Pakistan flood relief 2022
Pakistan’s flood-affected families receiving relief packages from RFI. 

ISLAMABAD, Pakistan – Shujaat Ali Khan’s community in the Swat valley of Pakistan was devastated by recent flash floods, leaving thousands displaced and destroying infrastructure and crops. 

“Land in the area was completely destroyed and the community needed urgent support,” said Khan, who wanted to help his community.

He found that climate activists from the social enterprise organisation, Resilient Future International (RFI), were more responsive than the government.

“We managed food package deliveries at micro-level to the flood-affected farmers in Swat with the collaboration of RFI to help people in this difficult time,” said Khan.

In early 2022, a report from the Sixth Assessment Report of the Intergovernmental Panel on Climate Change (IPCC), described Pakistan as a climate hotspot, in the top ten climate-impacted countries in the world.

“In South Asia, extreme climatic conditions are threatening food security; thus, agro-based economies, such as those of India and Pakistan, are the most vulnerable to climate change,” the report said.

A few months later, the report’s words were borne out by floods that killed some 1400 people  and left about one-third of the country’s land under water, affecting about 33 million people from Khyber Pakhtunkhwa in the far north to Baluchistan, Punjab, and Sindh province in the far south.

Last week at the COP27 climate change talks in Egypt, Pakistan´s Prime Minister, Muhammed Shehbaz Sharif, made an urgent appeal for loss and damage funds to assist his country to recover from the August floods, pointing out that Pakistan had a tiny carbon footprint but was suffering from emissions from wealthy countries.

“Estimated damage and loss have exceeded $30 billion and this is despite our very low carbon footprint. We became a victim of something with which we had nothing to do,” said Sharif, speaking about the August flooding.

Government unprepared

Pakistan’s government was unprepared for the scale of the flood, and NGOs and social enterprises have stepped into the vacuum. 

In the case of RFI, supporting immediate disaster relief is also a means of raising more awareness about the risks of climate change and the benefits of early action. 

The RFI was founded in October 2017 by Aftab Alam Khan, who has over 20 years’ experience in developing climate resilient and people-centric solutions in Asia, Africa, Latin America. 

Khan, a graduate from the University of Wales Swansea in the United Kingdom, has advised the governments of Pakistan, Indonesia, South Africa, as well as the G-20 and G-77 on sustainable and pro-poor policies.

RFI provides research, training and consultancy services on climate-resilient, people-centric solutions. Khan is also currently designing two academic courses on tackling climate change.

In an interview with Health Policy Watch, Khan said his enterprise aims to develop the capacity of the communities, media, and entrepreneurs to face the challenges of climate change through initiatives in research, training, monitoring and evaluation. 

 “I have worked globally on climate resilience for the past 20 years, but I realized that limited or no work on crucial areas needed for climate resilient future in Pakistan has been done,” he said.

A major focus, he adds, is building youth capacity, including the integration of climate change into the university curriculum through short courses, internships, and online sessions – as well as media engagement. 

Building local networks

During the flood emergency, however, RFI also swung into action, mobilizing its platform and student network to respond to the most immediate needs of the crisis – the distribution of relief packages of food and other essential goods.

The RFI provided relief support in Swat with TechMark Agro Volunteers and extended its support to local activists in fundraising and connecting national and international relief organizations with potential fundraising opportunities.

While many organizations were focused on distributing mosquito repellents to flood-affected people, RFI provided early and indigenous solutions and suggested local people also use inexpensive local herbal oil to save them from mosquito bites. 

And at the same time, says Khan, RFI used its platform to assist local activists on how to highlight their local needs and issues.

He said RFI has brought climate to a practical level by various means by promoting climate resilient agriculture, mentoring youth on importance of learning, conducting research about climate challenges, and also training journalists to play role in building mass awareness on climate issues and the like.

Flood Affected farmers of Swat, Khyber Pakthunkhwa describing their damages to standing crops to relief activists

Fostering student climate research  

Over the past five years, the organization has also helped students to frame and develop research on local climate-related issues that have been understudied until now. 

Lahore environmental sciences student Meharwar Uppal says that she got inspiration and guidance from the RFI website, which offers Urdu translations of the IPCC findings as well as analyses of the government’s National Climate Change Policy.

Uppal says that this helped her shape her final year research project on heat waves in Pakistan at Lahore College Women’s University.

Despite such efforts, there is still a long way to go before Pakistani educators and decision-makers become more engaged in the climate challenge, says Khan. 

Too many leaders and top officials in education and government prefer to stick to their day-to-day routine, rather than taking on more strategic challenges in an area that still seems futuristic to many.  

“I hope the current floods will change that trend,” said Khan.

In the wake of the 2022 floods, RFI is launching a series of seminars with university students, which it aims to lead to the drafting of a public letter to the planned UNFCCC Loss and Damage Finance Facility, demanding aid. 

Dr Iqra Ashfaq, RFI’s youth ambassador, said that she didn’t realize the importance of climate change until she joined the organization.  

“I learned what climate change actually is and the impacts it’s causing on our planet. I learned how climate change is a whole cycle of events initiated and accelerated due to our actions and behavior,” said Iqra, who recently qualified as a medical doctor.

She said engagement with climate resilient organizations is helping youth to learn the magnitude of effects caused by excessive carbon emissions into the atmosphere and what are the ways by which such effects could be managed and tackled through mitigation and adaption.

“After realizing the seriousness of climate threat, I am looking forward to conduct research correlating climate change and health care in order to find out solutions for common people,” said Ashfaq.

Image Credits: Resilient Future International.

vaccine trials
Three Ebola vaccine candidates will be tested in Uganda soon.

Clinical trials on three Ebola vaccine candidates for the Sudan strain of the virus are due to start soon in Uganda, according to the World Health Organization (WHO).

“I’m pleased to announce that a WHO committee of external experts has evaluated three candidate vaccines and agreed that all three should be included in the planned trial in Uganda. WHO and Uganda’s Minister of Health have considered and accepted the committee’s recommendation,” WHO Director-General Dr Tedros Adhanom Ghebreyesus told a media briefing on Wednesday.

Doses of the vaccine candidates are set to arrive in Uganda next week. 

Uganda has been reeling from an Ebola outbreak, with 163 confirmed and probable cases and 77 confirmed and probable deaths. 

Tedros expressed appreciation for the Ugandan government’s efforts in containing the outbreak: “The government’s efforts to respond to the outbreak have slowed transmission in most districts, and two districts have not reported any case for 42 days, indicating the virus is no longer present in those districts.”

Too late for trials?

However, with the outbreak in decline, it might mean that it will be hard to test the vaccines.

The clinical trials will be conducted by a group of organisations including the WHO, Uganda’s Makerere University, the Coalition for Epidemic Preparedness Innovation (CEPI) and Gavi, the global vaccine alliance.

In a joint statement earlier this month, the WHO said that while the vaccines were developed by the Lung Institute at Makerere University, WHO, CEPI and GAVI will ensure that sufficient doses are available for the clinical trials. 

We can confirm that we have received written confirmation from the developers that a sufficient number of doses will be available for the clinical trial and beyond if necessary,” Dr Ana Maria Henao-Restrepo, the co-lead of R&D blueprint for epidemics at WHO. 

While Uganda’s outbreak appears to be largely contained and its caseload is declining, Henao-Restrepo said that it is difficult to predict the evolution of an outbreak. 

She pointed out that when the Ça Suffit (French for Ebola) trial on Ebola was conducted in Guinea, researchers were also unsure about whether enough evidence would be generated and if it was too late to conduct trials. 

“It’s better for us to work towards generating the evidence and put all our efforts on that rather than trying to second guess the evolution of the outbreak,” said Henao-Restrepo.

