BRUSSELS — The European Union needs to draft in Mario Draghi, the mastermind
behind reforms to revive its single market, to ensure that member countries
rally behind efforts to boost growth and prosperity, a senior European lawmaker
said Tuesday.
Member countries should “mandate Draghi” to build political consensus for reform
and pierce through national “deep state” resistance to force a radical rethink
of the single market project, Pascal Canfin, a French Renew MEP, told POLITICO’s
Competitive Europe Summit in Brussels.
“We need somebody that could do so at the very top level, with heads of state
and government and quite deep state level,” Canfin said, arguing that the bloc
has reached a “historical crossroads” where it must choose between deeper
integration or economic irrelevance.
In 2024, the former Italian Prime Minister and head of the European Central Bank
delivered a report on Europe’s competitiveness deficit that one commissioner has
referred to as the “bible” for Ursula von der Leyen’s second Commission.
EU leaders backed a plan to relaunch the 30-year old single market — with its
freedoms in the movement of goods, capital, services and people — at a summit
earlier this month.
According to Canfin, Draghi’s work is not yet done, and the former Italian
leader could build a “coalition of the willing” of member states willing to
integrate their economies. Canfin also suggested that the requirement for
consensus among all 27 member states has become a challenge.
“It’s not an objective not to do it at 27, but maybe at the end, we will not be
able to do it for political reasons,” Canfin said, specifically citing the
frequent vetoes and disruptions caused by Hungarian Prime Minister Viktor
Orbán.
The move toward a multi-speed Europe is increasingly viewed by proponents of
integration as the only way to compete with the massive industrial subsidies and
streamlined decision-making of the United States and China.
Canfin described a recurring cycle of political failure where national leaders
travel to Brussels and make commitments, only to see them disassembled at home.
“They go to Brussels … then they go back home, and there are all the people
locally, in Paris, in Berlin, in Rome, in Madrid, saying the opposite,” Canfin
said. “Including in the deep state, including in some companies that have built
the knowledge to manage and navigate complexity.”
Canfin identified three obvious candidates for accelerated integration: defense,
energy, and finance.
“The political will has always been in the hands of the capitals,” Canfin said.
“Technical, yes, but today, would we be politically able?”
Tag - Growth
Europe’s competitiveness agenda is in full swing. Cutting red tape for business
is now a central mantra of EU policymaking, Brussels is digesting new plans to
accelerate Europe’s industrial capacity, and the single market is getting new
political momentum as well as a rebrand.
But as a new war in the Middle East adds to existing geopolitical turmoil and
economic disruption, calls are growing for the EU to become more self-sufficient
in areas such as tech, energy and defense.
Against this backdrop, how is the EU’s competitiveness push shaping up so far?
Is it moving quickly enough? Are the right policy levers being pulled? And how
can European policymakers balance the push for growth without compromising
priorities such as environmental protection and regulatory certainty?
Follow all the discussions and news from our spring edition of POLITICO’s
Competitive Europe Summit as we discuss these questions with politicians,
policymakers and experts.
See the full program here and follow along here from 9 a.m.
LONDON — Keir Starmer’s keeping Britain out of the war in Iran — but he can’t
duck the conflict’s grave economic consequences.
In a sign of growing fears about the impact of the war on Britain, the prime
minister chaired a rare meeting of the government’s emergency COBRA committee
Monday night, joined by senior ministers and Governor of the Bank of England
Andrew Bailey.
Starmer’s top finance minister, Rachel Reeves, will update the House of Commons
on the economic picture Tuesday, as an already-unpopular administration worries
that chaos in the Middle East is shredding plans to lower the cost of living and
get the British economy growing.
For Starmer’s government — headed for potentially brutal local elections in May
— the crisis in the Gulf risks a nightmare combination of a rise in energy
prices, interest rates, inflation and the cost of government borrowing that
threatens to undermine everything he’s done since winning office.
Economists are now warning that even if Donald Trump’s promise of a “complete
and total resolution of hostilities” with Iran were to bear fruit, the effects
on the British economy could still last for months.
Already there are signs of a split within Starmer’s party over how to respond.
Labour MPs want the government to think seriously about action to protect
households — but Starmer and Reeves have long talked up the need for fiscal
responsibility, and economics are warning that there’s little room for maneuver.
Fuel prices displayed at a Shell garage in Southam, Warwickshire on March 23,
2026. | Jacob King/PA Images via Getty Images
Jim O’Neill, a former Treasury minister who served as an adviser to Reeves, told
POLITICO the government should “not get sucked into reacting to every external
shock” and “concentrate on boosting our underlying growth trend.”
WHY THE UK IS SO HARD HIT
Just before the outbreak of war, there was reason for Starmer and Reeves to feel
quietly optimistic about the long-stagnant British economy. The Bank of England
had expected inflation to fall back sustainably toward its two percent target
for the first time in five years, giving the central bank the space to carry on
cutting interest rates.
With the Iran war in full flow, it was forced to rewrite those forecasts at the
Monetary Policy Committee’s meeting last week — and now sees inflation at around
3.5 percent by the summer.
The U.K. is a big net importer of energy and also needs constant imports of
foreign capital to fund its budget and current account deficits. That’s made it
one of first targets in the financial markets’ crosshairs. The government’s cost
of borrowing has risen by more than half a percentage point over the last month.
That threatens both the real economy and Reeves’ painstakingly-negotiated budget
arithmetic. Higher inflation means higher interest rates and a higher bill for
servicing the government’s debt: fiscal watchdog the Office for Budget
Responsibility estimates a one-point increase in inflation would add £7.3
billion to debt servicing costs in 2026-2027 alone.
The effect on businesses and home owners is also likely to be chilling.
Britain’s banks are already repricing their most popular mortgages, which are
tied to the two-year gilt rate. Hundreds of mortgage products were pulled in a
hurry after the MPC meeting last week, something that will hit the housing
market and depress Reeves’ intake from both stamp duty and capital gains.
