A new UNAIDS report found that while new HIV infections have declined globally since 2010, the rate of progress has slowed, with some regions showing increases in new infections. Available resources for HIV have also dropped by US$ 1 billion in 2018, marking the first time global HIV funding declined since 2000.

UNAIDS’ Global AIDS Update, Communities at the Centre, launched today in South Africa, shows a “mixed picture” of progress, differing across countries and regions. It also shows a decline in HIV funding – US$ 7.2 billion short of the US$ 26.2 billion UNAIDS estimates is needed by 2020 – resulting in slowed progress towards reaching targets to end the AIDS epidemic.

The overall decline in new cases – 16 percent since 2010 – signifies an impressive improvement, which is driven largely by steady progress across eastern and southern Africa, the regions most affected by HIV. However, there have been increases in new HIV infections in eastern Europe and central Asia (29%), in the Middle East and North Africa (10%) and in Latin America (7%), according to a UNAIDS press release.

“While considerable progress has been made, there is a risk that we will lose momentum. If the world is to be on track to end AIDS by 2030, there must be adequate and predictable financing for development. But, for the first time since 2000, the resources available for the AIDS response globally have declined,” Gunilla Carlsson, UNAIDS acting Executive Director, said in the report forward.

Carlsson called on all partners to “step up action and invest in the response,” which includes “fully funding the Global Fund to Fight AIDS, Tuberculosis and Malaria with at least US$ 14 billion at its replenishment in October and through increasing bilateral and domestic funding for HIV.”

“We urgently need increased political leadership to end AIDS,” Carlsson said, quoted in the release. “This starts with investing adequately and smartly and by looking at what’s making some countries so successful. Ending AIDS is possible if we focus on people not diseases, create road maps for the people and locations being left behind, and take a human rights-based approach to reaching people most affected by HIV.”

In 2018, an estimated:

  • 9 million people globally were living with HIV
  • 3 million were accessing antiretroviral therapy
  • 7 million people became newly infected with HIV
  • 770,000 people died from AIDS-related illnesses

Improved Access to HIV Testing and Treatment, Insufficient Progress on Prevention

The report shows that improvements in providing access to testing and treatment options have helped to reduce AIDS-related deaths, which fell by 33 percent to 770,000 between 2010 and 2018. This improvement was made possible through improved delivery of both HIV and tuberculosis services.

Progress has also continued towards UNAIDS’ 90–90–90 targets: that 90 percent people living with HIV know their status; 90 percent of people living with HIV who know their status are on treatment; and 90 percent of people on treatment have suppressed viral loads.

According to the release, some “79% of people living with HIV knew their HIV status in 2018, 78% who knew their HIV status were accessing treatment and 86% of people living with HIV who were accessing treatment were virally suppressed, keeping them alive and well and preventing transmission of the virus.”

This progress towards the 90–90–90 targets, however, has varied greatly by region and by country. “In eastern Europe and central Asia for example, 72% of people living with HIV knew their HIV status in 2018, but just 53% of the people who knew their HIV status had access to treatment.”

The chart below from the report shows progress on each of these targets compared to the total population of people living with HIV.

Additionally, around 82 percent of pregnant women living with HIV now have access to antiretroviral medicines – an increase of more than 90% since 2010 – which has resulted in a 41 percent reduction in new HIV infections among children, “with remarkable reductions achieved in Botswana (85%), Rwanda (83%), Malawi (76%), Namibia (71%), Zimbabwe (69%) and Uganda (65%) since 2010.”

While access to testing and treatment options has improved, “the full range of options available to prevent new HIV infections are not being used for optimal impact,” the release said.

“For example, pre-exposure prophylaxis (PrEP), medicine to prevent HIV, was only being used by an estimated 300,000 people in 2018, 130,000 of whom were in the United States of America. In Kenya, one of the first countries in sub-Saharan Africa to roll out PrEP as a national programme in the public sector, around 30,000 people accessed the preventative medicines in 2018,” indicating that more progress can be made in expanding access to PrEP.

Addressing Needs of Key Populations

In 2018, the report shows that more than half of all new HIV infections – 54 percent – were among key populations, including sex workers; people who use drugs; gay men and other men who have sex with men; transgender people; and prisoners; as well as their partners.

In 2018, these key populations accounted for around 95 percent of new HIV infections in eastern Europe, central Asia, the Middle East and North Africa.

While gains have been made against HIV-related stigma and discrimination in many countries, “discriminatory attitudes towards people living with HIV remain extremely high,” and there remains “an urgency to tackle the underlying structural drivers of inequalities and barriers to HIV prevention and treatment, especially with regard to harmful social norms and laws, stigma and discrimination and gender-based violence,” according to the release.

The report also highlights that community empowerment and ownership has been key to much of the progress across all sectors of the AIDS response. However, insufficient funding for community-led responses, along with negative policy environments, have impeded these successes from reaching full scale and generating maximum impact.

As part of achieving the 2030 Agenda for Sustainable Development, “governments must protect and uphold the human rights of everyone,” Carlsson of UNAIDS said in the report forward. “As the eyes and ears of the AIDS response, communities play a critical role in holding decision-makers to account and demanding political leadership.”

Japan said on Friday that it disagrees with aspects of an already-adopted Human Rights Council (HRC) resolution on access to medicines, claiming that there is no evidence that “delinkage” between the cost of research & development (R&D) and the price of medicines improves access to medicines. Japan also disagreed with pursuing alternative frameworks for R&D incentives, which it said disregards existing R&D frameworks.

These and other provisions had been previously criticised by other developed countries during the informal consultations on the resolution as treading too far out of the Human Rights Council domain and into the technical ground of other UN agencies such as the World Health Organization, the World Trade Organization (WTO) and the World Intellectual Property Organization (WIPO), where such debates are already taking place.

During Friday’s closing session of the HRC, Switzerland, on behalf of Australia, Canada, the Czech Republic, France, Liechtenstein, Slovakia and the United Kingdom, said: “While the Human Rights Council can consider the right to the enjoyment of the highest attainable standard of health, it lacks the necessary technical expertise and competence to address the full complexity thereof.”

Debates abound regarding the best way to create incentives for research and development of new medicines and vaccines while ensuring that the resulting products are widely affordable. Some member states in the HRC see this as a technical matter, while others see it as a human rights imperative.

Delinkage is one model that, according to its proponents, can help to ease the tension between drug innovation and accessible pricing. It refers to delinking R&D incentives from the expectation of receiving exclusive patent rights for the final product, which critics say create monopolies that drive up prices. Delinkage, rather, offers alternative financial incentives to invest in the research and development of new medicines and vaccines. Such incentives may include cash rewards for new innovations that emerge from the drug pipeline, as well as upfront funding in the form of public subsidies, grants, research contracts, or offers of tax credits.

Human Rights Council – Photo: Reuters/Denis Balibouse

Knowledge Ecology International (KEI), a leading NGO promoting access to medicines, describes delinkage as “the idea that temporary monopolies and the associated high drug prices should not be used to fund pharmaceutical research and development.”

The day before Japan’s and Switzerland’s comments, on 11 July, the Human Rights Council passed the resolution on “Access to medicines and vaccines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health,” which was sponsored by the “core group” of Brazil, China, Egypt, India, Indonesia, Senegal, South Africa and Thailand, and cosponsored by 45 other countries.

Japan explained during Friday’s session of the HRC that it joined the consensus of member states to adopt the resolution “given the importance of access to medicines and vaccines,” but it raised concern that the resolution does not accurately reflect the opinions expressed during the informal consultations with member states, and that it does not appropriately take into account relevant technical discussions occurring at the WHO, the WTO and WIPO.

In the statement, Japan expressed disagreement with paragraph OP5 on delinkage, claiming that “there has been no evidence found to prove that delinkage between the cost of R&D and the price of medicines will improve access to medicines.”

Japan further disagreed with paragraph OP8 on alternative frameworks to reward innovation because “it disregards existing frameworks,” and because a “common understanding on an alternative framework does not exist.”

