Health in a post-pandemic EU

As this magazine goes to press, the World Health Organisation has registered just shy of seven million global deaths due to COVID-19. It also has registered over 13.5 billion doses of vaccines administered. When it comes to health, it’s truly an extraordinary period to be alive. And to stay alive, if all works out as it seems to be doing.

As this magazine goes to press, the World Health Organisation has registered just shy of seven million global deaths due to COVID-19. It also has registered over 13.5 billion doses of vaccines administered. When it comes to health, it’s truly an extraordinary period to be alive. And to stay alive, if all works out as it seems to be doing.


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02<br />

23<br />

A ‘cure’ for obesity<br />

Interview with ECDC’s<br />

Andrea Ammon<br />

Rare no more?<br />

Keep<strong>in</strong>g an eye on<br />

AI-powered drugs<br />

<strong>Health</strong> <strong>in</strong> a <strong>post</strong>-<strong>pandemic</strong> <strong>EU</strong>







<strong>Health</strong> <strong>in</strong> a<br />

<strong>post</strong>-<strong>pandemic</strong> <strong>EU</strong><br />


NO<br />

NO<br />

As this magaz<strong>in</strong>e goes to press, the World <strong>Health</strong> Organisation has registered<br />

just shy of seven million global deaths due to COVID-19.<br />



It also has registered over 13.5 billion doses of vacc<strong>in</strong>es<br />

adm<strong>in</strong>istered.<br />

This is an astonish<strong>in</strong>g feat, especially given that these vacc<strong>in</strong>es<br />

did not exist a mere three years ago.<br />

In June of this year, New York Times journalist David Wallace-Wells,<br />

who did fantastic health report<strong>in</strong>g throughout<br />

the <strong>pandemic</strong>, wrote an article titled ‘Suddenly, It Looks<br />

Like We’re <strong>in</strong> a Golden Age for Medic<strong>in</strong>e.’<br />

In a newspaper normally not given to hyperbole, he describes<br />

the advent of a whole new wave of pharmaceutical<br />

<strong>in</strong>novation that might drastically change our relationship<br />

with diseases over the next couple of decades.<br />

Just take mRNA vacc<strong>in</strong>es, which were so successfully used<br />

to push back the coronavirus, and the potential offered<br />

by the precise eng<strong>in</strong>eer<strong>in</strong>g of genetic material to combat<br />

illness.<br />

Currently, mRNA vacc<strong>in</strong>es are be<strong>in</strong>g developed to fight<br />

some of the most deadly <strong>in</strong>fectious diseases on the planet;<br />

from malaria to H.I.V., to dengue, zika and tuberculosis.<br />

The same method is also show<strong>in</strong>g promis<strong>in</strong>g results aga<strong>in</strong>st<br />

certa<strong>in</strong> types of cancers.<br />

The better understand<strong>in</strong>g of disease pathways is also<br />

lead<strong>in</strong>g to scores of new drugs, some of which seem to be<br />

perform<strong>in</strong>g at previously unimag<strong>in</strong>able efficacy.<br />

Targeted chemotherapy aga<strong>in</strong>st certa<strong>in</strong> types of breast cancer<br />

have extended life expectancy by one hundred percent.<br />

A small group of patients receiv<strong>in</strong>g a new drug that fights<br />

rectal cancer were actually cured.<br />

And then we haven’t even gotten <strong>in</strong>to developments <strong>in</strong><br />

gene therapy, which could be a life-saver for people with<br />

s<strong>in</strong>gle-gene mutations, drugs that effectively treat obesity<br />

and preventive detection methods.<br />

In this magaz<strong>in</strong>e, we take a look at some of these developments,<br />

and why there is reason for hope on many fronts<br />

– while at the same time also explor<strong>in</strong>g new health risks<br />

due to climate change, shift<strong>in</strong>g demographics and future<br />

<strong>pandemic</strong>s.<br />

When it comes to health, it’s truly an extraord<strong>in</strong>ary period<br />

to be alive. And to stay alive, if all works out as it seems to<br />

be do<strong>in</strong>g.<br />



HEALTH IN A POST-PANDEMIC <strong>EU</strong><br />

In this issue<br />

6<br />

10<br />

16<br />

26<br />

30<br />

32<br />

A ‘cure’ for obesity<br />

Who cares?<br />

Roche -A call for<br />

dialogue<br />

“It’s not just about<br />

slogans”<br />

Novartis - Prevent<strong>in</strong>g<br />

the death of 200<br />

people per hour<br />

Keep<strong>in</strong>g an eye on<br />

AI-powered drugs<br />

18<br />

20<br />

24<br />

36<br />

38<br />

In sickness and <strong>in</strong> health<br />

Rare no more?<br />

Moderna - The loom<strong>in</strong>g<br />

threat of ‘Disease X’<br />

Miltenyi Biotec -<br />

The miss<strong>in</strong>g piece of<br />

the puzzle<br />

Prescrib<strong>in</strong>g our way out:<br />

The <strong>EU</strong>’s fight aga<strong>in</strong>st<br />

antimicrobial resistance<br />


HEALTH IN A POST-PANDEMIC <strong>EU</strong><br />

Appetite-suppress<strong>in</strong>g drugs have<br />

generated popular excitement, and<br />

endless coverage <strong>in</strong> ma<strong>in</strong>stream<br />

media, but potential side effects<br />

and addiction issues mean the drug<br />

revolution is not happen<strong>in</strong>g without<br />

concerns.<br />

A ‘cure’ for obesity<br />

Follow<strong>in</strong>g the success of diabetes drugs for weight loss, concerns<br />

rema<strong>in</strong> about long-term effects – both for health and society.<br />


Two months after Danish pharmaceutical<br />

company Novo Nordisk launched<br />

Wegovy, its blockbuster weight-loss<br />

drug, <strong>in</strong> Europe, demand has exploded.<br />

Overweight Germans are desperate to<br />

get a hold of the drug, hop<strong>in</strong>g to lose<br />

weight. 48-year-old Philipp Lang from<br />

Bad Homburg, near Frankfurt <strong>in</strong> Germany<br />

is one of them.<br />

Lang has a background <strong>in</strong> <strong>in</strong>vestment<br />

bank<strong>in</strong>g and IT. He runs a family bus<strong>in</strong>ess,<br />

act<strong>in</strong>g as the manag<strong>in</strong>g director of<br />

an illum<strong>in</strong>ation company <strong>in</strong> Friedrichsdorf<br />

while runn<strong>in</strong>g restaurants <strong>in</strong> Frankfurt<br />

on the side. Lang is a busy man.<br />

From his car, he tells <strong>EU</strong>observer about<br />

his weight journey. Like many, Lang<br />

ga<strong>in</strong>ed weight dur<strong>in</strong>g the COVID <strong>pandemic</strong>.<br />

His weight peaked at 120 kilograms.<br />

In August 2022, he was hospitalised<br />

for psoriasis spread<strong>in</strong>g out as<br />

arthritis and went through cortisone<br />

treatment, a steroid hormone that relieves<br />

pa<strong>in</strong> and <strong>in</strong>flammation.<br />

He started tak<strong>in</strong>g Ozempic, a diabetes<br />

drug commonly used to obta<strong>in</strong> weightloss,<br />

to prevent weight ga<strong>in</strong> as a result of<br />

the cortisone treatment. When Wegovy<br />

(which conta<strong>in</strong>s the same active <strong>in</strong>gredient,<br />

semaglutide, <strong>in</strong> a higher concentration)<br />

was made available <strong>in</strong> Germany, he<br />

immediately took it.<br />

“It worked well,” Lang says. Without implement<strong>in</strong>g<br />

lifestyle changes, he quickly<br />

shed weight and is now at 105 kilograms.<br />

Ozempic and Wegovy mimic a hormone<br />

called glucagon-like peptide-1 which<br />

targets parts of the bra<strong>in</strong> that regulate<br />

appetite. The hormone slows down the<br />

rate of ‘gastric empty<strong>in</strong>g’, which means<br />

people feel fuller and have less desire to<br />

eat. It also encourages the body to break<br />

down fat.<br />

In 2018, Ozempic was approved <strong>in</strong> the <strong>EU</strong><br />

for type 2 diabetes, but not for weightloss.<br />

By the end of 2021, the European<br />

Medic<strong>in</strong>es Agency (EMA) approved the<br />

drug <strong>in</strong> a higher concentration, under<br />

the brand name Wegovy, for chronic<br />

weight management <strong>in</strong> the <strong>EU</strong>.<br />

The share price of Novo Nordisk, the<br />

company beh<strong>in</strong>d the popular weightloss<br />

drugs, surged by almost 120 percent<br />

s<strong>in</strong>ce the debut of Wegovy on the US<br />

market <strong>in</strong> June 2021, mak<strong>in</strong>g it Europe’s<br />

second-most valued, listed company and<br />

transform<strong>in</strong>g the economy of its home<br />

nation, Denmark.<br />

Rival obesity drugs are already under<br />

way. Mounjaru, a diabetes drug produced<br />

by Eli Lilly, an American drugmaker, was<br />

approved by the US Food and Drug Adm<strong>in</strong>istration<br />

<strong>in</strong> May for diabetes and is<br />

expected to expand to weight loss soon.<br />

Novo Nordisk is currently advanc<strong>in</strong>g<br />

its next-generation offer<strong>in</strong>gs with high<br />

hopes for CagriSema, another obesity<br />

drug, currently <strong>in</strong> phase 3 development.<br />

Amgen, AstraZeneca, Pfizer and smaller<br />

biotech companies are rac<strong>in</strong>g to develop<br />

new drugs as well.<br />

Appetite-suppress<strong>in</strong>g drugs have generated<br />

popular excitement, and endless<br />

coverage <strong>in</strong> ma<strong>in</strong>stream media, but potential<br />

side effects and addiction issues<br />

mean the drug revolution is not happen<strong>in</strong>g<br />

without concerns.<br />

A grow<strong>in</strong>g problem<br />

Globally, obesity rates have almost tripled<br />

s<strong>in</strong>ce 1975. The COVID <strong>pandemic</strong><br />

compounded this problem. A 2022 World<br />

<strong>Health</strong> Organisation report estimates<br />

that 59 percent of adults <strong>in</strong> the European<br />

region are overweight or obese.<br />

Overweight can have devastat<strong>in</strong>g effects,<br />

caus<strong>in</strong>g more than 1.2 million deaths<br />

across the European cont<strong>in</strong>ent every<br />

year, accord<strong>in</strong>g to WHO estimates. Be<strong>in</strong>g<br />

overweight can lead to heart disease,<br />

stroke, diabetes, fatty liver, <strong>in</strong>creased risk<br />

of cancer, knee pa<strong>in</strong> and a myriad of other<br />

health issues.<br />



HEALTH IN A POST-PANDEMIC <strong>EU</strong><br />

Weight-loss drugs provide a solution for patients who are not overweight enough to undergo surgery and with a weekly jab, it’s less <strong>in</strong>vasive too.<br />

Source: iStock<br />

The economic costs are considerable as<br />

well. The World Obesity Federation predicts<br />

that the global cost of overweight<br />

and obesity will reach more than 4 trillion<br />

USD annually by 2035 – almost three<br />

percent of global GDP.<br />

Until now, many obese people felt they<br />

had few options to tackle their weight<br />

problems. But combatt<strong>in</strong>g obesity holds<br />

the promise of economic benefits, improved<br />

livelihoods – and ultimately<br />

saved lives.<br />

Sky-high expectations<br />

Last year, doctors granted more than 5<br />

million prescriptions for key weight-loss<br />

drugs – a 2,000 percent <strong>in</strong>crease from<br />

2019, accord<strong>in</strong>g to Komodo <strong>Health</strong>, a<br />

healthcare data-<strong>in</strong>sights platform.<br />

Doctors warn<br />

about hitt<strong>in</strong>g<br />

a weight<br />

plateau;<br />

the body<br />

acclimates<br />

to the<br />

drug and<br />

establishes a<br />

new normal.<br />

“In the first six months of 2023, our obesity<br />

care sales grew by 157 percent at<br />

constant exchange rates, ma<strong>in</strong>ly driven<br />

by Wegovy® <strong>in</strong> the US,” a spokesperson<br />

from Novo Nordisk wrote <strong>in</strong> an email<br />

statement.<br />

The drugmaker is proud of its blockbuster<br />

drug: “Wegovy represents significant<br />

<strong>in</strong>novation for obesity treatment,” the<br />

spokesperson highlights. In phase 3 cl<strong>in</strong>ical<br />

trials, Wegovy led to an average of 17<br />

to 18 percent weight loss over 68 weeks.<br />

Data shows the drug reduced the risk of<br />

major adverse cardiovascular events by<br />

20 percent, accord<strong>in</strong>g to the company.<br />

“There’s a lot of excitement amongst<br />

people with diabetes,” says Tanja Thybo,<br />

head of research at the Danish Diabetes<br />

Association. She says general<br />

practitioners experience pressure to prescribe<br />

Ozempic to people with diabetes,<br />

who prefer it over other drugs due to its<br />

weight-reduc<strong>in</strong>g properties.<br />

Weight-loss drugs provide a solution for<br />

patients who are not overweight enough<br />

to undergo surgery, like Lang, and with a<br />

weekly jab, it’s less <strong>in</strong>vasive too.<br />

Wegovy allowed Lang to cont<strong>in</strong>ue eat<strong>in</strong>g<br />

and dr<strong>in</strong>k<strong>in</strong>g as he used to. He asked<br />

himself: “What’s the worst th<strong>in</strong>g that can<br />

happen? Noth<strong>in</strong>g. I can just go off the<br />

drug,” Lang concluded. He never experienced<br />

any issues.<br />

But patient excitement may be grounded<br />

<strong>in</strong> the fact that risks are not discussed<br />

enough, says Kimberly Dennis, a doctor<br />

specialised <strong>in</strong> eat<strong>in</strong>g disorders.<br />

Dennis says there have been aggressive<br />

market<strong>in</strong>g campaigns from Big Pharma.<br />

“I get suspicious when Big Pharma advertises<br />

drugs at bus stops,” she says. Novo<br />

Nordisk and other drugmakers have<br />

been criticised for lobby<strong>in</strong>g doctors and<br />

<strong>in</strong>surers, as well as runn<strong>in</strong>g biassed educational<br />

