The World Health Organization and African Union have signed a sweeping Memorandum of Understanding to collaborate on improving access to medicines, strengthening epidemic preparedness, and expanding universal health coverage across the African continent.

These are the three main pillars of the MOU signed Monday by the WHO Director-General Dr Tedros Adhanom Ghebreyesus and African Union Chair Moussa Faki Mahamat at a two AU meeting in Geneva.

Moussa Faki Mahamat (left) and Dr Tedros Adhanom Ghebreyesus (right) hold the signed MOU

The MOU commits WHO to providing technical expertise to the newfound African Medicines Agency (AMA), in order to support regulatory approvals and local production of essential medicines, hopefully increasing access to quality-assured drugs. The African Union voted just last year to endorse a treaty to establish the AMA, and officially adopted the treaty in February 2019.

It is hoped that the AMA’s creation will foster more uniform drug rules and regulations across the continent, also fostering faster approval for new medications and cheaper prices. Up until now, most African countries wait until a new drug is approved by a developed country regulatory authority, such as the US Food and Drug Administration or the European Medicines Agency, and then a number of regional African entities, or each country individually, considers if to approve the drug for use.

“The three pillars of our new MOU pose three challenges that we must address together if we are to realize our shared vision for a healthier, safer, fairer Africa,” said Dr Tedros in a statement to the AU Commission Chair and AU ambassadors on Sunday.

“First, we must invest in access to medical products that are high-quality, safe and effective. Second, we must invest in preparedness, not panic. And third, we must invest in primary health care.”

Once it is up and running, the AMA will be responsible for assessing the safety and efficacy of new health products proposed for use in Africa, issuing guidance to African Union countries regarding regulatory approval and use. It will be modeled after the European Medicines Agency, which provides regulatory guidance for new health products introduced on the European continent.

The next steps are to define more precisely the scope of activities for the new regulatory body. In particular, Tedros says, the AMA should also focus on “creating an enabling environment to foster local production,” noting that “too many of our brothers and sisters don’t have access to the medicines they need, or use medicines that are substandard or falsified.”

About 1 in 10 medical products in low- and middle-income countries is either manufactured or packaged in substandard ways or falsified, according to a 2017 WHO report. The WHO African Region contributed 42% of the substandard or falsified product reports to this analysis.

The AMA will also provide a continental approach towards harmonizing existing regional initiatives to regulate new health products,  including those by the Economic Community of West African States (ECOWAS), the South African Development Community (SADC), and the East African Community Medicines Regulatory Harmonisation (EAC MHR).

Civil Society Pushes ARIPO to Use More TRIPS Flexibilities

The MOU announcement between WHO and the AU coincided with an open letter published by over 90 civil society organizations demanding reform of the African Regional Intellectual Property Organization (ARIPO), which handles patent applications for pharmaceutical products for 18 countries contracted to the Harare Protocol.

The civil society organizations signed an open letter to Ministers of ARIPO asking them to take bolder actions in leveraging TRIPS flexibilities to promote access to generic medicines at the ARIPO Ministerial Meeting from November 18 – 20 in Liberia.

ARIPO’s patent practices are largely dictated by the Harare Protocol, and the patents issued apply to the ARIPO region, which includes countries such as Kenya and Zimbabwe. The letter urges Ministers to update the Harare protocol to incorporate more TRIPS flexibilities at the regional level to allow generic versions of new drugs to enter the market earlier.

TRIPS flexibilities, which allow countries to remedy anti-competitive practices in situations of public health need, are currently not being implemented in the ARIPO patent process, the letter says. Specifically, key TRIPS flexibilities such as the Least Developed Country (LDC) patent exemption, which gives the LDCs maximum flexibility in patenting pharmaceutical products until 2033, have not been implemented through the Harare Protocol. Some 13 of the 18 ARIPO member states are classified as LDCs according to UN.

Experts say that establishing the AMA and reforming ARIPO patent practices together could improve access to cheaper, quality assured generic medications.

“IP reform has to go hand in hand with regulatory reform and coordination to remove two of the main barriers to robust generic competition in quality assured medicines,” says Brook K. Baker, professor at Northeastern University School of Law and senior policy advisor at Health GAP (Global Access Project), an HIV advocacy organization that works in several ARIPO countries.

Setting high standards for issuing patents could allow generics to be produced for more medicines, and having the regulatory mechanisms that can assess the safety and efficacy of these products will provide the regulatory approval needed to to speed their entry to market, he says.

Epidemic Preparedness and Universal Health Coverage on MOU  Agenda

The other two pillars of the WHO-AU MOU also focus on building capacity in the African continent, to respond more strongly to epidemic threats and to expand primary health care.

Tedros called the ongoing Ebola outbreak in the DRC as “a stark reminder than many AU countries are vulnerable to the impact of epidemics.”

Dr Tedros delivering a statement at the Sunday meeting with the AUC Chair and AU ambassadors

For too long, he said, the world has “invested in panic, rather than in epidemic preparedness,” noting that the global health community has largely responded to outbreaks reactively, instead of preemptively investing in health systems to prevent epidemics.

Working with the African Center for Disease Control, the WHO will support efforts to strengthen the health workforce in AU countries and establish a Volunteer Health Corps for Africa, and support the development of national action plans for emergency preparedness.

Lastly, the MOU commits the WHO to support the implementation of the Addis Ababa Call to Action on universal health coverage, endorsed by the African Union Summit in February. The WHO will help facilitate dialogue between Health and Finance Ministers to help countries increase domestic financing for primary health care by at least 1% GDP.

Image Credits: Twitter: @WHO, Twitter: @DrTedros.

Millions of sanitation workers in the developing world are forced to work in toxic conditions, coming into direct contact with human waste and toxic chemicals, with little to no pay or legal protections. Sanitation workers provide essential public services, yet are often the most marginalized, poor, and discriminated against members of society.

