| The Campaign for Freedom of Information |
| Medicines Information Bill: Government Blocks Release of Safety Data |
This article appeared in the Campaign's Secrets newspaper in August 1993.
|
|||
A bill to give the public more information about the safety of medicines was blocked in 1993 - despite the government's 'open government' policy. The Medicines Information Bill was introduced in January 1993 by Labour MP Giles Radice, with all-party support. It was jointly drafted and promoted by the Campaign for Freedom of Information, the National Consumer council and Social Audit. The Bill should have been an obvious candidate for government support. It provided consumers with more information - and implemented a promise in the Conservative manifesto to remove unnecessary legal restrictions on disclosure.
But the Bill was vigorously opposed by the Department of Health and the drugs industry. Together, they ensured that it was killed off.
The Bill would have dealt with one of the most unacceptable secrecy provisions on the statute book. Section 118 of the Medicines Act 1968 makes the release of all information which the medicines licensing authorities obtain under that Act an offence. Publishing even safety data is a criminal offence punishable by up to two years imprisonment. This intolerable section is actually more restrictive than the 1989 Official Secrets Act, which only prohibits unauthorised disclosures. The Medicines Act blocks even authorised disclosures. Ministers themselves are bound by it. But if a British drug is sold in the USA, safety data is readily available under the American Freedom of Information Act. The Bill also had a British precedent. When a new pesticide is approved a detailed evaluation of the manufacturer's safety studies, often running to 90 pages, can be obtained from the Ministry of Agriculture. Nothing of the sort is available for medicines. The Bill was supported by the British Medical Association, by the former chairman of the government's Committee on Safety of Medicines Sir William Asscher, by Consumers' Association, Patients Association, MIND, the College of Health and the Association of Community Health Councils.
At first, the government had seemed positive about the Bill. At second reading on January 15 1993 the junior health minister, Mr Tom Sackville, said: "I am sure that it is right to view very positively the prospects for opening up to public scrutiny at least some of the information held by the United Kingdom Medicines Licensing Authority. I am sure that steps in that direction are, in principle, something which the Government would wish to consider very positively...A number of its aspects on more freedom of information in the medicinal licensing field would be beneficial". Mrs Bottomley, the Health Secretary was quoted as saying that the government would give the Bill "a fair wind". The Bill had an unopposed second reading. But by the time it went into Committee, a month later, the government objected to every part of it. Mr James Couchman (Conservative, Gillingham) tabled a series of amendments which he himself acknowledged "could be called wrecking amendments". He proposed to delete 8 of the bill's 9 clauses (sparing only the clause which contained the bill's title) and insert two new clauses providing for absolutely minimal disclosure. Mr Couchman declared that he was a paid adviser to the American pharmaceutical company, Pfizer. But the wrecking amendments had been drafted by the government - not the industry. This was clear from a remarkable overlap between Mr Couchman's amendments and the minister's. (Mr Sackville tabled just one amendment. This defined terms used only in Mr Couchman's amendments, revealing that the two sets of amendments had been drafted together.) It later became clear that Mr Couchman had also been supplied with speaking notes written by civil servants. The amendments did not succeed. Most of the time the Minister was alone in opposing the Bill and Mr Sackville was defeated 12-1 and 11-2 on the votes. (The only Conservative MP who voted with the minister later told the Commons he did so because he "felt sorry for him".) But at the Bill's Report stage on April 30 more than a hundred amendments were put down - nearly all by Conservative MPs opposed to the Bill. The same MPs also made extended speeches on a modest two-clause bill which came up earlier in the day, deliberately reducing the time left for the Medicines Bill. There was no chance that the amendments could all be debated in the remaining time, and Bill was 'talked out'. The minister justified his opposition to the Bill on the grounds of its supposed costs. The Medicines Control Agency is funded entirely by licence fees from pharmaceutical firms. The government refused to cover any costs arising from the Bill, and said these would have to be met by putting up the licence fee. The industry bitterly opposed this, claiming that British companies would then face higher costs than their European competitors. The Bill's supporters believed that costs would have been minimal, and would also have been faced by other European companies operating in the UK. Moreover, new EC licensing rules mean that disclosure will increasingly be required in future. Mr William Waldegrave reportedly pressed for a more positive response to the Bill - but was overruled by the Department of Health. The government's position may have reflected negotiations with the industry on two quite separate issues. In the face of severe industry opposition, ministers were planning to extend the 'limited list' policy under which only specified medicines can be prescribed on the NHS. Separate negotiations with the industry were also taking place over the price the NHS would pay for drugs. Ministers apparently decided to sacrifice the Bill to appease the industry on these completely unrelated issues. A few days later an industry spokesman told the Financial Times (May 10) that there was "quite a lot of good will" between the two sides. Information about medicines will not be covered by the new law on access to health and safety information announced in the recent White Paper. Instead, the Department of Health claims to be trying to agree a voluntary code of practice on disclosure with the drugs industry. The weakness of this approach has been underlined by the steps taken by the Ministry of Agriculture, Fisheries and Food to release comparable information about pesticide safety. Pesticide disclosure regulations were introduced in 1986 and further regulations, to allow retrospective access, are soon to be brought in. Earlier this year MAFF rejected the idea of a code of practice saying "Ministers require statutory powers to release information to the public. A voluntary agreement could not be expected to receive the full co-operation of data owners/providers" [the pesticide companies]. |
| More articles from Secrets. | |
| Environmental & Safety Information. | |
| Home page. |