campaigns for patients.<br />

Risks and rewards<br />

S<strong>in</strong>ce July 3, several weight-loss drugs are<br />

undergo<strong>in</strong>g a review by the EMA, after<br />

reports about suicides amongst users. In<br />

an email response, the EMA says the review<br />

is expected to conclude <strong>in</strong> November<br />

2023.<br />

Nausea, diarrhoea, vomit<strong>in</strong>g, constipation,<br />

and stomach pa<strong>in</strong> have been reported<br />

as common side effects of the<br />

weight-loss drugs. The drugs also come<br />

with warn<strong>in</strong>gs about more serious side<br />

effects such as <strong>in</strong>creased risk of thyroid<br />

cancer, <strong>in</strong>flammation of the pancreas,<br />

gallbladder issues, low blood sugar, damage<br />

to kidneys and ret<strong>in</strong>as, and suicidal<br />

thoughts.<br />

“Patient safety is a top priority for Novo<br />

Nordisk,” the company spokesperson<br />

writes, expla<strong>in</strong><strong>in</strong>g that Novo Nordisk collaborates<br />

closely with authorities. “EMA<br />

cont<strong>in</strong>uously monitors for safety signals<br />

and so does Novo Nordisk. Novo Nordisk<br />

rema<strong>in</strong>s confident <strong>in</strong> the benefit risk<br />

profile of the products.”<br />

Dennis however fears these drugs are too<br />

radical for many patients, and that they’ll<br />

create severe addiction problems. “Like<br />

what we saw with the opioid crisis.”<br />

Doctors warn about hitt<strong>in</strong>g a weight plateau;<br />

the body acclimates to the drug and<br />

establishes a new normal. “If you stop<br />

tak<strong>in</strong>g the drug, you’ll rega<strong>in</strong> weight,”<br />

Thybo expla<strong>in</strong>s. These drugs are thus <strong>in</strong>tended<br />

for lifelong use.<br />

In our fat-phobic society, weight-loss<br />

drugs may re<strong>in</strong>force weight stigma. Sylvia<br />

Weiser, who runs an obesity cl<strong>in</strong>ic<br />

near Frankfurt, fears the drugs will<br />

be misused by <strong>in</strong>dividuals who are not<br />

obese. “The body adapts to the drugs.<br />

Giv<strong>in</strong>g the medic<strong>in</strong>e to people without<br />

disease may actually cause the disease,”<br />

she says.<br />

Weiser says obesity must be recognised<br />

as a disease. “People often th<strong>in</strong>k it’s just<br />

about lifestyle and m<strong>in</strong>dset, about willpower.<br />

That’s simplified and wrong.” She<br />

says underly<strong>in</strong>g biology can keep people<br />

from los<strong>in</strong>g weight, and that gut hormones<br />

are responsible for most obesity<br />

cases. It’s often because of miscommunication<br />

between the bra<strong>in</strong>, the gut, the<br />

liver, and the pancreas. “The body simply<br />

won’t accept weight-loss,” she says.<br />

“If you have a disease, medic<strong>in</strong>e will<br />

help,” Weiser says. “Medic<strong>in</strong>e is a way of<br />

accept<strong>in</strong>g obesity as a disease,” she adds.<br />

Weiser says these drugs can f<strong>in</strong>ally help<br />

struggl<strong>in</strong>g, stigmatised patients. “About<br />

80 percent of my patients who took the<br />

drugs don’t feel hungry anymore. It’s really<br />

impressive, they feel better,” she says.<br />

What awaits<br />

However effective these drugs are at<br />

treat<strong>in</strong>g obesity, we need to <strong>in</strong>tervene<br />

earlier, accord<strong>in</strong>g to Dennis. Structural<br />

<strong>in</strong>equalities like limited access to affordable<br />

healthy food, limited access to quality<br />

healthcare, particularly mental health<br />

care, and limited access to green spaces<br />

to exercise for some population groups<br />

exacerbate obesity issues.<br />

But the drugs are not here to tackle the<br />

root causes of obesity. They’re here to<br />

profit from the treatment of it. While<br />

there’s a huge potential to help obese patients,<br />

there’s a need for caution too.<br />

“This looks different for each patient.<br />

Why they’re obese and how they’re best<br />

treated,” Weiser says. She hopes there’ll<br />

be more research on the topic and better<br />

patient and doctor education.<br />

For Philipp Lang, the drugs have made<br />

his life better. But perhaps the pharmaceuticals’<br />

promises won’t hold for everyone.<br />

•<br />

About<br />

Mie Hoejris Dahl<br />

Mie Hoejris Dahl is a Danish freelance<br />

journalist based <strong>in</strong> Mexico<br />

City, Mexico. She reports on politics,<br />

economics, health and social<br />

issues.<br />


Who<br />

cares?<br />

Europe’s future health problems are<br />

here today, emphasis<strong>in</strong>g the need for<br />

policy makers to focus on provid<strong>in</strong>g<br />

more avenues for car<strong>in</strong>g for an age<strong>in</strong>g<br />

population.<br />



WHO CARES?<br />

HEALTH IN A POST-PANDEMIC <strong>EU</strong><br />

With an<br />

age<strong>in</strong>g<br />

population,<br />

the ‘care’ <strong>in</strong><br />

healthcare<br />

needs to<br />

become more<br />

prom<strong>in</strong>ent,<br />

experts say.<br />

Across Europe, over the last 50 years, life<br />

expectancy has <strong>in</strong>creased considerably.<br />

Europe is gett<strong>in</strong>g older, and people are<br />

liv<strong>in</strong>g longer. By 2050, those aged 65 and<br />

over are expected to make up one quarter<br />

of the population <strong>in</strong> Europe. Most babies<br />

born s<strong>in</strong>ce 2000 <strong>in</strong> France, Germany,<br />

Italy, and other developed countries are<br />

expected to live to celebrate their 100th<br />

birthdays. The projected population pyramid,<br />

as a result, will look top heavy. As<br />

such, the health challenges faced by the<br />

population is go<strong>in</strong>g to see a dramatic<br />

shift.<br />

The paradox at play is that better health<br />

has been the ma<strong>in</strong> driver of <strong>in</strong>creased<br />

longevity of people <strong>in</strong> Europe, while liv<strong>in</strong>g<br />

longer comes with additional health<br />

problems such as cardiovascular disease,<br />

diabetes, lower-back compla<strong>in</strong>ts, arthritis,<br />

leg ulcers, hypertension, and asthma.<br />

Diseases previously thought of as ‘silent’,<br />

such as type 2 diabetes, hypertension,<br />

and some cancers, now get diagnosed<br />

earlier and receive better treatment than<br />

before. Overall behavioural changes <strong>in</strong><br />

lifestyle over the years, <strong>in</strong>clud<strong>in</strong>g reduced<br />

exposure to carc<strong>in</strong>ogens such as tobacco<br />

smoke have also contributed to <strong>in</strong>creased<br />

longevity <strong>in</strong> the population.<br />

This overarch<strong>in</strong>g shift means health systems<br />

now must focus less on acute care<br />

and the prevention of premature death<br />

to focus<strong>in</strong>g on provid<strong>in</strong>g a cont<strong>in</strong>uum<br />

of care that promotes health across the<br />

life course. With an age<strong>in</strong>g population,<br />

the ‘care’ <strong>in</strong> healthcare needs to become<br />

more prom<strong>in</strong>ent, experts say.<br />

Confront<strong>in</strong>g <strong>in</strong>adequacy<br />

Accord<strong>in</strong>g to the World <strong>Health</strong> Organisation,<br />

with<strong>in</strong> the European Region 135<br />

million people are liv<strong>in</strong>g with disabilities,<br />

and nearly one <strong>in</strong> three older people<br />

cannot meet their basic needs <strong>in</strong>dependently.<br />

“The lessons of the <strong>pandemic</strong> are clear.<br />

But are we better prepared now to face a<br />

challenge of this scale? What we know is<br />

that we need to <strong>in</strong>vest more <strong>in</strong> our health<br />

systems, <strong>in</strong>clud<strong>in</strong>g <strong>in</strong> the way we deliver<br />

long-term care to those who need it,”<br />

said Dr Natasha Azzopardi-Muscat,<br />

WHO Europe’s Director of Country<br />

<strong>Health</strong> Policies and Systems.<br />

The COVID-19 <strong>pandemic</strong> exposed the<br />

vulnerabilities of care systems, <strong>in</strong>clud<strong>in</strong>g<br />

<strong>in</strong>adequate long-term care services and<br />

poor <strong>in</strong>tegration with health-care delivery.<br />

In the European Union alone, the<br />

<strong>in</strong>itial waves of the <strong>pandemic</strong> resulted<br />

<strong>in</strong> approximately 200,000 deaths among<br />

residents of long-term care facilities.<br />

“Medical care can’t address the many<br />

issues that we are fac<strong>in</strong>g right now,” expla<strong>in</strong>s<br />

Alfonso Lara-Montero, CEO of<br />

the European Social Network, a pan-European<br />

network for public authorities<br />

with responsibility for social services.<br />

“We need to put <strong>in</strong> place a system which<br />

as much as possible supports people <strong>in</strong><br />

their communities, <strong>in</strong> their homes, and<br />

<strong>in</strong> their communities by creat<strong>in</strong>g an ecosystem<br />

of care”.<br />

Such demographic and epidemiological<br />

transitions that are tak<strong>in</strong>g place <strong>in</strong><br />

Europe suggest a potential problem of<br />

resource allocation to the health care<br />

sector, and more concretely expose a<br />

current lack of staff <strong>in</strong> the service sector,<br />

with subsequent consequences for the<br />

future design of healthcare workforces<br />

and services.<br />

Integrat<strong>in</strong>g care<br />

In 2018, the European Commission undertook<br />

a study of national policies on<br />

long-term care. The report found that<br />

<strong>in</strong> most countries, long-term care for<br />

the elderly is not a dist<strong>in</strong>ct social policy<br />

field, with provisions characterised by<br />

a fragmentation of responsibilities and<br />

consequently a lack of <strong>in</strong>tegration between<br />

health and social aspects of care<br />

provision. As such, there is a lack of formal<br />

long-term care facilities across much<br />

of Europe, lead<strong>in</strong>g to a high <strong>in</strong>cidence of<br />

<strong>in</strong>formal care.<br />

Across Europe, many actors are push<strong>in</strong>g<br />

for more <strong>in</strong>tegrated delivery of care<br />

– when people can access the care they<br />

need <strong>in</strong> a timely and comprehensive way,<br />

with services rang<strong>in</strong>g from prevention,<br />

treatment, long-term care to rehabilitative<br />

or palliative care.<br />

“Some choices have been made at a policy<br />

level to significantly <strong>in</strong>vest <strong>in</strong> secondary<br />

and specialist health care, but not <strong>in</strong><br />

community care. Community care <strong>in</strong>cludes<br />

both health and also social care,”<br />

Alfonso expla<strong>in</strong>s. Invest<strong>in</strong>g <strong>in</strong> community<br />

care allows for more work on prevention,<br />

which <strong>in</strong> turn prevents older people<br />

from be<strong>in</strong>g hospitalised.<br />


WHO CARES?<br />

This is a human rights issue, we talk<br />

about the European social welfare<br />

model. So let’s make sure <strong>in</strong> the<br />

first place that we are support<strong>in</strong>g<br />

people <strong>in</strong> the best possible way.”<br />

Alfonso Lara-Montero<br />

With<strong>in</strong> Europe, the split between formal,<br />

<strong>in</strong>formal, community, and facility-based<br />

care differs from region to region. Homecare<br />

services and community-based care<br />

are often the most difficult to access,<br />

s<strong>in</strong>ce they are underdeveloped <strong>in</strong> many<br />

countries.<br />

Home and community-based services<br />

are most developed <strong>in</strong> the Nordic countries<br />

such as Denmark and F<strong>in</strong>land, while<br />

countries <strong>in</strong> the southern region face <strong>in</strong>sufficient<br />

availability of home care provision.<br />

One of the consequences of the<br />

priority given to home care and community-based<br />

provision has been that the<br />

availability of residential care has been<br />

decreas<strong>in</strong>g <strong>in</strong> several European countries<br />

over the past 25 years.<br />

and Policies explored the possibilities<br />

of ‘w<strong>in</strong>–w<strong>in</strong>’ politics that produce good<br />

outcomes for people of all ages, with a<br />

focus on embrac<strong>in</strong>g social determ<strong>in</strong>ants<br />

of health and allow<strong>in</strong>g economic productivity<br />

even at old age.<br />

In order to keep healthcare systems affordable<br />

and susta<strong>in</strong>able, governments<br />

are <strong>in</strong>creas<strong>in</strong>gly tak<strong>in</strong>g <strong>in</strong>to consideration<br />

the reliance on <strong>in</strong>formal care provided by<br />

family members, friends, or neighbours.<br />

The assumption is that more emphasis<br />

on this type of <strong>in</strong>formal care will eventually<br />

alter societal norms towards more<br />

family responsibility <strong>in</strong> care provision, so<br />

that people will become more <strong>in</strong>cl<strong>in</strong>ed<br />

to take care of age<strong>in</strong>g family members<br />

themselves.<br />

“This is a human rights issue,” expla<strong>in</strong>s<br />

Alfonso. “We talk about the European<br />

social welfare model. So let’s make sure<br />

<strong>in</strong> the first place that we are support<strong>in</strong>g<br />

