§ Mr. HeppellTo ask the Secretary of State for Health if Hoechst Roussel Ltd. sought to make it a condition of its licence to supply Norplant in the United Kingdom that its use be restricted to specially trained and experienced doctors. [3127]
§ Mr. MaloneApplications from companies for licences are confidential under section 18 of the Medicines Act.
Training of doctors in the use of a device such as a Norplant implant is a matter for the professional bodies, in this case the Royal Colleges of Obstetricians and Gynaecologists and of General Practitioners.
The Royal College of Obstetricians and Gynaecologists has recently introduced a scheme for recognition of training in the insertion and removal of Norplant and this includes the company training scheme. The product information is therefore being changed to add to the recommendation that Norplant is inserted and removed by a trained health professional.
§ Mr. HeppellTo ask the Secretary of State for Health what plans he has to revoke the licence granted to Hoechst Roussel Ltd. to supply Norplant in the United Kingdom. [3126]
§ Mr. MaloneThe licensing authority has no such plans. Like all hormonal contraceptives, Norplant has hormone-related side effects, which may lead to a need to discontinue this method of contraception. The product literature informs doctors and patients of these known side effects.