Duncan Weldon, an economist and author, said: “Even if this were to stop
tomorrow, the inflation numbers and growth numbers are going to look materially
worse throughout 2026.
“If this continues for longer… it’s an awful lot more challenging and you end up
with a much tougher budget this autumn than the government would have been
hoping to unveil.”
DECISION TIME
The U.K.’s economic plight presents an acute political headache for Starmer, as
he faces a mismatch between his own party’s expectations about the government’s
ability to help people and his own scarce resources.
Energy Secretary Ed Miliband has promised to keep looking at different options
for some form of assistance to bill-payers hit by an energy price shock. A pain
point is looming in July, when a regulated cap on energy costs is due to expire
and bills could jump significantly.
One left-leaning Labour MP, granted anonymity to speak frankly, said: “They
[ministers] need to be treating this like a financial crisis. They need plans
for multiple scenarios with clear triggers for government support.”
A second MP from the 2024 intake said “it’s right that a Labour government steps
in, particularly to help the most vulnerable.”
Foreign Secretary Yvette Cooper and Chancellor of the Exchequer Rachel Reeves at
the first cabinet meeting of the new year at No. 10 Downing St. on Jan. 6, 2026
in London, England. | Pool photo by Richard Pohle via Getty Images
This demand for action is being felt in the upper echelons of the party too, as
Culture Secretary Lisa Nandy recently argued Reeves’ fiscal rules — seen as
crucial in the Treasury to reassure the markets — may need to be reconsidered if
prices continue to rise and a major support package is needed.
One Labour official said there are clear disagreements with Labour over how to
go about drawing up help and warned “the fiscal approach is going to be a
massive dividing line at any leadership election.” The same official pointed to
recent comments by former Starmer deputy — and likely leadership contender —
Angela Rayner about the OBR, with Rayner accusing the watchdog of ignoring the
“social benefit” of government spending.
Despite the pressure, ministers have so far restricted themselves to criticizing
petrol retailers for alleged profiteering, and have been flirting with new
powers for markets watchdog the Competition and Markets Authority. The
government said Reeves would on Tuesday set out steps to “help protect working
people from unfair price rises,” including a new “anti-profiteering framework”
to “root out price gouging.”
But Starmer signaled strongly in an appearance before a Commons committee Monday
evening that he was not about to unveil any wide-ranging bailout package,
telling MPs he was “acutely aware” of what it had cost when then-Prime Minister
Liz Truss launched her own universal energy price guarantee in 2022.
O’Neill backed this approach, saying: “I don’t think they should do much… They
can’t afford it anyhow. The nation can’t keep shielding people from external
shocks.”
Weldon predicted, however, that as the May elections approach and the energy cap
deadline draws nearer, the pressure will prove too much and ministers could be
forced to step in.
The furlough scheme rolled out during the pandemic to project jobs and Truss’s
2022 intervention helped create “the expectation that the government should be
helping households,” he said.
“But it’s incredibly difficult. Britain’s growth has been blown off-course an
awful lot in the last 15 years by these sorts of shocks.”
Geoffrey Smith, Dan Bloom, Andrew McDonald and Sam Francis contributed to this
report.
U.S. regulators this week proposed easing capital rules on big U.S. banks in a
package of proposals that departs from globally agreed-upon standards. Now, it’s
sparking calls from European trade groups to loosen the EU’s own version of the
rules.
On Thursday, U.S. bank regulators released a number of potential rule changes
intended to align U.S. policy with a 2017 global agreement known as Basel III.
Its provisions imply a 2.4 percent decrease in capital held by the largest U.S.
banks and bigger cuts for smaller banks.
European regulators, anticipating the U.S. move, had already been discussing
loosening their own requirements, which currently call for raising the capital
that banks must have on hand by around 8 percent by 2033.
But the breadth of the U.S. proposal has prompted trade groups in Europe to push
officials to move faster. Taken together, the moves could weaken the global
regulatory framework instituted on both sides of the Atlantic after the 2008
financial crisis.
“The U.S. proposal appears to mark a clear shift toward easing capital
constraints to support lending and growth, while Europe seems to continue moving
in a different direction,” said Sébastien de Brouwer, deputy CEO of the European
Banking Federation, a trade group. The United States’ pullback is “making it
more urgent than ever to review the EU framework to preserve competitiveness and
financing capacity of European banks,” he said.
Over the past few months, European regulators had started to reevaluate the
competitiveness of the bloc’s banking sector, especially as major European
economies have struggled to keep pace with U.S. growth.
EU heads of government called Thursday night, in a statement agreed upon before
the release of the U.S. proposal, for the European Commission “to propose
targeted amendments to the prudential framework in order to enhance the capacity
of the banking sector to finance the European economy.”
The Commission is also authoring a report on the competitiveness of its banking
sector, due after the summer, which will pave the way for legislative proposals.
This is set to be a wide-ranging report that could relate to bank capital
requirements or other policies.
The European Central Bank has already made recommendations for simplifying the
bloc’s banking rules ahead of the report, including calling for lighter Basel
rules for small banks and for capital buffers to be merged. None of its
recommendations were as sweeping as what the U.S. has proposed, however.
The U.S. proposal departs from the intent of the original Basel accords, a long
process in which global regulators worked to address the root causes of the
global financial crisis, critics say. Regulators in 2017 reached an agreement
around the framework for jurisdictions to mitigate risks.
“This definitely goes against not just the ethos but the intent, spirit and goal
of Basel III,” said Dennis Kelleher, CEO of Better Markets, an advocacy group
that supports stronger financial regulation. “This proposal when finalized will
inevitably ignite another global race to the regulatory bottom”
One of the biggest departures relates to the unwinding of the “output floor,”
which sets a minimum capital threshold for banks’ trading activities. The new
proposal uses a new risk-weighting approach that would do away with the
threshold.
