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.”
Tag - Health systems
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.
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.
Disclaimer
POLITICAL ADVERTISEMENT
* This is sponsored content from AstraZeneca.
* The advertisement is linked to public policy debates on the future of cancer
care in the EU.
More information here.
Europe has made huge strides in the fight against cancer.[1] Survival rates have
climbed, detection has improved and the continent has become home to some of the
world’s most respected research hubs.[2],[3] None of that progress came easy —
it was built on years of political attention and cooperation across borders.
However, as we look to 2026 and beyond, that progress stands at a crossroads.
Budget pressures and tougher global competition threaten to push cancer and
health care down the EU agenda. Europe’s Beating Cancer Plan — a flagship
initiative aimed at expanding screening, improving early detection and boosting
collaboration — is set to expire in 2027, with no clear plan to secure or extend
its gains.[4],[5]
“My [hope is that we can continue] the work started with Europe’s Beating Cancer
Plan and make it sustainable… [and] build on the lessons learned, [for other
disease areas] ” says Antonella Cardone, CEO of Cancer Patients Europe.
A new era in cancer treatment
Concern about the lapsing initiative is compounded by two significant shifts in
health care: declining investment and increasing scientific advancement.
Firstly, Europe has seen the increased adoption of cost-containment policies by
some member states. Under-investment in Europe in cancer medicines has been a
challenge — specifically with late and uneven funding, and at lower levels than
international peers such as the US — potentially leaving patients with slower
and more limited access to life-saving therapies.[6],[7],[8] Meanwhile, the
U.S., which pays on average double for medicines per capita than the EU,[9] is
actively working to rebalance its relationship with pharmaceuticals to secure
better pricing (“fair market value”) through policies across consecutive
administrations.[10] All the while, China is rapidly scaling investment in
biotech and clinical research, determined to capture the trials, talent, and
capital that once flowed naturally to Europe.[11]
The rebalancing of health and life-science investment can have significant
consequences. If Europe does not stay attractive for life-sciences investment,
the impact will extend beyond cancer patient outcomes. Jobs, tax revenues,
advanced manufacturing, and Europe’s leadership in strategic industries are all
at stake.[12]
Secondly, medical science has never looked more promising.[7] Artificial
intelligence is accelerating drug discovery, clinical trials, and diagnostics,
and the number of approved medicines for patients across Europe has jumped from
an average of one per year between 1995 and 2000 to 14 per year between 2021 and
2024.[13],[14],[15], [7] Digital health tools and innovative medtech startups
are multiplying, increasing competitiveness and lowering costs — guiding care
toward a future that is more personalized and precise.[16],[17]
Europe stands at the threshold of a new era in cancer treatment. But if
policymakers ease up now, progress could stall — and other regions, especially
the U.S. and China, are more than ready to widen the innovation gap.
Recognizing the strategic investment
Health spending is generally treated as a budget item to be contained. Yet
investment in cancer care has been one of Europe’s smartest economic
bets.[18],[19] The sector anchors millions of high-skilled jobs (it employs
around 29 million people in the EU[11]) and attracts global life sciences
investment. According to the European Commission, the sector contributes nearly
€1.5 trillion to the EU economy.[12] Studies from the Institute of Health
Economics confirm that money put into research directly translates into better
survival outcomes.[20]
The same report shows that although the overall spend on cancer is increasing,
the cost per patient has actually decreased since 1995, suggesting that
innovative treatments are increasing efficiency.[20]
Those gains matter not only to patients and families, but to Europe’s long-term
stability: healthier populations mean fewer costs down the line, stronger
productivity, and more sustainable public finances.[20]
Fixing Europe’s access gap
Cancer medicines bring transformative value — to patients, to society and to the
wider economy. [21]
However, even as oncology therapies advance, patients across Europe are not
benefiting equally. EFPIA’s 2024 Patients W.A.I.T. indicator shows that, on
average, just 46 percent of innovative medicines approved between 2020 and 2023
were available to patients in 2024.[22] On average, it takes 578 days for a new
oncology medicine to reach European patients, and only 29 percent of drugs are
fully available in all member states.[23]
This is not caused by a lack of breakthrough medicines, but by national policy
mechanisms that undervalue innovation. OECD and the Institute for Health
Economics data show that divergent HTA requirements, rigid cost-effectiveness
thresholds, price-volume clawbacks, ad hoc taxes on pharmaceutical revenues and
slow national reimbursement decisions collectively suppress timely access to new
cancer medicines across the EU.[24]
These disparities cut against Europe’s long-standing reputation as a collection
of societies that values equitable, high-quality care for all of its citizens.
