BRUSSELS — The world is rapidly closing in on the 1.5 degrees Celsius warming
limit that serves as a threshold for ever more dangerous climate change,
European scientists have warned.
Average global temperatures are now around 1.4C higher than during the
pre-industrial era, according to data released Wednesday by the European Union’s
Copernicus planetary observation service. The scientists also found that 2025
was the third-hottest year on record.
If this warming trend continues, temperatures will breach the 1.5C limit set out
in the Paris Agreement before the end of this decade. In the 2015 landmark
climate accord, governments pledged to limit global warming to “well below” 2C
and ideally to 1.5C.
The threats from climate change, such as more intense heat waves and rising sea
levels, increase with every tenth of a degree of warming. Scientists also warn
that passing 1.5C risks triggering so-called tipping points, from rainforest
diebacks to ocean circulation collapse, that bring about irreversible and
extreme climatic changes.
In theory, the world could return to 1.5C after crossing it by using technology
to remove vast amounts of carbon dioxide from the atmosphere, a scenario known
as “overshoot.” This technology, however, is not yet available at the scale
required.
“With the 1.5C in the terms of the Paris Agreement around the corner, now we are
effectively entering a phase where it will be about managing that overshoot,”
Carlo Buontempo, director of the Copernicus Climate Change Service, told
reporters at a press conference.
“It’s basically inevitable that we will pass that threshold, and it’s up to us
to decide how we want to deal with the enhanced and increased higher risk that
we will face as a consequence of this,” he said. The longer and greater the
overshoot, the bigger the risk, he added.
The hottest year — and the only one so far to exceed the 1.5C threshold —
remains 2024 with 1.6C. However, the Paris Agreement targets refer to long-term
trends rather than those lasting a few years, and Buontempo said three different
Copernicus models, including five-year averages and 30-year linear trends,
showed warming has now reached around 1.4C.
Copernicus data shows that 2025 was the third-warmest year on record at 1.47C
above pre-industrial levels, just marginally cooler than 2023. That’s despite El
Niño, a naturally occurring climate pattern that tends to bring hotter
temperatures on top of the human-induced warming, ending in mid-2024 and a
cooling La Niña phase emerging late last year.
“The last three years in particular have been extremely warm compared to earlier
years,” said Samantha Burgess, deputy director at Copernicus. Taken together,
she noted, the three-year period exceeded 1.5C, something that had not occurred
before.
“The primary reason for these record temperatures is the accumulation of
greenhouse gases in the atmosphere, dominated by the burning of fossil fuels,”
Burgess said. “As greenhouse gases continue to accumulate in the air,
temperatures continue to rise, including in the ocean; sea levels continue to
rise, and glaciers, sea ice and ice sheets continue to melt.”
For the European continent, 2025 also marked the third-warmest year on record,
the data shows. Hot and windy conditions contributed to record wildfires,
resulting in Europe’s worst fire-related emissions since monitoring began 23
years ago.
Half the world experienced an above-average number of days causing strong heat
stress, meaning temperatures that feel like 32C or more. Burgess added that some
regions — including most of Australia, parts of Northern Africa and the Arabian
Peninsula — saw more days with extreme heat stress, when perceived temperatures
reach dangerous levels above 46C.
“The summers we are facing now are very different to the summers that our
parents experienced, very different to the summers that our grandparents
experienced,” Burgess said. “Children today will be exposed to more heat hazards
and more climate hazards than perhaps we were or our parents were.”
The polar regions saw significantly higher temperatures in 2025, with the
Antarctic experiencing its hottest year and the Arctic its second-warmest year
on record.
Accordingly, the expanse of polar sea ice was below average throughout the year,
and in February 2025 briefly hit a record low since monitoring began in the
1970s. The shrinking of the ice caps accelerates global warming by reducing the
amount of sunlight reflected back into space.
European science officials also expressed concern about the Trump
administration’s climate science cuts and erasure of datasets.
“Data and observations are obviously central to our efforts to confront climate
change … and these challenges don’t know any borders,” said Florian
Pappenberger, director of the European Centre For Medium-Range Weather
Forecasts, which oversees Copernicus. “Therefore, it is of course concerning
that we have an issue in terms of data.”
Hanne Cokelaere contributed to this report.
Tag - Public health
Europeans’ world-leading drinking habits are putting their health at risk, but
governments are failing to use higher taxes to help curb consumption, warned the
World Health Organization.
Beer has become more affordable in 11 EU countries since 2022, and less
affordable in six, the WHO report revealed Tuesday. There was a similar but even
more dramatic trend for spirits, which became more affordable in 17 EU countries
and less affordable in two. And for wine, 14 EU countries do not tax it at all,
including big producers Italy and Spain, the report found.
The EU includes seven of the 10 countries with the highest per-capita alcohol
consumption globally, with Romania, Latvia and Czechia among the biggest
drinkers. Alcohol is a major driver of cancer, with risk scaling alongside
higher consumption.
It’s also linked to a wide range of illnesses including cardiovascular disease
and depression, all of which are adding pressure to stretched health systems.
The WHO said governments should target alcohol consumption to protect people
from its ill effects. Increasing the cost of booze through taxes is one of the
most effective measures governments can take, the WHO said. Yet, some EU
countries have minimal or no taxes on certain types of alcohol.
The fact that more than half of EU countries don’t tax wine at all is “unusual”
by international standards, WHO economist Anne-Marie Perucic said. She pointed
out that the more affordable alcohol is, the more people consume.
“Excluding a product is not common. It’s always for political reasons,
socio-economic reasons [like] trying to protect the local industry. Clearly, it
doesn’t make sense from a health perspective,” Perucic told POLITICO.
Those 14 countries span the EU’s northern and central regions, such as Germany,
Austria and Bulgaria.
“More affordable alcohol drives violence, injuries and disease,” said Etienne
Krug, director of the WHO’s department of health determinants, promotion and
prevention. “While industry profits, the public often carries the health
consequences and society the economic costs.”
The EU has touted its plans to protect its wine industry from threats including
declining consumption and climate change. EU institutions agreed a package of
measures to prop up the sector in December.
Meanwhile, the European Commission recently backed down from proposing an
EU-wide tax on alcopops; the sweet, pre-mixed alcoholic drinks that taste like
sodas, as part of its Safe Hearts plan.
In a separate report, the WHO reported that sugary drinks have also become more
affordable in 13 EU countries since 2022, data published in a separate WHO
report found. A diet high in sugar is linked to obesity, Type 2 diabetes, heart
disease, fatty liver disease and certain cancers.
The German government rejected claims by U.S. Health Secretary Robert F. Kennedy
Jr. that Berlin prosecuted doctors and patients for refusing Covid-19
vaccinations or mask mandates.
