More public disclosure and information-sharing about drug prices and their R&D costs, is key to determining a fair price for essential medicines, concludes a series of five articles on fair pricing published Monday in the BMJ. The series, supported in part by the World Health Organization, highlights the increased priority drug price transparency is receiving on WHO’s agenda.

The five articles discuss the barriers to information-sharing between private and public sectors about R&D costs, as well as between health systems in different countries, which typically keep data on real drug purchase prices confidential, which have become a central theme on the transparency agenda over the past year.

But the series also explores some new, win-win approaches to pricing that could help make higher-price medicines more affordable while maintaining incentives for the private sector to invest in R&D and manufacturing, according to the study authors.

“Transparency is a key element to determine what is fair, but there is an absence of reliable data on development costs,” Alison Colbert, technical officer in the Essential Medicines and Health Products Department at WHO wrote in an introductory editorial published in the BMJ for the series. The editorial was co-authored by top WHO officials, including the director and assistant-director of the Essential Medicines and Health Products Department at WHO, Suzanne Hill and Mariângela Simão, along with Soumya Swaminathan, chief scientist at the WHO.

The WHO officials add that “ultimately, there is no simple algorithm that will calculate a fair price for each medicine,” but that transparency and collaboration will ensure that the “right data” are available to the “right stakeholders” to help ensure affordable access to essential medicines.

However, before “fair” prices can be set, the global health community must first agree about what a “fair” price means.

“”For too long, governments and other purchasers of medicines have not had clear frameworks for how to assess the fairness of medicines prices, especially when considering pricing within a global market. We know medicines prices have been climbing year after year, but how can we assess when a high price is too high?” asked Suerie Moon, co-director of the Global Health Centre at the Graduate Institute.

Suerie Moon et al. propose hypothetical price ceilings (ie, the maximum that is affordable to the buyer) and fair prices for countries with different affordability thresholds. Prices below the red line indicate hypothetically “fair” prices.

In the first article in the series, Moon and her colleagues from WHO highlight the differences between what matters to sellers’ and buyers’ in defining a “fair price.” The authors note that both groups have a very different set of parameters.  Buyers may consider a drugs overall value to individuals and health systems;  affordability and financial hardship risks; and supply security. Pharmaceutical companies, on the other hand, are concerned with prices that cover the costs of R&D, regulation, manufacturing, and distribution while generating a profit.

Moon and her colleagues propose a framework that combines both buyers’ and sellers’ concerns in defining a range of fair prices for medications, proposing that price ceilings for medicines could be set by consideration of consumers’ concerns while price floors could be set by manufacturers’ priorities. Public intervention should occur in cases where prices fall outside of this range.

“A key concept here is that companies can earn a fair profit, but the profit should not be excessive and should not come at the cost of affordability to patients,” Moon clarified.

Altogether, the series includes five papers that address issues around medicines prices that could be described as “fair” while still incentivizing the pharma industry to invest, entitled as follows:

While generally, high prices are associated with patented medicines, the second and third papers also explore lesser-publicized issues of high pricing for biosimilars, generic medications, as well as the prices of  off-patent drugs which may have too few manufacturers. The fourth paper argues for a radical shift towards alternate business models that reward the pharma industry for innovation, but not through the vehicle of prices, to spur more development in areas of unmet health need.

Finally, the last paper presents how the WHO’s Market Information for Access to Vaccines database has allowed middle-income countries to share market data and negotiate more equitable prices, highlighting an example of a transparency initiative that has helped increase access to essential vaccines.

The series’ authors include researchers from WHO, the Organization for Economic Co-operation and Development (OECD), the Graduate Institute in Geneva, University of KwaZulu-Natal, and Harvard University, among others.

Image Credits: BMJ, Suerie et al. Defining the concept of fair pricing for medicines.

[UN News] Kenya, Mozambique and Niger curbed different outbreaks of vaccine-derived poliovirus over the past 24 months which affected 14 children, said a senior WHO official on Monday.

Although wild poliovirus virus has not been detected in Africa since 2016, roughly 12 countries are currently facing outbreaks of vaccine-derived poliovirus.