It risks eroding one of the EU’s defining strengths: the commitment to fairness
and collective progress.
Cancer policy solutions for the EU
Although this is ultimately a matter for member states, embedding cancer as a
permanent EU priority — backed by funding, coordination, and accountability —
could give national systems the incentives and strategic direction to buck these
trends. These actions will reassure pharmaceutical companies that Europe is
serious about attracting clinical trials and the launch of new medicines,
ensuring that its citizens, societies and economies enjoy the benefits this
brings.
Europe’s Beating Cancer Plan delivered progress, but its expiry presents a
pivotal moment. 2026 and beyond bring a significant opportunity for the EU to
build on this by ensuring that member states implement National Cancer Control
Plans and have clear targets and accountability on their national performance,
including on investment and access. To do this, EU policymakers should consider
three actions as an immediate priority with lasting impact:
* Embed cancer and investment within EU governance. Build it into the European
Semester on health with mandatory indicators, regular reviews, and
accountability frameworks to ensure continuity. This model worked well during
Covid-19 and should be adapted for non-communicable diseases starting with
cancer as a pilot.
* Secure stable and sufficient funding. The Multiannual Financial Framework
must ensure adequate funding for health and cancer to encourage coordinated
initiatives across member states.
* Strengthen EU-level coordination. Ensure that pan-EU structures such as the
Comprehensive Cancer Centres and Cancer Mission Hubs are adequately funded
and empowered.
These are the building blocks of a lasting European commitment to cancer. With
action, Europe can secure a sustainable foundation for patients, resilience and
continued scientific excellence.
--------------------------------------------------------------------------------
[1] European Commission, OECD/European Observatory on Health Systems and
Policies. 2023. State of Health in the EU: Synthesis Report 2023. Available at:
https://health.ec.europa.eu/system/files/2023-12/state_2023_synthesis-report_en.pdf
[Accessed December 2025]
[2] Efpia. 2025. Cancer care 2025: an overview of cancer outcomes data across
Europe. Available at:
https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/ihe-cancer-comparator-report-2025/
[Accessed December 2025]
[3] Cancer Core Europe. 2024. Cancer Core Europe: Advancing Cancer Care Through
Collaboration. Available at:
https://www.cancercoreeurope.eu/cce-advancing-cancer-care-collaboration/
[Accessed December 2025]
[4] European Commission. 2021. Europe’s Beating Cancer Plan. Available
at:https://health.ec.europa.eu/system/files/2022-02/eu_cancer-plan_en_0.pdf
[Accessed December 2025]
[5] European Parliament. 2025. Europe’s Beating Cancer Plan: Implementation
findings.
https://www.europarl.europa.eu/RegData/etudes/STUD/2025/765809/EPRS_STU(2025)765809_EN.pdf
[Accessed December 2025]
[6] Hofmarcher, T., et al. 2024. Access to Oncology Medicines in EU and OECD
Countries (OECD Health Working Papers, No.170). OECD Publishing. Available at:
https://www.oecd.org/content/dam/oecd/en/publications/reports/2024/09/access-to-oncology-medicines-in-eu-and-oecd-countries_6cf189fe/c263c014-en.pdf
[Accessed December 2025]
[7] Manzano, A., et al. 2025. Comparator Report on Cancer in Europe 2025 –
Disease Burden, Costs and Access to Medicines and Molecular Diagnostics (IHE).
