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The Secret Life of Pharmaceuticals

A slightly edited version of this article was originally published in Chemistry & Industry magazine, December 1994

 

Why is the regulation of pharmaceutical safety so secretive?

The story starts with an event which should have ensured maximum openness: thalidomide. For many years the full account of this tragedy was suppressed by the courts: it took the European Court of Human Rights to rule that a Sunday Times expose could be published.

The legislation that resulted should have guaranteed the public’s right to know. But in true British style, it protected the drug industry’s right to suppress information instead.

Under section 118 of the 1968 Medicines Act it became a criminal offence for an official to reveal, without the supplier’s consent, any information obtained by the licensing authority in the course of its duties. The restriction, meant to protect commercial secrets, in fact prevents the disclosure of safety data, the advice of the government’s expert committees and the reasons for licensing decisions.

The result has been a blanket of secrecy. Time after time ministers have stood up in parliament and refused to say what research has been submitted on a product, why a particular license has been granted or withdrawn, and what the authorities are doing to tackle some contentious drug safety issue.

Yet the same information can often be obtained from Washington under the American Freedom of Information Act. Under it, even British citizens living in the UK have an enforceable right to information denied to MPs in the House of Commons.

The chance to change this came in 1993 with Giles Radice MP’s private member’s Medicines Information Bill. The bill partly implemented the government’s own manifesto promise to limit the scope of excessive disclosure restrictions. It also proposed positive access rights to safety and efficacy information, subject to exemptions for confidential manufacturing details and products under development.

The bill obtained an unopposed second reading, though both the industry and the Department of Health later opposed it. But it was their less than straightforward lobbying tactics that left a sour taste.

During the bill’s committee stage a Conservative backbencher began by declaring an interest as a paid adviser to a leading pharmaceutical firm, and then proceeded to move a series of what he himself acknowledged were “wrecking amendments”. All within the House of Commons rules, but how different from local government – where a councillor may neither speak nor vote on a topic on which he has an interest.

Next, the British Pharma Group – representing Glaxo, Fisons, Boots, SmithKline Beecham, Zeneca and Wellcome – demonstrated a particularly artless form of lobbying. Announcing that it could live with most of the bill, it argued that one central clause was objectionable. If enacted, firms would boycott the UK licensing authority and seek their initial clearances elsewhere in Europe it warned. But the remaining bill would be “unlikely to create significant problems” if this provision were removed. Compromising, Mr Radice dropped the contentious clause and widened the commercial confidentiality provisions. The BPG, having achieved its goal, suddenly reneged on its previous position, declaring war on the remaining clauses, though days earlier these had been largely acceptable. Even the rump of the bill would now cause “real and lasting damage to the industry” it unashamedly told the government, resuscitating its increasingly implausible threat that British companies would “simply cease to use” the UK licensing system. The stance gave the government the excuse it needed to oppose the bill, which was then talked out.

The health minister Tom Sackville announced an alternative approach. He told MPs that his department had “begun to discuss with the pharmaceutical industry a new voluntary code of practice to increase the amount of information that they give to the public”. Three months later, the Open Government white paper confirmed that the Department of Health was “currently discussing” this code with the industry. But was it?

Asked what discussions had actually taken place at that time, the Department reluctantly admitted, under pressure from the Parliamentary Ombudsman who supervises new Whitehall “open government” rules, that there had been no discussions during this period. The issue had been one of several raised at a single “informal meeting” prior to second reading and followed a few days later by one “further contact by letter”. Then total silence until the following year. The continuing, substantive talks implied in the white paper had simply not occurred by the time the white paper appeared. They had been concocted, to spare the government embarrassment.

The government argued that British companies should not be disadvantaged by requiring them to be more truthful than their European competitors. Mr Sackville’s answer was for Britain to take a lead in promoting greater openness under new European drug licensing rules. How successful has he been?

Two new European approval schemes are due to come into force next month. Under the centralised procedure, co-ordinated by the new European Medicines Evaluation Agency, a product may be licensed for use throughout the European Union. Under the decentralised procedure, a license is obtained in one member state, but subsequently must be recognised by other states unless they have objected within a fixed period. Any objections will be dealt with by binding arbitration.

For a product licensed under the centralised procedure, a summary assessment of its safety and effectiveness will be made public – a welcome step. But this centralised procedure is compulsory only for genetically engineered and certain other hi-tech products. The vast majority will probably be licensed under the decentralised procedure. Here there will be no disclosure. Member states accept that openness should come eventually, but only after they have seen how the centralised arrangements work. And no change will be made without fresh European legislation – a proviso likely to ensure indefinite delay.

So safety data on all existing UK products, and most of those introduced in future, will still fall under the archaic restrictions of section 118. Government and industry have killed real moves to greater openness – but neither has done its reputation much good.

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