was announced in 2021, Dr Ken Kengatharan, co-founder and chairman of the California-based biotech firm Renexxion, told Health Policy Watch that a COVID-19 challenge study was “as dumb and dangerous an idea as it gets”.

“SARS-CoV-2 is an atypical coronavirus (without any comparable out there or historically, and we are just learning about its mode of action,” Kengatharan said at the time.   

Many of Kengatharan’s apprehensions have since been proven right. Around 36 million people in Europe – one in 30  – may have developed long-COVID over the first three years of the pandemic, the World Health Organization (WHO) announced Tuesday.

“Clearly much more needs to be done to understand it,” WHO European Director Dr Hans Kluge said. “Ultimately, the best way to avoid long-covid is to avoid COVID-19 in the first place.”

Understanding the role of “superspreaders” in the COVID pandemic could be and important component of effective policy making frameworks for future outbreaks.  Superspreader patterns were also identified during earlier coronavirus outbreaks, such as the SARS outbreak that began in 2002, and the outbreak of Middle East respiratory syndrome coronavirus a decade later.  

WHO’s symptomatic criteria for testing were ill-founded

Viral emissions mostly occurred after participants developed early symptoms and began to test positive by lateral flow tests, the study found.

The authors of the study reckon the unique perspective their data provides on several key public health questions about the COVID-19 virus justifies the risks taken by the volunteers.

The unpredictable nature of COVID-19 has led scientists and average people alike to speculate that pre-symptomatic infections were a big reason the virus proved so hard to contain. Scientific modelling has estimated that at least 30-50% of community transmission occurred before people became visibly sick, but models are only accurate to the extent of the assumption that underpin them.

The data released by the Imperial study is also the first to quantify pre-symptomatic viral emissions in a real-world setting, and tells a different story: just 10% of virus emissions recorded occurred before the onset of symptoms. 

In that respect the study also challenged the usefulness of the WHO’s suspected case criteria, observing that over one-third of virus particles emitted by participants were shed before symptoms met the WHO guidelines.

The UN health agency’s criteria, used by governments around the world to determine eligibility for COVID-19 testing at the height of the pandemic, are “relatively poor definers of the onset of contagiousness,” the study said.

In contrast to the inefficacy of the WHO criteria, lateral flow tests were able to identify infections in most participants before symptoms and viral shed began – demonstrating their potential power for containing future outbreaks.  

“A heightened awareness of early symptoms prompting self-testing could identify a large proportion of infectiousness,” the study said.

Researchers said further challenge studies on newer variants of COVID-19 such as Omicron are planned for the near future.

Image Credits: Unsplash, ClimateWed/Twitter, Maxpixel.

The Gambia
Medicated syrups manufactured in India have come under the global scanner for contamination.

The Gambia has mandated pre-shipment quality testing on all pharmaceutical products exported from India. The requirement will come into effect on 1 July 2023. It can be understood as an after-effect of last year’s scandal whereby India-manufactured cough syrups allegedly claimed the lives of 66 children in The Gambia in 2022 . 

Following the episode, WHO conducted independent testing of the cough syrup samples that had been administered to the children in Switzerland, finding 23 samples contaminated with the industrial chemicals, DiEthylene Glycol (DEG), and Ethylene Glycol (EG).  

In May, following a series of scandals involving contaminated cough syrups both domestically and abroad, India made it mandatory for all exported syrups to undergo testing and certification from a government laboratory from 1 June.  No such requirement yet exists, however, for domestic production. 

However, the new rules regarding exports, as well as imposition of quality-assurance requirements by other countries, such as The Gambia, should further put the industry on alert regarding long standing issues with quality assurance.  

According to a communique sent by the Medicines Control Agency (MCA) of The Gambia to the Drugs Controller General of India (DCGI), and published by the Indian drug control agency, all pharmaceutical products that will be exported to the country shall be inspected and sampled for testing to ensure they conform to quality standards. 

To make sure that the products meet quality-assurance criteria, the MCA has appointed Quntrol Laboratories Private Limited, an independent verification, inspection and testing company, to carry out the process and issue a Clean Report of Inspection and Analysis (CRIA) for each shipment from India to The Gambia, beginning in July. 

“All shipments arriving into The Gambia with bill of lading [export document] dated on or after 1 July 2023 will be required to provide the CRIA for customs clearance at the Ports of Entry in The Gambia,” the communiqué dated 15 June 2023 said. 

The DCGI has circulated the communiqué among all the state drugs controllers, their counterparts at the zonal and sub-zonal levels, and the various manufacturing associations in India. “This is for your information and immediate action,” the letter from the Indian DCGI to the other stakeholders said. 