Available at: https://ihe.se/app/uploads/2025/03/IHE-REPORT-2025_2_.pdf
[Accessed December 2025]
[8] Efpia. [no date]. Europe’s choice. Available at:
https://www.efpia.eu/europes-choice/ [Accessed December 2025]
[9] OECD. 2024. Prescription Drug Expenditure per Capita.
https://data-explorer.oecd.org/vis?lc=en&pg=0&snb=1&vw=tb&df[ds]=dsDisseminateFinalDMZ&df[id]=DSD_SHA%40DF_SHA&df[ag]=OECD.ELS.HD&df[vs]=&pd=2015%2C&dq=.A.EXP_HEALTH.USD_PPP_PS%2BPT_EXP_HLTH._T..HC51%2BHC3.._T…&to[TIME_PERIOD]=false&lb=bt
[Accessed December 2025]
[10] The White House. 2025. Delivering most favored-nation prescription drug
pricing to American patients. Available at:
https://www.whitehouse.gov/presidential-actions/2025/05/delivering-most-favored-nation-prescription-drug-pricing-to-american-patients/
[Accessed December 2025]
[11] Eleanor Olcott, Haohsiang Ko and William Sandlund. 2025. The relentless
rise of China’s Biotechs. Financial Times. Available at:
https://www.ft.com/content/c0a1b15b-84ee-4549-85eb-ed3341112ce5 [Accessed
December 2025]
[12] European Commission, Directorate-General for Communication. 2025. Making
Europe a Global Leader in Life Sciences. Available at:
https://commission.europa.eu/news-and-media/news/making-europe-global-leader-life-sciences-2025-07-02_en
[Accessed December 2025]
[13] Financial Times. 2025. How AI is reshaping drug discovery. Available at:
https://www.ft.com/content/8c8f3c10-9c26-4e27-bc1a-b7c3defb3d95 [Accessed
December 2025]
[14] Seedblink. 2025. Europe’s HealthTech investment landscape in 2025: A deep
dive.
https://seedblink.com/blog/2025-05-30-europes-healthtech-investment-landscape-in-2025-a-deep-dive
[15] European Commission. [No date]. Artificial Intelligence in healthcare.
Available at:
https://health.ec.europa.eu/ehealth-digital-health-and-care/artificial-intelligence-healthcare_en
[Accessed December 2025]
[16] Codina, O. 2025. Code meets care: 20 European HealthTech startups to watch
in 2025 and beyond. EU-Startups. Available at:
https://www.eu-startups.com/2025/06/code-meets-care-20-european-healthtech-startups-to-watch-in-2025-and-beyond
[Accessed December 2025]
[17] Protogiros et al. 2025. Achieving digital transformation in cancer care
across Europe: Practical recommendations from the TRANSiTION project. Journal of
Cancer Policy. Available at:
https://www.sciencedirect.com/science/article/pii/S2213538325000281 [Accessed
December 2025]
[18] R-Health Consult. [no date]. The case for investing in a healthier future
for the European Union. EFPIA. Available at:
https://www.efpia.eu/media/xpkbiap5/the-case-for-investing-in-a-healthier-future-for-the-european-union.pdf
[Accessed December 2025]
[19] Pousette A., Hofmarcher T. 2024.Tackling inequalities in cancer care in the
European Union. Available at:
https://ihe.se/en/rapport/tackling-inequalities-in-cancer-care-in-the-european-union-2/
[Accessed December 2025]
[20] Efpia. 2025. Comparator Report Cancer in Europe 2025. Available at:
https://www.efpia.eu/media/0fbdi3hh/infographic-comparator-report-cancer-in-europe.pdf
[Accessed December 2025]
[21] Garau, E. et al. 2025. The Transformative Value of Cancer Medicines in
Europe. Dolon Ltd. Available at:
https://dolon.com/wp-content/uploads/2025/09/EOP_Investment-Value-of-Oncology-Medicines-White-Paper_2025-09-19-vF.pdf?x16809
[Accessed December 2025]
[22] IQVIA. 2025. EFPIA Patients W.A.I.T. Indicator 2024 Survey. Available at:
https://www.efpia.eu/media/oeganukm/efpia-patients-wait-indicator-2024-final-110425.pdf
[Accessed December 2025]
[23] Visentin M. 2025. Improving equitable access to medicines in Europe must
remain a priority. The Parliament. Available at:
https://www.theparliamentmagazine.eu/partner/article/improving-equitable-access-to-medicines-in-europe-must-remain-a-priority
[Accessed December 2025]
[24] Hofmarcher, T. et al. 2025. Access to novel cancer medicines in Europe:
