“Creaking health systems” are among the leading risks faced by the global community, according to the World Economic Forum’s Global Risks 2020 Report. People live longer, but health gains have also plateaued in recent decades. Threats from longstanding infections as well as those from emerging diseases pose a double set of challenges.

Along with that, the growing burden of non-communicable diseases and aging populations, coupled with workforce shortages, have emerged as new and destabilizing forces to health systems. In an era of rapid technological advances, health systems are struggling to define who should pay for promising new treatments, and how much, when new gene and cell therapies can cost as much as US $2 million per patient.  Like climate change, health risks pose an “expensive and expanding” transnational challenge.”

Following on from Part I, Health Policy Watch’s interviews with leading global health experts zoomed into four key issues facing health systems in the decade leading up to the 2030 Sustainable Development Goals milestone:

• Emergence of new diseases at an increasing rate and intensity – as reflected in the Wuhan outbreak of a new coronavirus;
• Stalled action on medicines price tranparency – watch to see if European countries take a lead this year in adopting stronger measures;
• Failing medicines markets contributing to the rise of anti-microbial resistance (AMR) – when prices for other vital drugs, particularly antibiotics, dip too low;
• Non-communicable Diseases (NCDs) and Universal Health Coverage – how these issues are linked to each other, and to the global “syndemic” of obesity, undernutrition and climate change.

A broader pattern of health inequalities, which also hold back development, is a crosscutting problem, raised by global health leaders.

“We are living in a world where extreme inequality is out of control,” new Executive Director of UNAIDS, Winnie Byanyima declared at the opening of the World Economic Forum’s annual meeting in Davos, Switzerland.

“About 2,100 billionaires own as much wealth, more wealth, than 4.6 billion people in this world. Half of the world lives on less than US$ 5.5 dollars a day. Half the world struggles and does not have access to quality health care. Everyday, ten thousand people die because they could not access health care. It’s unacceptable, immoral and unsustainable.” (see related story)

Emergence of New Infectious Diseases

New diseases are emerging at an increasing rate and intensity – and these “will place growing strains on fragile systems for outbreak preparedness and response,” Suerie Moon, co-director of the Geneva Graduate Institute’s Global Health Centre, told Health Policy Watch.

“In early January alone, we’ve seen ongoing difficulties with the dual Ebola and measles outbreaks in DRC, and the novel coronavirus recently identified in Wuhan, China,” she observed. “It’s not just the on-the-ground response systems that are being pressure-tested, but also international agreements on sensitive issues like when and how countries share data and who gets access to any benefits that might result (such as publications, diagnostic tests or drugs).”

Indeed, the web of people infected with the pneumonia-like virus that first surfaced among workers and visitors to a live animal market in the city of Wuhan, has been expanding daily. As of Monday, 27 January, there were over 2800 confirmed cases, and 81 people had died. While most cases remained concentrated in the city of 10 million people, cases elsewhere in Hubei Province where Wuhan is located, other Chinese cities, as well as other countries, including Taiwan, Thailand, Japan, South Korea, and the United States, reflected the virus steadily expanding range. Some 50 million Chinese were under a government imposed lockdown just as the Lunar New Year began on Saturday. Health authorities were struggling to contain the infection’s further spread, as human-to-human transmission accelerated, although the fatality rate remained relatively low in comparison to the 2002-03 SARS outbreak.

While attention focused on the Wuhan virus, an Ebola outbreak in the Democratic Republic of Congo (DRC) simmered on, with an average of 13 cases a week of the deadly virus over the past 21 days. As of 14 January, there had been 3406 reported cases and 2236 deaths in the 18-month old outbreak, which global media had, for the time forgotten.

Many, or most, new disease threats emerge after having lept the animal-human barrier, notes Stephen Morse, a professor of infectious disease epidemiology at Columbia’s Mailman School of Public Health and chair of the university’s Biosafety Committee.

Such leaps have always occurred. However, they may be happening more frequently, or have greater impact, due to changes in both rural and urban economies of low and middle income countries, he notes. In rural areas, deforestation and environmental degradation can lead to greater human contact with wild animal species that spread infections.