According to the process outlined by The Gambian MCA, the exporter of the pharmaceutical products is responsible for raising an inspection request with Quntrol Laboratories, which will then retrieve samples from the shipment and send them to be tested in MCA approved labs. Upon successful testing of the samples, a CRIA is sent to the exporter, which shall be shared with the importer. The importer shall use this certificate to take possession of the shipments from The Gambian Ports of Entry. 

Deaths in The Gambia strongly linked to Indian cough syrups

In October 2022, the World Health Organization (WHO) issued a product alert for substandard cough syrups manufactured in India, linked to the deaths of at least 66 children in The Gambia. The syrups were manufactured by Maiden Pharmaceuticals in India. 

India halted production at the plant temporarily after WHO commissioned lab tests found DiEthylene Glycol (DEG) in the range of 1% to 21.30% weight/volume in the cough syrup samples. DEG is completely banned in pharmaceutical products. 

India has, however, also maintained that its tests on the control samples of the cough syrups collected from the batches exported to The Gambia showed no traces of contamination.

Meanwhile, The Gambia had sought the assistance of the US CDC to investigate the sudden spike in AKI in children between June and September 2022. In March 2023, the US CDC released its report that suggested strong links between the cough syrups consumed by the children and their AKI. 

“This investigation strongly suggests that medications contaminated with DEG or Ethylene Glycol (EG) imported into The Gambia led to this AKI cluster among children,” the report stated. 

Other product alerts for Indian cough syrups

In January 2023, WHO issued another alert flagging two products manufactured in India and exported to Uzbekistan and Cambodia as containing “unacceptable amounts” of DEG and/or EG. Both these products were manufactured by Marion Biotech Private Limited in India. The alert came after Uzbekistan alleged that 18 children died after consuming the syrup. 

In April 2023, the WHO issued yet another product alert flagging a contaminated syrup identified in Marshall Islands and Micronesia. The syrup was manufactured by Trillium Pharma in India and also contained “unacceptable amounts of DEG and EG”, as per the WHO report. Trillium Pharma, however, has maintained that it did not sell these products in these countries. 

Within India, as well, communities in states as far-flung as Kashmir and central as Uttar Pradesh have reported a series of adverse events associated with the administration of cough syrups. 

The problems occur primarily in the manufacturing process. When paracetamol syrup or cough syrups are manufactured, they need a solvent to dissolve the active ingredients, add sweetness, and act as a lubricant. The solvents used are either glycerine or propylene glycol, a clear, faintly sweet, and viscous liquid.

Glycerine Indian Pharmacopoeia (IP) grade is supposed to be used in drugs and medicines, in line with good manufacturing practices framed by the WHO.  However, when industrial glycerine, used in chemicals and cosmetics, is used instead, it can contain contaminants such as diethylene glycol and ethylene glycol. 

Image Credits: Photo by Towfiqu barbhuiya on Unsplash.

Medicines Patent Pool

The Medicines Patent Pool (MPP) announced sublicensing agreements with seven manufacturers to produce and distribute generic versions of Japanese pharmaceutical company Shinogi’s COVID-19 antiviral treatment in 117 low- and middle-income countries. 

Ensitrelvir is an oral antiviral currently only approved in Japan under the country’s emergency regulatory approval system. The drug is being evaluated under a fast-track designation by the US Food and Drug Administration, and its regulatory authorization is still pending in all the 117 countries listed in the license agreement. 

“Even though COVID-19 is no longer classified as a Public Health Emergency of International Concern, we see numbers ebb and flow across continents as we learn to live with the disease,” said Charles Gore, Executive Director of MPP. “Having quality effective treatments readily available in LMICs is still so important.” 

The absence of regulatory approval for Shinogi’s drug stands in contrast to Paxlovid, a similar oral antiviral rolled out by Pfizer in the early months of the pandemic. Paxlovid has been available under emergency authorization in the United States since December 2021, which was followed a month later by the European Union. Full marketing approval was granted by both the US and EU in the first half of 2023. 

Ensitrelvir has a steep hill to climb

MPP signed sublicensing agreements to manufacture and distribute Paxlovid in 95 low- and middle-income countries in November 2021. Under the terms of the agreement, Pfizer abstained from royalties on sales as long as COVID-19 remained classified as a Public Health Emergency of International Concern.

The WHO’s declaration of the end of the COVID-19 public health emergency in May changed the terms, but not by much. Pfizer became entitled to a 5% royalty fee on sales to the public sector in lower-middle-income and upper-middle-income countries. Low-income countries, however, can still purchase Paxlovid without paying royalties. 

Ensitrelvir still has a steep hill to climb if it is to make an impact. But for communities on the ground in LMICs, the prospect of having access to another treatment is good news. 