Japan’s comments regarding delinkage and alternative R&D frameworks follow intense debate among member states at the recent World Health Assembly in May, over a resolution on the transparency of medicines markets. This landmark resolution primarily focused on enhancing the transparency of medicines prices, and due to the intense negotiations, included only watered-down provisions on R&D cost transparency, which emphasised the voluntary nature of such disclosures.

KEI Says Monopolies Cause High Prices, Calls For Delinkage From Monopolies

James Love, Director of Knowledge Ecology International (KEI), a leading NGO promoting models for delinkage, responded to Japan’s statement at the HRC, saying that monopolies cause high prices, and high prices limit access.

“There is certainly plenty of evidence that temporary legal monopolies, such as patents, pediatric, orphan drug or test data exclusivity, lead to high prices,” Love told Health Policy Watch.

There is also “plenty of evidence that when monopolies end, prices fall, dramatically, more than 95 percent for small molecules in the United States, and access expands. Anything that delinks the incentives from the monopoly and high prices is going to expand access, in some cases very dramatically,” he said.

Regarding the definition of delinkage, Love clarified that there is “of course, not much of a direct link between R&D costs and prices, but that is not the point. The monopoly is the primary incentive to invest in R&D, and that incentive is very clearly and very strongly linked to higher prices.”

“As regards evidence, Japan was one of a handful of countries that is seeking to block transparency of R&D costs, so complaining about the lack of evidence is not a good look for Japan, as long as they oppose transparency of R&D costs.”

“The real issues for delinkage,” Love explained, “are (1) how would alternatives be designed, (2) what would they cost, (3) what would be the progressive transition from the status quo, (4) how would they be evaluated, for example, in a feasibility study?”

Love noted that KEI and others including economist Joseph Stiglitz and US Members of Congress are calling for a balanced delinkage regime – one that “includes expanded government funding and subsidies for research, and new market entry rewards to replace the monopoly as the incentive mechanism.” In such a balanced regime, “[d]ifferent governments could embrace different approaches on delinkage, just as they do on pricing and intellectual property policies today.”

“To move the delinkage debate forward,” he said, “there needs to be more transparency, an issue that the World Health Assembly has advanced and other UN bodies are debating, on the entire value chain for medical innovations, including R&D costs, prices, revenues, access and outcomes. There also needs to be clear specifications of the alternatives, including the transitions from the status quo.”

“What you see in these UN debates are efforts to block any questioning of monopolies, and even feasibility studies of alternatives. If Industry did not think alternatives would work, and work better for the public, they would not oppose the feasibility studies.”

Japan detailing concerns on 12 July regarding aspects of the adopted Human Right Council resolution on access to medicines and vaccines. Photo: UN Web TV

Japan Narrowly Interprets Intellectual Property Flexibilities, Disagrees Over HRC Intersessional Seminar

In addition to its concerns over delinkage and alternative frameworks to reward innovation, Japan also disagreed with paragraph PP24 in the preamble, which affirms the rights of states to flexibly apply intellectual property rules. These intellectual property “flexibilities,” enshrined in the WTO TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement and its amendments, allow states to override patents and legally manufacture affordable generic versions of patented drugs for the purposes of protecting public health.

Japan described the resolution paragraph affirming the use of these flexibilities by states as “misleading,” and that intellectual property flexibilities such as compulsory licensing of patented drugs “is possible only under certain conditions.”

Lastly, Japan disagreed on the final paragraph OP14 to hold a full-day HRC intersessional seminar “on good practices, key challenges and new developments relevant to access to medicines and vaccines,” because a similar discussion is already being led by the WHO; relevant technical organisations such as the WTO are not being included; and such a seminar has “program budget implications.”

Despite Japan’s complaint about the intersessional seminar, it will proceed as planned and as outlined in the resolution, according to sources.

Image Credits: Reuters/Denis Balibouse, UN Web TV.

In the wake of a new Ebola case in the border city of Goma, WHO and its UN partners are calling on donors to make major new funding commitments to halt the outbreak in the Democratic Republic of Congo (DRC) – while WHO will reconvene an expert Emergency Committee to consider if the outbreak should be considered a “public health emergency of international concern.”

WHO Director General Dr Tedros Adhanom Ghebreyesus made the twin announcements at a high-level meeting in Geneva today on the emergency response, hosted by the UN Office for the Coordination of Humanitarian Affairs (OCHA). The meeting followed confirmation of the first Ebola case in Goma, a major city along the Rwandan border, as well as the weekend murder of two Ebola responders in their homes in Beni, in North Kivu, where the outbreak has raged since last August.

Ring Vaccination in Goma – Photo: WHO/Tania Seburyamo

Dr Tedros’ call for donors to “step up to the bat” was echoed by the British Secretary of State for International Development Rory Stewart and the UN’s Under-Secretary-General for Humanitarian Affairs Mark Lowcock, among others.

The Geneva meeting also included DRC’s Minister of Health, as well as other top WHO and UN emergency response officials speaking live from DRC and Washington DC. The event further included Geneva’s UN representatives of the European Union, USA, Sweden and Norway, as well as the International Committee of the Red Cross, Wellcome Trust, and other civil society groups.

Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization, on 15 July addressed the first case of the Ebola virus in the city of Goma, Congo. (Reuters)

“We need a bigger, more comprehensive response,” Lowcock told a packed room of some 200 people, noting that the global community had spent some US$ 2 billion on the 2014-15 epidemic in West Africa, but only “a fraction of that” in the DRC.

Lowcock said that since January, major improvements in the emergency effort had better aligned the UN agencies with each other, as well as with the DRC government and NGOs on the ground. Local communities in the DRC’s North Kivu and Ituri regions, where the outbreak has festered against a background of chronic civil unrest, have also been engaged more constructively, he said.

“But, if we don’t get an increase in the funding level, treatment centres are going to close, there will be fewer teams to conduct vaccinations, fewer mobile teams available to identify contacts, isolate cases and get them to treatment,” Lowcock warned.

While the USA has so far been the largest national donor to the Ebola response, the United Kingdom took the lead in today’s meeting, pledging more money to a fourth phase of outbreak fund-raising that is getting underway. The Secretary of State for International Development said that the UK would commit some US$ 63 million to the next phase, and challenged “our dear friends from the other G7 [Group of 7 most industrialised] countries” to respond in kind.

“One of the sad truths of the situation is that we are going to need considerably more investment if we are going to get [Ebola transmission] down to zero in eastern DRC,” Stewart said. Reflecting on a recent visit to an Ebola treatment centre in Butembo, at the epicentre of the outbreak, which had been burned down earlier in the year, Stewart praised the work of WHO, civil society, government and other UN partners to rebuild and “address everything from disease prevention to child care in a very difficult environment.”

And at the same time, operations remain “literally on a knife edge,” he added. “You will see that although there is really good medical procedure, there are really worrisome security procedures, with only a few sandbags behind which doctors and nurses can hide if they are attacked. There is still an enormous amount of work to be done.”

Goma Case Highlights Risk of DRC Outbreak Spreading to Other Countries

The Ebola case confirmed in Goma highlights the need to further scale up preparedness in neighboring countries that share a border with the DRC, Lowcock and others underlined. The case involved a pastor who had traveled by bus from the city of Butembo in North Kivu to Goma, a border city of 1 million people that sees heavy foot traffic every day between the DRC and neighboring Rwanda.

While speakers praised Uganda’s response after 3 Ebola cases were identified there several weeks ago, involving people who had crossed over from the DRC along a frontier marked by dense jungle areas, the situation in neighboring Burundi and South Sudan, which also share a border with the DRC, is regarded as far more fragile.

“We also need to scale up the response to deal with the high risk of the virus spreading further,” said Lowcock, adding: “The cheapest strategy is to invest fully and stop the current outbreak, rather than have it linger, and spread further.”