These are the main findings of a new report, Health, Safety, and Dignity of Sanitation Workers, released Thursday by the World Health Organization, International Labour Organisation, WaterAid, and the World Bank. The report examines case studies of sanitation workers’ conditions in nine countries – Bangladesh, Bolivia, Bukina Faso, Haiti, India, Kenya, Senegal, South Africa, and Uganda – and is the most extensive study of sanitation workers’ occupational conditions and livelihoods to date.

Manual pit emptying in India

“A fundamental principle of health is “first do no harm.” Sanitation workers make a key contribution to public health around the world – but in so doing, put their own health at risk. This is unacceptable,” said Dr Maria Neira, director of WHO’s Department of Public Health and Environment in a press release. “We must improve working conditions for these people and strengthen the sanitation workforce, so we can meet global water and sanitation targets.”

Meanwhile, a report published by OECD on the same day found that antibiotics and other pharmaceutical residues are being discharged into freshwater systems through untreated household wastewater and runoff from municipal wastewater treatment plants – throwing ecosystems out of balance and potentially exacerbating the problem of growing drug resistance in deadly bacterial, fungal, and viral diseases.

Sanitation workers provide key public health services such as cleaning public toilets, emptying pits and septic tanks, cleaning sewers and manholes, and transporting fecal sludge. Workers are often exposed to a number of hazardous chemicals or diseases such as cholera in untreated waste or water, the WHO report finds.

Many sanitation workers work informally for little pay, and have few legal or social protections. The work is often stigmatized and done at night with little lighting or protective equipment, increasing the occupational risks to the job. While there are few statistics on how many sanitation workers there are around the world, the report estimates that one sanitation worker dies every five days in the sewers of India.

Still, report ends on a positive note, highlighting examples of countries such as South Africa where sanitation work is more formalized and protected under national labor standards and explaining next steps that can be taken to improve the health, dignity, and autonomy of sanitation workers.

Despite the horrid working conditions, sanitation work is an essential public health service, and the workers themselves know it. The report quotes workers like Senzi Dumakude, a sewage blockage crew member in South Africa, who says, “I enjoy serving the community, making sure that our city is clean… We are making sure it is safe.”

Risks Faced by Sanitation Workers and Potential Solutions

While some sanitation workers are public or private employees that have benefits and clear legal protections, a number of people work informally, for little to no pay in ghastly conditions exposing workers to a number of health hazards. The WHO report found four key challenges and risks to sanitation workers:

  • Sanitation workers are exposed to multiple occupational and environmental hazards.
  • Sanitation workers have weak legal protection resulting from working informally, a lack of occupational and health standards, and weak agency to demand their rights.
  • Financial insecurity is a great concern because typically, informal and temporary sanitation workers are poorly paid, and income can be unpredictable. Some sanitation workers report being only paid in food.
  • Social stigma and discrimination exist, and in some cases, are experienced as total and intergenerational exclusion.

The report highlights so-called “manual emptiers” as a particularly vulnerable class of workers. These laborers are responsible for emptying pits, cleaning toilets or sewers with little to no protective clothing, and often use buckets, ropes, and shovels for their work. Some workers can only use their hands and feet. Efforts to ban manual emptying have driven the practice underground, where workers have even fewer protections in the informal sector.

Sanitation workers who are not protected by adequate health and safety measures are at high risk of health problems. Dizziness, fever, cholera, hepatitis, and polio, along with physical trauma such as puncture wounds and cuts, back pain, and death by asphyxiation from noxious gases have all been directly associated with unprotected sanitation work, the report notes.

Countries such as Bangladesh and South Africa have formalized the sanitation sector, which represents a huge step in protection sanitation workers. To protect the health and safety of sanitation workers, the report recommends five good practices:

  • Providing acknowledgment and formalization to sanitation workforce (including legal protections)
  • Mitigating occupational health risks for sanitation workers, such as protective clothing or mechanical equipment for sanitation work.
  • Delivering health services to sanitation workers
  • Establishing standard operating procedures and guidelines
  • Promoting workers’ empowerment through unions and associations
Antibiotic Residues In The Environment Could Contribute To AMR
Credit: aus der Beek T. et al., 2016

Antibiotics and other pharmaceutical residues are being found in water systems around the world, with untreated wastewater as a primary source of these runoffs. An OECD report, Pharmaceutical Residues in Freshwater: Hazards and Policy Responses, released Thursday pointed to a growing prevalence of pharmaceutical residues in the environment, citing studies that show residues from up to 200 different compounds have been found in parts of the world. The report cited a forthcoming study that found antibiotics in 65% of 711 river sites in 72 countries.

In 111 of the sites, the concentrations of antibiotics exceeded safe levels, with the worst cases more than 300 times over the safe limit set by the AMR Industry Alliance. The over-use and mis-use of antibiotics is greatly associated with growing antimicrobial resistance, as continued exposure to antibiotics may enable bacteria to evolve new genes resistant to the drugs.

Drug-resistant infections are currently estimated to cause 700,000 deaths annually, and an AMR review commissioned by the UK Prime Minister estimates that AMR-related deaths could increase to 10 million per year by 2050.

Image Credits: CS Sharada Prasad/Water AId/Safai Karmachari Kavalu Samiti, Health, Safety, and Dignity of Sanitation Workers: An Initial Assessment.

Pakistan became the first country in the world to introduce the typhoid conjugate vaccine (TCV) into its routine immunization program on Friday. The government of Pakistan is launching the national vaccine with a campaign in Sindh Province, which has already been deploying the vaccine on an emergency basis since April 2019 to tackle an ongoing extensively drug-resistant (XDR) typhoid outbreak that began in November 2016.

“Children are disproportionately affected by typhoid and its associated complications, and we strongly believe that TCV would protect our children against potentially fatal disease of typhoid,” said Dr Zafar Mirza, Special Assistant to the Prime Minister on Health said in a press release issued by Gavi, The Vaccine Alliance. “Starting with Sindh Province, where the need is most urgent, the government of Pakistan has planned a phased national introduction strategy with strong, coordinated support from global and local partners.”

A child is prepared for a vaccine in Pakistan.