“Through my work, I support two sisters who lost their parents to COVID-19 at the height of the pandemic. In our communities, such loss goes beyond the terrible grief as the young adolescents have been left to fend for themselves at a vulnerable age,” said Nombeko Mpongo of the Desmond Tutu HIV Center in South Africa. 

“Access to treatment is so much more than a question of life and death, it is about the well-being of entire communities,” he said. “I welcome this announcement that will enable equitable access to COVID-19 treatments in my country and other LMICs.”

Oasis de Huacachina in Ica, Peru

Peru is experiencing its worst-ever outbreak of dengue fever, with over 172,000 cases by Monday, according to the country’s health department.

Of these, over 92,000 are confirmed while almost 80,000 are suspected cases, with countrywide floods and increasing temperatures driving the outbreak.

The country has declared a health emergency in 222 districts. The north-western provinces of Piura and Lambayeque are worst affected, while the worst affected cities are Lima and Ica.

Some 228 people have been confirmed to have died from the viral infection that is transmitted by infected Aedes mosquitos. However, the fatality rate is expected to rise as health authorities investigate further deaths.

Peru’s caseload is already double that reported in the same period last year, and more than four times higher than the average of the last five years, according to the World Health Organization (WHO).

Meanwhile, Argentina also experienced one of the largest dengue outbreaks in its history in the first three months of this year (dengue is most prevalent there between October and May). 

“The incidence of dengue has grown dramatically around the world in recent decades, especially in the Americas, which reported 2.8 million cases and 1,280 deaths last year,” WHO Director-General Dr Tedros Adhanom Ghebreyesus told a media briefing last week.

“The WHO is preparing for the very high probability that 2023 and 2024 will be marked by an El Nino event, which could increase transmission of dengue and other so-called arboviruses, such as Zika and chikungunya,” Tedros added.

“The effects of climate change are also fueling mosquito breeding and the spread of this disease.”

By 8 June, 2,162,214 cases and 974 dengue deaths have been reported globally, according to the European Centre for Disease Prevention and Control. Brazil, Bolivia, Peru and Argentina, in that order, had the highest caseloads.

Dengue is endemic in 129 countries, with 70% of cases in Asia. There are about 390 million infections per year, and there has been an 85% increase in cases between 1990 and 2019, according to the Drugs for Neglected Diseases initiative (DNDi).

Last year, the WHO launched the Global Arbovirus Initiative to strengthen the world’s ability to prevent, detect, and respond to outbreaks of arthropod-borne viruses (Arboviruses) such as dengue, yellow fever, chikungunya and Zika. Arboviruses are public health threats in tropical and sub-tropical areas where approximately 3.9 billion people live.

Image Credits: Wikipedia.

Mpox
Countries including the US, the UK, Spain, Belgium, and the Netherlands are seeing an increase in Mpox cases in the past few weeks.

Europe reported 22 cases of Mpox in May, prompting the World Health Organization (WHO) to urge people in high risk communities to get vaccinated if possible. 

WHO Europe director Dr Hans Kluge said that the virus is still in circulation, particularly affecting men who have sex with men. He added that people in high risk groups can also protect themselves from getting infected by following preventative measures. 

“There are things you can do – get vaccinated against Mpox if vaccines are available, limit contact with others if you have symptoms, and avoid close physical contact including sexual contact with someone who has Mpox,” Klugo told a WHO Europe briefing on Tuesday. 

In addition to the Mpox update, the Kluge addressed the health emergency situation in Ukraine after the Nova Kakhovka dam was destroyed three weeks ago, long COVID, and extreme heat in Europe. 

“Mpox resurgence not surprising”

Countries including the US, the UK, Spain, Belgium, and the Netherlands are seeing an increase in Mpox cases in the past few weeks. Health officials in Los Angeles and Colorado have issued alerts and launched vaccination campaigns to protect those in high risk groups, while London has extended the vaccination programme for Mpox due to the spike in cases in the city. 

WHO Euro
Dr Catherine Smallwood, Senior health emergency officer, WHO Europe.

Requesting those at high risk to remain vigilant and protected, Dr Catherine Smallwood, WHO Europe’s senior health emergency officer, said extreme vigilance is necessary, especially during the summer when travelling is at its peak. 

“As we enter this period of the Pride celebrations and the travel across the region, we need to remain extremely vigilant at that population level to catch early signs of disease,” she said. 

Adding that the current resurgence is not a surprise, Smallwood explained that the learnings from the outbreak in 2022, with thousands of new cases being reported every day across the continent, were immense. 

