Peter O'Donnell
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European Union health ministers and health regulators have suddenly become more important. That's one of the side effects
of the H1N1 pandemic. In the broad scheme of European politics, health has never counted for much—largely because the EU member
states have never relinquished much of their national power over health policy, so EU competence is rather limited.
But now that Europe's population appears to be faced with a real health threat, these hitherto shadowy politicians are emerging
into the European limelight. On October 12, health ministers held an extraordinary meeting of what is known as the EU Health
Council—extraordinary because it normally meets only once or twice a year, and doubly extraordinary because it was the second
such extraordinary meeting in just a few months.
It's also good news for the European Union itself, always hungry to demonstrate its merits. The member states are showing
an unprecedented degree of interest in coordinating their actions in an area they have usually jealously guarded as their
own prerogative. Twenty five of them took an active part in the discussions. They are keen on sharing information, swapping
experiences, harmonizing their communications with health professionals and the public, cooperating in research, and even
pooling their stocks of vaccines.
Five of the EU's smaller member states have not secured supplies of the three vaccines so far authorized—and have no experience
of public procurement of vaccines. But they are on the point of issuing calls for tenders, with some support from the EU to
maximize their negotiating power with suppliers. The European Commissioner for Health, Androulas Vassiliou, proudly announced
that the EU has helped them develop an approach that stands a better chance of making themselves heard with drug manufacturers
that tend to focus on regular customers in larger countries. Meanwhile, mechanisms are being set up to share where there are shortfalls, particularly to ensure vaccination of health care
workers. "Everyone agrees that we need to go forward together," said Vassiliou after the meeting on October 12.
The threat of H1N1 has done more to raise the public profile of the EU as an important player in medicines provision than
years of diligent but low-key public relations by its official spokespeople. Nowadays in Europe, people with no connection
to health care—other than as potential patients—can be heard discussing the EU's central authorization procedure, accelerated
approval, the need for more focused clinical trials, or risk/benefit ratios.
The reason is simple. Swine flu has provided the first opportunity for making use of specific EU legislation that provides
for flexibility on data requirements and accelerated authorization of vaccines once WHO has declared a pandemic. So all eyes
have been fixed on the roles—and reflections—of the European Medicines Agency (EMEA), the European Centre for Disease Control
(ECDC), and the European Commission, which have, as a consequence, acquired an unprecedented currency. And the political masters
in health ministries around Europe are also basking in the reflected glory of this newfound sense of common purpose.
The health ministers conclusions from their meeting in October recognize "the need for the member states to take all appropriate
measures to ensure the most efficient protection of citizens, based on the most recent scientific evidence and drawing on
consultations at the European level and with the WHO, and taking account of developments in the epidemiological situation."
Ministers agreed that they should assure some degree of coordination of their public information and communication campaigns.
Conflicting messages should be avoided, they said, and there should be "continuous trust-building and sharing of key lines
of messages to the media, in order to minimize possible unwanted social and economic consequences."
The commitments to joint action went so far as to embrace "agreements on common key strategic lines on important issues,"
such as the level of risk posed by the virus, the challenges the member states could face due to the pandemic, and the importance
of measures for individuals to protect themselves.
And while they carefully noted that "the preparations for, and response to, health risks in the EU falls within the competence
of the member states," ministers went on to remark that "public health measures can be supported and enhanced by further cooperation
and sharing of information and experiences through the WHO and existing EU structures."
In fact, they went further and formally emphasized that "the effectiveness of national measures is further enhanced by
cooperation and coordination measures taken by the Commission and the member states with the assistance of the ECDC and EMEA
and in cooperation with the WHO," and underlined "the need for member states to work together."
A coordinated EU approach should, they said, "ensure wide availability of vaccines, robust regulatory procedures, and close
monitoring for any unexpected serious adverse reactions to allow for reassessment of the risk–benefit ratio where necessary,
with close cooperation between member states, the EMEA, and the ECDC, as well as post-marketing surveillance including pharmacovigilance
and risk-management plans."
