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.

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.

From left: Maria Neria, Riccardo Puliti, Mamunur Rahman Malik, Harish Hande and Francesco La Camera at WHO COP27 event.

SHARM EL-SHEIKH, Egypt – The International Renewable Agency (IRENA), on Tuesday, said it would pump $1billion into a new effort that would electrify health facilities, along with food storage and agriculture, with solar power, while the World Bank said it also plans to triple its investments in solar electrification efforts to reach 100,000 health facilities by 2030. 

The initiative aims to tackle the gaps in health care that leave an estimated one billion people around the world reliant on healthcare facilities with either no electricity or an unreliable supply, IRENA´s Director General, Francesco La Camera.

He was speaking at a high level event, “Energizing health: accelerating electricity access in health-care facilities,” organized by the World Health Organization at its COP27 Health Pavilion

La Camera said that his agency is assessing the energy gaps in healthcare systems in a number of the poorest sub-Saharan African countries, beginning with Burkina Faso, Malawi and Mali in order to get a better idea of the gaps in energy access, and how they impede health service delivery.

A 2013 WHO-sponsored study of 11 sub-Saharan African countries found that 26% of health facilities had no electricity at all, and only 28% of facilities, on average, had reliable electricity access. Even at hospital level, only 34% of hospitals had reliable electricity.  Traditionally, the fallback power option for the health sector in areas with poor grid access has been diesel generators, which are not only highly polluting but costly, with fuel expense and breakdowns leaving a large proportion idle.  

During the pandemic, there was a major push to add solar powered refrigeration capacity to African health centers to roll out COVID vaccines, which require a reliable cold chain.  But there remains a lack of systematic investment, along with comprehensive data on gaps and needs on the ground. 

Francesco La Camera, director-general of IRENA

Even with the limited data available, however, it´s apparent that the lack of electricity and impacts on healthcare are particularly severe in Africa, agreed panelists at the event, which included representatives from the World Bank, WHO´s office in Somalia and a leading Indian solar entrepreneur. 

Their discussion focused on energy needs in healthcare facilities, the potential for shifting to renewable energy sources, and the funds needed for such initiatives.

“In view of the COP28, we aim to create a partnership with government, philanthropies, foundation trust, charitable funds, the World Bank and the private sector among other stakeholders, and naturally, WHO, to commit $1 billion towards the empowering lifts and livelihood, renewables, follow adaptation, initiative to connect people and livelihood through renewable energy solution in agriculture, food and health sectors,” La Camera said, of the IRENA commitment. 

World Bank also doubling finance to focus on mini-grids 

The IRENA initiative comes on top of an existing $1.3 billion a year World Bank investment  in renewable energy access for farms, schools and health facilities in off grid communities, said  Riccardo Puliti, the vice-president of the Bank’s infrastructure division. But of that amount, not more than $100 million goes towards healthcare facilities, he admitted.

Efforts to invest in healthcare facilities accelerated during the COVID-19 pandemic, he noted. In that period, the Bank developed and disseminated improved tools for facilities to estimate their energy requirements, so as to allow for the more reliable electrification of cold chains, and thus storage of vaccines. 

Riccardo Puliti, vice-president of World Bank’s Infrastructure division.

However, the Bank now plans to ramp up funding for community-based mini-grids, from which health facilities as well as homes, schools and other community functions, might all benefit. 

Mini grids are decentralized energy facilities that may involve solar arrays, battery storage and generator backup, and can be used to produce and distribute electricity within small communities that are too far removed from the grid to enjoy reliable service from conventional power supplies.  

The idea is to provide mini grids for half a billion people and 100,000 health facilities by 2030. We plan to triple our $1.2 billion per year in order to achieve that,” Puliti said.

Learning from Nigeria and Somalia

Among sub-Saharan African countries, Somalia ranks as one of the most under-served. Some 85% of Somalia’s population do not have access to electricity. Only 28% of healthcare centres in the east African country have access to electricity and only 27% of the population can easily access healthcare, said Dr Mamunur Rahman Malik, WHO´s representative in Somalia, who also appeared at the event. 

The price of electricity in Somalia is between $1-$2 per kilowatt hour, while its neighbouring regions pay anywhere between $0.02 and $0.03. 

