Efforts to eliminate river blindness, a debilitating parasitic disease that causes vision loss in 1.15 million people, may be threatened by another infection known as African eye worm, according to a modelling study published in Clinical Infectious Diseases. While the World Health Organization has set a target to eliminate river blindness in most African countries in the next five years, the study predicts that 4 million people living in areas with African eye worm will still be at risk of the blinding disease in 2025, threatening almost four decades of elimination efforts.

The study, co-authored by researchers from Erasmus MC, University Medical Center Rotterdam in the Netherlands, and the Drugs for Neglected Diseases Initiative, also predicts that 90% of these people will live in areas currently not covered by treatment programmes for river blindness.

A villager’s eyes are being examined for African eye worm by Dr Philippe Urwotho, a medical doctor and Provincial Coordinator of the DRC’s Neglected Tropical Disease National Programme.

Elimination of river blindness, also known as onchocerciasis, is mainly reliant on a strategy of “mass drug administration,” whereby entire communities living in endemic areas are given a safe and effective drug called ivermectin regularly in order to prevent the parasitic disease from progressing or spreading. Ivermectin only targets the juvenile worms that can cause blindness or severe chronic skin itching, so mass drug administration needs to be repeated for the full life span of the adult parasite – 10 to 12 years – to fully eliminate the parasite from a community.

The problem arises when communities live in areas with both the river blindness parasite and the African eye worm, or Loa loa – people who have a high number of Loa loa larvae in their blood are at risk of life-threatening complications if they receive ivermectin. As a result, ivermectin cannot be safely used in mass drug administration campaigns in areas co-endemic for both diseases, and river blindness treatment programmes in these areas have not started.

“The current approach to preventing river blindness based on mass drug administration of ivermectin has been extraordinarily successful,’ says Sabine Specht, Head of Filarial Clinical Programme at DNDi, in a press release. “But alternative treatment strategies will be needed if we want to eliminate the disease, including the development of entirely new tools that offer a rapid and safe cure for river blindness.”

The authors predict that in 2025, there will still be at least 31,000 individuals infected with onchocerciasis and unable to use ivermectin, due to the high load of  Loa loa worms in their bloodstream – as the current treatment regimens for co-infected people are not well adapted for use in the field. According to the study, there are also currently no safe medications that can be used to kill adult forms of the worms that cause river blindness. The authors highlight that the lack of existing field-friendly treatments and diagnostics for both diseases merit further R&D for both diseases.

River blindness is transmitted by the bite of infected blackflies, which live near fast-moving rivers. The disease can progress to severe itching, skin lesions, and eventual blindness. Before large-scale control campaigns began in the mid-1970s, whole villages would eventually go blind from the disease. In 2017, it was estimated that 14.6 million people infected with onchocerciasis had severe chronic itching and skin disease, and 1.15 million had vision loss.

African eye worm, or Loa loa, gets its name from its most infamous tell-tale sign: the visible passing of the Loa loa worm through the eye. While previously thought to be rather mild, recent studies show that Loa loa infection can cause severe illness such as cardiac fibrosis, encephalopathy, and neurological or psychiatric disorders.

Image Credits: DNDi.

Italy’s former Undersecretary of State for Health, Armando Bartolazzi, discusses the implications of recent moves to replace the head of the Italian Medicines Agency (AIFA), based on political considerations of the a new Health Minister.  

“Health is a Political Choice” said WHO Director-General Dr Tedros in his keynote session at the World Health Summit, Berlin, 29 October 2019.

I fully support this statement. However, what about Health Officials?

There is a long tradition in Italy of politicians appointing key health officials for the National Health System (NHS). However, I was part of an initiative in 2018 to change that system and ensure that key appointments in the health system were based on technical experience and merit, rather than political connections.  Now, that initiative may be reversed by the new Health Minister, Roberto Speranza – to the detriment of the Italian public as well Italy’s image in international health leadership.

In February 2018, just before the general political elections, I was approached by top representatives of the fast-rising 5 Stars Movement to discuss my possible involvement within the government if the movement won the elections. I had a positive impression from Luigi Di Maio, the soon-to-become Vice Prime Minister when we met in front of the hospital where I worked in Rome. The message was crystal clear: “please help us to promote and guarantee that meritocracy, expertise and competence become the only criteria behind the appointments of high-level managers in the health sector”.

Armando Bartolazzi, former Italian Underscretary of State for Health

The 5 Stars Movement did win the elections shortly thereafter, and I took on the role of Undersecretary of State for Health for the new Government, between June 2018 and August 2019. I immediately started working to use a different approach in selecting top health officials.

The first selection coming up was that of the Director General of the Italian Medicines Agency (AIFA). Based on my professional experience at the Karolinska Institute of Stockholm, Sweden, I proposed to the Health Minister Giulia Grillo to use a blind international selection process, something well established abroad, but never used before in Italy, instead of the classical Italian selection process known as “concorso” which generally doesn’t guarantee an independent judgment based on meritocracy, but fits very well with the pre-defined political inclinations of ministers in charge.

Around 100 CVs were received. Three independent international experts, including Sir Andrew Dillon, one of the most prominent experts in the pharmaceutical sector, were recruited to screen out the candidates and make their recommendations.

After three independent evaluations, Dr Luca Li Bassi, then head of a health sector strengthening initiative at the International Atomic Energy Agency, was finally included among the top candidates.

