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Tag - Drug shortages
Europe has a plan to avert drug shortages — to make more of them and tie their
contracts to their availability.
The Critical Medicines Act, to be presented Tuesday afternoon in Strasbourg by
European Health Commissioner Olivér Várhelyi and Commission Executive Vice
President Teresa Ribera, will set out plans on medicines procurement, subsidies
for drug production and forging new global partners to avoid supply
dependencies.
Europe is heavily dependent on India and China for supplies of medicines and
their ingredients, particularly for cheaper generic drugs. This over-reliance
has made EU supply chains more vulnerable, with any disruption potentially
leading to shortages in Europe.
At the heart of the European Commission’s proposal is an overhaul of procurement
rules so that countries don’t simply opt for the cheapest available product and
instead prioritize security of supply, according to a draft of the document,
obtained by POLITICO on Monday.
Under the act, countries would procure drugs based on new criteria — beyond
price-only awards — including stockholding obligations, the number of
diversified suppliers, monitoring of supply chains, transparency and performance
clauses. Countries would also procure from multiple suppliers where appropriate.
Where the EU is reliant on a single third country for a critical product,
authorities should favor suppliers that manufacture a significant proportion in
Europe. The act also includes plans for joint procurement of critical medicines
by countries or by the Commission on their behalf.
On subsidies, the proposal says countries can financially support “strategic
projects” — those located in the EU that will create, increase or modernize
manufacturing capacity for critical medicines or their components. In such
cases, supplies to the EU market should have priority, and both countries and
the EU could fund these manufacturing projects.
State support normally goes to “first-of-its-kind” projects, meaning many
manufacturers of critical medicines — commonly prescribed, everyday medicines —
wouldn’t ordinarily qualify.
A new Critical Medicines Coordination Group, featuring two representatives from
each country, would share information on manufacturing capacity, projects in
line for state support and vulnerability in supply chains.
The draft is lighter on detail when it comes to new international partnerships.
It says the Commission will “explore possibilities” to diversify supplies of
critical medicines, active ingredients and starting materials.
The Critical Medicines Act is the Commission’s attempt to tackle manufacturing
supply chain vulnerabilities from dependencies on India and China. It is meant
to complement the revision of the pharmaceutical legislation to re-establish the
bloc’s independence and boost its competitiveness in the pharmaceutical field,
while ensuring access to medicines for its patients.
Things are about to get spicy.
Hungary’s Olivér Várhelyi will face what’s predicted to be one of the most
aggressive European commissioner hearings on Wednesday, defending his
credentials to members of the European Parliament as the European Union’s
prospective representative for health and animal welfare.
This isn’t his first rodeo. Having overseen the enlargement portfolio in
Commission President Ursula von der Leyen’s first term, he’ll be coming in well
prepared for questioning. But given the criticism he faced during his previous
tenure, he may not make the cut.
We’ll be bringing you all the live action from 6:30 p.m. on Nov. 6.
Background reading:
— How the hearings work
— Who’s most likely to get the chop
P.S. If you want to follow more of the action from the hearings, our reporters
will be bringing you blow-by-blow updates from all 26 commissioner interviews
here.