“We took a lot of time to look at why that was happening, and look at the factors that determined not only the rise in infections, but also the decline. And we understood that certainly it was linked to increased travel, particularly around June months, where there was a lot of travel to Pride events for the first time during the pandemic.”

The clear policy response to tackle Mpox, she said, is to continue investing in an elimination strategy. “We have the benefit here in Europe of not having an animal reservoir of the virus. It means stopping sustained human to human transmission is quite possible. And that’s what we implore member states, countries in the region to look into doing.”

Extreme weather events killed 16,000 in 2022

Referring to a recent report on the impact of global warming on Europe, Kluge warned that in the coming years, extreme heat in the continent will be a norm rather than an exception. 

The World Meteorological Organization (WMO) and the Copernicus Climate Change Service (C3S*) jointly released their annual State of the Climate in Europe 2022 report on 19 June. 

The report states that Europe is the fastest warming region in the world, “warming twice as much as the global average since the 1980s”. In 2022, high-impact weather and climate events have killed over 16,000 persons, of which around 99.6% were attributed to heat waves. 

WHO Euro
Dr Hans Henri P Kluge, WHO Europe Regional Director.

“Extreme heat in the summer months is becoming the norm, not the exception,” Kluge said, adding that the high temperatures greatly increase the risk of wildfires across the continent.

He pointed out that parts of Spain and Portugal recorded temperatures over 40 degrees Celsius last year between June and August. “So look out for each other during the summer months by checking in on your elderly relatives and neighbours, limiting outdoor activity when it’s very warm, staying hydrated, keeping your home school, and allowing yourself time to rest alongside an increased recent risk of extreme heat.”

In addition, Kluge also mentioned that WHO Europe will be co-hosting the first Indoor Air Quality Conference in Berne, Switzerland, in September, 2023, with the Institute of Global Health. The conference will aim to make a case for monitoring and improving air quality inside buildings, in order to prevent transmission of respiratory infections.

Ukraine’s health risks compounded by dam disaster

Three weeks since Ukraine’s Nova Kakhovka dam gave in, the region remains susceptible to high risk of water borne diseases. Around one million people are without safe, clean water. 

WHO Euro
Dr Gerald Rockenschaub, WHO Europe regional emergency director.

“All kinds of communicable diseases due to the contamination of drinking water are a major public health risk there… We had already prepositioned supplies, testing kits etc which we could mobilize to provide to local authorities,” said Dr Gerald Rockenschaub, regional emergency director at WHO Europe.  

Expressing concern over the risk of leaving people behind, especially in areas like Mariupol and Donbas where the WHO still does not have access to provide healthcare services, Kluge said the agency has been calling for an international humanitarian corridor in the region for over a year to reach people living in these areas. 

“We are working together to beef up surveillance particularly for what we call ‘water borne diseases’ which include diseases like cholera, typhoid, hepatitis etc… We have been calling for an international humanitarian corridor for over a year now [to address] the lack of access to people in areas such as Mariupol and Donbass where still WHO does not have access and are very concerned that people are being left behind.”

Spotlight on Long COVID in transition plan

Although the WHO has declared an end to the pandemic, long COVID continues to remain a huge challenge to people and experts alike. According to the latest data from the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, Seattle, nearly 36 million people across western European may have experienced long COVID in the first three years of the pandemic, Kluge said. 

“That’s approximately one in 30 Europeans over the past three years. That’s one in 30 who may still be finding it hard to return to normal life, one in 30 who could be suffering in silence left behind as others move on from COVID-19,” he said. 

“We are listening to the calls from long covid patients and support groups and raising awareness of their plight, but clearly much more needs to be done to understand it.”

The WHO Europe released “The transition from the acute phase of COVID-19: Working towards a paradigm shift for pandemic preparedness and response in the WHO European Region” on 12 June, detailing the regional strategy in dealing with COVID-19 and its after effects in Europe in the coming years. 

While emphasizing on the importance of individuals getting vaccinated according to their risk status, the document also outlines the structural and sustainable changes that need to be made in order to bolster up the resilience of health systems in the region. 

“Some of these measures are very, very clear, but for member states, governments, public health authorities, the real message here is that this is not the time to pack up and move away from COVID-19,” Smallwood said. 

“Right now, we have a huge opportunity to invest in and sustain the gains made…We need to right-size those COVID response operations into day-to-day public health operations, public health services.” 

Image Credits: National Institute of Allergy and Infectious Diseases (NIAID).

Gavi was one of the key pillars of the global COVID-19 vaccine platform, COVAX.

Six weeks before its new CEO was due to assume office, global vaccine alliance Gavi has announced that Dr Muhammad Pate is no longer available for the position.