This was based on his strong and wide experience related to medicines assessment, procurement, access and delivery in numerous international agencies, including the Global Fund to Fight AIDS Tuberculosis and Malaria. These activities had led to concrete achievements influencing national as well as global markets and achieving impressive results when addressing major challenges in this sector. With an MD from Milan University, and degrees in both Management and Public Health obtained in New Zealand, Dr Li Bassi made a convincing final interview with the Minister. No one in the Ministry knew him directly and he did not know any of us, considering that he had spent most of his professional career abroad, working in three different continents for the previous 25 years.

With this process, we had effectively started a new approach, based on the principle that making health a “political choice” also must include choosing to free up the National Health System from political influences when selecting its top management.

It includes recognizing that better health for people, Universal Health Access and greater health gains based on available resources cannot have a political colour – but need to be anchored in professional, evidenced-based decisions, and in the case of medicines regulation are also among the most technical issues faced by health policymakers. We explained this principle in a letter published in The Lancet and were proud to have made this change for the first time in our country, where the inequalities in the health system are still growing. This may arguably also be attributed to the various political influences at local, regional and national level that are diverting health investments to other political interests, regardless of the best interests of their constituents.

A New Approach Brings Results    

Key achievements reached by AIFA in the past year are quite clear for any outsider. A few weeks after his nomination, the new DG Li Bassi, was able to negotiate the core of the historic agreement with the Italian pharma lobby group (Farmindustria) that unlocked € 2.4 billion for the national health system, a deal that had been awaited since 2013!

He then went on to negotiate consensus among 192 World Health Assembly (WHA) Member States on what the  Chair of Committee A had declared to be “the most contentious issue in global health” with adoption last May of the WHA Transparency Resolution [Improving the transparency of markets for medicines, vaccines and other products].

I witnessed his hard work arguing on technical grounds with delegations from all over the world, and I was honoured to speak in the Plenary of the Assembly and receive the chilling applause and hugs of hundreds of delegates.

Luca Li Bassi holding Italy’s placard at the 72nd World Health Assembly with other lead co-sponsors of the WHA Transparency Resolution.

It was an historic moment – more so since Italy has never been able to take a leadership role before in the World Health Assembly.

At national level, he then successfully raised the issue of medicines shortages, implementing measures that have since been taken up as examples by other EU countries, such as the need for national stockpiling, longer advance notices by producers, and export bans and penalties in case of lack of supply, all focused to protect public health.

As a matter of fact, I note that nobody was talking about the emergencies caused for many national health systems by shortages in the international fora only 6 months ago, while now this has become a priority issue in the European Union. It was also declared a priority by the International Coalition of Medicines Regulatory Authorities (ICMRA) at its last summit, which was hosted for the first time in Rome last month at the behest of the AIFA DG.

In addition, Li Bassi led AIFA to negotiate under an innovative “payment for results” scheme, the reimbursement of expensive new CAR-T technologies for treatment of leukaemia (and likely other type of cancers in the near future) making finance for such treatments sustainable for the NHS, and rewarding the suppliers only when the treatment is successful.

In order to make sure that this technology is effectively adopted by the NHS, AIFA also gathered experts nationally and internationally to discuss how the Ministry could invest in independent facilities that in the future will be able to develop production capacity in public “cell factories” around the country. The Ministry has now decided to allocate €60 million for the next year on this project, another visionary move that would not have been possible without the catalysing efforts of AIFA.

Back to Politics Again in the New Italian Government?

With the new government coming into power as result of the political crisis last August, Italy now has a new Health Minister, Roberto Speranza, representing a small party from the far left (Article One). With his decision to announce the recruitment of a new DG in AIFA, he has effectively given into the principle of awarding this sensitive position to someone based on his politics, rather than professional skills. This will also bring to the national regulatory authority for medicines, a highly technical and supposedly independent agency, the third DG in three years.

Yes, health is a “political choice” – But as health professionals, our aspirations and concrete accomplishments in delinking politics from management of the health system has been trashed at a blink of an eye. Most importantly, all the ground-breaking work that has been done by AIFA under the current leadership over the past year both in the national as well as international fora is threatened. It could  vanish, or in the best case suffer delays, ultimately to the detriment of people’s health.

It is obviously the right and responsibility of any new Minister to revise priorities and indicate objectives. It is the role of health managers as the technical and operational arm of the NHS to then implement those objectives, and to become accountable against these new priorities, in terms of performance.

So why not take such approach, giving AIFA’s current DG the opportunity to respond and be accountable? Where is the need to go back to the old logic of political appointments and appointees?

What can a political element provide to technical work that has not been delivered in the past year? Why do meritocracy and competence have to be traded off with politics? As an example, the head of the European Medicines Agency does not normally change after the EU elections and the establishment of a new Commission, was was just experienced recently.

As a health professional myself, I doubt that the decision taken by the new Minister is the best line of action for the interest of patients and the public-at-large. Italy’s NHS needs good managers, strong leaders in the global arena and undisputed focus on the best interests of the whole community that it is supposed to serve.

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Armando Bartolazzi, MD, is an oncologist-pathologist by training. He served as former Italian Undersecretary of State for Health between June 2018  and August 2019. He is currently Professor of Pathology (first level Dirigente) at Sant’ Andrea University Hospital, Rome, Italy, and Research Associate at the Department of Pathology-Oncology, Karolinska Hospital, Stockholm, Sweden. Since 1987 he has worked in the field of cancer research and diagnosis

 

 

 

 

Image Credits: @Armando Bartolaz, HP-Watch/E Fletcher.

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.