“This will encourage other jurisdictions to do the same, undermining a key
reform and cornerstone of the Basel III agreement,” Federal Reserve board
member Michael Barr said Thursday.
In the 2017 international talks, the U.S. had argued in favor of a restrictive
output floor. Major European banks argued that would hike their capital
requirements above and beyond those of the U.S., given the makeup of European
banks’ trading books, stymieing lending to the real economy.
The threshold was ultimately set at a lower rate than what American negotiators
wanted.
European regulators had recently moved to delay implementation of the
Fundamental Review of the Trading Book, the portion of Basel focused
specifically on so-called market risk, or rules governing how to capitalize
banks’ trading activities.
“Removing the output floor for market risk is a divergence from international
standards, and we will carefully assess the impact on internationally active
banks, in particular, with respect to the ongoing discussions on EU FRTB
implementation and banking competitiveness in Europe,” said Caroline Liesegang,
head of prudential regulation and research at the Association for Financial
Markets in Europe, which represents large banks.
In the past, U.S. regulators had tended to “gold plate” the country’s rules for
big banks, meaning they put in provisions above and beyond what Basel requires
in order to acknowledge the United State’s central role in the global financial
system and push for stricter global standards. In 2023, U.S. regulators failed
to pass a capital proposal that would have raised aggregate capital by 16
percent and would have adhered more strictly to the international framework.
On Thursday, U.S. regulators said the international standards should not be an
unnecessary barrier to the needs of the U.S. financial system.
“We should not seek to punish U.S. consumers and businesses by imposing higher
costs of credit, or forcing credit availability outside of the banking system,
particularly if this is done only to show greater alignment with Basel or any
other international standard,” said Federal Reserve Vice Chair for Supervision
Michelle Bowman, who led the U.S. central bank’s crafting of the proposal.
The dilution of the agreement and its pullback on capital “will make it more
challenging for the U.S. to use Basel, as it so often has, to further its own
agenda,” said Kathryn Judge, professor at Columbia Law School.
In the U.K., which has since left the bloc, the capital rules are expected to
have less of an impact on banks than EU peers. A spokesperson for the Prudential
Regulation Authority, the U.K.’s main banking regulator, said that the
thinking remains the same as in its final rules, which will see the market risk
rules apply from 2028.
The European Commission declined to comment. The Basel Committee said it doesn’t
comment on individual jurisdictions. The Federal Reserve declined to comment.
Bjarke Smith-Meyer and Elliot Gulliver-Needham contributed to this report.
Many describe our geopolitical moment as one of instability, but that word feels
too weak for what we are living through. Some, like Mark Carney, argue that we
are facing a rupture: a break with assumptions that anchored the global economic
and political order for decades. Others, like Christine Lagarde, see a profound
transition, a shift toward a new configuration of power, technology and societal
expectations. Whichever perception we adopt, the implication is clear: leaders
can no longer rely on yesterday’s mental models, institutional routines or
governance templates.
Johanna Mair is the Director of the Florence School of Transnational Governance
at the European University Institute in Florence, where she leads education,
training and research on governance beyond the nation state.
Security, for example, is no longer a discrete policy field. It now reaches
deeply into energy systems, artificial intelligence, cyber governance, financial
stability and democratic resilience, all under conditions of strategic
competition and mistrust. At the same time, competitiveness cannot be reduced to
productivity metrics or short-term growth rates. It is about a society’s
capacity to innovate, regulate effectively and mobilize investment toward
long-term objectives — from the green and digital transitions to social
cohesion. This dense web of interdependence is where transnational governance is
practiced every day.
The European Union illustrates this reality vividly. No single member state can
build the capacity to manage these transformations on its own. EU institutions
and other regional bodies shape regulatory frameworks and collective responses;
corporations influence infrastructure and supply chains; financial institutions
direct capital flows; and civic actors respond to social fragmentation and
governance gaps. Effective leadership has become a systemic endeavour: it
requires coordination across these levels, while sustaining public legitimacy
and defending liberal democratic principles.
> Our mission is to teach and train current and future leaders, equipping them
> with the knowledge, skills and networks to tackle global challenges in ways
> that are both innovative and grounded in democratic values.
The Florence School of Transnational Governance (STG) at the European University
Institute was created precisely to respond to this need. Located in Florence and
embedded in a European institution founded by EU member states, the STG is a hub
where policymakers, business leaders, civil society, media and academia meet to
work on governance beyond national borders. Our mission is to teach and train
current and future leaders, equipping them with the knowledge, skills and
networks to tackle global challenges in ways that are both innovative and
grounded in democratic values.
What makes this mission distinctive is not only the topics we address, but also
how and with whom we address them. We see leadership development as a practice
embedded in real institutions, not a purely classroom-based exercise. People do
not come to Florence to observe transnational governance from a distance; they
come to practice it, test hypotheses and co-create solutions with peers who work
on the frontlines of policy and politics.
This philosophy underpins our portfolio of programs, from degree offerings to
executive education. With early career professionals, we focus on helping them
understand and shape governance beyond the state, whether in international
organizations, national administrations, the private sector or civil society. We
encourage them to see institutions not as static structures, but as arrangements
that can and must be strengthened and reformed to support a liberal, rules-based
order under stress.
At the same time, we devote significant attention to practitioners already in
positions of responsibility. Our Global Executive Master (GEM) is designed for
experienced professionals who cannot pause their careers, but recognize that the
governance landscape in which they operate has changed fundamentally. Developed
by the STG, the GEM convenes participants from EU institutions, national
administrations, international organizations, business and civil society —
professionals from a wide range of nationalities and institutional backgrounds,
reflecting the coalitions required to address complex problems.
