|Social Audit Ltd|
|P O Box 111 London NW1 8XG|
|Telephone/Fax 44 (0)207 586 7771|
|Mr Roy Alder, Head of Executive Support|
|Medicines Control Agency|
|Market Towers, 1 Nine Elms Lane|
|London SW8 5NQ||
29 November 2002
Dear Mr Alder,
In my letter to you of 30 January 2000 I asked for information about [a] the number of occasions in the previous year on which the MCA had made representations about possible breaches of the medicines advertising regulations to licence holders, indicating in each case [b] the identity of manufacturer/ product and [c] the nature of complaint. Please treat this letter as a formal request under the Code for this same information over each of the past three years.
If you are able to provide this information, then questions 1 to 11 below become irrelevant and need no response. In that case, please treat them as a formal grovel by me that my expectations of the MCA may sometimes be ungenerous or critical to a fault. If so, I would want to thank and congratulate you: it would clearly show that that the MCA does good things too.
Failing this, it might help if I did a recap. In your very belated reply, dated 11 October 2000, you refused to disclose any information in response to questions [b] and [c], under Exemption 4c of the Code. I thought then that the Agencys position was pitiful and you dropped more than hint that you could see my point when you wrote, "The Agency recognises that the regulation of advertisements is an area of legitimate public concern." You also indicated the MCA was doing something about it: "We are currently reviewing our policy on what information we can make public concerning our regulatory activity on advertisements, whilst remaining within the Code."
The following questions arise, not least because the MCA is, even now, making obsequious noises about patients rights to information, with a view to relaxing the regulations that now prohibit the advertising of OTC products for "psychiatric diseases," among other illness. I have attached an extract of some of the arguments deployed in the MCA consultation paper (MLX 288) all arguing that patients have a right to know.
Leave aside the very unwelcome specifics of that proposal: would it not be absurd to permit any relaxation of advertising controls, so long as MCA also claimed the right to keep secret all evidence of its own activity and competence, or the lack of it, in medicines advertising control?
Please would you give me further information about the policy review in this area that the MCA has been carrying out over the past two and a half years. Please provide a copy of all agendas, minutes of meetings and other available documentation relevant to any of the following questions:
1. Has any such review taken place?
2. Has the review been concluded?
3. What were its terms and findings?
4. Who conducted the review?
5. Was the ABPI or any member company consulted?
6. What other consultations took place?
7. If the review is not yet complete, please explain why not and give an estimated completion date.
Turning to the meaning of Exemption 4c in the Code of Practice, please could you explain:
8. Does the MCA believe that that disclosure of the requested information would "cause unjustified harm to the subject of an investigation", other than in cases in which the MCAs representations to a license holder proved "unsubstantiated or irrelevant"?
9. In how many of the cases identified in question [a] above did the MCA pursue what were clearly not "unsubstantiated or irrelevant" matters?
10. Does the MCA consider that disclosing the requested information "could prejudice the effective operation" of the Agency, and if so how?
11. What weight does the MCA put on the public interest in disclosure within the meaning of the formal Purpose and Aims of the Code of Practice on Access to Government Information?
Please could you also explain something of the division of responsibilities for control of advertising and product promotional activity between the MCA and either the ABPI or Prescription Medicines Code of Practice Authority:
12. Please provide a copy of any note or memorandum of understanding between the MCA and either of these bodies about the division of responsibilities for control of advertising and product promotional activity.
13. Does the MCA ever refer complaints relating to possible breaches of regulations relating to product advertising or promotion for investigation or adjudication to the ABPI/PMCOPA and, if so, how often does this happen and under what circumstances?
14. On what basis, did the Agency decide to take no unilateral action in the matters relating to GlaxoSmithKlines promotion of Seroxat (paroxetine) referred to in my letter of 12 October to Dr Raine until after the findings of the PMCOPA became known?
15. Does the MCA agree with the conclusion of the PMCOPA Appeal Board, that no statement in the GSK, "Reactive Key Messages and Issues Document" (19 December 2001) is incompatible with the Seroxat SPC? I asked this in my letter to Dr Raine of 12 October 2002 and a reply is overdue.
Finally, I have some questions about the activity of the MCAs Independent Review Panel for Advertising, and to the conduct of their meetings.
16. On how many occasions this century has this Review Panel actually assembled to consider matters relating to how many advertisements?
17. In what sense is this an "Independent Panel", when eight of the nine members who have disclosed interests have personal interests in pharmaceutical companies, including six who are shareholders?
18. What arrangements have been or would be made to consider regulatory matters involving products made by GlaxoSmithKline, when eight of the ten Panel members currently list personal interests in either GlaxoWellcome or SmithKline Beecham, including five who directly own shares?
Thank you for your attention. I look forward to hearing from you I hope with the information we seek but if not, then with some response on all these points.
Yours sincerely, Charles Medawar
CLICK HERE TO READ ON
MCA CONSULTATION LETTER: MLX 288
ADVERTISING OF MEDICINES TO THE PUBLIC:
PROPOSED AMENDMENTS TO THE MEDICINES
(ADVERTISING) REGULATIONS 1994
"The recent report by the European High Level Group on innovation and provision of medicines recognised that patients have a right, and an increasing expectation, to have access to good quality objective information about the medicines they take and to be actively involved in decisions about their treatment. They concluded that: "There should be no restrictions on advertising of non-prescription medicines in line with existing requirements for advertising to encourage the rational use of the product and not to be misleading."
Patients now receive far more information with their medicines through improved patient information leaflets and information on packaging, approved by the MCA. This includes information on indications, dosage, side effects, contraindications, duration of use and when to seek medical advice. The leaflet may include information on the illness in general and on lifestyle changes, which the patient can adopt to reduce the need for medication.
The Expert Patient report on a new approach to chronic disease management recognises that patients can become key decision-makers in the treatment process. By ensuring that knowledge of their condition is developed to a point where they are empowered to take some responsibility for its management and work in partnership with their health and social care providers, patients can be given greater control over their lives.
A patient centred health service is one in which patients can receive information, including advertising information, about medicines they can purchase OTC, empowering them to manage their own conditions where it is safe to do so. The proposal to remove the restrictions on advertising OTC medicines discussed in this consultation will contribute to this. It will also contribute to measures to increase freedom of information and contribute to the Governments agenda to reduce regulatory burdens on industry."