Court orders hearing of HSE bid to lift vaccine contract suspension

A judge has directed an urgent hearing of the Health Service Executive’s bid to lift the automatic suspension of a contract for supply of the “critical” six-in-one vaccines.

The HSE said an early hearing was vital because of the need to ensure future supplies of the vaccines.

The HSE’s decision last January to award the five-year contract to GlaxoSmithKline (GSK) was automatically suspended by the issuing on February 2nd of legal proceedings by an unsuccessful tenderer, Sanofi Aventis Ireland Ltd, trading as Sanofi Pasteur.

In seeking to have the suspension lifted, the HSE said, in documents put before the Commercial Court on Monday, the implications of any disruption in the supply of the vaccine would be “extremely serious”, including increased risk of the diseases currently preventable by the vaccine.

For reasons including an ongoing shortage in the pertussis (whooping cough) and hepatitis B components of the vaccine, it was “vital” to have lengthy forecasts for orders of the vaccines, Dr Brenda Corcoran of the National Immunisation Office said in a sworn statement.

Lead-in time

Supplies of the vaccine available under the current contract would be exhausted by the end of January 2018 and a reasonable estimate of the lead-in time for production of vaccines ordered under the new contract would be 12 months, she said.

If new supplies were not ordered by March 1st, there would “simply be no guarantee of supply”.

The HSE said the estimated value of the new contract, based on the purchase costs to the HSE, is between €22 million and €28 million, less VAT, based on an estimated number of doses of the vaccine. The HSE said it does not know the actual costs to the manufacturer.

Catherine Donnelly, for the HSE, said that in order to ensure future supply of these “critical” vaccines it wanted an urgent hearing date of February 23rd for its application to lift the automatic suspension of the contract.

While Sanofi pointed to the HSE having indicated there would be some leeway of a month or so, the HSE maintained that unless supplies were ordered by March 1st next there would be no guarantee of supply, counsel said.

Joe Jeffers, for Sanofi, urged the court to give his side until February 27th, saying the proposed timescale was very tight.

Mr Justice Brian McGovern agreed the matter was urgent and fixed the hearing of the application for February 23rd as sought by the HSE. The parties would just have to be ready for hearing, he remarked.

The contract is for supply, over about five years, of about a million doses of the six-in-one vaccine, which relates to diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio vaccine and haemophilus influenza type B.

In its challenge over the award of the contract to GSK, Sanofi alleges the HSE failed to comply with various European Union directives and regulations governing the award of public supply contracts.