WHO’s Dr Tedros said that since yesterday’s case was identified in Goma, people who had been in contact with the pastor had already been vaccinated with the experimental vaccine that has shown a high degree of efficacy, and other containment measures were also being taken.

However, he stressed that the simultaneous murders of the two Beni health workers underlined the fact that “we are dealing with one of the world’s most dangerous viruses in one of the most dangerous areas of the world. Every attack sets us back, makes it more difficult to trace contacts, vaccinate and perform safe burials. And Ebola gets a free ride.” There have been 198 attacks on responders over the past year, with seven killed, including the Beni victims, he said in remarks that were also published online.

While WHO, UN and DRC government speakers displayed a united front in describing the improved quality of the emergency response, some doubts over vaccine strategy were expressed by Wellcome Trust at the meeting. Dr Josie Golding, Epidemics Lead at Wellcome, questioned if supplies of the current vaccine, approved for “compassionate use” while still undergoing clinical trial development, were indeed sufficient to sustain the massive “ring vaccination strategy” of Ebola case contacts that has dramatically reduced virus transmission. She said that use of a second vaccine in-the-waiting should be reconsidered.

“We are very concerned that supplies of the Merck vaccine currently being used will run out before this epidemic ends, which would have devastating consequences. There is an urgent need to deploy a second vaccine, which has been developed by Johnson & Johnson, complementary to the Merck vaccine and as a primary prevention to protect all who may be at risk,” said Golding to the meeting heads, in a statement also published online.

“We regret the recent announcement against the use of the J&J vaccine and ask for this to be reconsidered. The lives of healthcare workers and the people in North Kivu, across DRC and the region depend on it,” she added, saying: “There is a grave risk of a major increase in numbers, or spread to new locations – as we’ve heard today in Goma. There is also always the potential another Ebola outbreak will begin elsewhere.”

Golding also echoed remarks made by the WHO UN leadership that overall the DRC Ebola response remains, “overstretched and underfunded, with only a small number of countries providing funding. Funding needs to reach the communities affected. A step-up in the national and international response is critical. We need support at the highest political levels, including at the UN and G20. Countries should not wait for Ebola to spread across borders or appear on their doorstep before acting.”

Building Stronger Health Systems Key to Sustained Ebola Control

To be successful over the long term, health and humanitarian efforts need to dispel community mistrust that create fertile ground for violence against Ebola responders – and that means building stronger health systems that tackle other long-standing disease control issues in the DRC, stressed WHO’s Dr Tedros as well as the DRC Health Minister, Oly Ilunga.

“The Ebola epidemic is not a humanitarian crisis, it is a public health crisis,” said DRC’s Ilunga. “Strengthening the health system allows us to maintain the sustainability of the response. It is time to think about the post-Ebola period and about development plans which are properly tailored, ambitious, and the only response to the vital problems faced by the population.”

Since the outbreak began last August, some 2500 people have become infected by the Ebola virus and over 1665 have died, according to the WHO’s Director General, in remarks also published online. However that pales in comparison to malaria, the leading cause of death in the DRC – which kills more than 50,000 people every year in the DRC – or even the current outbreak of measles, which has killed almost 2,000 children since January, said Dr Tedros.

“Frankly, I am embarrassed to talk only about Ebola,” Dr Tedros told the gathering. “Together, we will end this outbreak. But unless we address its root causes – the weak health system, the insecurity and the political instability – there will be another outbreak.”

“This is the moment to practice what we preach. WHO is committed not just to ending this outbreak, but to strengthening DRC’s health system so that it never comes back. That’s also what the community in North Kivu is asking. To build trust, we must demonstrate that we are not simply parachuting in to deal with Ebola and then leaving once it’s finished.”

Find out more about the Ebola outbreak here.

Image Credits: WHO/Tania Seburyamo.

[WHO/UNICEF News Release]

New York/Geneva – 20 million children worldwide – more than 1 in 10 – missed out on lifesaving vaccines such as measles, diphtheria and tetanus in 2018, according to new data from WHO and UNICEF.

Globally, since 2010, vaccination coverage with three doses of diphtheria, tetanus and pertussis (DTP3) and one dose of the measles vaccine has stalled at around 86 percent. While high, this is not sufficient. 95 percent coverage is needed – globally, across countries, and communities – to protect against outbreaks of vaccine-preventable diseases.

“Vaccines are one of our most important tools for preventing outbreaks and keeping the world safe,” said Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization. “While most children today are being vaccinated, far too many are left behind. Unacceptably, it’s often those who are most at risk– the poorest, the most marginalized, those touched by conflict or forced from their homes – who are persistently missed.”

Child receiving measles vaccination in Guatemala. Photo: WHO

Most unvaccinated children live in the poorest countries, and are disproportionately in fragile or conflict-affected states. Almost half are in just 16 countries – Afghanistan, the Central African Republic, Chad, Democratic Republic of the Congo (DRC), Ethiopia, Haiti, Iraq, Mali, Niger, Nigeria, Pakistan, Somalia, South Sudan, Sudan, Syria and Yemen.

If these children do get sick, they are at risk of the severest health consequences, and least likely to access lifesaving treatment and care.

Measles outbreaks reveal entrenched gaps in coverage, often over many years

Stark disparities in vaccine access persist across and within countries of all income levels. This has resulted in devastating measles outbreaks in many parts of the world – including countries that have high overall vaccination rates.

In 2018, almost 350,000 measles cases were reported globally, more than doubling from 2017.
“Measles is a real time indicator of where we have more work to do to fight preventable diseases,” said Henrietta Fore, UNICEF’s Executive Director. “Because measles is so contagious, an outbreak points to communities that are missing out on vaccines due to access, costs or, in some places, complacency. We have to exhaust every effort to immunize every child.”

Ukraine leads a varied list of countries with the highest reported incidence rate of measles in 2018. While the country has now managed to vaccinate over 90 percent of its infants, coverage had been low for several years, leaving a large number of older children and adults at risk.

Several other countries with high incidence and high coverage have significant groups of people who have missed the measles vaccine in the past. This shows how low coverage over time or discrete communities of unvaccinated people can spark deadly outbreaks.

Human papillomavirus (HPV) vaccine coverage data available for the first time

For the first time, there is also data on the coverage of human papillomavirus (HPV) vaccine, which protects girls against cervical cancer later in life. As of 2018, 90 countries – home to 1 in 3 girls worldwide – had introduced the HPV vaccine into their national programmes. Just 13 of these are lower-income countries. This leaves those most at risk of the devastating impacts of cervical cancer still least likely to have access to the vaccine.

Together with partners like Gavi, the Vaccine Alliance and the Measles & Rubella Initiative, WHO and UNICEF are supporting countries to strengthen their immunization systems and outbreak response, including by vaccinating all children with routine immunization, conducting emergency campaigns, and training and equipping health workers as an essential part of quality primary healthcare.

About the data

Since 2000, WHO and UNICEF jointly produce national immunization coverage estimates for Member States on an annual basis. In addition to producing the immunization coverage estimates for 2018, the WHO and UNICEF estimation process revises the entire historical series of immunization data with the latest available information. The 2018 revision covers 39 years of coverage estimates, from 1980 to 2018. DTP3 coverage is used as an indicator to assess the proportion of children vaccinated and is calculated for children under one year of age. The estimated number of vaccinated children are calculated using population data provided by the 2019 World Population Prospects (WPP) from the UN.

Image Credits: WHO.

[WHO/Europe Press Release]

Brussels, Belgium, 15 July 2019

Two new studies from WHO/Europe show that a high proportion of baby foods are incorrectly marketed as suitable for infants under the age of 6 months, and that many of those foods contain inappropriately high levels of sugar.

WHO’s long-standing recommendation states that children should be breastfed, exclusively, for the first 6 months. Its 2016 global Guidance on Ending the Inappropriate Promotion of Foods for Infants and Young Children explicitly states that commercial complementary foods should not be advertised for infants under 6 months of age.