people <strong>in</strong> the best possible way.” That<br />

means provid<strong>in</strong>g the type and quality<br />

of care that best suits the <strong>in</strong>dividual –<br />

whether that is <strong>in</strong>stitutional, community,<br />

or <strong>in</strong>formal care. •<br />

“A human rights issue”<br />

Population age<strong>in</strong>g is often treated as a<br />

threat to the susta<strong>in</strong>ability of health systems.<br />

As such, policies are often framed<br />

around reduc<strong>in</strong>g overall costs and the<br />

f<strong>in</strong>ancial burden to states.<br />

In 2021, the Economic Policy Committee<br />

produced a set of long-term projections<br />

of age-related expenditure, f<strong>in</strong>d<strong>in</strong>g<br />

that age-related expenditure as a share<br />

of GDP is projected to <strong>in</strong>crease <strong>in</strong> com<strong>in</strong>g<br />

years, driven by long term care and<br />

healthcare.<br />

However, analysis done by the European<br />

Observatory on <strong>Health</strong> Systems<br />

Informal care has been estimated to have<br />

an economic value equivalent to 50 to 90<br />

percent of the overall cost of long-term<br />

care across the <strong>EU</strong>. Researchers estimated<br />

that around 80 percent of all care<br />

ceived by people of all ages <strong>in</strong> the <strong>EU</strong> is<br />

provided by <strong>in</strong>formal carers – of which<br />

two thirds are women.<br />

Gender <strong>in</strong>equalities are a constant challenge<br />

<strong>in</strong> health delivery, and even more<br />

so <strong>in</strong> the context of age<strong>in</strong>g. The devaluation<br />

of care work and the fact that women<br />

deliver the majority of both paid and<br />

unpaid care are as a result of structural<br />

power imbalances that should be addressed<br />

<strong>in</strong> policy.<br />

About<br />

Charles Ebikeme<br />

Dr. Charles Ebikeme is a science<br />

writer based <strong>in</strong> London. He holds<br />

a PhD <strong>in</strong> Parasitology and has<br />

worked across science and policy.<br />

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HEALTH IN A POST-PANDEMIC <strong>EU</strong><br />

Stakeholder Article<br />

A call for dialogue<br />

If <strong>in</strong>novators and legislators listen to each other, the <strong>EU</strong>’s<br />

pharmaceutical reforms will transform patient care and improve<br />

the bloc’s global competitiveness.<br />

By PADRAIC WARD, Head of Roche Pharma Europe, Ch<strong>in</strong>a and International.<br />

The <strong>EU</strong>’s ongo<strong>in</strong>g revision of the General Pharmaceutical<br />

Legislation has the potential to impact healthcare across Europe<br />

for decades to come.<br />

I am committed to help<strong>in</strong>g this revision be a success and I<br />

th<strong>in</strong>k to do so requires <strong>EU</strong> legislators, the life sciences <strong>in</strong>dustry<br />

and all <strong>in</strong>volved to recognise our <strong>in</strong>terdependence <strong>in</strong> provid<strong>in</strong>g<br />

the best possible healthcare for patients.<br />

It is only if the solutions <strong>in</strong> this legislation work for all that Europe<br />

will have a future characterised by high quality healthcare.<br />

One prerequisite is the presence of a strong <strong>in</strong>novation<br />

sector across Europe. This boosts patients’ health through<br />

access to the latest <strong>in</strong>novations and heightens <strong>EU</strong> competitiveness<br />

on the global stage.<br />

Currently, whilst almost all parties are united <strong>in</strong> their belief<br />

we need to improve access to care <strong>in</strong> Europe, there are clear<br />

signs that more openness and collaboration is needed before<br />

a pragmatic way forward can be found.<br />

Unfortunately, as it stands, some of the proposals, whilst laudable<br />

<strong>in</strong> ambition, are simply not practical. To give an example,<br />

the <strong>EU</strong> is propos<strong>in</strong>g to remove two years of regulatory data<br />

protection (part of <strong>in</strong>tellectual property protections) from<br />

any product that a pharmaceutical company fails to launch <strong>in</strong><br />

all <strong>EU</strong> member states with<strong>in</strong> two years of receiv<strong>in</strong>g market<strong>in</strong>g<br />

authorisation.<br />

No one could disagree that we should take steps to address<br />

the considerable delays <strong>in</strong> access to <strong>in</strong>novation we see <strong>in</strong> some<br />

areas of Europe. The problem with this proposal is that it is<br />

not solely with<strong>in</strong> the gift of the life sciences sector to make it<br />

happen. While fil<strong>in</strong>g for new medic<strong>in</strong>es is our responsibility,<br />

the speed of the f<strong>in</strong>al reimbursement decision is not down<br />

to us alone. It is dependent on many local factors such as a<br />

country’s health technology assessment (HTA) process, and<br />

the availability of cl<strong>in</strong>ical expertise and budgetary processes.<br />

We therefore believe it is unrealistic to expect new products<br />

to become available <strong>in</strong> all 27 member states with<strong>in</strong> two years.<br />

Our counter-proposal – as part of our membership of EFPIA<br />

– is for <strong>in</strong>novators to commit to file future products for reimbursement<br />

with<strong>in</strong> two years <strong>in</strong> all <strong>EU</strong> countries. This is someth<strong>in</strong>g<br />

the <strong>in</strong>dustry can control and deliver on.<br />

As mentioned before I believe that we are all try<strong>in</strong>g to achieve<br />

the same outcome with this new legislation: excellent healthcare<br />

for the citizens of the <strong>EU</strong>. I believe, too, that we face similar<br />

challenges: economic downturn, <strong>in</strong>flation, <strong>in</strong>stability of<br />

war, forc<strong>in</strong>g us all to prioritise budgets and spend<strong>in</strong>g even<br />

more than before. I therefore believe that the impractical elements<br />

of the <strong>EU</strong>’s proposed reforms are not down to different<br />

ambitions, but <strong>in</strong>stead because we are not work<strong>in</strong>g closely<br />

Europe has long had<br />

strengths that set it<br />

apart from other parts<br />

of the world, from<br />

excellent scientific talent<br />

to expansive health<br />

coverage for citizens.<br />

enough together to design solutions that will truly improve<br />

patient access <strong>in</strong> Europe.<br />

We know that when <strong>in</strong>dustry and policymakers engage closely,<br />

it can be transformational for patients. For <strong>in</strong>stance, the<br />

life sciences <strong>in</strong>dustry recently worked closely with the <strong>EU</strong><br />

Commission to exam<strong>in</strong>e the European Medic<strong>in</strong>es Agency’s<br />

review processes. This has now resulted <strong>in</strong> the <strong>in</strong>troduction<br />

of faster and more flexible methods when the EMA assesses<br />

highly <strong>in</strong>novative products. This welcome move has the potential<br />

to speed up patients’ access to the most life-chang<strong>in</strong>g<br />

<strong>in</strong>novations.<br />

My call therefore is for <strong>EU</strong> legislators and the life sciences<br />

<strong>in</strong>dustry to use the com<strong>in</strong>g months to work together to revise<br />

the proposed reforms to the General Pharmaceutical Legislation,<br />

ensur<strong>in</strong>g that the f<strong>in</strong>al text provides a susta<strong>in</strong>able and<br />

competitive environment for life sciences <strong>in</strong>novators across<br />

Europe that enables a true change for patients.<br />

Europe has long had strengths that set it apart from other<br />

parts of the world, from excellent scientific talent to expansive<br />

health coverage for citizens. I hope that, with our long<br />

history <strong>in</strong> Europe, Roche can help restore the k<strong>in</strong>d of relationship<br />

between <strong>in</strong>novators and <strong>EU</strong> bodies that cont<strong>in</strong>ues to<br />

keep Europe a world-lead<strong>in</strong>g life science hub and the cradle<br />

of so many advances for patients. •<br />

www.roche.com<br />

Scan QR code<br />

for more <strong>in</strong>fo<br />



HEALTH IN A POST-PANDEMIC <strong>EU</strong><br />

In sickness<br />

and <strong>in</strong> health<br />

The European Commissioner for <strong>Health</strong> and Food Safety on where<br />

we were and where we are go<strong>in</strong>g <strong>in</strong> terms of health policy and<br />

preparedness for the future.<br />


Stella Kyriakides, Member designate of the EC <strong>in</strong> charge of <strong>Health</strong> - Source: Central Audiovisual Library of the European Commission<br />

In March 2020, follow<strong>in</strong>g a statement<br />

from the World <strong>Health</strong> Organization,<br />

Europe began to shut its borders for the<br />

first time <strong>in</strong> over 70 years.<br />

Airports like Paris Orly, Dusseldorf and<br />

Heathrow saw planes grounded, sitt<strong>in</strong>g<br />

idle.<br />

Little thought of airport equipment on<br />

misused laneways arose when it became<br />

apparent that we were all for now immobile<br />

and <strong>in</strong> quarant<strong>in</strong>e. Schools, offices,<br />

cities and countries shut down.<br />

COVID 19 resulted <strong>in</strong> millions of deaths.<br />

Unprecedented pneumological symptoms<br />

and medical <strong>in</strong>eptness filled up<br />

hospitals, funeral parlours and cemeteries.<br />

When the <strong>pandemic</strong> hit, European Commissioner<br />

Stella Kyriakides was just<br />

one year <strong>in</strong>to her term as Commissioner<br />

com<strong>in</strong>g from a Council of Europe (CoE)<br />

Parliamentary Committee on social affairs,<br />

health and regional development.<br />

Her largest project focused on child sexual<br />

abuse.<br />

But even as far back as 2014 and 2015,<br />

when her term at CoE began, she would<br />

wear a p<strong>in</strong>k beat cancer button on her<br />

lapel. Earlier still, <strong>in</strong> 2004, she had been<br />

President of the European Breast Cancer<br />

Coalition.<br />

“We are not where we were three years<br />

ago,” the Commissioner says, when<br />

asked about the <strong>EU</strong>’s <strong>post</strong>-<strong>pandemic</strong> situation.<br />

“But we need to rema<strong>in</strong> cautious<br />

and vigilant. The virus is still with us.<br />

Our protection is now significantly better,<br />

but it is still circulat<strong>in</strong>g and evolv<strong>in</strong>g,<br />

and some uncerta<strong>in</strong>ty rema<strong>in</strong>s,” Commissioner<br />

Kyriakides said.<br />

Overall spend<strong>in</strong>g on healthcare-related<br />

measures that member states committed<br />

to through their national Recovery and<br />

Resilience Plans amounts to over €43bn.<br />

This is an important <strong>in</strong>vestment that can<br />

make a real difference and clearly shows<br />

that health is a priority <strong>in</strong> the <strong>EU</strong>.<br />

The European Union pulled together<br />

and pooled purchases of covid vacc<strong>in</strong>es,<br />

which on the one hand seemed to make<br />

these vacc<strong>in</strong>es more readily available, but<br />

on the other still raises questions on the<br />

methods used.<br />

The Commissioner sees this only as a<br />

strong spirit of cooperation developed<br />

among the <strong>EU</strong>’s member states dur<strong>in</strong>g<br />

the <strong>pandemic</strong>.<br />

“We saw how much more we can do together<br />

<strong>in</strong> the area of health. This is where<br />

the project to build a strong European<br />

<strong>Health</strong> Union was born. Our Vacc<strong>in</strong>es<br />

Strategy is the most evident case <strong>in</strong> po<strong>in</strong>t<br />

– both <strong>in</strong> its real-world impact <strong>in</strong> terms<br />

of lives saved, but also <strong>in</strong> terms of how<br />

we should move forward <strong>in</strong> tackl<strong>in</strong>g the<br />

<strong>pandemic</strong> and so many other challenges<br />

<strong>in</strong> the area of health,” Commissioner<br />

Kyriakides says.<br />

“In the end, we have taken our biggest<br />

challenges and made them <strong>in</strong>to an opportunity<br />

to redef<strong>in</strong>e <strong>EU</strong> health policy,”<br />

she says.<br />

Learn<strong>in</strong>g from her long – more than 27<br />

years – of medical history and <strong>in</strong>volvement<br />

<strong>in</strong> fight<strong>in</strong>g cancer we asked the<br />

Commissioner about the mRNA vacc<strong>in</strong>es<br />

that have resulted from this <strong>pandemic</strong><br />

necessity and the <strong>EU</strong>’s <strong>in</strong>vestment.<br />

What would their role be <strong>in</strong> developments<br />

for future health challenges?<br />

“Dur<strong>in</strong>g the <strong>pandemic</strong>, we saw very<br />

clearly the important potential of mRNA<br />

technologies. A scientific and <strong>in</strong>dustrial<br />

endeavour made <strong>in</strong> Europe, for the<br />

world. A discovery that provided the basis<br />

for millions of the lifesav<strong>in</strong>g COVD-<br />

19 vacc<strong>in</strong>es, and have proven to be<br />

adaptable to different variants of the<br />

same disease.<br />

“We should recall that the discovery of<br />

the COVID vacc<strong>in</strong>es was developed on<br />

the experience of develop<strong>in</strong>g mRNA<br />

vacc<strong>in</strong>es for cancer. Because of its adaptability,<br />

there is also a possibility that<br />

this technology could be used for personalised<br />

medic<strong>in</strong>e tailored to the needs<br />

and characteristics of each patient,” the<br />

Commissioner said.<br />

A clear example of this is happen<strong>in</strong>g currently,<br />

with several vacc<strong>in</strong>e manufacturers<br />

build<strong>in</strong>g on the COVID experience<br />

to conduct research <strong>in</strong>to mRNA vacc<strong>in</strong>es<br />

for cancer.<br />

Of course, there is still work to be done<br />

to fully ascerta<strong>in</strong> the viability of mRNA<br />

technology for these purposes, but based<br />

on the COVID vacc<strong>in</strong>e model, there are<br />

signs of promise. •<br />

About<br />

Alia Papageorgiou<br />

Alia Papageorgiou is President<br />

of Press Club Brussels Europe,<br />

she has worked as a journalist <strong>in</strong><br />

Australia, Greece and Belgium cover<strong>in</strong>g<br />

the <strong>EU</strong>.<br />


HEALTH IN A POST-PANDEMIC <strong>EU</strong><br />

Rare<br />

no more?<br />

A European collaboration called Screen4Care<br />

bets on genetic test<strong>in</strong>g and new tech to speed up<br />

diagnoses for rare diseases.<br />


For people liv<strong>in</strong>g with a rare disease, it can take at least five years to get<br />

the right diagnosis – but that timel<strong>in</strong>e could get a lot shorter if a European<br />