© UNICEF/Claudio Fauvrelle
Mothers take their babies to receive vaccinations at a mobile unit in Molumbo district, Mozambique.

“Ending outbreaks in the three countries is proof that response activities along with high quality immunization campaigns and vigilant disease surveillance can stop the remaining outbreaks in the region”, said Dr. Modjirom Ndoutabe, coordinator of WHO-led polio outbreaks Rapid Response Team for the African Region.

“We are strongly encouraged by this achievement and determined in our efforts to see all types of polio eradicated from the continent. It is a demonstration of the commitment by governments, WHO and our partners to ensure that future generations live free of this debilitating virus”.

Polio is a highly infectious viral disease that can lead to paralysis.  It mainly affects children under five.

While there is no cure, the disease can be prevented through a simple vaccine.

Polio is transmitted from person-to-person and is spread through contact with infected faeces or, less frequently, through contaminated water or food.  The virus enters the body via the mouth and multiplies through the intestines.

“When children are immunized with the oral polio vaccine, the attenuated vaccine virus replicates in their intestines for a short time to build up the needed immunity and is then excreted in faeces into the environment where it can mutate”, Ndoutabe explained.

Vaccine-derived polioviruses are rare, according to WHO. They only emerge in areas where overall immunization rates are low and sanitation is inadequate, leading to transmission of the mutated polio virus via sources such as contaminated sewage.

Another 12 African countries continue to experience vaccine-derived polio outbreaks, including: Angola, Benin, Cameroon, Central African Republic, Chad, Côte d’Ivoire, Democratic Republic of the Congo, Ethiopia, Ghana, Nigeria, Togo and Zambia.

Weak routine vaccination coverage, vaccine refusal and difficulty in accessing some locations, are some of the risk factors behind these outbreaks, according to WHO.

 

Image Credits: © UNICEF/Claudio Fauvrelle.

The number of cholera cases decreased by 60% in 2018 compared to 2017. Cholera-endemic countries such as Haiti, Somalia, and the Democratic Republic of the Congo saw some of the highest reductions.

Cholera vaccination in Nigeria

“The decrease we are seeing in several major cholera-endemic countries demonstrates the increased engagement of countries in global efforts to slow and prevent cholera outbreaks and shows the vital role of mass cholera vaccination campaigns,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus in a press release. “The long-term solution for ending cholera lies in increasing access to clean drinking water and providing adequate sanitation and hygiene.”

There were 499,447 reported cases and 2990 deaths in 2018, significantly lower than the 1.2 million cases and 5654 deaths reported in 2017. The country most affected by the ongoing cholera pandemic continues to be Yemen, which reported 128,121 cases and 2485 deaths in 2018, according to data collected by WHO.

However, several cholera-endemic countries saw dramatic decreases in the number of cases – including Haiti, Somalia, DRC, Zambia, South Sudan, United Republic of Tanzania, Somalia, Bangladesh, and Nigeria – thanks to the implementation of new national action plans for cholera control.

“The global decrease in case numbers we are observing appears to be linked to large-scale vaccination campaigns and countries beginning to adopt the Global Roadmap to 2030 strategy in their national cholera action plans,” said Dr Dominique Legros, head of WHO’s cholera programme in Geneva.

“We must continue to strengthen our efforts to engage all cholera-endemic countries in this global strategy to eliminate cholera.”

Nearly 18 million doses of Oral Cholera Vaccine (OCV) were shipped to 11 countries in 2018, financed in part by Gavi, the Vaccine Alliance. However, experts at WHO say that vaccination must be supplemented with efforts to improve access to clean water and sanitation. Vibro cholerae, the bacterium that causes the acute diarrhoeal infection, breeds in contaminated food and water.

Mass vaccination and water and sanitation interventions are recommended as part of the Global Roadmap strategy, which provides a three-pillar framework for national action plans focusing on:

  • Early detection and rapid response to contain outbreaks
  • A multisectoral approach integrating strengthened surveillance, vaccination, community mobilization, and water, sanitation and hygiene to prevent cholera in hotspots in endemic countries
  • An effective mechanism of coordination for technical support, resource mobilization and partnership at the local and global levels.