The program is structured to fit the reality of leadership today. Delivered part
time over two years, it combines online learning with residential periods in
Florence and executive study visits in key policy centres. This blended format
allows participants to remain in full-time roles while advancing their
qualifications and networks, and it ensures that learning is continuously tested
against institutional realities rather than remaining an abstract exercise.
Participants specialize in tracks such as geopolitics and security, tech and
governance, economy and finance, or energy and climate. Alongside this subject
depth, they build capabilities more commonly associated with top executive
programs than traditional public policy degrees: change management,
negotiations, strategic communication, foresight and leadership under
uncertainty. These skills are essential for bridging policy design and
implementation — a gap that is increasingly visible as governments struggle to
deliver on ambitious agendas.
Executive study visits are a core element of this practice-oriented approach. In
a recent Brussels visit, GEM participants engaged with high-level speakers from
the European Commission, the European External Action Service, the Council, the
European Parliament, NATO, Business Europe, Fleishman Hillard and POLITICO
itself. Over several days, they discussed foreign and security policy,
industrial strategy, strategic foresight and the governance of emerging
technologies. These encounters do more than illustrate theory; they give
participants a chance to stress-test their assumptions, understand the
constraints facing decision-makers and build relationships across institutional
boundaries.
via EUI
Throughout the program, each participant develops a capstone project that
addresses a strategic challenge connected to a policy organization, often their
own employer. This ensures that executive education translates into
institutional impact: projects range from new regulatory approaches and
partnership models to internal reforms aimed at making organizations more agile
and resilient. At the same time, they help weave a durable transnational network
of practitioners who can work together beyond the programme.
Across our activities at the STG, a common thread runs through our work: a
commitment to defending and renewing the liberal order through concrete
practice. Addressing the rupture or transition we are living through requires
more than technical fixes. It demands leaders who can think systemically, act
across borders and design governance solutions that are both unconventional and
democratically legitimate.
> Across our activities at the STG, a common thread runs through our work: a
> commitment to defending and renewing the liberal order through concrete
> practice.
In a period defined by systemic risk and strategic competition, leadership
development cannot remain sectoral or reactive. It must be interdisciplinary,
practice-oriented and anchored in real policy environments. At the Florence
School of Transnational Governance, we aim to create precisely this kind of
learning community — one where students, fellows and executives work side by
side to reimagine how institutions can respond to global challenges. For
policymakers and professionals who recognize themselves in this moment of
rupture, our programs — including the GEM — offer a space to step back, learn
with peers and return to their institutions better equipped to lead change. The
task is urgent, but it is also an opportunity: by investing in transnational
governance education today, we can help lay the foundations for a more resilient
and inclusive order tomorrow.
Biotechnology is central to modern medicine and Europe’s long-term
competitiveness. From cancer and cardiovascular disease to rare conditions, it
is driving transformative advances for patients across Europe and beyond . 1
Yet innovation in Europe is increasingly shaped by regulatory fragmentation,
procedural complexity and uneven implementation across m ember s tates. As
scientific progress accelerates, policy frameworks must evolve in parallel,
supporting the full lifecycle of innovation from research and clinical
development to manufacturing and patient access.
The proposed EU Biotech Act seeks to address these challenges. By streamlining
regulatory procedures, strengthening coordination and supporting scale-up and
manufacturing, it aims to reinforce Europe’s position in a highly competitive
global biotechnology landscape .2
Its success, however, will depend less on ambition than on delivery. Consistent
implementation, proportionate oversight and continued global openness
will determine whether the a ct translates into faster patient access,
sustained investment and long-term resilience.
Q: Why is biotechnology increasingly seen as a strategic pillar for Europe’s
competitiveness, resilience and long-term growth?
Gilles Marrache, SVP and regional general manager, Europe, Latin America, Middle
East, Africa and Canada, Amgen: Biotechnology sits at the intersection of
health, industrial policy and economic competitiveness. The sector is one of
Europe’s strongest strategic assets and a leading contributor to research and
development growth . 3
At the same time, Europe’s position is under increasing pressure. Over the past
two decades, the EU has lost approximately 25 percent of its global share of
pharmaceutical investment to other regions, such as the United States and
China.
The choices made today will shape Europe’s long-term strength in the sector,
influencing not only competitiveness and growth, but also how quickly patients
can benefit from new treatments.
> Europe stands at a pivotal moment in biotechnology. Our life sciences legacy
> is strong, but maintaining global competitiveness requires evolution .” 4
>
> Gilles Marrache, SVP and regional general manager, Europe, Latin America,
> Middle East, Africa and Canada, Amgen.
Q: What does the EU Biotech Act aim to do and why is it considered an
important step forward for patients and Europe’s innovation ecosystem?
Marrache: The EU Biotech Act represents a timely opportunity to better support
biotechnology products from the laboratory to the market.
By streamlining medicines’ pathways and improving conditions for scale-up and
investment, it can help strengthen Europe’s innovation ecosystem and accelerate
patient access to breakthrough therapies. These measures will help anchor
biotechnology as a strategic priority for Europe’s future — and one that can
deliver earlier patient benefit — so long as we can make it work in practice.
Q: How does the EU Biotech Act address regulatory fragmentation, and where will
effective delivery and coordination be most decisive?
Marrache: Regulatory fragmentation has long challenged biotechnology development
in Europe, particularly for multinational clinical trials and innovative
products. The Biotech Act introduces faster, more coordinated trials, expanded
regulatory sandboxes and new investment and industrial capacity instruments.
The proposed EU Health Biotechnology Support Network and a u nion-level
regulatory status repository would strengthen transparency and
predictability. Together, these measures would support earlier regulatory
dialogue, help de-risk development and promote more consistent implementation
across m ember s tates.