The appointment of Pate, a former Nigerian health minister, was announced in February following a meeting of the Gavi board. He was to replace current CEO Dr Seth Berkley, who has led the alliance for the past 12 years and is stepping down in August.

However, in a short statement on Monday, Gavi said that its board had appointed Chief Operating Officer David Marlow as interim CEO, following communication from Pate that he will not be able to join Gavi. 

“Dr Pate informed the Gavi Board Chair and Vice Chair that he has taken an incredibly difficult decision to accept a request to return and contribute to his home country, Nigeria. Gavi fully respects the decision and wishes Dr Pate the very best for the future,” said Gavi.

Gavi was unable to tell Health Policy Watch what position Pate would be assuming in Nigeria. However, the Harvard-based Pate has been active in promoting primary healthcare and was well-respected as the country’s health minister between 2011 and 2013.

The announcement came as the Gavi board was meeting this week in Geneva, amidst a Reuters report that a $2.6 billion surplus remains to be spent in COVAX, the WHO co-sponsored COVID-19 vaccine platform that Gavi co-operdinates alongside the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization (WHO).

While around a quarter of the funds is likely to go towards COVID-19 vaccination programmes, big decisions need to be made about whether some of the money should be poured into COVID vaccine distribution, pandemic preparedness, and bolstering vaccine production capacity in Africa.

“These are COVAX [Advanced Market Commitment] funds which have been donated to Gavi so the decision on how to spend them is ultimately for the Gavi Board and donors to make,” a CEPI spokesperson told Health Policy Watch.

The Gavi COVAX AMC is the innovative financing instrument that supported the participation of 92 low- and middle-income economies in the COVAX Facility.

“Our understanding is that no decision has been made to repurpose the COVAX AMC funds as yet,” added the CEPI spokesperson.

Even though the WHO has declared that COVID-19 no longer is a public health emergency of international concern, thereby acknowledging that the worst and most deadly phase of the pandemic is over, it is important to recognize that we will all be living with COVID-19 and its effects for a long time to come so it is prudent to remain prepared to respond quickly should the COVID-19 situation deteriorate.

“One of the key learnings from the COVID-19 pandemic is that predictable and sustainable end-to-end financing and flexible surge financing – including for R&D and manufacturing – that is readily available in the event of a new outbreak with pandemic potential are key to enabling equitable access to vaccines and other medical countermeasures.

“CEPI is advocating for such financing mechanisms to be established through our engagement with the Pandemic Accord process and the G20 and G7, and we would welcome leftover COVAX funds contributing towards them if the Gavi Board and donors chose to pursue that option.”

Gavi is the biggest vaccine procurement group in the world and is currently responsible for vaccinating almost half the world’s children.  It had not responded to queries about the COVAX surplus funds at the time of publication.

UN Special Rapporteur on the right to health, Dr Tlaleng Mofokeng submits her report on digital health to the UN Human Rights Council (HRC)

Real challenges exist in improving human rights within the digital world of health, according to the UN Special Rapporteur on the right to health, Dr Tlaleng Mofokeng, addressing a UN Human Rights Council (HRC) side event on Friday. 

Shortly after submitting her report on “Digital innovation, technologies and the right to health” to the HRC, Mofokeng said: “We will need to ensure that rights holders know their rights. They understand that digital technologies are not just a safe space.”

The COVID-19 pandemic brought to the fore the use of digital systems and artificial intelligence in healthcare. For many, health care was only provided through online appointments with health professionals. 

Meanwhile, the use of the track-and-trace applications used by many governments worldwide raised legal and ethical questions about people’s private and personal human rights. 

Due to the speed at which the pandemic hit, new rules were often introduced speedily, without the necessary guarantees to protect human rights that other regular frameworks would include. 

The Special Rapporteur’s report analysed the impact of digital technologies on privacy and data protection, and these issues were brought up several times during Friday’s event. 

Allan Maleche, KELIN Executive Director; Timothy Wafula Makokha, KELIN; Timothy Fish Hodgson, ICJ (Africa); Dr Tlaleng Mofokeng, UN Special Rapporteur on the Right to Health; Joyce Ouma, Y+ Global; Dr Mandeep Dhaliwal, UNDP.

“Companies such as Facebook have been quietly amassing health data for years,” Mandeep Dhaliwal, director at the HIV and Health Group, Bureau of Policy and Programme Support, United Nations Development Programme, stated. “Now is the time to make sure that we put that on the table so that people understand that they own their data. That, for me, is fundamental to the rights-based approach to this.”

Timothy Fish Hodgson, a legal advisor on economic, social, and cultural rights at the International Commission of Jurists (ICJ), agreed, telling the audience, “The issue here is that big corporations that are operating in the space of technology and on technological platforms have control over what we do and do not share all over the world. They need to be held responsible.

