Department of Health
MEDICINES CONTROL AGENCY
Market Towers 1 Nine Elms Lane London SW8 5NQ
TEL:  020 7273 0400
FAX:  020 7273 0675 .
E-mail: [email protected] 4 March 2003

Dear Mr Medawar,

Mr Bagwell’s letter to you of 8 January contained a response to some of the questions in your letter of 28 November. I am now in a position to answer the remaining ones and am sorry for the delay in doing so.

The statistics about potential breaches of the Medicines (Advertising) Regulations 1994 for the last three years you asked for are as follows:

 

2000

2001

2002
Number of complaints investigated involving MAHs

35

51

26
Number of potential breaches identified as a result of these complaints

28

35

18
Number of MAHs contacted as a result of scrutiny*

24

102

50

Number of potential

breaches identified as

a result of scrutiny

6

52

25

* This includes companies contacted to supply references from an advertisement in addition to those where correspondence referred to a potential breach of the Regulations. In a number of these cases, internal review of the advertising and references supplied will have led to the case being closed with no further action taken by the MCA.

You asked about the MCA’s policy review on what information can be made public concerning the Agency’s regulatory activity on advertisements, whilst remaining within the Code of Practice on Access to Government information (the Code). I think it would be most helpful if I answered your questions as written.

Your letter asked for responses to a number of questions on a range of issues. The first group of questions related to the MCA’s policy review of the information we can make available on advertising casework.

As I said in my letter of 11 October 2000, we recognise that the regulation of medicines advertising is an area of legitimate public concern. For this reason, we have kept our policy on what information we can make public concerning our regulatory activity on advertising under continual review. In response to your request I will set out the steps we have taken to date and the areas where we are still working to achieve a satisfactory outcome on this issue.

The MCA’s primary objective in the control of advertising is to protect and safeguard public health through applying relevant controls which will contribute to the safe and effective use of medicines. This is achieved by a range of measures to ensure that advertising complies with the statutory requirements, in particular that it should promote rational use of the product and not be misleading. In 1999, the Agency published a Guidance Note, ‘Advertising and Promotion of Medicines in the UK’, which sets out the Agency’s interpretation of the legislation on advertising for medicines. It also provides information on the self regulatory framework that operates in the UK and the role and procedures of the Agency in the control of medicines advertising.

As set out in this guidance, where the MCA’s provisional opinion is that a breach of the Regulations has occurred, the company is required to withdraw or amend their advertising. In serious cases it is important for public health that the recipients of the advertising are not left with an incorrect perception of the benefits of the product. In the past the Agency has used Current Problems in Pharmacovigilance to alert health professionals to the problem and a copy of an article which serves as an example is attached for your information. This mechanism has also been used to get across general messages arising from concerns about products. The Agency has always had the option to require a corrective statement to be sent to recipients of misleading advertising. Recently the Agency has increased the use of this method and I enclose for your information three statements that have been published in journals and/or sent to health professionals in receipt of previous advertising material considered by the MCA to be in breach of the Regulations in the last year.

The MCA updating service, MAIL, is another way of disseminating messages about our work on advertising and a copy of an article published in MAIL last year is enclosed for your information. This month’s MAIL includes an announcement of the publication of guidelines on the advertising of medicines which are promoted for use during pregnancy. Further articles are planned depending on the general points that can be usefully conveyed to companies to help them to improve their advertising practice. All these activities contribute to informing a wider audience about the activities the MCA undertakes to regulate medicines advertising.

The Agency has identified a number of potential benefits from dissemination of information about specific advertising cases, primarily the public health benefit detailed above that recipients should be aware of advertising that is found to be misleading or otherwise inadequate. In addition to this the dissemination of more information would also make stakeholders including the professions and industry more aware of the work of the MCA Advertising Unit and increase confidence in the regulatory role of the Agency in this area. Information on actions taken also provides information and encouragement to companies to ensure compliance.

Within the MCA, we have looked at how we might improve the transparency of the decision making on advertising issues. The MCA’s usual practice to seek the agreement of the company to withdraw advertising voluntarily before invoking the statutory procedure. This policy is set out in the Guidance Note on advertising published by the MCA. When an advertisement has been investigated as a result of a complaint or scrutiny of published material, the Agency routinely writes to the company concerned to give its provisional opinion if it considers that an advertisement may breach the Regulations. In most cases the company then agrees voluntarily to amend or withdraw the advertising material in response to MCA’s concerns. No formal determination is made in such cases as to whether the advertisement breaches the Regulations since the statutory procedure and/or criminal proceedings are not invoked.

Our legal advice has been that the Agency is constrained from making identifiable information available on individual advertising cases, without the permission of the companies involved. We were initially advised that it would be wrong to publicise the MCA’s conclusion when there has not been a prosecution so the company has not had the opportunity of a court hearing.

We are not satisfied that the current position on the disclosure of information about advertising casework is in the best interests of public health and are continuing to explore the possible options for increased disclosure of details of cases investigated. This has taken much more time than originally anticipated. Any change in policy will be made public and interested parties given an opportunity to comment. I will ensure that you are notified of any change.

