As trilogue discussions on the Critical Medicines Act (CMA) approach, its
potential effects on medicine supply, patient access and Europe’s
competitiveness are increasingly in focus. From an industry standpoint, several
considerations are central to understanding how this act can best achieve
its objectives and support a robust pharmaceutical ecosystem in Europe.
Keeping the CMA focused where it matters
Much of the debate around the CMA has centered on its promises to strengthen the
availability and security of supply of critical medicines in the EU while
improving accessibility to other medicines. These are goals that our industry
fully supports.
The European Commission’s proposal is designed to focus on critical medicines,
with a vulnerability assessment foreseen to identify which products are truly at
risk of disruption and tailor solutions accordingly. Alongside critical
medicines, the proposal also introduces a new definition of ‘medicinal products
of common interest’. Under current wording, this would include any medicine
unavailable in at least three member states, regardless of
the underlying reason.
Such a broad definition risks turning a targeted framework for resilience into
an all-encompassing mechanism covering almost every medicine on the market,
blurring the distinction between supply and access challenges. These are
fundamentally different issues that require fundamentally different policy
tools.
> Applying the CMA’s tools across the entire medicines market would dilute
> priorities, stretch healthcare budgets and create administrative burdens for
> industry without delivering real benefits for patients.
The act will be far more effective if it remains focused on where the risks are
greatest — in other words, by limiting the ‘medicinal products of common
interest’ definition to cases of demonstrable market failure and directing
measures toward genuinely critical medicines with a proven risk of supply
disruption.
Fixing supply and access hurdles needs more than joint procurement
The CMA places joint procurement at the center of its strategy to address both
supply and access challenges. While this approach can contribute to improving
availability in certain circumstances, joint procurement will only deliver
lasting results if it is designed to address the underlying causes of access
delays and shortages, which vary across geographies and products.
For medicines where the main challenge lies in fragile supply chains, joint
procurement can play a role, particularly when it enhances predictability and
economic viability for suppliers. Experience from the Covid-19 pandemic has
shown that coordinated purchasing can be effective in targeted situations. For
medicines facing access delays, joint procurement could help improve
availability in countries where genuine market failures exist. However, the
value of joint procurement for countries where products are already available,
or where access barriers can be better addressed by improving national pricing
and reimbursement systems, is very questionable.
To ensure that joint procurement does not hinder access, several safeguards are
essential. Tenders should reward quality and promote innovation, recognizing the
value that innovative medicines bring to patients and society. Price
confidentiality must be protected to prevent unintended spillovers, such as
reference pricing effects. Once joint procurement agreements are concluded, to
ensure commercial and supply predictability there should be
no additional national renegotiations or expenditure control measures. Finally,
allowing national procurement processes to run in parallel will be key
to avoid delays and maintain flexibility.
Beyond these design safeguards, real progress will depend on tackling the
broader root causes of shortages and access delays. For supply fragility, this
means, among other actions, reducing strategic dependencies where necessary,
improving transparency across supply chains and avoiding rigid national
stockpiling rules. For access delays, progress will require addressing national
pricing and reimbursement challenges, and a greater willingness from governments
to reward the value that innovative medicines deliver.
Protectionism won’t make Europe stronger
Few elements of the CMA debate have attracted as much attention as the idea
of prioritizing EU-made medicines. The rationale is straightforward: producing
more within Europe is expected to reduce reliance on third countries, reinforce
strategic autonomy and, ultimately, improve supply security. While this
narrative is understandable, taking it at face value risks overlooking the
realities of how medicines are manufactured and supplied today.
Europe already has one of the world’s strongest pharmaceutical manufacturing
footprints and, unlike some other pharma manufacturing regions, Europe exports
71 percent of its pharmaceutical production. This output depends on global
supply networks for active substances,
raw materials and specialized technologies. Introducing local-content
requirements or preferential treatment for EU-made products would disrupt those
networks, fragment supply chains and drive up costs, with limited evidence that
such measures would enhance resilience. Local-content requirements could also
affect Europe’s trade relationships and weaken, rather than strengthen, its
industrial base in the long term, while distorting competition within the single
market and undermining the competitiveness of both European and international
companies operating in Europe. The likely outcome would be less diversity and
greater concentration in supply chains: the opposite of what a resilient system
requires.
If procurement criteria referencing resilience or strategic autonomy are used,
they should be proportionate and tied to clearly demonstrated dependencies or
supply risks. Protectionist approaches, however well-intentioned, cannot
substitute for the broader policy environment needed to keep Europe attractive
for investment in research and development and manufacturing. A competitive
European ecosystem depends first and foremost on predictable
intellectual-property rules, timely regulatory processes, access to capital, and
a strong scientific and technical skills base.
The EU institutions still have time to steer the CMA on course
The CMA offers a real chance to get things right. The European Parliament’s
proposal for more consistent contingency stock rules could help if it stays
focused on medicines genuinely at risk of shortage. The act can also make
reporting more efficient by using existing systems rather than creating new
ones. Policymakers should also be aware that wider regulatory initiatives
directly affect Europe’s ability to manufacture and supply medicines. A more
coherent policy framework will be essential to strengthen resilience.
Europe’s goal must be to build an environment where pharmaceutical innovation
and production can thrive. Europe’s choice is clear: supply security cannot be
achieved by weakening the industry that ensures it. The CMA will only work if it
tackles the right problems with the right tools and keeps competitiveness at its
core.