They also create an opportunity to address complexities surrounding combination
products — spanning medicines, devices and diagnostics — where overlapping
requirements and parallel assessments have added delays.5 This builds on related
efforts, such as the COMBINE programme,6 which seeks to streamline the
navigation of the In Vitro Diagnostic Regulation , 7 Clinical Trials Regulation8
and the Medical Device Regulation9 through a single, coordinated assessment
process.
Continued clarity and coordination will be essential to reduce duplication and
accelerate development timelines .10
Q: What conditions will be most critical to support biotech
scale-up, manufacturing and long-term investment in Europe?
Marrache: Europe must strike the right balance between strategic autonomy and
openness to global collaboration. Any new instruments under the Biotech Act
mechanisms should remain open and supportive of all types of biotech
investments, recogni z ing that biotech manufacturing operates through globally
integrated and highly speciali z ed value chains.
Q: How can Europe ensure faster and more predictable pathways from scientific
discovery to patient access, while maintaining high standards of safety and
quality?
Marrache: Faster and more predictable patient access depends on strengthening
end-to-end pathways across the lifecycle. The Biotech Act will help ensure
continuity of scientific and regulatory experti z e, from clinical development
through post-authori z ation. It will also support stronger alignment with
downstream processes, such as health technology assessments, which are
critical to success.
Moreover, reducing unnecessary delays or duplication in approval processes can
set clearer expectations, more predictable development timelines and earlier
planning for scale-up.
Gilles Marrache, SVP and regional general manager, Europe, Latin America,
Middle East, Africa and Canada, Amgen. Via Amgen.
Finally, embedding a limited number of practical tools (procedural, digital or
governance-based) and ensuring they are integrated within existing European
Medicines Agency and EU regulatory structures can help achieve faster
patient access . 11
Q: What role can stronger regulatory coordination, data use and public - private
collaboration play in strengthening Europe’s global position in biotechnology?
Marrache: To unlock biotechnology’s full potential, consistent implementation is
essential. Fragmented approaches to secondary data use, divergent m ember
state interpretations and uncertainty for data holders still limit access to
high-quality datasets at scale. The Biotech Act introduces key building blocks
to address this.
These include Biotechnology Data Quality Accelerators to improve
interoperability, trusted testing environments for advanced innovation, and
alignment with the EU AI Act ,12 European Health Data Space13 and wider EU data
initiatives. It also foresees AI-specific provisions and clinical trial guidance
to provide greater operational clarity.
Crucially, these structures must simplify rather than add further layers of
complexity.
Addressing remaining barriers will reduce legal uncertainty for AI deployment,
support innovation and strengthen Europe’s competitiveness.
> These reforms will create a moderni z ed biotech ecosystem, healthier
> societies, sustainable healthcare systems and faster patient access to the
> latest breakthroughs in Europe .” 14
>
> Gilles Marrache, SVP and regional general manager, Europe, Latin America,
> Middle East, Africa and Canada, Amgen.
Q: As technologies evolve and global competition intensifies, how can
policymakers ensure the Biotech Act remains flexible and future-proof?
Marrache: To remain future-proof, the Biotech Act must be designed to evolve
alongside scientific progress, market dynamics and patient needs. Clear
objectives, risk-based requirements, regular review mechanisms and timely
updates to guidance will enhance regulatory agility without creating unnecessary
rigidity or administrative burden.
Continuous stakeholder dialogue combined with horizon scanning will be essential
to sustaining innovation, resilience and timely patient access over the long
term. Preserving regulatory openness and international cooperation will be
critical in avoiding fragmentation and maintaining Europe’s credibility as a
global biotech hub.
Q: Looking ahead, what two or three priorities should policymakers focus on to
ensure the EU Biotech Act delivers meaningful impact in practice?
Marrache: Looking ahead, policymakers should focus on three priorities for the
Biotech Act:
First, implementation must deliver real regulatory efficiency, predictability
and coordination in practice.
Second, Europe must sustain an open and investment-friendly framework that
reflects the global nature of biotechnology.
And third, policymakers should ensure a clear and coherent legal framework
across the lifecycle of innovative medicines, providing certainty for the use
of artificial intelligence — as a key driver of innovation in health
biotechnology.
In practical terms, the EU Biotech Act will be judged not by the number of new
instruments it creates, but by whether it reduces complexity, increases
predictability and shortens the path from scientific discovery to patient
benefit.
An open, innovation-friendly framework that is competitive at the global level
will help sustain investment, strengthen resilient supply chains and deliver
better outcomes for patients across Europe and beyond.
--------------------------------------------------------------------------------
References
1. Amgen Europe, The EU Biotech Act Unlocking Europe’s Potential, May 2025.
Retrieved from
https://www.amgen.eu/media/press-releases/2025/05/The_EU_Biotech_Act_Unlocking_Europes_Potential
2. European Commission, Proposal for a Regulation to establish measures to
strengthen the Union’s biotechnology and biomanufacturing sectors, December
2025. Retrieved from
https://health.ec.europa.eu/publications/proposal-regulation-establish-measures-strengthen-unions-biotechnology-and-biomanufacturing-sectors_en
3. EFPIA, The pharmaceutical sector: A catalyst to foster Europe’s
competitiveness, February 2026. Retrieved from
https://www.efpia.eu/media/zkhfr3kp/10-actions-for-competitiveness-growth-and-security.pdf
4. The Parliament, Investing in healthy societies by boosting biotech
competitiveness, November 2024. Retrieved from
https://www.theparliamentmagazine.eu/partner/article/investing-in-healthy-societies-by-boosting-biotech-competitiveness#_ftn4
