It would appear to be a happy and satisfying relationship. “Our priorities are aligned,” says one document. There have been “notable successes” says another, citing “another example” of where the two sides “cooperated well”. In business partners, this would seem to indicate a harmony of views. The documents obtained by the Guardian, however, relate to meetings between the drug industry and the watchdog body set up by government to police it.
Critics say the drug regulator and the industry are too close. Their proceedings have long been shrouded in secrecy because of the drug companies’ insistence on the commercial sensitivity of information relating to their products.
Today, documents obtained by the Guardian under the open government code reveal the reality of relations between the Medicines and Healthcare products Regulatory Agency (MHRA) and the trade association of the industry it regulates. The documents show that:
· the regulator and the industry have been engaged in a joint lobbying campaign in Europe;
· the industry privately drew up its own detailed blueprint of how the MHRA should be run;
· the industry has been pushing for higher level representation at the MHRA against ministers’ wishes.
Since 1989, when the then prime minister, Margaret Thatcher, took drug regulation out of the hands of the Department of Health, the MHRA has been 100% funded by the pharmaceutical companies.
The MHRA’s chief executive, Kent Woods, appointed in January, has no drug company background, but critics say the agency continues in the unquestioning belief that the regulator and the industry are working together in the mutual interests of public health.
John Abraham, professor of sociology at Sussex University, who is well respected for his books on drug regulation, says that in 1989 there was a reconstruction of the regulators’ mission alongside the new fees relationship. The MHRA came to believe the interests of public health are coherent with the promotion of the industry.
“The criticism of the old Department of Health medicines department in the 70s was that it didn’t have any teeth. Not only does it now not have any teeth, but it is not motivated to bite,” he said.
The MHRA told the Commons health select committee inquiry into the influence of the industry that it does not consider the fee relationship to be a problem.
“I would suggest to a lay person there is a big problem with the concept of independence from industry of a body that is fully funded by industry,” said Professor Abraham. The UK’s regulatory agency competes with those of other countries to approve drugs for the whole of Europe.