§ Lord Clement-Jonesasked Her Majesty's Government:
What legal advice they have received in connection with the legality under the Human Rights Act 1998 and the European Convention on Human Rights of the new procedures to be adopted by the Medicines Control Agency under the provisions of the Medicines (Advertising and Monitoring of Advertising) Amendment Regulations 1999 (S.I.267); and whether they will place a copy of all the legal advice given concerning this matter in the Library of the House; and [HL2783]
Under what circumstances a notice, a threat of a notice or a request to cease advertising will be made by Ministers or Medicines Control Agency officials under the Medicines (Advertising and Monitoring of Advertising) Amendment Regulations 1999 (S.I.267); and whether the independent panel will have the right to consider whether such a notice, threat of issue of notice or request has been properly issued; and [HL2784]
How, under the new procedures to be adopted by the Medicines Control Agency under the provisions of the Medicines (Advertising and Monitoring of Advertising) Amendment Regulations 1999 (S.I.267) they will ensure that justice is not only done but is seen to be done and that the critical precedents needed to ensure consistency in future advertising decisions will routinely be made publicly available; and [HL2785]
Whether pre-publication approval of specific advertisements will be routinely undertaken by the Medicines Control Agency (MCA) secretariat; and, if so, how the MCA will avoid pre-approvals by it unduly influencing decisions by the same officials following a complaint after publication of the advertisement on whether that advertisement is in breach of the Medicines (Advertising) Regulations; and [HL2786]
177WAWhether the new procedures to be adopted by the Medicines Control Agency under the provisions of the Medicines (Advertising and Monitoring of Advertising) Amendment Regulations 1999 (S.I.267) give a company to whom the agency issues a notice that it is minded to take action the right to a full oral hearing before the independent review panel at which all evidence can he challenged and questioned. [HL2787]
§ Baroness HaymanWe have clear legal advice that the proposals are compatible with both Community law and the European Convention on Human Rights. To publish the advice itself I would break with the long standing and important principle that legal advice given to Ministers is privileged. This is reflected in theCode of Practice on Access to Government Information (2nd Edition (1997) paragraph 4(d)), which provides that information covered by legal professional privilege, such as counsel's opinion, is exempt from disclosure under the code.
There are specific circumstances under which notices may be issued to advertisers under the procedures in the amending regulations. These are:
- Under paragraph 1—to request a copy of an advertisement;
- Under paragraph 3—to advise an advertiser that health Ministers are "minded to" make a decision that an advertisement is in breach of the advertising regulations;
- Under paragraph 4—to advise an advertiser that an advertisement would not be in breach; and
- Under paragraph 5—to advise an advertiser that, after consideration of the advice of the independent review panel, health Ministers have decided an advertisement is in breach.
Notices under paragraphs 1 or 3 may require an advertiser to cease advertising on an interim basis. At any stage the recipient of a notice can seek judicial review of the decision to issue that notice.
The issue of notices under the schedule will not be automatic. The Medicines Control Agency (MCA) will continue, as now, to discuss problems with advertising with the company concerned so as to secure acceptable changes. There is no provision for, or purpose in, threatening to issue a notice. The formal procedures will come into play only when informal negotiation fails to reach an appropriate outcome.
The remit of the independent review panel will be to consider written representations from advertisers who have been issued with a notice under paragraph 3 and advise health Ministers on the compatibility of the advertisement in question with the advertising regulations. The panel will not consider the issue of notices or other procedural matters. The amending regulations provide for the making of written representations by the company concerned but do not preclude oral hearings where these are considered appropriate by the Panel. We have no objection to the reports of the review panel meetings being made publicly available. Furthermore, the MCA has already established a working group, the Medicines Advertising 178WA Liaison Group, to provide a forum for all regulatory and self-regulatory bodies concerned with the advertising of medicines to exchange information and opinions on advertising issues.
These regulations clarify and strengthen existing procedures in the control of medicines advertising. The MCA undertakes pre-publication assessment of advertising in exceptional circumstances only and has no intention of extending that role. Any opinion given on the suitability of the advertisement for publication is based on the information provided by the company and the current scientific knowledge and is issued without prejudice to any action the MCA may have to take against a future complaint. In the unlikely event that a complaint is received about an advertisement which officials have previously agreed is acceptable for publication the advertisement will be reconsidered taking any new information into account in reaching a decision.