inequities across countries and their drivers. ESMO Open. Available at:
https://www.esmoopen.com/action/showPdf?pii=S2059-7029%2825%2901679-5 [Accessed
December 2025]
Thirty-six million Europeans — including more than one million in the Nordics[1]
— live with a rare disease.[2] For patients and their families, this is not just
a medical challenge; it is a human rights issue.
Diagnostic delays mean years of worsening health and needless suffering. Where
treatments exist, access is far from guaranteed. Meanwhile, breakthroughs in
genomics, AI and targeted therapies are transforming what is possible in health
care. But without streamlined systems, innovations risk piling up at the gates
of regulators, leaving patients waiting.
Even the Nordics, which have some of the strongest health systems in the world,
struggle to provide fair and consistent access for rare-disease patients.
Expectations should be higher.
THE BURDEN OF DELAY
The toll of rare diseases is profound. People living with them report
health-related quality-of-life scores 32 percent lower than those without.
Economically, the annual cost per patient in Europe — including caregivers — is
around €121,900.[3]
> Across Europe, the average time for diagnosis is six to eight years, and
> patients continue to face long waits and uneven access to medications.
In Sweden, the figure is slightly lower at €118,000, but this is still six times
higher than for patients without a rare disease. Most of this burden (65
percent) is direct medical costs, although non-medical expenses and lost
productivity also weigh heavily. Caregivers, for instance, lose almost 10 times
more work hours than peers supporting patients without a rare disease.[4]
This burden can be reduced. European patients with access to an approved
medicine face average annual costs of €107,000.[5]
Yet delays remain the norm. Across Europe, the average time for diagnosis is six
to eight years, and patients continue to face long waits and uneven access to
medications. With health innovation accelerating, each new therapy risks
compounding inequity unless access pathways are modernized.
PROGRESS AND REMAINING BARRIERS
Patients today have a better chance than ever of receiving a diagnosis — and in
some cases, life-changing therapies. The Nordics in particular are leaders in
integrated research and clinical models, building world-class diagnostics and
centers of excellence.
> Without reform, patients risk being left behind.
But advances are not reaching everyone who needs them. Systemic barriers
persist:
* Disparities across Europe: Less than 10 percent of rare-disease patients have
access to an approved treatment.[6] According to the Patients W.A.I.T.
Indicator (2025), there are stark differences in access to new orphan
medicines (or drugs that target rare diseases).[7] Of the 66 orphan medicines
approved between 2020 and 2023, the average number available across Europe
was 28. Among the Nordics, only Denmark exceeded this with 34.
* Fragmented decision-making: Lengthy health technology assessments, regional
variation and shifting political priorities often delay or restrict access.
Across Europe, patients wait a median of 531 days from marketing
authorization to actual availability. For many orphan drugs, the wait is even
longer. In some countries, such as Norway and Poland, reimbursement decisions
take more than two years, leaving patients without treatment while the burden
of disease grows.[8]
* Funding gaps: Despite more therapies on the market and greater technology to
develop them, orphan medicines account for just 6.6 percent of pharmaceutical
budgets and 1.2 percent of health budgets in Europe. Nordic countries —
Sweden, Norway and Finland — spend a smaller share than peers such as France
or Belgium. This reflects policy choices, not financial capacity.[9]
If Europe struggles with access today, it risks being overwhelmed tomorrow.
