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.

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.

Plastic
Plastic threads rest on a coral reef off the coast of Wakatobi National Park, Indonesia.

SHARM EL-SHEIKH, EGYPT – As global delegations fight to keep the dream of limiting warming to 1.5C within reach, plastic pollution contaminating aquatic life, soil quality and the human body, is skyrocketing.

The relentless growth of demand for plastics driven by subsidies for fossil fuels, coupled with the failure of recycling and waste management systems to keep pace, has set a trajectory whereby plastics consumption will account for 20% of global oil and gas consumption by 2050.

“One million plastic bottles are consumed every minute,” Ecuadorian Environment Minister Gustavo Manrique Miranda told COP27 delegates at a United Nations (UN) Conference on Trade and Development on Thursday. “By the end of our meeting, the world will have consumed 60 million bottles.”

Plastics consumption quadrupled over the past 30 years

Plastics

In the past 30 years, plastic consumption has quadrupled to reach 460 million tons in 2019. Global production of recycled plastics has more than quadrupled in this same period to 29.1 megatons per year, but this represents just 6% of global plastics production. The other 94% are ‘virgin’ plastics made new from crude oil or gas, according to the OECD.

Unrecycled plastics compound the environmental impacts of their production. Of the plastics that don’t get reprocessed and reused, 19% are incinerated, 50% end up in landfills, and 22% end up being burned in open pits, wind up in uncontrolled dumpsites, or scattered along roadsides, farmland or the waters of poorer countries.

“I don’t think the magnitude of the connection between climate and plastics can be overstated,” said Susan Garder, director of the ecosystems division at the UN Environmental Programme (UNEP). 

“The world is trying to and must decrease emissions by 45% by 2030 to keep the dream of 1.5C alive, and we’re seeing plastics move in the opposite direction.”

Plastics’ health impacts not well documented, but warning lights are flashing 

Microplastics were detected in human blood for the first time this year, heightening research efforts to understand their effects on our health.

Since its invention in the 1950s, the world has produced as much as ten billion tons of plastic, most of which still exists today. The gradual breakdown and dispersal of most of that plastic material over time has led to the shedding of chemicals and microplastics, which are now ubiquitous in the bodies of terrestrial wildlife, oceans and fisheries.

A 2021 report by the Food and Agriculture Organization (FAO) found that plastic contamination of farmland from single-use soil and plant coverings, tubing and other materials, poses an increasing threat to soil quality, food safety and human health. 

On the seas, a recent Nature study found that the blue whales, which typically feed upon krill, may consume some 10 million pieces of microplastics a day, a taste of what other large fish like tuna and salmon are likely eating as well.

The fact that human exposure to plastic additives such as DEHP and Phthalates, used to soften polyvinyl chloride (PVC), leads to higher risks of cancer and hormonal disorders that cause reproductive health problems is well documented.  

Along with its uses in waterproof garments and building materials, PVC is ubiquitous in healthcare settings where it is a key component of basic medical devices like IV tubes. Not only are the phthalate additives health harmful, but the production of PVC out of fossil fuel-derived ethylene, also generates considerable mercury emissions toxic to humans and to wildlife.

Plastics
Unrecycled plastics have knock-on effects on the environment, emissions, biodiversity, and human health.

During the COVID pandemic, the healthcare sector, already heavily reliant on all sorts of plastics, doubled down on their use as single-use masks and protective gear became the norm for infection prevention, while pollution concerns were put on the backburner.

Studies of the health effects of broader classes of microplastics are still in their infancy, but early findings have triggered alarm bells in the medical community.

A 2020 study conducted by a team of Portuguese researchers linked plastics exposure to chronic inflammation and the development of neoplasms, or tissue abnormalities (neoplasia), that may be carcinogenic. 

“Exposure may occur by ingestion, inhalation and dermal contact due to the presence of microplastics in products, foodstuff and air,” the report found.

“In all biological systems, microplastic exposure may cause particle toxicity, with oxidative stress, inflammatory lesions and increased uptake or translocation. The inability of the immune system to remove synthetic particles may lead to chronic inflammation and increased risk of neoplasia. Furthermore, microplastics may release their constituents, adsorbed contaminants and pathogenic organisms.”