In and around urban areas, industrialized livestock production has led to strained sanitation and safety systems in farms, slaughterhouses, and markets. Infections harboured by animals housed in crowded conditions can more easily mutate and jump to human hosts.

Hunting, slaughter and traditional consumption of certain wild animal species, which also harbour diseases readily transmissible to humans, may trigger the initial species leap – although this is only the start. Increased urban densities, as well as greater mobility within and between countries, leads to faster and more intense transmission of new infections, he said.

“Ebola, very probably HIV, and a number of other infections have entered the human population this way at various times,” Morse said. “Once Ebola infected a person or a few people from its original natural source, then human to human transmission (however inefficient) became the driving event. Crowded conditions and movement of people amplified this beyond anything seen before.

“Large agricultural systems are another place where we can see unintended consequences.  The suggestion that the last influenza pandemic (A/H1N1 pdm2009) appears to have arisen from an industrial pig farming operation in Mexico (these are often called “CAFOs” – concentrated agricultural feeding operations – in the industry) is a demonstration of the potential dangers.

“Given the UN estimates on increasing urbanization, and on rural to urban migration, it was nothing less than a failure of imagination to believe that Ebola would remain sequestered in the remote rural areas where it usually is introduced initially and has usually stayed in the past.

Outbreaks are often exacerbated by lack of trust in government, he said. “That is another widespread phenomenon these days, which made it hard to find and treat the cases before the epidemic exploded in the cities, and hard to disseminate health information. The same is true in Eastern Congo, but even worse, given its status as a severe conflict zone.”

Even so, Morse said, sanitation and health authorities can do a great deal to both prevent and contain future outbreaks and epidemics by insisting on better sanitation infection control in communities, markets, food production and health facilities

“With a few notable exceptions, most zoonotic diseases do not spread easily from person-to-person, making source reduction a viable strategy,” he said.

In “factory farming”, he added, “there has been increasing emphasis on farm biosecurity, carefully monitoring what goes in, testing and quarantining new arrivals, and instituting good infection control practices. This has limited avian flu (H5N1) in some poultry operations, as well as livestock diseases that would have economic consequences,” he noted, although in many low- and middle-income countries, with a large proportion of “backyard” subsistence poultry farms, these measures are much more difficult to implement.

“In markets,” said Morse, “some fairly basic hygienic precautions, such as keeping different species separate, wearing gloves (possibly masks), washing hands, and effectively cleaning environmental surfaces and knives, could help at relatively low cost. Other measures might include wrapping or packaging the meat, minimizing handling before cooking, washing hands, utensils, and surfaces used with the uncooked meat, and adequate cooking.”

Addressing such root causes would likely be cost-effective, as compared with containing epidemics later, he notes. “The problem is that until an epidemic erupts, there is little incentive and funding for low and middle-income countries to adopt such measures in busy markets. They require incentives (education and advertising are among the possible incentives) and funding or supply of material.”

Basic structural investments in sewage and sanitation systems, often left behind, are another important piece of the puzzle, Morse added.

The February WHO Executive Board is one upcoming event where observers will see how these issues play out. Among the items on the agenda are a draft World Health Assembly Resolution on strengthening preparedness for health emergencies, proposed by Finland, as well as another measure that will examine ways to accelerate action on food safety.

Along with that, WHO’s Dr Tedros Adhanom Ghebreyesus has long made the point that stronger health systems overall, as part of the global drive to attain Universal Health Coverage, can also better address emerging disease threats such as those seen this year.

Stalled European Action on Medicines Price Transparency

Advocates pressing for greater transparency around medicines prices, will be watching the European arena closely this year for signals and practical examples of measures that other countries and regions might follow. This follows passage of a landmark World Health Assembly resolution on the issue last May, which proponents believe would help curb rising prices seen for many drugs in markets of rich and poor countries alike.

Following the WHA resolution, Italy’s government and France’s Parliament approved new rules to require pharma companies to disclose public contributions received for R&D on new drugs – as part of requests for reimbursement by the public health system of new drug costs. But implementation of the new measures stalled at year’s end – over procedural issues in France and following a government reshuffle in Italy.