Union-funded effort succeeds.<br />

Rare diseases affect more than 300 million people worldwide, <strong>in</strong>clud<strong>in</strong>g more<br />

than 30 million <strong>in</strong> Europe, and delayed diagnoses can make it harder for patients<br />

to f<strong>in</strong>d relief, given treatments are also scarce. There are more than<br />

6,000 known rare diseases worldwide, yet only 5% have at least one approved<br />

treatment.<br />

In order to be catalogued as a rare disease <strong>in</strong> the <strong>EU</strong>, the condition must affect<br />

fewer than 1 <strong>in</strong> 2,000 people. These diseases <strong>in</strong>clude forms of neurological<br />

conditions, <strong>in</strong>tellectual disabilities, some cancers, auto<strong>in</strong>flammatory diseases<br />

and other health issues, and they can be disabl<strong>in</strong>g and even life-threaten<strong>in</strong>g.<br />


HEALTH IN A POST-PANDEMIC <strong>EU</strong><br />

More diagnosis will lead to<br />

more research and overall<br />

improv<strong>in</strong>g outcomes for so<br />

many rare disease patients that<br />

don’t have a treatment, that<br />

don’t have a care path<br />

Nicolas Garnier<br />

A new approach<br />

Now, a European collaborative is work<strong>in</strong>g<br />

to detect rare diseases earlier through<br />

a two-pronged strategy called Screen-<br />

4Care.<br />

The first arm <strong>in</strong>volves deploy<strong>in</strong>g widespread<br />

newborn genetic test<strong>in</strong>g to identify<br />

babies who may develop rare diseases,<br />

72 percent of which have genetic orig<strong>in</strong>s.<br />

The second prong is to use artificial <strong>in</strong>telligence<br />

(AI) to create a meta-symptom<br />

checker for patients struggl<strong>in</strong>g to understand<br />

their complications, and to flag<br />

patients at risk for rare diseases based on<br />

their electronic health records.<br />

The five-year, €25 million project<br />

launched <strong>in</strong> late 2021 and has about three<br />

dozen academic, government and <strong>in</strong>dustry<br />

partners across 14 countries. Governed<br />

<strong>in</strong> part by patient advocacy groups,<br />

housed by the Innovative Medic<strong>in</strong>es Initiative<br />

and funded by the <strong>EU</strong> and the European<br />

Federation of Pharmaceutical Industries<br />

and Associations, Screen4Care<br />

aims to create a framework for rare disease<br />

detection that can be adapted across<br />

the bloc and beyond.<br />

The goal is<br />

to deliver<br />

“tra<strong>in</strong>ed<br />

and tested”<br />

algorithms<br />

that can<br />

flag at-risk<br />

patients<br />

based on<br />

their medical<br />

records<br />

before the<br />

project wraps<br />

<strong>in</strong> 2026.<br />

“More diagnosis will lead to more research<br />

and overall improv<strong>in</strong>g outcomes<br />

for so many rare disease patients that<br />

don’t have a treatment, that don’t have a<br />

care path,” said Nicolas Garnier, patient<br />

advocacy lead for rare diseases at the<br />

pharmaceutical giant Pfizer and Screen-<br />

4Care’s EFPIA project lead.<br />

After a couple of years <strong>in</strong> the plann<strong>in</strong>g<br />

and development phase, the group is prepar<strong>in</strong>g<br />

to launch five cl<strong>in</strong>ical trials early<br />

next year to test the newborn screen<strong>in</strong>g<br />

tool <strong>in</strong> Germany and Italy.<br />

Heel prick 2.0<br />

Newborn genetic test<strong>in</strong>g is a tried-andtrue<br />

public health tool – the heel prick<br />

test has been practiced s<strong>in</strong>ce the 1960s<br />

– but the Screen4Care trials will look for<br />

several hundred rare diseases, aim<strong>in</strong>g to<br />

make newborn genetic screen<strong>in</strong>g cheaper<br />

and thus more broadly accessible.<br />

Meanwhile, the consortium is reth<strong>in</strong>k<strong>in</strong>g<br />

its second prong, which focuses on<br />

AI and mach<strong>in</strong>e learn<strong>in</strong>g, given the explosive<br />

growth of generative AI tools <strong>in</strong><br />

2023. The Screen4Care <strong>in</strong>itiative was <strong>in</strong>itially<br />

dreamt up <strong>in</strong> mid-2019, and Garnier<br />

said he wants to “future-proof” the<br />

AI tools to prevent them from becom<strong>in</strong>g<br />

obsolete as that technology evolves. The<br />

goal is to deliver “tra<strong>in</strong>ed and tested”<br />

algorithms that can flag at-risk patients<br />

based on their medical records before the<br />

project wraps <strong>in</strong> 2026.<br />

At that time, Garnier said the consortium<br />

will present <strong>EU</strong> policymakers with<br />

a list of recommendations to expand on<br />

its work. One key policy area is equity,<br />

given gaps <strong>in</strong> rare disease detection are<br />

stark even with<strong>in</strong> Europe. As of 2022, Italy<br />

screened newborns for more than 45<br />

diseases, for example, while France tested<br />

for fewer than ten and Romania and<br />

Cyprus looked for only two diseases <strong>in</strong><br />

their national programs.<br />

“Even right now, with similar technologies<br />

available across different countries,<br />

the adoption is really different,” Garnier<br />

said.<br />

That’s due largely to public policy. The<br />

logic follows that if a disease isn’t treatable,<br />

don’t screen for it, Garnier said. But<br />

he wants these conditions to be identified<br />

anyway, to better understand the<br />

size of the patient population for specific<br />

rare diseases and to <strong>in</strong>centivise drug<br />

companies to <strong>in</strong>vest <strong>in</strong> research and development<br />

to treat them.<br />

Equitable detection<br />

Over time, regional disparities could<br />

become even more apparent across the<br />

globe. With<strong>in</strong> ten years, Garnier said that<br />

widespread genetic newborn screen<strong>in</strong>g<br />

will likely be commonplace <strong>in</strong> the <strong>EU</strong> and<br />

the U.S., but that some countries could<br />

fall beh<strong>in</strong>d due to a lack of resources.<br />

The Screen4Care program is <strong>in</strong>ternationally<br />

adaptable, Garnier said, but its<br />

long-term success will depend on policy<br />

efforts to prioritise rare disease diagnosis<br />

– the first step toward widespread access<br />

to treatments for the millions of people<br />

globally liv<strong>in</strong>g with rare diseases.<br />

“Science and <strong>in</strong>novation are go<strong>in</strong>g to<br />

move a lot faster than policy – that’s not<br />

new,” Garnier said. “The limit<strong>in</strong>g factor<br />

is really go<strong>in</strong>g to be policy. That will be<br />

the challenge, and that will be the decid<strong>in</strong>g<br />

factor for what rare disease diagnosis<br />

looks like <strong>in</strong> 2033.” •<br />

About<br />

Gaby Galv<strong>in</strong><br />

Gaby Galv<strong>in</strong> is a freelance journalist<br />

based <strong>in</strong> Amsterdam. Her work<br />

has appeared <strong>in</strong> Euronews, U.S.<br />

News & World Report and <strong>Health</strong>care<br />

Brew, among others.<br />


Stakeholder Article<br />

The loom<strong>in</strong>g threat<br />

of ‘Disease X’<br />

Harness<strong>in</strong>g mRNA technology to mitigate future<br />

<strong>pandemic</strong>s <strong>in</strong> Europe.<br />


Hamilton Bennett is the Senior<br />

Director of Vacc<strong>in</strong>e Access and<br />

Partnerships at Moderna.<br />

Europe has faced numerous global health challenges <strong>in</strong> recent<br />

years, with the COVID-19 <strong>pandemic</strong> be<strong>in</strong>g the starkest<br />

rem<strong>in</strong>der of our vulnerability. While SARS‐CoV‐2 has demonstrated<br />

that we cannot stop the evolution of viruses, it has<br />

also highlighted the importance of safeguard<strong>in</strong>g our healthcare<br />

systems.<br />

Today, there is another loom<strong>in</strong>g threat that demands immediate<br />

attention from European government and <strong>in</strong>dustry stakeholders<br />

alike: Disease X.<br />

The concept of Disease X arose from the recognition that new<br />

<strong>in</strong>fectious diseases can emerge unexpectedly, as demonstrated<br />

by previous outbreaks such as MERS and COVID-19.<br />

Its possible emergence arises from the constant evolution<br />

and adaptation of pathogens, <strong>in</strong>creased global travel, urbanisation,<br />

changes <strong>in</strong> human-animal <strong>in</strong>teractions, and other<br />

factors that can facilitate the emergence and spread of novel<br />

<strong>in</strong>fectious diseases such as climate change.<br />

In 2018, the World <strong>Health</strong> Organization (WHO) identified priority<br />

pathogens that could cause deadly future <strong>pandemic</strong>s,<br />

such as Zika, Ebola, and ‘Disease X.’ In parallel, the scientific<br />

<strong>in</strong>itiative Global Virome Project identified around 1,67 million<br />

unknown viruses, <strong>in</strong>clud<strong>in</strong>g 827,000 that had the potential<br />

to be transmitted to humans.<br />

Def<strong>in</strong>ed as “an unknown pathogen that could cause a serious<br />

<strong>in</strong>ternational epidemic,” Disease X stands out as a global public<br />

health challenge.<br />

To anticipate uncerta<strong>in</strong> but potentially dangerous epidemics,<br />

healthcare organisations must prepare to provide a susta<strong>in</strong>able<br />

response to a scenario that could become a reality sooner<br />

than we th<strong>in</strong>k. Key technologies and <strong>in</strong>novations should be<br />

leveraged towards this objective, <strong>in</strong>clud<strong>in</strong>g mRNA technology<br />

for vacc<strong>in</strong>e development, which has proven its value and<br />

potential dur<strong>in</strong>g the COVID-19 <strong>pandemic</strong>.<br />

mRNA technology is one of the major keys to prevent<strong>in</strong>g future<br />

<strong>pandemic</strong>s. The value of mRNA lies <strong>in</strong> its ability to rapidly<br />

adapt to new viral stra<strong>in</strong>s, mak<strong>in</strong>g it a vital tool <strong>in</strong> the fight<br />

aga<strong>in</strong>st emerg<strong>in</strong>g variants and pathogens.<br />

Furthermore, mRNA technology offers several advantages,<br />

<strong>in</strong>clud<strong>in</strong>g faster development timel<strong>in</strong>es, scalability, and<br />

improved safety profiles compared to traditional vacc<strong>in</strong>e<br />

approaches. Its versatility enables rapid response to future<br />

<strong>pandemic</strong>s, as scientists can quickly design and manufacture<br />

mRNA-based vacc<strong>in</strong>es tailored to specific viral threats. The<br />

profound impact of mRNA technology on <strong>pandemic</strong> preparedness<br />

cannot be understated, mak<strong>in</strong>g it a cornerstone <strong>in</strong> our<br />

collective efforts to safeguard public health.<br />

While the potential of mRNA is extensive, <strong>pandemic</strong> response<br />

beg<strong>in</strong>s with <strong>pandemic</strong> prevention. To this end, at Moderna,<br />

we have a broad portfolio of vacc<strong>in</strong>e programs that target<br />

emerg<strong>in</strong>g or neglected <strong>in</strong>fectious diseases that threaten public<br />

health. Those <strong>in</strong>clude respiratory threats with high <strong>pandemic</strong><br />

potential, like <strong>in</strong>fluenza and beta-coronaviruses, and<br />

pathogens identified by WHO and the Coalition for Epidemic<br />

Preparedness Innovation that frequently cause localised outbreaks<br />

and <strong>in</strong>form future preparedness for Disease X. By the<br />

end of 2022, Moderna had 12 Global Public <strong>Health</strong> programs<br />

<strong>in</strong> research and development.<br />

Other actions we have taken to improve <strong>pandemic</strong> preparedness<br />

<strong>in</strong>clude the creation of a collaboration-based program,<br />

mRNA Access, allow<strong>in</strong>g disease experts around the world to<br />

translate their understand<strong>in</strong>g of immune markers of protection<br />

<strong>in</strong>to effective mRNA vacc<strong>in</strong>es. Researchers can utilise<br />

Moderna’s mRNA technology platform to pursue research<br />

<strong>in</strong> their lab to design novel vacc<strong>in</strong>es aga<strong>in</strong>st emerg<strong>in</strong>g and<br />

neglected <strong>in</strong>fectious diseases. As of today, 15 geographically<br />

dispersed <strong>in</strong>stitutions are participat<strong>in</strong>g <strong>in</strong> the program.<br />

A key pillar of our global health strategy is build<strong>in</strong>g regional<br />

manufactur<strong>in</strong>g capability. We have previously announced<br />

plans to build facilities <strong>in</strong> Australia, Canada, Kenya, and the<br />