“Good nutrition in infancy and early childhood remains key to ensuring optimal child growth and development, and to better health outcomes later in life – including the prevention of overweight, obesity and diet-related noncommunicable diseases (NCDs) – thereby making United Nations Sustainable Development Goal 3 to ensure healthy lives and promote well-being for all at all ages much more achievable,” says Dr Zsuzsanna Jakab, WHO Regional Director for Europe.

Nutritional quality of products

WHO developed a draft Nutrient Profile Model (NPM) for children aged 6–36 months to guide decisions about which foods are inappropriate for promotion for this age group. This was put forward to Member States and stakeholders for consideration and further discussion.

WHO/Europe also developed a methodology for identifying commercial baby foods available in retail settings, and for collecting nutritional content data on labels as well as other information from packaging, labelling and promotion (including claims).

This methodology was used to collect data on 7955 food or drink products marketed for infants and young children from 516 stores in 4 cites in the WHO European Region (Vienna, Austria; Sofia, Bulgaria; Budapest, Hungary; and Haifa, Israel) between November 2017 and January 2018.

In all 4 cities, a substantial proportion of the products – ranging from 28% to 60% – were marketed as being suitable for infants under the age of 6 months.

Although this is permitted under European Union law, it does not pay tribute to the WHO International Code of Marketing of Breastmilk Substitutes or the WHO Guidance. Both explicitly state that commercial complementary foods should not be marketed as suitable for infants under 6 months of age.

“Foods for infants and young children are expected to comply with various established nutrition and compositional recommendations. Nonetheless, there are concerns that many products may still be too high in sugars,” says Dr João Breda, Head of the WHO European Office for the Prevention and Control of Noncommunicable Diseases.

In 3 of the cities, half or more of the products provided over 30% of the calories from total sugars. Around a third of the products listed sugar, concentrated fruit juice or other sweetening agents as an ingredient. These added flavours and sugars could affect the development of children’s taste preferences by increasing their liking for sweeter foods.

Although foods such as fruits and vegetables that naturally contain sugars are appropriate for infants and young children, the very high level of free sugars in puréed commercial products is also cause for concern.

The draft NPM for infants and young children was developed by following recommended WHO steps, and was informed by data from several sources, including a literature review. It refers to existing European Commission directives and Codex Alimentarius standards, and reflects the approach used for the WHO/Europe NPM for children over 36 months.

The draft NPM was validated against label information from 1328 products on the market in 3 countries in 2016–2017, and pilot-tested in 7 additional countries in 2018 with a further 1314 products.

Commercial foods for infants and young children in the WHO European Region (2019)
Ending inappropriate promotion of commercially available complementary foods for infants and young children between 6 and 36 months in Europe (2019)
Sustainable Development Goal 3
Guidance on Ending the Inappropriate Promotion of Foods for Infants and Young Children (2016)
International Code of Marketing of Breastmilk Substitutes (1981)

Image Credits: WHO/Europe.

New maximum residue limits for more than 30 different types of pesticides in animal feed and foodstuffs, updated standards for food additives, and a new standard for high value vegetable oils, and well as for hybrid varieties of palm oil, were approved today at the 42nd meeting of the Codex Alimentarius Commission (CAC42), the UN member state body that sets international food safety standards guiding the world food trade as well as significant national legislation.

Closing a week-long session in Geneva, delegates from some 100 countries also agreed to a code of practice for reducing chemical contaminants common to palm oil production, as well as to launch new work on allergen labeling, e-commerce, aflatoxins in cereals and cereal-based products, and bio-pesticides, among other topics.

42nd meeting of the Codex Alimentarius Commission (CAC42), Geneva

The Commission also agreed to develop guidelines for the control of Shiga toxin-producing Escherichia coli (STEC) in beef meat, leafy greens, raw milk and cheese produced from raw milk, and sprouts (sprouted seeds). While most E. coli bacteria living in human and animal intestines are harmless, those producing shiga toxin (STEC) are an important cause of foodborne disease, and infections. WHO estimates that Shiga toxin E. Coli caused about 1 million cases of illness In 2010, ranging from mild diarrhoea to kidney failure.

The Commission, however, delayed the final adoption of a standard for maximum levels of cadmium in certain cocoa products of .3 mg/kilogram – due to controversies between member states about whether the proposed standard was high enough – or higher than required – to protect public health. Some delegates noted that the standard for cadmium levels is even higher in grains and rice (.4 mg/kg), which are far more heavily consumed. Cadmium, a heavy metal, is naturally-occurring in some soils, and its presence in areas of cocoa cultivation has posed a barrier to international sales for some countries, particularly in Africa.

In 2015, WHO estimated that over 420,000 people every year die from foodborne diseases, and almost 30 percent of those deaths are in children under the age of 5. The report, which considered diseases and deaths caused by some 31 agents – bacteria, viruses, parasites, toxins and chemicals – found that almost 10 percent of the world’s population fall ill from some form of foodborne contamination every year. The risks are most severe in low- and middle-income countries, where unsafe water and sanitation, and poor hygiene conditions in food production, storage and preparation, as well as weak regulatory systems, all contribute to food safety risks, said WHO.

The Codex Alimentarius (Food Code), established in 1963, is jointly administered by WHO and the Food and Agriculture Organization (FAO). While the Codex standards are voluntary, in principle, the World Trade Organization (WTO) agreement on Sanitary and Phytosanitary Measures (SPS) refers to the Codex as a benchmark reference for international food trade. So along with country delegations, industry and some civil society representatives regularly attend the annual Codex Commission meetings, insofar as Commission decisions will have far-reaching impacts of what foods can be internationally traded, how and where.

Balancing Health and Trade 

Short of standards, the Codex also is active in creating codes of practice, which can provide guidance for reducing key health risks. One example is new work to get underway in the area of aflatoxins in cereals, particularly children’s cereal preparations. There is emerging evidence that such aflatoxins, poisonous substances produced by some forms of mold, can play a role in childhood malnutrition and stunting, said Sarah Cahill, a senior food standards officer with the joint FAO/WHO Food Standards Programme that supports the work of the Commission. “We know it is a carcinogen and that is why we have been regulating it for many years. But we now have new data emerging, and we are seeing that it is contributing to stunting in children. So the consequences of having these contaminants in foods are really far reaching.”

The new work would build on existing codes and standards to provide guidance on good harvest and storage practices – a stage where contamination can become very widespread. It will focus on maize, rice, semolina, sorghum, and cereal-based foods for infants and young children, Cahill said.

Placing pheromone lures in a citrus orchard near Agadir, Morocco, as a bio-pesticide strategy to prevent and control medfly and Ceratitis Capitatata pests.

Another emerging area is in the regulation of “bio-pesticides,” biological alternatives to traditional chemical pesticides, which are increasingly being used in integrated pest management and organic agriculture.

Bio-pesticides may include so-called “beneficial” bacteria, insects, fungi or other biological tools that attack a plant’s pests. Proponents say that these can offer healthier alternatives to conventional chemical compounds, to which farm-workers may be heavily exposed and which leave residues on foods. But little formal assessment has in fact been conduced into the health impacts of bio-pesticides, and regulation is inconsistent between countries. “We don’t have a harmonised regulatory approach when it comes to food safety. This work is trying to develop a framework by which we could approve the use of these in a harmonised way, and understand if there are any implications for human health,” said Cahill.

While much of the Commission’s work is aimed at assessing and limiting risks to health, in other areas, setting standards can help spur trade of both high value and healthier foods. The new standard adopted by the Codex Commission for quality and food safety of almond, flaxseed, hazelnut, pistachio and walnut oils may do just that.

The oils are some of the oldest types of edible oil consumed by humankind and have been traditionally produced and consumed in Middle Eastern countries, Africa, Europe and South America, notes the CODEX news portal, in a summary of today’s final decisions. “The oils are sought as healthy options due to their essential fatty acid and micronutrient content. This standard sets quality and as well as food safety criteria for these edible oils to facilitate international trade.”

