EU Health Commissioner, Androulla Vassiliou. yesterday released a 12-page “”https://ec.europa.eu/health/ph_threats/com/Influenza/docs/com481_2009_en.pdf">EU strategy on Pandemic (H1N1) 2009," as well as five Commission working documents – on vaccine development, vaccination strategies, joint procurement, communication with the public and media, and support for third countries.
It’s difficult to see much new in the package, however. The Commission press release says that “A joint procurement mechanism is proposed to support the Member States that are still in the process of ordering vaccines.” This echoed a proposal the incoming Swedish presidency of the EU made in July.
That seemed a bit odd. With incoming surveillance data signaling an uptick in the spread of pandemic flu in European countries, which could herald the imminent onset of the peak phase in the pandemic, it seems a bit late in the day to start discussing ordering vaccine at the EU level, in particular given that it’s been obvious since early May that a pandemic was underway.
The text of the policy itself agrees, however, and notes that “Given the stage of development of the pandemic, and the advance purchase orders already concluded by several member states, it is not considered reasonable or efficient at this stage to launch a joint procurement procedure at EU level between interested member states for vaccine procurement.” Instead, it argues for considering launching “a bundle of national calls for tender by the interested Member States to be carried out simultaneously or as a whole.”
I’ve checked with the media people at the Commission’s health directorate. It seems there was some confusion in the wording of the press release – finally there will be no joint procurement scheme. The Commission will basically try to “help different countries to help themselves,” says a spokesperson. Many European countries have already ordered vaccine to cover large proportions of their populations, and so the scale of the problem the Commission is seeking to address is not clear either. “It is a problem,” in some countries, according to the spokesperson, but couldn’t say more, or in which countries, as the Commission apparently doesn’t have “a table of who has ordered what.” “Member states aren’t obliged to inform us.”
The rest of the EU strategy largely recapitulates on what EU bodies have already being doing, as well as reiterating well-trodden issues surrounding the current pandemic. It’s worth also bearing in mind that legally, a Communication by the Commission is simply a policy document outlining what it intends its actions to be, but it has no legislative clout. There’s also no new money on the table.
Moreover, many of those outside the EU, and indeed some, who live there, might be forgiven for assuming that its the European Union, and its executive arm, the European Commission, which are in charge of Europe’s pandemic efforts. But the EU has in fact a limited role in responding to the pandemic. It is the national governments of the member states who are in the driving seat.
The EU historically has had very few powers in public health, and although article 152 of the 2003 Treaty of Nice does give it an explicit role here, this remains very limited, and most powers and responsibilities for healthcare lie in the hands of the member states. “Our role in the pandemic is to help coordinate,” says the spokesperson.
The EU’s Health Security Committee also adopted 25 August a priority list of those who it considered should get vaccine first – all those over 6 months old with underlying chronic conditions increasing the risk for severe disease, pregnant women, and health care workers But as the accompanying documents to the EU strategy, acknowledge, “It should be stressed that the responsibility for developing a vaccination strategy against pandemic (H1N1) 2009 lies with the Member States. Therefore, Member States may develop different vaccination strategies, taking into account their epidemiology, health service structures, available resources and cost-effectiveness of available vaccines. ”
As WHO and the Commission point out, vaccine strategies adopted by countries may also differ in their priority goals of vaccination. Although reducing sickness and death is a major priority, other priorities strategies might be to keep functioning the healthcare system, as well as other critical infrastructure and essential services, or on vaccinating schoolchildren, to limit the speed of spread — and hence peak burdens of hsopitalizations in the health system.
Where the EU does have extensive powers with respect to the pandemic is in approving drugs and vaccines, and to a lesser extent in coordinating surveillance and other scientific data. Marketing approvals for several pandemic vaccines are currently under review at the European Medicines Agency (EMEA) in London, which was created in 1995. It will also be responsible for enforcing post marketing surveillance for any side effects — only such surveillance can pick up rare events.
The European Centre for Disease Prevention and Control in Stockholm, created in 2005, for its part, has a mandate for pan-European epidemiological surveillance and early warning, including gathering data from national surveillance systems. In September 2008 the former European Influenza Surveillance Scheme (EISS) was absorbed into ECDC, and it has become the central gateway for updates on the spread of the virus in the EU. It also gathers experts from across the EU to produce common scientific opinions, on aspects of the pandemic. Last week it announced, new surveillance techniques to monitor the pandemic during the imminent peak wave, as did the US CDC.
The EU says that the strategy and working papers will be the basis of discussions at an extraordinary meeting of EU health ministers on 12 October 2009.