And as microplastic pollution was detected in human blood for the first time in March of this year, with scientists finding the tiny particles in nearly 80% of the people tested, a review of 17 studies published in the Journal of Hazardous Materials in 2021 found evidence that ingested microplastics can trigger cell death, allergic responses, and damage to cell walls.

“We are exposed to these particles every day: we’re eating them, we’re inhaling them, and we don’t really know how they react with our bodies once they are in,” Evangelos Danopoulos, the first author of the review told the Guardian. “We should be concerned. Right now, there isn’t really a way to protect ourselves.”

Plastics are destroying oceans’ ability to absorb carbon

By 2050, our oceans are projected to contain more plastics than fish.

Along with the direct effects of plastics on health, their proliferation is also destroying the ocean’s ability to absorb carbon.

Our oceans, like the Amazon Rainforest or Africa’s Congo Basin, are “carbon sinks”, Nicholas Hardman-Mountford, Head of Oceans and Natural Resources of the Commonwealth Secretariat explained at the COP27 side event. 

Oceans absorb more carbon from the atmosphere than they release, making them critical to the balance of our climate, and any hopes of limiting the increase in temperature of the planet.

By 2050, projections show that our oceans may contain more plastics than fish. These will not only suffocate marine life, but also phytoplankton, the microorganisms at the heart of oceans’ abilities to absorb carbon dioxide, as forests and plants do on dry land. 

As millions of tons of plastic break down in oceans across the world, the resulting microplastics infiltrate the phytoplankton, damaging their ability to carbon capture by blocking sunlight, and preventing the process of photosynthesis.

This “biological carbon pump” transfers about 10 gigatons of carbon from the atmosphere to the deep seas every year, according to NASA’s Earth Observatory.

“The oceans have taken up a third of the carbon dioxide we put into the atmosphere since the start of the Industrial Revolution,” said Hardman-Mountford.

“If we damage that carbon sink, we are just making the atmospheric problem even worse.” 

Oil and gas subsidies fueling plastic boom 

Fossil fuel subsidies by percentage of global GDP, per the IMF.

Fossil fuel subsidies have taken center stage at COP27, and for good reason. These subsidies, amounting to some $5.9 trillion in 2020, are widely known to drive countries’ continued addiction to coal, oil and gas, but a crucial detail is often absent: they are artificially deflating the price of plastics. 

Global fossil fuel subsidies almost doubled in 2021, and the International Monetary Fund projects they will continue to grow to 7.4% of GDP in 2025, up from 6.8% in 2020. Accordingly, the UNEP Emissions Gap report found that global emissions in 2022 likely broke the all-time record set by the world in 2019, leaving “no credible path” to keeping temperature rise under 1.5° C.

WTO has begun to take heed of the fossil fuels subsidy issue – just barely

Ngozi Okonjo-Iweala, Director of the World Trade Organization, speaking on a WTO panel at COP27 in Egypt.

The World Trade Organization (WTO) has recently taken heed of the damage fossil fuel subsidies are doing to the climate, a shift attested to in their report on Trade and Climate released earlier this week at COP27.

WTO members have only just begun discussing the fossil fuel subsidy issue informally, with a small subset of 44 countries signing onto a statement calling for the phaseout of “inefficient fossil fuel subsidies”. But these subsidies are an important form of income support for the poor in many developing countries, and their reduction can, and has in the past, provoked civil unrest in the past.

Adding to the political complexity is the fact that the WTO rules are extremely lax on the kinds of fossil fuel subsidies that can be doled out to consumers.  However, the rules contain strict limitations on governments’ provision of subsidies to favor local manufacture of goods such as solar panels – since such subsidies are seen as discriminatory and thus a barrier to free trade.

In the past, for example, governments such as India that tried to invest in renewable energy by enacting “local content” requirements to jump-start the development of local green industries, as well as jobs and social benefits, lost cases in the global trade fora brought by rich countries such as the United States.

But paradoxically, by the same WTO rules, a government can invest in fossil fuel production deals with a big multinational to create a domestic fossil fuels industry – which generates long-term economic benefits in the form of cheaper domestic fuels along with income on exports for years to come.  So the built-in biases of trade rules, not to mention capital flows, still heavily favor fossil fuels development.