Said Cahill, “These are high value, but low volume oils,” in terms of total amounts traded. As a result of the price they can command, such products are also vulnerable to fraudulent marketing claims. “The idea was to set a commodity standard that would identify the key characteristics of these oils in trade, so that if you are buying oil, you know it meets these standards.”

Such a standard, she noted, is “very important for developing countries in the Middle East, which produce a lot of these oils. It ensures that they can direct their industry in terms of the quality standards that they need to meet and facilitate their access to other markets.”

Image Credits: FAO/Bob Scott, FAO.

If the fight against cancer has yielded substantial results on survival rates in high-income countries, low- and middle-income countries are lagging behind, while cancer is gaining ground, with a particularly worrying trend in children.

A first-ever International Health Congress on Integrative Oncology, held 28-30 June in Geneva, presented traditional and alternative medicines as precious allies for conventional medicine, including for promoting good health and cancer prevention.

The Congress was organised by Swiss Alternative Medicine, in partnership with Globethics.net and the World Health Innovation Summit. The event brought together academics, pharmacists, laboratories, doctors, and international organisations to promote a holistic integrative cancer patient care that also engages communities.

Meditation after chemotherapy

What Is Integrative Oncology?

Integrative oncology refers to the use of traditional and complementary medicines (T&CM) for cancer prevention and treatment. These are generally understood to include a wide range of methods, such as acupuncture, ayurvedic medicine, chiropractic, herbal medicine, homeopathy, naturopathy, osteopathy, traditional Chinese medicine, and Unani medicine.

Iranian-born pharmacist Shima Sazegari, founder of Swiss Alternative Medicine, told Health Policy Watch that the event gathered professionals from diverse disciplines to integrate knowledge, bring about synergies, and spark collaborations. The Congress also aims to build bridges between patients and T&CM medicine practitioners, as well as between practitioners and researchers.

Traditional therapies can support cancer prevention by promoting healthy approaches to diet, physical activity and stress reduction, speakers and participants said. For people with cancer, T&CM can be complementary to allopathic (conventional) cancer treatments, by reducing pain, improving quality of life and certain forms of care, as well as helping patients to be aware of treatment choices. This is important in light of growing cancer incidence and soaring treatment costs, affecting low and middle-income countries in particular.

Cancer is Gaining Ground, Low- and Middle-Income Countries Most at Risk

Approximately 70 percent of deaths from cancer occur in low- and middle-income countries, WHO’s André Ilbawi told conference participants. In 2018, some 9.6 million deaths were attributable to cancer – now the second leading cause of death globally – which is far more than HIV/AIDs (1.1 million) and malaria (1.4 million) combined.

Half of all cancers could be prevented, Ilbawi said, adding: “Smoking still kills too much everywhere” – a risk that WHO holds accountable for some 22 percent of cancer deaths. Lack of adequate treatment for infectious diseases that can cause cancer, such as hepatitis C and human papillomavirus, is another significant factor, he said, while other major cancer risks include obesity, and exposure to indoor and outdoor air pollution.

In high-income countries, the chances of surviving cancer are much higher than the global average. Those countries offer adequate and early diagnosis, which leads to effective treatments that see diminishing rates of relapse, pushing the chance of survival at 5 years to 70-80 percent.

Low- and middle-income countries generally suffer from weak national cancer control planning, including late or incorrect diagnosis, inaccessible and/or unaffordable care, and low-quality treatment, Ilbawi added. On cancer management in LMICs, “it is the wild west out there,” he said.

Only 7 percent of low- and middle-income countries have cancer monitoring mechanisms (e.g. cancer registries) and only 10 percent have a dedicated cancer budget. While high-income countries’ total health expenditure averages US$ 4,800 per capita per year, with about 5-10 percent spent on cancer medicines, the total average health expenditure of middle-income countries is only US$ 90 dollars per capita per year, with a substantial portion of this going to cancer medicines. As such, most of cancer treatment in middle-income countries must be financed through private means.

While some low- and middle-income countries have breast cancer screening programmes, there is often no affordable access to treatment for women who are diagnosed with a malignancy, leading to financial catastrophe for patients, Ilbawi said.

Dr André Ilbawi of the WHO at the International Health Congress on Integrative Oncology, held 28-30 June in Geneva.

Sazegari also told Health Policy Watch after the event that in low- and middle-income countries, the lack of robust health systems and infrastructures often leads to late diagnosis. Clinics are typically hard to reach by the population, with people who have to walk long distances bearing the cost of travel. Alternative medicine provides local medical care, fostering early detection of cancer, and can also relieve some side effects associated with allopathic cancer medicine, commonly resulting from chemotherapy, radiotherapy, and immunotherapy. She underlined the importance for patients to be able to understand and manage their illnesses.

Reducing Risks – Promoting Health Holistically

Against this difficult landscape, reducing exposure to risk factors such as tobacco use would significantly reduce cancer incidence, but so would a comprehensive health and wellbeing approach, according to speakers like Gareth Presch, founder of the World Health Innovation Summit (WHIS).

The current health system is designed around a pathogenic approach (process of disease), when it should really be focused on a salutogenic approach (factors of health), according to Presch.

He made the case for stronger community engagement in health promotion activities, and WHIS has launched a number of such initiatives: for pregnancy wellbeing; WHISatwork (Stress management within the workplace); WHISSeniors (Elderly care to improve quality of life); and WHISGreen (Energy, waste, water).

Presch also talked about the “alarming number” of child cancers occurring worldwide. Some 300,000 children and adolescents die each year of cancer around the world, he said (see WHO fact sheet). The WHISkids six-week, school-based programme helps children improve their physical and emotional wellbeing, and can be tailored to ages 4 to 11. WHISkids Switzerland was launched on 28 June, Presch told Health Policy Watch.

WHO implementing its Traditional Medicine Strategy

According to the World Health Organization’s 2019 Global Report on Traditional and Complementary Medicine, interest in such treatments is undergoing a revival in the face of soaring health costs, and tight health budgets. The report notes that those medicines are “an important and often underestimated health resource with many applications, especially in the prevention and management of lifestyle-related chronic diseases, and in meeting the health needs of ageing populations.”

The WHO is also halfway through the implementation of its Traditional Medicine Strategy 2014-2023, aiming to develop norms, standards, and a technical document “based on reliable information” to help countries provide safe, qualified and effective traditional and complementary medicines services, and integrate them into health systems for achieving universal health coverage.

Growing Interest in Countries

Some 170 WHO members are using traditional and complementary medicine (T&CM), according to the WHO report on T&CM. Those countries have developed policies, laws, regulations, programmes and offices for T&CM. For example, 34 countries across the six WHO regions included traditional or herbal medicines in their national essential medicines lists. Some of them, such as Ghana, have a separate list of essential herbal medicines.

As of 2018 some 50 percent of WHO members had a national policy on T&CM, most of them in the African region (40), followed by the Western Pacific region (17), the Southeast Asia region (11), the European region (11), and the Eastern Mediterranean region (9).

In a survey conducted by WHO prior to the report, Benin, Brazil, Chile, China, Cuba, South Korea, India, Mali, Oman, Peru, Thailand, and the United States said they had government or public research funding for T&CM.

Benin, Bolivia, Brazil, Cuba, South Korea, Ghana, Guatemala, Haiti, India, Mali, Mexico, Nicaragua and Thailand said they had an existing national plan for integrating T&CM into their national health service delivery.

The top five difficulties faced by countries in implementing T&CM, as listed by the countries, are: the lack of research data; the lack of financial support for research on T&CM; the lack of mechanisms to monitor safety of T&MC practice; the lack of education and training for T&CM providers; and the lack of expertise within national health authorities and control agencies.

Evidence of efficacy from scientific trials is also a common challenge for health systems. In France, for instance, a commission of the French National Health Authority (Haute Autorité de Santé) recently recommended that public reimbursement of costs of homeopathic medicine be halted, after a scientific assessment found there was insufficient evidence of efficacy. The assessment was requested by French Health Minister Agnès Buzin, who made the decision this week to follow and implement the National Health Authority’s recommendations.