Pakistan’s current extensively drug resistant (XDR) outbreak of typhoid, which has infected more than 10,000 people, mostly in Sindh province, is the first-ever reported outbreak of typhoid resistant to all but one oral antibiotic for typhoid. Use of the World Health Organization-recommended TCV has helped protect some individuals against the deadly strain.

Typhoid, a serious illness caused by Salmonella Typhi, is spread through contaminated food and water and disproportionally impacts children and low-resource communities in Asia and sub-Saharan Africa. The Global Burden of Disease study estimates that, in 2017, there were nearly 11 million typhoid cases and more than 116,000 typhoid deaths worldwide.

In 2017, 63% of typhoid cases and 70% of typhoid deaths in Pakistan were among children younger than 15 years of age. TCV is the first typhoid vaccine that can be given to children as young as 6 months of age and confers longer term protection against typhoid.

With funding support from Gavi, the vaccine introduction will begin with a two-week vaccination campaign targeting 10 million children 9 months to 15 years old in urban areas of Sindh Province. It will be followed by a transition to routine immunization of 9-month-old infants in all parts of the province once the campaign ends. The vaccine will be introduced in neighboring Punjab Province and Islamabad next year and then nationally in 2021.

“Typhoid is a highly contagious disease that spreads more quickly and easily when people live in crowded neighborhoods with weak water and sanitation infrastructure. Beginning the vaccination in urban areas is critical in preventing the disease among the communities most at risk,” said Dr. Azra Fazal Pechuho, Provincial Minister of Sindh for Health, and Population Welfare. While she claims vaccination is the best protection against typhoid, the government will also be promoting water, sanitation, and hygiene solutions.

WHO issued its formal recommendation in support of typhoid conjugate vaccine introduction in March 2018 following positive results from clinical trials conducted in Bangladesh. In anticipation of the availability of typhoid conjugate vaccines, Gavi earmarked US$85 million to support eligible countries with the introduction of typhoid conjugate vaccines into their routine immunization programs.

“Before the discovery of antibiotics, typhoid would kill as many as one in five people who contracted it,” said Dr Seth Berkley, CEO of Gavi. “The rise of extreme drug resistant typhoid risks bringing us back to levels of mortality not seen since the 19th century, posing a risk to all of us.”

Liberia and Zimbabwe are also preparing to introduce the typhoid conjugate vaccine next year with Gavi support, and several other countries are considering use of the vaccine as they review data on the incidence of typhoid in their countries.

For more information see the press release.

Image Credits: CDC.

The debate around drug price transparency was a highlight of the 4th Forum on Access to Medicines in Europe, hosted by the European Public Health Alliance (EPHA) Thursday. The forum focused its discussions around cancer therapies, medicines shortages, and transparency around R&D costs.

“It is high time to challenge the status quo on medicines policy – it can no longer be dismissed as business as usual,” said Fiona Godfrey, secretary-general of the EPHA, in an opening statement at the day-long event.

The high costs of cancer treatment was singled out as a topic of particular interest, guiding discussions in the first plenary session. Speakers noted that new cancer treatments often show low evidence of substantial clinical benefit as compared to drugs already on the market, but are still priced at exorbitant prices.

“Cancer drugs should be the cheapest. I don’t understand how we pay so much when we don’t know what we are buying. We need a dialogue to find a better balance between commercial and non-commercial research,” said Denis Lacombe, director-general of the European Organisation for Research and Treatment of Cancer.

The session also shed light on the inequity in cancer treatment between Eastern and Western Europe, challenges in scaling up innovative products, and the opacity around cancer R&D, observers noted.

Bjørn-Inge Larsen speaking at the 4th EPHA Forum on Access to Medicines in Europe.

Along with other figures that have been driving the transparency agenda in global health policy-making, Bjørn-Inge Larsen, secretary-general of Norway’s Ministry of Health and Care Services, challenged policy-makers to tackle the transparency issue and growing concerns about rising drug prices.

“We need to find balance between new technology and costs…It’s good that so many new medicines are available, but we need to make sure patients can benefit from them” said Bjørn-Inge Larsen in a keynote speech.

Inge Larsen highlighted the importance of drug price transparency and the challenges associated, noting that “we need to show how we are spending [taxpayers’] money, and currently politicians cannot explain prices and availability to patients.” He added that Norway was in discussions with Denmark and Iceland to jointly negotiate access to innovative, but expensive new therapies.

Image Credits: Twitter: @EPHA_EU.

WHO’s agenda for the next Executive Board (EB) meeting, scheduled for 3-8 February 2020, will see discussions grouped for the first time ever around the three key pillars of the WHO Global Plan of Work for 2019-2023, including expanding health and wellbeing, protection from health emergencies, and universal health coverage to one billion more people.

This is an innovation in the way governing board sessions are organized – but may also help to bring greater focus to debate, organized around key themes.

The 144th Meeting of the EB

Proposed EB discussions on access to gene and cell therapies for cancer and medicines for rare diseases, requested by South Africa and Peru respectively, will be merged and postponed until 2021, according to the list of topics to be tackled at the next EB session included in a note on the EB agenda released Thursday.

The decision received a mixed response from access groups wishing to keep these two issues alive following last year’s approval of the milestone WHA Resolution on transparency in medicines markets.

“The challenges of providing equal access to the new technologies are significant, and the WHO needs to engage now. That said, the deferral to the 2021 Executive Board [meeting] gives everyone more time to prepare and reflect on the measures needed to address the shocking inequalities of access,” said James Love, director of Knowledge Ecology International.

KEI also welcomed the fact that there will be a discussion of public health, innovation and intellectual property issues as proposed by Brazil in the February 2020 meeting.

It is likely that the tight schedule for this year’s governing body meetings also has created pressure to keep the agendas more limited, observers noted.

Exceptionally, the next meeting of the Executive Board, which includes some 34 country representatives elected by the World Health Assembly for 3-year terms, has been scheduled for February. Usually meetings are in the first month of the year but the schedule has been shifted due to the Lunar New Year on January 25.