Plastics lost in the shuffle of free trade rules

Lost in the shuffle is the impact these free-trade rules also have on the production of plastics. Because plastics are produced from the by-products of both natural gas and crude oil refining, a subsidy for fossil fuels is a subsidy for plastics. 

Like fossil fuels, the current boom in plastics consumption is being driven primarily by growth in emerging markets.  And without rectification of the basic economic incentives driving the subsidized production and use of plastics, consumer behavior is unlikely to change.

Projected impacts of fossil fuel subsidy reform on carbon dioxide emissions.

While environment ministers agreed in March to negotiate a treaty on plastics pollution, the negotiations will likely take years, and will not have an effect on market dynamics in the near-term. 

“You have a very cheap product because the fuel is cheap. And why is the fuel cheap? Because it is subsidized,” said Aik Hoe Lim, director of the WTO’s Trade and Environment division. 

“If the subsidies for fossil fuels do not change, the economics [for reducing plastics] don’t work out. Production will continue to flow unless this very basic economic question is addressed,” Lim said.

With the world hurtling beyond the 1.5C ceiling at lightning speed, any hopes of stopping at this target will depend on a reversal in the plastics boom. Otherwise, as panelists repeatedly noted, plastics will not only represent one-fifth of oil and gas production by 2040, but by 2050, plastics will represent one-tenth of the planet´s entire available “budget” of carbon emissions from all sources – including not only fossil fuels burning but also from food and medicines production, building construction, waste management, and other emissions-generating activities essential to life as we know it. 

“The production and incineration emissions from plastics currently sit at around 850 million tons of greenhouse gas per year – that’s equivalent to nearly 190 500-megawatt coal-fired power stations,” said Hardman-Mountford.

“By 2030, it will be 300 power stations. And by 2050, it will be 10% of the carbon budget we have left to remain under 1.5C.”

Image Credits: QPhia, Plastic Soup Foundation, University of Oregon, IMF.

TRIPS Waiver protest in Indonesia. Civil society protested globally against the delay and destruction of the TRIPS waiver.

Deadlock may once again be the name of the game at the World Trade Organization’s (WTO’s) Council for Trade-Related Aspects of Intellectual Property Rights—TRIPS, for short.

A communication from Switzerland and Mexico questioning the need to extend the waiver on intellectual property rights on COVID-19 vaccines to therapeutics and diagnostics is laying bare the divergences and complexities of one of the most contentious issues facing the organization. 

Readers may remember that the 12th Ministerial Conference (MC12) was hailed as a major success: “The WTO is back,” claimed, in essence, headlines around the world. In the wee hours of a sunny Geneva morning on 17 June, as bleary-eyed delegates concluded their work, they announced, among other agreements, a deal on conditionally waiving patents on COVID-19 vaccines. 

While marking a true milestone in negotiations which had begun in 2020, when India and South Africa introduced a text demanding such a waiver, the agreement, made after intense negotiations, was narrower in scope than the original proposal. If the WTO could claim success, in reality the agreement satisfied no one: its proponents, health activists, and civil society rejected it as too limited, while Big Pharma had fought tooth and nail to prevent any waiver agreement at all.

The June agreement explicitly called for the vaccine waiver to be extended to the “production and distribution of COVID-19 diagnostics and therapeutics” within six months of adoption, setting the deadline for passage of an agreement to December 19—the first business day after 17 December.

With less than six weeks remaining, time is running out. “The level of urgency within the WTO to reach consensus on this issue is difficult to assess,” according to global health writer Priti Patnaik, author of a newly published book on the subject. “A range of countries remain undecided and have sought more information. It is not even clear whether the proponents will go the last mile to fight for this.”

Informal discussions about the extension were held in September but led nowhere. 

Rising concerns

 In a meeting last week in Geneva, the chair of the TRIPS Council, Ambassador Lansana Gberie of Sierra Leone, said that the absence, at this late stage, of concrete, text-based proposals on the issue of the extension is “very concerning,” and urged delegations to explore all options to make progress.

The ambassador will begin reaching out to individual members in the coming weeks to look for areas of possible convergence. South Africa, co-sponsor of the initial waiver proposal, also reported that its delegation has recently been holding bilateral contacts to try to find a way through the impasse.

The only document put forward so far has been a communication submitted on 1 November by Mexico and Switzerland, which does not represent a formal negotiating position. It does, however, raise questions about the ability of the trade body to meet its objective of reaching an agreement by mid-December.

