Earl Baldwin of Bewdleyasked Her Majesty's Government:
Further to the Written Answers by Baroness Hayman on 4 November (WA 44–45), whether the process by which the Medicines Control Agency reaches a conclusion as to whether a blend of herbs and vitamins is a medicine involves consultation with scientific experts; and if so, which ones. [HL3868]
§ Baroness HaymanWhere the functionality of a product is a factor in whether it should be classified as a medicine, the Medicines Control Agency takes advice from its medical and pharmaceutical assessors.
Earl Baldwin of Bewdleyasked Her Majesty's Government:
Further to the Written Answers by Baroness Hayman on 4 November (WA 44–45), by what means the Medicines Control Agency notifies a manufacturer of its decision to class a product as a medicine; in what format the reasons for that decision are set out; and whether the absence of such stated reasons would invalidate such a decision in law. [HL3869]
§ Baroness HaymanWhen the Medicines Control Agency notifies a manufacturer of a decision to classify a product as a medicine, it does so in writing, setting 173WA out the reasons for its decision. To do otherwise would infringe principles of natural justice. Failure to give reasons does not, however, automatically invalidate a decision. To date, the decision-making process has been conducted on an administrative basis, but the Government now propose to place it on a statutory footing.
Earl Baldwin of Bewdleyasked Her Majesty's Government:
Further to the Written Answers by Baroness Hayman on 4 November (WA 44–45), whether the Court of Appeal judgment to which they refer was the recent case involving melatonin, which is licensed as a medicine in most other European Union member states; and why, if so, they deem this case relevant to cases of herbal and vitamin blends which are sold under food, not medicines, law in many other member states. [HL3870]
§ Baroness HaymanThe judgment referred to involved melatonin. The court recognised that it is for national authorities, subject to review by the courts, to determine on a case by case basis the classification of each product, and that, at this stage of the development of the Community, complete harmonisation is not possible. This applies to all products irrespective of their ingredients. The Medicines Control Agency considers each case on its merits, applying the tests of whether a product is a medicinal product set out in the Pharmaceutical Directive 65/65.
Earl Baldwin of Bewdleyasked Her Majesty's Government:
Whether they have any plans to meet with representatives of DGIII and DGXV of the European Commission to discuss consumers' right to have access to safe herbal and vitamin blends under food law within the European Union Single Market. [HL3871]
Waiting list numbers (provider based), as at 30 September each year 1993 1994 1995 1996 1997 1998 No. of Months Over 12 Over 18 Over 12 Over 18 Over 12 Over 18 Over 12 Over 18 Over 12 Over 18 Over 12 Over 18 England 71,022 6,527 62,341 4,481 27,938 43 14,993 25 57,666 794 63,480 0 Wales N/A N/A 6,520 1,649 5,246 872 5,303 999 6,547 1,670 9,429 3,304 Scotland N/A N/A 2,136 174 1,197 29 416 3 235 1 N/A N/A Northern Ireland N/A N/A 4,130 1,592 2,507 849 4,474 1,698 10,637 5,466 8,563 5,679 General Notes:
1. Data for September 1998 are provisional. September 1993 data are not comparable.
Specific Notes:
2. Scottish information excludes guarantee exceptions, repeat and deferred waiting lists. Scottish information for 30 September 1998 is not yet available.
174WA
§ Baroness HaymanThere are no immediate plans to do so.
Earl Baldwin of Bewdleyasked Her Majesty's Government:
When the Medicines Control Agency intends to commence its forthcoming consultation exercise about its intention more rigorously to enforce the Medicines Act in relation to herbal remedies and herbal and vitamin blends; what form that consultation will take; whether the consultation will include Consumers for Health Choice; and whether, until that exercise is completed, the Agency will refrain from taking unilateral enforcement action against safe herbal and vitamin blends. [HL3872]
§ Baroness HaymanThe Medicines Control Agency's consultation package was issued on 6 November, seeking responses by 31 December. Copies have been placed in the Library. It proposes to put the decision-making process for classifying borderline products on to a statutory basis. Organisations consulted include "Consumers for Health Choice". In order to protect public health, the agency will continue on behalf of the licensing authority to ensure that, as the law requires, only medicinal products which are licensed, or exempt from licensing, are placed on the United Kingdom market.