Next year’s WHA meeting in May 2020 will also take place over only 4 ½ days due to the concurrence of the Muslim festival of Eid al-Fitr, making the scheduling for that meeting particularly tight.

One change welcomed by civil society has been the publication of more detailed notes under Director-General Dr Tedros Adhanom Ghebreyesus’s tenure, such as this one, which give an indication of upcoming priorities and discussion items in the WHO governing boards.

Other key items on the EB agenda will include a discussion of the WHO’s NCD Action Plan, including an item on the elimination of cervical cancer as a public health problem, the Roadmap on Neglected Tropical Diseases (NTDs), healthy ageing, nutrition, WHO’s work in health emergencies, and a global digital health strategy.

For more details see the Preliminary Draft Agenda of the 146th EB Meeting and the Note for the Record on the October 5 EB Meeting.

 

Image Credits: WHO.

Nairobi, Kenya – The US has thrown considerable weight behind opponents of the Nairobi Summit on Population and Development (ICPD25), saying it will only support family planning programmes that offer alternatives to abortions. 

The statement by Valerie Huber, the US special representative for global women’s health, on the Summit’s closing day, added fuel to the already fiery opposition to the conference mounted by Kenyan church-based and anti-abortion groups, which have been protesting in the streets as well as holding their own parallel event alongside the conference venue.

Huber said that while the US was a long-time supporter of family planning and had invested heavily in programmes to combat gender-based violence, prevent early childhood marriage, and end human trafficking, those initiatives shouldn’t compromise “the inherent value of every human life – born and unborn.”

Anti-abortion activists protest outside the International Conference on Population and Development in Nairobi. Credit: CitizenGO

“The U.S. is committed to promoting a healthy understanding of child spacing and non-coercive family planning to help couples either achieve or prevent pregnancy. The U.S. is the largest bilateral funder for family planning. That hasn’t changed,” Huber said.

“Our global health programs, including those for family planning, are consistent with the ICPD pronouncement that abortion is not a method of family planning and that programs should seek to provide women alternatives to abortion,” she said.

She added that while the US was “sharing this statement of our commitment to empowering women and girls to thrive, it “is not to be used as an endorsement of the commitments” of the ICDP25 Summit, which went beyond the agreement negotiated by UN member states at the 1994 Cairo International Conference on Population and Development (ICPD).

Speaking later to reporters, Huber added that the US still regarded the 1994 Cairo ICDP agreement as the foundation for international action:

“We wish to emphasize that the agreement reached in Cairo remains the solid foundation for addressing the new challenges in a consensus-driven process,” she said. “The ICPD programme of action was reached by consensus … We are deeply concerned about the priorities of this conference. We do not support reference in international documents to ambiguous terms and expressions such as sexual and reproductive health rights (SRHR), which do not enjoy international consensus.

“The use of the term may be used to support practices like abortion.”

Huber appeared in the press conference alongside Kenyan Parliamentarians that were opposed to the meeting’s outcomes.

Her statement came as the conference ended with a “Nairobi Summit Statement” affirming the right of women to access safe abortions as part of achieving “universal access to sexual and reproductive health and rights as a part of universal health coverage (UHC).” That, the statement said, should include “zero unmet need for family planning information and services, and universal availability of quality, accessible, affordable and safe modern contraceptives.

As part of achieving “zero preventable maternal deaths and maternal morbidities,” the statement supported “a comprehensive package of sexual and reproductive health interventions, including access to safe abortion to the full extent of the law, measures for preventing and avoiding unsafe abortions, and for the provision of post-abortion care, into national UHC strategies, policies and programmes, and to protect and ensure all individuals’ right to bodily integrity, autonomy and reproductive rights, and to provide access to essential services in support of these rights.”

The official Summit statement also affirmed the right to safe abortion in humanitarian emergencies and conflict zones, noting the importance of  “…access to safe abortion services to the full extent of the law, and post-abortion care, to significantly reduce maternal mortality and morbidity, sexual and gender-based violence and unplanned pregnancies under these conditions.”

The three-day Summit, marking the 25th anniversary of the landmark Cairo ICDP event, was intended to be a moment where world leaders pledged to redouble efforts to end preventable maternal deaths, achieve universal access to family planning, and end violence and harmful practices against women and girls, such as rape, female genital mutilation and child marriage.

However, the focus on those aims has been blurred by the steady drum-beat of opposition by anti-abortion groups, including a demonstration Monday as well as the parallel conference event, followed by Huber’s statements on Thursday. More than 100,000 people have signed a petition to reject “the pro-abortion and sexualisation agenda at [the] ICPD+25 Nairobi summit.”

We are concerned that the ICPD+ 25 process excluded pro-life and pro-family voices input, and that the ICPD+ 25 outcome document does not represent the majority of the people of the world,” said Anne Mbugua, the chair of the Kenya Christian Professional Forum ( KCPF). The group had planned a second protest on Thursday, that was cancelled due to police fears that it could get out of hand.

“We don’t agree with the agenda of ICPD25. We have made it very clear that its agenda is not [what] we stand for. Even the president has made it very clear, saying we have to stand for the family. Even members of parliament and members of the church have spoken very clearly. The US has spoken against the event,” Ann Kioko, campaigns director for CitizenGo in Africa, was quoted by The Guardian as saying.

In her statement to reporters, Huber, said that indeed, the US “would have appreciated more transparency and inclusiveness process of  preparation of the conference including the criteria for civil society participation.

“While the Cairo programme of action was negotiated and implemented by the entire UN General Assembly,” she said only a small group of countries was consulted on the planning and modalities of the Nairobi 2019 summit.

“Therefore the outcomes are not a result of intergovernmental negation or as result of a consensus. As a result they should not be considered normative.

“We call in member states to maintain the original and legitimate 1994 ICPD principles.”

Image Credits: Twitter: @CitizenGO.