“The statements made by the U.S. Secretary of Health are completely unfounded,
factually incorrect, and must be rejected,” German Health Minister Nina Warken
said in a statement late Saturday.
“I can happily explain this to him personally,” she said. “At no time during the
coronavirus pandemic was there any obligation for doctors to carry out vaccines
against Covid-19,” Warken added.
“Anyone who did not wish to offer vaccines for medical, ethical or personal
reasons were not criminally liable and did not have to fear penalties,” she
said.
Warken added that “criminal prosecution took place only in cases of fraud and
forgery of documents, such as the issuing of false vaccine certificates” or
exemption certificates for masks.
“Doctors [in Germany] decide independently and autonomously on the treatment of
patients,” the minister stressed, adding that “patients are also free to decide
which treatment they wish to receive.”
Kennedy said in a video post on Saturday that he had written to Warken after
receiving reports that Germany was restricting “people’s abilities to act on
their own convictions” in medical decisions.
He claimed that “more than a thousand German physicians and thousands of their
patients” faced prosecution for issuing exemptions from mask-wearing or Covid-19
vaccination requirements during the pandemic.
Kennedy did not provide specific examples or identify the reports he cited, but
he said Germany was “targeting physicians who put their patients first” and was
“punishing citizens for making their own medical choices.”
He accused Berlin of undermining the doctor–patient relationship and replacing
it with “a dangerous system that makes physicians enforcers of state policies.”
Former German Health Minister Karl Lauterbach also pushed back on the claims,
telling Kennedy on X to “take care of health problems in his own country.”
People who stop taking weight-loss drugs regain body mass four times faster than
those who lost their excess pounds through diet and exercise, according to an
analysis of the latest studies.
The additional benefits from taking weight-loss drugs, such as improvements in
cholesterol and blood pressure, were also reversed when patients quit the
medications, the study found.
The research, published in the British Medical Journal on Thursday, adds to a
growing body of evidence that suggests life-long treatment of obesity is needed
to maintain control of the condition. But the high cost of the latest drugs — as
well as their side effects — present barriers to long-term use.
“We know that obesity is a chronic relapsing condition. We know that when
treatment stops, weight is regained. And so, some kind of treatment needs to be
continued. What [that] treatment should be, I don’t know,” co-author Susan Jebb,
professor of diet and population health at the Nuffield Department of Primary
Care Health Sciences, University of Oxford, told journalists.
Rates of obesity and overweight are growing rapidly on the continent, with
around 51 percent of people in the EU aged 16 years or over being overweight in
2022. Obesity significantly increases the risk of chronic illnesses such as
diabetes, heart disease and cancers, and health systems are struggling to cope.
Researchers analyzed weight gain from 37 trials of multiple weight-loss drugs,
including older medications and the newer GLP-1s. The latest drugs, including
Novo Nordisk’s diabetes and weight-loss drugs Ozempic and Wegovy and Eli Lilly’s
Mounjaro, saw the greatest weight loss and the fastest weight regain when
treatment stopped.
Compared with another analysis of behavioral weight management programs
supporting low energy diets and exercise, weight regain was faster after ending
medication than after ending behavioral programs.
THE LONG-TERM DILEMMA
The newer weight-loss drugs have seen a boom in uptake across Europe and
America, despite their high prices. Ozempic, Wegovy and Mounjaro soared in
popularity after demonstrating roughly 15 percent weight loss in trials, and
were pounced on by celebrities and influencers.
However, around half of people who take these drugs will stop them after one
year. Side effects such as nausea and vomiting, costs or dissatisfaction with
weight loss as it plateaus are driving decisions to halt treatment, lead author
Sam West, a postdoctoral researcher also at the Nuffield department at the
University of Oxford, told journalists during the briefing.
Most people in the U.K. — around 90 percent — pay privately for their
weight-loss medication, Jebb said. But those who access it through the National
Health Service are subject to a two-year cap on access to the drugs, known as
GLP-1s. Similar limits apply in other EU countries.
Dimitris Koutoukidis, associate professor in diet, obesity and behavioral
sciences at the University of Oxford, suggested the U.K. may not be getting the
value for money it envisioned with these weight-loss drugs.
The model used to assess whether Lilly and Novo’s medicines were cost-effective
assumed people would regain their lost weight after two years, he told
journalists — but their study shows weight is regained at around 1.5 years.
“It is really hard to treat obesity and keep the weight off long-term,” Jebb
said.
“That should make us put even more effort into preventing weight gain in the
first place. And if we could transform our food environment to make it easier
for people to manage their weight it would stop them gaining weight in the first
place and help people — after a successful weight loss attempt — to keep it
off.”
“These treatments are not a whole solution,” she added.
Faced with an ageing population and rising chronic disease rates, Europe wants
to make its citizens healthier.
It also needs to keep its most powerful industries happy. In the basket of
health policies that EU lawmakers rushed to get across the line before
Christmas, industry was the big winner: The pharmaceutical, food and drink
sectors walked away with a set of major policy wins — and (potentially)
healthier profits.
While the pharma industry previously feared losing some of its monopoly rights
on new drugs, the Commission this month offered it an extra year of patent
protection for novel biotech drugs — among the most expensive treatments in the
world. The food and drink sectors, meanwhile, successfully pushed back against
proposals to tax ultra-processed foods and alcopops, for now.
On Dec. 16 the Commission published its Biotech Act and Safe Hearts Plan, which
landed just days after a long-awaited update of the pharmaceutical legislation.
Taken together, they seek to incentivize industries to innovate and do business
in Europe, improve access to medicines, and tackle the burden of cardiovascular
disease.
The pharma industry broadly celebrated the biotech proposal.
The Biotech Act “reflects priorities we’ve intensively advocated to keep Europe
globally competitive in life sciences,” Ognjenka Manojlovic, head of policy at
European pharmaceutical company Sanofi, told POLITICO. That includes
accelerating clinical trials, boosting intellectual property, and strengthening
financing for Europe’s biotech ecosystem, Manojlovic said.
The pharmaceutical sector had pushed for longer monopoly rights in the pharma
legislation. In the end they were kept at the current standard eight years —
instead of being cut by two years as the European Commission had initially
proposed.
For Europe’s public health insurers, who pay for drugs, the decisions taken to
maintain and then extend market protections for medicines are hard to square.
“We are puzzled by the Commission’s intentions,” said Yannis Natsis, director of
the European Social Insurance Platform, a network of Europe’s social insurance
organizations, warning that taxpayers will have to pick up the bill.