Image Credits: WHO.

For the first time in two decades, tobacco use is projected to decline among men in 2020, according to a new World Health Organization report on trends in global tobacco use. However, the new report does not consider trends in e-cigarette use, where use may in fact be increasing.

“For many years now we had witnessed a steady rise in the number of males using deadly tobacco products. But now, for the first time, we are seeing a decline in male use, driven by governments being tougher on the tobacco industry,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus in a press release about the new report.

Based on data collected from 149 countries, global tobacco use has been steadily declining for the past 18 years, from 1.397 billion people in 2000 to 1.337 billion in 2018. But that downward trend had been primarily driven by declining use in women.  About 100 million fewer women used tobacco in 2018 as compared to 2000, and women’s use of tobacco is projected to decline further over the coming five years.

However, over the same 2000-2018 period, the number of men using tobacco actually increased by 40 million people, and males currently represent some 82% of tobacco users.

Yet over just the past year, prevalence of tobacco use in males has plateaued, and it is now projected to begin declining in 2020, the latest data shows. WHO estimates that there will be 2 million fewer male users in 2020 as compared to 2018, and 5 million fewer by 2025.

“Showing that tobacco use can be reversed gives the public health community confidence we can get back on track and meet the global targets of a 30% reduction [in smoking rates] by 2025 as compared to 2010,” Ruediger Krech, director of WHO’s Department of Health Promotion said at a press briefing.

Projections of a decline in male tobacco use for 2020 are not the same across all regions either, the WHO officials cautioned. While fewer men are expected to be seen smoking in the Americas, Europe, and Western Pacific regions, WHO’s South-East Asian region, which currently has the highest proportion of male smokers at 62.5%, is projected to see a slight increase in absolute numbers over the next five years. Numbers of male smokers are also predicted to increase in the WHO Eastern Mediterranean and African regions.

And around the world, 43.8 million children between 13-15 used tobacco in 2018. That number excludes the use of e-cigarettes and other such nicotine delivery devices, which some country specific surveys have found is on the rise in youth in countries such as the United States.

Krech credited the inroads made against tobacco use over the past two decades to increasingly strong policy measures such as: banning smoking in public places, tobacco taxation, and marketing restrictions like plain packaging of tobacco products, as well as bans on marketing aimed at teens and children.  But he said that such measures must be amplified in order to reach the global targets.

“The downwards trend in tobacco use offers a challenge to governments. We cannot be satisfied with a slow decline when over 1 billion people are still using tobacco,” said Krech. “We must dramatically accelerate tobacco control measures to protect current and future generations from tobacco.”

The Unknown Contribution of E-Cigarette Use

Another unknown involves the use of smokeless tobacco devices. Use of e-cigarettes, as welll as other electronic nicotine delivery and heated tobacco devices were all excluded from the analysis, raising questions about whether potential smokers might also be shifting away from traditional tobacco products over to such methods.

Originally marketed as smoking cessation devices, electronic nicotine delivery systems (ENDS) have gained increasing notoriety for allegedly hooking young people onto nicotine at earlier ages. According to the US National Youth Tobacco survey, one of the most comprehensive national surveys that collects data on nicotine consumption annually, the proportion of high-school students who have used an ENDS device at least once shot up to 27.5% in 2019, as compared to only 12% in 2017. Manufacturers have been accused of targeting their marketing directly towards young people, particularly by producing the nicotine liquid pods in a variety of flavors popular among teenagers.

“If there are flavors like chewing gum or strawberry, who is the target audience? Me or my grandchildren,” Krech remarked.

As for whether an increase in e-cigarette use has perhaps led to a decrease in use of other tobacco products, Krech said that WHO could not at this time “say whether that has an impact or not.”  However, he acknowledged that many tobacco smokers are so-called “dual-users” – using both combustible cigarettes and e-cigarettes.