In essence, the Swiss and Mexican communication uses the same rationale already advanced by Switzerland when opposing a waiver for COVID-19 vaccines at the height of the pandemic: a waiver would not, argued Switzerland and its pharmaceutical industry, along with a number of Western countries, accelerate the rate of vaccination in the world, because the main problem lies, the industry claimed, in the manufacturing and distribution of the newly developed vaccines. 

 Today, the two countries write, the same argument can be made, even if in this case, the problem is not one of scarcity but of a surplus of available therapeutics and diagnostics: “No shortage of therapeutics exists. Instead, large parts of innovators’ production capacity remain idle due to lack of demand. […] This involves issues with logistics and distribution, which are not IP-related, but that need to be addressed.”

Three ‘camps’

Diplomatic sources close to the negotiations say that as it stands now, governments are broadly divided into three groups:

  • Those who favor the extension of the waiver to include therapeutics and diagnostics include South Africa, India, Kenya, Indonesia, Zimbabwe, Pakistan, Egypt, Bolivia, Argentina, Venezuela, and the African, Caribbean and Pacific Group of states.
  • Countries questioning the need for an extension include Switzerland, Singapore, Japan, Canada, South Korea, the European Union, and the United Kingdom.
  • A third group, consisting of Colombia, Costa Rica, Uruguay, Mexico, China and Chinese Taipei, is considering a compromise solution; a limited extension to include a specific list of therapeutic and diagnostic products. Today, over 1,800 COVID-19 therapeutics are currently in different stages of the R&D pipeline.

The joint Swiss–Mexican letter notes that 138 bilateral voluntary licensing agreements with 127 countries have resulted in the creation of 191 production sites for COVID-19 therapeutics worldwide. Based on this information, the communication states, “we do not face a situation where we have an IP-induced lack of access to or a lack of manufacturing capacity of COVID-19 therapeutics and diagnostics. As a consequence, no adjustments to the IP system seem to be required.”

 However, these arguments have so far failed to sway the proponents of a broad waiver as initially proposed by India and South Africa. “The European Union, Switzerland, and the United Kingdom are playing a cynical game of running down the clock in WTO negotiations on extending the [MC12 TRIPS agreement] to diagnostics and therapeutics,” said Thiru Balasubramaniam, Geneva representative of Knowledge Ecology International.

Balasubramaniam also noted that just this week, WHO’s Director-General, Tedros Adhanom Ghebreyesus, said that “one of the most important lessons of the pandemic is that manufacturing capacity for medicines, diagnostics, vaccines and other tools is concentrated in too few countries.” 

For Balasubramaniam, “WTO members expressing doubts about the barriers posed by intellectual property with respect to accessing COVID-19 therapeutics and diagnostics should pay heed to the advice of the World Health Organization, the leading authority on global health.”

The TRIPS Council will meet again, informally, on 22 November. “We do not have a lot of time,” the chairperson acknowledges. Further meetings are scheduled for 6 December, with the possibility of calling members for another meeting on December 15, four days before the deadline.

Additional reporting by Philippe Mottaz.

This article was first published by the Geneva Observer.

Image Credits: Raja Mataniari .

Kenya’s draft family policy aims to discourage divorce without regard for women in abusive relationships.

Newly elected Kenyan President William Ruto has made his position on critical human rights issues such as safe abortion and LGBTQ rights clear over many years – and now,  by including a controversial  “family protection policy” in his first executive order, he is likely to promote a narrow definition of family that stigmatises anyone who is not part of a nuclear family.

 After the August elections, anti-rights groups started to clamour for the Department of Labour and Social Protection to revive the 2019 National Policy on Family Promotion and Protection that was drafted by an isolated handful of individuals devoid of public participation. This draft was not signed into policy and hence never implemented.

With the passage of his first Executive Order, the President has now responded with a thumbs-up, indicating that establishing a family policy is one of his priority areas.

Narrow, nuclear definition of ‘family’

The wording of the draft policy is problematic. It promotes an extremely narrow Western definition of a nuclear family and stigmatises all other families – including women-headed households, families born through surrogates, polygamous families and same-sex couples. This exclusion goes against the very values that the Presidency has always espoused as a Christian.