Dr Mike Ryan, the executive director of WHO’s health emergencies programme, said that there was no time for “if onlys”. 

“We’re making these investments, and if we don’t get to the required numbers, we’ve built the collaboration, we’ve built the platform to do this,” he stressed, adding that the Ça Suffit trial in Guinea had also helped to build the necessary infrastructure to prevent future outbreaks and increase protection. 

Apart from the three vaccine candidates, a separate group of experts have also chosen two therapeutics for clinical trials, which are under review. 

India’s Covaxin still suspended by WHO

Controversy over Covaxin is unresolved.

The WHO has still not resumed supplies of Covaxin, India’s indigenous vaccine against COVID-19, the global body confirmed. 

In March, the WHO inspected the manufacturing site of Bharat Biotech, which produces Covaxin and found serious irregularities in the Good Manufacturing Practices (GMP) at the site. 

This resulted in the global health agency suspending the supply of the vaccine through UN’s procurement agencies in April, stating the company had altered the GMP after it received the Emergency Use Licence (EUL) from WHO. 

India’s journalists have consistently questioned the discrepancies in the Covaxin clinical trial data since it was released in 2020. However, these questions have always been met with silence from the manufacturer and the Indian Council of Medical Research.

There were several irregularities in Covaxin’s clinical trials and that the country’s drug regulator did not clamp down on the discrepancies, according to a recent investigation by Stat News

The report also quoted company executives acknowledging their mistakes. “They also argued they faced “political” pressure to get a vaccine out of the laboratory door as quickly as possible, but denied taking any shortcuts. And they insisted the steps taken to speed the trial were vetted during discussions with regulators,” the report added. 

 Dr Mariangela Simao, WHO assistant director-general for drug access, vaccines and pharmaceuticals, said that the WHO is yet to receive a corrective and prevention action plan (CAPA) from Bharat Biotech. Once they received and reviewed the CAPA, further steps would be taken on the suspension. 

Image Credits: Photo by Diana Polekhina on Unsplash.

Modern hospitals consume a huge amount of energy.

The healthcare sector is responsible for over 5% of global carbon emissions, double the amount of the aviation sector. But there is a way for healthcare actors to reduce this while at the same maintaining the quality of care in developed countries and expanding access to healthcare in developing countries. 

This is according to panellists at a recent event on “Healthcare and climate change: Victim or perpetrator hosted by the  Graduate Institute’s Global Heath Center.   

Sonia Roschnik, executive director at the Geneva Sustainability Centre, said that how the planet is faring is inherent to people’s health. The centre, which opened this year, has put greening healthcare delivery for better health and a healthier climate at the core of its agenda.  

“We can’t have healthy people on a sick planet, but of course, we also can’t have a healthy planet with sick people,” Roschnik said, adding that reducing the environmental impacts of health care will contribute to reducing the burden of disease and social inequities.

Sonia Roschnik, executive director of the Geneva Sustainability Centre, Bruno Jochum, executive director of the Climate Action Accelerator and Suerie Moon, co-director of the Global Health Centre at the Geneva Graduate Institute.

Reducing emissions by smarter drug procurement

“There are some things that are healthcare specific that if the healthcare sector doesn’t do nobody else is going to do,” Roschnik added.

“For instance, one that is often quoted is anaesthetic gases. Some of those gases are 100 times more potent than carbon dioxide, and actually, there are other ways of delivering that care.” 

One of these is nitrous oxide, which has a climate warming effect 300 times that of CO2, but new technologies have recently been put developed to safely capture and reuse such anaesthetic gases, including a Newcastle, UK hospital  last year.  

Bruno Jochum, founder and executive director of The Climate Action Accelerator, said that mid-level health facilities can do a lot to help decarbonize. He described his group’s work as an initiative “getting organizations to really adopt by themselves science-based targets without waiting for policy change.”

“Often hospitals are the first employer of any territory,” he noted. “They see patients, they see families, they have suppliers, they talk to authorities. They really have the space to make things move.”

According to Jochum, lowering emissions, between now and 2030 is “absolutely feasible and achievable.” 

Healthcare is vulnerable to climate extremes 

Sharing the experience of the Philippines, one of the top 10 most climate vulnerable countries, was physician Renzo R Guinto, of St Luke’s Medical Center in Manila and the Sunway Centre for Planetary Health in Malaysia.

“We’ve witnessed firsthand the confluence between two crises, the climate crisis on one hand and the COVID-19 crisis on the other,” he said. “Imagine you are a poor Filipino, confronting the dilemma: do I stay in the house to protect myself from the unseen coronavirus only for the roof of the house to be blown away by the strong wind?”

Guinto also emphasized that climate change does not only affect physical health, but also mental health.

“In a recent survey, it was found out that the Filipino young people are the most climate anxious in the world,” he pointed out. “At least 90% of the young Filipinos surveyed are moderately to extremely worried about their climate and stable future.”

But the Philippines is already leading the way in the fight to make health facilities more climate resilient, he added. The country´s Ministry of Health put in place a framework to adapt the health system to climate change beginning two decades ago. 

Echoing the climate change and health message at COP27

Maria Neira, the director of the World Health Organization’s Department of Environment, Climate Change and Health joined the panel from the COP27 Climate conference in Sharm El Sheikh, Egypt, where WHO has hosted a series of events on health and climate themes every day at a WHO pavilion – including sessions on greening health facilities.

Dr Maria Neira speaking at the event.

“We hope that we will be not only able to convince everyone that climate change is already affecting our health in a very negative way, but also to present the policy arguments and the reasons why we need to do much more to tackle the causes of climate change and air pollution, because the health benefits will be enormous,” said Neira.

The panellists agreed that decarbonizing should not come at the expense of ensuring access to healthcare in developing countries, where often facilities lack access to electricity, let alone green energy.

Solar panels provide electricity to Mulalika health clinic in Zambia.

However, they pointed out that there are opportunities to build systems in low-resourced settings and solar energy.

While there are health systems around the world that need to decarbonize “others are wanting of support and resources in order to enhance resilience and to adapt to the impacts of climate change that are already being experienced now,” said Guinto. 

“In fact, these health systems, which have nothing to do with the climate crisis, in terms of emissions are also doing their share by adopting solar or embracing sustainable healthcare waste management practices,” he added.

For this reason, the physician emphasized, it is not possible to adopt a “one size fits all approach.” 

“Instead, we need to be coming up with solutions that are tailored to the different contexts and to the different situations,” he concluded.

The event was co-organized by the Institute of Global Health of the University of Geneva and the Geneva Health Forum. The panel was introduced by Jelena Milenkovic, Director of Operations at the Geneva Health Forum and moderated by Suerie Moon, Co-Director of the Global Health Centre.

Image Credits: Richard Catabay/ Unsplash, Twitter: @GVAGrad_GHC, Twitter: @GVAGrad_GHC, UNDP/Karin Schermbrucker for Slingshot .

preterm baby
Preterm baby in incubator

The World Health Organization (WHO) has strongly recommended that babies born before 37 weeks of gestation (preterm) or with low birth weight should be provided immediate skin to skin contact with a caregiver, which in turn increases their chances of survival. 

This recommendation by the global health agency is a significant change from the previous guideline which stated that preterm babies and babies born with low birth weight should be first stabilised in an incubator before any other interventions. 

The WHO released the new guidelines for care of preterm or low birth weight infants days before World Prematurity Day, 17 November, which is promoting skin to skin contact as the theme of this year.  

The change in the existing guidelines comes in light of strong evidence of survival in babies born before a gestational period of 37 weeks or with a birth weight of under 2.5kgs. The new guidelines consist of 25 recommendations, of which 11 are described by WHO as “strong” recommendations based on robust evidence, and 14 are conditional recommendations, based on emerging evidence. 