Consideration of these issues has so far been internal to the Agency. The ABPI and specific companies have not been consulted. However, the topic has been discussed several times at meetings of the Medicines Advertising Liaison Group (MALG). MALG members include representatives of the Prescription Medicines Code of Practice Authority (PMCPA), Proprietary Association of Great Britain, Advertising Standards Authority, Radio Advertising Clearance Centre, Independent Television Commission, Radio Authority, Broadcast Advertising Clearance Centre, British Dental Trade Association, Advertising Association and Medicines Control Agency.

We have provided statistics above on cases for the last three years as you requested. Clearly in all complaints where a potential breach of the regulations was identified, the matters were not "unsubstantiated or irrelevant".

The Agency operates under the Code and its associated Guidance. All requests are considered on a case by case basis. Where there is an important issue of public health or safety then the Agency does not hesitate to disclose information, even if in doing so confidentiality is broken.

The Code will be replaced in January 2005 by the full implementation of the Freedom of Information (FOI) Act 2000. The principles outlined in the Code encouraging government departments and agencies to keep disclosure policy under review are also reflected in the FOI Act. The Information Commissioner is also encouraging departments to expand their publication schemes. These are issues that the Agency will be addressing in detail over the coming months in preparation for 2005.

You also ask about the division of responsibilities for advertising control between the MCA and either the ABPI or PMCPA.

The control of medicines advertising in the UK is based on a long established system of self-regulation underpinned by statutory powers administered by the Agency. The PMCPA is one of these self regulatory bodies and acts independently from the MCA to administer their Code of Practice and complaints procedure. The Guidance Note referred to above also provides information on the PMCPA and its role in advertising control. The MCA Advertising Unit has regular informal contact with the PMCPA and more formal contact occurs through the Medicines Advertising Liaison Group (MALG) referred to above. The agreed remit for this group is to provide a regular forum for discussion of current issues in medicines advertising control.

The Agency does not get involved in investigations carried out by the PMCPA in order not to compromise their independence, although the Agency does maintain informal links with the PMCPA. The MCA’s policy is to investigate all complaints about advertising which is potentially in breach of the Advertising Regulations. In accordance with powers under regulation 5 of the Medicines (Monitoring of Advertising) Regulations 1994, the Agency will refer to the PMCPA any complaint that appears to be a breach of the Code of Practice for the Pharmaceutical Industry that does not appear to breach the Regulations. The Agency may also at its discretion refer to the PMCPA other cases, but does not routinely do so.

With regard to your questions concerning Seroxat, my letter of 13 November in response to yours of 12 October 2002 covered these issues. A copy is attached.

The MCA has not received a complaint about GlaxoSmithKline’s promotion of Seroxat and therefore has not conducted an investigation into the matter referred to in your letter of 12 October. We were, however, aware that this was being investigated by the PMCPA and the Agency provided evidence of the views of the Committee on Safety of Medicines (CSM) to aid the PMCPA enquiry, in response to your letter of 9 September. A copy of this letter is attached. The MCA, advised by CSM, has also reviewed the product information for Seroxat to ensure it reflects the current evidence in relation to withdrawal reactions.

Finally, I turn to the Independent Review Panel (IRP) for Advertising. An IRP was constituted to consider one case but the company withdrew on the eve of the hearing so the case was not considered by the Panel. Members of the IRP have, however, visited the MCA to familiarise themselves with advertising regulations and to undertake training.

Members of the medicines advisory bodies including the Independent Review Panels are required to follow a Code of Practice relating to declarations of interests in the pharmaceutical industry. Both the Code and the individual details of members’ interests are published annually in the Advisory Bodies’ Reports ~Medicines Act Advisory Bodies -Animal Reports for 2001 was published in July 2002 and is available from the Medicines Control Agency (MCA)). These reports are also available on the MCA’s website at www. mca.gov. uk.

The Code of Practice specifies different types of interests, how they must be declared by members and indicates what action the Chairman should take in various circumstances. Members of the Medicines Act Advisory Committees are professionals of the highest standing in their fields and most Committees (including the IRP) also have lay members.

The pharmaceutical industry funds much of the research in leading scientific academic departments and it would not be possible for these committees to have a membership of the necessary scientific expertise without some members having interests. Indeed, the Medicines Act actually requires the Medicines Commission to have at least one member with "wide and recent experience of and shown capacity in" the pharmaceutical industry. However, the Code of Practice followed by these committees is extremely robust and is fully enforced at each meeting to ensure the integrity of the advice given to Ministers by those committees.

We have not yet had to deal with any conflicts of interest in IRP cases but we are aware of the potential for such specific problems relating to conflicts of interest to arise. However, not all members of the Panel sit at the same time to consider a matter. A panel for a hearing will usually consist of the Chairman and only two other members. In most cases, therefore, it should be possible to select a panel which will not hold any interests in the company under review. If, however, we do find ourselves in a situation where we cannot select a panel from the current list of members, then we are permitted to choose members from another Panel or from a list of expert advisors available to us. Potential sources include the members of the Independent Review Panel for Borderline Products and the list of CSM members and experts. Details of the membership of both these are published on the MCA website.

Yours sincerely
DR J M RAINE,
Director, Post-Licensing Division

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List of correspondence with MCA/CSM