Rare-disease patients — already facing some of the longest delays — cannot
afford for systems to fall farther behind.
EASING THE BOTTLENECKS
Policymakers, clinicians and patient advocates across the Nordics agree: the
science is moving faster than the systems built to deliver it. Without reform,
patients risk being left behind just as innovation is finally catching up to
their needs. So what’s required?
* Governance and reforms: Across the Nordics, rare-disease policy remains
fragmented and time-limited. National strategies often expire before
implementation, and responsibilities are divided among ministries, agencies
and regional authorities. Experts stress that governments must move beyond
pilot projects to create permanent frameworks — with ring-fenced funding,
transparent accountability and clear leadership within ministries of health —
to ensure sustained progress.
* Patient organizations: Patient groups remain a driving force behind
awareness, diagnosis and access, yet most operate on short-term or
volunteer-based funding. Advocates argue that stable, structural support —
including inclusion in formal policy processes and predictable financing — is
critical to ensure patient perspectives shape decision-making on access,
research and care pathways.
* Health care pathways: Ann Nordgren, chair of the Rare Disease Fund and
professor at Karolinska Institutet, notes that although Sweden has built a
strong foundation — including Centers for Rare Diseases, Advanced Therapy
(ATMP) and Precision Medicine Centers, and membership in all European
Reference Networks — front-line capacity remains underfunded. “Government and
hospital managements are not providing resources to enable health care
professionals to work hands-on with diagnostics, care and education,” she
explains. “This is a big problem.” She adds that comprehensive rare-disease
centers, where paid patient representatives collaborate directly with
clinicians and researchers, would help bridge the gap between care and lived
experience.
* Research and diagnostics: Nordgren also points to the need for better
long-term investment in genomic medicine and data infrastructure. Sweden is a
leader in diagnostics through Genomic Medicine Sweden and SciLifeLab, but
funding for advanced genomic testing, especially for adults, remains limited.
“Many rare diseases still lack sufficient funding for basic and translational
research,” she says, leading to delays in identifying genetic causes and
developing targeted therapies. She argues for a national health care data
platform integrating electronic records, omics (biological) data and
patient-reported outcomes — built with semantic standards such as openEHR and
SNOMED CT — to enable secure sharing, AI-driven discovery and patient access
to their own data
DELIVERING BREAKTHROUGHS
Breakthroughs are coming. The question is whether Europe will be ready to
deliver them equitably and at speed, or whether patients will continue to wait
while therapies sit on the shelf.
There is reason for optimism. The Nordic region has the talent, infrastructure
and tradition of fairness to set the European benchmark on rare-disease care.
But leadership requires urgency, and collaboration across the EU will be
essential to ensure solutions are shared and implemented across borders.
The need for action is clear:
* Establish long-term governance and funding for rare-disease infrastructure.
* Provide stable, structural support for patient organizations.
* Create clearer, better-coordinated care pathways.
* Invest more in research, diagnostics and equitable access to innovative
treatments.
Early access is not only fair — it is cost-saving. Patients treated earlier
incur lower indirect and non-medical costs over time.[10] Inaction, by contrast,
compounds the burden for patients, families and health systems alike.
Science will forge ahead. The task now is to sustain momentum and reform systems
so that no rare-disease patient in the Nordics, or anywhere in Europe, is left
waiting.