Krech added that WHO is currently collecting data on e-cigarette use and tobacco vaping, and is planning to release a more comprehensive report on the subject in February 2020. Countries have only begun collecting nationally representative data on the use of ENDS in 2013, and currently data from 42 countries is available, with more reports coming in every day.

“There is no “safety” associated with e-cigarettes,” said Krech. “There are a lot of risks associated with e-cigarettes, and we’re going to be a bit more concrete about those risks [in the February report].”

Accelerate Actions to Decrease Tobacco Use

In terms of policy measures, the report finds a clear trend towards more stringent government policies and regulations aimed at reducing tobacco use and second-hand smoke exposures. As of 2018, 137 countries have put into place at least one of the six methods recommended by the WHO in line with guidelines of the Framework Convention on Tobacco Control (FCTC).

Some 116 of these 137 countries have seen their tobacco use rates decline since implementing the measures, which include stronger measures for monitoring tobacco use; protection against second-hand smoke exposures; quit smoking programmes; awareness raising about tobacco’s dangers; restrictions and bans on tobacco advertising, promotion, and sponsorship of activities; and increased taxes on tobacco products.

The report found that strong declines in average tobacco use prevalence were mostly seen in regions that implemented the policies. This was true for the WHO South-East Asia region, which saw reductions in tobacco use – mostly in smokeless tobacco – after all 11 countries of the region had implemented at least one policy.

“Continuing to reduce tobacco use will help save lives, nurture families, and strengthen communities,” said Krech. “We must dramatically accelerate tobacco control measures to protect current and future generations from tobacco.”

Civil society organizations agreed. Gan Quan, director of Tobacco Control at the International Union Against Tuberculosis and Lung Disease and a partner in tobacco industry watchdog STOP (Stopping Tobacco Organizations and Products), said in a statement, “The problem is that the tobacco industry continues to undermine such measures all over the world and to market their products aggressively.”

Quan added, “The data is clear: tobacco use falls when governments implement policies that are proven to encourage quitting and deter youth from starting to use tobacco.”

Image Credits: WHO, WHO global report on trends in the prevalence of tobacco use, MomentiMedia/Flickr.

After collecting a windfall of nearly US$14 billion in donor commitments in October, the Global Fund to Fight AIDS, TB and Malaria, on Wednesday published its blueprint to distribute most of the money to over 100 low- and middle-income countries worldwide, saying that allocations will increase by 23% over the next three years.

Nigeria, Mozambique and the Democratic Republic of Congo are set to receive the largest awards with over $US 890 million, $US 751 million and $US 644 mllion respectively. according to the  allocation plan published on the Global Fund website. Tanzania, Uganda, South Africa, Malawi, India and Zimbabwe would receive allocations of $US 500-US $600 million each,  followed by grants ranging from tens of million to several hundred million dollars each to other qualifying African, Asian and Latin American countries, as well as Russia and former Soviet Union states. The allocation amounts represent threshholds against which countries then apply for final funding in one or all of the disease categories.

The country allocations total some US$12.71 billion, the agency said in a press release, adding, “The funds will help save 16 million lives, cut the mortality rate for the three diseases in half and get the world back on track to end the epidemics of AIDS, tuberculosis and malaria by 2030.”  In addition, countries can also apply to a separate fund of US$890 million for so-called “catalytic investments” that aim to scale up specific aspects of HIV and TB prevention or treatment, as well as strengthening health services overall.

French President Emmanuel Macron (center), and Microsoft’s Bill Gates, (far right), stand triumphantly with other Global Fund partners and supporters at the end of the successful Replenishment Drive in October that collected nearly US$14 billion in commitments.

Most eligible countries will receive funding increases, the Global Fund said. Countries in Africa are receiving around US$2 billion more than in the previous period, and countries in West & Central Africa have the biggest increase – US$780 million. Worldwide, there are 32 countries with an increase of 40% or higher.

Allocations to individual countries are calculated using a formula that is predominantly based on each country’s disease burden and economy, and then further adjusted to account for “important contextual factors”, the press release stated.