Alternative medicine does not yet have a universal legal framework, unlike allopathic medicine. Sazegari told Health Policy Watch after the event that once an alternative medicine discipline has been academically and legally recognised, it should be integrated into the health system. That would allow alternative medicine to grow and would represent and economic gain for countries, and globally. Switzerland recognises four disciplines which are reimbursed by basic health coverage schemes (mostly private in Switzerland). The four disciplines are: anthroposophic medicine, homeopathy, traditional Chinese medicine, and phytotherapy.

Ethics Key to Sustainable Health

Advocates of alternative therapies contend that while patients should be well informed, they should also be given choices for treatment, and advice about the different complementary options at their disposal.

Swiss Alternative Medicine founder and pharmacist Shima Sazerari advocated for a multidisciplinary approach and “proven techniques” in natural medicines to restore health.

“Healthily living is grounded on living ethically,” according to Obiora Francis Ike, Globethics.net executive director and Nigerian Catholic priest.

He attributed a number of shortcomings in health care to “fraud and redundancy” and “corruption around governments,” leading to funds disappearing “in the pockets of people doing the budget,” as well as lack of morals from pharmaceutical companies, lobbies, and insurance companies.

If governments understood that sustainable health is founded on good character and ethics, the health issues would be halved, he insisted, while at the moment, “people die at the hands of doctors who bought their degree.”

A second Congress is expected to take place in April 2020, with a focus on mental health.

Image Credits: Phillip Jeffrey, Catherine Saez.

A new plan to improve collaboration across 12 United Nations and multilateral agencies to support UN member states to reach 2030 targets on health includes not only the ambitious aim of reducing bureaucracy and increasing efficiency, but of working better across sectors to address environmental, commercial and social factors that harm health.

These factors, which lead to serious health risks such as air pollution exposure and unhealthy foods, as well as health inequalities such as gender discrimination, pose a formidable barrier to reaching many targets of the 2030 Sustainable Development Goals (SDGs). The new plan, rooted in national strategies and leadership, aims to address these complex challenges and accelerate progress on SDGs.

The Global Action Plan for Healthy Lives and Well-being for All, or GAP, “is the key vehicle for greater collaboration, and a good example of how countries and agencies can work together to accelerate progress,” a representative of Norway said yesterday at a side event of the UN High Level Political Forum on Sustainable Development.

“Not surprisingly, some of the biggest gaps are in the targets that need action across sectors,” she said, “and that is why we are here together.”

Led by the World Health Organization, and spearheaded by the governments of Ghana, Germany and Norway, GAP aims to accelerate progress to reach SDGs by 2030, in what has been dubbed the “decade of delivery,” to make up for the shortfall on progress since the SDGs were launched in 2015.

The 12 UN and multilateral agencies GAP will unite include Gavi, the Vaccine Alliance; the Global Financing Facility; the Global Fund to Fight AIDS, TB and Malaria; UNAIDS; UNDP; UNFPA; UNICEF; Unitaid; UN Women; World Bank Group; World Food Programme; and WHO.

The plan, which is flexibly structured to respond to country demand and to build on existing interagency collaboration, identifies seven cross-cutting areas where collective action has a high potential to accelerate country progress on the health-related SDGs.

These “accelerators” include: 1. Sustainable financing; 2. Primary health care; 3. Community and civil society engagement; 4. Determinants of health; 5. Research, development, innovation and access; 6. Data and digital health; 7. Innovative programming in fragile and vulnerable states and for disease outbreak responses.

Developing this plan involved an extensive consultation process with member states, including discussions at the World Health Assembly in May along with country dialogues, as well as a public consultation process during which other stakeholders were invited to provide feedback on the draft plan.

The Global Action Plan will be launched this September in New York as part of the UN General Assembly’s High-Level Week, during which the UN High-Level Meeting on Universal Health Coverage will also take place.

Cross-Sectoral Action to Address Determinants of Health

“Health is a broader concept than healthcare,” one of the coordinators of the GAP process said at the side event. It includes environmental, commercial and social “determinants,” which are those factors that, in turn, can lead to specific health risks and disease threats.

A number of the panelists also cited that 7 million people die each year from air pollution, which one noted is equivalent to the entire population of Switzerland dying each year.

Mandeep Dhaliwal, Director of UNDP’s HIV, Health and Development Group highlighted at the event that throughout the GAP consultation process, there has been a lot of feedback on accelerator 4, “Determinants of health.”

One of the major complications of this accelerator in particular are the competing policies which play out at the national level and limit progress on health-related SDGs.

Dhaliwal asserted that GAP will help member states to deal with these “unhealthy contradictions,” which include: committing to health and wellbeing while providing fossil fuel subsidies; promoting gender equality while criminalizing LGBT communities; committing to health and wellbeing while not creating awareness of healthy diets and prevention of noncommunicable diseases (NCDs).

Taking a multi-sectoral and multi-stakeholder approach has proved successful in the AIDS response, particularly in addressing the broad social determinants of infection and transmission, Simon Bland of UNAIDS noted at the event. But such collaboration doesn’t come easy, he said; it requires “the leadership, incentives, and demands that force determination.”

Dhaliwal noted that such determination has already been put in writing in a number of high level declarations including the Rio Declaration on Environment and Development, the recent political declarations on HIV/AIDS, tuberculosis, and NCDs, as well as in the draft declaration on universal health coverage, to be issued this September.

Effectively addressing these determinants will require multi-stakeholder and multi-sectoral responses, but also inclusion, which she clarified as meaning “women and men in all their diversity.”

Mandeep Dhaliwal, Director of UNDP’s HIV, Health and Development Group, at the side event.

Addressing determinants of health, such as gender equality, has the potential to advance multiple other SDGs, a representative from UN Women said, stressing that achieving gender equality requires strengthening comprehensive healthcare, which includes sexual and reproductive health and rights (SRHR). “By 2030 and beyond, we want to see more women and girls with greater control of their bodies.”

The representative of Women Deliver clarified that addressing determinants of health is not a new agenda, noting that “these issues have been longstanding and under-addressed because they are sticky.” She then strongly advocated for a gender lens for health to be included throughout the entire action plan, which she said should include gender budgeting and auditing, health data collection disaggregated by gender, and research and development (R&D) of health products to meet the needs of girls and women throughout the life course.

“In order to make progress, we need to address the intersectionality of all the SDGs – that is why we can only succeed if we work together,” Norway’s representative said.

GAP Designed to Improve Efficiency, Not to Develop New Policies

Concerns were raised by member states during the side event regarding the accountability of the Global Action Plan, and whether or not it has a role in developing new policies.

A representative of the United States clarified that it is important to recognise that GAP is not a member state-negotiated document, and that the plan is not the outcome of member state consensus. The representative noted that the US does not agree with particular aspects of the plan, which include references to sexual and reproductive health and rights (SRHR) and drug decriminalisation.

The US representative also called for more positive references to the private sector to be added to the plan, saying that the current draft focuses too heavily on the private sector’s health-harmful role. The representative emphasised that the private sector will play a pivotal role in achieving the SDGs.

A representative of Russia echoed the US concern that the plan does not represent member state consensus, but did not clarify the aspects of the plan with which Russia disagrees. The representative also raised concern regarding the accountability of GAP, in particular to the governing boards of its agencies and to member states, as well as whether or not GAP will play a role in determining policies.

A WHO representative involved in process of developing the Global Action Plan responded to these concerns. He clarified that there is broad agreement that this is not a policy-creating mechanism, but that it is designed to help countries implement already agreed-on policies at the country level.

“There’s a wide recognition that each of the agencies have their strategies which have been adopted by their respective governing boards… and the Global Action Plan is not meant to supersede, but to spell out how collaboration in implementing these strategies will happen, to really enhance the impact of working jointly,” which he said “is very much in line with the efforts of UN reform, to provide coherent support for member states in driving the SDG agenda.”