“The first embrace with a parent is not only emotionally important, but also absolutely critical for improving chances of survival and health outcomes for small and premature babies,” Dr Karen Edmond, Medical Officer for Newborn Health at WHO said, in a press release. She added that separating babies from their mothers at childbirth is catastrophic to the health of these babies, as seen during Covid-19. “These new guidelines stress the need to provide care for families and preterm babies together as a unit, and ensure parents get the best possible support through what is often a uniquely stressful and anxious time.”

The latest guidelines also include a good practice statement on the need for parental leaves and entitlements for parents and other primary caregivers of preterm or low birth weight babies. 

Immediate Kangaroo-mother-care 

Every year, 15 million babies across the world are born before reaching a gestational age of 37 weeks. This is over 10% of the total births annually. Prematurity is the leading cause of deaths in children under the age of five. 

Skin to skin contact, also known as Kangaroo-mother care (KMC), between the infant and the caregiver immediately after birth has shown to reduce infections, hypothermia and improve feeding. 

In making its recommendations, WHO analysed 27 randomised controlled trials conducted from 1994 to 2021, which involved 11,956 infants, that studied the differences in outcomes between later KMC of preterm and low birth weight infants and infants provided with KMC immediately. These studies were conducted in high-income, upper-middle income, lower-middle income and lower income countries. 

A study published in the New England Journal of Medicine (NEJM) in 2021, which laid the foundation for the new WHO recommendations, found  that based on the available data, initiating skin to skin contact immediately after birth has the potential to save up to 150,000 babies from dying each year. 

KMC was already known to reduce mortality by 40% when started after the infants are clinically stabilised. Starting the process immediately after birth improves the chances of survival by an additional 25%, as per the NEJM study. 

A clinical trial, which was part of the study, was conducted across five countries – India, Malawi, Nigeria, Tanzania and Ghana. 

Role of community support crucial

In the new guidelines, the WHO has also emphasised the importance that one’s family, community and local resources can have in improving the survival of preterm or low birth weight babies. 

Apart from education and counselling programmes, the agency pointed out that adequate and appropriate leave for parents and primary caregivers of such babies can go a long way in improving their outcomes. 

“Home visits by trained health workers are recommended to support families to care for their preterm or low-birth-weight infant,” the recommendations continued. 

Sperm count
A new study has mapped a massive decline in sperm count – environment primary suspect.

A worldwide decline in sperm counts of more than 50% over the past 46 years has been identified by a team of international researchers, and the decline has accelerated since the year 2000, according to an article in the journal Human Reproduction Update published on Tuesday.

The article updates a previous study published in 2017, providing strong evidence for the first time of a decline in sperm count and total sperm concentration in men from South and Central America, Asia and Africa.  A previous study showed a similar decline in North America, Europe and Australia. 

Threat to human survival?

“We have a serious problem on our hands that, if not mitigated, could threaten mankind’s survival,” said Professor Hagai Levine of the Hebrew University- Hadassah Braun School of Public Health, who led the study in collaboration with a team of scientists from Denmark, Brazil, Spain and the United States.

Levine described the findings as a “canary in the coal mine – a red flag. There is a loss of biological diversity around the world. We know that reproduction is very sensitive to the environment and it is essential for future existence.”

A mom and her newborn baby in Dhaka, Bangladesh.  Exposures to environmental toxins in the womb could be one of the reasons for reduced sperm count, researchers say.

Data from 53 countries was included in the meta-analysis, including Australia, Bangladesh, Belgium, Brazil, Canada, Chile, China, Cuba, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Greenland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Peru, Poland, Russia, Singapore, Slovenia, South Africa, Spain, Sweden, Taiwan, Tanzania, United Republic of Thailand, Tunisia, Turkey, Ukraine, United Kingdom and the United States.

The previous study focused only on countries in North America, Europe and Australia and was based on samples collected between 1973 and 2011. The latest study includes seven additional years of sample collection. 

Levine told Health Policy Watch that the data shows a decline of around 2.5% each year in mean sperm concentration since the year 2000, which is “a clear signal that something is wrong with men’s sperm count around the world, something that cannot be explained by genetics.”

Sperm count
Dr Hagai Levine

Sperm count is the total number of sperm a man produces. Sperm concentration is the number of sperm per millilitre of semen. 

These are not the only predictors of fertility. Another predictor is total motile sperm, which looks at what percentage of sperm are able to swim and move. Infertility is generally defined as a couple’s inability to get pregnant for one year despite regular intercourse. 

Sperm concentration and count are not only good markers of men’s ability to participate in conception, but have also been linked to men’s general health, including premature mortality and morbidity risks.

In other words, men with lower sperm counts have higher chances of becoming sick or dying at a younger age, Levine said.

He noted that the worldwide decline in sperm concentration and count is consistent with other adverse trends in men’s health, including increasing rates of testicular cancer and genital birth defects.

Primary suspect: mother’s exposure to environmental toxins in pregnancy

Heavy metals, toxic gasses, urban air pollution and unhealthy lifestyles may all lower sperm count; portrayed here, air pollution in Cairo, Egypt

While the study does not aim to prove the cause of the decline in sperm count and concentration, Levine said animal research points to a connection between environmental toxins and hormonal disruptions or imbalances, which in turn impede reproductive capacity. 

Growing evidence that plasticisers, pesticides, herbicides, heavy metals, toxic gasses, air pollution and poor lifestyle choices such as sedentary behaviour, poor diet and smoking all are tied to abnormal sperm count. 

“The primary suspect is a mother’s exposure to man-made chemicals during pregnancy,” Levine told Health Policy Watch. “We also know exposure in adult life and lifestyle choices such as smoking and poor nutritional habits can be associated with poor sperm count.”

He stressed, however, that the research is neither definitive nor does it establish which chemicals specifically may be causing the decline.

Dr Ryan Smith, associate professor of urology at the University of Virginia, confirmed Levine’s assessment. After reviewing the paper, he said that “the impact of reproductive toxins on male infertility deserves further investigation and there is cause for concern”. 

Environmental toxins a threat to reproductive health

Microplastics collected from the Rhode River, Maryland, whose tributeries feed into the Chesapeake Bay.

“Environmental toxin exposure represents a clear threat to our global reproductive and general health. Increased public awareness and advocacy that leads to more careful monitoring and regulation will be critical to protect our future global health and our environment,” Smith said. 

He added that while the authors acknowledge that sperm count is an imperfect assessment of fertility and point out that a higher sperm count does not necessarily imply a higher probability of conception, “the authors should be commended for this work and their prior investigations into the decline in male reproductive health.”

The 2017 study that focused primarily on developed countries was well received. However, there were some researchers who pushed back at the report, including a team from Harvard’s GenderSci Lab led by Sarah S. Richardson, which called the previous assessment “overblown” and noted that separate research contradicted the assumption that there was a causal link between declining sperm counts and declining fertility and between exposure to certain chemicals and lower sperm counts. 

Health Policy Watch reached out to Richardson and asked her to evaluate the updated study, but Richardson could not respond by press time.

Levine said that in his own country and in the US there are a growing number of theoretically healthy couples who struggle to conceive and require assistance. “This is not something that is supposed to be,” he said. “Our species is supposed to be able to reproduce.”

New study includes meta-analysis of over 10,000 publications

To develop the analysis, Levine and team systematically reviewed all the relevant studies published until 2019 that they could find according to a strict protocol. Then, using sophisticated modelling they adjusted the data from different places and studies to get one estimate about the global trend in sperm count and concentration.

“This requires enough data, and so we screened over 10,000 publications that gave data on sperm count,” Levine explained. “We read the papers, and with a large team of researchers and according to a strict protocol, identified which studies met our criteria and then, from those studies, extracted the relevant data.”

