Summary  This complaint against the Medicines Control Agency (MCA) arises from a request for information made under the Code of Practice on Access to Government Information ('The Code'), Complainant alleges that the MCA's response to his enquiries about DTCA [a] involved unacceptable delay and violation of the Code; and [b] indicates a continuing pattern of abusive lack of transparency.

Background   Direct-To-Consumer Advertising (DTCA) is the practice of advertising prescription-only medicines directly to the public and related promotional activity - such as "disease awareness" campaigns. DTCA is permitted in the USA (also New Zealand) but is at present illegal elsewhere and throughout the European Union (EU).

DTCA has been an established feature of medicine in the USA since 1997, when the US Food & Drug Administration approved a change in television advertising regulations. It has grown explosively in the past five years: US expenditure on DTCA is now around $2billion/year - i.e. it has become extremely important for pharmaceutical companies. They have been exerting great pressure to change EU law, to permit DTCA here.

The style of the industry's campaign is described in attached report from Pharmaceutical Marketing (May 2000). This report forms part of this complaint, because it clearly suggests that the emphasis in the campaign is on swaying opinion, rather than carefully examining the costs and benefits of DTCA. This needs to be done, for the health and economic implications of DTCA are profound.

The prospect of a review of EU advertising law has existed for at least two years. The pharmaceutical industry's campaign for legalisation is now coming to a head and the European Commission (EC) has already begun a formal consultation on the issue, with a deadline for first-round comments of 15 July 2000.

This is very much a live issue and a matter of great public interest. It was reasonable to expect a meaningful response to enquiries about the basis on which the Medicines Control Agency was addressing this issue.

Preliminary enquiries

25 February 2000 Complainant wrote to the MCA asking [a] "if either the MCA or CSM is presently conducting, or has completed, any assessment of the possible impacts, including costs, that might result from a change in the law that now prohibits the promotion of prescription-only medicines directly to the public"; and [b] "has any attempt been made to assess what the additional benefits, risks and costs might be - and has the CSM considered any such questions to date? I would be grateful for any information you are able to provide, including citations to any data not generated by the MCA/CSM, but on which it relies." (Appendix 2)

16 March 2000 The MCA replied (Appendix 3) saying it couldn't reply within the 20 days specified in the Code, but would do so "as soon as possible". This prompted a snarling response from complainant (Appendix 4), an expression of dismay about the emptiness of the MCA's response and the prospect of yet another long delay - on this occasion on an important and highly topical issue. Paucity of information and long delays have been characteristic of the 3-year correspondence between Social Audit and the MCA (which speaks also for a number of independent advisory satellite bodies, such as the Medicines Commission [MC] and the Committee on Safety of Medicines [CSM].)

20 April 2000 Nearly two months after the original request, complainant received a short letter from the MCA (Appendix 5). This said that the Agency had not conducted any analysis of the likely benefit, costs and risks of DTCA. It also said the MCA had prepared a paper on the issue, at the request of the Medicines Commission. The MCA said that the paper contained no costings, nor conclusions, but was intended to inform the MC's discussion. The MCA refused to give any further information, citing part of Exemption 2 of the Code. This justifies the withholding of: "Information whose disclosure would harm the frankness and candour of internal discussion, including … internal opinion, advice, recommendation, consultation and deliberation".

Continuing enquiries

12 May 2000 Complainant responded at length to the MCA's refusal to disclose (Appendix 6). He raised a number of specific further questions, seeking to establish the depth of the MCA's enquiries into DTCA, and requested a formal review of the MCA's earlier decision not to disclose. The urgency of the request was emphasised, as were eight separate grounds for appeal. Briefly:

6 June 2000 The MCA sent a holding letter (dated 6 March), saying that a review was being done by Dr Gordon Munro (MCA) and should be completed by 26 June (Appendix 7). Shortly afterwards, the MCA wrote to communicate the finding of the review, and to respond to the specific points raised in complainant's letter of 12 May (Appendix 7)

5 July 2000 Complainant responded on 5 July, informing the MCA he would be seeking adjudication by the Ombudsman. (Appendix 8)

This complaint relates not only the MCA's response in this instance. In considering whether or not to take up this complaint, the Ombudsman is asked also to take account of its previous findings against the Medicines Control Agency and the outcome of the other seven reviews requested by the complainant in the past two years. "Dr Munro's review is the last in a series of responses to complaints from Social Audit, and each time the finding has upheld our right to receive better information than the Agency chose to provide."

Specific grounds for complaint

1. Dr. Munro's review is insufficient in addressing only point five of the eight grounds for complaint. It does not comment on the delay. It justifies the MCA's decision to provide an edited summary of the document (not the document itself, if necessary with deletions) partly on the grounds of (unspecified provisions in) Exemption 10 of the Code. The MCA had not previously relied on this Exemption; it had cited only Exemption 2.

2. There was and is a paramount need in this case to publish (so much as possible of) the original document, not a studiedly edited version. One important reason for thinking this is that the public needs and has every right to know how much the paper omits. That seems all the more relevant when the MCA's paper had not been informed by public consultation.

3. The editing that was carried out was over-zealous and insensitive. Thus, the edited version of the requested document referred merely to the paper suggesting "a range of advantages and disadvantages of any suggestions to change current arrangements". Complainant contends that these could and should have been spelled out. It is clearly important that the options available to the authorities should be known. No attempt was made to justify non-disclosure and there is no reason to think that harm would have been done if this information had been provided.

4. The MCA letter of 20 April gave the clearest impression that it was the Medicines Commission that initiated action on this issue. It concealed the fact that the MCA had prepared an earlier paper, requesting action: "Ministers would welcome the Medicines Commission's advice on this important issue".

5. The MCA letter of 20 April said that the Medicines Commission had asked the MCA to prepare a report, but it appears (letter of 29 June) that the report was drafted jointly. The attached minutes of the Medicines Commission meeting of 18 November (Appendix 9) withholds the names of those responsible for preparing the report on DTCA on the grounds of Exemption 12 of the Code - privacy of an individual. Complainant objects as a matter of principle. This was a factual analysis and the work of several people. In the light of the Guidance on Interpretation, no real privacy issues would arise. The names should be disclosed, if only to explain the authors' areas of experience and responsibility (and in the case of the Medicines Commissioner any disclosure of possible conflict of interest).

6. The MCA's letters of 20 April and 29 June both failed to respond to the request for "citations to any data not generated by the MCA/CSM on which it relies".

7. The MCA's letter failed to respond to the two key questions raised in complainant's letter of 12 May - namely, whether or not the MCA considered there was adequate evidence of the benefits, risks and costs of DTCA - and the relevance of "the precautionary principle". These questions are of fundamental importance: is there adequate evidence to go on and, if not, would it seem prudent to permit any change in the law?

General grounds for complaint

The MCA's response to this and other request for information indicates persistent violation of the Code. The Agency has habitually failed to respond within recommended time limits, and has consistently provided less information than should have been disclosed. At July 2000, requests were outstanding from 2 December 1999, 22 January 2000, 30 January and 23 March. See Appendix 10.