The world is experiencing a record-breaking surge in wildfires, downward trends in crop production, unprecedented heat waves, and a rise in infectious diseases as a result of the unabated pace of climate change – affecting the health and safety of hundreds of millions of people worldwide. However, dramatic action now could still keep the global average temperature rise to below 2 degrees Celsius if bold new, approaches are taken.

These are among the main findings of the annual Lancet Countdown on Health and Climate Change, one of the most comprehensive scientific reviews of the ongoing effects on health of climate change. The report collates data on some 41 key climate and health indicators culled from studies by 35 academic and research institutions and 120 experts worldwide, to lay out the lifelong health consequences of rising temperatures should the world follow a “business-as-usual” pattern.

A woman shows how her maize ears have dried in her drought-stricken garden. Due to lack of rain exacerbated by climate change, people living in the Mauritanian Sahel were at risk of food insecurity in 2012.

This year, the accelerating impacts of climate change have become clearer than ever”, said Professor Hugh Montgomery, co-chair of The Lancet Countdown and director of the Institute for Human Health and Performance at University College London in a press release. “The highest recorded temperatures in Western Europe and wildfires in Siberia, Queensland, and California triggered asthma, respiratory infections and heat stroke.”

But while the world is already seeing the very immediate health impacts from climate change in terms of greater exposures to heatwaves, wildfires, and extreme weather, as well as greater food insecurity, the lion’s share of the health burden will fall on the younger and future generations, the report warns. Children born today could be threatened by even more widespread food insecurity, even greater increased risks of infectious diseases, and lasting health effects from environmental pollution related to climate change.

“Children are particularly vulnerable to the health risks of a changing climate. Their bodies and immune systems are still developing, leaving them more susceptible to disease and environmental pollutants,” says Dr Nick Watts, executive director of The Countdown.

If global action against climate change isn’t accelerated, average global temperatures could rise between 4-7 degrees Celsius by the end of the century, according to the report. However, a 7.4% year-on-year reduction in fossil fuel-related CO2 emissions starting between 2019 to 2050 could still limit global warming to under 1.5 degrees Celsius by 2050, the report concludes. Limiting global warming to 1.5 Celsius is one of the goals outlined in the 2015 Paris Agreement.

Sobering Trends and a Glimmer of Hope

Among the most sobering trends, the Countdown notes the following:

  • Globally, 77% of countries experienced an increase in daily population exposure to wildfires from 2001–2004 to 2015–18. India and China sustained the largest increases, with an increase of over 21 million exposures in India and 17 million exposures in China over this time period.
  • In 2018, vulnerable populations experienced 220 million additional heatwave exposures globally, breaking the previous record of 209 million set in 2015. Already faced with the challenge of an ageing population, Japan had 32 million heatwave exposures affecting people aged 65 years and older in 2018, the equivalent of almost every person in this age group experiencing a heatwave.
  • In 2018, 45 billion potential work hours were lost globally; southern areas of the USA lost 15–20% of potential daylight work hours during the hottest month of 2018.
  • In low-income countries, almost all economic losses from extreme weather events are uninsured, placing a particularly high burden on individuals and households.
  • Downward trends in global yield potential for all major crops tracked since 1960 threaten global food production and food security. Crop growth season duration has been reduced by 2.9% for maize, 3.8% for winter wheat and 3.1% for soybean crops from 1988 to 2017. Air pollution as well as more extreme heat, rainfall and drought can reduce crop productivity.

Despite this gloomy outlook, the Countdown report finds positive trends as well, which could be the basis for slowing warming, if these picked up momentum.

For instance, despite a small increase in total coal use in 2018, in key countries such as China coal’s share in electricity generation has declined.

Renewables accounted for 45% of global growth in power generation capacity in 2016, and low-carbon electricity reached a high of 32% of global electricity in 2016.

Global per capita use of electric vehicles increased by 20.6% between 2015 and 2016, and now represents 1.8% of China’s total transportation fuel use.

Improvements in air pollution seen in Europe from 2015 to 2016 could lead to significant reductions in air pollution-related illness and disability if trends are maintained over the course of the average lifetime, potentially saving economies up to €5.2 billion annually.

And cities and health systems are becoming more resilient to the effects of climate change; about 50% of countries and 69% of cities surveyed reported efforts to conduct national health adaptation plans or climate change risk assessments.

Authors Urge For Action For Future Generations

However the positive trends are nowhere strong enough at present to blunt the continued increase in climate emissions. Bold new actions are required to keep global warming below 2 degrees Celsius, the report says. The health impacts of climate change can be mitigated by four key actions:

  • Delivering rapid, urgent, and complete phase-out of coal-fired power worldwide.
  • Ensuring high-income countries meet international climate finance commitments of US$100 billion a year by 2020 to help low-income countries shift to low-carbon technologies and adapt to climate change.
  • Increasing accessible, affordable, efficient public and active transport systems, particularly walking and cycling, such as the creation of cycle lanes and cycle hire or purchase schemes.
  • Making major investments in health system adaptation to ensure that the health impacts from climate change don’t overwhelm the capacity of emergency and health services.

Authors of the report point to the upcoming COP25 Climate Change Conference in Madrid (2-13 December) and a growing global movement against climate change, led by young people as catalysts for more assertive action.

Co-Author Dr. Stella Hartinger was quoted in The Countdown’s press release saying, “We must listen to the millions of young people who have led the wave of school strikes for urgent action. It will take the work of the 7.5 billion people currently alive to ensure that the health of a child born today isn’t defined by a changing climate.”

For more information about the 2019 Report, its findings and policy implications, see the Lancet Countdown’s Resources Page.

Image Credits: Pablo Tosco/Oxfam, The Lancet Countdown on Health and Climate Change, The Lancet Countdown.

The World Health Organization announced Wednesday that it would implement a pilot programme to include human insulin products in its Prequalification of Medicines programme, in an effort to expand access to treatment for diabetes in low- and middle-income countries. The move is the first in a series of steps WHO is taking to address the growing burden of diabetes, which is now one of the top ten leading causes of death around the world.