“To regulate these companies is very difficult for any country because they operate on a global scale, and we need to improve that. Secondly, we need to make very clear specific guidelines for these companies.”

Aside from corporate access to private health data, a second central area of concern related to the impact of growing digital use in countries, particularly in the Global South, where medical data could help perpetuate racism, sexism, or other forms of discrimination – such as countries where abortion is illegal or LGBTQ+ rights are infringed upon. 

One example explained how a woman who approaches a doctor about abortion in a state where abortion is criminalised may risk repercussions for herself and her doctor unless safeguards protecting her right to privacy are maintained. 

Documentation and criminalisation

“There is a direct line between documentation and criminalisation of marginalised groups all around the world, which needs to be taken seriously in this process,” Fish Hodgson said. 

The report concludes with 23 recommendations for the HRC, stating, “Vulnerable groups who face multiple forms of discrimination and oppression in some cases lack access to digital technology and face criminalization, stigmatization, and state surveillance.”

“If we are not thinking properly and thinking through, we run the risk of actually further marginalizing people because the issues of privacy data breaches are heightened,” Mofokeng said.

“Some states have used data searches on your phone, which leave a digital footprint. They can then go and ask the police to trace your search history or retrieve your search history. If you find that it is related to abortion or contraception, they may charge you, and you may end up in prison.”

Mofokeng’s report reiterates the need for state actors to ensure their responsibilities are fulfilled, affirming: “States must embed human rights principles of equality, non-discrimination, participation, transparency and accountability in implementation, in order to meet their obligations to respect, protect and fulfil the right to health in relation to digital innovation and technologies.”

Joyce Ouma, Advocacy and Campaigns Officer at the Global Network of Young People living with HIV (Y+ Global), was optimistic about digital healthcare. 

“Digital technologies and digital health are bringing us closer to Universal Health Coverage. They are bringing us closer to self-care, to taking self-care where we, as young people, can take control of our own lives and our own health,” said Ouma.

As the report maintains, digital innovation and technologies can be an asset when used appropriately to realize the right to health. However, it is up to the HRC to implement the Special Rappoteur’s recommendations as best they can and ensure states and companies protect the rights of all. 

The event was organized by the Kenya Legal and Ethical Issues Network on HIV and AIDS (KELIN) in collaboration with the Permanent Mission of Brazil in Geneva, the Permanent Mission of the Federal Republic of Germany in Geneva, Global Network of People Living with HIV (GNP+), Privacy International, STOPAIDS, the Global Health Centre of the Graduate Institute, International Commission of Jurists (Africa), the Global Governance Centre at Geneva Graduate Institute, and the Centre for Interdisciplinary Methodologies at University of Warwick.

 

United Nations member states meet in New York on Monday and Tuesday (26-27 June) to discuss the latest draft of the Political Declaration on Pandemic Prevention, Preparedness, and Response, ahead of the high-level meeting in September.

The 58-page behemoth compilation draft sent to member states this week is a mass of red, indicating country additions and edits to the zero draft.

Notable are new clauses on the impact of COVID-19, and the inclusion of more references to climate change and the sustainable development goals.

But the mass of contradictory red text on a number of contentious issues, including research and development for vaccines and medicines, indicates that the negotiations have some way to go before consensus is achieved.

Extract from the Political Declaration on HLM on pandemics (compilation draft 1)

Multilateral mechanisms

More attention is also directed a developing “adequately funded multilateral response mechanisms” to address future pandemics.

One clause calls for the UN to “establish, as soon as possible, a mechanism for a coordinated and powerful response in the event of future pandemics”.

Norway wants the WHO to host “an accountable multi-stakeholder coordination mechanism for pandemic-related medical countermeasures” that is “ready when pandemic emergencies hit” but can be scaled back to “essential operational coordination capacity in inter-pandemic periods”.

The EU wants an “interim coordination mechanism for medical countermeasures” that builds on the ACT-Accelerator model to feed into the pandemic accord negotiations. This “will be the legal underpinning for a permanent medical countermeasures platform, and will be adjusted to the outcomes” of those negotiations.

In a new section on global governance, Costa Rica, Canada, Australia, New Zealand (CANZ) and the EU all call for independent monitoring of countries’ implementation of pandemic governance obligations.

In another new section headed “scientific research and development”, the EU wants a reference to “promoting” innovative incentives removed, along with the deletion of R&D “financing mechanisms” for vaccines, therapeutics, diagnostics and other health technologies.

Meanwhile, the US encourages the development of “voluntary patent pools” to develop pandemic products. 

