§ Mr. HainTo ask the Secretary of State for Health (1) what consultations she undertook with organisations representing consumers and practitioners of herbal medicines prior to drafting the proposed Medicines for Human Use (Marketing Authorisations, Pharmacovigilance and Related Matters) Regulations;
(2) if she will make a statement on the future availability of herbal medicines; and if she will indicate in particular the effect upon that availability of the implementation of (a) the proposed Medicines for Human Use (Marketing Authorisations, Pharmacovigilance and Related Matters) Regulations and (b) the implementation of any other European directives which have been agreed, which are being negotiated, or which are expected in the near future;
(3) which sections of the Medicines Acts currently exempt certain herbal medicines from the requirement to obtain a product licence; by which procedure products are exempted; and if she will take steps to ensure that such exemptions are sustained when she brings forward for consideration and implementation (a) the proposed Medicines for Human Use (Marketing Authorisations, Pharmacovigilance and Related Matters) Regulations and (b) the implementation of any other European directives which have been agreed, which are being negotiated, or which are expected in the near future.
§ Mr. SackvilleI will write to the hon. Member.
Mr. TreddinnickTo ask the Secretary of State for Health (1) if she will list those herbal products which are currently exempt from the requirement for a product licence under the terms of Medicines Acts and which would become unavailable should the European Community bring forward harmonisation procedures following the acceptance of the provisions of the proposed Medicines for Human Use (Marketing Authorisations, Pharmacovigilance and Related Matters) Regulations;
(2) if she will list those organisations specialising in herbal medicines which were consulted about the proposed Medicines for Human Use (Marketing Authorisations, Pharmacovigilance and Related Matters) Regulations; and what steps she is taking to ensure that such organisations are routinely consulted on future occasions;
1278W(3) what information she has concerning the number of individuals in the United Kingdom who currently use herbal medicines; what information she has to suggest that there is a serious health risk posed by the use of such medicines; upon what basis she believes legislation in this area is necessary; and if she will make a statement.
§ Mr. David NicholsonTo ask the Secretary of State for Health (1) what consultations she undertook with right hon. and hon. Members prior to the drafting of the proposed Medicines for Human Use (Marketing Authorisations, Pharmacovigilance and Related Matters) Regulations; and what steps she will take to ensure that such consultations are undertaken in future;
(2) what information she currently has about the average cost associated with the supply of all necessary information and research data by a manufacturer in connection with an application to the Medicines Control Agency for a product licence; and what assessment she has made of the implications of such expenses for the suppliers of herbal medicines should such products be brought within the scope of the licensing regime either through the implementation of the proposed Medicines for Human Use (Marketing Authorisations, Pharmacovigilance and Related Matters) Regulations, or subsequent harmonisation moves by the European Community.
(3) what steps she intends to take to guarantee the availability of herbal medicines within the United Kingdom should the European Community bring forward moves towards harmonisation in the availability of such products following the implementation of the proposed Medicines for Human Use (Marketing Authorisations, Pharmacovigilance and Related Matters) Regulations, and the implementation of any other European directives which have been agreed, which are being negotiated, or which are expected in the near future.
§ Mr. SackvilleI will write to my hon. Friends.