The aim is to drive funding to: “higher burden, lower income countries, specifically accounting for HIV epidemics among key and vulnerable populations, the threat of multidrug-resistant TB, and for the risk of malaria resurgence.” On the other end of the spectrum, the Global Fund aims to provide “sustainable and paced reductions where funding is decreasing” in middle and upper middle income countries that have made significant inroads in reducing disease but still require support.

“World leaders came together at our Replenishment and made commitments to step up the fight to end these epidemics by 2030,” said Peter Sands, Executive Director of the Global Fund, in the press release. “Now the real work begins. Our allocations will allow partners to expand programs that work, and to find innovative solutions for new challenges. In addition to more money, we need better collaboration and more effective programs.”

The Global Fund’s 2020-2022 allocation methodology is geared toward increasing the overall impact of programs to prevent, treat and care for people affected by HIV, TB and malaria, and to build stronger health systems, the press release stated. “The allocations provide significantly more resources for the highest burden and lowest income countries, while maintaining current funding levels or moderating the pace of reductions in other contexts.”

The allocations include increased investments in Eastern and Southern Africa for HIV prevention among adolescent girls and young women; more funding for the countries with the highest burden of TB in Africa and Asia; continued investments in Eastern Europe to cover the costs of treatment for multidrug-resistant TB; more funding for African countries with a high burden of malaria, and increased focus in the Sahel region to boost vector control and seasonal prevention campaigns.

The full list of allocations is available on the Global Fund website, along with a detailed explanation of the allocation process. In the next step of the funding process, countries convene coordinating committees to prepare and submit funding requests to the Global Fund for review and approval of the grant allocations, which may be disbursed to government as well as non-governmental funding recipients and partners.

 

Image Credits: The Global Fund.

Novartis has relinquished a patent granted by the European Patent Office for Kymriah, a promising new gene therapy for certain forms of leukemia, claiming the patent was no longer essential to the development and marketing of the treatment. The decision followed the moves by the Swiss-based NGO, Public Eye and the French-based Doctors of the World/Médecins du Monde to contest the patent in the European Patent Office. Their opposition, filed in in July, claimed that the price of the innovative therapy was “exorbitant” – with one infusion of the therapy costing CHF 370,000 in Switzerland.

Frozen T-cells of cancer patients are genetically modified to attack cancer cells in novel CAR-T therapies.

Kymriah, one of the first CAR-T [Chimeric antigen receptors T cell] therapies to receive marketing approval in Europe, is specifically designed for treating relapsing or treatment-resistant forms of acute lymphoblastic leukemia (ALL). It was developed by the University of Pennsylvania and later licensed exclusively by Novartis. CAR-T cell therapies rely on an innovative process in which a patient’s own T cells, which are critical to the body’s immune system, are collected and genetically modified to target cancer cells more effectively, and then reinfused back into the patient to attack the cancer.

The Kymriah treatment is so far being used in a limited number of patients, for instance about 100 people a year in Switzerland.  However, the underlying technology of CAR-T therapy holds much promise for treating other kinds of cancer as well. This could mean a rapid increase in the demand for similar therapies in the near future. Thus, the decision on the “patentability of such procedures” is “crucial” for setting a precedent, Public Eye said in a July statement about the patent opposition.

In a letter to the European Patent Office dated 29 November, representatives for Novartis and the University of Pennsylvania, requested the revocation of the patent on the grounds that “the proprietor no longer approves the text on the basis of which the patent was granted, and will not be submitting an amended text.”

The unexpected move was welcomed by Public Eye and Médicines du Monde, who had prepared for a long fight after they officially filed an opposition with the European Patent Office in July on the grounds that the “subject-matter lacks novelty.” The NGOs said the patent would pave the way for the Swiss pharma company to claim broad, exclusive rights not only over Kymriah, as such, but over other CAR-T cell technologies on the European market. Surprisingly, the patent holders submitted a request to withdraw the patent before the opposition procedure had in fact begun.

In response to the recent patent revocation request, Public Eye said in a statement, “This volte-face confirms that the patent should never have been granted in the first place, given that the underlying technology is not novel. It also questions the validity of other patents on Kymriah and weakens the monopoly position of the Swiss giant in future price reviews.”

