§ 2.59 p.m.
§ Lord Clement-Jones asked Her Majesty's Government:
§ What progress they are making in setting up an independent panel to review decisions on advertisements to be made by the Medicines Control Agency under the new Medicines (Advertising and Monitoring of Advertising) Amendment Regulations.
§ Lord Hunt of Kings HeathMy Lords, the Medicines Control Agency issued a consultation letter to a wide range of professional, consumer and industry bodies asking for nominations of suitably qualified members for the panel. The closing date for nominations is 28th May 1999. The Government are aiming to have the panel in place by July.
§ Lord Clement-JonesMy Lords, the Minister is no doubt aware of the strongly held view that these regulations are a classic case of gold plating which gives the Medicines Control Agency and the Department of Health new powers without any evidence at all that they are needed. Does the Minister accept that whatever the eventual composition of the panel, the regulations will not comply with the Human Rights Act? If he does not accept that, will he undertake to publish the legal advice that the department has received; or, perhaps, is the Minister relying on the fact that it seems from recent reports that the Act will not be brought into force until the year 2001?
§ Lord Hunt of Kings HeathMy Lords, the amending regulations make explicit those powers which were implicit in the principal regulations and in the Medicines Act 1968 which provided for health Ministers to be responsible for the control of advertising of medicines. During the drafting of the regulations Ministers sought counsel's advice on the compatibility of the regulations with the European Convention on Human Rights. Ministers were assured that the regulations, even without the review procedure which we have introduced, comply fully with the relevant principles of the convention. In relation to the publication of that legal advice, I understand that that 1087 was debated in another place a week or so ago and that Ministers are considering the point at the moment. The noble Lord's point will be communicated to them.
Earl HoweMy Lords, does the Minister accept that pharmaceutical companies believe that they are entitled to an independent appeal mechanism on decisions made by the Medicines Control Agency and that the proposed review panel will not provide that mechanism? How do the Government intend to make the process transparent and fair?
§ Lord Hunt of Kings HeathMy Lords, I believe that the Government have made this a fair and transparent system. Let me make it clear that the system underpins self-regulation by making the procedures clearer than was the case in the past. Most of the cases dealt with by the MCA will, I believe, be dealt with through negotiation. Only a relatively small number of cases will be dealt with formally. Companies of course have the right to make written representations before final decisions are taken. Those representations will be considered by the independent review panel. In taking the final decision Ministers will pay scrupulous attention to the review panel's recommendations. If Ministers depart from those recommendations, their reasons will be given in writing. The whole process is, of course, open to challenge by judicial review.
§ Lord Pearson of RannochMy Lords, in clarification of his assurance that consumer, professional and industry interests will be represented on this new panel, can the Minister give the House an assurance that consumer interests will be properly represented?
§ Lord Hunt of Kings HeathYes, my Lords. In line with the Nolan recommendations, we are consulting with industry, professional and consumer interests on the nomination of suitably qualified people. As regards the consideration of individual cases, advice will be given by three independent people, comprising those with experience in the practice of human medicine or pharmacy; in the law, with particular reference to medicines or advertising; and a lay person with particular interest in medicines, public health or consumer affairs. I hope that that meets the point that has been made.
The Earl of ClanwilliamMy Lords, is the noble Lord aware that there is considerable concern among the complementary medicines associations that the MCA is liable to confer medicinal status on herbal products? Will he ensure that this does not occur?
§ Lord Hunt of Kings HeathMy Lords, I suspect that the noble Earl refers to what are known as "borderline issues"; namely, the proposals which are currently being considered to clarify the borderline between medicines and other products. That is a separate and distinct issue from the Question on the Order Paper. A review and a consultation process have been undertaken. Ministers will announce a response on this as soon as possible.