In Italy, new Health Minister Roberto Speranza, who took office in September, failed to publish the transparency decree signed by the former Health and Finance ministers in August, just prior to a government reshuffle. And the rule can’t take effect until it is published in the Italian Gazette, the official government journal. Why that final step hasn’t been taken by Speranza, who represents the far-left Article One party, remains a mystery.

“It is already five months, and this decree only needs to be published in the Italian Gazette. It doesn’t need to be discussed,” said one observer. “It would be indeed surprising to see a far-left Minister blocking a transparency measure that could benefit people in order to protect pharma lobbyists.”

Transparency advocates are hopeful that the logjam might be unlocked after WHO scientist Nicola Magrini takes on his new position as head of the Italian Medicines Agency (AIFA), after accepting Speranza’s offer of the post earlier this month.

However, it remains to be seen if Magrini will have a range of action comparable to that of his predecessor, Luca Li Bassi. In his brief year-long tenure under former Health Minister Giulia Grillo, Li Bassi paved the way for a series of national reforms in medicines markets as well as making Italy the lead sponsor of the WHA transparency resolution.

In France, things remain equally unsettled. A similar measure for disclosure of public contributions to R&D as part of medicines reimbursement requests was attached to the French Social Security Budget bill up for approval in the Parliament. It’s passage in early December was celebrated by French civil society groups, led by l’Observatoire Transparence Médicaments (The Observatory for Medicines Transparency).

But shortly after the bill’s approval, the French Constitutional Council struck the provision down on a technicality, which now must be overruled by the government.

In early January, French MP Caroline Fiat filed a public question to Health Minister Agnès Buzyn, asking her if the government will issue such a decree. But Prime Minister Emmanuel Macron is unlikely to approve such a move anytime soon, observers say.

“The decision is highly political. The feedback we have is that the Elysée does not want this amendment and so the chances for the government to issue a decree are very thin,” said one well-placed observer.

Meanwhile, the NGOs have gone back to the media to make their case.

Requiring disclosure of public contributions for R&D costs can  ensure that the public doesn’t “pay twice” for medicines – once during the R&D process and again at the cash register, said Pauline Londeix, co-founder of Observatoire Transparence Médicaments, in a recent Le Monde OpEd, co-authored with another French NGO, Santé Diabète.

The controversy raging over a costly new gene therapy, Zolgensma, which treats spinal muscular atrophy in babies, is one example of such double billing, the Op-Ed stated. The drug has been priced at €2 million, even though French public charities contributed to its development. Recently, the patent holder Novartis proposed a lottery to select some infants that could be treated for free – although that idea raised even more ire.

“As if this lottery were not shocking enough, the scandal doesn’t end at this shameful strategy….because Zolgensma was developed thanks to Telethon, money from tax-free donations, and public and charitable funds,” Londeix and her co-authors noted.

Disclosure of Clinical Trial Results also in Dispute

On a related front, transparency advocates in Europe as well as the United States have battled over the disclosure of clinical trial results from drug studies.

In Europe, attention focused on a pharma appeal to the European Court of Justice regarding the European Medicines Agency’s policy of publicly sharing summary reports of clinical trial results for new drugs undergoing approval.

A 2018 European court ruling that upheld the EMA practice was appealed to the Court of Justice, by Merck and PTC Therapeutics, on the grounds that it violated confidentiality and harmed their commercial interests. Fears that the High Court might upend the lower court’s ruling climaxed late last year, following a September legal review of the case by Court of Justice Advocate General, Gerard Hogan, who held that disclosure of trial results could indeed undermine companies’ commercial interests. In December 2019, 35 civil society groups issued an open letter calling on authorites to protect the current EMA policy of publishing the summaries.

“Without information and knowledge about the real benefits of drugs, how can informed decisions be made for the benefit of patients?” said one observer.

On Wednesday, (22 January), however, those fears were allayed when the High Court rejected both pharma appeals. The decision, “confirms the right of access to documents contained in the file of a marketing authorization application,” according to a press release issued by the court, adding that “objections to such access must explain the nature, purpose and scope of the data whose disclosure would undermine commercial interests.”

In the United States, media attention has focused on lax enforcement of a new FDA rule that requires trial sponsors to report their results on the data base of ClinicalTrials.gov within 1 year of a study’s completion. A study published last week by The Lancet found that only about 40% of trials were compliant. Government agencies lack sufficient budget as well as high-level political backing  to enforce the rule, critics have said.