Tight process

June and July are crunch times for the political declaration negotiations. The deadline for the revised text after negotiations on 26-27 June is 30 June.

The third reading of the declaration is set for 5-6 July, with the final reading on 24-25 July.

On 26 July, the final text will be placed under “silence procedure”. This refers to the period at the end of negotiations when tentative agreement has been reached, but delegations may need to get final approval from their governments. 

The final resolution will be debated at the high-level meeting on 20 September.

Image Credits: Wikimedia Commons.

French Health Minister François Braun (left) at an event to introduce HIIP.

Three multilateral development banks and the World Health Organization (WHO) announced the launch of an investment platform on Thursday aimed at supporting low and middle-income countries to build their primary healthcare (PHC) services via grants and concessional loans.

PHC is widely recognised as the most effective way to improve health and well-being, and the recent World Health Assembly recognised it as the driver of universal health coverage, one of the United Nations Sustainable Development Goals (SDGs).

The Health Impact Investment Platform (HIIP), launched during the Summit for a New Global Financing Pact in Paris, will make an initial €1.5 billion available to LICs and LMICs in concessional loans and grants to expand the reach and scope of their PHC services.

HIIP’s founding members are the African Development Bank (AfDB), European Investment Bank (EIB), Islamic Development Bank (IsDB) and WHO. The Inter-American Development Bank (IDB) is also considering joining this partnership, which would extend this initiative to Latin America and the Caribbean region.

“Around 90% of essential health services can be delivered through PHC – on the ground, in communities, via health professionals, doctors and nurses, in local clinics. The broad spectrum of services that PHC provides can promote health and prevent disease, avoid and delay the need for more costly secondary and tertiary services, and deliver rehabilitation,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus at the launch in Paris.

Dr Tedros and African Development Bank Group President Dr Akinwumi Adesina

WHO will act as the platform’s policy coordinator, ensuring the alignment of financing decisions with national health priorities and strategies. HIIP’s secretariat will support governments to develop national health and prioritize PHC investment plans. 

“The COVID-19 pandemic showed significant gaps in health systems around the world, and this is particularly true in primary healthcare,” French Health Minister François Braun told the launch.

“Our world urgently needs a more coordinated financing approach, which bridges the gap between health system investment needs and the challenge of domestic funding.”

European Investment Bank president Dr Werner Hoyer said the platform will “ensure countries in need are better able to build resilient primary health care services that can withstand the shocks of future health crises, and safeguard communities and economies for the future.” 

“The platform will facilitate access to crucial international financing for the most vulnerable. It is a concrete deliverable of President Macron’s call to increase international financial solidarity with the Global South,” he added.

European Investment Bank president Dr Werner Hoyer

The new platform builds on experience gained during the pandemic when countries worked with multilateral organizations and development banks to strengthen their health systems. 

For example, WHO, the EIB and the European Commission worked closely with Angola, Ethiopia and Rwanda to strengthen their health systems. These interventions mobilized technical assistance, grants and investments with advantageous terms to build up PHC.

Rwandan Prime Minister Édouard Ngirente said that his country had worked with several partners for over a decade to build its PHC, resulting in improved life expectancy and other health indicators.

“We believe in partnerships. You can’t build your health system alone,” Ngirente stressed.

African Development Bank Group President Dr Akinwumi Adesina said the bank “will work with countries individually to identify gaps in national health systems, design interventions and investment strategies, find funding, implement projects and monitor their impact”.

European Union offices in Brussels.

The European Union’s proposals to strengthen the pharmaceutical ecosystem are not ambitious enough to address health inequities

The recent meeting of the European Union’s (EU) Employment, Social Policy, Health and Consumer Affairs Council on 13 June, was an opportunity for Health Ministers make proposals to  strengthen the pharmaceutical ecosystem in support of competitiveness and equitable access to medicines. 

The discussion resulted from the Commission’s recently released proposal for the revision of pharmaceutical legislation.

The COVID-19 crisis showed that there are many issues to be resolved regarding the accessibility and availability of lifesaving medicines and the need for effective incentives to produce medicines that truly respond to medical needs, particularly during global public health emergencies.

While it is challenging to improve the pharmaceutical legislation and address the concerns of different stakeholders,  we urge the EU to do better. 

The pharmaceutical package should take into account the impact of quality service provision, make clear the most suitable drugs for particular patients, and enhance inter-agency cooperation – not only at EU-national level, but also within the EU (for example, Directorates General for Trade, International Partnerships, Health Emergency Preparedness and Response Authority, European Centre for Disease Prevention and Control, European Health and Digital Executive Agency).