Calling Somalia’s plight a “social injustice”, Malik described how emergency surgeries and pediatric procedures are frequently performed under kerosene lamps or even in candle lights.

Inevitably, lack of electricity access also contributes to the country´s high rates of  childhood mortality.  

“A child who is born today (in Somalia) is 16.5 times more likely to die before the child reaches the age of five,” Malik said. “This is not the fault of the child, it´s because we don’t have health facilities which can provide health services. We don’t have refrigerators to preserve vaccines. One in seven children in Somalia is missing out on these lifesaving vaccines.”

Dr Mamunur Rahman Malik, WHO´s representative in Somalia, describing the benefits of solar electrification of health facilities in Somalia.

In January 2021, the Somalian health ministry, with WHO’s support, piloted a solar-powered oxygen delivery system at a government hospital in Galmudug. This has, in turn, saved the lives of several children who came to the hospital suffering from respiratory issues like asphyxia, pneumonia and accidents and trauma. 

Following this, the system was also set up in four more hospitals.  Then in 2022, the government  also began scaling up other solar energy systems to provide building-based electricity to 100 primary healthcare centres. 

Malik said that the reason why WHO supported the equipping of Somalian healthcare facilities with solar energy is because it is the most practical solution for a country that is arid and receives over eight hours of sunlight a day. 

Cost is also a crucial factor in this decision, he said. “A health facility or a laboratory spends $8,000 to $10,000 to pay the electricity bill (from grid services or diesel fuel based generators). If it is solarized, they’re going to pay only $30 just to maintain the electricity line, the electricity will be free.” 

He added that solar power will also help reduce medical waste of medicines and vaccines from poor storage conditions. 

Similarly, the federal power minister of Nigeria, Abubakar D.Aliyu shared his experience with switching health facilities to renewables in his country. 

The experience began when two health facilities in every district of the country, designated to receive vaccines, were equipped with solar energy.

The government also has equipped at least one million houses with solar panels over the past year, the minister said; the aim is to electrify six million homes by the end of 2023.  

“And I know it can happen. If we have a common will, if we have the will to do it, it’s gonna happen,” he declared. 

Intersectoral collaboration is key

While money could be an obvious barrier to achieving targets when it comes to the switch to renewable energy, it is more often the political will that’s missing, observed Harish Hande, the cofounder of SELCO India, a Bangalore based social enterprise company that has been deeply involved in national solar electrification efforts. 

SELCO India, in partnership with Ikea Foundation, has a target of installing solar energy systems in 25,000 healthcare facilities over the next four years. “If a very small organization like SELCO with 150 employees has taken a pledge to do 25,000 [facilities] with Ikea Foundation, the other institutions should do 20 times more. And by 2026 we should stop talking about solarizing of health,¨ he declared.

COP27
Harish Hande (second from the right)

He added that more efforts also need to be invested into harnessing the innovation capacity of the private sector – particularly in the design and manufacture of essential appliances that consume less energy. 

“We would lose out on an opportunity if we just look at this as an issue of electrification… It’s not about solar power. It’s a combination of innovations that will spur further innovation.” 

Meanwhile, La Camera stressed the need to put the necessary basic solar  infrastructure in place, which can then be harnessed for scaling up solar power. “Industrial sector should work in cooperation,” he said. 

And there is also a need to incentivise industries in the most underserved regions, such as Africa, to manufacture solar equipment at cheaper, or even subsidized prices. 

Puliti pointed out that unlike five years ago, solar arrays and batteries are affordable and competitive in almost any setting. 

In dense urban areas, more reliable grid-based power using a mix of renewable and non-renewable energy sources is the more likely short-term aim, he said. But particularly in sub-Saharan Africa, there’s a “huge urban and rural divide” with rural areas lacking any possibility to link to the grid in the near term. 

“In sub Saharan Africa 52% of the population do not have any access to electricity,” he said, adding that cities have an electrification grid of 80-85% in contrast to the countries like Somalia and Central African Republic with minimal access to electricity. 

“So we have to work both on, making sure that the cities get electricity, usually on grid, and then we develop as much as possible, all kinds of off grid…with batteries.  We must understand that solar and batteries are competitive with everything we can think of. Five years ago, solar was and batteries were not competitive. It is competitive now,” he explained. 

