Proposed Regulatory Changes Related to the Marketing of Pharmaceuticals

The Norwegian Medicines Agency (NOMA) has proposed an audit of the Medicines Regulation chapter 13, mainly for the purpose of alignment with the structure of Directive 2001/83/EF art. 86-100 which regulates the marketing of pharmaceuticals, but also for the avoidance of deviations between the interpretation of the Norwegian Medicines Regulation and the Directive. However, the audit encompass some material changes to the current Medicines Regulation. NOMA proposes:

  • That radiographers and nutrition physiologists are incorporated into the professional groups defined as health personnel and thus the group who may receive advertising for prescription drugs according to the Medicines Regulations chapter 13.

  • That all marketing material, regardless of platform and design, and thus not only written material, should be made available to NOMA prior to implementation.

  • To remove the current access for NOMA to issue a permanent marketing ban. As NOMA deem a permanent marketing ban to be an administrative penalty, only temporary bans should be available.

  • To remove the opening for the pharmaceutical industry to establish its own supervising council body which may sanction violations of the Medicines Regulation. Since 2015 there has been no voluntary industry council and the sited regulation has not been in use. NOMA now propose to remove the clause entirely as neither NOMA believes it desirable to uphold the possibility for a voluntary industry council to govern the Medicines Regulation.

  • Wider access for the industry to prepare and distribute material oriented towards patients. According to the current Medicines Regulation, "marketing" of prescription drugs are illegal towards the public. NOMA proposes that patient-oriented drug information shall fall outside the definition of marketing if: (i) The material is related to active substance, not product name, trademark or logo. (ii) The material is solely be used by patients using generic or biotensive drugs. (iii) The material is to be accessible via a common electronic platform. (iv) The sender's name and contact information is to be clearly displayed on the material. (v) The sender shall not have direct contact with the patient and (vi) the information may be made available or provided by prescriber or pharmacist.

 The proposal of NOMA are currently distributed for a public hearing. The deadline for comments is 4 January 2019.