Introduction
The government recently gave an assignment to the Swedish Medical Products Agency (the agency) to review the possible use of substance names for prescriptions, rather than the trade name of a medicinal product. More specifically, the agency has been assigned to prepare for substance names to be included in the register that it provides to the Swedish eHealth Agency regarding medicinal products, and that are used for prescribing and dispensing these products.
Substance name-based prescribing means that prescribers no longer prescribe the medicinal product by its trade name, and thereby a specific brand, but rather the desired substance regardless of its manufacturer. It would then be up to a pharmacist to, under the relevant law, decide which medicinal product containing the relevant active ingredient to give the patient.
The idea is for the agency to create: standardised designations for the substances to simplify the process and increase the convenience of the patients; and a uniform labelling model, regardless of the pharmacy operator. Since there exist detailed provisions regarding the prescription and dispensation of medicinal products, including mandatory substitution to generic products, the government found it appropriate for the agency to review the current regulatory framework to propose changes that are necessary to its own, or other competent authorities’ regulations, to accommodate generic prescription. This includes the Dental and Pharmaceutical Benefits Agency, the Swedish agency for pricing and reimbursement of medicinal products.
Substance names
The agency must investigate how to present substance names during the different phases of prescription, distribution and the process of follow ups with patients. To achieve this, the government has asked the agency to look over and prepare the necessary changes to its IT support needed to enable the necessary information to be entered in the relevant places in its systems and registers