United K<strong>in</strong>gdom, which can be deployed <strong>in</strong> response to a<br />

<strong>pandemic</strong> outbreak.<br />

One of the key aspects of our mRNA platform is that a s<strong>in</strong>gle<br />

manufactur<strong>in</strong>g facility can be used to manufacture any<br />

of our mRNA medic<strong>in</strong>es. Specifically <strong>in</strong> Europe, Moderna has<br />

worked closely with established contract manufacturers <strong>in</strong><br />

Italy, Spa<strong>in</strong>, and Switzerland to set up a manufactur<strong>in</strong>g and<br />

supply network <strong>in</strong> the region. Spa<strong>in</strong> has s<strong>in</strong>ce matured <strong>in</strong>to<br />

Moderna’s largest end-to-end production hub outside the US.<br />

The world must learn from past experiences and prepare<br />

to act faster when faced with the next <strong>pandemic</strong>. As recently<br />

witnessed, mRNA technology offers a potential<br />

solution <strong>in</strong> the fight aga<strong>in</strong>st future <strong>pandemic</strong>s and Disease<br />

X, provid<strong>in</strong>g a versatile and effective defence mechanism.<br />

Our responsibility is to collaborate and work to<br />

maximise its potential to build resilient healthcare systems<br />

capable of combat<strong>in</strong>g future threats and safeguard<strong>in</strong>g public<br />

health. •<br />

Scan QR code<br />

for more <strong>in</strong>fo<br />


HEALTH IN A POST-PANDEMIC <strong>EU</strong><br />

“It’s not<br />

just about<br />

slogans”<br />

A candid talk with ECDC chief Andrea Ammon about<br />

communicat<strong>in</strong>g <strong>in</strong> times of crisis, and how to build<br />

trust when th<strong>in</strong>gs calm down.<br />


European Center for Disease Control<br />

(ECDC) chief Andrea Ammon spoke candidly<br />

about how her organisation is prepar<strong>in</strong>g<br />

itself to help the <strong>EU</strong> be prepared<br />

for the next <strong>pandemic</strong>.<br />

Ammon has been head<strong>in</strong>g up the ECDC<br />

s<strong>in</strong>ce 2017. Tra<strong>in</strong>ed as a medical doctor,<br />

and specialised <strong>in</strong> public health, she is an<br />

alumni of the first cohort of the field epidemiology<br />

programme (EPIET) offered<br />

by the ECDC. She jo<strong>in</strong>ed the organisation<br />

<strong>in</strong> 2005, build<strong>in</strong>g the European surveillance<br />

system, and slowly mak<strong>in</strong>g her<br />

way to the top job.<br />

The ECDC was thrust <strong>in</strong> the spotlight<br />

dur<strong>in</strong>g the COVID-19 <strong>pandemic</strong>, and<br />

s<strong>in</strong>ce then has seen its mandate expand<br />

through new regulations.<br />

Our conversation ended up revolv<strong>in</strong>g<br />

around communication, and what both<br />

the ECDC and the media could do better<br />

<strong>in</strong> – hopefully not anytime soon – a next<br />

<strong>pandemic</strong>.<br />

Alejandro Tauber: I’d like to briefly talk<br />

about new regulations and changes to<br />

the ECDC mandate. Can you run me<br />

through some of the policy changes<br />

we’ve seen s<strong>in</strong>ce the <strong>pandemic</strong>?<br />

Andrea Ammon: The serious cross border<br />

health threat regulation aims at regulat<strong>in</strong>g<br />

all the different elements connected<br />

to health emergencies. That starts<br />

with the surveillance, the laboratories,<br />

but then also the response to emergencies.<br />

So that’s the risk assessment and risk<br />

management package. Now, our regulation<br />

is tailored for the ECDC, and it has a<br />

lot of cross references to the serious cross<br />

border health regulation.<br />

So a lot of what is <strong>in</strong> the serious cross<br />

border health regulation actually refers to<br />



HEALTH IN A POST-PANDEMIC <strong>EU</strong><br />

us to our work. In pr<strong>in</strong>ciple, our mandate<br />

stayed the same as it was before, <strong>in</strong> terms<br />

of that we are deal<strong>in</strong>g with <strong>in</strong>fectious<br />

diseases. But some of the tasks have been<br />

specified. We have new aspects of our<br />

tasks. And then there are a few new elements<br />

<strong>in</strong>, for <strong>in</strong>stance, the <strong>EU</strong> reference<br />

laboratories, the <strong>EU</strong> <strong>Health</strong> Task Force,<br />

the foresight and modell<strong>in</strong>g, we look at<br />

determ<strong>in</strong>ants prevention and health system<br />

<strong>in</strong>dicators. So there are a few new<br />

elements that have been added, as<br />

lessons learned from the <strong>pandemic</strong>.<br />

What were some key lessons learned<br />

from the <strong>pandemic</strong>?<br />

We must enhance our surveillance, and<br />

improve preparedness and risk communication.<br />

The particular emphasis now,<br />

which has been evolv<strong>in</strong>g <strong>in</strong> the past year,<br />

is the emphasis on the workforce. Every<br />

country has experienced the same scene<br />

– that the health workforce has massive<br />

issues. There are people leav<strong>in</strong>g the service<br />

due to burnout, and we have the<br />

loom<strong>in</strong>g crisis of people go<strong>in</strong>g to retire<br />

<strong>in</strong> the next five to 10 years, without sufficient<br />

supply <strong>in</strong> the pipel<strong>in</strong>e.<br />

That is verg<strong>in</strong>g on labour communication,<br />

or maybe workforce policy, rather<br />

than <strong>in</strong>fectious diseases.<br />

Exactly. That is where our mandate and<br />

our <strong>in</strong>fluence is limited. Of course we<br />

can advocate, and that’s what I’m also<br />

do<strong>in</strong>g. But <strong>in</strong> the end, the real turn<strong>in</strong>g<br />

of the tide can only be done with policy<br />

changes <strong>in</strong> the countries that we cannot<br />

do ourselves. Although we can of course<br />

provide tra<strong>in</strong><strong>in</strong>g for people that would<br />

like to be specialised <strong>in</strong> public health. But<br />

we cannot, you know, change the salary<br />

structure, the career perspective, the<br />

work<strong>in</strong>g conditions, that is someth<strong>in</strong>g<br />

that has to happen <strong>in</strong> the national systems.<br />

That must be frustrat<strong>in</strong>g to see.<br />

Well, when you come to work for an<br />

agency like this, you know where the<br />

remits of the mandate lie. And then you<br />

The<br />

particular<br />

emphasis<br />

now, which<br />

has been<br />

evolv<strong>in</strong>g<br />

<strong>in</strong> the past<br />

year, is the<br />

emphasis<br />

on the<br />

workforce.”<br />

Andrea Ammon<br />

have to work with<strong>in</strong> these remits and see<br />

how you can advocate for anyth<strong>in</strong>g that<br />

you f<strong>in</strong>d important for the mandate.<br />

That’s really <strong>in</strong>terest<strong>in</strong>g. The <strong>pandemic</strong><br />

has shown that the remit of the ECDC<br />

expands quite a bit beyond the gather<strong>in</strong>g<br />

of relevant data and the coord<strong>in</strong>at<strong>in</strong>g<br />

and communication of responses to<br />

that data. So for example, on <strong>in</strong>fectious<br />

diseases, <strong>in</strong>to the realm of communication<br />

– the more ‘soft’ science of br<strong>in</strong>g<strong>in</strong>g<br />

across a certa<strong>in</strong> scientific message<br />

or a way to evaluate risk for both public<br />

health officials but also for citizens. Has<br />

that changed the organisation a lot?<br />

It has brought some changes, yes, especially<br />

<strong>in</strong> the way we do our work, not so<br />

much <strong>in</strong> the substance that we are deal<strong>in</strong>g<br />

with. There is an article on communication<br />

<strong>in</strong> the new Found<strong>in</strong>g Regulation<br />

that has actually not changed.<br />

However, there are other elements <strong>in</strong><br />

the regulation, which <strong>in</strong>fluenced the<br />

communication. For <strong>in</strong>stance, that our<br />

mission statement has been expanded<br />

not only that we identify, analyse and<br />

communicate threats to human health<br />

from <strong>in</strong>fectious diseases, but we also<br />

make reports thereof available and easily<br />

accessible.<br />

This ‘accessible’ doesn’t mean that we<br />

put it free of charge on the website, but<br />

that they’re also formulated <strong>in</strong> a language<br />

that politicians and policymakers understand.<br />

So here we have to change our<br />

communication.<br />

We are a scientific organisation, and we<br />

have our scientific reports, but we have<br />

to now add a summary with key messages<br />

for public health decision makers,<br />

so that they can be used to actually implement<br />

and apply <strong>in</strong> public policy and<br />

practice.<br />

Right. So messages like, for example,<br />

like ‘flatten<strong>in</strong>g the curve’, which were<br />

successful, but I th<strong>in</strong>k maybe the communication<br />

around mask<strong>in</strong>g which was<br />

slightly less successful.<br />

Well, I th<strong>in</strong>k we have positive and negative<br />

examples <strong>in</strong> abundance over the<br />

three years. I th<strong>in</strong>k it’s not about slogans<br />

only. It’s really about expla<strong>in</strong><strong>in</strong>g. And<br />

that is why, when you have seen our<br />

lessons learned document, one of these<br />

four lessons that we put forward is Risk<br />

Communication and Community Engagement.<br />

And I th<strong>in</strong>k this community engagement<br />

was someth<strong>in</strong>g that really did not<br />

work very well <strong>in</strong> most places. People at<br />

one po<strong>in</strong>t dur<strong>in</strong>g the <strong>pandemic</strong> had not<br />

understood why they still had to wear<br />

masks, stay at home, keep that distance,<br />

get tested, and so forth.<br />

That is where I th<strong>in</strong>k our messag<strong>in</strong>g<br />

should help. It should help local politicians<br />

expla<strong>in</strong> this to the general population,<br />

but also then to specific populations,<br />

like young people, for <strong>in</strong>stance.<br />

What do you base best practices on? Is<br />

there actually a lot of science around<br />

effective communication dur<strong>in</strong>g public<br />

health crises and community engagement?<br />

Is there someth<strong>in</strong>g that you can<br />

fall back on?<br />

Yes, there is. And that’s the <strong>in</strong>terest<strong>in</strong>g<br />

part, that the fact that it hasn’t been used<br />

to its full potential is not because there<br />

is no science beh<strong>in</strong>d it – there is science.<br />

But these scientists were not necessarily<br />

part of the crisis groups. More and more<br />

countries have recognised that social scientists,<br />

risk communicators, ethicists,<br />

behavioural <strong>in</strong>sight specialists, should<br />

be part of the crisis team. And we have<br />

also now assembled a small team here at<br />

ECDC that deals specifically with that.<br />

Risk communication is a very difficult<br />

th<strong>in</strong>g to do I can imag<strong>in</strong>e. Risk is<br />

dependent on a lot of variables, and<br />

br<strong>in</strong>g<strong>in</strong>g across a complex message is<br />

very challeng<strong>in</strong>g for the general public<br />

to understand. So for example, I didn’t<br />

know the risks for someone over eighty<br />

when vacc<strong>in</strong>ated are vastly different<br />

from those for a person over 60 who is<br />

also vacc<strong>in</strong>ated. I th<strong>in</strong>k that tailor<strong>in</strong>g<br />

specific messages like that must be very<br />

complicated.<br />

Yeah, and I th<strong>in</strong>k that the risk communication<br />

has to evolve dur<strong>in</strong>g the course<br />

of such a crisis, but it’s important that it<br />

starts at the beg<strong>in</strong>n<strong>in</strong>g with clarifications<br />

that everybody can understand.<br />

At the beg<strong>in</strong>n<strong>in</strong>g of the <strong>pandemic</strong>, these<br />

differentiations weren’t even possible,<br />

because we didn’t know about all the different<br />

risks to different people.<br />

And that, I th<strong>in</strong>k, has to be very clearly<br />

said at the beg<strong>in</strong>n<strong>in</strong>g. What is known,<br />

what is not known, where there is evidence<br />

and where there are decisions<br />

based on analogy with similar <strong>in</strong>fections.<br />

I th<strong>in</strong>k people can understand that there<br />

is an evolv<strong>in</strong>g situation, so that the fact<br />

that one day, they hear one message, and<br />

the next day someth<strong>in</strong>g else, is not necessarily<br />

<strong>in</strong>terpreted as ‘they don’t know<br />

what they’re do<strong>in</strong>g.’<br />

That touches on someth<strong>in</strong>g else as well,<br />

because up to now, we’re talk<strong>in</strong>g about<br />

proactive communication based on evidence.<br />

But another phenomenon that<br />

the <strong>pandemic</strong> showed was that the importance<br />

of reactive communication to<br />

counter explicit mis<strong>in</strong>formation is also<br />

a huge part of public health communication.<br />

That is true, part of this risk communication<br />

is also health education, <strong>in</strong> which<br />

the basics are expla<strong>in</strong>ed to the population.<br />

In general, if we could <strong>in</strong>crease the<br />

health literacy of the public, then mis<strong>in</strong>formation<br />

would have a bit of a harder<br />

time gett<strong>in</strong>g through. But that is of<br />

course, not someth<strong>in</strong>g that you can do <strong>in</strong><br />

a crisis, that is someth<strong>in</strong>g that needs to<br />

be built <strong>in</strong>to the preparedness.<br />

My background was <strong>in</strong> science journalism.<br />

And if I know one th<strong>in</strong>g, it’s that<br />

it’s very hard to <strong>in</strong>terest people <strong>in</strong> someth<strong>in</strong>g<br />