The WHO representative also took note of the US request for more positive references to the private sector in the GAP document.

A representative from Morocco, one of the countries actively embracing the Global Action Plan, underlined that the plan will help to prevent “doubling work.” There are many UN agencies represented in Rabat, she said, and the government had to work with each agency bilaterally; but now, “this platform will prevent extra work and achieve efficiency.”

The political declaration on UHC is now being negotiated, she said, stressing that what comes after the declaration is the most important step. “Implementation is always hard,” she said, and “GAP will help with implementation at the national level.”

Image Credits: UN Web TV.

Kawaldip Sehmi, CEO of the International Alliance of Patients’ Organizations (IAPO), answers 5 questions on why the Essential Medicines List is important for patients. IAPO is a United Kingdom-based alliance of 276 member organisations from 71 countries representing 50 disease areas, and working in collaboration with civil society, UN agencies and the healthcare industry. Sehmi holds a Masters in Public Health from the London School of Hygiene and Tropical Medicine, and has previously served as Director of the Global Health Inequalities Programme and as Chairman of the European Network of Quitlines. This article is republished from “Global Health Matters,” a blog of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

IFPMA: What does the addition of new medicines on the 2019 Essential Medicines List (EML) update mean for patients?

Sehmi: The inclusion of any medicine, including innovative and specialty medicines, on the World Health Organization’s Essential Medicines List is good news: it should increase patient access to new treatment options, including to the latest innovative generics and biosimilar medicines. But this will only happen if the necessary steps are taken in each and every country to support delivery and uptake of these medicines. Getting a medicine on the list is an important but relatively tiny first step.

Countries need to strengthen their health systems and work with stakeholders, including patients, public and private funders of health systems, to ensure that sustained funding is available and that the health system infrastructure is robust and resilient if they are to safeguard the effective delivery of essential medicines to the patients and the community.

Even so, it is positive to see that more and more medicines are being included with each EML update, thus keeping abreast of medical innovation while recognizing that there are still unmet medical needs and increasing societal expectations, with more treatments added in areas such as Hepatitis C and Cancer.

IFPMA: How is the EML useful for patient representatives in your advocacy efforts?

Sehmi: There is a sea change in healthcare policy and decision-making as patients are increasingly being asked to support healthcare service development through experience-based co-design and co-creation partnerships. Expert-patients’ engagement on national essential medicines lists is slow to catch up with this approach.

It is important to have the patient perspectives on essential medicines lists. EML is just the tip of a huge healthcare infrastructure, workforce and resources iceberg. By just concentrating on the EML is like applying a sticky plaster to a compound fracture within the healthcare body.

However, the List is an important guide to what medicines should be available anywhere at any time – these should be seen as the bare minimum that any health system should be able to deliver. It should not become a box-ticking exercise, a bare minimum standard, the delivery of which absolves the State’s obligation to do much better. But, at the end of the day, the patient-physician partnership must be able to decide what is the most appropriate treatment for patients. For patient organizations, one idea is that the EML can be used along with individual country medicines lists to advocate for ‘missing’ treatments.

They can also benchmark their own country list with those used by neighboring countries, or countries with similar medical needs/health systems. We will be informing, educating and developing capacity within patient organizations to work towards this partnership-based approach now that the new list has been released. We need to do more work post-launch of EMLs.

IFPMA: What do you mean by doing more on “post-launch” of EML?

Sehmi: This year we are going to be marking the first World Patient Safety Day [17 September]. Medication safety is a central pillar in the WHO Director General’s global action on patient safety. When new medicines are included on the list, it is crucial that clear guidance be given to patients and health professionals on how they should be properly utilized (i.e., treatment guidelines, safe medication practices) and any necessary supporting systems, such as disease surveillance systems/registries, pharmacovigilance systems, diagnosis, patient monitoring, adherence, and management of comorbidities. Proper utilization of medicines is an issue very close to my heart and at the core of IAPO’s work. Unsafe medication practices and medication errors have become a global public health problem. The number of patients either injured, disabled or killed while accessing unsafe healthcare has become a huge global concern.

As one patient advocate said at the 72nd World Health Assembly: “In my country, people are afraid to go to hospitals as they think they will come out in a coffin or with a severe disability. Hospitals and healthcare services stand the risk of being empty if the community does not trust them.” I’m therefore delighted that the WHO Member States from all 194 countries endorsed the establishment of a World Patient Safety Day to be marked annually on 17 September and officially included on the WHO list of health dates.

IFPMA: WHO’s Report on Pricing of cancer medicines and its impacts released last year makes considerations about different pricing approaches to cancer medicines listed on the EML. What is IAPO’s view on this topic?

Sehmi: Ultimately, every patient must be able to access and afford the healthcare services they need – this is also one of the five principles outlined in IAPO’s Declaration on Patient Centred Healthcare. Our vision is that the needs of patients are placed at the center of all healthcare decision-making and, equally importantly, that patients have a direct role as partners in all matters from policy to individual choices. I think we all agree that there is no point in innovation if people cannot benefit from it.

But, equally, we should not lose sight of the fact that many medicines such as antibiotics, malaria treatments and statins, albeit relatively cheap, still do not reach patients who need them. For example, all the basic hypertension medicines are generic, inexpensive, safe and effective; they have been used in high income countries for more than half a century, but they are still not being used routinely in low income countries. In the case of oncology medicines, because of the complexities associated with cancer treatment, issues with supply chain integrity, insufficient health workers, low capacity for diagnosis and overall infrastructure limitations have to be part of the debate on access, along with pricing.

IFPMA: Looking ahead, what would you like to see in the next EML update?

Sehmi: A multi-stakeholder approach to the next EML update is key, starting with greater patient engagement and participation. Engaging patients in health policy decision-making is essential in order to ensure that policies adequately reflect patient and caregiver needs, preferences and capabilities. It is also important that the processes around the EML are open, inclusive and impartial. Deliberations of the advisory working groups established to advise the Expert Committee would be significantly improved with a wider membership, including patient organizations, National Regulatory Agencies, and NSAs, as official interlocutors with the WHO. Especially for innovative medicines, involving regulators in the discussion is key, as regulators are the ones reviewing the most detailed data regarding safety and efficacy of these medicines.

Image Credits: UNICEF/Noorani, Kawaldip Sehmi.

WHO has added ten new cancer drugs, including some pricey ones, to its 2019 Essential Medicines List, which provides global guidance to countries and health systems about drugs deemed most essential to patients and public health systems.

The addition of major new cancer treatments in five categories, melanoma (skin), lung, blood and prostate cancers, reflects both the rapid pace of cancer drug research – as well as the growing need to respond to the worldwide increase in cancers and other non-communicable diseases.

In another long-awaited development, WHO also promoted the drug mifepristone-misoprostol for induced abortions from a complementary list to a more select core list, which together comprise over 450 essential medicines. However, it preserved a footnote saying that the drug should be used “where permitted under national law and where culturally acceptable,” which WHO’s Department of Reproductive Health and Research, backed by the United Nations Population Fund and numerous civil society groups, had requested be removed. However, WHO’s Director General Dr Tedros Adhanom Ghebreyesus ultimately decided to retain the longstanding nod to national and cultural norms, sources told Health Policy Watch.

In a press release, issued Tuesday, WHO said that improved survival rates were a key criteria for including the new cancer therapies as “essential medicines” – even if some of the treatments are costly.

“The inclusion in this list of some of the newest and most advanced cancer drugs is a strong statement that everyone deserves access to these life-saving medicines, not just those who can afford them,” said WHO’s Dr Tedros in the press release.

The new cancer therapies included two recently developed immunotherapies (nivolumab and pembrolizumab) “that have delivered up to 50% survival rates for advanced melanoma, a cancer that until recently was incurable,” the WHO release said. The therapies are produced by Bristol-Myers Squibb and Merck & Co.