At the same time, the Germany’s drug regulatory agency has taken a stronger line with academic researchers on the same issue, threatening to cut off funding to universities that fail to publish studies, as requested by current EU legislation.

And a recent OECD report also called out the need for more transparency in relation the performance of medicines – saying that health system reimbursement contracts requiring such information would also be useful for other payers, scientists and the general public.

European Countries Explore Ways to Negotiate Over Prices as a Bloc

Meanwhile, groups of European countries are also looking for ways to share analysis and information on the value and benefits of new drugs eventually to negotiate more effectively together. The ten southern European countries of the so-called Valletta Group are hopeful that Croatia will put the issue on the agenda of the European Employment, Social Policy, Health and Consumer Affairs Council [EPSCO] sometime in 2020, Malta’s Deputy Prime Minister and Health Minister told Health Policy Watch in a recent interview.

And the new Spanish government of Prime Minister Pedro Sánchez, has also pledged action on transparency in medicine prices under its four-year “social patriotism” programme.

“On medicines, the issue of high prices is not disappearing anytime soon,” said Suerie Moon, co-director of Geneva Graduate Institute’s Global Health Centre.

“In the first week of January alone, the US saw price spikes on over 500 medicines by 100 companies,” she observed. “Other more-regulated countries may not see the same kind of price increases, but are still struggling with the budget implications of drugs that are priced at hundreds of thousands to millions of dollars of Swiss francs/Euros per patient.

“I think we’ll see more legislative action at national level, particularly in Europe, to address the affordability issue. Importantly, there is also growing appetite to re-examine and potentially reform the underlying R&D system that generates such high prices — and this implies an ongoing demand for increased transparency of that system. But putting in place any kind of meaningful reform will require at least some international cooperation — and that remains in short supply.”

AMR and Failing Medicines Markets

“Antimicrobial resistance is steadily increasing and is one of the most significant and dangerous global health threats, yet no new antibiotics are in the drug discovery pipeline,” notes Oksana Pyzik, board trustee of the Commonwealth Pharmacists’ Association, and a founder of the UCL-hosted Fight the Fakes alliance.

“The current death toll amounts to 1.6 million every year with another 10 million falling ill either because of resistance due to overuse in humans and animals.” A comprehensive UN report issued in April 2019 warned that deaths from new drug-resistant bacteria, viruses and parasites could rise more than ten-fold, to as many as 10 million people a year by 2050 if no action is taken.

Bacterial resistance to existing antibiotics is rising due to widespread overuse in animals as well as people in some countries’ health systems, as well as increasing availability of poorly regulated substandard medicines. Many low- and middle-income countries are also riddled with so-called “fake medicines” containing weakened active ingredients, which can also foster resistant microbes to emerge, she notes.

Another factor is poorly treated sewage effluent from drug manufacturing sites, animal production and municipal waste. Those drug residues in turn promote new forms of drug resistant microbes.

But one other, oft-ignored aspect of AMR is the supply bottlenecks and shortages for many commonly used antibiotics in many middle and high-income countries, as well as a broader, overall lack of access to many effective antibiotic treatments for millions of people in the developing world.

A newly published report by the AMR Industry Allliance estimated that some 5.7 million people a year die to lack of access to appropriate antibiotic treatments.

One of the root causes of the problem, manufacturers say, is that the prices of some antibiotics and other essential drugs have dipped very low – leading to closures of manufacturing plants in many places around the world. Production has become more and more concentrated in just a few sites.  This makes global supply chains more fragile, especially when demand surges or if manufacturing interruptions occur at just one manufacturing site.

Low prices have also dampened industry investment in R&D, particularly at the late stage of costly clinical trials.

Small biotech companies that successfully brought new products to market approval, or near-approval have gone bankrupt, or are struggling to secure investments that “will allow them to survive,” says Greg Frank, director of Infectious Disease Policy at the Biotechnology Innovation Organization, in an interview with Health Policy Watch.

And with the exit of several large research-based biopharmaceutical companies such as Novartis, Sanofi, and AstraZeneca from the AMR drug development space in the past two years, smaller companies are no longer able to “shop around” and sell that product to a larger company that has the capital to take on the risk of bringing a new antimicrobial to market.