The NGO added that the revocation should benefit an initiative by a number of leading Swiss university hospitals, among others, “to develop similar but considerably cheaper cancer therapies.”

In the patent revocation letter, Novartis and the University of Pennsylvania’s representatives claimed that the opposition’s arguments were “without merit.”

“[We] strongly believe in the importance of intellectual property rights as an incentive for ground-breaking innovation such as Kymriah. However, the opposed patent is not critical to the continued developement and marketing of Kymriah and the decision has therefore been taken to withdraw the opposed patent,” a Novartis spokesperson was quoted as saying to the Swiss online journal, swissinfo.ch.

Last September, Novartis also dropped a second patent application for another aspect of the treatment. However, Novartis does hold a patent on Kymriah, as such, in Europe and elsewhere. Experts in intellectual property law say that this patent still protects Novartis against the production of identical versions of Kymriah by competitors.  However, withdrawal of the other two patents leaves open a wider door for competitors to lower costs with the advance of further CAR-T innovations.

Image Credits: Novartis, Novartis.

The number of new Ebola virus cases in the ongoing outbreak in the Democratic Republic of the Congo shot up to 27 confirmed cases in the last week, triple the number of 9 confirmed cases reported between 27 November to 3 December. The recent surge in cases comes in the wake of insecurity and a series of violent attacks on Ebola workers that froze the response.

“Since the beginning of the response, there is a factor that we cannot control – the context of the intervention, including insecurity,” Michel Yao, incident manager for the World Health Oganization’s Ebola Response in the DRC said at a press conference (translated from French). “In the zones [where cases are arising], there is one particular zone, Lwemba [in Beni Health Zone], that we have not been able to access for three weeks.”

Ebola vaccinators return to Biakato Mines following a deadly attack on healthcare workers in the area on 27 November.

According to the latest WHO Disease Outbreak Notice, most cases in the past week have arisen from Mabalako and Beni Health Zones, where the Ebola response seems to be mobilizing again after temporarily scaling back activities in the last two weeks of November due to violence and riots in those affected areas. Some 18 cases were reported from Mabalako, and 6 cases from Beni, and the remaining 3 cases originated from Mandima and Oicha. Six of the confirmed cases were health care workers – including 5 traditional practitioners – representing a spike in the number of health care workers infected in the outbreak.

Despite the surge, WHO says that the average proportion of contacts under surveillance in the last seven days has returned to normal levels, and the investigation of alerts has also been improving. To ensure continued care, WHO has mounted a limited daily helicopter “air bridge” operation to transport epidemiologists to investigate cases, but to also primarily send vaccinators to hard-to-reach communities. Dr Yao noted that the communities had come to the Ebola responders seeking help.

They “want the intervention”, he insisted, “but around we have armed groups that prevent us from reaching these communities…We’re mobilising communities all around to come and get vaccinated in a situation where there are (health) alerts but we can’t go to investigate because access is restricted.”

On Thursday, the first Ebola vaccinators returned to the Biakato Mines Area, where three Ebola responders were killed in late November, to continue fighting the outbreak.

So far, 17 of the new cases have been linked to one individual – who reportedly presented with EVD illness for the second time within a 6-month period. According to WHO, rare cases of relapses of Ebola, in which a person who has previously recovered from EVD gets symptoms again, have been recorded. However, DRC officials are also investigating the possibility of reinfection – a scenario in which an individual who has recovered from Ebola gets infected with EVD from another person – which has never been documented before.

Previous studies have shown that Ebola survivors can develop immunity to the disease which can last for over a decade, but experts have long been concerned about the possibility of relapse or reinfection. The possibility of relapse or reinfection could indicate a need to revisit the kind of care provided to survivors, and how Ebola survivors are involved in future response activities.

Image Credits: Twitter: @DamelSoceFall.

The World Health Organization issued new guidelines for the treatment of multi drug-resistant (MDR) tuberculosis on Wednesday, prioritizing for the first time an all-oral treatment regimen. The new treatment recommends replacing the painful injectable drugs that patients had to endure under previous treatment guidelines with a shorter course of oral bedaquiline – one of only three new drugs approved for treatment of TB within the last half century.

