Contracts for swine flu vaccine held by countries such as Britain with pharmaceutical companies abroad could be broken easily if governments decide to impose export bans as the pandemic worsens.
Experts warn that the pressure on governments to prevent vaccine supplies from being sent abroad while their own populations are suffering could be very high if death rates spiral — and make contracts difficult to enforce.
Professor Peter Dunhill, of the Department of Biochemical Engineering, University College London, told The Times that “nationalising” policies would be inevitable at the peak of a severe pandemic, with politicians unable to resist public demand to stop shipments.
“If you look at the situation, the amount of vaccine being produced globally is very small,” Prof Dunhill said.
“The issue should not come up unless things get really bad, because I think people will show a degree of caution about getting vaccinated. But if the backstops fall away and this virus gets more troublesome and resistant to anti-virals, then the issue becomes much sharper.
“Pharmaceutical companies will not want to constrain availability to the most powerful buyers in the drugs markets. But they may find that governments just dictate.”
Prof Dunhill said it would become “politically impossible” for leaders not to block shipments of vaccine from leaving the country, just as the United States did in 1976 when it reneged on a vaccine agreement with Canada. However such problems are unlikely to rise if the pandemic remains mild.
His comments came as the US pharmaceutical company Baxter International, which is manufacturing supplies for Britain in the Czech Republic, said it could not take any more orders for H1N1 vaccines. It has already signed contracts with five countries for a total of 80 million doses.
The possibility of a territorial struggle over vaccine does not bode well for Britain — with all of its flu vaccines produced abroad — or the United States, which makes only 20 percent of the regular flu vaccines it uses.
Britain is in line to get around 60 million doses of the vaccine — enough to cover half the population — by the end of December, with the rest of the doses following next year.
The first batches are expected in August and the Government has drawn up a priority list of people to receive the jab.
However, there is expected to be some delay between when Baxter and GlaxoSmithKline, which is producing batches in Germany, deliver the supplies and people receive their first vaccinations.
Prof Dunhill added that should governments “nationalise” vaccine producers within their borders, then Britain would have production at Speke, near Liverpool, as its fall-back. Novartis and MedImmune, which both have multi-million dollar deals with the US Government, have bases at Speke, though it is not yet known how many doses the facilities would likely produce.
Michael Osterholm, director of the Center for Infectious Diseases Research and Policy at the University of Minnesota, said politicians would not be able to withstand the pressure.
“This isn’t rocket science. If there is severe disease, countries will want to hang onto the vaccine for their own citizens.”
David Fedson, a retired vaccine industry executive, added that the “consequences of shipping vaccine to another country when your own people don’t have it would be devastating”.
A vaccine for Britain has to be approved by the Joint Committee on Vaccination and Immunisation (JCVI) and the Medicines and Healthcare products Regulatory Agency (MHRA) before it can be used. Sir Liam Donaldson, the Chief Medical Officer, said on Thursday that vaccine orders remained on course. “We will get initial supplies by the end of August unless there is some problem in the manufacturing process,” he said.
In past pandemics, vaccines were never exported before the country that produced them had enough for its own population. But unlike the last two pandemics in 1957 and 1968, many more countries this time around have struck deals with companies which they say guarantee them first access to vaccine.
David Fidler, a professor of law at Indiana University who has consulted for World Health Organisation, said: “Pandemic vaccine will be a valuable and scarce resource, like oil or food during a famine. We’ve seen how countries behave in those situations, and it’s not encouraging.”
Countries with flu vaccine plants might decide to seize all vaccines and ban their export, thus breaking the pharmaceutical contracts promising other countries vaccine supplies. These private contracts are not binding international law between two countries, Professor Fidler said.
He said most vaccine contracts include a clause allowing them to be broken under extraordinary circumstances, such as a health emergency. That would leave the countries who had brokered such deals not only without vaccine, but without legal recourse.
“There’s nothing in international law that helps you resolve this, it’s just a political nightmare happening in the midst of an epidemiological nightmare,” Prof Fidler said.
Neither the Department of Health nor the vaccine manufacturers would comment on delivery plans.
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