Meanwhile, health campaigners are also unhappy at the Commission’s “missed
opportunity” to tackle obesity and heart disease with junk food taxes — as
proposed in an earlier draft of the Safe Hearts Plan.
Samuele Tonello, at consumer organization BEUC, said the Safe Hearts Plan “lacks
teeth” to better protect consumers from unhealthy foods, and flagged the
“urgency of [cardiovascular diseases].”
A MAN ON A MISSION
Health Commissioner Olivér Várhelyi has made no secret of his support for
industry, and has championed the Commission’s competitiveness mantra since
taking office in late 2024.
Health Commissioner Olivér Várhelyi has made no secret of his support for
industry, and has championed the Commission’s competitiveness mantra since
taking office in late 2024. | Thierry Monasse/Getty Images
The standout feature of his end-of-year bonanza was the 12-month patent
extension in the Biotech Act I — legislation that was split in two late in the
day, allowing Várhelyi to meet his end-of-year deadline for the pharma
component.
The proposal came just a week after the Commission, countries and MEPs clinched
a deal to reform Europe’s pharmaceutical laws, in which IP rights were among the
last issues to be settled.
Updates to the pharma laws were a legacy of the last Commission, whereas the
Biotech Act became something of a personal mission for Várhelyi.
He repeatedly stressed that there was “no time to lose” in delivering a targeted
policy aimed at revitalizing Europe’s flagging biotech industry, which risks
being overtaken by competition from China and the U.S. Few commissioners are
more vocal than Várhelyi about the premium they place on the competitiveness of
European industry.
Industry insiders had heard whispers of his plans to expand IP incentives for
the biotech sector, even if Council representatives were dismayed not to have
been informed in advance — especially with the ink barely dry on the Pharma
Package.
That’s not to say pharma is happy with its lot. Industry lobby group the
European Federation of Pharmaceutical Industries and Associations (EFPIA)
tempered its praise of the Biotech Act, lamenting that the extra year of
monopoly rights would only apply to a “limited subset of products.”
The extra year of protection is tied to the Commission’s efforts to locate more
pharma research and manufacturing in Europe. It would apply only to new
products, tested and at least partially made in Europe.
But the generics sector, which makes cheaper, off-patent drugs to compete with
branded medicines, sees the Biotech Act as a further sweetening of what is
already one of the world’s most generous IP systems. Lobby group Medicines for
Europe claims each year of delayed competition for the top three biologic drugs
would cost countries €7.7 billion.
Longer IP “will have a dramatic impact on healthcare budgets and delayed
patients’ access to essential medicines,” said Adrian van den Hoven, head of the
lobby.
These kinds of estimates would normally be included in an impact assessment
published alongside the proposal, but in its haste to get the Biotech Act out
the Commission didn’t do one.
POLITICO asked the Commission for an estimate of what the extra year of patent
protection would cost. A Commission spokesperson would not give a figure but
said they had used the impact assessment for the pharma legislation as a
reference.
“It is also important to stress that the number of products eligible for an
additional year of SPC will be limited to only those that are truly innovative
and tested and manufactured in the EU. The approach is deliberately targeted to
incentivise genuinely innovative therapies that deliver a clear added value for
patients and support European innovation,” the spokesperson said.
LUCKY ESCAPE FOR UPFS
The big food and drink sectors are on shakier ground with Várhelyi. The
commissioner has repeatedly made known his distaste for ultra-processed food,
and an early leaked version of the Safe Hearts Plan included new taxes on
unhealthy highly processed foods and alcopops.
But the final proposal showed the Commission had undertaken a significant
climbdown. Concrete targets to tax unhealthy food and drink in 2026 were gone,
replaced with a much woollier commitment to “work towards” such a levy. Alcopops
were excluded altogether.
Industry lobby FoodDrinkEurope took a far more measured tone on the final plan
than its explosive reactions to the earlier leaks, but that may well ramp up
again if and when health tax proposals emerge. The text suggests the soft drinks
industry may be the Commission’s first target if it does decide to pursue new
levies, while UPFs remain in Várhelyi’s sights.
“In the next couple of years, we will need to tackle the issue of
ultra-processed food much more,” he told MEPs in December.
For now, though, the plan seems to have let industry off easy. Health NGOs saw
it as a disappointment, given its lack of hard-hitting policies to reduce
consumption of UPFs and other unhealthy products.
While the pharma legislation is all wrapped up, the Biotech Act still needs to
win the approval of EU countries and the European Parliament.
For the food and pharma sectors, the proposals set out this month are
confirmation they have allies in the Berlaymont.
President Donald Trump has told his health secretary, Robert F. Kennedy Jr., to
consider aligning the U.S. vaccination schedule with those in Europe, where many
countries recommend fewer vaccines.
Kennedy has taken up the charge with gusto and is considering advising parents
to follow Denmark’s childhood schedule rather than America’s.
Many who specialize in vaccination and public health say that would be a
mistake. While wealthy European countries do health care comparatively well,
they say, there are lots of reasons Americans are recommended more shots than
Europeans, ranging from different levels of access to health care to different
levels of disease.
“If [Kennedy] would like to get us universal health care, then maybe we can have
a conversation about having the schedule adjusted,” Demetre Daskalakis, who led
the Centers for Disease Control and Prevention’s National Center for
Immunization and Respiratory Diseases before resigning in protest in August,
told POLITICO.
Children, especially those who live in poor and rural areas, would be at greater
risk for severe disease and death if the U.S. were to drop shots from its
schedule, Daskalakis said. Denmark, for instance, advises immunizing against
only 10 of the 18 diseases American children were historically recommended
immunizations against. It excludes shots for potentially serious infections,
including hepatitis A and B, meningitis and respiratory syncytial virus.
Under Kennedy, the government has already changed its hepatitis B vaccine
recommendations for newborns this year, even as critics warned the new advice
could lead to more chronic infections, liver problems and cancer. The health
department points out that the new guidance on hepatitis B — that mothers who
test negative for the virus may skip giving their newborn a shot in the hospital
— now align more closely with most countries in Europe.
Public health experts and others critical of the move say slimmer European
vaccine schedules are a cost-saving measure and a privilege afforded to
healthier societies, not a tactic to protect kids from vaccine injuries.
Kennedy’s interest in modeling the U.S. vaccine schedule after Europe, they
point out, is underpinned by his belief that some childhood vaccines are unsafe
and that American kids get too many too young.
Kennedy’s safety concerns don’t align with the rationale underpinning the
approach in Europe, where the consensus is that childhood vaccines are safe.