“Diabetes is on the rise globally, and rising faster in low-income countries,” says Dr Tedros Adhanom Ghebreyesus, WHO Director-General in a press release. “Too many people who need insulin encounter financial hardship in accessing it, or go without it and risk their lives. WHO’s prequalification initiative for insulin is a vital step towards ensuring everyone who needs this life-saving product can access it.”

Human insulin has been on the WHO Essential Medicines List since 1977, which guides many national government decisions about products to support in public health services. However, only about half of the 65 million people with Type 2 Diabetes who need insulin can actually access it, WHO estimates, due to the high prices of insulin products and unavailability in public health facilities.

Currently just three pharmaceutical companies – Novo Nordisk, Eli Lilly, and Sanofi – control most of the global market for insulin products, and prevailing prices remain prohibitive for many people and low-income countries, and even in some high-income groups as well.

Including insulin in WHO’s Prequalification of Medicines programme, would make it more attractive for new competitors to enter the market – by submitting proposals to WHO review for production of quality-assured insulin products at lower prices. WHO prequalified products also are used as the basis for many donor-supported initiatives to make bulk purchases of products at preferred prices for low- and middle-income countries.

The ultimate result, WHO officials believe, would be an increase in the number of quality-assured human insulin products on the international market, and a wider range of choices for patients at lower prices.

“Prequalifying products from additional companies will hopefully help to level the playing field and ensure a steadier supply of quality insulin in all countries,” said Dr Mariângela Simão, assistant director general for Medicines and Health Products at WHO.

A WHO spokesperson told Health Policy Watch that already, at least three new market entrants have informally expressed their interest in applying for WHO Prequalification as part of the pilot.

“Clearly we hope more come forward now that the pilot is official, because clearly the more companies that meet international quality standards, the larger the chance that insulin will become affordable,” said the spokesperson.

The target WHO assessment time is 270 days, meaning if companies submit their applications within the next few months, new WHO-prequalified products could be on the market as early as this time next year.

Prequalification is a process in which WHO evaluates the quality, safety, and efficacy of medical products and issues guidance on their use. Many low- or middle-income countries also see WHO prequalification of a product as a stamp of approval to begin registering the health product for use in their own countries.

Access To Insulin A Global Challenge

From 2016-2019, human insulin was available only in 61% of all health facilities and analogue insulins (altered forms of human insulin) were only available in 13%, according to WHO data from 24 countries. The data showed that a month’s supply of insulin would cost the average worker in Accra, Ghana almost a quarter of their monthly income.

Even in high-income countries, the high price of insulin results in many people rationing its use, which can be deadly for people who do not receive the appropriate daily dose.

Globally, some 422 million people live with diabetes. Diabetes is the seventh leading cause of death globally and a major cause of costly and debilitating complications such as heart attacks, stroke, kidney failure, blindness and lower limb amputations.

People with Type 1 diabetes need insulin for their very survival and to maintain their blood glucose at levels to reduce the risk of common complications such as blindness and kidney failure. People with Type 2 diabetes need insulin for controlling blood glucose levels, and to avoid further complications when oral medicines become less effective as the illness progresses.

Decision Follows Debate Over Inclusion of Analogue Insulin in WHO Essential Medicines List 

WHO’s decision to pilot human insulin prequalification also follows a contentious debate earlier this year over the proposed inclusion of still more pricey insulin analogues (altered forms of human insulin) in WHO’s Essential Medicines List (EML). The list is used by many countries as a basis for national decisions on the basket of medicines to be procured, offered or supported.

Civil society, scientific experts, and patient access groups opposed the petition to include analogues in the EML, arguing that including these products without addressing the lack of competition in the insulin space could send the wrong message to governments, making analogue insulin the new norm. And that could actually drive up prices that low- and middle- income countries were paying for insulin products.

The Pre-Qualification initiative appears aimed at addressing some of those existing needs and gaps. Health Action International (HAI), one of the same civil society groups that opposed the petition to include analogues in the EML, commended the WHO’s decision to include human insulin in the prequalification program.

Dr. David Beran, University of Geneva professor and co-lead investigator of a HAI study group focusing on insulin access (ACCISS) expressed his hope that WHO’s decision will impact the limited competition in the insulin market in a statement released by the group. “This initiative should ultimately lead to greater competition and hopefully lower prices, thus improving affordability for people and health systems.”

This story was updated November 14.

Image Credits: WHO.

Nairobi, Kenya  – A three day summit marking 25 years since the historic UN Conference on Population and Development (ICPD) in Cairo opened here in the Kenyan capital on Tuesday, with a focus on actions that save mothers’ lives, make contraception and family planning more accessible, and end violence against women and girls.

But as the Nairobi Summit (ICPD25)  kicked-off under the theme “Accelerating the promise,” abortion opponents and faith-based groups were holding a parallel meeting at a Catholic church next to the venue, saying that the meeting didn’t reflect their views and positions.

“The reproductive rights of women and girls are not up for negotiation. We shall protect and uphold them. Reproductive rights are human rights and we will not back down,” Natalia Kanem, United Nations Population Fund (UNFPA) executive director said in the opening session, in an oblique reference to the protests outside.

The Nairobi ICPD25 Summit is organized by the government of Kenya and Denmark, and the UNFPA. About 12,000 people from 160 countries, ranging from heads of state, ministers and parliamentarians to hundreds of representatives of non-governmental organizations, are set to attend.

Natalia Kanem, Executive Director of the UNFPA, speaks at the ICPD25

“The purpose of the conference is not to talk about ‘what’, but to discuss ‘the doing’. The goal is to speed up the momentum,” Kanem told a news conference on November 12. “We have to finish the intended business of the ICPD. [This] remarkable turnout gives me confidence we will reach the goal by 2030.”

Discussions are focusing on five themes; sexual reproductive health as part of Universal Health Coverage; funding required to realise ICPD’s programmatic goals; demographic diversity and its power to drive economic growth and sustainable development; measures to end gender-based violence and harmful practices; and the right to sexual and reproductive health care.