That means that highly promising early-stage discoveries may never reach patients unless investment in later and more costly stages of R&D for these products is ramped up, and new government incentives for antibiotic research are created.

Solutions for these problems include health systems’ recognition of the value of more orderly, planned and long-term drug procurement – so that manufacturers can reliably respond.  Frank notes that a “Netflix” model of longer-term contracts between health systems and drug manufacturers, can allow drug suppliers to rationally plan production and therefore supply, without fear of the sudden loss of a customer.

In terms of the development of new antibiotics to fight AMR, the market challenges are compounded by the fact that such drugs should, in principle, be reserved for a limited number of cases – infections that cannot be treated by other products.

One potential solution, says Frank, is the creation of new “market-entry rewards” for private companies that get marketing approval for a new antibiotic – which needs to be used very judiciously. Such rewards could take the form of transferable vouchers, he says, that might allow the company to extend the patent life of a more profitable product – or even sell that benefit to another company.

Interestingly enough, other types of market entry rewards have also been used as an incentive for the development of certain drugs for neglected diseases (NTDs) – a group of debilitating parasitic and bacterial diseases that affect the poorest and most marginalized populations.

And civil society advocates have also proposed the creation of cash prizes or other forms of “market entry awards” for researchers or companies that forego patent exclusivity on important new health innovations, which they say are driving high prices in the cancer, rare diseases and non-communicable disease spaces.

Watch if, and how, new publicly-supported incentives are shaped to help drive development of new drugs in the NTDs and AMR space, which might also set a precedent for public rewards or incentives related to other types of medicines.

NCDs and Universal Health Coverage

As the new decade dawns, non-communicable diseases (NCDs) are a rising priority on the global health agenda, particularly from the World Health Organization. As part of the NCD agenda, mental health is also receiving more attention, as reflected in a powerful conversation on the first day of the World Economic Forum between WHO Director General Dr Tedros Adhanom Ghebreyesus and Indian actress and activist Deepika Padukone  (see related story).

Non-communicable diseases, responsible for some 70% of deaths annually, is also the fourth item on the agenda of the 146^th Meeting of WHO’s Executive Board, preceded only by discussions on primary health care and universal health coverage.

Progress on combatting NCDs is also integral to the success of the Universal Health Coverage agenda – which aims to reduce NCD-related deaths by at least one-third by 2030. These include cardiovascular and respiratory diseases, often due to smoking and air pollution exposures, as well as diabetes, related to unhealthy diets, physical inactivity and obesity; cancer; and mental health issues.

Addressing NCDs would also reduce catastrophic financial health costs in low and middle-income countries – which occur because chronic health conditions are identified too late – making treatment more expensive and leading to higher rates of early death.

“We have a wealth of information about the global burden of disease and injury, we already know the best practices that will help to reduce that burden, and we’re only too well aware of the obstacles,” said José Luis Castro, president and CEO of the global health NGO Vital Strategies.

A key challenge for the decade leading up to the critical goal will be financing and equipping primary health systems with the tools to prevent and treat the leading NCDs, says Nina Renshaw director of policy and advocacy at the NCD Alliance.

Government health systems in low-income countries are typically built around maternal and newborn care, immunization, and HIV/TB and malaria programmes – all of which are heavily funded by international aid.

Advocates have pointed out that stronger primary health care could easily incorporate a basket of basic NCD prevention and treatment measures into existing maternal and child health care programmes, for instance, offering pregnant women and mothers blood pressure and diabetes checks, as well as breast cancer screening.

But what should seem simple is not. Existing vaccine, maternal and child health and disease control programmes often operate in siloes. National health systems are poorly-financed and international donors spend only about 1-2% of their disease prevention and control budget on NCD prevention and treatment.

Changing Global Health Architecture

Correcting this balance will therefore require a sea-change in the architecture of health systems and health finance. It would also require a much larger focus by national governments on prevention – e.g. preventing obesity through healthier diets and preventing air-pollution that is a cause of 7 million deaths annually, mainly related to cancer, stroke, heart attack and respiratory illness.