Wealthy European countries in many cases eschew vaccines based on a risk-benefit
calculus that doesn’t hold in America. European kids often don’t get certain
shots because it would prevent a very small number of cases — like hepatitis B —
or because the disease is rarely serious for them, such as Covid-19 and
chickenpox. But since the U.S. doesn’t have universal access to care,
vaccinating provides more return on investment, experts say.
“We just have a tradition to wait a little bit” before adding vaccines to
government programs, said Johanna Rubin, a pediatrician and vaccine expert for
Sweden’s health agency.
Swedish children are advised to get vaccines for 11 diseases before they turn
18.
Rubin cited the need to verify the shots’ efficacy and the high cost of new
vaccines as reasons Sweden moves slowly to add to its schedule. “It has to go
through the health economical model,” she said.
VACCINE SAFETY’S NOT THE ISSUE
Martin Kulldorff, a Swedish native and former Harvard Medical School professor
who led Kennedy’s vaccine advisory panel until this month, pointed to that
country’s approach to vaccination and public health in an interview with
POLITICO earlier this year.
Before the Centers for Disease Control and Prevention this month dropped its
recommendation that children of mothers who test negative for hepatitis B
receive a vaccine within a day of birth, Kulldorff cited Sweden’s policy.
“In Sweden, the recommendation is that you only do that if the mother has the
infection. That’s the case in most European countries,” he said. “You could have
a discussion whether one or the other is more reasonable.”
The U.S. policy, as of Dec. 16, more closely resembles Sweden’s, with hepatitis
B-negative mothers no longer urged to vaccinate their newborns against the virus
at birth. But Sweden’s public health agency recommends that all infants be
vaccinated, and the country’s regional governments subsidize those doses, which
are administered as combination shots targeting six diseases starting at 3
months.
Public health experts warn that even children of hepatitis B-negative mothers
could catch the virus from others via contact with caregivers who are positive
or shared household items.
The prevalence of chronic hepatitis B in the U.S. is 6.1 percent compared to 0.3
percent in Sweden, according to the Coalition for Global Hepatitis Elimination,
a Georgia-based nonprofit which receives funding from pharmaceutical companies,
the CDC and the National Institutes of Health, among others.
Michael Osterholm, the director of the Center for Infectious Disease Research
and Policy at the University of Minnesota, said the U.S. has taken a more
comprehensive approach to vaccination, in part because its population is sicker
than that of some Western European countries, and the impact of contracting a
disease could be more detrimental.
Osterholm pointed to the Covid pandemic as an example. By May 2022, the U.S. had
seen more than 1 million people die. Other high-income countries — though much
smaller — had more success controlling mortality, he said.
“People tried to attribute [the disparity] to social, political issues, but no,
it was because [peer nations] had so many more people who were actually in
low-risk categories for serious illness,” Osterholm said.
Kennedy and his advisers also cited European views on Covid vaccination in the
spring when the CDC dropped its universal recommendation, instead advising
individuals to talk to their providers about whether to get the shot.
Last month, the Food and Drug Administration’s top vaccine regulator, Vinay
Prasad, linked the deaths of 10 children to Covid vaccination without providing
more detailed information about the data behind his assertion.
European countries years ago stopped recommending repeat Covid vaccination for
children and other groups not considered at risk of becoming severely sick.
Covid shots have been linked to rare heart conditions, primarily among young
men.
European vaccine experts say Covid boosters were not recommended routinely for
healthy children in many countries — not because of safety concerns, but because
it’s more cost-effective to give them to high-risk groups, such as elderly
people or those with health conditions that Covid could make severely sick and
put in the hospital.
In the U.K., Covid-related hospitalizations and deaths declined significantly
after the pandemic, and now are “mostly in the most frail in the population,
which has led to more restricted use of the vaccines following the
cost-effectiveness principles,” said Andrew Pollard, the director of the Oxford
Vaccine Group in the United Kingdom, which works on developing vaccines and was
behind AstraZeneca’s Covid-19 shot.
Pollard led the Joint Committee on Vaccination and Immunization, which advises
the U.K. government, for 12 years before stepping down in September.
In the U.S., more moves to follow Europe are likely.
At a meeting of Kennedy’s vaccine advisers earlier this month, Tracy Beth Høeg,
now acting as the FDA’s top drug regulator, pointed to Denmark’s pediatric
schedule, which vaccinates for 10 diseases, while questioning whether healthy
American children should be subject to more vaccines than their Danish
counterparts.
Danish kids typically don’t get shots for chickenpox, the flu, hepatitis A and
B, meningitis, respiratory syncytial virus and rotavirus, like American children
do, though parents can privately pay for at least some of those vaccines. The
country offers free Covid and flu vaccines to high-risk kids.
After the vaccine advisory meeting wrapped, Trump said he was on board,
directing Kennedy to “fast track” a review of the U.S. vaccine schedule and
potentially align it with other developed nations. He cited Denmark, Germany and
Japan as countries that recommend fewer shots. Last week, Kennedy came within
hours of publicly promoting Denmark’s childhood vaccine schedule as an option
for American parents.
The announcement was canceled at the last minute after the HHS Office of the
General Counsel said it would invite a lawsuit the administration could lose, a
senior department official told POLITICO.
The notion that the U.S. would drop its vaccine schedule in favor of a European
one struck health experts there as odd.
Each country’s schedule is based on “the local situation, so the local
epidemiology, structure of health care services, available resources, and
inevitably, there’s a little bit of political aspect to it as well,” said Erika
Duffell, a principal expert on communicable disease prevention and control at
the European Centre for Disease Prevention and Control, an EU agency that
monitors vaccine schedules across 30 European countries.
Vaccine safety isn’t the issue, she said.
For example, even though most Europeans don’t get a hepatitis B shot within 24
hours of birth, the previous U.S. recommendation, “there is a consensus that the
effectiveness and safety of the vaccine has been confirmed through decades of
research” and continuous monitoring, she said.
European nations like Denmark and the U.K. have kept new cases of hepatitis B
low. Denmark recorded no cases of mother-to-child transmission in 2023, and
Britain’s rate of such spread is less than 0.1 percent — though the latter does
routinely recommend vaccinating low-risk infants beginning at 2 months of age.
European experts point to high levels of testing of pregnant women for hepatitis
B and most women having access to prenatal care as the reasons for success in
keeping cases low while not vaccinating all newborns.
The major differences between the U.S. and the U.K. in their approach to
hepatitis B vaccination are lower infection rates and high screening uptake in
Britain, plus “a national health system which is able to identify and deliver
vaccines to almost all affected pregnancies selectively,” Pollard said.
The CDC, when explaining the change in the universal birth dose recommendation,
argued the U.S. has the ability to identify nearly all hepatitis B infections
during pregnancy because of ”high reliability of prenatal hepatitis B
screening,” which some European experts doubt.