While he said that relying on modelling was not foolproof nor a substitute for additional research of specific populations at specific points in time, Levine noted that modelling is a good way to evaluate long-term trends. 

“We are seeing the forest from the trees,” he said. “We aim to look at the overall picture.”

Urgent call for action to promote healthier environments

Healthier lifestyles and environments reduce exposure to environmental toxins.

“As clinicians, we can educate our patients and advocate for continued research and public health support,” Smith said. 

He said the topic should be given attention not only by clinicians and scientists but also from decision-makers and the general public.

“Men need to be aware that their health and lifestyle choices can impact their reproductive health and that lifestyle changes, such as increased exercise and a healthy diet can have positive impacts,” Smith concluded. 

Added Levine “We urgently call for global action to promote healthier environments for all species and reduce exposures and behaviors that threaten our reproductive health.”

Image Credits: Photo by Nadezhda Moryak, UN Photo/Kibae Park/Flickr, Avi Hayon Hadassa, Kim Eun Yeul / World Bank, Will Parson/Chesapeake Bay Program, WHO.

Digital Health
Young people rely more on social media to get information on health.

New report highlights the impact of social media on the health of young people in middle- and low-income countries. 

The digital transformation of health offers both significant empowerment potential and significant risks for young people, according to a new study published Tuesday by the Global Health Centre of the Graduate Institute of International and Development Studies.

The report, “Digital health and human rights of young adults in Ghana, Kenya and Vietnam,” highlights young people’s increasing dependence on social networks such as Facebook, Instagram, YouTube and TikTok to access health information, and demonstrates the challenges and opportunities that arise in the realm of human right as a result. 

“We hear all this excitement around digital health and we don’t know how much is hype and how much is true,” explained Prof Sara “Meg” Davis, a senior researcher for the Digital Health and Rights Project, who led the study. “There are also concerns for people who are marginalized or vulnerable” on the digital platforms.

Davis told Health Policy Watch that the digital ethnography her team conducted was “revealing” because it confirmed just how much young people were using social media to get their health answers. It also raised concerns that the World Health Organization’s definition of digital health does not even mention social networks.

Digital health generally centers on telemedicine and the use of technology to receive care, or on tailored digital health applications, Davis said. But it leaves out mainstream social media as a source of care. Her study showed that Google searches and social networks are the primary source of health information for many young people. 

Davis and her international team have been working on the report for two years. It will be formally released during a public webinar on November 22 titled “Digital justice: How social media is transforming young people’s health and rights.” The webinar will take place from 14:00-15:30 CEST. Registration is available online.

Transnational participatory action research

The report is based on qualitative research with 174 young people and 33 experts in Ghana, Kenya and Vietnam. It specifically centers on their use of mobile phones to access information on HIV, sexual and reproductive health and COVID-19. Carried out using a transnational participatory action research (PAR) approach, teams in all three countries explored the tensions between the benefits and risks to young people’s rights to health and human rights, identified themes and patterns in the data, and helped identify areas for policy action. 

The research team included academic social scientists, staff at national community-led networks, human rights groups and civil society organizations. 

“The study represents the first transnational participatory action research project in global digital health,” Davis said. “Participatory action research empowers the community to have a voice in the design, data-gathering and analysis of the findings for action. Our study is a unique collaboration between global and national networks of social scientists and affected communities. We are excited to share both the findings and the approach, which we believe is key to creating new forms of evidence and public participation in the digital age.” 

The November 22 event will include a panel discussion, including some of the staff who took part in the study. Participants will be Stephen Agbenyo, Executive Director, Savana Signatures; Terry Gachie, Country Coordinator, Love Matters Kenya; Professor Catalina Gonzalez-Uribe, Universidad de los Andes; Tabitha Ha, Advocacy Manager, STOPAIDS; and Tigest Tamrat, Technical Officer, Sexual and Reproductive Health and Rights, WHO.

Health champions

The study documents a growing group of social media influencers and other health champions who offer health information and advice from medically sound sources in a language and level of acceptability that is comfortable for today’s young people. There are also chat rooms and social media groups that have successfully managed to recruit young people to join them and that have become safe online spaces for discussion on sensitive topics. 

Young people emphasized the importance of these “online families” for access to medicines, financial aid and psychosocial support, especially during COVID-19 lockdowns.

“[Our social media group] is more or less like a family, because we can help someone if that person is in need,” an HIV peer outreach counsellor in Ghana said. “If that person is sick and needs some help – maybe that person is in an abused case – we can step in. …The great benefit that we are getting out of it is the education that we are putting out there, and the services they are receiving.” 

Davis said that young people expressed enthusiasm for accessing health information through online channels because they believed their anonymity was protected online and they could therefore avoid some of the stigmas they might otherwise experience in clinics. 

At the same time, young people in all three countries shared serious harms linked to their use of digital health services, including verbal abuse and threats. This was especially true of young women, LGBTQ+ people and sex workers. 

“One of my friends posted on Facebook that she feels cold, has a headache, wondering what could be the problem? Just asking in the Kisumu Moms group. She was told: ‘You are pregnant, you have sugar daddies,’ and so on. People started throwing words at her until she withdrew that post,” explained a 25-year-old woman from Kenya.

Another thing the researchers found was a group of “really innovative people on social media” with significant followings in the tens of thousands or even millions in all three countries, who are serving as champions of sexual and reproductive health, David said.

“Young people have used their online access to information and social media networks to form extraordinarily powerful communities, investing little more than their own airtime and energy, and have literally saved lives by sharing medicines and information during COVID-19 lockdowns,” it says in the study. “As one young social media health champion suggested in Nairobi, they could do so much more by working together in partnership with health agencies.”

The work of some of these groups and individual influencers will be showcased during the webinar on the 22nd. Among them will be two of the organizations that participated, Love Matters Kenya with its 1.5 million Facebook followers, and Savana Signatures, which is running a hotline in 10 languages on reproductive health in Ghana. 

Misinformation 

Gachie of Love Matters Kenya said that her group has found censorship to be among the biggest challenges. Facebook, she said, often inadvertently censors content on the topic of sex, even when it is educational. The group has had many posts pulled down, marked as “escort services,” for example.

In addition, she said the government has sometimes intervened in the sharing of content, as have more conservative group members, who will report some posts. 

Another challenge is misinformation, said Pham Huyen Trang, program manager of the Vietnam Network of People living with HIV and a researcher on the study.

“There is information online that is not true, and sometimes young people access it before they realise and then they are scared,” Trang said. She noted that sometimes even untested medicines and other treatments can be offered that put people at risk. 

“Not everyone comes to learn,” said Gachie. “Some people come to sell products that are not even approved on the market. There is always a balance between being open and keeping people out who can do harm.”

Gachie added that minimal staffing is also a challenge because of the lack of understanding about how important it is to have experts working with these online groups. 

Finally, the youth need to have a better grasp of their online rights and the ability to protect their data.

“Our review also found that the use of social media, social chat and web searches for health information and peer support is generally not addressed in global health strategies and policies,” the report said. “While all three countries have data protection laws and policies, key informants in each country described implementation and enforcement as weak.

“Young people in the study generally had little knowledge of these laws or their rights,” the study continued. “Many expressed enthusiasm, nonetheless, to learn more about digital technologies and governance, and to play an active role in the digital transformation. They called for more resources and training and a voice in policy.”

The findings also demonstrated the need for governments and WHO to work together to roll out more robust regulations of social media and web platforms in the area of health. 

Trang said the interviews highlighted the need for training and noted that those interviewed said they wanted to learn to be able to take a more active role in their health. 

“Future digital health strategies should engage young people in creative thinking about ways to bridge the intersectional digital divides, empower young people with knowledge and information, and consult them in the design and governance of digital technologies,” according to the study.