that is not go<strong>in</strong>g on at that moment,<br />

but that might have importance<br />

later. Is rais<strong>in</strong>g the bar for public health<br />

knowledge among the citizens part of<br />

the next <strong>pandemic</strong> preparedness plan?<br />

In my view, it should be a chapter <strong>in</strong> the<br />

<strong>pandemic</strong> preparedness plans that are<br />

now be<strong>in</strong>g looked at and reviewed. And<br />

<strong>in</strong> terms of people not be<strong>in</strong>g <strong>in</strong>terested,<br />

we have to learn a bit from advertis<strong>in</strong>g,<br />

because <strong>in</strong> the end it concerns them as<br />

persons. Moreover, we have health issues<br />

ongo<strong>in</strong>g with mosquitoes, with climate<br />

change, with West Nile virus, with <strong>in</strong>fluenza,<br />

with measles. These diseases are<br />

there, and we could use each of these as<br />

opportunities to take aspects of health<br />

to help people become more <strong>in</strong>-depth<br />

<strong>in</strong>formed.<br />

Right. What role could the media play<br />

or what could they do better?<br />

It’s not just the media of course who<br />

could do better, but it’s also from the scientist’s<br />

side. Some <strong>in</strong>itiatives have to go<br />

out <strong>in</strong>to media brief<strong>in</strong>gs, so that it’s not<br />

just a sensational story to report, but also<br />

to help <strong>in</strong>form the media so that they<br />

know where certa<strong>in</strong> pieces of <strong>in</strong>formation<br />

fall <strong>in</strong>to.<br />

I th<strong>in</strong>k this is someth<strong>in</strong>g that we probably<br />

will not succeed one hundred percent.<br />

But you have to try your best and<br />

see what could reasonably be done to put<br />

out trustworthy <strong>in</strong>formation. Even when<br />

there is weak evidence there, so that<br />

people know that we are not fabricat<strong>in</strong>g<br />

th<strong>in</strong>gs. And that is a reputation that you<br />

have to build <strong>in</strong> non-crisis time, so that<br />

you can count on this <strong>in</strong> times of crisis. •<br />

About<br />

Alejandro Tauber<br />

Alejandro Tauber is publisher of<br />

<strong>EU</strong>observer, and previously was<br />

editor at VICE’s Motherboard, and<br />

publisher of TNW, with a background<br />

<strong>in</strong> science and tech report<strong>in</strong>g.<br />


HEALTH IN A POST-PANDEMIC <strong>EU</strong><br />

Stakeholder Article<br />

Prevent<strong>in</strong>g the<br />

death of 200<br />

people per hour<br />

Prevent<strong>in</strong>g cardiovascular disease – a cost or an<br />

<strong>in</strong>vestment <strong>in</strong> <strong>EU</strong> health resilience?<br />

By HASEEB AHMAD, President, Europe, Novartis.<br />

is massive, stand<strong>in</strong>g at around €282<br />

billion every year. Yet only 55% of that<br />

sum (€155bn) goes to healthcare costs.<br />

Productivity loss (17%) and <strong>in</strong>formal<br />

care for people liv<strong>in</strong>g with CVD (28%)<br />

make up the rema<strong>in</strong><strong>in</strong>g €127bn.<br />

In fact, a London School of Economics<br />

(LSE) report “Trends <strong>in</strong> Avoidable<br />

Mortality from Cardiovascular Disease<br />

<strong>in</strong> the European Union” published <strong>in</strong><br />

April 2023, found that the largest portion<br />

of avoidable deaths from CVD<br />

occur among the work<strong>in</strong>g-age population.<br />

All <strong>in</strong> all, this amounts to 29.43<br />

million years of lost life.<br />

In Europe, an average patient with<br />

acute coronary syndrome lost 59 (37-<br />

79) workdays. Caregivers lose 11 (0-<br />

16) workdays every year, with a total<br />

mean <strong>in</strong>direct cost per case of €13,953<br />

(€6641- €23,160).<br />

What would you say if I told you that<br />

we could <strong>in</strong>vest <strong>in</strong> healthcare now, potentially<br />

save the lives of 200 people an<br />

hour dy<strong>in</strong>g of a preventable disease,<br />

and spend less <strong>in</strong> the long run?<br />

Because we can. Cardiovascular disease<br />

(CVD), a collection of conditions<br />

affect<strong>in</strong>g the heart or blood vessels, is<br />

the lead<strong>in</strong>g cause of death and disability<br />

<strong>in</strong> the <strong>EU</strong>.<br />

Up to 80% of CVD, <strong>in</strong>clud<strong>in</strong>g heart disease<br />

and strokes, can be prevented by<br />

<strong>in</strong>vest<strong>in</strong>g <strong>in</strong> early detection and treatment,<br />

which saves lives and lowers<br />

overall costs. Without a systemic m<strong>in</strong>dset<br />

shift, however, putt<strong>in</strong>g prevention<br />

<strong>in</strong>to practice is anyth<strong>in</strong>g but straightforward.<br />

As it stands, there’s still a tendency to<br />

th<strong>in</strong>k of money that goes <strong>in</strong>to manag<strong>in</strong>g<br />

a chronic disease as a cost, rather<br />

than an <strong>in</strong>vestment with real returns<br />

for people, the susta<strong>in</strong>ability of the<br />

healthcare system, the economy, and<br />

society.<br />

The shift <strong>in</strong> focus from treat<strong>in</strong>g CVD-related<br />

illness to preserv<strong>in</strong>g wellness<br />

can take many forms, from realign<strong>in</strong>g<br />

hospital <strong>in</strong>centives, to implement<strong>in</strong>g<br />

rout<strong>in</strong>e screen<strong>in</strong>gs, to leverag<strong>in</strong>g data<br />

to identify at-risk populations. And<br />

no s<strong>in</strong>gle organisation can take these<br />

transformative steps alone.<br />

Genu<strong>in</strong>e change also requires policy<br />

support, and the upcom<strong>in</strong>g revision<br />

to the <strong>EU</strong> Pharmaceutical Legislation<br />

could be just the opportunity. With the<br />

right amendments, the legislation can<br />

help the <strong>EU</strong>’s life-sciences ecosystem<br />

evolve, support<strong>in</strong>g competitiveness,<br />

<strong>in</strong>novation, and better, more equitable<br />

healthcare across Europe.<br />

CVD’s economic cost<br />

For households throughout the <strong>EU</strong>, the<br />

workplace is an essential source of f<strong>in</strong>ancial<br />

security – particularly amid<br />

cont<strong>in</strong>ued economic challenges. But<br />

the impact of diseases like CVD means<br />

too many are denied the ability to<br />

work. This is an avoidable hit to households’<br />

f<strong>in</strong>ancial security and the overall<br />

<strong>EU</strong> economy.<br />

Accord<strong>in</strong>g to the 2023 Economic Burden<br />

of Cardiovascular Diseases <strong>in</strong> the<br />

European Union study published by<br />

the European Heart Journal, the cost<br />

burden CVD puts on the <strong>EU</strong> economy<br />

Surely we cannot afford to be complacent<br />

about los<strong>in</strong>g workers due to treatable<br />

conditions?<br />

No household should be made to bear<br />

the brunt of this f<strong>in</strong>ancial loss, and the<br />

impact stretches beyond the household<br />

to the wider <strong>EU</strong> economy. As the<br />

population of older people liv<strong>in</strong>g <strong>in</strong> the<br />

<strong>EU</strong> grows, so too will the need for <strong>EU</strong><br />

countries to ma<strong>in</strong>ta<strong>in</strong> a strong active<br />

workforce that contributes to the tax<br />

base and funds welfare commitments.<br />

The best way to avoid the economic<br />

loss related to CVD is to prevent chronic<br />

ill health and premature death <strong>in</strong><br />

the first place. And that starts with an<br />

<strong>in</strong>vestment <strong>in</strong> early identification and<br />

treatment.<br />

Prevention’s return on <strong>in</strong>vestment<br />

Yes, prevention costs money, but it pays<br />

off <strong>in</strong> the long run. If we prevented half<br />

of the <strong>EU</strong>’s CVD events, the bloc would<br />

see an annual GDP growth of 2%, accord<strong>in</strong>g<br />

to research by the WifOR Institute.<br />

Similarly, a global report by McK<strong>in</strong>sey<br />

concludes that every $1 <strong>in</strong>vested<br />

<strong>in</strong> known health improvements can<br />

generate up to $4 <strong>in</strong> GDP <strong>in</strong> return.<br />

These ga<strong>in</strong>s can go a long way <strong>in</strong><br />

strengthen<strong>in</strong>g Europe’s health systems<br />

and societies more broadly. COVID-19<br />

won’t be the last <strong>pandemic</strong> the world<br />

faces, and CVD isn’t the only chronic<br />

disease that burdens healthcare systems.<br />

In the long run, sav<strong>in</strong>gs made<br />

from prevent<strong>in</strong>g CVD can be re<strong>in</strong>vested<br />

<strong>in</strong>to build<strong>in</strong>g more resilient healthcare<br />

systems that are better prepared<br />

to withstand shocks and manage future<br />

challenges.<br />

Prioritis<strong>in</strong>g CVD prevention can help<br />

Europe save lives, boost economic<br />

growth, and build stronger societies.<br />

Haseeb Ahmad, President, Europe, Novartis.<br />

But systematically reshap<strong>in</strong>g how we<br />

manage CVD is no small feat. Creat<strong>in</strong>g<br />

a comprehensive approach to manag<strong>in</strong>g<br />

CVD – one that prioritises early<br />

diagnosis, prevention, and <strong>in</strong>novation<br />

– will take a concerted effort.<br />

At Novartis, we’re ready to play<br />

our part, partner<strong>in</strong>g with governments,<br />

bus<strong>in</strong>esses, and civil society<br />

organisations to help make CVD prevention<br />

possible. •<br />

Scan QR code<br />

for more <strong>in</strong>fo<br />


Keep<strong>in</strong>g an<br />

eye on AIpowered<br />

drugs<br />

There is a<br />

question as<br />

to whether<br />

Europe is<br />

actually<br />

us<strong>in</strong>g Africa<br />

as a gu<strong>in</strong>ea<br />

pig.”<br />

Faten Aggad<br />

The European Medic<strong>in</strong>es Agency is explor<strong>in</strong>g<br />

ways to regulate how artificial <strong>in</strong>telligence is<br />

used to f<strong>in</strong>d and develop new drugs and medic<strong>in</strong>es.<br />


Medic<strong>in</strong>es created us<strong>in</strong>g artificial <strong>in</strong>telligence could be com<strong>in</strong>g<br />

to a pharmacy counter near you – but just how soon depends<br />

on whether they live up to the hype <strong>in</strong> cl<strong>in</strong>ical tests.<br />

AI may have become the buzzword of 2023, but major pharmaceutical<br />

companies and startups alike have been <strong>in</strong>vest<strong>in</strong>g <strong>in</strong><br />

the tech for years. In 2020, Brita<strong>in</strong>-based Exscientia became<br />

the first company to launch human tests for an AI-designed<br />

drug molecule, with the hopes of treat<strong>in</strong>g obsessive compulsive<br />

disorder. S<strong>in</strong>ce then, dozens of AI-powered drugs have entered<br />

cl<strong>in</strong>ical trials, and many more are on the way.


If these tests are successful, AI could<br />

upend the drug discovery process. Researchers<br />

typically spend years sift<strong>in</strong>g<br />

through troves of data and test results to<br />

land on promis<strong>in</strong>g drug candidates <strong>in</strong> the<br />

lab – only for many to fail dur<strong>in</strong>g cl<strong>in</strong>ical<br />

trials.<br />

AI models could improve the odds by<br />

help<strong>in</strong>g researchers identify the right target<br />

<strong>in</strong> the body for a particular disease,<br />

then f<strong>in</strong>d or even create the right molecule<br />

to <strong>in</strong>teract with it, and lastly, predict<br />

which patients it could help. Pharma<br />

companies could then <strong>in</strong>vest <strong>in</strong> only<br />

the most favorable options, cutt<strong>in</strong>g out<br />

much of the early trial and error.<br />

It isn’t a surefire strategy: Exscientia’s<br />

OCD trial, for example, shuttered <strong>in</strong> 2021<br />

after fail<strong>in</strong>g to meet its targets. But ultimately,<br />

the goal is to br<strong>in</strong>g cheaper medic<strong>in</strong>es<br />

to patients faster, while br<strong>in</strong>g<strong>in</strong>g <strong>in</strong><br />

billions of dollars <strong>in</strong> profits.<br />

“Just from drug discovery to cl<strong>in</strong>ical<br />

development, that span is about five and<br />

a half years,” said Aarti Chitale, a senior<br />

<strong>in</strong>dustry analyst for health care and life<br />

sciences at the advisory firm Frost & Sullivan.<br />

“Some of the lead<strong>in</strong>g AI vendors<br />

are able to br<strong>in</strong>g that duration down to<br />

only about 18 months.”<br />

Money pours <strong>in</strong><br />

Investors have taken note of the opportunity,<br />

pour<strong>in</strong>g at least $10 billion <strong>in</strong>to<br />

startups target<strong>in</strong>g AI <strong>in</strong> early drug development<br />

s<strong>in</strong>ce 2019, while European<br />

pharma giants have announced major<br />

deals to expand their AI capabilities.<br />

France’s Sanofi, for example, <strong>in</strong>ked a<br />

$1.2 billion pact with Atomwise to sort<br />

through small molecules <strong>in</strong> 2022, while<br />

the British-Swedish AstraZeneca expanded<br />

its partnership with the United<br />

K<strong>in</strong>gdom’s BenevolentAI to hunt for<br />

treatments for systemic lupus erythematosus<br />

and heart failure, <strong>in</strong> addition<br />

We believe<br />

that there is<br />

huge promise<br />

from artificial<br />

<strong>in</strong>telligence<br />

<strong>in</strong> terms of<br />

medic<strong>in</strong>es<br />

development,”<br />

Peter Arlett<br />

to chronic kidney disease and idiopathic<br />

pulmonary fibrosis.<br />

As of 2022, there were nearly 270 companies<br />

work<strong>in</strong>g on AI-powered drug discovery<br />

around the world, with Western<br />

Europe serv<strong>in</strong>g as a grow<strong>in</strong>g hub, accord<strong>in</strong>g<br />