“If we change a program, we need to prepare the public, we need to prepare the
parents and the health care providers, and say where the evidence comes from,”
said Pierre Van Damme, the director of the Centre for the Evaluation of
Vaccination at the University of Antwerp in Belgium.
He suggested that, if there was convincing evidence, U.S. health authorities
could have run a pilot study before changing the recommendation to evaluate
screening and the availability of testing at birth in one U.S. state, for
example.
WHERE EUROPEANS HAVE MORE DISEASE
In some cases, European vaccination policies have, despite universal health
care, led to more disease.
France, Germany and Italy moved from recommending to requiring measles
vaccination over the last decade after outbreaks on the continent. The U.S.,
until recently, had all but eradicated measles through a universal
recommendation and school requirements.
That’s starting to change. The U.S. is at risk of losing its
“measles-elimination” status due to around 2,000 cases this year that originated
in a Texas religious community where vaccine uptake is low.
The 30 countries in the European Union and the European Economic Area, which
have a population of some 450 million people combined, reported more than 35,000
measles cases last year, concentrated in Romania, Austria, Belgium and Ireland.
Europe’s comparatively high rate is linked to lower vaccination coverage than
the level needed to prevent outbreaks: Only four of the 30 countries reached the
95-percent threshold for the second measles dose in 2024, according to the
European Centre for Disease Prevention and Control.
Kennedy touted the U.S.’s lower measles rate as a successful effort at
containing the sometimes-deadly disease, but experts say the country could soon
see a resurgence of infectious diseases due to the vaccine skepticism that grew
during the pandemic and that they say Kennedy has fomented. Among
kindergarteners, measles vaccine coverage is down 2.7 percentage points as of
the 2024-2025 school year, from a peak of 95.2 percent prior to the pandemic,
according to CDC data.
That drop occurred before Kennedy became health secretary. Kennedy and his
advisers blame it on distrust engendered by Covid vaccine mandates imposed by
states and President Joe Biden. But Kennedy led an anti-vaccine movement for
years before joining the Trump administration, linking shots to autism and other
conditions despite scientific evidence to the contrary, and he has continued to
question vaccine safety as secretary.
In some EU nations, vaccines aren’t compulsory for school entry. Swedish law
guarantees the right to education and promotes close consultation between
providers and patients. Some governments fear mandates could push away
vaccine-hesitant parents who want to talk the recommended shots over with their
doctor before giving the vaccines to their children, Rubin explained.
In the U.S., states, which have the authority to implement vaccine mandates for
school entry, rely on the CDC’s guidance to decide which to require. Vaccine
skeptics have pushed the agency to relax some of its recommendations with an eye
toward making it easier for American parents to opt out of routine shots.
Scandinavian nations maintain high vaccine uptake without mandates thanks to
“high trust” in public health systems, Rubin said. In Sweden, she added, nurses
typically vaccinate young children at local clinics and provide care for them
until they reach school age, which helps build trust among parents.
CHICKENPOX
Another example of where the U.S. and Europe differ is the chickenpox vaccine.
The U.S. was the first country to begin universal vaccination against the common
childhood illness in 1995; meanwhile, 13 EU nations broadly recommend the shot.
Denmark doesn’t officially track chickenpox — the vaccine isn’t included on its
schedule — but estimates 60,000 cases annually in its population of 6 million.
The vastly larger U.S. sees fewer than 150,000 cases per year, according to the
CDC.
Many European countries perceive chickenpox as a benign disease, Van Damme said.
“If you have a limited budget for prevention, you will spend usually the money
in other preventative interventions, other vaccines than varicella,” he said,
referring to the scientific term for chickenpox.
But there’s another risk if countries decide to recommend chickenpox
vaccination, he explained. If the vaccination level is low, people remain
susceptible to the disease, which poses serious risks to unborn babies. If it’s
contracted in early pregnancy, chickenpox could trigger congenital varicella
syndrome, a rare disorder that causes birth defects.
If children aren’t vaccinated against chickenpox, almost all would get the
disease by age 10, Van Damme explained. If countries opt for vaccination, they
have to ensure robust uptake: vaccinate virtually all children by 10, or risk
having big pockets of unvaccinated kids who could contract higher-risk
infections later.
Europe’s stance toward chickenpox could change soon. Several countries are
calculating that widely offering chickenpox vaccines would provide both public
health and economic benefits. Britain is adding the shot to its childhood
schedule next month. Sweden is expected to green-light it as part of its
national program in the coming months.
While the public doesn’t see it as a serious disease, pediatricians who see
serious cases of chickenpox are advocating for the vaccine, Rubin told POLITICO.
“It is very contagious,” she said. “It fulfills all our criteria.”
The U.K. change comes after its vaccine advisory committee reviewed new data on
disease burden and cost-effectiveness — including a 2022 CDC study of the U.S.
program’s first 25 years that also examined the vaccine’s impact on shingles, a
painful rash that can occur when the chickenpox virus reactivates years later.
Scientists had theorized for years that limiting the virus’ circulation among
children could increase the incidence of shingles in older adults by eliminating
the “booster” effect of natural exposure, but the U.S. study found that
real-world evidence didn’t support that hypothesis.
On its current trajectory, Europe’s target for ending HIV as a public health
threat by 2030 — a key UN goal — will not be met. Whereas once we talked of this
being realized, we now find ourselves discussing the need to adjust our approach
and accelerate action if we are to get back on track.
This is not where we want, or can afford, to be. But it is where we are.
> While the global incidence of HIV has declined by 39 percent since 2010, parts
> of Europe are now seeing infections rise.1
A key concern is that over half of those diagnosed in the World Health
Organization’s (WHO) European region in 2023 were identified at a late stage.
Late diagnoses lead to higher mortality and morbidity, and significantly
increase healthcare costs, adding a considerable burden to European governments,
reaching billions of euros annually. Mortality risk is estimated to be nine
times higher in those diagnosed late, while medical costs in the first year are
nearly double those of early diagnosed patients.2,3,4
A broader concern is that a failure to provide timely prevention and treatment
exacerbates the epidemic by enabling continued transmission.
Altering the Trajectory of HIV In Europe, a report by the Office for Health
Economics (OHE) and commissioned by ViiV Healthcare, clearly demonstrates the
significant consequences of a failure to effectively prevent and treat HIV for
patients, healthcare professionals and governments.5
European governments must also manage the complex and evolving healthcare needs
of an increasingly elderly HIV community.6 Based on observed trends in
prevalence across eight European countries, the report suggests there could be
~100,000 new diagnoses by 2030.