A second phase of the study has been launched in Bangladesh and Colombia.

Image Credits: Photo by S O C I A L . C U T on Unsplash.

ContraceptionIn the aftermath of massive pandemic-related disruptions to family planning services, the World Health Organization (WHO) says that women can be taught to give themselves contraceptive injections.

This is one of the practical measures to ensure the continuity of family planning services during epidemics that is contained in the WHO’s updated family planning handbook, which was launched at the International Conference on Family Planning (ICFP 2022) in Thailand on Tuesday.

The world’s population reached eight billion by Tuesday, according to the United Nations Population Fund (UNFPA).

UNFPA Executive Director Dr Natalia Kenam told the opening of the ICFP conference on Monday that  “eight billion is a success story. It’s a story of people living longer and healthier lives, a story of more resilient and effective healthcare systems, of more women and babies surviving childbirth”.

Pandemic disruptions

But during the first few months of the COVID-19 pandemic in 2020, “approximately 70% of countries reported disruptions to these vital services, intensifying risks of unintended pregnancies and sexually transmitted infections,” according to the WHO.

Its handbook details practical measures to support family planning services during epidemics,  including “wider access to self-administered contraceptives, and direct distribution of contraceptives through pharmacies”.

A progestin-only contraceptive, depot medroxyprogesterone acetate  (DMPA), can now be safely injected just under the skin rather than into the muscle making it easier to self-administer, according to the WHO. 

Many women prefer injectable contraceptives as they are private and non-intrusive and last for two to three months.

“The updated recommendations in this handbook show that almost any family planning method can be used safely by all women and that accordingly, all women should have access to a range of options that meet their unique needs and goals in life,” said Dr Mary Gaffield, scientist and lead author of the handbook. 

“Family planning services can be provided safely and affordably so that no matter where they live, couples and individuals are able to choose from safe and effective family planning methods.”

In a video message to the IFPC opening, WHO Director-General Dr Tedros Adhanom Ghebreyusus said that “quality family planning and reproductive health and rights are essential components of universal health coverage and primary health care”.

“Family planning is also key to meeting development aims including education, food security, economic prosperity, and even climate change. WHO is working around the world to support countries with family planning programmes, including supporting 96 countries to update their national clinical practice guidelines,” he added.

For the first time, the 2022 edition of the handbook includes a dedicated chapter to guide family planning services for women and adolescents at high risk of HIV, including people living where there is high HIV prevalence, have multiple sexual partners, or whose regular partner is living with HIV.

It also incorporates the latest WHO guidance on cervical cancer and pre-cancer prevention, screening and treatment, which can all be provided through family planning services; management of sexually transmitted infections, and family planning in post-abortion care.

Now in its fourth edition, WHO’s Family Planning Handbook is the most widely used reference guide on the topic globally, with over a million copies distributed or downloaded to date. It is complemented by the medical eligibility criteria tool for contraceptive use, also downloadable as a dedicated App.

Image Credits: Reproductive Health Supplies Coalition/ Unsplash.

Colombian civil society group Red PaPaz outside Congress during the vote.

Colombia’s Congress has voted to impose taxes on ultra-processed foods and sugary drinks to curb obesity and address other health issues.

Ultra-processed foods facing taxes are those with high added sugars, salt, and saturated fats, including sausages, cereals, jellies and jams, purees, sauces, condiments and seasoning. 

These will face a 10% tax in September 2023, 15% in 2024, and 20% in 2025.

The tax on sugary drinks comes into effect in July 2023, covering drinks including sodas, malt-based beverages, tea or coffee-type beverages, fruit juices and nectars, energy drinks, sports drinks, flavoured waters, and powder mixes. The tax rate will depend on the amount of sugar contained in the drinks.

The taxes are part of a package that also imposes a new carbon tax on coal and single-use plastics, additional taxes on oil and gas companies, and taxes for people earning over $2000 a month. The new package is estimated to generate $4 billion, or around 1.4% of GDP.

For over six years, civil society groups led by the children’s rights group Red PaPaz have advocated for additional taxes on junk food and drinks.

They eventually succeeded in getting support across party lines for the measures after an advocacy campaign that targeted the finance ministry and members of Congress, as well as educating the public.

Research from the Colombian government has found that three-quarters of children and young people drank at least one sugary drink every day (Ministerio de Salud y Protección Social, 2018).

Meanwhile, 22.4% of Colombian women were overweight or obese – largely as a result of unhealthy eating.

Earlier in the year, Red PaPaz, the Center for the Study of Justice, Law, and Society (Dejusticia). José Alvear Restrepo Lawyers Collective (CAJAR) reported on how they had faced huge push-back from the industry as they campaigned for warning signs on unhealthy food and increased taxes.

Undue corporate influence on policies and regulations poses a significant risk to the rights to health and to adequate food of vulnerable populations, particularly children, women, and indigenous people,” the organisations said in a media report.

“There are several reported cases in Colombia in which corporations have exercised their influence on the government to prevent the adoption of higher standards of protection for the rights to health and to adequate food, including front-of-package warning labels on ultra-processed products, taxes on sweetened beverages, restrictions on the sale of ultra-processed products in schools, and regulations on advertising to children. These four policy measures have been recommended by the World Health Organization and the Pan-American Health Organization as cost-effective forms of preventing obesity and overweight.”

Image Credits: Ashley Green / Unsplash.

Niger Delta
Oil and gas extraction has poisoned the Niger Delta since the first drilling license was granted by British colonialists in 1958.

SHARM EL SHEIKH, EGYPT – Ken Henshaw’s story of his Niger Delta community’s experience with fossil fuel extraction reads like the fallout from a war zone without the ready presence of international media to document the devastation.

Henshaw lives at ground zero of one of Africa’s earliest and longest-running experiences with oil extraction, a six decade saga that has transformed Nigeria’s Niger Delta region, the vast wetlands that opens to the Atlantic, into one of the most polluted areas on earth.

The situation continues to worsen over time, said the Executive Director of the Port Harcourt-based NGO, We the People, the largest city in the area that has suffered from decades of pollution due to fossil fuels extraction to its rivers, soils and air.

“I was born into a crude oil age, where we saw companies like Chevron, Exxon Mobil, and Shell invade our communities, invade our swamps, invade our rivers, invade our wetlands, our farmlands, everything, drilling for crude oil and gas,” said the longtime activist, speaking at a WHO-sponsored event Friday at COP27 on the Health Impacts of Fossil Fuels.

“It’s a place where crude oil has been extracted nonstop for the last 64 years with devastating environmental and health consequences.”

On May 12, 2016, hundreds of people gathered at the first-ever oil well in the Niger Delta demanding a halt to drilling and rehabilitation of the area.

Henshaw spoke in a panel that included leading pollution and health experts, as well as activists from New Delhi, which is currently facing  a perennial air pollution emergency, and representatives of Alberta Canada’s First Nation Cree, where tribal lands have been defiled by repeated oil spills over the past decade, as recently as 2021. 

The Niger Delta’s dense swamps, rivers and wetlands that empty into the Atlantic, and have become the poster child for the devastating impacts oil and gas extraction can have on vulnerable and remote communities.

“There has been an unprecedented penetration of every nook and cranny of the Niger Delta for the last 64 years,” Henshaw said. The first drilling license in the Delta was granted in 1958 by British colonial rulers to the oil and gas company that later became Shell Oil.  The license, as he tells it, “basically gave them permission to go into any farmland, any river, any creek to drill for crude oil.

“Illicit wedlock”, says Ken Henshaw.

“And they have continued that way for 64 years up to today, drilling nonstop for crude oil in our space.

“We live in a community where people have been literally kicked out of their homes for oil to be extracted for the Nigerian state and the oil company partners.