A healthcare worker counsels a patient with MDR-TB

The update was announced in a rapid communication released by WHO after an independent panel reviewed new evidence on treating multi-drug resistant (MDR) and rifampicin-resistant (RR) TB in November. Compelling data from the South African TB programme, collected in collaboration with research and technical partners such as The Union, showed that replacing injectable drugs with oral bedaquiline resulted in significantly better treatment outcomes for patients with MDR/RR-TB. Not only that, but more patients also completed the full 9-month treatment when provided all-oral regimen.

“The Union supports the move towards shorter all oral treatment regimens with better outcomes, lower toxicity and reduced side effects for people with drug-resistant TB,” said Grania Bridge, director of the Department of TB at The Union said in a press release. “As new all-oral regimens are developed, there is a clear need for more and better evidence to support their implementation around the world.”

Much of the new recommendations were based on evidence coming out of traditional clinical trials and operational research – which tests the regimens that pass through clinical trials under real-life conditions, where barriers to health care, stigma, and other factors can contribute to the likelihood of patients successfully completing a full course of treatment. This is especially important to observe for the long 9 to 11-month treatment regimens recommended for MDR/RR-TB.

“The WHO rapid communication emphasizes the importance of operational research in generating high quality programmatic data,” said Bridge, highlighting the need for countries and funders to “prioritise operational research to guide future treatment guidelines, as well as complement the data expected from clinical trials currently underway.”

In the update, WHO also issued guidance for the BPAL regimen – a breakthrough regimen for treating XDR TB that just received regulatory approval from the US Food and Drug Administration this August. In the rapid communication, WHO recognized that the BPAL regimen showed high treatment success when used in 108 XDR-TB patients in South Africa, but has refrained from recommending programmatic implementation of the regimen worldwide until more evidence has been generated. For the time being, WHO recommends collecting more evidence for the BPAL regimen under operational research conditions conforming to WHO standards.

WHO is set to release the next full update of consolidated guidelines on the treatment of all forms of drug-resistant TB in March 2020. The rapid communication was preemptively issued in order to prepare national TB programmes and other key stakeholders for what changes they can expect, in order to roll out the new guidelines as quickly as possible.

Image Credits: WHO PAHO.

On 22 November, the Norwegian government broke new ground for the non-communicable disease response. The Norwegian Ministry of Foreign Affairs launched the first international development strategy to focus on combatting NCDs in low- and middle-income countries (LMICs). The NCD Alliance, the Norwegian Cancer Society and other civil society partners around the world have heralded this as a major milestone. I had the pleasure of attending and speaking at the launch event of “Better Health, Better Lives” in Oslo. But why is this such a big deal and what are the broader implications?

A panel at the launch of Norway’s new NCD-focused development strategy. (left-right) Maria Neira, WHO; Omnia El Omrani, (IFMSA); Mamka Anyona, UNICEF; Tiy Chung, CCA Coalition; Andrea Winkler, Centre for Global Health, the University of Oslo; Katie Dain, NCD Alliance.

Let’s start with the numbers, as they speak volumes. NCDs including heart disease, stroke, diabetes, cancer and respiratory disease are now the cause of some 70% of total deaths worldwide. It is widely recognised that NCDs have a detrimental impact on many aspects of sustainable human development. Contrary to the perception of NCDs as a rich world problem, they impact most heavily on LMICs, where NCDs are responsible for over two-thirds of deaths and will cost $7 trillion in economic losses over the next two decades. However, the world’s biggest cause of premature death and disability are collectively the target of an astoundingly pitiful 1.7% of health-related development assistance (or $611 million).

Whilst bilateral donors (e.g. national governments or their development agencies) are the dominant source of funding in global health more broadly, providing 52% of overall development assistance for health, they have until now simply been absent in the field of NCDs. Between 2010-2015, non-governmental organisations (NGOs) collectively provided more than twice as much aid for NCDs than bilateral donors, and considerably more than multilateral organisations such as the World Bank and WHO.

