National Institute for Health and Welfare: Research funding does not influence choice of vaccine

Pharmaceutical companies are obliged to test their products among large populations

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The research funding from pharmaceutical companies has nothing to do with the choices made of medicines and vaccines, says special researcher Rose-Marie Ölander from the National Institute for Health and Welfare (THL). For many years, she has been responsible for the procurement and distribution of vaccines at THL.
      Ölander is referring to the recent debate on alleged bribery and a conflict of interest in connection with the choice of the vaccine that was administered last winter against H1N1, or swine flu virus.
     
There have later been claims that THL would have had a conflict of interest, as it had received financing worth EUR 6 million from GlaxoSmithKline (GSK) for its pneumococcus research. Two complaints were filed on the matter to the Chancellor of Justice in late 2009. Both complaints were made by private individuals.
      The swine flu vaccine was ordered from GSK, which was the easiest available source at a time when the epidemic was rapidly approaching Finland, and there was a need to start the vaccines as soon as possible. At that point, there was no time to order any public bid for tenders.
     
The procurement procedure of vaccines is totally separated from research funding, Ölander says.
      The purchasing process is normally started by ordering a public and open bid for tenders, in which ”all pharmaceutical companies are allowed to participate regardless of how many studies they have promised to finance”, Ölander continues.
      In such tender rounds, it is the price that is decisive in 80 to 100% of cases. Naturally the quality-price-ratio is also taken into consideration, but in fact, the quality of all products is normally good, as they have all been granted a trading licence in Europe.
     
It has been a coincidence, Ölander says, that research at THL has lately been focusing on GSK.
      One of the factors behind the choice of GSK’s Pandemrix was a competitive tendering arranged a few years ago on a pre-pandemic H5N1 vaccine, which GSK won. Later on it was easy to use the avian flu vaccine to make a swine flu vaccine just by replacing its H5N1 virus by the H1N1 swine flu virus.
      The National Advisory Committee on Vaccination (NACV) submitted its recommendation while THL issued its statement relating to the three supplier candidates that were known to the authorities.
      While one potential supplier’s vaccine had not been completed yet, even the earlier tenders of another pharmaceutical company had been too expensive. Moreover, at that point, the pre-pandemic vaccine of GSK was already available.
     
”The quality-price-ratio was all right and the reliability of delivery was previously known as accurate”, Ölander argues. That is why the Ministry of Social Affairs and Health exceptionally decided to make a decision on the alternative vaccines itself, opting for the alternative recommended by THL, even though the decision is normally made unilaterally by THL.
      THL has received financing from GSK, as in order to get a trading licence, even large pharmaceutical companies have to find partners to do research on their new products among a sufficiently large population.
      Pharmaceutical companies usually choose countries which have good research culture and in which research is conducted in a professional way, Ölander describes.
      ”One cannot say that THL benefits from research funding, as those funds are used for research purposes, including setting up clinics and hiring physicians”, Ölander explains. ”This is of use to the entire population”, she adds.
     
In order to obtain a European trading licence, medicine and vaccine research has to be done in a population of as many as 100,000 people.
      But when the medicine is later used by millions or tens of millions of people, it may happen that some entirely new and unforeseen adverse effects emerge. An example of such effects is an intussusception, a rare medical condition in which a part of the intestine has invaginated into another section of intestine, which has sometimes emerged in connection with rotavirus vaccines.
     
Ölander has been involved in vaccine production and quality control for 30 years.
      She says that the procurement procedure has become significantly more open, particularly thanks to the Act on Public Procurement which came into force in 2007.
      The act states clear criteria by which choices can be made.
     
FACTFILE
     
The national vaccine programmes are subject to a new tender round every two or three years.
     
THL then launches a public and open bid for tenders, whereupon normally two contestants come forward.
     
GlaxoSmithKline (GSK) operates in more than 100 countries. It is headquartered in Great Britain. In terms of sales of prescription drugs, GSK is the third largest pharmaceutical company in Finland.
     
Another regular candidate is Sanofi Pasteur MSD, which is a part of the multi-national Sanofi-Avantis pharmaceutical group, headquartered in France.
     
Frequently the losing party in a tender competition submits the deal to the Market Court.


Previously in HS International Edition:
  Ministry investigates whether suspicions over swine flu vaccine side-effects were withheld (27.8.2010)
  Ministry official defends decision to order swine flu vaccine (26.8.2010)

See also:
  H1N1 vaccinations suspended over narcolepsy scare (25.8.2010)

Links:
  The Finnish National Institute for Health and Welfare (THL)
  The Market Court

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