The Federal Office of Public Health has announced that the Federal Board has submitted to Parliament a draft law on therapeutic products which proposes to create an institute for the control of these products. It also suggests solutions to certain problems such as mail order sale of medicines (including Internet) and parallel imports.

Up to now, these products have been regulated at a cantonal level and the Intercantonal Union for the Control of Medicines (UICM) has been trying to set up an agreement that would bring the regulations into line with European Law. The new draft law aims at protecting human and animal health by guaranteeing the registration of high- quality, safe and effective therapeutic substances. As regards medicines, the means foreseen to achieve this goal include a system of marketing approval, surveillance, directives concerning quality and the obligation for manufacturers and wholesalers to have an authorization.

As regards medical devices, quality control measures implemented by the the manufacturer and the distributor are of the first importance since a marketing authorization is not required for medical devices. The role of the control authorities will consist mainly in monitoring the marketing of these products and ensuring that they fulfil the necessary requirements for protection of health and to ensure against fraud.

Sale of medicines by mail order remains prohibited in principal in order to guarantee the safety of products and protect the patient. The reason for this is to prevent, for example, the sale of prescription medicines via the Internet without presentation of a prescription and in the absence of any controls. However, mail order sale of medicines prescribed by a doctor will be permitted if the safety requirements are fulfilled.

The full text is available on request (in French and German).

Reference: Press Release from the Federal Office of Public Health, 1 March 1999.