“There is an illicit wedlock cemented in petrol profits, at the detriment of the people of the Niger Delta region.

“In this period, the Niger Delta people have become poorer and oil extraction has happened with the worst form of technology imaginable,” he added.

Routine flaring of methane continues despite 1979 ban

Gas Flare
Burning Gas flare Nembe Creek, Nigeria.

Henshaw described how routine flaring of methane, a practice technically banned by the government in 1979, continues to this day, with actual enforcement delayed over more than four decades.  The flaring of pent-up gas locked in oil wells occurs at hundreds of facilities across the region, contributing to air pollution that harms health and ecosystems by creating acid rain.

Fumes from the methane flaring combine with those of artisanal oil extraction, which is common in a region where locals have no formal access to the oil and gas resources exploited by the multinationals. These also combine at times with emissions from the Port Harcourt refinery to form a heavy soot that periodically blackens the skies of the regional capital, infiltrating homes and surfaces everywhere.

“We woke up one morning and we saw soot everywhere, on windows, our beds,” Henshaw said, describing one recent event including a display of pictures of his soot-blackened hand.

Fossil fuels responsible for about 65% of excess air pollution deaths from avoidable human sources

WHO-organized session at COP27 Friday on the health harms of fossil fuels, with activists from Nigeria, India and Canada, as well as pollution experts.

Globally, air pollution from fine particulate matter generated by both fossil fuels and biomass burning causes about 7 million deaths a year, according to WHO estimates. Other reputable studies have pegged that number even higher, at 8.793 million excess deaths, According to that latter analysis, about 5.55 million excess air pollution deaths a year are from sources created by human activities, 65% of which represent fossil fuels combustion. The other 35% is largely attributable to biomass burning for home cooking and heating, according to the 2018 study by researchers at Germany´s Max Planck Institute, the London School of Hygiene and Tropical Medicine and the University of California.

Tiny particles of pollution emitted by both fossil fuels and biomass penetrate deep into the lungs, the blood system and even the brain, and carry with them an array of particularly toxic and cancer-causing chemicals, explained Dr. Poornima Prabhakaran, of the Public Health Foundation of India, and one of the experts at the session.

Not surprisingly, Indians who are exposed to some of the highest levels of air pollution in the world, also have high levels of air pollution linked diseases, such as hypertension and cardiovascular diseases, she said.

Public Health Foundation of India

Pollution pervasive not only in the air, but in water and soils

Henshaw also sees first-hand the high levels of respiratory illness, but also abnormal hormonal changes, birth defects and a reduced life expectancy from fossil fuels pollution that is not only pervasive in the air, but in water sources and soils.

“Assessments indicate that more and more people living in the Niger Delta region are suffering respiratory illnesses. But not only that, there are increasing numbers of children born with deformities on account of black soot. There are women who go into menopause at the age of 25. And while the average life expectancy in Nigeria is low, life expectancy in the Delta region is only about 46 – about ten years less than the national average,” he related.

Pollution from crude oil leaks, including pipeline breaks and sabotage in the Niger Delta region.

Water pollution in the region is particularly severe, he said. Constant ruptures to the several thousand kilometers of oil pipes, some of which date back to the British colonial period, darken the Delta’s waters. Some of the sabotage is committed by people desperate for fuel that they do not otherwise benefit from.

“Pipelines have been buried in the swamps, the creeks and the farmlands of the Niger Delta region,” Henshaw explained.  “And as routine as clockwork, on an almost daily basis, the pipelines rupture.

Spatial distribution of pipeline oil spills in the Niger Delta from 2007-2015

“You don’t know the health impact of an oil spill until you see one,” he added, displaying images of the destruction wreaked. “A few barrels of crude oil spilling into the river sends thousands of fisherfolks into starvation.

“If the spill happens on farm lands, one whole year of crops die instantaneously. If it’s in the forest, these are not just forests, these are also our pharmacies.  When they are destroyed we lose medicines upon which we also depend.

“And there’s never a time when there’s no oil spill in the Niger Delta region. As I speak to you  there is an ongoing oil spill. There are always spills.”

Fossil fuels harm health all along the product lifecycle 

Health
A cascading chain of health impacts from fossil fuels; Lancet’s 2022 Countdown report.

Henshaw’s stories illustrate how the global obsession with fossil fuels causes health threats all along the life cycle chain of production and use, said Jane Burston, executive director of the Clean Air Fund, and moderator of the COP27 session.

“It causes really serious threats to our health, both from the air pollution it causes and the process of extraction, which I think is talked about much less often,” said Burston.

A fossil fuels addiction

Marina Romanello, Executive Director of the Lancet Countdown on Climate and Health.

“We have a fossil fuels addiction,” said  Dr. Marina Romanello, summing up the findings of The Lancet Countdown on Climate and Health. The 2022 report, a collaboration of nearly 100 researchers around the world, was published just as COP27 opened on 6 November.

“It is not only exacerbating the health impacts of climate change, it is reducing our capacity to cope with and to respond to other crises that we’re facing,” said Romanello, executive director of the project that regularly tracks and reports upon 44 indicators at the intersection of health and climate change.

“We’re not only dealing with a climate crisis, we’re also dealing with a war in Ukraine, with a cost of living crisis, with an energy crisis, with a food crisis. And climate change is just acting to exacerbate the impacts of those other effects that we’re seeing on our health.”

And in terms of those indicators, “everything is going upwards and that is no good. Up is bad.”

Four billion more days of heat wave exposure a year

The IPCC Sixth Assessment Report (2021) projections of increased frequency of extreme events compared to the pre-industrial era for heat waves, droughts and heavy precipitation events, for various global warming scenarios.

Romanello described the Lancet’s findings of increased exposure of vulnerable populations to heat waves; in people over 65 years of age and very young children, heat stress can be a life-threatening risk.

“We are exposed to 4 billion more present days of heat wave exposure in the latest years with respect to a very recent baseline,” she explained.

“We’re seeing that heat exposure is reducing our labor capacity and undermining our livelihood by reducing incomes.  That is affecting people who are also facing a cost of living and price increases, and are struggling to afford their basic energy needs.”

Food insecurity is also on the rise, she added, noting that farm workers are among the most affected by heat stress.

“Labor supply is being lost mostly in the agricultural sector. We’re also seeing extreme weather events affecting our crops, supply chains disrupted, and that the increasing heatwaves are  directly correlated with almost 10 million more people self-reporting that they could not afford the food that they needed last year.”

Extreme weather and wildfires also destroying homes and livelihoods

Expansion of extremely hot regions in a business-as-usual climate scenario. Black and hashed areas represent unliveable zones. Absent migration, that area would be home to 3.5 billion people in 2070.

Extreme weather events are not only on the rise, but also becoming more lethal, Romanello pointed out.

“We’re seeing that exposure to wildfire danger is increasing as a result of the drier temperatures, putting people at acute risk of wildfires that not only affects us through direct burns, but also affects our infrastructure, disrupts the essential services that we need and exposes us to air pollution. That has enormous effects on our health.

“We’re also seeing that infectious diseases are being spread more easily because of the changing weather conditions. We’re seeing malaria in highland areas of Africa previously relatively protected from malaria. We’re seeing vector borne diseases shifting more northwards and southwards across the globe.

“And that means that new populations are being exposed to hazards that they’re not used to dealing with and our health systems are not used to facing.

“This is the result mostly of the continuing burning of fossil fuels,” Romanello concluded, pointedly noting that fossil fuels were referenced as a sector only for the first time at last year’s COP26 outcome document.

Fossil fuels not the only culprit, but a leading one

Shell Oil sign in Accra, Ghana, 1962. Multinational oil companies have been in Africa since the first half of the 20th century.