5. Amgen Europe, The EU Biotech Act Unlocking Europe’s Potential, May 2025.
Retrieved from
https://www.amgen.eu/docs/BiotechPP_final_digital_version_May_2025.pdf
6. European Commission, combine programme, June 2023. Retrieved from
https://health.ec.europa.eu/medical-devices-topics-interest/combine-programme_en
7. European Commission. Medical Devices – In Vitro Diagnostics, March 2026.
Retrieved from
https://health.ec.europa.eu/medical-devices-vitro-diagnostics_en
8. European Commission, Clinical trials – Regulation EU No 536/2014, January
2022. Retrieved from
https://health.ec.europa.eu/medicinal-products/clinical-trials/clinical-trials-regulation-eu-no-5362014_en
9. European Commission, Simpler and more effective rules for medical devices –
Commission proposal for a targeted revision of the medical devices
regulations, December 2025. Retrieved from
https://health.ec.europa.eu/medical-devices-sector/new-regulations_en#mdr
10. Amgen Europe, The EU Biotech Act Unlocking Europe’s Potential, May 2025.
Retrieved from
https://www.amgen.eu/docs/BiotechPP_final_digital_version_May_2025.pdf
11. AmCham, EU position on the Commission Proposal for an EU Biotech Act
12. European Commission, AI Act | Shaping Europe’s digital future, June 2024.
Retrieved from
https://digital-strategy.ec.europa.eu/en/policies/regulatory-framework-ai
13. European Commission, European Health Data Space, March 2025. Retrieved from
https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space-regulation-ehds_en
14. The Parliament, Why Europe needs a Biotech Act, October 2025. Retrieved
from
https://www.theparliamentmagazine.eu/partner/article/why-europe-needs-a-biotech-act
--------------------------------------------------------------------------------
Disclaimer
POLITICAL ADVERTISEMENT
* The sponsor is Amgen Inc
* The ultimate controlling entity is Amgen Inc
* The political advertisement is linked to advocacy on the EU Biotech Act.
More information here.
When Italy’s Prime Minister Giorgia Meloni attended her first European leaders’
summit in Brussels in December 2022, few would have expected her to become one
of the most effective politicians sitting around the table four years later.
In fact, few would have expected that she’d still be there at all, as Italian
leaders are famously short-lived. Remarkably, her right-wing Brothers of Italy
party looks as rock solid in polls as it did four years ago, and she now has her
eye on the record longest term for an Italian premier — a feat she is due to
accomplish in September.
A loss in what is set to be a nail-biting referendum on the bitter and complex
issue of judicial reform on March 22 and 23 would be her first major set back —
and would puncture the air of political invincibility that she exudes not only
in Rome but also in Brussels.
Meloni has thrived on the European stage, and has become adept at using the EU
machinery to her advantage. Only in recent months, she has made decisive
interventions on the EU’s biggest dossiers, such as Russian assets, the Mercosur
trade deal and carbon markets, leveraging Italy’s heavyweight status to win
concessions in areas like farm subsidies.
Profiting from France’s weakness, Meloni is also establishing a strong
partnership with German Chancellor Friedrich Merz — a double act between the
EU’s No. 1 and No. 3 economies — to mold the bloc’s policies to favor
manufacturing and free trade.
CRASHING DOWN TO EARTH
For a few more days, at least, Meloni looks like a uniquely stable and
influential Italian leader.
Nicola Procaccini, a Brothers of Italy MEP very close to Meloni and co-chair of
the European Conservatives and Reformists (ECR) group, called the government’s
longevity a “real novelty” in the European political landscape.
“Until recently, Italy couldn’t insert itself into the dynamics of those that
shape the European Union — essentially the Franco-German axis — because it
lacked governments capable of lasting even a year,” said the MEP. “Giorgia
Meloni is not just a leader who endures; she is a leader who shapes decisions
and influences the direction to be taken.”
But critics of the prime minister said a failure in the referendum would mark a
critical turning point. Her rivals would finally detect a chink in her armor and
move to attack her record, particularly on economic weaknesses at home. The
unexpected, new message to other EU leaders would be clear: She won’t be here
for ever.
Brando Benifei, an MEP in Italy’s center-left opposition Democratic Party,
conceded that other EU leaders saw her as the leader of a “ultra-stable
government.” But, if she were to lose the referendum, he argued “she would
inevitably lose that aura.”
“Everyone remembers how it ended for Renzi’s coalition after he lost his
referendum,” Benifei added, in reference to former Democratic Party Prime
Minister Matteo Renzi who resigned after his own failed referendum in 2016.
MACHIAVELLIAN MELONI
Meloni owes much of her success on the EU stage to canny opportunism. At the
beginning of the year, she slyly spotted an opportunity — suddenly wavering on
the Mercosur trade deal, which Rome has long supported — to win extra cash for
farmers that would please her powerful farm unions at home. She held off from
actually killing the agreement, something that would have lost her friends among
other capitals.
German Chancellor Friedrich Merz and Italy’s Prime Minister Giorgia Meloni at a
signing ceremony during an Italy-Germany Intergovernmental Summit in Rome on
Jan. 23, 2026. | Pool photo by Michael Kappeler/AFP via Getty Images
The Italian leader “knows how to read the room very well,” said one European
diplomat, who was granted anonymity to discuss European Council dynamics.
Teresa Coratella, deputy head of the Rome office at the think tank European
Council on Foreign Relations, said Meloni had “a political cunning” that
allowed her to build “variable geometries,” allying with different European
leaders by turn based on the subject under discussion.
One of her first victories came on migration in 2023. She was able to elevate
the issue to the top level of the European Council, and even managed to secure a
visit by European Commission President Ursula von der Leyen to Tunisia,
eventually resulting in the signing of a pact on the issue.
Others wins followed.
Last December, with impeccable timing, Meloni unexpectedly threw her lot in with
Belgium’s Prime Minister Bart De Wever at the last minute, scuppering a plan to
fund Ukraine’s defenses with Russian frozen assets, instead pushing for more EU
joint debt.
Italian diplomats said that Meloni is a careful student, showing up to summits
always having read the relevant documents, and having asking the apposite
questions. That wasn’t always the case with former Italian prime ministers.