> Europe’s goal must be to build an environment where pharmaceutical innovation
> and production can thrive.
Our industry remains ready to engage with EU and national policymakers to make
that happen. A high-level forum on the CMA involving all stakeholders could help
guide the act’s implementation in a way that improves supply security and speeds
up access for patients, while reinforcing Europe’s position as a global player
in life sciences.
Disclaimer
POLITICAL ADVERTISEMENT
* The sponsor is European Federation of Pharmaceutical Industries and
Associations (EFPIA)
* The political advertisement is linked to the Critical Medicines Act
More information here.
Tag - Accessibility
Sanna Marin is a Tony Blair Institute’s strategic counselor. She’s the former
prime minister of Finland.
As the world’s leaders gather in Rome for this year’s Ukraine Recovery
Conference, there is no illusion as to what’s at stake.
Ending Russia’s war of aggression remains Ukraine’s overriding priority. But the
truth is, even that won’t secure lasting stability.
True recovery will demand more than reconstruction funds or military deterrence.
It will require deep, sustained investment in the systems that underpin a strong
sovereign state. One of the most vital — and most overlooked — of those systems
is Ukraine’s own people.
Too often, the conversation surrounding Ukraine’s workforce begins and ends with
refugee return. But recovery cannot be deferred until people come home. Nor can
it depend entirely on external support. Ukraine’s greatest untapped asset is
already within its borders: millions of citizens ready to work, retrain and
rebuild, if allowed the opportunity.
This isn’t a soft-side issue — it’s a strategic imperative. And new research
from the Tony Blair Institute shows that taking bold action now could expand
Ukraine’s workforce by 25 percent, even while war continues.
There are more than 3 million people inside Ukraine today who, with the right
policies and support, could be brought into the workforce.
Unlocking this potential isn’t just the most realistic way to stimulate economic
growth and power Ukraine’s recovery, it’s also the smartest and fastest way to
build long-term resilience in the face of ongoing war.
This isn’t about abstractions. It’s about mothers who can’t find childcare;
displaced people struggling to rebuild their lives after being forced to flee;
job seekers struggling to find work that matches their skills and offers the
stability that formal employment should provide. It’s also about veterans and
individuals with disabilities who are ready to contribute but often encounter
barriers due to limited workplace accommodation.
Ukraine’s workforce is motivated, but it’s constrained by systems that haven’t
kept up. Today, 83 percent of Ukrainians with disabilities are out of work.
Women face a 15-point participation gap compared to men. And over one-third of
internally displaced people are unemployed. Meanwhile, 40 percent of businesses
say they can’t find the skilled talent they need.
This mismatch is more than a missed opportunity — it’s a risk to Ukraine’s
recovery and long-term sovereignty.
Ukraine’s greatest untapped asset is already within its borders: millions of
citizens ready to work, retrain and rebuild, if allowed the opportunity. |
Sergey Kozlov/EPA
The good news is, Ukraine has the tools to change this, and the country has
momentum on its side: billions in donor support, a nearly finalized new labor
code and real political will. It has digital infrastructure that’s the envy of
governments across Europe. It also has a population ready to adapt, with almost
40 percent of Ukraine’s unemployed saying they’re willing to retrain and a
quarter of them willing relocate for the right job.
That’s an extraordinary national resource. And Ukraine’s partners can help turn
this potential into progress by acting on four fronts:
First, bring Ukraine’s job market into the 21st century. The country is already
a world leader in digital ID. It has ambitious plans to build platforms that
would match workers with jobs and training opportunities — especially in regions
where the disconnect between supply and demand is stark. It needs international
funding and expertise to do this.
Second, put employers in the driver’s seat by tying every reskilling program to
a real job opportunity. Even though there are hundreds of available courses,
many teach skills that businesses don’t need, or they target workers who already
have jobs instead of those seeking work. Reskilling support should be contingent
upon employers co-designing curriculums and committing to hire successful
graduates.
Third, finalize the new labor code. The current one dates back to 1971. Reform
is essential — not just for EU accession but for unlocking flexibility,
formality and fairness in the workplace. Technical assistance and public
advocacy from international partners can help here.
Finally, break down the systemic barriers to participation. This means scaling
up access to childcare, improving workplace accessibility for those with
disabilities and supporting underrepresented groups, from women and young people
to the elderly and displaced. These changes are morally right, economically
vital and should align with donor priorities.
I’m proud to join that conversation, and urge us all to keep people — not just
infrastructure — at the heart of recovery.
Of course, the return of refugees will be critical to Ukraine’s long-term
recovery. But with only half of them currently planning on returning, and most
of them uncertain exactly when, this cannot be the cornerstone of today’s
strategy.
Ukraine cannot afford to wait. The focus must be on unlocking the potential of
those already inside the country’s borders. And that starts with modernizing the
job market, removing the barriers that prevent people from working, and
investing in the skills that will power Ukraine’s reconstruction from the ground
up.
Recovery doesn’t begin with return, it begins with reform. Ukraine has already
proven its courage. Now its people can build a workforce ready to win the peace.
But the country needs partners to expedite this task and help its people scale
with what they have.
With the right investment, Ukrainians won’t just rebuild — they’ll lead.