Only by working together – states, financial institutions, institutions like IRENA, WHO, the civil society – (can we achieve this)..,” said Puliti. “This is different from 10-12 years ago where it (the cause) was mostly ignored. I have this strong feeling that we are going to overcome this by 2030, even though we are in the middle of a big crisis, we had a pandemic and all the rest.”  

Link here to the calendar of COP27 events on climate and health, and access to livestreaming from the WHO Pavilion in Sharm el-Sheikh.

Image Credits: Megha Kaveri/HPW.

COP27 plenary on Monday as countries make their case for more climate finance and better terms on cash received.

SHARM EL-SHEIKH, Egypt – Small island states and other African and Asian developing nations stepped up their appeals Tuesday for a reboot of the global financial system to make climate finance more affordable to their debt-ridden nations, now battling a rising wave of climate emergencies along with demands to “go green”.

Reducing interest rates on climate loans; shifting more climate finance from loans to grants; imposing a carbon tax on fossil fuel producers; and a fossil fuels ¨non-proliferation treaty¨  were among the proposals tabled by countries from South Africa to Bermuda and Pakistan to Mali, in the second day of high-level statements at the UN Climate Conference (COP27). 

“The oil and gas industry continues to earn almost $3 billion daily in profits,” said Gaston Browne, Antigua’s prime minister, speaking on behalf of the Alliance of Small Island States, whose very existence is threatened by sea level rise and extreme weather. 

“It is about time that these companies are made to pay a global carbon tax on their profits as a source of funding for loss and damage,” he said. “While they are profiting, the planet is burning.”

Loss and damage pledges inadequate

Mia Mottley, Prime Minister of Barbados, has set a trend for calls to revamp climate finance.

Meanwhile, a handful of rich countries announced about $60 million in initial pledges of aid for climate ¨loss and damage”.

Civil society groups immediately decried the pledges as woefully inadequate against the more than $1 trillion a year of actual costs for low and middle-income countries, ranging from flood-ravaged Pakistan to the drought-ridden Horn of Africa, and small island states devastated by increasingly powerful cyclones and hurricanes. 

However, just getting loss and damage on the climate agenda is “a significant achievement”, observed Mia Mottley, Barbados´ prime minister.

¨It recognizes that those countries such as ours, who have not contributed greatly to the emissions of greenhouse gasses should not be crowded out of our fiscal space in order to be able to finance the reconstruction after a climatic event,¨ she said. 

But she warned that ¨we will not achieve the conclusion of it¨ at the present COP.

The even bigger challenge involves finding new ways to finance climate actions that reduce, rather than add to, the already heavy debt load – including interest rates on that debt – of low- and middle-income nations, Mottley noted.

 ¨The reality is that unless our financial institutions can speak to the current realities, they will not be able to help us transition in this new way,¨ said the prime minister. 

She added that her ¨Bridgetown agenda¨ for financial reform, including an agreement with the IMF and others on a new ¨Blue-Green¨ finance facility to preserve the ecosystem of the Caribbean region with a 10-year interest moratorium, could provide one such model. 

 Remake global financial institutions or face millions of climate refugees

Phillip Davis, Prime Minister of Bahamas warns of a tide of climate refugees if rich countries don’t act faster.

It´s in the interest of rich countries to rethink finance arrangements on all fronts – mitigation, adaptation and loss-and-damage, added Phillip Davis, prime minister of the Bahamas. 

¨What is it worth for you, the world, to keep millions of climate refugees from turning into tens of millions and then hundreds of millions, putting pressure on borders and security and political systems around the world,¨ he asked. 

¨ I´m not telling you to overhaul the World Bank for this new climate era because it´s the right thing to do, I´m telling you to get smart and act quickly,¨ said Davis who also echoed a recent World Health Organization appeal for countries to agree on a  ¨fossil fuels non-proliferation treaty to steer our models towards renewables. 

¨Let´s get real about what is coming.  Let´s get real about what we need to do next,¨ Davis added. ¨We have no other choice… The alternative compels us to present ourselves at your borders as refugees.  The alternative consigns us to a watery grave.¨

Pakistan reeling from multiple needs 

Muhammed Shehbaz Sharif, prime minister of Pakistan.