They said her choice of functionaries — rewarding competence over and above
political affiliation — also helps. These include her chief diplomatic
consigliere Fabrizio Saggio and Vincenzo Celeste, ambassador to the EU. Neither
is considered close politically to Meloni.
Her biggest coup, though, has been shunting aside France as Germany’s main
European partner on key files, with her partnership with Merz even being dubbed
“Merzoni.”
ROLLING THE DICE
Meloni’s strength partly explains why she dared call the referendum.
Italy’s right has for decades complained that the judiciary is biased to the
left. It’s a feud that goes back to the Mani Pulite (Clean Hands)
anti-corruption drive in the 1990s that pulverized the political elite of that
time, and the constant court cases against playboy premier and media tycoon
Silvio Berlusconi, father of the modern center-right.
The proposal in the plebiscite is to restructure the judiciary. But it’s a
high-stakes gamble, and why she called it seems something of a puzzle. The
reforms themselves are highly technical — and by the government’s own admission
won’t actually speed up Italy’s notoriously long court cases.
Prime Minister of Italy, Giorgia Meloni attends the European Council meeting on
June 26, 2025 in Brussels. | Pier Marco Tacca/Getty Images
Instead, the vote has turned into a more general vote of confidence in Meloni
and her government. The timing is tough as Italians widely dislike her ally U.S.
President Donald Trump and fear the war in Iran will drive up their already high
power prices.
Still, she is determined not to suffer Renzi’s fate and insists she will not
step down even if she loses the referendum.
Asked at a conference on Thursday whether a loss would make Rome appear less
stable in its dealings with other European capitals, Foreign Minister Antonio
Tajani was adamant that the referendum has “absolutely nothing to do with the
stability of the government.”
“This government will last until the day of the next national elections,” he
added.
A victory on Monday will put the wind in her sails before the next general
elections, which have to be held by the end of 2027. It would also set the stage
for other reforms that Meloni wants to enact: a move to a more presidential
system, with a direct election of the prime minister, making the role more like
the French presidency.
But a loss would galvanize the opposition — split between the populist 5Star
Movement, and the traditional center-left Democratic Party.
The danger is her rivals would round on her particularly over the economy. Even
counting for the fact Italy has benefitted from the largest tranche of the
Covid-era recovery package — growth has been sluggish, consistently below 1
percent, falling to 0.5 percent in 2025.
“We have a situation in which the country is increasingly heading toward
stagnation and we have to ask ourselves what would have happened if we had not
had the boost of the Recovery Fund,” said Enrico Borghi, a senator from Italia
Viva, Renzi’s party.
Procaccini, however, defended her, both on employment and growth.
“It could be better,” he conceded. “But we are still talking about growth,
unlike countries that in this historical phase are recording a decline, as in
the case of Germany.”
FRANKFURT — Europeans will feel the pain of the war on Iran in their wallets
this year, even if things don’t get any worse from here on, the European Central
Bank warned on Thursday.
The ECB’s new forecasts show that inflation is set to rise to 2.6 percent this
year—well above the 1.9 percent forecast as recently as December, while growth
will slow as businesses and households have to divert more of their spending
power to essentials such as energy.
“The war in the Middle East has made the outlook significantly more uncertain,
creating upside risks for inflation and downside risks for economic growth,” the
ECB said, drawing on new quarterly forecasts for the eurozone outlook. The
forecasts were published after its policy-making Governing Council left the
Bank’s official interest rates unchanged, as expected.
The renewed hit comes just as purchasing power was starting to recover from the
last surge in prices caused by Russia’s invasion of Ukraine in 2022. That pushed
headline inflation up to 10 percent within a year.
On the upside, this forecast suggests that the ECB expects the problem to
correct itself without it needing to raise interest rates aggressively. It sees
inflation easing back towards the ECB’s 2 percent target within a couple of
years, the time horizon that the ECB uses to guide its policy decisions. The
economy is forecast to grow, albeit slightly less than previously expected: the
Bank trimmed its forecast to 0.9 percent from 1.2 percent for this year, and to
1.3 percent from 1.4 percent for next year.
Central banks are generally reluctant to respond to so-called supply shocks
because their main policy tool — control over interest rates — only works with
long and often uncertain time lags, while the geopolitical situation behind the
supply shock can change at very short notice.
However, they have to balance that against the risk of appearing complacent and
letting expectations of high inflation become self-fulfilling, as constant price
increases by retailers lead to more aggressive pay demands from workers.
In its regular policy statement, the ECB stressed that it is “closely monitoring
the situation” and will set monetary policy as appropriately. Investors have bet
that this means raising the key deposit rate twice this year, to 2.5 percent.
But policymakers around the globe have cautioned against rushing to such
conclusions.
“The thing I really want to emphasize is that nobody knows,” Federal Reserve
Chair Jerome Powell told reporters following the Fed’s decision to leave rates
unchanged on Wednesday. “It is too soon to know the scope and duration of the
potential effects on the economy.” ECB President Christine Lagarde is expected
to echo that message at her press conference later on Thursday.
However, the Bank did say that it had looked at the possible consequences of an
extended disruption of global oil and gas supplies, and warned that this “would
in the supply of oil and gas “would result in inflation being above, and growth
being below, the baseline projections.”
There is broad consensus among central bankers and private-sector economists
that the longer the conflict lasts, the more likely it is to create so-called
“stagflation” — a combination of economic stagnation and inflation.
While the ECB, like other central banks around the world, was content to adopt a
“wait-and-see” policy on Thursday, analysts don’t expect its patience to last
very long. A clearer picture is expected to emerge as soon as next month. “If
the current situation persists through to the April meeting, a hike becomes a
distinct possibility,” according to ABN AMRO’s chief economist Nick Kounis.
The Bank of England warned it may have to take a tougher line on interest rates
as the spike in energy prices caused by the U.S.-Israeli war on Iran pushes
inflation higher.
