(Parliamentary Commissioner for Administration)

This is a further complaint of maladministration by the Medicines Control Agency (MCA), similar in origin to three previous complaints referred to the PCA by Richard Shepherd MP on 17 August 1998. Again, the complaint involves the MCA's advisory body, the Committee on Safety of Medicines (CSM), and relates to refusals to disclose under the Code of Practice on Access to Government Information. Relevant correspondence is attached.


1. Background to complaint

[a] In the context previously described, complainant had criticised the authorities for accepting as valid the main conclusions of a study of paroxetine (Seroxat®), jointly conducted by a (then) member of the CSM and an employee of the manufacturers of this medicinal drug. Their study was later published in a journal edited by this CSM member, who also had personal interests with, inter alia, the manufacturers of this drug.

[b] On 2 December 1997, the MCA was sent a copy of the paper in which this criticism was explained, and complainant underlined his concern about it in a letter to the MCA's Chief Executive, on 28 January. Dr Jones did not respond on this point, but the CSM Chairman subsequently did. Professor Rawlins wrote to complainant on 8 May, saying he considered the study gave good evidence for the manufacturer's claim that "long-term treatment with Seroxat® has shown that antidepressant efficacy is maintained for periods of at least one year". This claim is made in product data sheets (1991-8) and was therefore formally approved by the MCA/CSM.

[c] Complainant wrote to Professor Rawlins on 10 June, providing many reasons and much evidence to underline his conviction that the CSM/MCA assessment of this study was confused. At the same time, complainant raised a number of questions about the basis of the authorities' assessment of the study, asking that these be treated a formal Code requests.

[d] On 1 July, Professor Rawlins wrote to say he did not intend to respond, mainly on the grounds that answers had already been provided. This was not and could not have been so. On 5 July, complainant wrote back to Professor Rawlins, urging him to reply: "It is not fair to suggest that you would have 'to rehearse the arguments yet again'. This was the first time such questions had arisen. My questions related specifically to the reasons you gave for claiming that Montgomery & Dunbar (1993) had presented good evidence and reached reliable conclusions. I came back with abundant evidence to show that you and the CSM need to think again on this - and my questions asked if you would do so".

[e] Professor Rawlins did not reply, but had previously written (3 July) in response to another letter, to say that "the Committee's arrangements for disclosure are determined by s118 of the Medicines Act and are not governed by the Code of Practice on Open Government." On these grounds he directed complainant to the MCA.

[f] Complainant submits that s.118 of the Medicines Act did not stand in the way of a response, as the study in question was later published Also, the law permits disclosure if "made in the performance of … duty". Complainant believes this would be such a case, since a refusal to answer would tend to cast doubt on the judgement, authority and leadership of the drug regulators, and on their ability to properly assess drug benefits and risks.

[g] On 16 June, the MCA wrote to say that it would deal with the questions addressed to Professor Rawlins, as requests under the Code. However, in a letter dated 14 July, MCA explained they could not do so because "important questions of operational practice" were involved. As with the previously referred complaints, the refusal was made sine die.


2. Basis of complaint

Given this impasse, complainant requests an independent review. The question for adjudication is not whether complainant has well-founded concerns about drug safety, but whether the authorities are entitled under the Code to refuse to respond to pertinent questions relating to such concerns.

The MCA has offered no credible evidence that disclosure of confidential information might be involved, nor given any indication of harm that might be done if the information requested were put in the public domain. There is no indication that the MCA/CSM has considered where the public interest in disclosure lies in this case, nor why they believe it to be outweighed by the need for secrecy. Moreover, in view of the criticisms made of them, the authorities might find it hard to take an impartial view on this.

In a previous complaint, reference was made to complications that seemed to arise because the CSM is so much in the frame, yet not covered by the Code. Complainant maintains this should not prevent disclosure in this case, on the grounds of the following caveat about "Expert advice" in Guidance on Interpretation of the Code at (II) 2.11.

"There is less need for confidentiality in respect of advice from expert advisory committees, especially where the members of committees are not civil servants, where the availability of the assessment will enhance public debate and understanding of an issue, and it is important that there should be opportunities for scientific assessment and analysis to be contested or made available for peer group review"

That is exactly what this complaint is about. Complainant believes no proper justification exists for refusing to respond, and seeks disclosure and investigation of the reasons and justification for the delay.

Charles Medawar,
Social Audit Ltd.

22 August 1998