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.
Tag - Biotech drugs
C-ANPROM/EUC/NON/0052
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BRUSSELS — Europe needs to get its “act together” and unleash its potential in
the pharmaceutical sector, supporting it with better incentives and ensuring
access to innovation for patients, urged Stefan Oelrich, president of Bayer’s
pharmaceuticals division.
“Europe used to be the pharmacy of the world. Nine out of 10 new medicines were
discovered in Europe. That’s no longer the case,” Oelrich, who is also president
of the European Federation of Pharmaceutical Industries and Associations
(EFPIA), said at the POLITICO 28 Gala Dinner. “We’re losing competitiveness
rather than gaining.”
China and the U.S. are pulling ahead on pharmaceutical innovation and clinical
trials. About one third of medicines approved by the U.S. Food and Drug
Administration (FDA) don’t make it to Europe, Oelrich said. And amid the U.S.
tariffs threat, companies are increasingly looking outside of Europe for
investments.
But there is hope — both for the pharmaceutical industry and beyond. Per
Franzén, CEO and managing partner at EQT, a global investment organization, said
he is seeing “an unprecedented interest to invest into Europe.”
“It’s a real window of opportunity, a unique moment in time for Europe,” he
said. “In order to make the most out of that opportunity, what we need to do is
really to drive a more business-friendly, more innovation-friendly agenda,” he
said. But with the pace of change, driven by artificial intelligence, “time is
of the essence,” he added.
Over-regulation isn’t holding Europe back in medicines innovation, it’s a lack
of substantial incentives for companies to invest in Europe, Oelrich said.
But it doesn’t have to be this way, he said: “We have some of the best
universities in the world that publish some of the coolest science in the world.
So there is no reason why this wouldn’t work. And we need to get our act
together,” he said.
“Instead of trying to complicate our lives and come up with a new bureaucratic
idea, we should come up with with ways of how we unleash our forces.”
BRUSSELS — EU lawmakers have clinched a long-awaited agreement on the bloc’s
overhaul of its two decades-old pharmaceutical rules — one of the EU’s biggest
health files.
The revamp is designed to restore Europe’s competitive edge and give companies
more certainty that the EU remains an attractive market, while also pushing for
more equal access to medicines across member countries.
The deal between the Parliament and the Council was struck at 5 a.m. on
Thursday, more than two years after the Commission tabled the proposal, which
consists of directive and regulation, in spring 2023.
It marks a major victory for the Danish presidency, which pledged to wrap up the
file before the end of the year, and for Health Commissioner Olivér Várhelyi,
who has pushed to seal the reform amid growing geopolitical uncertainty.
LONDON — The American drugmaker Eli Lilly wants to see more changes to Britain’s
medicine market before it pivots on its abandoned £279 million investment in a
biotech incubator project.
The U.K. government has drawn up proposals to increase the amount the
state-funded National Health Service is allowed to pay pharmaceutical firms for
drugs after intense discussions with officials from Donald Trump’s
administration.
The U.S. president has demanded lower drug prices for Americans, and suggested
other developed countries should pay more. The British plans under consideration
could increase the threshold at which the NHS pays firms for medicines by up to
25 percent.
But for the U.S. pharmaceutical company — which shelved its planned facility
meant to support early-stage life sciences businesses with lab space, mentorship
and potential financial backing — the proposal alone is not enough.
“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.
“I think once we see the right signs from the U.K. government, we’re more than
happy to restart those discussions, and we could move quite quickly,” Jonsson
said. However, “we need to see some significant and sustainable change here.”
The comments will be a blow to British negotiators, who are in advanced talks to
agree their drug-pricing deal with the U.S. administration as part of wider
trade negotiations. Officials are hoping to wrap up the pharma talks ahead of
the U.K.’s budget in late November.
Ministers last week granted a two-week extension to the deadline by which pharma
firms must tell the government if they intend to leave the NHS’s voluntary drug
pricing scheme.
If Washington and London strike a deal — effectively committing the NHS to
higher drug spending — Chancellor Rachel Reeves will face pressure to spell out
how much the increase will cost taxpayers.
‘WE NEED THE RIGHT CONDITIONS’
Drugmakers have long called for changes to the U.K.’s tightly-controlled drug
prices.
Britain limits the annual cost for a year of good-quality life (QALY) for a
patient at £30,000 for most drugs. Industry also pays an annual rebate to the
NHS at 23 percent of their U.K. sales.
These measures have contained the medicine bill for the U.K.’s publicly-funded
health care system.
While Jonsson acknowledged the U.K. is “well positioned to be a source of
innovation” thanks to a “small but really impressive group of scientists,” he
said the country needs to demonstrate sustained changes.
