Social Audit Ltd

P O Box 111 London NW1 8XG

Telephone/Fax 44 (0)171 586 7771

Dear Mr Cayzer,

I am enclosing some comments on the White Paper on Freedom of Information, to add to the enthusiastic remarks I made in a recent letter to Dr David Clark. In general, I very much welcome this important initiative. We have not been here before, and it is very encouraging to have arrived thus far.

If the resulting legislation reflects the spirit of these proposals, the benefits should be considerable, and would go far beyond the intrinsic value of any disclosed data. The real value of a good FOI law is to do with a better quality of government and greater trust and understanding between who make decisions and those who live with them.

As an independent policy analyst and writer on medicines, I have on several occasions used the 1994 Code of Practice, also the US Freedom of Information Act. Each of the requests I made under the Code went to appeal. All succeeded, but they took up ridiculous and quite unjustifiable amounts of energy and time. In one case involving the Department of Health - which surely knew it had barely a leg to stand on - it took 70-pages of correspondence and an opinion from Leading Counsel; the process lasted over two years including the wait for a decision from the Ombudsman.

Clearly, I would prefer never to have had to use the Code, and the same will apply with any future Act. Although it has given requesters some good basic rights, the Code has also provided officials with opportunities for protracted and futile argument. [See attached paper on Secrecy in Medicines (Medawar C: Int J Risk & Safety in Medicine, 9, 1996, 133-141).] I hope this can be avoided with the new Act. In a better world, there would be less paper on my desk, not more; and reasonable requests for information would be granted promptly, without any thought of recourse to an Act or Code.

My comments specifically concern the proposed exemption relating to "commercial confidentiality" - and the most important thing to say is simply that the Act should spell out as precisely as possible what this test really means. This is not clear in the discussion on p. 18 of the White Paper. Moreover, what is said clearly opens up the possibility that, at least in my field, nothing much will really change.

My field concerns [a] scientific evidence (including what passes for it) relating to the benefits and risks of different drug treatments; and [b] good quality evidence relating to the competence of the medicines' control authorities and the quality of their assessments in "the public interest", whatever that might be. As a policy analyst, I have never needed nor requested the kinds of information which are traditionally and rightly regarded as trade secrets. These overwhelmingly relate to the development and operation of manufacturing processes, including their cost.

Most of the information I seek relates to evidence of drug safety and efficacy from clinical trials, in particular those relied on by the licensing authorities, the Medicines Control Agency and Committee on Safety of Medicines. Six years ago, a prominent and seasoned CSM member told me that, in his opinion, "a small part of individual (license) applications might be regarded as commercial confidential but the major proportion could, with little loss to anyone, be made publicly available. Similarly, I see no objection to the Committee's paper being publicly available". However, nothing has changed.

In practice, and in spite of the introduction of the Code of Practice, all requests for information about license applications are refused, unless the license holder gives consent. In practice, this diminishes the public accountability of both license applicants and the regulatory agencies. It also means that the most favourable evidence is prominently published while unfavourable findings are not. This distorts understandings and perceptions of benefit and risk, and necessarily exposes patients to needless risks. I can provide extensive evidence of this, though I think you will find enough in the enclosed paper (Medawar C: Int J Risk & Safety in Medicine, 10, 1997, 75-126) and in the correspondence arising with the MCA/CSM. (Updates of this correspondence will shortly be posted on a new website at: http://www.socialaudit.org.uk).

The problem is that "commercial confidentiality" has come to embrace all matters which are commercially "sensitive" - which naturally includes any significant data about drug safety and efficacy. This is evident from the terms of the "commercial in confidence" classification used in the Department of Health's Security Instructions, DSI No 2, November 1987: It applied to:

"material relating to a commercial undertaking's processes or affairs, and in many cases provided by it, which may be of commercial value to its competitors or speculators. Leakage of such information would damage the necessary trust between commercial undertakings and the government."

Although the term "commercial in confidence" no longer applies as a formal classification, in the apparent absence of any clear alternative definition, its spirit and meaning linger on. Indeed the White Paper echoes this old definition in suggesting the need to protect information "which could affect share prices". I believe this test alone could completely undermine any reform in this field; it seems quite inappropriate for several reasons:

The main one is simply that the disclosure of new data relating to the safety or efficacy of a medicinal drug is always likely to affect a company's share price. To give one example, I refer you to the report "Imigram talks hit Glaxo" from the Financial Times, 17/18 December 1994. This mentions a fall of 1% in the Glaxo share price, attributed to publication of a letter in The Lancet "which examined data that had been discussed before and did little more than continue an academic debate".