Kenyan families, like most African families, cannot be boxed into neat nuclear definitions. Many of us are descendants of polygamous grandparents, with a huge collection of blood relatives and family members who were taken into our household after wars, drought, HIV or adopted after the death of a parent.

While other African countries such as Rwanda, Ethiopia and South Africa have “family and social protection” policies, their versions protect vulnerable members of family and community from injustices arising from oppressive social structures. Yet the proposed draft policy on family seeks to promote the exclusionary, conservative Christian model of the family, prevent divorce, and disregard other family models. 

By asserting that “family cohesion is founded on the unity of spouses”, the draft stigmatizes and excludes single-parent families and divorced people. By defining marriage as being between “two persons of the opposite sex”, it excludes polygamous and same-sex partnerships, which are amongst us whether we like it or not.

“The primary function of the family is to ensure the continuation of society, biologically through procreation and to promote and emphasize marriage preparation,” according to the policy. Such statements already isolate child-free couples! It also identifies “the key policy issues” as being related to “ensuring that the family that emerges from marriages becomes a true foundation for social order in Kenya”.

Priority of ‘preventing divorce’ ignores abuse in marriage

Kenyan Olympics runner Agnes Tirop died after being stabbed multiple times, and her husband has since been arrested.

The document prioritizes “preventing divorce” by any means necessary, including alternative dispute resolution, but this culture known as “vumilia ndoa” does not recognise the vulnerability of women and children in abusive marriages. Contrary to the Marriage Act, the policy discourages divorce as a valid solution and prioritizes “protecting the union” over protecting the women in abusive marriages.

The recent murders of Olympic bronze medallist, runner Agnes Tirop, allegedly after she had resolved to divorce her abusive husband, and athlete Edith Muthoni  – and the subsequent arrest of their partners – have taught the nation that we must prioritize safety over marriage.

Violence has been normalised in the country, with 42% of women aged 15-49 years considering that a husband is justified in beating his wife in certain instances, according to research.

 

Regionally, the draft does not match up to the African Union’s 2004 Plan of Action on the Family in Africa, which requires member states to create a conducive environment for ALL family members to thrive.

Compared to other countries’ policies, Kenya’s draft offers no practical help – no income support services, child day care, no campaigns against domestic violence, no promotion of gender equality, or the extension of economic and social opportunities to women. So the policy’s intention appears simply to identify those that are worthy of protection and those that are not – based on a discriminatory view of the family.

Unless the text of the 2019 version of the family protection policy is revised, the current draft will subject more women to violent marriages, further stigmatise divorce, and exclude the diverse relationships of so many of our families.

Tabitha Saoyo is a feminist human rights lawyer. She draws inspiration for this article from her own past experiences working on the complexities of marriage and divorce as a former International Federation of Women Lawyers (FIDA) Programs Officer. She is a board member of Amnesty International (Kenya).

 

 

Nerima Were is a feminist and human rights activist, and an advocate of the High Court in Kenya. She is the Deputy Executive Director at the Kenya Legal and Ethical Issues Network on HIV & AIDS (KELIN), as well as a tutorial fellow and doctoral candidate at the University of Nairobi.

The Rosa Luxemburg Foundation provided support for this article.

Vials of Pfizer´s COVID-19 vaccine; vaccines mostly reached countries in same region they were produced, WHO report finds.

The World Health Organization (WHO) has urged governments worldwide to step up the supervision of vaccine manufacture and distribution, especially when public funding is used in vaccine R&D or manufacture, so as to prioritise essential vaccines and ensure they are distributed equitably. 

The global health agency’s call to governments came as it released its annual Vaccine Market Report on Wednesday. It also pressed for countries to agree on stronger rules for the more equitable global distribution of vaccines. 

“WHO is calling on governments around the world to expand research and manufacturing outside its traditional centers to increase investment in an oversight of vaccine manufacturing and distribution, especially for vaccines that are developed with public funds, and to agree on rules to collaborate on sharing vaccines equitably when demand is high,” said Dr Tedros Adhanom Ghebreyesus, director-general of WHO, speaking about the report at a press conference on Wednesday. 

The 2022 annual report is the first report to include the impact of Covid-19 pandemic on the global vaccine production and supply chain. The report is also viewed as a guiding tool to achieve the WHO’s goals of the Immunization Agenda 2030 that was adopted at the World Health Assembly 2021. 