“We need more action,” said Rasmus Prehn, Denmark’s Minister for Development Cooperation. “The summit is about how, but not what to accelerate.”

 

Women’s Rights & Well-Being Key to Prosperous Societies

In an opening address, Kenya’s President Uhuru Kenyatta said the large numbers of conference attendees confirmed the premise that advancing people’s rights, and in particular women’s rights, choices and well-being, is the path to prosperous and resilient societies.

“… Our women are the gatekeepers to family health; they exert such a powerful influence on intergenerational outcomes for their children. Empowering women essentially empowers all our families, empowers our societies, empowers our nations and it empowers the world,” said Kenyatta.

In the milestone 1994 meeting in Cairo, 179 governments called for the empowerment of women and girls in all spheres of their lives, including in areas regarding sexual and reproductive health.

Since then, Kenyatta said, the world had changed a great deal, with respect to population and development-related issues.

“The world faces increased health threats including threats from reproductive cancers such as breast, cervical and prostate cancer. And there are also growing environmental pressures including the urgent threat of climate change,” said the Kenyan leader, while adding that these health challenges had made the Cairo commitments more urgent and more complex.

Significant achievements in strengthening maternal health care, and expanding access to quality contraception information and services, are being highlighted at the event. At the same time, speakers have underlined that millions of women and girls have not befitted from those gains.

“…let us bear in mind the fact that the most important participants in this Summit are actually not in this Conference,” said Kenyatta. “I am referring to the 1-in-5 women from all corners of the world that this year alone, will experience gender-based violence, most likely from someone who is close to them.”

Closing Equity Gaps Will Cost Billions
Uhuru Kenyatta welcomes delegates at the Summit’s opening. @Nairobi Summit

One recent study, discussed at the conference, suggests that an estimated at US $264 billion will be needed over the next decade to achieve universal access to modern family planning, end preventable maternal deaths, and end harmful practices such as female genital mutilation and child marriage.

But only US$42 billion in development assistance is currently targeted to those aims, according to the study, a joint project of the UNFPA and John Hopkins University in collaboration with Victoria University, the University of Washington and Avenir Health. So an additional US$222 billion would be needed in the next decade to close the gaps, whether in form of direct investment, private spending or domestic allocations.

At the conference, however, some new financial commitments were also made. Private sectors organizations including the Ford Foundation, Johnson & Johnson, Philips and World Vision, among others, pledged to mobilise US$8 million. A press release said that the funds would support achievement of the triple goals for 2030 of zero preventable maternal deaths, zero unmet need for family planning, and zero gender-based violence and harmful practices. Groups ranging from health care and technology companies to private foundation, International NGOs and sports have also stepped forward with new commitments.

“We know how much and where we need to invest. These figures are a drop in the ocean compared to dividends,” Dr. Kanem. “Smart and affordable investments will transform the lives of women and girls.”

UNFPA statistics indicate that an estimated 232 million women want to prevent pregnancy but are not using modern contraception. More than 800 women die from preventable causes during pregnancy and childbirth each day, and 33,000 girls are forced into marriage. Still every year, more than 4 million girls are subjected to female genital mutilation.

“As critical accelerators for the Sustainable Development Goals, the outcomes of ICPD must be carried forward. The success of the global agenda for sustainable development, our common framework for the people, planet, prosperity, peace and partnership, depends on it,” said United Nations Deputy Secretary-General Amina Mohammed, speaking at the Summit’s opening ceremony.

Proponents say that the summit will re-energise the global community, breathe new life into the ICPD agenda and sustain and amplify gains made since 1994. It will be a springboard for governments and other organizations to announce voluntary, global commitments – including financial ones-that will accelerate progress. “The Nairobi Statement is not a government statement, but a stakeholders’ statement,” said Dr. Kanem.

 

Conference Opponents Stage Parallel Event

But on Monday, the day before the Nairobi Summit opened, groups opposed to the meeting’s aims and themes demonstrated in the streets outside of the venue. As the conference opened Monday, the protesters held their own, parallel meeting at a Catholic church next door. Under the banner of what they called a Pro-family Caucus, they cautioned governments against making legal commitments to the Nairobi outcome document, and to rather reaffirm their commitment to the ICPD Cairo Programme of Action, which they said had a stronger “pro-life and pro-family” platform.

The groups opposing the current conference say it has been organized without the authority of the United Nations General Assembly. They add that it has ignored the traditional consensus-building approach of the UN, in favor of imposing a “liberal sexualization” agenda. They have also charged that the summit deliberately excluded civil society groups or members of national delegations who support their positions.

“The organizers of the Nairobi Summit….believe in anti-population and pro-abortion ideology. They have openly stated their intention to use the Nairobi Summit to advance their ideology internationally and apply pressure on pro-family groups and countries that are pushing back against the SRHR [sexual and reproductive health rights] agenda,” said the groups in a statement.

Anti-abortion protestors march in the street at the start of the ICDPD25. Photo: Fredrick Nzwili

Image Credits: @NairobiSummit , @Atayeshe.

The World Health Organization has “pre-qualified” a new Ebola vaccine in record time, just a day after the vaccine, Ervebo, received European regulatory approval.

“This is the fastest vaccine prequalification process ever conducted by WHO,” said the organization in press release Tuesday evening. The WHO approval was described as a “critical step that will help speed up its licensing, access and roll-out in countries most at risk of Ebola outbreaks.”

Dr Tedros Adhanom Ghebreyesus, WHO Director-General, called it “a historic step towards ensuring the people who most need it are able to access this life-saving vaccine. Five years ago, we had no vaccine and no therapeutics for Ebola. With a prequalified vaccine and experimental therapeutics, Ebola is now preventable and treatable.”

The WHO move followed Monday’s news of the European Commission (EC) decision to grant conditional marketing authorisation to the pharmaceutical company Merck Sharp & Dohme (Merck) for the first-ever vaccine against the deadly Ebola virus. The announcement drew cheers in the global health community from boardrooms to laboratories where researchers had worked for years to create a safe vaccine for the virus that kills two-thirds of its victims. The EC move followed a recommendation from the European Medicines Agency (EMA). 

