“The decisions of
the United States administration are changing the global rules on drug pricing
and are causing a wave of concern in European healthcare systems. If Europe
does not take urgent action, its patients risk losing access to innovative,
life-saving medicines, and treatment could become prohibitively expensive.
Today’s situation
requires not only close monitoring of events across the Atlantic. Europe’s
competitiveness strategy must be fundamentally revised, because not only the
future of the innovative pharmaceutical industry is at stake, but also human
health. The new rules are changing market conditions The reason for the alarm
bells is US President Donald Trump’s ambition to introduce the so-called Most
Favored Nation (MFN) pricing policy. Artificial intelligence-generated drugs
and Trust in science: isn’t it dangerous? For now, the White House is only
seeking voluntary agreements with drugmakers, rather than mandatory pricing.
But the political landscape is constantly changing. The MFN policy requires
pharmaceutical companies to charge US consumers the same prices as the lowest
prices in other economically developed countries. Since the US market is the
largest in the world, and many major pharmaceutical companies generate at least
half of their revenue in the States, such drastic requirements will force manufacturers
to fundamentally change their strategies in Europe.
Helmut Brand, a professor of European public health at
Maastricht University, told Politico that tying US prices to the lowest prices
paid in other high-income countries would have a huge knock-on effect in the
European Union.
Rather than lower prices in the US and risk losing huge
revenues, some companies are delaying the introduction of new drugs in European
markets or refusing to supply them at all. If a new drug were to be introduced
in Europe at a significantly lower price, it would automatically fall on the US
market, which would significantly harm further drug research and innovation.
Alexander Natz,
head of the European Pharmaceutical Business Association (EUCOPE), agrees,
sharing his impressions from conversations with US companies developing drugs
for rare diseases in the same publication. He not only emphasized that slower
drug delivery to the market means poorer opportunities for patients, but also
pointed out that drug manufacturers, who were previously firmly convinced that
they would go to Europe first, especially Germany, are now not 100 percent
sure. Will Europe remain in the “waiting room”? These worrying trends are also
confirmed by figures in a publication prepared by the independent economic
research and consulting company Copenhagen Economics (CE) in conjunction with
EUCOPE in 2026. It provides a detailed analysis of the trade and investment
outlook against the backdrop of new US decisions.
In response to
strict MFN pricing, as many as 64 percent of companies admit that they will
likely delay or cancel drug deliveries in selected EU countries in the near
future. And in the long term, this figure may increase to as much as 82
percent. Moreover, the study revealed that the majority of manufacturers, in
order to maintain balance, will increase drug prices outside the US. This will
mean that the financial burden may soon fall directly on the shoulders of
European countries and patients themselves. As many as 57 percent of the
companies surveyed predict that such measures will inevitably reduce overall
global investments in research and development and will affect scientists
working on the old continent. Neil Grubert, a global market access analyst who
closely monitors these processes, believes that the influence of MFN is no
longer just theoretical and draws attention to the signals from European
officials. For example, Han Steutel, president of the German Association of
Innovative Pharmaceutical Industries, acknowledged the scale of the problem in
an interview with the newspaper Ärzte Zeitung. “Germany has always been very
proud of the fact that almost all innovations are available here very quickly.
But that is no longer the case. There are several companies that are not
introducing new products or are delaying their release. They are waiting and
watching what exactly the changes in America will mean,” said H. Steutelis.
A similar
sentiment prevails in southern Europe. Spanish Health Secretary Javier Padilla
emphasized in his blog that MFN causes delays and a reluctance to introduce
innovative drugs. According to him, solutions must be aimed at ensuring
immediate patient access to cell therapy, biologics and treatments for rare
diseases. Instead of reducing prices in the US and thus risking losing revenue,
companies will likely simply raise drug prices in other countries. The CE study
reveals that 60 percent of companies in the short term and even 70 percent in
the long term plans to increase prices outside the states. For example – in
Europe. Such possible decisions by companies will hit the most vulnerable
hardest. As Toma Mikalauskaitė, policy coordinator of the European Association
of Cancer Leagues, said in an email to Swissinfo.ch, when patients are already
facing delays and shortages of medicines, increasing drug prices would leave a
part of oncology patients without the products and care they urgently need.
The necessary
response is to save the European pharmaceutical industry
The
pharmaceutical industry draws attention to the urgent need to respond not in
isolation, but by combining efforts across the continent. It is necessary to
urgently seek sustainable solutions that increase Europe’s competitiveness in
the field of biotechnology. After all, over the past two decades, Europe has
already lost a quarter of the global share of investment, and research budgets
have grown more slowly than in the US or China. We must not forget the
fundamental fact – without a strong pharmaceutical sector, the EU’s trade
balance would instantly turn from an impressive €147 billion surplus to a €47
billion deficit. Moreover, this is a particularly sensitive issue for European
countries, as any delay or failure to adapt will mean only one thing – our
citizens will wait even longer for innovative medicines or will not receive
them at all. The European Federation of Pharmaceutical Industry Associations
(EFPIA), of which the Innovative Pharmaceutical Industry Association (IFPA) is
a member, has also responded to the critical situation. It has proposed a
ten-step plan, the implementation of which would help strengthen the region's
competitiveness and ensure the development of innovations. EFPIA emphasizes the
need to modernize the regulatory and clinical research system at a European
level, strengthen intellectual property protection. At the country level,
excessive national cost-limiting mechanisms should be gradually abandoned, all
aspects of the value of innovative medicines should be integrated into health
technology assessment, pricing and reimbursement mechanisms, and financing for
the reimbursement of innovative medicines should be increased. The document
particularly emphasizes the importance of urgent strategic dialogue between all
participants in the health ecosystem.
The seriousness
of the situation is also perfectly illustrated by the fact that even large
countries such as Germany are already facing challenges in the area of
accessibility of innovations. Therefore, it is obvious that if joint actions
are not taken, less attractive markets, including Lithuania, will inevitably
feel the consequences of this crisis even more painfully. “This is a ‘now or
never’ moment for Europe to protect its industry, reduce its dependence on
external factors and ensure the supply of new medicines to its citizens,” said
Nathalie Moll, the federation’s director general. According to the federation,
only a united approach based on open cooperation can ensure that Europe not
only maintains its competitiveness in the life sciences sector, but also
guarantees that the latest treatments reach patients in a timely manner. In
light of all this, it is essential to review how we value innovation, increase
investment in innovative treatments and create an environment that encourages
research in Europe itself. Otherwise, if European policymakers fail to create
an ecosystem that is conducive to innovation, the price to be paid will be
measured not only in billions of euros lost, but also in opportunities to save
people’s health and even lives.”
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