--------------------------------------------------------------------------------
[1]
https://nordicrarediseasesummit.org/wp-content/uploads/2025/02/25.02-Nordic-Roadmap-for-Rare-Diseases.pdf
[2]
https://nordicrarediseasesummit.org/wp-content/uploads/2025/02/25.02-Nordic-Roadmap-for-Rare-Diseases.pdf
[3]
https://media.crai.com/wp-content/uploads/2024/10/28114611/CRA-Alexion-Quantifying-the-Burden-of-RD-in-Europe-Full-report-October2024.pdf
[4]
https://media.crai.com/wp-content/uploads/2024/10/28114611/CRA-Alexion-Quantifying-the-Burden-of-RD-in-Europe-Full-report-October2024.pdf
[5]
https://media.crai.com/wp-content/uploads/2024/10/28114611/CRA-Alexion-Quantifying-the-Burden-of-RD-in-Europe-Full-report-October2024.pdf
[6]
https://www.theparliamentmagazine.eu/partner/article/a-competitive-and-innovationled-europe-starts-with-rare-diseases?
[7]
https://www.iqvia.com/-/media/iqvia/pdfs/library/publications/efpia-patients-wait-indicator-2024.pdf
[8]
https://www.iqvia.com/-/media/iqvia/pdfs/library/publications/efpia-patients-wait-indicator-2024.pdf
[9]
https://copenhageneconomics.com/wp-content/uploads/2025/09/Copenhagen-Economics_Spending-on-OMPs-across-Europe.pdf
[10]
https://media.crai.com/wp-content/uploads/2024/10/28114611/CRA-Alexion-Quantifying-the-Burden-of-RD-in-Europe-Full-report-October2024.pdf
Disclaimer
POLITICAL ADVERTISEMENT
* The sponsor is Alexion Pharmaceuticals
* The entity ultimately controlling the sponsor: AstraZeneca plc
* The political advertisement is linked to policy advocacy around rare disease
governance, funding, and equitable access to diagnosis and treatment across
Europe
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.
Sprawling defense legislation set for a vote as soon as this week would place
new restrictions on reducing troop levels in Europe, a bipartisan rebuke of
Trump administration moves that lawmakers fear would limit U.S. commitments on
the continent.
A just-released compromise version of the National Defense Authorization Act —
which puts Congress’ stamp on Pentagon programs and policy each year — has been
in the works for months. The measure stands in stark contrast to President
Donald Trump’s new national security strategy, which sharply criticizes European
allies and suggests the continent is in cultural decline.
Lawmakers also endorsed a slight increase in the Pentagon budget with a price
tag that is $8 billion more than Trump requested. And it would repeal
decades-old Middle East war powers, a small win for lawmakers who’ve been
fighting to reclaim a sliver of Congress’ war-declaring prerogatives.
The final bill is the result of weeks of negotiations between House and Senate
leadership in both parties, heads of the Armed Services panels and the White
House. The measure had been slowed in recent days by talks on issues unrelated
to defense, including a major Senate-backed housing package and greater scrutiny
of U.S. investment in China.
The defense bill typically passes with broad bipartisan support. Speaker Mike
Johnson will likely need to win back some Democrats who opposed the House GOP’s
hard-right initial bill in September. And the speaker will have to contend with
fellow Republicans upset that their priorities weren’t included.
But both House and Senate-passed defense bills reflected bipartisan concerns
that the Trump administration would seek to significantly reduce the U.S.
military footprint in Europe. Both measures included language that imposes
requirements the Pentagon must meet before trimming military personnel levels on
the continent below certain thresholds.
Republicans, led by Senate Armed Services Chair Roger Wicker (R-Miss.) and House
Armed Services Chair Mike Rogers (R-Ala.), broke with the Trump administration,
arguing that troop reductions — such as a recent decision to remove a rotational
Army brigade from Romania — would invite aggression from Russia.
The final bill blocks the Pentagon from reducing the number of troops
permanently stationed or deployed to Europe below 76,000 for longer than 45 days
until Defense Secretary Pete Hegseth and the head of U.S. European Command
certify to Congress that doing so is in U.S. national security interests and
that NATO allies were consulted. They would also need to provide assessments of
that decision’s impact.
