The Guardian

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.

But Professor Woods says that neither industry funding nor close liaison is a problem. "It is important that the regulator understands the regulated industry.

"I have to say that our areas of overlapping interests are not 100%. There are some things where we have common cause but our prime responsibility is to ensure we protect public health. These are aims which the industry shares. I don't think there is a necessary antipathy between what the ABPI [The Association of the British Pharmaceutical Industry] is trying to achieve and what we are trying to achieve. But there are other areas in which we can't agree."

Richard Ley, spokesman for the ABPI, denied that the ABPI had the MHRA "in its pocket". "The objective of the MHRA is to ensure that medicines are assessed to be effective and as safe as possible. Those are also our aims. We have an absolute desire to have good quality medicines."

The documents record the regular meetings and dinners between the MHRA and the ABPI over the past year.

Among the "notable successes" of its close collaboration with the industry, the MHRA paper cited how it "cooperated well" with the trade association to lobby other European governments and the European commission on a review of legislation governing drug companies. It was, according to the briefing paper, "another example where the Association of the British Pharmaceutical Industry and the MHRA worked closely together".

Minutes of a meeting between the ABPI and senior MHRA officials in April record that the "ABPI thought there was a remarkable concordance between MHRA and their priorities..."

At their meeting with the MHRA top officials in June, the ABPI presented an eight-page blueprint detailing how it thinks the MHRA should be run to "build upon the excellent working relationship" between the industry and the regulator. According to this document, "our priorities are aligned [ABPI/MHRA]".

Following this meeting, Nicky Lilliott, the ABPI's head of regulatory affairs, wrote to Professor Woods, to confirm that, as agreed, the ABPI would develop an action plan to discuss a wide range of issues for the future of the agency. "I would propose that over the summer the ABPI drafts an action plan and this is then circulated to yourself and colleagues for comments, with the intention to agree the action plan at our meeting in September."

"The action plan would need assigned topic leaders, joint ABPI/MHRA, in order to achieve the agreed objectives/milestones. The main driver for the actions and timelines for these issues will be the implementation (of) the new pharmaceutical legislation by October 2005". Professor Woods said the action plan related to establishing a framework for bilateral meetings. The documents show the ABPI is unhappy at proposed changes to the structure of the MHRA. It used to have three people on the ministerial advisory board and two on the Medicines Commission, the drug licensing appeal body.

Pressure

In a letter to Professor Sir Alistair Breckenridge in January, Dr John Patterson, the ABPI president, wrote: "We remain concerned at the lack of representation of the pharmaceutical industry at board level within the MHRA ... As the only regulatory agency that is fully industry-funded, we believe it is essential that we have a say on a variety of issues, not least financial matters relating to fees and service levels."

After more pressure, MHRA officials discussed alternative arrangements. Roy Alder, a senior MHRA official, suggested in March that "there could be scope for industry to make a similar input to MHRA business and operational policy" through other ways. He wrote: "Ministers are clear that the MHRA board should have no current industry people. There seems no option on this issue." He suggested someone recently retired from the industry could possibly be put on the board, "but ministers may want to avoid any perception of industry interests at board level."

The Committee on the Safety of Medicines (CSM), made up of independent experts, advises the MHRA on which drugs to license after studying clinical trial data on safety and efficacy. Its members are supposed to declare any sponsorship or payments they receive for lectures or advice from industry. The last complete declaration of interests of CSM members, for 2001, shows 17 out of 36 members had personal financial links to the industry, while others have declared non-personal interests such as research grants.

The documents show that industry has been agitated about ministers' "unrealistic" plans to tighten the rules on conflicts of interests. The ABPI complained ministers were "being too restrictive in the requirement for experts to not hold any personal interests in the pharmaceutical industry."

Professor Abraham claims there is too much of the "revolving door" syndrome at the MHRA. Not only do CSM members take fees from industry, but many agency officials used to work for drug companies, such as the former head of worldwide drug safety at GlaxoSmithKline, who is now the MHRA's head of licensing.