The Immunization Agenda 2030 targets to save 50 million lives over the next decade by improving access to vaccines to everyone across the world. 

Governments need to invest and bear risks

“Diseases such as hookworm, schistosomiasis and leishmaniasis, and pathogens prioritized by the WHO R&D Blueprint, such as Zika, Lassa fever, Nipah and henipaviral diseases, Rift Valley fever, Crimean–Congo haemorrhagic fever and filoviruses, are still missing a vaccine,” the report stated. 

Vaccine manufacturing involves heavy investments upfront with high risks, the report noted. The profits that vaccines bring are also less than that brought in by other pharmaceutical products. In an attempt to mitigate these barriers, the report urges governments topport  measures that prime the market, such as ¨investing in new vaccine technologies, regional research and development and manufacturing hubs, and by enabling regulatory harmonization.”

Distributed supply is key

Although WHO has a repertoire of over 90 approved vaccine manufacturers across the world, a large chunk of the supply is concentrated in the hands of just 10 manufacturers, the global health agency noted. Around 70% of the vaccine doses come from these manufacturers. When it comes to individual vaccines, often, the supply may be concentrated in the hands of just two or three manufacturers, the report notes.  The resulting market concentration has led to supply shortages, as seen in the response to recent emergencies such as monkeypox or cholera. In the case of the latter, vaccine shortages recently led to WHO´s recommendation in October to ration supplies by administering only one vaccine dose, as compared to two.

“Each of the human papillomavirus, pneumo- coccal conjugate and measles, mumps and rubella combination vaccines is used by at least 100 countries, but each market is highly dependent on one or two manufacturers that account for more than 80% of vaccines by volume,” the report added. 

In the case of COVID vaccines, vaccine distribution was also mostly focused in the regions where particular vaccines were produced, the report notes.  As a result, regions without vaccine manufacturing capacity were left dependent on other regions to cater to their demands, often belatedly. 

Vaccine
Vaccine manufacturing and distribution pattern (WHO Vaccine market report, 2022)

So despite the fact that COVID vaccines were developed and manufactured in record time, parts of the world were left without access to vaccines for many months, since the technology and the production was centered in limited number of companies and countries, the report found. To remedy that, WHO called upon governments to strategically and aggressively invest  in more vaccine manufacturing capacity for the future. The report also urged governments to define principles and establish rules for collaboration, especially on intellectual property and sharing of raw materials. 

The report also urged countries to explore more pooled procurement options with other countries in their region, as compared to relying only upon national mechanisms.

“Compared to self-procurement, pooled procurement attains lower prices for 14 of the 18 vaccines most widely used in middle-income countries, the average price for all 18 vaccines combined being 42% lower, although differences vary significantly for individual vaccines,” the report found. 

WHO also called on the vaccine industry to align their research and development activities more closely with the WHO´s priority pathogen list and target product profiles, and to ensure there is transparency in their value chain. 

Free-market dynamics don’t work

A stark feature of this edition of the Vaccine Market Report is the emphasis on the need for governments to keep public welfare in mind when dealing with the vaccine value chain. 

Invoking the fact of vaccine disparities between wealthier countries and low and middle income countries during the Covid-19, relying primarily on market dynamics in vaccine distribution does not promote global public health goals, the report states. 

“We must acknowledge both that vaccines are under-invested and that free market dynamics do not optimize for social and health impact.” 

Pointing out that the WHO-supported COVAX vaccine facility´s share in the total quantity of vaccines procured and distributed globally  only 12%, the report emphasized that globally-managed financing and procurement efforts alone are not enough to ensure that vaccines reach everyone in all the corners of the world. In October, COVAX was criticised as having been too ambitious” in an independent evaluation of its performance as part of the WHO-supported Access to Covid-19 Tools Accelerator (ACT-A). 

“Despite the impressive number of approximately 15 billion doses delivered globally through various mechanisms as of October 2022, COVAX accounted for only 12% of this volume, indicating that serving all populations more equitably and ending future pandemics requires more than financing and procurement efforts.”

“The right to health means the right to vaccines,” Dr Tedros added. 

Image Credits: Photo by Mat Napo on Unsplash, World Health Organization.