> The total estimated cost of new diagnoses alone could reach €4.4
> billion between 2025 and 2030 across seven European countries. This figure,
> however, represents only a fraction of the overall financial burden – the
> total estimated cost of all HIV care in just five European countries for the
> same period is projected to be €56.7 billion.
Given the substantial financial implications, an urgent reality check is needed.
Europe cannot afford to be complacent when it comes to its HIV response. Failure
to act decisively now will result in significant long-term financial and
societal burdens.
How, then, should we move forward?
Ultimately, what the OHE report delivered was recognition of the urgent need for
a coordinated effort, one that addresses the challenges facing the European HIV
community while acknowledging the consequences if we fail to do so. This is also
reinforced by a powerful consensus statement published last year urging the
European Commission to address pressing issues related to HIV’s threat in
Europe.
Signed by multiple stakeholders in the HIV community, including ViiV Healthcare,
it sets out a series of recommendations for how Europe should move forward.
These include:
* Increasing access and adherence to antiretroviral therapies;
* Adopting the latest European AIDS Clinical Society guidelines;
* Advancing research into new and accessible medicines to enhance the HIV
response in Europe; and
* Ensuring that underserved populations, including migrants and refugees, have
access to healthcare.
In addition, the statement calls for community, health organizations,
governments and other stakeholders to play a greater role in policy shaping, and
for Europe’s institutions to recognize the crucial role civil society can play
in reaching key populations.
Other goals should include:
* Scaling up testing among key populations, particularly hard-to-reach migrant
and refugee groups;
* Promoting early diagnosis;
* Strengthening primary prevention by expanding access to condoms, PrEP
(pre-exposure prophylaxis), PEP (post-exposure prophylaxis) and ART
(antiretroviral treatment); and
* Improving data monitoring and collection by developing closer relationships
with partner organizations such as the European Centre for Disease Prevention
and Control and WHO Europe.
> However, these goals will only have real impact if they are pursued in an
> environment that supports and incentivizes new patient-centric medicines and
> solutions, which will be key to driving positive change in HIV treatment and
> prevention.
For example, while oral pills for HIV prevention treatment are highly effective,
we know that some people find it unsuitable and difficult to adhere to, a
reticence that affects both health outcomes and overall wellbeing.
Long-acting injectables (LAIs) will ultimately enhance adherence7 rates and help
reduce the stigma that some users may face through daily pill intake.8 ViiV
Healthcare, as the sole global company entirely dedicated to HIV, has been at
the forefront of this scientific advancement, pioneering the world’s first
long-acting injectables for both treatment and prevention. Our extensive
research and development of LAIs underscore our conviction that they are set to
play a vital role in ending the HIV epidemic.
To drive impact at scale, these transformative solutions must be delivered, and
adequately funded, in partnership with governments and other key stakeholders.
Now is not the time for complacency or cutbacks; too much is at stake.
> We stand at a critical juncture, and it is imperative we recognize that
> prioritizing HIV is not merely a public health imperative, but an economic and
> social necessity demanding a collective effort.
With a new European Parliament in place, politicians committed to Europe meeting
the UNAIDS’ target of ending the HIV epidemic as a public health threat by 2030
have the opportunity to advocate for this. This leadership is essential,
particularly as global political attention to HIV challenges appears to be
diminishing.
While some may argue Europe cannot afford to address these challenges, the
reality is that the cost of complacency is far greater. The clock is ticking.
But there is still time and, by coming together, we can change the trajectory of
this epidemic.
--------------------------------------------------------------------------------
References:
1 The urgency of now: AIDS at a crossroads. Geneva: Joint United Nations
Programme on HIV/AIDS (2024). Available at:
https://www.unaids.org/sites/default/files/media_asset/2024-unaids-global-aids-update_en.pdf.
2 Boardman E, Boffito M, Chadwick DR, Cheserem E, Kabagambe S, Kasadha B,
Elliott C. Tackling late HIV diagnosis: Lessons from the UK in the COVID-19 era.
International journal of STD & AIDS. 2024 Mar;35(4):244-53.
3 Guaraldi G, Zona S, Menozzi M, Brothers TD, Carli F, Stentarelli C, Dolci G,
Santoro A, Da Silva AR, Rossi E, Falutz J. Late presentation increases risk and
costs of non-infectious comorbidities in people with HIV: an Italian cost impact
study. AIDS research and therapy. 2017 Feb 16;14(1):8.
4 The Late Presentation Working Groups in EuroSIDA and COHERE. Estimating the
burden of HIV late presentation and its attributable morbidity and mortality
across Europe 2010–2016. BMC Infect Dis 20, 728 (2020).
https://doi.org/10.1186/s12879-020-05261-7
5 Radu P, Hayes H, Tunnicliffe E, Mott D, Hampson G. Altering the Trajectory of
HIV in Europe. OHE Contract Research Report, London: Office of Health Economics.
Available at:
https://www.ohe.org/publications/altering-the-trajectory-of-hiv-in-europe/.
6 Kiplagat J, Tran DN, Barber T, Njuguna B, Vedanthan R, Triant VA, Pastakia SD.
How health systems can adapt to a population ageing with HIV and comorbid
disease. The Lancet HIV. 2022 Apr 1;9(4):e281-92.
7 Zhang C, Liu Y. Understanding the association between PrEP stigma and PrEP
cascade moderated by the intensity of HIV testing. Tropical Medicine and
Infectious Disease. 2022 May 16;7(5):74.
8 Brooks RA, Cabral A, Nieto O, Fehrenbacher A, Landrian A. Experiences of
pre-exposure prophylaxis stigma, social support, and information dissemination
among Black and Latina transgender women who are using pre-exposure prophylaxis.
Transgender health. 2019 Aug 1;4(1):188-96.
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Disclaimer
POLITICAL ADVERTISEMENT
* The sponsor is ViiV Healthcare
* The ultimate controlling entity is GSK Plc
* The advertisement is linked to policy advocacy regarding the progress of HIV
response in Europe and actions to end HIV as a public health threat by 2030
More information here.
LONDON — A mutated influenza strain is spreading early in Europe this winter,
but some experts warn talk of a “superflu” is misleading, erodes public trust
and distracts from the underlying problems of the National Health Service.
The new strain has triggered dramatic headlines in the U.K., where health
leaders are warning of a “worst-case scenario” for the country’s NHS. Health
Secretary Wes Streeting described it as a “tidal wave of flu tearing through our
hospitals” and labelled it a “challenge unlike any [the NHS] has seen since the
pandemic.”