The legislation applies the same conditions to restrict the U.S. from vacating
the role of NATO’s Supreme Allied Commander in Europe, a role that the U.S.
officer who leads European Command chief has held simultaneously for decades.
Negotiators included similar limitations on reducing the number of troops on the
Korean Peninsula below 28,500, a provision originally approved by the Senate.
Lawmakers agreed to a slight increase to the bill’s budget topline, reflecting
some momentum on Capitol Hill for more military spending. The final agreement
recommends an $8 billion hike to Trump’s $893 billion flat national defense
budget, for a total of roughly $901 billion for the Pentagon, nuclear weapons
development and other national security programs.
The House-passed defense bill matched Trump’s budget request while the Senate
bill proposed a $32 billion boost. Republicans separately approved a $150
billion multi-year boost for the Pentagon through their party-line tax cut and
spending megabill earlier this year.
Regardless of the signal the topline budget agreement sends, the defense policy
bill does not allocate any money to the Pentagon. Lawmakers must still pass
annual defense spending legislation to fund Pentagon programs.
House Armed Services ranking member Adam Smith (D-Wash.) described the agreement
as a “placeholder” that would allow lawmakers to finish the NDAA, while
congressional appropriators continue their talks on a separate full-year
Pentagon funding measure.
A House Republican leadership aide who, like others, was granted anonymity to
discuss details of the bill ahead of its release, said the revised topline is a
“fiscally responsible increase that meets our defense needs.”
The bill also would repeal a pair of old laws that authorize military action in
the Middle East, including 2002 legislation that preceded the invasion of Iraq
and the 1991 Gulf War. Those repeals were included in both the House and Senate
defense bills as bipartisan support for scrubbing the old laws — which critics
contend could be abused by a president — overcame opposition from some top
Republicans.
Repealing those decades-old measures is a win for critics of expansive
presidential war powers, who argued the measures aren’t needed anymore. They
point to the potential for abuses — citing Trump’s use of the 2002 Iraq
authorization to partly justify a strike that killed Iranian military commander
Qasem Soleimani in Iraq in 2020.
A second House GOP leadership aide said the repeal of the two Iraq
authorizations won’t impact Trump’s authority as commander-in-chief.
But the repeal is ultimately a minor win for lawmakers seeking to reclaim
congressional power. The 2001 post-9/11 authorization that undergirds much of
the U.S. counterterrorism operations around the world remains on the books.
And the bill is silent on Trump’s ongoing campaign against alleged drug
smuggling vessels in the Caribbean. Many lawmakers — including some Republicans
— have questioned the administration’s legal justification for the lethal
strikes.
The final bill also doesn’t include an expansion of coverage for in-vitro
fertilization and other fertility services for military families under the
Tricare health system. The provision, backed by Sen. Tammy Duckworth (D-Ill.),
Rep. Sara Jacobs (D-Calif.) and others, was included in both Senate and House
bills before it was dropped.
Johnson reportedly was seeking to remove the provision, which similarly was left
out of last year’s bill.
The World Health Organization has recommended the use of novel weight-loss drugs
to curb soaring obesity rates, and urged pharma companies to lower their prices
and expand production so that lower-income countries can also benefit.
The WHO’s new treatment guideline includes a conditional recommendation to use
the so-called GLP-1s — such as Wegovy, Ozempic and Mounjaro — as part of a wider
approach that includes healthy diet, exercise and support from doctors. The WHO
described its recommendation as “conditional” due to limited data on the
long-term efficacy and safety of GLP-1s. The recommendation excludes pregnant
women.
While GLP-1s are a now well-established treatment in high-income countries, the
WHO warns they could reach fewer than 10 percent of people who could benefit by
2030. Among the countries with the highest rates of obesity are those in the
Middle East, Latin America and Pacific islands. Meanwhile, Wegovy was only
available in around 15 countries as of the start of this year.