Fossil fuels are not the only driver of climate change and health effects. Household cooking and heating on biomass stoves also contribute significantly to air pollution and climate change when the wood or material being used is not sustainably harvested.

Land use changes, including deforestation, as well as agriculture and agro-waste burning are other factors affecting climate emissions.

But “by and large the culprit of this is a fossil fuel burning and we should not forget that,” Romanello said.

“Because we’re so addicted, and we were so late in the adoption of renewable energies, we’re still heavily dependent on a fossil fuel market that fluctuates, that is very sensitive to geopolitical conflicts. And [in homes] we’re still using biomass rather than clean energies, which can be made available at point of source.”

“This is what annoys us the most. We’re seeing governments and companies still prioritizing fossil fuels, even though they know this data.  Of the 86 countries that contribute about 90% of all emissions, 50% of them are still subsidizing fossil fuels.

“We’re looking at the fossil fuel companies. If you enter the websites of BP or one of the other fossil fuel giants, they probably look like a renewable energy company.

“But when you look at what they’re doing today, it will only take them until 2040 to exceed the levels of emissions compatible with the Paris agreement by over 103%. Their strategies are incompatible with a healthy future.”

Fossil fuel industry still planning major expansion  

Fossil fuel companies with the highest overshoot of the IEA’s net zero emissions scenario, in planned new oil and gas extraction.

Romanello´s remarks are supported by a raft of new reports on fossil fuel extraction forecasts, globally and in Africa, which were released by civil society researchers over the past several days. They include projections of:

  • Global glut of liquified natural gas production by 2030500 megatones a year oversupply, five times as much gas as the EU imported from Russia last year, if all of the natural gas expansion projects triggered by Europe’s “dash for gas” are realized, according to a new report by Climate tracker.
  • Fossil fuel industry expansion: 95% of the world’s leading companies are planning expansions, pouring $160 billion of capital into new exploration since 2020. Together these will result in 115 billion more tonnes of climate-heating CO2 being pumped out into the atmosphere, equivalent to more than 24 years of US emissions, a new analysis by the German NGO Urgewald. LNG exports would  more than double. The International Energy Agency warns that no new fossil fuel expansion can go ahead if the world is to reach the 1.5 C target.
  • Dire warnings of irreparable damage in Africa´s Congo Basin: the world´s second largest rainforest and the continent´s green lungs. Moreover, many of the areas put up for auction as oil and gas blocks by the Democratic Republic of Congo also overlap with  dense peat bogs, says the Rainforest Foundation. Drilling there risks the release of millions of tons of methane emissions, which have 86 times the warming potential of CO2.
New oil and gas drilling in the Congo Basin, the world´s second largest rainforest, poses a regional and global climate threat.

While European leaders have showcased their deals with countries like South Africa and Egypt for model projects to develop green hydrogen and other renewables, their response so far at COP27 to criticism of the EU’s large strategic oil and gas expansion plans in Africa has been weak.

Jacob Werksman, head of the European Commission’s COP27 delegation.

“The dash for gas is a very sensitive issue,” said Jacob Werksman, the European Commission’s lead at COP27, in a press conference on Wednesday. “Obviously, the EU has responsibilities to ensure that we have access to the energy supplies that are necessary for our population.

“And we have to do so in a context where we cut off supplies from Russia; this is requiring us to go out into the world and find the supplies and the partners that we haven’t reached out to before.  And some of them are in Africa. We will do this in a way that is as environmentally and socially responsible as we would in any circumstances.

Oil and gas projects in Africa are set to quadruple; projects in the Congo Basin, the world´s second largest rainforest, pose a major risk to regional and global climate stability.

“But in this circumstance, in particular, we feel an obligation to ensure that as we enter into any kind of relationship with a country that is making a choice between doubling down on investment in fossil fuel, that we are offering them and encouraging them to take an alternative as well.

He said the EU was working with the African countries with which it would sign deals to “see how, whatever continued sales of fossil fuels they might engage in, they are, at the same time planning for a transition away from fossil fuels towards renewables. We will look at ways in which we can strike that balance.”

What needs to change ?

The natural beauty of the Niger River on display at its confluence with the Forçados River at Bomadi Local Government, Delta State, Nigeria.

Data can and should make a difference, but it is the human drama that can often be more persuasive, observed Burston at Friday’s WHO panel.

Yet from Canada’s First Nation tribes to Africa and Latin America, the impacts of oil exploitation in developing countries and on indigenous groups often occur in remote regions, and far from the media cameras.

It is in those same vulnerable rural communities where the environmental impacts and human rights violations that accompany oil exploitation may be far more acute, and kept under wraps by governments with poor environmental and human rights records, panelists observed.

See related Health Policy Watch story on lead poisoning of indigenous communities from oil extraction in the Amazon:

Lead Poisoning Still Causes 900,000 Deaths Per Year

“Over the past 64 years I’d say things have gotten worse,” observed Henshaw, referring to the cycle of local opposition and repression that has wracked the area for years.  “The power dynamics led by the oil companies still exists. In fact, it has even gotten even stronger.

“There is the same level of repression, human rights abuses, suppression of dissent and all the rest. In 2019 alone, my organization documented three cases where the military working for oil companies invaded and bombed Niger Delta communities.

“In May 2019, one community was bombed by air, land and sea, a tiny unarmed community, just to allow crude oil flow.  So nothing has changed, what needs to change. What needs to change is [inclusion] in this kind of forum right? We need global and international support, working closely with frontline communities sending one message: leave the oil in the ground.

“Some 65 years of oil extraction has bled our environment, our health systems, everything. Nigerians have become poorer because of it. The Niger Delta is worse for it.

“If you do not bring the oil out, then you will not burn it. You will not mess up the planet. Then you will not destroy our lives.  Leave it in the ground. That’s what needs to change.”

Stefan Anderson contributed reporting form Brussels. 

Image Credits: SU, E. Fletcher/Health Policy Watch , Sara Leigh Lewis, Dr. Poornima Prabhakaran, Public Health Foundation of India, Ucheke, Environment international 2018: Quantifying the exposure of humans and the environment to oil pollution in the Niger Delta , PNAS, ASC Leiden, Rainforest Foundation , Rainforest Foundation and Earth Insight, 2022, Jay Jay Agbor.

Biotherapeutic products represent a new therapeutic revolution in disease treatment and are by far the fastest-growing segment of the pharmaceutical industry – yet the recent biosimilar guidelines issued by the World Health Organization (WHO) are myopic, inconsistent or vague about some well-established scientific issues

Biosimilar products include recombinant proteins and hormones, monoclonal antibodies (mAbs), cytokines, growth factors, gene therapy products, vaccines, cell-based products, gene-silencing or gene-editing therapies, tissue-engineered products, and stem cell therapies among others. 

Biotherapeutic products in the form of targeted therapies have transformed the landscape of how diseases will be cured and alleviated in future. Biotherapeutic products are large, complex molecules that are manufactured through biotechnology in living systems such as microorganisms, plant or animal cells, which results in an inherent variability amongst them. This differentiates them from conventional small molecules which are synthesized chemically and have the same active ingredients.

Alarming lack of access

Monoclonal antibodies (mABs) constitute one of the most transformative treatment regimens and have an increased dominance in the biotherapeutic landscape. In 2021 among the top 10 selling medicine brands, four were mABs. 

However, it is alarming that looking from an access perspective, 80% of the market for these mABs is concentrated in just three geographical areas, the USA, Canada and Europe. 

The arrival of biosimilars (non-originator’s products, like generics in the case of small molecules) has significantly driven cost savings, improved patient access and significant budget impact on health systems. But even after the entry of biosimilars, the competition in the biotherapeutics space is limited because of the heavy costs associated with setting up a manufacturing facility, the presence of patent thickets and regulatory barriers. 