The British plans under consideration could increase the threshold at which the
NHS pays firms for medicines by up to 25 percent. | Anna Barclay/Getty Images
“At the end of the day if you want us to research, develop and produce medicines
in your country you need to put the right conditions in place so that your
citizens can get access to those patients at least who need it most,” Jonsson
said.
An editorial in the Lancet medical journal last week said “the argument that
paying more for medicines leads to more innovation is unfounded.”
“If the U.K. Government wants to attract pharma investment, it should follow the
evidence. Rather than handing over more money for medicines, it should invest in
creating fertile conditions for attracting world-leading scientists, boosting
public infrastructure for research and development, and facilitating clinical
trials,” the article states.
“Although the tangible outcomes of applied research might appeal to politicians,
investing massively in a second-to-none basic science sector will allow
scientific innovation to flourish.”
Jonsson was speaking to POLITICO as the company announced a €2.6 billion new
manufacturing facility in the Netherlands to produce oral medicines, including
its first GLP-1 weight-loss pill.
A Department of Health and Social Care spokesperson said: “We will always
prioritise the needs of NHS patients. Investment in patient access to innovative
medicines is critical to our NHS.
“We are now in advanced discussions with the US Administration to secure the
best outcome for the UK, reflecting our strong relationship and the
opportunities from close partnership with our pharmaceutical industry,” the
spokesperson added.
The European Commission is set to unveil the Biotech Act I, an EU cardiovascular
health plan and a simplification of the bloc’s medical devices and in vitro
diagnostics rules on Dec. 16, according to the latest Commission agenda
published Monday.
The first part of the Biotech Act will focus on the pharmaceutical industry and
is being produced without a dedicated impact assessment. The second part —
covering other biotech sectors — is expected in the third quarter of 2026.
The upcoming cardiovascular health plan — inspired by the bloc’s Beating Cancer
Plan — will cover prevention, early detection and screening, treatment and
management, and rehabilitation.
Meanwhile, simplification of the bloc’s medical devices and in vitro diagnostics
rules comes after the regulations drove up assessment costs, caused
certification delays, and led to product withdrawals from the market. Europe’s
Health Commissioner Olivér Várhelyi has previously said the sector needs a
“major overhaul.”
Additionally, the Commission’s agenda includes a “drugs package” comprising new
rules on drug precursors and an EU Drugs Strategy and European action plan
against drug trafficking — both scheduled for Dec. 3.
It could have been the ominous cold open to a classic Bond film.
The Russian and Chinese leaders caught on a hot mic at a Beijing military
parade, casually musing about cheating death.
“With the development of biotechnology, human organs can be continuously
transplanted and people can live younger and younger, and even achieve
immortality,” Russian leader Vladimir Putin told Chinese ruler Xi Jinping, his
tone half clinical, half conspiratorial.
“Predictions are that this century, there is a chance of living to 150,” Xi
replied.
But this wasn’t a scriptwriter’s villainous fantasy. It was a jaw-droppingly
real exchange between two of the world’s most powerful, heavily armed leaders.
While it may have sounded absurd, behind palace walls, the obsession with
longevity is more than idle chatter.
The Russian and Chinese leaders were caught on a hot mic at a Beijing military
parade, casually musing about cheating death. | Pool photo by Alexander
Kazakov/AFP via Getty Images
In 2024, the Kremlin ordered scientists to fast-track anti-aging research on
cellular degeneration, cognitive decline and the immune system. Meanwhile, China
has also been pouring resources into exploring nanotechnology-delivered hydrogen
therapy and compounds such as betaine and lithocholic acid, hoping to slow down
aging and extend healthy lifespans.
But even as the world’s autocrats fantasize about replacing body parts like car
tires, the science remains far less accommodating.
James Markmann, executive council president at the American Society of
Transplant Surgeons, called Xi and Putin’s idea of living to 150 through
transplants “unfounded.”
“There is currently no evidence suggesting that living to 150 years of age is
possible through organ transplantation,” Markmann said. “While there is much
interest in related research and some progress in intervening in the aging
process, there is no evidence that a 150-year lifespan can currently be
achieved.”
While organ transplantation can and does save lives, there’s no data that it can
also slow or reset an individual’s biological clock, Markmann said. Replacing a
single organ, or even several, may improve health temporarily, but it cannot
halt the overall aging process of the body.
“The concerning idea here is that there is a surplus of organs available that
can consistently be replenished for a single individual to prolong their life;
this is simply not the case,” Markmann said.
THE OLDEST OBSESSION
The Xi-Putin exchange didn’t happen in a vacuum. History is littered with rulers
who believed they could outsmart death.