to consultancy firm McK<strong>in</strong>sey & Co.<br />

“We believe that there is huge promise<br />

from artificial <strong>in</strong>telligence <strong>in</strong> terms of<br />

medic<strong>in</strong>es development,” said Peter Arlett,<br />

head of data analytics and methods<br />

for European Medic<strong>in</strong>es Agency, which<br />

oversees pharmaceutical products for the<br />

European Union.<br />

Notably, the use of AI for drug discovery<br />

is generally considered low-risk because<br />

if a potential medic<strong>in</strong>e fails, it fails <strong>in</strong> a<br />

simulation, not a patient. Instead, AI<br />

likely poses a greater risk <strong>in</strong> later stages of<br />

drug development given the potential for<br />

ethical issues, risks of human biases to<br />

work their way <strong>in</strong>to algorithms or flawed<br />

data analyses that are used <strong>in</strong> a drug’s application<br />

for regulatory approval.<br />

Regulat<strong>in</strong>g pharma AI<br />

As pharmaceutical companies lean more<br />

heavily on AI across the therapeutic<br />

pipel<strong>in</strong>e, regulators are catch<strong>in</strong>g up to<br />

ensure these tools are used safely. The<br />

EMA published a draft paper this summer<br />

on the path forward for AI <strong>in</strong> drug<br />

development, and will hold a workshop<br />

<strong>in</strong> November to solicit feedback from the<br />

pharma sector and other stakeholders.<br />

“We see it as the start, the very start,<br />

of [AI] guidance and regulation <strong>in</strong> the<br />

pharmaceutical sector,” said Arlett, who<br />

is also co-chair of the EMA’s Big Data<br />

Steer<strong>in</strong>g Group.<br />

The reflection paper is set to be f<strong>in</strong>alized<br />

by late 2024, but it will likely “change<br />

significantly” before then based on external<br />

feedback, Arlett said. While the<br />

document won’t be b<strong>in</strong>d<strong>in</strong>g, it will offer<br />

a more concrete picture of the regulatory<br />

guidance to come <strong>in</strong> 2025 or 2026, which<br />

pharma companies will be expected to<br />

follow.<br />

Head<strong>in</strong>g <strong>in</strong>to the November workshop,<br />

Arlett said regulators broadly agree that<br />

they should categorize the risks of AI<br />

for different purposes so that “we don’t<br />

over-regulate where the use of AI may be<br />

just a background process, and not impact<br />

the benefit-risk balance for a medic<strong>in</strong>e.”<br />

Even so, he said regulators should have<br />

at least some access to drugmakers’ algorithms<br />

and the data used to tra<strong>in</strong> their<br />

models dur<strong>in</strong>g the discovery process, as<br />

well as <strong>in</strong>sight <strong>in</strong>to how algorithms are<br />

used to manage medic<strong>in</strong>es after they’ve<br />

been authorized – for example, if an algorithm<br />

helps to determ<strong>in</strong>e a patient’s<br />

<strong>in</strong>sul<strong>in</strong> dosages, the EMA wants to know<br />

how it works. The level of transparency<br />

that will be required is still up for debate.<br />

“Because the algorithm is learn<strong>in</strong>g, we<br />

will need probably to th<strong>in</strong>k <strong>in</strong>novatively<br />

as to how we oversee that,” Arlett said.<br />

“The exist<strong>in</strong>g framework, which is rather<br />

strict and very structured … may not be<br />

optimal for someth<strong>in</strong>g that’s as fast-mov<strong>in</strong>g<br />

as a learn<strong>in</strong>g algorithm.”<br />

The <strong>in</strong>dustry responds<br />

The pharma <strong>in</strong>dustry is keep<strong>in</strong>g tightlipped<br />

ahead of the November workshop,<br />

though executives from some<br />

lead<strong>in</strong>g firms, <strong>in</strong>clud<strong>in</strong>g Exscientia, have<br />

pushed back aga<strong>in</strong>st proposals to establish<br />

AI-specific drug discovery regulations.<br />

In a statement, the Brussels-based trade<br />

group European Federation of Pharmaceutical<br />

Industries and Associations<br />

said that new AI policies should “balance<br />

benefits and risks of AI while support<strong>in</strong>g<br />

and foster<strong>in</strong>g <strong>in</strong>novation,” and that<br />

“we already have a robust framework for<br />

handl<strong>in</strong>g statistical and predictive models<br />

and software that will apply to many<br />

uses of AI <strong>in</strong> medic<strong>in</strong>es development.”<br />

Regardless of loom<strong>in</strong>g changes to the<br />

regulatory landscape, drugmakers still<br />

need to figure out how to br<strong>in</strong>g AI-powered<br />

medic<strong>in</strong>es to market – and prove<br />

that they’re more beneficial than exist<strong>in</strong>g<br />

treatments. Ultimately, cl<strong>in</strong>ical success<br />

will be the key determ<strong>in</strong>ant for how<br />

widely AI is used for drug discovery, rather<br />

than time or cost sav<strong>in</strong>gs, as noted by<br />

the Boston Consult<strong>in</strong>g Group.<br />

Transform<strong>in</strong>g pharma<br />

The <strong>in</strong>dustry faces some other challenges,<br />

too. AI and mach<strong>in</strong>e learn<strong>in</strong>g models<br />

need robust, high-quality datasets<br />

to work well, and a central repository<br />

for drugmakers doesn’t yet exist <strong>in</strong> Europe.<br />

Further, most <strong>in</strong>vestment <strong>in</strong> the<br />

past five years has been <strong>in</strong> high-<strong>in</strong>come<br />

countries and focused on the profitable<br />

fields of oncology and neurology, leav<strong>in</strong>g<br />

<strong>in</strong>fectious diseases – which carry a much<br />

greater health burden globally – under<strong>in</strong>vested<br />

<strong>in</strong>, exclud<strong>in</strong>g COVID-19.<br />

Global economic uncerta<strong>in</strong>ty could also<br />

slow progress for smaller firms and startups,<br />

Chitale said. While venture capital<br />

fund<strong>in</strong>g for AI-powered drug discovery<br />

startups soared <strong>in</strong> 2021, reach<strong>in</strong>g $4.7 billion,<br />

that level was much lower <strong>in</strong> 2022<br />

and 2023, <strong>in</strong> l<strong>in</strong>e with a broader <strong>in</strong>vestment<br />

slowdown, accord<strong>in</strong>g to analytics<br />

firm CB Insights.<br />

Even so, <strong>in</strong>dustry players, academics and<br />

funders believe AI is poised to transform<br />

the pharma sector. In a recent survey, 84%<br />

of those currently us<strong>in</strong>g AI said they expect<br />

it to play a significant role <strong>in</strong> drug discovery<br />

over the next five years, compared with<br />

70% among those not us<strong>in</strong>g AI.<br />

In Europe, the use of AI isn’t limited to<br />

the early stages of research <strong>in</strong>to potential<br />

blockbuster medic<strong>in</strong>es. EFPIA, the drug<br />

<strong>in</strong>dustry trade group, said major pharma<br />

companies are “employ<strong>in</strong>g AI and ML<br />

approaches across the entire lifecycle of<br />

medic<strong>in</strong>es development” – from drug<br />

discovery and manufactur<strong>in</strong>g to safety<br />

monitor<strong>in</strong>g and beyond. •<br />

About<br />

Gaby Galv<strong>in</strong><br />

Gaby Galv<strong>in</strong> is a freelance journalist<br />

based <strong>in</strong> Amsterdam. Her work<br />

has appeared <strong>in</strong> Euronews, U.S.<br />

News & World Report and <strong>Health</strong>care<br />

Brew, among others.<br />


HEALTH IN A POST-PANDEMIC <strong>EU</strong><br />

After decades of efforts, recent years<br />

have seen significant progress <strong>in</strong> research<br />

and development (R&D) <strong>in</strong> the<br />

field of cell and gene therapy. Follow<strong>in</strong>g<br />

approvals of several therapies <strong>in</strong> haemato-oncology<br />

s<strong>in</strong>ce 2017, developers<br />

across the globe have now turned their<br />

attention to open<strong>in</strong>g entirely new treatment<br />

pathways for a variety of diseases<br />

beyond haematological cancers.<br />

" Personally, I was always driven by<br />

the vision to re<strong>in</strong>vent medic<strong>in</strong>e<br />

with new ways to tackle diseases<br />

through cell and gene therapies."<br />


Stakeholder Article<br />

The miss<strong>in</strong>g piece of<br />

the puzzle<br />

If proved effective, patients across Europe<br />

liv<strong>in</strong>g with a range of auto-immune<br />

diseases, as well central nervous<br />

system diseases such as multiple sclerosis,<br />

could be set to benefit. To realise<br />

this opportunity though, we must<br />

ensure the European Union is putt<strong>in</strong>g<br />

<strong>in</strong>novation, and the patients it serves,<br />

at the forefront.<br />

Aga<strong>in</strong>st this backdrop, the announcement<br />

of a revision to the European<br />

Union’s general pharmaceutical legislation<br />

was welcome news to European-based<br />

advanced therapy medic<strong>in</strong>al<br />

product (ATMP) developers and<br />

marked a potential once-<strong>in</strong>-a-lifetime<br />

opportunity for Europe to close the gap<br />

with global pioneers <strong>in</strong> the field of cell<br />

and gene therapy.<br />

will support these European developers<br />

to <strong>in</strong>crease access to, and improve<br />

affordability of, new, life-sav<strong>in</strong>g treatments<br />

for European patients. The<br />

Miltenyi Group is one such company<br />

that has been at the heart of global<br />

R&D <strong>in</strong> cell and gene therapy for many<br />

years.<br />

Miltenyi Biomedic<strong>in</strong>e is a biopharmaceutical<br />

company whose mission is to<br />

br<strong>in</strong>g treatments to patients liv<strong>in</strong>g with<br />

cancer and autoimmune diseases. The<br />

company is build<strong>in</strong>g on the experience<br />

of Miltenyi Biotec, founded <strong>in</strong> Germany<br />

more than 30 years ago. Despite<br />

this heritage <strong>in</strong> cell and gene therapy,<br />

the company, along with other European-based<br />

biotech companies, needs<br />

more support to rema<strong>in</strong> competitive.<br />

process <strong>in</strong> order to advance treatments<br />

that will help patients who fight serious<br />

diseases every day,” he cont<strong>in</strong>ued.<br />

A particularly welcome aspect of the<br />

new package for the development of<br />

cell and gene therapies has been the<br />

clarification of the decentralised manufactur<strong>in</strong>g-related<br />

requirements. This<br />

has the potential to democratise access<br />

to high-quality, effective, and vitally,<br />

safe ATMPs for patients <strong>in</strong> European<br />

countries that are typically forgotten.<br />

Likewise, the <strong>in</strong>troduction of regulatory<br />

sandboxes could support the test<strong>in</strong>g<br />

and implementation of new <strong>in</strong>novative<br />

technologies, such as po<strong>in</strong>t-of-care<br />

manufactur<strong>in</strong>g, to further <strong>in</strong>crease access<br />

to personalised ATMPs across the<br />

cont<strong>in</strong>ent.<br />

A regulatory environment that values <strong>in</strong>novation will put<br />

Europe at the forefront of global research <strong>in</strong> cell and gene<br />

therapies<br />



In the past, the European legislative<br />

environment has been complex and<br />

burdensome, putt<strong>in</strong>g ATMP developers<br />

<strong>in</strong> Europe at a disadvantage compared<br />

with those <strong>in</strong> other regions. Today, most<br />

<strong>in</strong>novations <strong>in</strong> cell and gene therapy<br />

are be<strong>in</strong>g pioneered <strong>in</strong> the USA or Ch<strong>in</strong>a.<br />

