The Swedish Association of Local Authorities and Regions (SALAR) recently announced that a purchase agreement had been signed with Sabofi Pasteur MSD for the procurement of its product Gardasil.
The agreement meant that the vaccine, already substantially delayed, could be offered from October.
But following an appeal by pharmaceutical giant GlaxoSmithKline the delays are set to continue and thousands of young Swedish females will remain at risk from cervical cancer, according to the National Board of Health and Welfare (Socialstyrelsen).
GlaxoSmithKline has argued that their vaccine Cervarix provides better protection that Gardasil. SALAR is furthermore accused of having breached procurement legislation by ignoring its own criteria.
“We have got ourselves in a very unfortunate situation,” said Anders Tegnell at the health and welfare board.
“We are starting to get close to the line where there are girls who don’t have time to get protection before their get the infection and thus run a slightly heightened risk of getting cancer.”
When the decision was taken to incorporate the vaccine into the general vaccination programme offered by the public health service, the health and welfare board estimated that 100 lives would be saved per annum.
This is the second time that the procurement process has been appealed. Last time the purchase agreement was won by Cervarix, and it was then MSD’s turn to appeal.
Anders Tegnell fears that there is a risk that the pharmaceutical companies will continue to appeal incessantly.
“It seems that in theory they could continue as long as they like.”
“The losers are the public,” said Göran Stiernstedt at SALAR.
Stiernstedt is critical to procurement legislation and concluded that it is completely without risk for all parties to appeal.
“I think the risk is relatively small that we lose this time. There are few procurement processes which are as scrutinised legally as this one. And we naturally won’t make the same mistake again.”
The deal which the vaccine manufacturers are fighting over concerns healthcare worth between 250 and 300 million kronor ($44 million).
This is the amount that the counties, according to the agreement, will pay for the vaccination over the coming four years, which is the duration of the agreement.
The sum is not particularly considerable in the context of the pharmaceutical industry.
But according to Bo Claesson at SALAR, a reason for the legal battle in Sweden could be that it is part of a larger game – played out in front of an international audience.
“Sweden has quite a good reputation and several countries look at what we choose and what we pay. Primarily countries are interested in how we value the condyloma protection afforded by the vaccine which won the contract.”
The National Association for Sexuality Education (RFSU) have reacted to GlaxoSmithKline’s decision to appeal the contract.
“It’s time to start vaccinations now. It is a serious disease which in the worst cases can be fatal. It is cynical to let the girls wait for a vaccine that can actually save lives,” said secretary-general Åsa Regnér.
She says that the delay has already led to a situation whereby girls with parents prepared to pay have already been vaccinated, while others have not.
The decision to vaccinate all girls born 1999 and later was taken by the board of heath and welfare in 2008. The responsibility for the vaccination was delegated to the counties.
According to the plan the vaccine is to be given to girls in grades five and six, when they are eleven or twelve.
Furthermore SALAR would like for further age groups to be included, those born between 1993 and 1999 and who would have got the vaccine had the programme not been delayed several years.
Cervical cancer afflicts relatively young women. The average age of sufferers in Sweden is around 55-years-old, but a quarter are younger than 40.
Around 450 women are diagnosed with cervical cancer each year in Sweden. This is around half compared to the 1960s, with the decline attributed to the regular check-ups offered all women aged between 23 and 60.
Despite the gynaecological examinations around 200 women die each year from the illness.
The county health authorities hope that a general vaccination programme to combat the human papillomavirus (HPV) with halve this number.