Qin Shi Huang, China’s first emperor, swallowed mercury pills in pursuit of
eternal life, a habit that eventually killed him. Egyptian pharaohs mummified
themselves for eternity, Cleopatra dabbled in youth potions and medieval
alchemists peddled elixirs. By the 20th century, Russia’s last czar, Nicholas
II, and Empress Alexandra were consulting Rasputin and other mystics for advice
on health and longevity.
Today, the same quest has migrated to Silicon Valley, where the mega-rich pour
fortunes into cryonics, anti-aging biotech and “biohacking” in the hope of
buying more time.
According to Elizabeth Wishnick, an expert on Sino-Russian relations and senior
research scientist at the Center for Naval Analyses (CNA), a non-partisan
research and analysis organization, this fixation is typical of the world’s
wealthiest and most powerful.
“They want to go into outer space, they want to go underwater … the human body
for them is just another frontier,” she told POLITICO. “It’s logical for people
who don’t feel limits to try to extend those boundaries.”
But there’s a stark contrast close to home. Life expectancy in Russia remains
just over 73 years, while in China, it hovers around 79 years, with access to
healthcare being deeply unequal.
In Wishnick’s view, Xi and Putin “would do better to focus on that, but instead
their focus seems to be on their own longevity, not the health of their
societies.”
UNFINISHED BUSINESS
There’s also a significant cultural dimension agitating Xi and Putin.
Robert Jay Lifton, the American scholar who coined the term “symbolic
immortality,” argued that humans invent religions, nations and political
legacies as ways of cheating death. Xi’s mantra of “national rejuvenation” and
Putin’s mission to restore a “great Russia” fit neatly into that framework —
even if they can’t physically live forever.
“Both of them are really hostage to their own propaganda,” said Wishnick. “They
truly believe they are the only leaders who can do the job. They’re concerned
about their legacy and how they’ll be remembered in history.”
That, she said, helps explain their obsession with reclaiming “lost” territories
— Taiwan for Beijing; Ukraine for Moscow — as if completing unfinished maps
might also complete their historical destinies.
Qin Shi Huang’s attempt at immortality, the Terracotta Army, still stands today.
| Forrest Anderson/Getty Images
They’ve made creeping moves toward that goal domestically. Xi has upended
China’s tradition of leadership turnover to maintain his dominance, while Putin
has dismantled elections and eliminated rivals until only he remains. “It’s not
surprising they would look to science as a way of extending that,” Wishnick
added.
While the scientific limitations persist, immortality will — at least for the
time being — remain tied to public consciousness and memory. See, for example,
Qin Shi Huang’s Terracotta Army, which still stands, or Russia’s expansionist
czar, Peter the Great, an 18th-century leader who inspires Putin even today.
But even in a world of nanotech and organ swaps, immortality has a catch: you
still have to live with yourself. And for the world’s Bond villains, that might
be the cruelest sentence of all.
Bill Anderson is the CEO of Bayer.
Europe was once the epicenter of progress. After centuries of the Dark Ages, a
radical new way of acquiring knowledge — the scientific method — cemented the
continent’s place at the apex of civilization.
Problem is, that was around 400 years ago.
Today, Europe is home to strong research universities and prodigious talent, but
it has been losing ground, particularly to the U.S. and China. In the 1990s, for
example, half of all new medicines originated in Europe — now, the figure’s down
to one in five. And the life sciences is just one of many such industries.
Europe must reverse this trend, and now is the time to act.
We stand on the precipice of a new world order, with increasing trade
uncertainty and multipolarity, and it’s not yet clear how things will shake out.
In this period of flux, Europe’s leaders rightly want to elevate science and
innovation to the heart of its economy. But for this to become a reality, its
member countries need to step up their game in terms of simplifying regulation.
Starting a business in Italy or Greece, for example, can take months due to
needless hurdles like in-person meetings, notary fees and bank account setups.
It’s no wonder that advances in AI are almost exclusively happening in the U.S.
and China. The biotech revolution attracts 75 percent of its talent in the U.S.
and Asia, and Brazil is at the forefront of agricultural innovation. Meanwhile
Europe is all too often sitting on the sidelines, asking “what’s allowed?”
rather than “what’s possible?”
Here’s the thing: Europe can produce world-changing innovation. In fact, some of
today’s pioneering startups, like CRISPR Therapeutics, emerged from Europe. But
thanks to a more accommodating regulatory environment, proximity to research
hubs and access to venture capital, these companies have expanded heavily in the
U.S.
This isn’t to say the U.S. is without problems, or that Europe should try to
refashion itself into Silicon Valley. In fact, Europe publishes about twice as
many scientific articles as the U.S., and is home to multiple research hubs that
foster international collaboration. However, we need a distinctly European
course correction to once again unleash Europe’s innovative spirit.