The WHO wants pharma companies to consider tiered pricing (lower prices in
lower-income countries) and voluntary licensing of patents and technology to
allow other producers around the word to manufacture GLP-1s, to help expand
access to these drugs.
Jeremy Farrar, an assistant director general at the WHO, told POLITICO the
guidelines would also give an “amber and green light” to generic drugmakers to
produce cheaper versions of GLP-1s when the patents expire.
Francesca Celletti, a senior adviser on obesity at the WHO, told POLITICO
“decisive action” was needed to expand access to GLP-1s, citing the example of
antiretroviral HIV drugs earlier this century. “We all thought it was impossible
… and then the price went down,” she said.
Key patents on semaglutide, the ingredient in Novo Nordisk’s diabetes and
weight-loss drugs Ozempic and Wegovy, will lift in some countries next year,
including India, Brazil and China.
Indian generics giant Dr. Reddy’s plans to launch a generic semaglutide-based
weight-loss drug in 87 countries in 2026, its CEO Erez Israeli said earlier this
year, reported Reuters.
“U.S. and Europe will open later … (and) all the other Western markets will be
open between 2029 to 2033,” Israeli told reporters after the release of
quarterly earnings in July.
Prices should fall once generics are on the market, but that isn’t the only
barrier. Injectable drugs, for example, need cold chain storage. And health
systems need to be equipped to roll out the drug once it’s affordable, Celletti
said.
LONDON — American pharmaceutical giants will start to shutter their U.K.
operations unless Keir Starmer’s government agrees to pay more for their drugs,
U.S. Ambassador to the U.K. Warren Stephens warned ministers on Wednesday.
“The U.K. needs to continue addressing its pricing structures for medicines to
ensure it can compete for investment from U.S. firms,” Stephens told a U.K.-U.S.
business gathering in central London attended by British trade and foreign
ministers.
“If there are not changes made, and fast, pharma businesses will not only cancel
future investments, they will shut down their facilities in the U.K.,” the
diplomat said. “This would be a major blow to a country that prides itself,
rightly so, on its life sciences sector.”
The U.K. is locked in drug-pricing negotiations with the Trump administration
and pharmaceutical firms about how much the National Health Service pays for
their products through the so-called Voluntary Scheme for Pricing, Access and
Growth (VPAG) scheme.
Britain has offered to increase the threshold at which the NHS pays firms for
medicines by up to 25 percent, POLITICO first reported in October. But
pharmaceutical executives are pushing the government to go further.
American drugmaker Eli Lilly’s international business chief said on Monday that
it wants to see more changes to Britain’s medicine market before it pivots on
its abandoned £279 million investment in a biotech incubator project.
“I don’t think we have heard enough to say that we are willing to get the Lilly
Gateway Lab started,” Patrik Jonsson, president of Lilly’s international
business, which covers all markets outside the U.S., told POLITICO.
The focus of talks has turned to the government’s “clawback” system, where firms
have to pay back part of their revenue if the total amount the NHS spends on
drugs rises above a certain cap. Unless ministers agree to also raise that cap,
any extra NHS spending will mean a larger clawback bill for pharma companies.
Pricing talks feature in the U.K.’s ongoing trade negotiations with Washington
after Starmer struck a framework trade deal with Trump in May, promising to
“improve the overall environment” for pharmaceutical firms operating in Britain.
U.K. negotiators are currently in Washington and “progress is being made on this
literally as we speak,” Stephens said, adding he hopes “that will yield some
success.”
The U.K.’s “chief obstacle” to growth is also its high energy costs, Stephens
added. “If there are not major reforms to U.K. energy policy, then the U.K.’s
position as a premier destination in the global economy is vulnerable.”
Britain’s Labour government is “completely signed up to an ambitious agenda for
business,” said Trade Minister Chris Bryant, in an address following Stephens’
speech. He set out how the government plans to “integrate” its industrial, small
business and trade strategies to grow the economy.