The European Commission is expected to adopt today (8 December) measures to co-ordinate the European response to health crises such as the 2009 swine-flu pandemic (H1N1). The goal is to avoid a repetition of the confused response that saw some member states – notably France – buy far too much medicine, while others – such as Poland – purchased none.
The Commission wants to strengthen the hands of smaller member states in negotiations with the pharmaceutical companies that make the vaccines.
Under the proposal member states would be able to buy such medicines as Tamiflu jointly, with the Commission negotiating on their behalf. The member states would then decide how much medicine was allotted to each country.
“We went through a process of learning the lessons from the H1N1 event, and we detected flaws in communication and in the vaccine procurement process,” John Dalli, the European commissioner for health, told European Voice. “The pharmaceutical industry imposed certain conditions on member states because they had their backs to the wall.”
The negotiation-pooling would be voluntary, and would be likely to benefit specifically small member states or member states that do not have a large domestic pharmaceutical industry. It would increase their negotiating power and allow them to ensure that each country received the appropriate amount of medicine.
Such a negotiation would be triggered once the Commission declared a public health emergency, another new element to the proposal. Approval of new vaccines would then be fast-tracked, taking two to three months instead of the normal seven.
Under the existing system, the EU can only call a health emergency once it has been declared by the World Health Organization (WHO). But the WHO only declares a pandemic once it has spread to at least two continents, so an outbreak occurring only in Europe would not qualify.
A member state would still be free to purchase no medicine if it so wished – unless by doing so it would jeopardise the health of Europe as a whole. The proposal would also allow the Commission to enforce cross-border action if a member state failed to take appropriate measures or was overwhelmed. “We are only as strong as our weakest link,” said Dalli. “Diseases do not respect borders. We need to make sure that the non-compliance of one member state does not affect the whole.”
The Commission would have the power to impose penalties on member states that failed to take action to combat a pandemic. In emergency situations where people were dying in large numbers and national measures were proving insufficient, the Commission would be able to introduce cross-border measures such as the quarantine and screening of infected citizens.
The proposal will need to be approved by member states and MEPs. During the 2009 swine flu outbreak, the Commission offered to provide response co-ordination, but member states rejected that offer. National capitals have since warmed to the idea, once it became clear that they had made mistakes in their 2009 medicine purchases.
Last year health ministers asked the Commission to improve co-ordination, and the Parliament expressed the same desire in a resolution earlier this year. But there may be some resistance among member states to the Commission designating itself as the body that decides when to declare a pandemic, rather than the Council.
Quality and safety liability
Michèle Rivasi, a French Green MEP who prepared a report on the issue for the European Parliament, said group purchasing of vaccines was a good idea, “provided that the manufacturers remain liable for the quality, safety and efficacy of their products.” She added: “Under no circumstances must governments be made liable for side-effects of vaccines that are supposed to be safe.”
The proposal would also tighten up existing response mechanisms. It will extend the existing Early Warning and Response System for communicable diseases created in 1998 to all health threats – including those from biological, chemical or environmental causes. It will also formalise the informal Health Security Committee created by health ministers in 2001 after the anthrax incidents in the United States. Member states would also have to prepare national response plans.