Monday’s approval of the new vaccine was not necessarily a big surprise. The Merck formulation has already proven to be highly effective under a special compassionate use protocol, which has seen more than 250 000 people immunized during the current Democratic Republic of Congo (DRC) outbreak. As such, it has has been operationally deployed for months as a key part of a “ring strategy” fighting the DRC outbreak, and used for immunizing health workers as well as people who were identified as known contacts of those infected with Ebola.

However, the formal EC decision still represented a huge milestone for a first-ever vaccine to protect against one of the world’s most deadly viruses.  Observers said it should ultimately help speed up production and expand use of the vaccine, which has been subject to supply bottlenecks and shortages at times.

WHO’s Pre-Qualification process or “Pre-Qual” as it is widely known, is a sign-off on the vaccine’s quality, safety and efficiency data, which will help get the product into the field more quickly – expediting national regulatory approvals and paving the way for countries to procure the vaccine from donor-supported programmes at preferred prices. 

Seth Berkley, head of Gavi, The Vaccine Initiative, said in a tweet that the Gavi board would also vote on 5 December on a recommendation to “open a window” of support for uptake of “outbreak and preventive vaccines”, such as the Ebola formulation.  The proposal calls for creating a long-term Gavi Ebola vaccine programme including creation of a global Ebola vaccine stockpile, enabling countries to access and rapidly deploy Ebola vaccines in response to outbreaks, Gavi said in a press statement. On top of the stockpile, the Board “will also consider, if recommended, future support for preventive vaccination of high-risk groups outside of an outbreak such as healthcare workers in countries classified as being at high risk.”

Wellcome Trust Head of Vaccines, Charlie Weller, said in a statement: “The Merck Ebola vaccine has already saved countless lives and been key in preventing the ongoing outbreak in the DRC spiralling into a repeat of the 2014-16 epidemic, where 11,000 people died.

“Now it has market authorisation it will be much easier to provide access to the vaccine for those who need it most. It’s been a long journey and made possible by a truly global collaborative effort of researchers, governments, NGOs, companies and funders. Wellcome is very proud to have been among those who have played a part. We commend Merck for their commitment to developing this vaccine. But we should all pay tribute to the brave healthcare workers who have provided the best possible care in conducting the trials, as well as the leadership in the DRC, for this vital research.”

Although the vaccine’s rights are now held by Merck (MSD), in fact, scores of scientists in universities and research institutions across North America, Europe, and Africa contributed to the path-finding research that led to the milestone breakthrough, noted STAT News. It cited John Rose, a scientist at Yale University who developed the vaccine’s biological “delivery system” – a genetically modified vesicular stomatitis virus (VSV) that infects livestock but doesn’t harm people, and could safely carry an Ebola protein into the immune system. “It’s thrilling to see the first licensing of a VSV-based vaccine vector system for use in humans,” Rose was quoted by STAT as saying. “Numerous scientists worked for many years in my laboratory at Yale to develop this potent vaccine platform.”

The European Commission decision on Ervebo also follows on the recent announcement of the launch of a clinical trial for a second Ebola vaccine regimen developed by Johnson & Johnson (Ad26.ZEBOV, MVA-BN-Filo), now getting underway in the DRC, with the support of the European Union’s Horizon 2020 research programme. Unlike the Merck vaccine, the J&J vaccine requires two injections a number of weeks apart to be effective. But it may potentially protect people against multiple strains of the Ebola virus which tend to circulate in endemic areas – while the Merck vaccine only protects against the  Zaire Ebola virus species that has been the cause of the recent large DRC and West African outbreaks. DRC health authorities say the second vaccine will not be tested in the DRC outbreak’s hotspots, but rather in more peripheral areas, which could still be at risk now or in the future.

The final approval of the Merck formulation, and test deployment of the J&J vaccine, come just as the current Ebola outbreak seems to be finally winding down after raging in eastern DRC for over a year.  Over the past month, there have been about 19 reported new cases a week, down from a peak of 126 cases a week in April.  However the scattered, rural locations of the new infections continues to confound efforts to entirely stamp out the outbreak.  Sporadic violence against health care workers, and the recent murder of a radio journalist underline the continued resistance that health teams still face to winning broad community acceptance in some areas, for effective Ebola control measures, such as the reporting of new infections to Ebola Treatment Centers, as well as the safe burial of Ebola victims.

Vaccine Development Pathway 

In terms of Ervebo, the first clinical trial results of the vaccine (VSV-ZEBOV) in December 2016 showed it provided a high level of protection against the so called Zaire species of Ebola when it was first deployed at the end of the 2014-2016 West African outbreak, which had raged across Liberia, Sierra Leone and elsewhere. Expedited research on the vaccine was funded by Wellcome, DFID and the Norwegian Government among others. The vaccine was thus stockpiled and somewhat more readily available for use in the current DRC outbreak.

“The global community showed the power of working together during the West African Ebola epidemic. Continuing to do so could be key to improving our future epidemic preparedness,” said Weller, outlining the story of the vaccine’s development in a blog, published on the Wellcome website.

“The first research [in July 2015] showing that VSV-ZEBOV vaccine could help protect against Ebola brought sighs of relief. It was an incredible and humbling achievement that had only been possible due to the global collaboration of researchers, NGOs, governments, industry and funders – all working towards a unified goal.

“It suggested that a single injection of VSV-ZEBOV might be highly effective in preventing people from contracting Ebola. …The VSV-ZEBOV news was positive for two reasons. Not only did this vaccine candidate appear to protect against contracting the Zaire strain of Ebola, but it had only taken about eight months to get to this point, rather than many years.

The West African Ebola outbreak killed over 11000 people as well as devastating economies across the region. During the current outbreak in DRC, a total of 3285 cases of confirmed and probable infections had been reported as of 5 November.  Some 2191 people have died since the DRC outbreak began in August 2018, for a case fatality rate of 67%.

 

Image Credits: WHO.