While hospital admissions have been rising sharply due to the early arrival of
flu season, there is currently no evidence that this season’s variant is more
deadly or transmissible, experts at the World Health Organization (WHO) and the
European Centre for Disease Prevention and Control (ECDC) told POLITICO. Neither
does the data suggest hospital admissions will peak higher than previous years —
although this is possible — just that they’re a few weeks early.
But some experts in the U.K. have criticized the government’s “superflu”
narrative, suggesting it’s being used as leverage in talks on doctor pay and
conditions ahead of a looming strike.
Prime Minister Keir Starmer wrote in The Guardian Friday it was “beyond belief”
doctors would consider striking in these “potentially dire” circumstances,
citing “a superflu epidemic.”
The British Medical Association (BMA), the union representing resident doctors
due to go on strike Wednesday, claimed it was “irresponsible to portray the
current winter flu crisis as unprecedented” given that rates of infection and
hospitalization were “comparable to most years,” a spokesperson told POLITICO.
Mathematician Christina Pagel, a professor at University College London, said
the “superflu” line was based on the “highly misleading use of statistics” and
had more to do with the impending doctors’ strike than real trends.
When contacted by POLITICO, the U.K. government stood by its health leaders’
warnings of the current flu season, in which they described it as an
“unprecedented wave of super flu.” They said staff were being “pushed to the
limit.” The government also pointed to stats showing the NHS is under pressure.
A DHSC spokesperson told POLITICO the government had offered the BMA an extended
mandate so they could strike in January instead, but the union rejected it. The
BMA told POLITICO the extension included “several restrictive conditions.”
THE IMPORTANCE OF TRUST
The government and NHS bosses have warned the heavy burden on hospitals in
December could set the health system up for a very severe winter. NHS statistics
published last week show an average of 2,660 patients in hospital with flu per
day, a record for this time of year, while the Health Foundation has said the
NHS could face “major pressures” if cases continue to climb rapidly in the weeks
ahead.
Yet, while NHS staff are stretched, Pagel and others argue this year is largely
consistent with previous severe flu seasons. However, without being clear about
this with the public, some experts are concerned the government’s messaging
could do more harm than good.
“One of the real issues we have with governments everywhere is trust,” Martin
McKee, professor of public health at the London School of Hygiene and Tropical
Medicine, told POLITICO.
While NHS staff are stretched, experts argue this year is largely consistent
with previous severe flu seasons. | Geography Photos/Getty Images
“The difficulty is we’ve seen them do all sorts of things for all sorts of
motives. That then becomes a problem whenever they are saying something
accurate,” McKee said, adding that the government should be more careful in its
flu messaging given the declining trust in science.
POLITICO put these concerns over trust in science to DHSC, but the department
did not respond by the time of publication.
A spokesperson for government-sponsored NHS England told POLITICO: “The NHS is
not misleading the public — this is the earliest flu season we have seen in
recent years with the latest data showing the numbers of patients in hospital
with flu is extremely high for this time of year.”
The NHS is struggling as it often does in winter, with a spike in delayed
discharges — people who are ready to leave hospital but have nowhere to go —
posing an extra challenge for hospitals, The Guardian reported Sunday.
Hospital admissions for flu per 100,000 rose 23 percent in last week’s data,
compared to 69 percent the previous week, but this doesn’t rule out another
surge in the weeks ahead.
McKee said the NHS was paying the price for chronic underinvestment. “We almost
seem surprised that it’s arrived,” he said of the current flu wave, citing a
“massive shortage” in beds, IT equipment and scanners.
WHAT THE EXPERTS SAY
There is no reason to think the current flu strain (H3N2 sub-clade K) causes
more severe disease than other types of flu, Hans Kluge, head of the World
Health Organization’s Europe office, told POLITICO.
Nor is there any solid evidence that it is more transmissible, said Edoardo
Colzani, a flu expert at the European Centre for Disease Prevention and Control.
It’s possible the lower level of immunity to this strain could lead to more
cases “but this is still speculative at this stage,” Colzani said.
“The epidemiological situation at the moment [in the EU] does not seem worse
than in previous years apart from the fact that it is two-to-three weeks
earlier,” Colzani said. Kluge said it was “about 4 weeks earlier than usual,”
which “is not out of the ordinary” and trending similar to the 2022–2023
influenza season.
There were some concerns the available flu vaccine might not be a “perfect
match” for the current strain, Kluge said, but early data from the U.K. suggests
it provides “meaningful protection” and may prevent severe disease and death,
especially among vulnerable groups.
“We [could] end up having a much bigger wave than usual but we have no
evidence,” Pagel said, adding she thought it was “most likely” to peak “in a
couple of weeks.” But the available data can’t tell us whether it will be a
normal wave that starts and ends early, or an especially bad season, she added.
“We don’t know when it will turn the corner but the actual shape of the wave
doesn’t look that different from previous years,” McKee said.
The NHS has previously warned of the risk of a “long and drawn-out flu season”
due to the early start. According to the WHO, some countries in the southern
hemisphere had unusually long flu seasons this year.
“Based on previous trends, this season is expected to peak in late December or
early January,” Kluge said.
The advice from EU and U.K. authorities remains the same — get a flu vaccine as
soon as possible, especially for those in a vulnerable group.
This article is presented by EFPIA with the support of AbbVie
I made a trip back to Europe recently, where I spent the vast majority of my
pharmaceutical career, to share my perspectives on competitiveness at the
European Health Summit. Now that I work in a role responsible for supporting
patient access to medicine globally, I view Europe, and how it compares
internationally, through a new lens, and I have been reflecting further on why
the choices made today will have such a critical impact on where medicines are
developed tomorrow.
Today, many patients around the world benefit from medicines built on European
science and breakthroughs of the last 20 years. Europeans, like me, can be proud
of this contribution. As I look forward, my concern is that we may not be able
to make the same claim in the next 20 years. It’s clear that Europe has a
choice. Investing in sustainable medicines growth and other enabling policies
will, I believe, bring significant benefits. Not doing so risks diminishing
global influence.
> Today, many patients around the world benefit from medicines built on European
> science and breakthroughs of the last 20 years
I reflect on three important points: 1) investment in healthcare benefits
individuals, healthcare and society, but the scale of this benefit remains
underappreciated; 2) connected to this, the underpinning science for future
innovation is increasingly happening elsewhere; and 3) this means the choices we
make today must address both of these trends.