Other new cancer drugs included Roche’s erliotinib treatment for lung cancer, which the report said demonstrated survival benefits similar to chemotherapy and improved quality of life. Jannsen Biotech’s abiraterone was included for treatment of patients with metastatic prostate cancer, following a request by the civil society organization Knowledge Ecology International (KEI). Other new treatments also were included for leukaemia and multiple myelomas.

The publication of the long-awaited update unleashed a wave of reaction from civil society, while sending a ripple through the pharma industry, as winners and losing drug candidates were examined and evaluated.

In South Africa, a coalition of nearly 45 patient advocacy groups said the WHO announcement offers new Health Minister Dr Zwelini Mkhize an “historic opportunity” to save lives by increasing access to one of the new drugs for multiple myeloma on the list, lenalidomide.

“Currently, the majority of cancer patients in South Africa who could benefit from lenalidomide cannot access it due to its prohibitively high cost – depriving many people of a chance at life,” said Salomé Meyer, from the Cancer Alliance in a blog posted online. In South Africa more than 400 new cases of multiple myeloma – a blood cancer of the plasma cells of bone marrow – are reported annually.

Other civil society advocates, however, said that WHO did not go far enough in embracing other cancer drugs that can improve survival rates for people with metastasised cancers.

KEI’s Director James Love told Health Policy Watch that two such breast cancer drugs, pertuzumab and trastuzumab–emtansine [TDM1], supported by KEI for inclusion into the list, didn’t make it, despite what he described as “robust evidence of efficacy.”

“What you now have is a list that has some effective and expensive drugs and not others, with a bias against metastasized cancers,” said Love of of the two breast cancer drugs; KEI had itself proposed inclusion of the trastuzumab-emtansine [TDM1] combination.

The WHO Executive Summary of the Essential Medicines List, on the other hand, said that the Committee had postponed inclusion of the these two breast cancer drugs pending further analysis, because the “large overall survival benefit” of pertuzumab found in one trial of women with metastasized cancers had not been seen in other trials, and for TDM1, alternative options are available on the list.

Dr Nicola Magrini, Secretary of the Essential Medicines List Expert Committee, noted that the new list is growing “rapidly and convincingly” with respect to cancer treatments – and health systems will face serious challenges just in responding to the new cancer drugs that have already been added to the list.

The WHO Expert Committee has also proposed a larger scientific and technical group meeting next year, together with countries and civil society, to discuss current challenges in providing cancer treatments and programs that meet the “expected EML [Essential Medicines List] standards, which are pretty high now,” he said.

New High-Priced Cancer Drugs

Indeed, efficacy is not the only issue involved in the debate over cancer drugs. Another key factor is pricing. As the Executive Summary notes, some of the cancer drugs chosen for inclusion are “high-priced cancer medicines.”

Love of KEI said that some of the rejected cancer drugs also would have introduced competition to drive down prices. He noted that the decision to exclude enzalutamide for treatment of prostate cancer ignores the pricing benefits that its inclusion would generate through competition with abiraterone, a drug that was accepted, but that carries a very high price.

Love said that exclusion of enzalutamide also could undermine efforts such as those by students at UCLA to convince the university to drop a patent suit in India against production of generic versions of the patented drug, marketed as Xtandi. Generic production would dramatically lower the price of enzalutamide, which currently costs around US$ 5,000 a month in India.

Love also noted that since enzalutamide is a monotherapy with smaller active ingredient (API) requirements than abiraterone, it would eventually become much cheaper to manufacture, making it a good option in terms of both efficacy and pricing in the long-term.

See below or here for details on the new cancer drugs added to the Essential Medicines List.

First All-Oral Drug for Sleeping Sickness

The latest Essential Medicines List also includes the first all-oral treatment for sleeping sickness, fexinidazole, an important milestone in the treatment of this neglected, and usually fatal, disease.

Registered by Sanofi and developed in clinical trials led by the Drug for Neglected Diseases initiative (DNDi), fexinidazole is used to treat the first and second stages of sleeping sickness, also known as Human African Trypanosomiasis, transmitted by the bite of a tsetse fly.

“65 million people, who live mainly in rural parts of East, West and Central Africa, are at risk of contracting sleeping sickness,” DNDi said in a statement.

Inclusion of the first all-oral drug in the Essential Medicines List “will spur governments in endemic countries to include fexinidazole in their treatment guidelines,” said Dr Nathalie Strub-Wourgaft, DNDi’s Director of Neglected Tropical Diseases, in the statement. “Inclusion of fexinidazole is also a further sign of WHO and Sanofi’s commitment to ensuring swift deployment of this paradigm-changing treatment.”

Insulin Analogues Not Included

During the WHO Expert Committee on the Selection and Use of Essential Medicines meeting in April of this year, debates were heated over how to address the rising cost of insulin, a life-saving essential medicine that has been available for nearly 100 years.

Some proposed for the inclusion of insulin analogues, an altered form of human insulin, to increase competition, but others strongly opposed this, noting that the high cost of insulin analogues – 8-11 times that of insulin – could actually drive insulin prices up.

The Committee ultimately decided not to include insulin analogues in the list, recognising “the need for a wider understanding of the complexities of access to insulin and the current insulin market,” and recommending that “WHO prioritize the coordination of a series of actions to address the issues of insulin access and affordability,” according to the Executive Summary.

“In the absence of other coordinated actions, the Committee considered that the inclusion of insulin analogues for adults on the EML [Essential Medicines List] would be inadequate to address the underlying issues of poor access and affordability of insulins,” it said.

The Committee’s decision was welcomed in a press release Wednesday by Health Action International (HAI), citing its recent study showing that analogue insulin can be as much as six times more expensive than human insulin, which is on the EML, and there is no independent evidence showing that the analogues are more cost-effective.

“A decision to include analogue insulins in the EML would increase pressure on national governments to purchase these far higher priced insulins. In low- and middle-income countries, where health systems budgets are already stretched; this would have disastrous consequences for people in need of insulin,” said Dr Margaret Ewen, co-lead of the HAI study in the statement, adding. “When the price of long-acting analogue insulin is lowered to an affordable level for governments and individuals, we would welcome a thorough evaluation on its value on the EML.”

Abortion Drug Moved to Core List, No Longer Requires Close Supervision

The drug combination mifepristone–misoprostol, used to end pregnancies that are less than 10 weeks along, was recommended by the Expert Committee to be moved from the complementary to the more select core list of medicines, and for the two drugs to be co-packaged.

The Committee further recommended the removal of the note accompanying the listing that the drug “Requires close medical supervision,” explaining in the Executive Summary that this is “based on the evidence presented that close medical supervision is not required for its safe and effective use.”

The Committee, however, noted that “its mandate did not extend to providing advice regarding the statement ‘Where permitted under national law and where culturally appropriate.’” So ultimately the decision to preserve the note was made by the WHO Director General.

Recommendations on Improving Access to and Affordability of Essential Medicines

In the Executive Summary, the Committee noted that throughout its April meeting to review and update the Essential Medicines List, issues of access to and affordability of the essential medicines was a core theme, particularly in the context of the rising cost of insulin and the high prices for the newly added cancer drugs. It further noted that this issue of affordability applies both to health systems and to patients.

While it acknowledged the “limited role of WHO in price setting at country level,” it “identified several different actions that could contribute to making some of the recently listed essential medicines more affordable at country level,” which include:

  • A wider adoption of biosimilars, which are the equivalent of less expensive generics for biologically-based drugs;
  • Expanding the remit of the Medicines Patent Pool, which negotiates with patent holders for licences of priority drugs to so as to make them available to low- and middle-income countries;
  • Expand the role of pooled procurement/tendering of drugs;
  • Use of patent flexibilities [available for health products], in the 1995 World Trade Organization (WTO) agreement on Trade Related Aspects of International Property Rights (TRIPS);
  • Other existing instruments, such as competition law;

Elaine Fletcher and David Branigan wrote this story.

Image Credits: WHO.