Medicines Control Agency (Hansard, 9 December 1998)

§ The Parliamentary Under-Secretary of State, Department of Health (Baroness Hayman)
My Lords, the Medicines Control Agency is consulting on its proposals to introduce a statutory process for classifying products as medicines. Following 935 consideration of the comments received, Ministers will consider whether and what legislative proposals will be put before Parliament.

Earl Baldwin of Bewdley
My Lords, I am grateful to the noble Baroness for that reply and the proposal for a statutory basis is certainly welcome. Is she aware, however, that there have been recent concerns about the MCA moving the goal posts in this contentious area and that the new proposal provides, and I quote, that, in any legal proceedings, a final decision"— that is, by the MCA— at the end of the process that a product was a medicinal product would he sufficient evidence that it was a medicinal product"? In other words, even in a court of law the agency is to be prosecutor, judge and jury in the very area that has been causing concern. Surely that cannot be right.

§ Baroness Hayman
My Lords, we are in the process of consulting on the proposals. We are very willing to listen to representations. I am grateful for the noble Earl's welcome and for his request for some clarification of the process in this complex area of the law. Perhaps I may reassure him that we are not in any way moving the goal posts or changing legal definitions. We are trying to ensure that there is an opportunity for manufacturers in particular to challenge judgments about whether something is or is not, under the law, a medicinal product. On the point about the decision being final in court, nothing that is proposed will in any way take away from manufacturers the possibility of contesting classification in either the civil or criminal courts or, indeed, of seeking a judicial review of the MCA's decisions.

§ Lord Clement-Jones
My Lords, will the Minister explain why the period of consultation by the Medicines Control Agency is so short, lasting only from 6th November to 31st December? Will her department consider extending the period of consultation beyond 31st December?

§ Baroness Hayman
My Lords, I believe that the period is within the generally accepted range for consultation. However, I recognise that it coincides with the Christmas period. Although I would not encourage people to be dilatory in responding, by the same token I would not like to suggest that we would not consider responses received within a reasonable time after the close of the consultation period.

§ Baroness Gardner of Parkes
My Lords, vitamins which are currently classified as "food supplements" presumably carry no VAT, but if certain items are reclassified as "medicines", will that change their status? Will all items classified as "medicines" require a prescription or will people still be able to buy simple medicines over the counter, as now?

§ Baroness Hayman
My Lords, it is not intended, under the proposals, to change the status of medicines or their classification which at present is subject to European and UK law. The question of whether a 936 medicine is a licensed medicine, an exempt medicine, a food supplement or, indeed, a cosmetic product is complex. It is because there are disputes around such borderline substances that we are trying to put in place a process of classification which is more transparent and which makes it easier for people to challenge the initial decisions of the MCA. I can reassure the noble Baroness that there is no desire to change the classification of food supplements or their status.

The Earl of Clanwilliam
My Lords, there are considerable efforts afoot on the part of Pharma Cartel to pressure the Codex Alimentarius Commission of the United Nations to outlaw information on vitamins and other natural products on the pretext of consumer protection. Is not that a form of censorship? Is the Minister aware that there is a further plan afoot by Pharma Cartel to have vitamins registered as medicines and thereby subjected to product licences and disproportionate costs, thus eliminating them from chemists' shelves?

§ Baroness Hayman
My Lords, the UK's position has been quite clear: we do not believe that there should be limits on the vitamin and mineral content of supplements on anything other than safety considerations. We should like still to be available as food supplements those products which are classified as safe.

§ Lord Pearson of Rannoch
My Lords, can the noble Baroness assure the House that the review panels referred to in the MCA's consultation letter of 6th November will, indeed, consist of experts who not only know the products in question well, but who do not represent the huge pharmaceutical interests which bear down upon this issue?

§ Baroness Hayman
My Lords, I hope that I can reassure the noble Lord. It is considered that the review panel needs to have a majority of expert members who are chosen for their knowledge and experience. As a rule, they will be MCA medical and pharmaceutical assessors. Exceptionally, an external assessor would be enlisted if in-house expertise were not available.