Some signs of change are indeed evident. Towards the end of 2019, Norway became the first major international donor to launch a development aid strategy targeted specifically for NCDs. Observers hope that other countries with major health aid operations, such as the United Kingdom, will soon follow suit.

“It’s time the global community mobilized to fund low-income countries, to help them take the actions they know will save lives,” said Castro. He also expressed hopes that the new Global Action Plan for Health Lives and Well-being launched by 12 powerful global health agencies – including WHO, the Global Fund, UNDP, UNICEF, UN Women, and the World Bank – might help create synergies between the programmes of different agencies on the ground.

Vital Strategies, along with the NCD Alliance and the Norwegians have all agreed with academics and emphasized the need to address risks upstream in policy measures. These include taxes and measures to reduce air pollution, and stronger tax policies for alcohol and tobacco.

“Here is an opportunity for policy makers to make the healthy choice, the easy choice, and roll-out tobacco restrictive public health policies in low- and middle-income settings that match those of high-income countries,” said Oksana Pyzik, senior teaching fellow at University College London.

Adds Castro, an abundance of clear guidance already exists, such as the WHO MPOWER policy measures for tobacco control and the SAFER technical package for alcohol control. But these measures are under-implemented globally. “No-one benefits when good policies sit on the shelf,” he added.

Simply increasing taxes on tobacco and alcohol products could save “millions of lives” every year, while simultaneously raising much needed financing for NCD programs, he noted.

The past year also saw NCD advocates grouping around stronger food policy measures such as front-of-package labelling standards for foods, taxes on sugary drinks, phaseout of unhealthy transfats, and other measures that discourage consumption of unhealthy foods and promote healthier diets.

Such measures have received strong uptake from many countries, including some key Latin American countries, such as Chile. But they have also encountered stiff opposition from other countries, including Italy and the United States, which at last year’s WHA sought to remove a summary of research findings on the health impacts of package labelling and sugar policies from a technical people that came before member states, claiming that the evidence was lacking.

The ‘Global Syndemic’ – Obesity, Undernutrition & Climate Change

At the same time, global reports released last year, including by The Lancet and WHO, have gone much further. They highlighted how food industries pushing diets heavy in processed foods, red meat, sugars and carbohydrates are driving a global syndemic of obesity, undernutrition and climate change.

One key 2020 moment for putting the nutrition issue more forcefully before countries and policymakers will be the 17-18 December Nutrition for Growth Summit.

Traffic injuries, among the top killers, are also often included in the NCD agenda or alongside it. That reflects the growing body of research showing that cities that prioritize cars, as compared to pedestrians, cyclists and public transport, not only create more traffic injury risks, but also inhibit physical activity, create health inequalities, generate  more air pollution, noise and mental stress – as well as higher carbon emissions per capita.

In short, fighting NCDs effectively, means addressing synergistic issues of food consumption, air pollution and climate change, requiring dialogue that goes well beyond the traditional health sector, to include urban actors, as well as a range of economic and development actors.

Says Castro, “We need to widen the pool of resources and talent to address the challenges before us. This will require a careful balancing act of bringing non-traditional partners to the table while guarding against vested interests like the tobacco, soda and fossil fuel industries.

“Despite clear examples of the terrible impacts of global climate change on habitats and health, now visibly playing out in Australia, and the inclusion of air pollution, the fourth leading killer globally, to the noncommunicable disease agenda, progress in these areas continues to be blocked by vested interests,” Castro claims.

“The next generation… is energized by these issues, but we can’t wait for them to become leaders of government and industry: the current incumbents must be held to account until they implement evidence-based policies to protect their people and the planet that supports us all.

“We need to make health integral to our environment and the priorities of government, civic and business life, so the healthy choice is the easy choice and the places where we live, work and play are empowering and healthy.”

Updated 27 January, 2020 – Grace Ren contributed to this story. 

Part 1 of The World On Fire: Five Global Health Stories to Watch in 2020 found here. 

 

Image Credits: AMR Industry Alliance, Arend Kuester/Flickr, Twitter/@OMSDRCONGO, Twitter/@Italy_UNGeneva, http://videos.assemblee-nationale.fr/, European Health Forum Gastein 2019, Interpol, Twitter: @WHO, Flickr/_chrisUK.