The implication is that the share price test might stifle all informed and intelligent debate and comment. This cannot possibly be justified in the era of so-called "evidence-based medicine", given also patients' rights to informed choice. In any case, share prices relate ultimately to perceptions of value by speculators, rather than real worth.

Disclosure of financially sensitive information may sometimes create problems, but I suspect that attempts to enforce blanket secrecy would tend to compound them. The nub of the problem here is not ultimately to do with disclosure of data; it relates to the need to prevent the unfair advantage that may be given to financial speculators by selective disclosure of information. The remedy, in other words, would lie in control of insider trading, not in trying to clamp down on disclosure of any and all price sensitive information.

It seems to me that the case for secrecy on matters relating to medicinal drugs should rely on two other basic tests. One relates to the degree of ownership of and legitimate interest in data - a principle that is clearly eroded when information relates to the performance of products initially tested on, and then used to treat, human and other animals. The second is whether and to what extent disclosure would give a competing company an unfair advantage - notably by providing information which would enable it to develop or refine the processes by which competing products might be made.

It is surely not the purpose of the proposed legislation to protect the commercial interests of suppliers and contractors to the extent of shielding them from reasonable and justifiable criticism (from their competitors or others) arising from the known and suspected shortcomings of their products.

Yet, if there is a real risk that a product is defective, or good grounds for supposing some significant change in its benefit-risk profile, substantial harm may be unavoidable. I would therefore suggest that the test to be applied in the Act should refer to something like, "unfair disclosure which would substantially harm commercial interests", or perhaps to "substantial and unjustifiable harm" to suppliers and contractors.

I am concerned also about the scope of the exemption relating to "information supplied in confidence", in particular as this relates to medicines' control. This may be something of a special case, because of the protracted nature of the drug development process and the endurance of many products in the market. This means that regulatory assessments and opinions may have been made several years ago about drugs which have yet to reach the market. All of these data would presently be covered by the catch-all section 118 of the 1968 Medicines Act. In addition, the opinions expressed by members of the Committee on Safety of Medicines have traditionally been given on the understanding of confidentiality. Thus it is very hard to see how, in this field, "there would only be very limited exceptions" to the general right of access to records of any date.

The impression given in the White Paper is that the exemption relating to information supplied in confidence is intended to protect against disclosure which might embarrass individuals rather than corporate bodies. The two examples given underline this, yet it is not at all clear to me why they are representative, and by what means disclosure of corporate information given in confidence might ever be disclosed.

I may be mistaken here, perhaps because of some apparent lack of clarity in section 6, "Information supplied in Confidence" (White Paper, p 18), or because I have misunderstood what is said. For example, I do not understand the phrase "in which case the relevant specified interests will apply", in the second sentence - and didn't realise that I didn't understand it until the third time of reading. On reflection, I suspect that all this means is that, if information supplied in confidence were covered by another exemption, it would not be disclosed anyway. On the other hand, the writer might have been struggling to say that information given in confidence would be disclosed provided it were not covered by another exemption. Clarification on this point would be welcome.

In this connection, it would be helpful to distinguish clearly between the need to protect the identity of an informant, and the need (or not) to treat in confidence any of the information provided. This distinction can be critical in pharmaceutical medicine - for example, information based on reports from doctors of suspected adverse reactions to drugs are now disclosed, though the authorities have declined to provide companies with the names of doctors who send in reports, to protect them from "harassment". (Brit Med J, 4 April 1987, 901-902). Presumably the same considerations might apply to the identification of individual members of the Committee on Safety of Medicines; one can readily envisage circumstances in which some members might be inhibited from expressing criticism of particular products.

This in turn implies the need to distinguish between information provided by individuals and corporate bodies - also to provide for the disclosure of documents in which relatively small amounts of data were covered by an exemption. Thus I would hope that, under the new FOI Act, it would be possible to obtain minutes of past meetings of the CSM, albeit with deletions, if necessary, to avoid identification of the individual concerned. As to the future, it would be important also to make a clear distinction between circumstances in which undertakings of confidentiality were offered because this was imperative, rather than convenient. As a general rule, I see no reason why offers of confidentiality should be routinely extended to experts working through bodies such as the Committee on Safety of Medicines.

I hope these comments will be helpful. I may add to them later; in the meantime, I shall post them also to UK Citizens' Online Democracy, as the White Paper suggests.

Yours sincerely,

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