While recent developments in modular facilities have drastically reduced the cost of establishing facilities, patent thickets and regulatory requirements still constitute a major impediment to the successful entry of biosimilar products.

The recently issued WHO Guidelines on Evaluation of Biosimilars, which replace guidelines issued in 2010, focus on removing some of the regulatory barriers affecting the cost of production of biosimilars, such as the waiver for comparative efficacy trials.

Despite the WHO’s revisions, the biosimilar guidelines remain myopic, inconsistent or vague about certain other well-established scientific issues. These, if not addressed, will continue to impede access to biosimilars, particularly among low and middle-income countries. 

Four key concerns are as follows:

1. Market Exclusivity

The guidelines suggest that the chosen reference product – the originator’s product – must be marketed for a “suitable period of time with proven quality, safety and efficacy”. This requirement provides a de-facto monopoly to the manufacturer of a reference product. 

This also means that a biosimilar manufacturer will have to wait for a suitable period of time, to develop a biosimilar version of a newly introduced biotherapeutic in the absence of patent protection or under a compulsory license. 

Through the use of these terms WHO is indirectly trying to import market exclusivity which goes beyond the data exclusivity requirements currently existing in EU and US. The absence of a definition of a suitable period of time provides a lot of latitude to national governments to decide what would constitute a suitable time period, which is not only illogical but highly improper. 

By adopting this new definition, the elbow room provided by the removal of comparative efficacy trials has been partially neutralized. There was no requirement of a suitable time period in the previous WHO Guidelines or the new UK Biosimilar Guidelines.

 2. Overemphasis on PD markers  

The guidelines mandate the use of PD markers in pharmacokinetic (PK) and pharmacodynamic (PD) studies – but maintain a stoic silence on alternatives in the absence of PD biomarkers.

A PD biomarker is “a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes or responses to an exposure or intervention”.

The objective of PK and PD studies in biosimilar development is to evaluate the similarities and differences between the proposed biosimilar and the reference product. 

PK, and PD studies help to establish the similarity of the biosimilar product with the reference product. 

However, in some cases, PD biomarkers are not available and identification of such PD biomarkers is a lengthy and resource-intensive process. In the absence of PD biomarkers, robust structural and functional characterization and clinical PK studies should be sufficient to establish meaningful differences between the two products. 

Rather than insisting on the use of PD biomarkers, WHO should follow a progressive approach and focus on the totality of evidence for meaningful assessment of biosimilarity.

 3. Barriers To interchangeability

 In the case of biotherapeutics, there is some resistance to interchangeability – the shifting from an originator’s product to a non-originator’s product – for safety reasons. But after 15 years of approval of various biosimilars and a flawless record of safety and efficacy, this is not a valid concern

 Taking note of the robust evidence available in favour of biosimilar safety, the European Medicine Agency (EMA) and the Heads of Medicines Agencies (HMA), on 19 September signed off on a policy of “interchangeability” of biosimilars.

 That means a biosimilar medicine approved in the EU can now be interchanged with its reference medicine or with an equivalent biosimilar approved in the EU. This will flatten the path for switching patients from the expensive originator’s biotherapeutics to biosimilars and will improve access and financial sustainability. For example, in the case of Roche’s Trastuzumab, interchangeability allows either a doctor or pharmacist to switch from the originator’s product to a biosimilar – such as those produced by Mylan/Biocon, Actavis, Apotex or Samsung Biosepis – or even amongst biosimilars themselves.

The guidelines not only exclude interchangeability but also create a barrier by insisting that “the biosimilar should be clearly identifiable by a unique trade name together with the INN”. The insistence on marketing the biosimilar with a trade name (brand name in the trademark context) is an added wrinkle for the competition in the market as it creates product differentiation based on trade names. Prescription using trade names forces biosimilar manufacturers to invest in promotion and branding.

 This would leave the patients worse off as the high costs incurred on branding and promotion activities will result in higher prices thus further diminishing the availability of affordable biosimilars. Allowing the NRAs unrestricted autonomy in the context of prescribing information would intensify uncompetitive behaviour and ultimately lead to the unaffordability of biosimilar products.

 From a public health perspective, marketing medicines using the INN (International Non-proprietary Name) is considered a pragmatic way of generating competition as such a move would prevent doctors from prescribing the medicines by trade name.

4. Reluctance to obviate animal studies

There is a growing consensus for waiving in-vivo animal studies, which stems from the recent advice by many regulatory bodies including EMA and UK that it is unnecessary to test new biological therapies in animals. However, WHO’s usage of language such as “animal studies may represent a rare scenario” in the guidelines maintains a status quo rather than providing clear guidance on the removal of animal studies. This creates uncertainty and often National Regulatory Agencies, especially in developing countries that are looking for clear guidance from WHO, and tend not to use their discretion in favour of speedy approval of biosimilars.

 Furthermore, the tone and tenor of the guidelines is not constructive in some places and do not clearly give articulate and cogent directions for implementation at the National Regulatory Agencies level. Instead of giving clear guidance, it often uses ambiguous language and conveys the idea of a case-to-case basis approach.

As an example, the guidelines mention that A comparative efficacy trial may not be necessary if sufficient evidence of biosimilarity can be inferred from other parts of the comparability exercise.”  Rather than underpinning that comparative efficacy trials are not required, statements like these continue to imply that comparative efficacy trials may well remain the norm, which is incorrect and clearly belie the purpose of updating the guidelines.

Removal of comparative efficacy trials will benefit biosimilar industry  

One of the most notable changes brought about by the WHO Guidelines has been the removal of the requirement for “comparative efficacy trials” to obtain marketing approval for biosimilars from regulatory agencies.

A recent study estimates the developmental cost of biosimilar manufacture in the US to be between $100-300 million and takes on an average six to nine years from analytical characterization to approval, and the clinical trials accounted for more than half of the budget. Such monumental developmental costs prevented biosimilar manufacturers from selling their products at an affordable price in comparison to small molecules drugs (chemical compounds manufactured through chemical synthesis) which are typically 80-85% cheaper, once the generics have entered the market. Evidence shows that biosimilar entry cuts the price of the original biologic product by only 30%.  

There is no doubt that the removal of this requirement will change how biosimilars are approved globally and drastically reduce the duration for marketing approval. This will lower the costs of biosimilars which in turn will result in cost savings and access to effective treatments for patients especially those suffering from chronic diseases like cancer.

Conclusion

Evidence-based regulatory reforms for the biosimilar industry have tremendous potential to reduce the cost of treatment, increase access and improve people’s health.

The WHO revisions have come out clearly as part of a long process since the adoption of the World Health Assembly (WHA resolution 67.21) in 2014. However, even after deliberating for eight long years, the guidelines are conspicuous by the absence of an effort from WHO to promote accessibility. 

While removing some barriers, it has created fresh barriers and thus stymied the availability of affordable biosimilars. In the current form, the guidelines thwart the repetition of the intense competition that was witnessed in the small molecule space after the entry of generic manufacturers.

Both the content and process of the guidelines raise serious concerns about WHO’s commitment to access to medicines. The most appropriate way to address these concerns is to make changes in the guidelines and not to come up with inadequate solutions like Frequently Asked Questions (FAQs) or changes in the Implementation Guidelines. 

The authors are afraid that a delay in addressing these concerns effectively and appropriately would lead to a situation wherein the decision of the WHO could result in the denial of the right to health and the denial of a human-right based approach to science, thus depriving inclusive access to benefits of scientific advancement to millions of  people.

KM Gopakumar is a senior researcher and legal advisor at Third World Network (TWN) and is based in New Delhi, India.

Chetali Rao is a biotechnology patent lawyer and works on pharmaceutical innovations, access to medicines and global health issues. She is based in New Delhi, India.