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A(H1N1): the state facing the risks of a pandemic
8/9/12

Sharing responsibilities: a legal but unbalanced contract

There are two major parts to the paper. The first one deciphers the contract signed between the Belgian government and GSK on a legal level as well as the resulting regime of liability. The second one is a political analysis of the Belgian government’s public action and its understanding of its own role in the face of such an event.

The first part clarifies several misunderstandings and areas of controversy regarding the legal justification of the contract and the sharing of responsibilities as a result of its signature. A shortened version of it was widely distributed and publicly discussed, basically stating that GSK declined all responsibility for any side effects caused by the vaccine that might lead to physical harm or death. The researchers indicate a major nuance concerning this point. In an initial draft of the contract, the pharmaceutical group did indeed seek to avoid any responsibility of this sort, a point that was rejected outright by all the European governments for it would have been illegal.

Finally, GSK did assume legal responsibility in case of complaint and legal proceedings. That said, the political and financial responsibilities would be assumed subsequently by the Belgian state. Had the vaccine turned out to be the cause of catastrophic side effects, the political consequences of legitimacy for the government in power would have been disastrous.  However, the greatest risk taken by the state was financial. If Belgian citizens were to file a complaint against GSK, and a causal link between a side effect and the vaccine was proven, GSK would have been held responsible and would have had to finance the compensation. However, in this particular case, the contract provides for the full reimbursement of the latter by the Belgian government, without limit. Over and above this compensation, the state would therefore ultimately guarantee the full reimbursement of the costs generated by such proceedings (fees, appeal costs, etc.).

H1N1_confirmed_cases-2009

Health above all

“The Belgian state took a massive financial risk”, explains François Thoreau. “The vaccine was fast-tracked although information on side effects was patchy... Had there been a death following the administration of the vaccine, this would have been an absolute disaster for the government’s image in terms of public health. Today, reliable studies have shown the existence of a link between the vaccination and the risk of narcolepsy. That said, we can also ask ourselves what would have happened if the Belgian state hadn’t taken any action in terms of prevention, while all the other European countries were acquiring vaccines according to similar clauses. It’s easy to see how the state was caught in the crossfire. It tried to do the best with the tools it had, by undoubtedly choosing the least harmful policy. It felt it had sufficient information from various assessments to consider, in principle, that the vaccine didn’t present a major risk in terms of harmful side effects. The authorities therefore preferred to rely on this information rather than dismissing the risk of a pandemic which, we should remember, was taken very seriously when the contract was signed.”

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