First, let’s use the example of migraine. As I have heard a patient say,
“Migraine will not kill you but neither [will they] let you live.”[1]
Individuals can face being under a migraine attack for more than half of every
month, unable to leave home, maintain a job and engage in society.[2] It is the
second biggest cause of disability globally and the first among young women.[3]
It affects the quality of life of millions of Europeans.[4] From 2011-21 the
economic burden of migraine in Europe due to the loss of working days ranged
from €35-557 billion, depending on the country, representing 1-2 percent of
gross domestic product (GDP).[5]
Overall socioeconomic burden of migraine as percentage of the country’s GDP in
2021
Source: WifOR, The socioeconomic burden of migraine. The case of 6 European
Countries.5
Access to effective therapies could radically improve individuals’ lives and
their ability to return to work.[6] Yet, despite the staggering economic and
personal impacts, in some member states the latest medicines are either not
reimbursed or only available after several treatment failures.[7] Imagine if
Europe shifted its perspective on these conditions, investing to improve not
only health but unlocking the potential for workforce and economic productivity?
Moving to my second point, against this backdrop of underinvestment, where are
scientific advances now happening in our sector?
In recent years it is impressive to see China has become the second-largest drug
developer in the world,[8] and within five years it may lead the innovative
antibodies therapeutics sector,[9] which is particularly promising for complex
areas like oncology.
Cancer is projected to become the leading cause of death in Europe by 2035,[10]
yet the continent’s share of the number of oncology trials dropped from 41
percent in 2013 to 21 percent in 2023.10
Today, antibody-drug conjugates are bringing new hope in hard-to-treat tumor
types,[11] like ovarian,[12] lung[13] and colorectal[14] cancer, and we hope to
see more of these advances in the future. Unfortunately, Europe is no longer at
the forefront of the development of these innovations. This geographical shift
could impact high-quality jobs, the vitality of Europe’s biotech sector and,
most importantly, patients’ outcomes. [15]
> This is why I encourage choices to be made that clearly signal the value
> Europe attaches to medicines
This is why I encourage choices to be made that clearly signal the value Europe
attaches to medicines. This can be done by removing national cost-containment
measures, like clawbacks, that are increasingly eroding the ability of companies
to invest in European R&D. To provide a sense of their impact, between 2012 and
2023, clawbacks and price controls reduced manufacturer revenues by over €1.2
billion across five major EU markets, corresponding to a loss of 4.7 percent in
countries like Spain.[16] Moreover, we should address health technology
assessment approaches in Europe, or mandatory discount policies, which are
simply not adequately accounting for the wider societal value of medicines, such
as in the migraine example, and promoting a short-term approach to investment.
By broadening horizons and choosing a long-term investment strategy for
medicines and the life science sector, Europe will not only enable this
strategic industry to drive global competitiveness but, more importantly, bring
hope to Europeans suffering from health conditions.
AbbVie SA/NV – BE-ABBV-250177 (V1.0) – December 2025
--------------------------------------------------------------------------------
[1] The Parliament Magazine,
https://www.theparliamentmagazine.eu/partner/article/unmet-medical-needs-and-migraine-assessing-the-added-value-for-patients-and-society,
Last accessed December 2025.
[2] The Migraine Trust;
https://migrainetrust.org/understand-migraine/types-of-migraine/chronic-migraine/,
Last accessed December 2025.
[3] Steiner TJ, et al; Lifting The Burden: the Global Campaign against Headache.
Migraine remains second among the world’s causes of disability, and first among
young women: findings from GBD2019. J Headache Pain. 2020 Dec 2;21(1):137
[4] Coppola G, Brown JD, Mercadante AR, Drakeley S, Sternbach N, Jenkins A,
Blakeman KH, Gendolla A. The epidemiology and unmet need of migraine in five
european countries: results from the national health and wellness survey. BMC
Public Health. 2025 Jan 21;25(1):254. doi: 10.1186/s12889-024-21244-8.
[5] WifOR. Calculating the Socioeconomic Burden of Migraine: The Case of 6
European Countries. Available at:
[https://www.wifor.com/en/download/the-socioeconomic-burden-of-migraine-the-case-of-6-european-countries/?wpdmdl=358249&refresh=687823f915e751752703993].
Accessed June 2025.
[6] Seddik AH, Schiener C, Ostwald DA, Schramm S, Huels J, Katsarava Z. Social
Impact of Prophylactic Migraine Treatments in Germany: A State-Transition and
Open Cohort Approach. Value Health. 2021 Oct;24(10):1446-1453. doi:
10.1016/j.jval.2021.04.1281
[7] Moisset X, Demarquay G, et al., Migraine treatment: Position paper of the
French Headache Society. Rev Neurol (Paris). 2024 Dec;180(10):1087-1099. doi:
10.1016/j.neurol.2024.09.008.
[8] The Economist,
https://www.economist.com/china/2025/11/23/chinese-pharma-is-on-the-cusp-of-going-global,
Last accessed December 2025.
[9] Crescioli S, Reichert JM. Innovative antibody therapeutic development in
China compared with the USA and Europe. Nat Rev Drug Discov. Published online
November 7, 2025.
[10] Manzano A., Svedman C., Hofmarcher T., Wilking N.. Comparator Report on
Cancer in Europe 2025 – Disease Burden, Costs and Access to Medicines and
Molecular Diagnostics. EFPIA, 2025. [IHE REPORT 2025:2, page 20]
[11] Armstrong GB, Graham H, Cheung A, Montaseri H, Burley GA, Karagiannis SN,
Rattray Z. Antibody-drug conjugates as multimodal therapies against
hard-to-treat cancers. Adv Drug Deliv Rev. 2025 Sep;224:115648. doi:
10.1016/j.addr.2025.115648. Epub 2025 Jul 11. PMID: 40653109..
[12] Narayana, R.V.L., Gupta, R. Exploring the therapeutic use and outcome of
antibody-drug conjugates in ovarian cancer treatment. Oncogene 44, 2343–2356
(2025). https://doi.org/10.1038/s41388-025-03448-3
[13] Coleman, N., Yap, T.A., Heymach, J.V. et al. Antibody-drug conjugates in
lung cancer: dawn of a new era?. npj Precis. Onc. 7, 5 (2023).
https://doi.org/10.1038/s41698-022-00338-9
[14] Wang Y, Lu K, Xu Y, Xu S, Chu H, Fang X. Antibody-drug conjugates as
immuno-oncology agents in colorectal cancer: targets, payloads, and therapeutic
synergies. Front Immunol. 2025 Nov 3;16:1678907. doi:
10.3389/fimmu.2025.1678907. PMID: 41256852; PMCID: PMC12620403.
[15] EFPIA, Improving EU Clinical Trials: Proposals to Overcome Current
Challenges and Strengthen the Ecosystem,
efpias-list-of-proposals-clinical-trials-15-apr-2025.pdf, Last accessed December
2025.
[16] The EU General Pharmaceutical Legislation & Clawbacks, © Vital
Transformation BVBA, 2024.