The regulatory frameworks and authorities<br />

<strong>in</strong> both countries have allowed<br />

for faster development and commercialisation<br />

of promis<strong>in</strong>g new therapies<br />

for patients.<br />

The good news? Europe already has<br />

leaders <strong>in</strong> the ATMP field. A revision<br />

of European pharmaceutical legislation<br />

that <strong>in</strong>cludes long-term oriented<br />

research fund<strong>in</strong>g dedicated to cell and<br />

gene therapy products and a flexible<br />

and risk-adapted legislative framework<br />

“We are a highly specialised company<br />

with truly world-lead<strong>in</strong>g expertise <strong>in</strong><br />

cell and gene therapy, and the potential<br />

to br<strong>in</strong>g personalised new therapies to<br />

patients <strong>in</strong> need. While operat<strong>in</strong>g globally,<br />

our roots are <strong>in</strong> Germany and we<br />

have significant R&D operations <strong>in</strong> the<br />

<strong>EU</strong>. In order to br<strong>in</strong>g faster new treatments<br />

to patients <strong>in</strong> need, we need a<br />

more supportive regulatory en- vironment,”<br />

said Stefan Miltenyi, CEO of<br />

Miltenyi Biomedic<strong>in</strong>e.<br />

“In a complex and rapidly evolv<strong>in</strong>g scientific<br />

field, <strong>in</strong>novative companies like<br />

us need a European regulatory environment<br />

that allows for improved <strong>in</strong>teractions<br />

with authorities by accelerat<strong>in</strong>g<br />

and <strong>in</strong>tensify<strong>in</strong>g the mutual feedback<br />

“Personally, I was always driven by the<br />

vision to re<strong>in</strong>vent medic<strong>in</strong>e with new<br />

ways to tackle diseases through cell and<br />

gene therapies. We are fully committed<br />

at Miltenyi Biomedic<strong>in</strong>e to mak<strong>in</strong>g this<br />

change happen, and fast, but we need<br />

the legal and political environment to<br />

do this from a European base while<br />

ensur<strong>in</strong>g we are competitive with companies<br />

from the USA or Ch<strong>in</strong>a,” said<br />

Stefan Miltenyi, founder and owner of<br />

Miltenyi Biotec and Miltenyi Biomedic<strong>in</strong>e.<br />

•<br />

Scan QR code<br />

for more <strong>in</strong>fo<br />


HEALTH IN A POST-PANDEMIC <strong>EU</strong><br />

Prescrib<strong>in</strong>g our<br />

way out: The <strong>EU</strong>’s<br />

fight aga<strong>in</strong>st<br />

antimicrobial<br />

resistance<br />

The silent <strong>pandemic</strong> that’s still too silent.<br />


“It’s not go<strong>in</strong>g perfect,” said Danish MEP<br />

Pernille Weiss (EPP) about the <strong>EU</strong>’s fight<br />

aga<strong>in</strong>st antimicrobial resistance (AMR).<br />

With 35,000 citizens dy<strong>in</strong>g every year directly<br />

due to AMR, it’s an issue Europe is<br />

struggl<strong>in</strong>g to conta<strong>in</strong>. Apart from the significant<br />

loss of life, it also hits economies<br />

hard, cost<strong>in</strong>g around €1.1 billion to the<br />

healthcare systems of <strong>EU</strong>/EEA countries.<br />

Weiss is the lead negotiator for the <strong>EU</strong>’s<br />

pharmaceutical directive. She also sits<br />

on the EP’s ENVI committee which deals<br />

with the topic of AMR.<br />

Bacteria are said to be resistant when,<br />

despite be<strong>in</strong>g <strong>in</strong> the presence of antibiotics<br />

meant to kill them, they manage<br />

to survive and cont<strong>in</strong>ue to cause illness.<br />

Similarly, parasites, viruses, and fungi can<br />

also develop a resistance to drugs that<br />

target them. In 2022, the European Commission<br />

designated AMR as one of three<br />

priority health threats.<br />

Should the <strong>EU</strong> step <strong>in</strong>?<br />

Despite the clear and quantifiable consequences<br />

of <strong>in</strong>adequate measures aga<strong>in</strong>st<br />

AMR, a jo<strong>in</strong>t report by the European<br />

Centre for Disease Prevention and Control<br />

(ECDC) and WHO <strong>in</strong> 2019 found that<br />



HEALTH IN A POST-PANDEMIC <strong>EU</strong><br />

several countries are only just start<strong>in</strong>g on<br />

their roadmap to implement effective <strong>in</strong>terventions<br />

to tackle AMR.<br />

The coronavirus <strong>pandemic</strong> provided<br />

Europe with a wake up call, said Weiss,<br />

add<strong>in</strong>g that the <strong>pandemic</strong> highlighted<br />

just how vulnerable citizens with health<br />

complications become when AMR national<br />

plans aren’t function<strong>in</strong>g optimally.<br />

Is it time for the <strong>EU</strong> to step <strong>in</strong> and take<br />

over? Weiss is optimistic and th<strong>in</strong>ks that<br />

it’s still a matter of national competencies.<br />

“I am a true believer of the member states<br />

as the best authority to have the responsibility<br />

for almost everyth<strong>in</strong>g related to<br />

healthcare,” Weiss said <strong>in</strong> an <strong>in</strong>terview<br />

with <strong>EU</strong>observer.<br />

Sett<strong>in</strong>g a deadl<strong>in</strong>e and threaten<strong>in</strong>g to<br />

take away a country’s authority isn’t an<br />

option, accord<strong>in</strong>g to the MEP. She says<br />

the member states know what they have<br />

to do and that there are member states<br />

that can help others improve.<br />

Work<strong>in</strong>g together<br />

Countries aren’t completely left to their<br />

own devices. The ECDC has been visit<strong>in</strong>g<br />

member states to discuss AMR issues<br />

s<strong>in</strong>ce 2006.<br />

While a country’s efforts aga<strong>in</strong>st AMR<br />

are assessed, the purpose of these visits<br />

is also to provide any assistance and exchange<br />

of knowledge that a state could<br />

benefit from.<br />

I am a true<br />

believer of<br />

the member<br />

states as the<br />

best authority<br />

to have the<br />

responsibility<br />

for almost<br />

everyth<strong>in</strong>g<br />

related to<br />

healthcare.”<br />

Pernille Weiss<br />

As of 2017, the country visits have been<br />

conducted jo<strong>in</strong>tly with DG SANTE to<br />

also consider the animal health and environmental<br />

aspects of AMR (the One<br />

<strong>Health</strong> approach) which are not covered<br />

by the ECDC’s mandate.<br />

A spokesperson for the ECDC told <strong>EU</strong>observer<br />

that they performed three One<br />

<strong>Health</strong> country visits on AMR <strong>in</strong> 2019.<br />

No visits were carried out between 2020<br />

and 2021 due to the COVID-19 <strong>pandemic</strong>.<br />

S<strong>in</strong>ce then, one country visit was carried<br />

out <strong>in</strong> 2022 with another planned for<br />

the last quarter of 2023.<br />

The ECDC did not study the most common<br />

issues among member states but<br />

the results of a 2022 study on what barriers<br />

countries are fac<strong>in</strong>g to effectively implement<br />

their AMR policies “should soon<br />

be available” the spokesperson said.<br />

A ‘silent <strong>pandemic</strong>’<br />

A new set of assessments is scheduled to<br />

start <strong>in</strong> 2024 as part of the implementation<br />

of <strong>EU</strong> Regulation 2022/2371 which<br />

was adopted with the aim of creat<strong>in</strong>g a<br />

stronger <strong>EU</strong> health security framework.<br />

By the end of 2026, all <strong>EU</strong>/EEA countries<br />

should have each received at least one<br />

visit.<br />

“These country assessments will be conducted<br />

as country visits and will <strong>in</strong>clude<br />

a substantial part cover<strong>in</strong>g AMR, healthcare-associated<br />

<strong>in</strong>fections, and <strong>in</strong>fection<br />

prevention and control, with correspond<strong>in</strong>g<br />

<strong>in</strong>dicators. The methodology<br />

is under development, <strong>in</strong>clud<strong>in</strong>g for the<br />

AMR-related areas,” the ECDC spokesperson<br />

said.<br />

<strong>Health</strong> First Europe, an alliance of patients,<br />

professionals, and the <strong>in</strong>dustry,<br />

f<strong>in</strong>ds that policymakers are becom<strong>in</strong>g<br />

more aware of the threat of AMR. However,<br />

a spokesperson for <strong>Health</strong> First Europe<br />

described the situation as a “silent<br />

<strong>pandemic</strong> that is still too silent.”<br />

Asked about what its AMR Patient Group<br />

th<strong>in</strong>ks about the robustness of the current<br />

national action plans <strong>in</strong> place, the<br />

spokesperson said they don’t comment<br />

on policies.<br />

“We see our objective <strong>in</strong> rais<strong>in</strong>g awareness<br />

on AMR. We don’t take positions<br />

on policies. In our recommendations<br />

to policy-makers, which are part of our<br />

declaration, we demand clear actions by<br />

policy-makers to tackle the issue,” the<br />

spokesperson for <strong>Health</strong> First Europe<br />

said.<br />

Fight<strong>in</strong>g AMR<br />

<strong>Health</strong> First Europe has three ma<strong>in</strong> proposals<br />

for the <strong>EU</strong> to strengthen its fight<br />

aga<strong>in</strong>st AMR. These <strong>in</strong>volve <strong>in</strong>creas<strong>in</strong>g<br />

awareness among patients and healthcare<br />

professionals, improv<strong>in</strong>g <strong>in</strong>fection<br />

prevention and control measures, and<br />

<strong>in</strong>vest<strong>in</strong>g <strong>in</strong> and promot<strong>in</strong>g the use of<br />

medical technologies.<br />

An emphasis on education has long been<br />

part of the global fight aga<strong>in</strong>st AMR. Despite<br />

this, countries still struggle to con-<br />

vey some of the most basic facts about<br />

this press<strong>in</strong>g health issue to their citizens.<br />

Nearly two out of five (39%) respondents<br />

<strong>in</strong> the <strong>EU</strong> <strong>in</strong>correctly th<strong>in</strong>k that antibiotics<br />

kill viruses, and more than one <strong>in</strong> ten<br />

(11%) <strong>in</strong>dicate they do not know if they’re<br />

effective aga<strong>in</strong>st viruses.<br />

To address these knowledge gaps, what<br />

more can the <strong>EU</strong> do now that it hasn’t<br />

already done <strong>in</strong> the past? Weiss says the<br />

focus should be on educat<strong>in</strong>g both members<br />

of the public and healthcare professionals.<br />

“I’m 55 so I was lucky to have learned the<br />

old-fashioned pr<strong>in</strong>ciples of hygiene <strong>in</strong><br />

school. But we’ve lost a couple of generations<br />

where hygiene has not been part<br />

of the curriculum <strong>in</strong> schools,” says Weiss.<br />

Wash your hands<br />

It sounds like a simple measure but promot<strong>in</strong>g<br />

hand hygiene and better hygiene<br />

<strong>in</strong> hospitals can more than halve a patient’s<br />

risk of death due to AMR.<br />

Before enter<strong>in</strong>g politics, Weiss was a<br />

homecare nurse. Today she sees a number<br />

of nurses jump<strong>in</strong>g to conclusions<br />

that a certa<strong>in</strong> <strong>in</strong>fection needs to be treated<br />

by antibiotics. The MEP suggests that<br />

the <strong>EU</strong> should <strong>in</strong>vest more <strong>in</strong> rapid test<br />

technologies that can help healthcare<br />

practitioners when they’re at a patient’s<br />

bedside to determ<strong>in</strong>e the best treatment<br />

plan.<br />

“This would allow health care professionals<br />

to only use antibiotics when<br />

there’s noth<strong>in</strong>g else they can do better,<br />

cheaper, or <strong>in</strong> a way that doesn’t create<br />

this resistance threat,” she adds.<br />

While there is a consensus that all these<br />

measures are useful, it still rema<strong>in</strong>s critical<br />

to ensure timely access to both new<br />

and exist<strong>in</strong>g antibiotics. It can take 10-15<br />

years and around €1 billion to develop a<br />

new antibiotic. Luckily, with advancements<br />

<strong>in</strong> the field of generative AI, the<br />

time and money required may be reduced.<br />

“The key to a successful fight is cooperation.<br />

Every group, <strong>in</strong>clud<strong>in</strong>g pharmaceutical,<br />

medtech, policy-makers or HCPs<br />

are part of the solution and we see fruitful<br />

discussions,” said a spokesperson for<br />

<strong>Health</strong> First Europe.<br />

Involv<strong>in</strong>g pharma<br />

Weiss seems to agree say<strong>in</strong>g that the<br />

pharmaceutical <strong>in</strong>dustry has been very<br />

proactive and wants to be part of the<br />

solution.<br />

The European Observatory on <strong>Health</strong><br />

Systems and Policies said <strong>in</strong> a report that<br />

the <strong>EU</strong> has a major role to play by support<strong>in</strong>g<br />

antibiotic research and development<br />

say<strong>in</strong>g that <strong>in</strong>creased and coord<strong>in</strong>ated<br />

fund<strong>in</strong>g at the <strong>EU</strong> level can support<br />

both push (e.g. grants and tax <strong>in</strong>centives)<br />

and pull (e.g. accelerated approval and liability<br />

protection) <strong>in</strong>centives.<br />

The European Commission wants to <strong>in</strong>troduce<br />

a system of transferable exclusivity<br />

vouchers to reward the development<br />

of novel antimicrobial products. These<br />

vouchers can be used to extend the time<br />

a more profitable drug from a company<br />

reta<strong>in</strong>s its market exclusivity.<br />

Led by the Netherlands, 14 <strong>EU</strong> states<br />

came out strongly aga<strong>in</strong>st this controversial<br />

proposal. While acknowledg<strong>in</strong>g<br />

that the current system of <strong>in</strong>centives had<br />

failed and that new ideas were required,<br />

they said such vouchers don’t directly <strong>in</strong>centivise<br />

the creation of new antibiotics<br />

and will actually stifle <strong>in</strong>novation. One<br />

of their proposals is for direct f<strong>in</strong>ancial<br />

<strong>in</strong>centives, such as the <strong>in</strong>troduction of<br />

market entry rewards for companies that<br />

br<strong>in</strong>g a product to the market.<br />

Overcom<strong>in</strong>g the threat of AMR will require<br />

a multidiscipl<strong>in</strong>ary approach. For<br />

a solution to be truly effective, the approach<br />

will also need to be a global one.<br />

Here<strong>in</strong> lies an opportunity for the <strong>EU</strong>.<br />

“We could make the <strong>EU</strong> world champions<br />

<strong>in</strong> combat<strong>in</strong>g antimicrobial resistance.<br />

Because if we can make it <strong>in</strong> the<br />

s<strong>in</strong>gle market where people, food, and<br />

animals can cross borders without <strong>in</strong>creas<strong>in</strong>g<br />

AMR, then the rest of the world<br />

can of course also learn from Europe,”<br />

Weiss believes. •<br />

About<br />

Christoph Schwaiger<br />

Christoph Schwaiger is a freelance<br />

journalist based <strong>in</strong> the Netherlands.<br />

He ma<strong>in</strong>ly focuses on health,<br />

technology, and current affairs stories.<br />


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