The picture of resources available to tackle NCDs hasn’t changed markedly since 2015, despite the transition from the Millennium Development Goals (MDGs) to the era of the UN Sustainable Development Goals (SDGs), when NCDs were finally included as a priority for global health and sustainable development. After many years of campaigning, NCD advocates around the world could have hoped that this would be the moment that would trigger donor countries to incorporate NCDs into their development policies and strategies. But although many development agencies including from the UK, US, Sweden and Australia are supporting NCDs via different channels (for example, via health system strengthening efforts, integrating NCDs into existing global health programmes, or tobacco control programmes in LMICs), overall they have remained far too silent and passive on NCDs.

Consequently, LMICs have been left to respond to increasing burdens of NCDs within their own scarce resources. Governments are juggling a backlog of common infections, undernutrition and maternal mortality together with growing burdens of NCDs, pandemics and the alarming health effects of the climate emergency. Budgets and health systems are crippled and few poor countries provide care for NCDs in their health benefits packages. The result of this is a hugely unjust and unjustifiable burden: in lower-middle income countries, people are largely asked to pay for the care and treatment they need out of their own pockets. 56% of health spending is taken from the people who need treatment, rather than from government spending or other sources. For the many who cannot afford treatment, this means the agonizing choice between foregoing life-saving or life-improving care or tipping their family into poverty. This is a desperate reality particularly for the poorest, most marginalized populations, who are still all too often left behind.

These statistics and realities are why the Norwegian government’s international development strategy on NCDs is so important and such a welcome step. Norway is the first OECD country to translate the inclusion of NCDs within the SDGs into their development policy, and back it up with a clear and much-needed overseas development resources. Norway has announced a tripling of its assistance for NCDs, allocating over $20 million to support the strategy for 2020 and this commitment is expected to increase towards 2024. This is a relatively modest amount in the context of global health giving, but already catapults Norway to the ranks of the top three supporters for NCD prevention and control, well ahead of the US, UK, France, Germany and Canada.

The Norway example provides an important precedent as well as a model for other OECD countries to follow, not just for it being the first, but also the substance and approach taken. First, while the strategy is led by the Ministry of Foreign Affairs, the launch event in Oslo made clear that this was a product of cross-government collaboration, with both the Minister of International Development, Dag-Inge Ulstein and the Minster of Health, Bent Høie taking the stage together, sending a strong signal of whole-of-government leadership. Secondly, the strategy builds upon WHO’s normative work on NCDs by supporting low-income countries implement the “Best Buys” and embracing the broader “5×5” approach to NCDs with a welcome focus on mental health and air pollution. Thirdly, the pillars of the strategy build off Norway’s track record in NCDs and public health domestically and internationally, evident by the strong focus on proven prevention measures; tobacco control and the FCTC, regulation and taxation of unhealthy products, and attention to the commercial determinants of NCDs which is so urgently needed in many LMICs. Fourthly, it clearly articulates this new focus on NCDs as an opportunity to build on and augment (rather than divert) Norway’s global health and development priorities and investments to date, such as women and children’s health, climate and the environment, and humanitarian crises. And finally, both at the event and in the strategy, there is clear recognition for the integral role civil society and communities play in responding to NCDs.

Five ingredients of a strategy that has positioned Norway as a global leader in responding to NCDs in low-income countries and saving lives, and a model for other OECD countries to follow. Who will be the next to follow?

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Katie Dain is Chief Executive Officer of the NCD Alliance, a global network of civil society organisations dedicated to transforming the fight against non-communicable diseases (NCDs). Katie has worked with the NCD Alliance since its founding in 2009. Katie is widely recognised as a leading advocate and expert on NCDs. She is currently a member of the WHO Independent High-Level Commission on NCDs, co-chair of the WHO Civil Society Working Group on the UN High-Level Meeting on NCDs, and a member of The Lancet Commission on NCDIs of the Poorest Billion. 

 

 

 

 

Image Credits: Stine Loe Jenssen.