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

Financially, the government didn’t strike a good deal by exposing itself to limitless risk. But it wasn’t in a position to negotiate either. There was a great deal of pressure and there were genuine threats concerning the deliverable stocks of vaccines. “From the moment the state was seeking to guarantee the health of its citizens – literally at any cost –, and that this essential requirement exceeded the financial issue and became the main value it had to guarantee, the bill was negotiated according to the pharmaceutical group’s goodwill. Undoubtedly, in an ideal scenario, society requires less urgency, greater serenity, and less media frenzy at the first sign of a scandal.  But these are the rules of the game of public action today. And in this sense, with a minimum of empathy, we can imagine that if we'd been in the government's position, we would probably have acted in the same way." Furthermore, it should be noted that in parliament, despite several criticisms concerning form, the opposition at the time was more or less in agreement regarding the initiative taken by the government.

An action not without forethought

While the signature of the contract certainly seemed hurried, it was part of a process within a longer time span than the appearance of the A(H1N1) flu. “The idea of implementing an epidemic prevention plan began to emerge in 2005, in the aftermath of the bird flu. The crisis of 2009 acted as a catalyst, in the chemical sense of the term. It simply served to accelerate and precipitate a reaction where all the ingredients were already in place.” Another argument that favoured the choice of this vaccine was that its components weren't all mixed together, but divided into two parts. One was a standard vaccine against the flu while the other one, an adjuvant to the vaccine, contained specific elements of the strain in question. This meant that if part of the doses weren't used, a significant part of the order could be used for a future epidemic. In this case, another adjuvant would simply have to be added.

In the end, this argument fell through because all these vaccines are now out of date. The state has been left with a stock of more than five million doses that have to be destroyed according to precise health standards. However, it was still more advantageous to sign an agreement with GSK instead of one of the other pharmaceutical groups. Considering the dual nature of the vaccine, it offered greater protection than others; the adaptability of the vaccine to other strains was still a significant argument in its favour at the time; GSK had a rapid production and delivery capacity; and finally, the group already had a strong presence in Belgium, where it employed 7500 people.

In the heat of the controversy concerning the signing of the contract and the real financial risk assumed by the Belgian state, Laurette Onkelinx defended herself by mentioning the possibility, in case of a complaint, of turning against the European Commission, which was actually responsible for marketing Pandemrix. But the authors of the article also question this point by stipulating that such a procedure must meet a whole series of very strict conditions, which must all be respected. The plaintiff must be able to prove the illegality of the misdeed. It would therefore be necessary to check whether the authorisation to market Pandemrix was issued according to European legislation or not, and, secondly, certify that this breach was of a very serious nature. It would also be necessary to demonstrate the reality of the damage and the existence of a cause and effect relationship between the vaccine’s sales authorisation and the damage.

According to the authors, any possible damages suffered by Belgium would be financial, given that it promised to bear the costs set out by GSK. If Belgium had to prove that it had suffered damages – i.e., the compensation paid to GSK – it would have to establish the direct causal link between the violation of European law and the damage suffered. For the rest, the authors remind us that a vaccine could well generate serious side effects even if all the European marketing procedures are strictly respected. Zero risk doesn't exist. In short, the authors express serious doubts on the chances of success of a possible procedure of the Belgian state against the European Commission.

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