“Monetary policy cannot reverse this shock” to world energy supply, Governor
Andrew Bailey said in a statement on Thursday, after the Monetary Policy
Committee voted unanimously to leave the Bank rate unchanged at 3.75 percent.
“Monetary policy must, however, respond to the risk of a more persistent effect
on U.K. consumer price inflation,” Bailey added.
The Bank had only last month declared victory over inflation, which has been
above its 2 percent target for over four years. However, its latest analysis
suggests headline inflation will rebound back above 3 percent in the next three
months and could add as much as 0.75 percentage points to the consumer price
index over the summer, as higher fuel bills percolate through the economy.
“The MPC is alert to the increased risk of domestic inflationary pressures
through second-round effects in wage and price-setting, the risk of which will
be greater the longer higher energy prices persist,” the Bank stressed. However,
it also acknowledged that the energy price spike is likely to hurt economic
growth, and that it is “assessing the implications for inflation of the
weakening in economic activity that is likely to result from higher energy
costs.”
Until the U.S. and Israel attacked Iran, most analysts had predicted that a
slowing economy and growing prospects of easing inflation would allow the MPC to
cut rates at Thursday’s meeting.
However, the invasion and the ensuing turmoil in world commodity markets have
turned the situation on its head, by closing a vital chokepoint at the mouth of
the Persian Gulf, through which irreplaceable volumes of oil, gas and fertilizer
pass every day.
As a result, the Bank warned that there is now a real threat of higher energy
prices causing a broader rise in prices across the economy. Food prices face a
similar risk.
ALREADY OUT OF DATE?
The situation is changing so fast that the Bank’s latest forecasts could already
be out of date. The Bank said they were based on the situation as of March 16,
when Brent oil futures were only at $100 a barrel. But a succession of strikes
on key energy installations around the Persian Gulf since then has already
pushed prices up by another 12 percent.
“The news flow around the war in Iran looks more worrying for global markets
with each passing day,” Deutsche Bank strategist Jim Reid said in a note on
Thursday.
Analysts argued ahead of the meeting that the Bank would prefer to err on the
side of keeping policy tight in the face of the new risks, given lingering
concerns about its credibility due to its slow response to the inflation shock
in 2022. Inflation peaked at 11.1 percent back then, the highest rate posted by
any major economy.
The Bank’s change in outlook will make life doubly uncomfortable for the Labour
government, which had hoped that its efforts to close the U.K. budget deficit
would be rewarded with lower inflation and lower interest rates.
Instead, the government’s key 10-year borrowing costs have risen by nearly half
a percentage point since the war started, and they leaped again on Thursday,
first in response to Iranian attacks on a Qatari gas field, then to the BoE’s
statement. At 4.89 percent, the 10-year gilt yield is now at its highest in 15
months. The pound, by contrast, was steady against the dollar and euro after the
decision.
The Office for Budget Responsibility earlier this month already cut its
forecasts for U.K. growth this year. That implies lower tax receipts which,
combined with higher borrowing costs, threaten a new two-way squeeze on
Chancellor Rachel Reeves’ fiscal arithmetic, less than six months after she had
to raise taxes sharply at her latest budget.
FRANKFURT — Germany’s government has redirected the bulk of funds originally
earmarked for infrastructure into covering budget gaps, according to new reports
from two leading research institutes — raising fresh doubts about Berlin’s
ability to deliver on its long-promised investment drive.
The findings — coming a year after German lawmakers approved historic
constitutional reforms to unlock hundreds of billions of euros in borrowing —
could expose Chancellor Friedrich Merz to fresh criticism that his government
has failed to harness a €500 billion infrastructure and climate fund to revive
Germany’s stagnating economy.
The scale of the misallocation is striking, according to the reports. The
Cologne-based German Economic Institute (IW) calculates that 86 percent of the
funds were diverted, while the Ifo Institute puts the figure at an even more
damning 95 percent.
“We have found that policymakers have used almost all of the debt-financed funds
for other purposes, namely, to cover budget shortfalls. This is a major
problem,” said Ifo President Clemens Fuest.
After two consecutive years of recession, Germany’s economy barely grew in 2025.
It was widely expected to pick up speed in 2026, helped by public investment.
But a rebound appears to have failed to materialize thus far.
New headwinds from the conflict in the Middle East will make any recovery even
more contingent on effective government spending, analysts warn.
The IW report calculated that, last year, the governing coalition of the
Christian Democratic Union (CDU) and Social Democratic Party (SPD) in Berlin
tapped just 42 percent of funds originally earmarked. The conservatives and SPD
“had the chance to clear the investment backlog. So far, they have not taken
it,” said Tobias Hentze of the German Economic Institute.
According to Ifo, borrowing from the €500 billion fund increased by €24.3
billion in 2025. Actual federal investments, however, rose by only €1.3 billion
overall from 2024.
The reason, says Ifo, is that Berlin shifted investment commitments from the
current budget into the special fund — known as the Special Fund for
Infrastructure and Climate Neutrality, or SVIK — in order to make room for
higher day-to-day spending. As such, the net increase in actual overall
investment has been minuscule.
“There were shifts of individual items from the core budget into the
debt-financed [special fund] SVIK, particularly grants in the transport sector,
which meant that less was invested in the core budget than in previous years,”
said Ifo researcher Emilie Höslinger. “A large part of the special fund’s
investments is therefore not truly additional.”
Germany’s Bundesbank has previously called on the government to use the SVIK’s
borrowing capacity “more purposefully” to ensure that the borrowed money
actually creates the potential for faster growth in future, which will in turn
make it easier to service the debt that has been taken on.
Before the fund was launched, critics including the Federation of German
Industries (BDI) warned that the potentially beneficial effects of the SVIK
risked being diluted unless the money was put to use properly.