I am confident that with the right mindset and conditions, this can be done —
but not if we continue down the path of business — or rather, bureaucracy — as
usual. As last year’s Draghi report on EU competitiveness stated: “The only way
to become more productive is for Europe to radically change.”
I’ve personally had the rare privilege of working and living in five different
European countries, including in Germany for the last two years, as the CEO of
Bayer — a 160-year-old life sciences company headquartered in Germany. And we’ve
now kicked off the most radical transformation since the company’s founding.
Upending decades of tradition is not for the faint of heart, but sometimes it’s
essential. And here are a few lessons worth bearing in mind, whether modernizing
a company or a continent:
Firstly, it’s time to simplify regulations and embrace the new technologies
required to solve our biggest challenges, just like the U.S., Canada and other
countries have already done. The U.K., for example, passed a bill allowing the
development and marketing of gene-edited crops in 2023.
As last year’s Draghi report on EU competitiveness stated: “The only way to
become more productive is for Europe to radically change.” | Teresa Suarez/EFE
via EPA
On this front, we welcome the EU’s increased openness toward gene editing in
agriculture, which carries tremendous potential to help farmers adapt to climate
change. For instance, Italy showed courageous leadership last year, breaking
with two decades of policy to allow the first field trial of a gene-edited crop,
which scientists developed to improve the rice plant’s resistance to a prevalent
fungus. The rest of the continent ought to follow this lead.
Next, Europe also needs investment. While innovation in Europe has grown, prices
for pharmaceuticals have decreased. And why is it that one of the most advanced
continents, with a market of 450 million people, is seen less and less as a
place to invest for developing the drugs of tomorrow? We need to change that.
Everyone deserves reliable and affordable access to medicines, and everyone has
a role to play. Investing in research and development (R&D) is the beating heart
of the life sciences — and it comes at an enormous financial cost: More than 90
percent of pharmaceutical research ends in failure. But without R&D, our
industry would be dead on arrival and have little to offer patients. So, it’s
time for Europe to step up and view paying fair prices for new pharmaceutical
innovation as an investment in the future — not just another cost to be
minimized.
At Bayer, we operate in a new model called “dynamic shared ownership,” where
employees enjoy the autonomy to make decisions, share resources and direct their
focus toward the biggest priorities. And we’re seeing the model pay off already,
with rapid growth in our pharmaceuticals business — together, our two biggest
launch medicines have grown 80 percent in sales year over year, and one is now a
blockbuster.
The truth is, the expat scientists who come to Europe won’t have an easy time
translating their discoveries into impactful products and therapies without
systemic changes. Supporting scientists also requires robust IP protection, a
speedier regulatory framework and a better environment for high-risk,
high-reward investors.
Any innovative life sciences company in Europe would welcome these dramatic
changes to the status quo. And as the world’s economic order shifts, it’s
Europe’s turn to level the playing field.
In 50 years, will we look back on 2025 as the moment our continent rose to the
challenge and opened its arms to the future? Will we celebrate the biotech hub
of Berlin as we now do Boston, with scientists flocking there to start
companies, test cures for diseases and develop tools to help farmers feed the
world? Or will we utter a collective sigh, pondering what could have been?
It’s time to decide.
BERLIN — Germany’s BioNTech has signed a deal to acquire its former Covid-19
vaccine competitor CureVac for around $1.25 billion (€1.08 billion), the
companies announced today.
Both biotechs are developers of mRNA vaccine technology and were rivals in the
race to produce a Covid-19 vaccine in the height of the pandemic.
BioNTech joined forces with U.S. pharma Pfizer and continues to dominate the
market with its updated Covid-19 shots. After U.S. President Donald Trump’s
attempt to buy the company, CureVac failed to get its candidate approved and
sold the rights to its Covid-19, flu and bird flu vaccine programs last year.
Both German companies have continued mRNA programs on so-called cancer vaccines.
“We intend to bring together complementary capabilities and leverage
technologies with the goal of advancing the development of innovative and
transformative cancer treatments,” Uğur Şahin, BioNTech CEO, stated.
CureVac shareholders will get an exchanged BioNTech share for approximately
$5.46. In total, the current shareholders will hold 4-6 percent of BioNTech.
CureVac will be absorbed by BioNTech and the brand will no longer exist.
Germany invested €300 million into CureVac during the pandemic and held 23
percent of its shares. While the government has sold some shares in recent
years, it still remains a shareholder and has to accept the offer.
The news lands as Europe hatches a plan to boost its bioeconomy with a
forthcoming Biotech Act, which is expected to support the growth of smaller
companies and smooth out the regulatory processes for innovative therapies.