New measures should be created to control and survey the modification of medicines that may extend patent protection inappropriately. Pharmaceutical companies must prove that the modifications they make are bringing additional value to the patients versus simply extending patents to prevent access to cheaper versions of their drugs.

We also recommend more transparency in R&D-related costs to bring benefits for health use and imply innovation, allowing a better understanding of the medicines landscape and tracking needs overall. 

The pay and bonuses of pharmaceutical company CEOs should also be directly linked to the impact on positive public health outcomes and access to medicines, especially in developing countries.

Pandemic products as public good

 Recognizing pandemic-related products as a public good during health emergencies and limiting the profit margins is the logical step to improve responses to crises.  It should become binding, not only in the pharmaceutical package, but also in the future pandemic accord.

In addition, the legislation under negotiation should bring more equity among EU member states by harmonizing marketing approvals and distribution of new products in all national markets. 

Finding the balance between national, private, and patients’ interests is hard, and taking sides may be inevitable. We strongly believe that the EU must, first and foremost, support the population, the community, and the patients – all who bear the brunt of a lack of access to affordable medicines.

The revision of the pharmaceutical legislation is also an opportunity to reflect on where we want our health systems to be in the future and the kind of care we can provide to people. 

Do we want to continue to incentivise the high salaries and profits for big pharmaceutical companies, with $19,2 million pay packages, while many struggle to access basic medicines and other health commodities? 

Can we allow companies to make $5.6 billion in sales while still in the pandemic period, while countries are operating in emergency mode and struggling to keep their respective responses going?

Customers queuing in Toulouse, France, as part of social distancing measures taken to reduce crowding in supermarkets during the COVID-19 pandemic.

Emerging divisions between EU members

Since the publication of the revised pharmaceutical legislation on 26 April,  divisions between member states are emerging. 

One group (Austria, Estonia, Hungary, the Netherlands, Poland, Slovakia) is pushing for more flexibility for the generic market and requiring new products to respond to unmet medical needs allowing profits from incentives. 

The other group (Germany, Italy, Denmark) is pushing for more protection of private industries, including a more predictable regulatory framework, voluntary commitments for companies, and the safeguarding of intellectual property rights.

The revision of the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is also closely linked with equal access to medicines and the revision of pharmaceutical legislation. 

The EU is strongly promoting its own vision of voluntary and compulsory licensing, leading to complicated negotiations at the WTO. Several patient advocacy associations have pointed to the need for revisions to TRIPS Agreement since voluntary licenses are often difficult to implement, have limited scope of distribution, exclude many middle-income countries, and sometimes do not even allow the sales of active pharmaceutical ingredients. 

As authorities leave the market unregulated, the profit-seeking nature of private companies often makes it  difficult access to lifesaving medicines, including for treatable conditions such as HIV and hepatitis C.

Patent evergreening, whereby pharmaceutical companies are able to extend patents by making small changes to the formulations that do not constitute a major innovation, and re-patenting them as new and improved drugs, also needs to be addressed by the EU.

 Patent evergreening creates barriers to affordable, generic medicines and keeps them from reaching low- and middle-income countries. It also carries societal costs and often deviates research from truly necessary medical needs, keeping costs higher and undermining access.

There is a danger that even the innovative incentives to produce medicines responding to unmet medical needs, such as exclusivity vouchers, risk the distortion and monopolization of markets of public interest. One year of market exclusivity is estimated to cost  around €500 million by the European Commission.

We echo the sentiments of other like-minded advocates like Dimitri Eynikel of Médecins Sans Frontières who states, “We urge EU member states and the European Parliament to not forsake this opportunity to legally safeguard public health interests and remain vigilant up until this new proposal is adopted as legislation: there must be no watering down of the provisions on transparency and compulsory licenses, and if access to affordable medicines in the EU is a priority, any inclusion of transferable exclusivity vouchers should be seriously challenged.” 

Only by taking responsibility and accepting accountability for people’s health now can the EU better prepare for future health crises and establish an innovative, fair, and inclusive health system that works for all.

AIDS Healthcare Foundation Europe is the European branch of world’s largest non-governmental HIV service provider, AIDS Healthcare Foundation (AHF). AHF Europe is active in nine European countries: Estonia, Georgia, Lithuania, Poland, Ukraine, UK, the Netherlands, Greece and Portugal;  supporting HIV/AIDS prevention, testing and treatment services. AHF Europe advocates for inclusive health care services, equal access to medicine, comprehensive prevention initiatives and multisectoral approach to health at national, regional and international levels.  For further information, contact Indre Karciauskaite, Europe Policy Director, indre.karciauskaite@ahf.org 

Image Credits: Carl Campbell/ Unsplash, Wikimedia Commons: Alteo31300.