¨Estimated damage and loss has exceeded $30 billion and this despite our very low carbon footprint. We became a victim of something with which we had nothing to do,¨ said Pakistan´s Prime Minister, Muhammed Shehbaz Sharif, speaking about the August flooding.

The flooding left nearly one-third of the country under water and some 33 million people displaced. 

¨Winter is setting in and we need to provide shelter, homes, food packages and medical treatment for people … for which we are spending billions of rupees from our meager resources,” he continued. ¨And at the same time we have to spend billions to protect people against other [future] floods and emergencies.

“How on earth can we do this on our own?¨ he asked. ¨Loss and damage needs to be part of the core agenda of COP27 to meet the pressing humanitarian needs of those that are trapped in a crisis of public financing fueled by debt, and yet have to fund climate disasters on our own.¨

South Africa – only 2.7% of aid from wealthy nations is in grants   

South Africa’s President Cyril Ramaphosa

Meanwhile, South Africa´s President Cyril Ramaphosa provided a tangible example of the problematics of green finance today – with reference to a new pact with Europe and the United States to support the country´s $98 billion plan for a  ¨just energy transition.¨ 

The deal, initiated at COP26 in Glasgow but only finalized on Monday at COP27, includes commitments by France, Germany, the UK, the US and the European Union, to provide some $8.5 billion in finance for the first phases of the South African plan.  The aim is to move the country away from its heavy dependence on coal and into green energy sources, including green hydrogen, as well as electric vehicles. 

Part of the financial package also will go to ensuring that coal worker and their communities – the people most affected by a transition – are not left behind. 

But of that support, only 2.7% is in the form of grants, with the rest to be made in ¨concessional loans and investments and risk sharing instruments,” according to a press release. 

And that is a big problem for debt-ridden nations like South Africa, complained Ramaphosa.

“Because South Africa already carries a fairly sizable loan burden, which it has to service from its fiscus, we require more grant funding,” Ramaphosa said, speaking in a separate press briefing. 

However, Ramaphosa expressed hopes that negotiations underway now could help shift that balance, creating a ¨real partnership,” as well as a climate finance model that other countries could emulate.  

“Industrialized countries … need to live up to the commitments that they have made, knowing full well that they – through development of their own economies – contributed a great deal more to the [climate] damage that many countries on our continent,” said the South African president.

Europe: Ambitious targets at home and new investments in Africa

Ursula Von der Leyen, ¨let´s earn the clean ticket to heaven.¨

The IPG investment in a green hydrogen facility in South Africa was one of several such announcements made over the past two days in this emerging technology. The European Union and Norway, meanwhile, announced similar partnerships with Namibia and Egypt. . 

¨The European Union’s additional renewable capacity is set to more than double this year, up to 50 gigawatts. And if we accelerate and if we scale up – and that is our plan – we can, in the next year, meet a new all-time record of over 100 gigawatts of additional renewable capacity,¨ said EU President Ursula Von der Leyen at the opening of the day`s plenary session, The EU leader’s comments also acknowledged, for the first time, need to talk about loss and damage. 

¨Because we know that every kilowatt-hour of electricity that we generate from renewable sources – like solar and wind, and green hydrogen – is not only good for our climate, but also good for our independence and our security of supply.

¨Here, the Global South has the resources in abundance. So let us team up. That is why the European Union is signing new hydrogen partnerships with Egypt, with Namibia and with Kazakhstan. That is why we are supporting partners such as Vietnam and South Africa to decarbonise their economies,¨ she  said. “Let us not take the highway to hell, let us earn the clean ticket to heaven.¨

And Norway´s Prime Minister Jonas Gahr Støre said that national climate commitments, updated since COP26 meant the Nordic country would increase carbon taxes to €200 per ton as well as reducing its own emissions by 55% by 2030, in line with the EU goal. 

¨We will fulfill our pledge to double climate finance within the next four years … and triple adaptation finance, with a particular emphasis on Africa,” declared Støre. He also welcomed Brazilian President-elect Lula da Silva´s ¨renewed commitment to the Amazon.¨ 

¨We also need to strengthen efforts to prevent loss and damage,¨ Støre added, almost as an aside.