The Norwegian Medicines Agency has proposed changes which would open for information on health and disease from the pharmaceutical industry to the general public. A proposal for the repeal of a provision which enables the Agency to derogate from the rules for pharmaceutical advertising has also been presented.
Pharmaceutical advertising is governed by chapter 13 of the Medicinal Product Regulation, which implements the corresponding rules of Directive 2001/83/EC. However, section 13-12 of the Regulation grants the Norwegian Medicinal Agency (the Agency) the authority to make exemptions from the provisions of chapter 13, based either on public interests or considerations of patients' safety or health.
Generally speaking, section 13-12 has usually been applied in three circumstances:
- To allow participation for certain groups of healthcare personnel (HCP) to information meetings held by the industry. According to section 13-7, advertising may only be directed towards certain groups of HCPs, such as physicians, dentists, veterinarians, pharmacists etc. For the participation of other HCPs at such meetings, an exemption must be made. The Agency has approved such exemptions provided it is deemed as relevant in a professional matter for the healthcare personnel.
- Information material made by a pharmaceutical company which provides information on a prescription medicinal product to patients. Such information is deemed as advertising, and generally not allowed.
- Information material supplied on therapeutic areas to the general public (disease awareness campaigns). If the company markets product within such therapeutic areas, the Agency's traditional practice has been to view such material as advertising.
Thus in order to supply patients or the general public with e.g. patient brochures, a pharmaceutical company would have to apply to the Agency for a derogation with basis in section 13-12. The Norwegian Agency has interpreted section 13-12 extremely strictly, particularly concerning promotional materials such as patient brochures, and has not allowed such material unless the material has been considered to fulfil an unmet need. This strict practice has also resulted in several administrative complaints to the Ministry of Health and Care.
The proposed amendments
The Agency has recently proposed that section 13-12 should be repealed. If this derogation provision is repealed, it will no longer be possible for the pharmaceutical industry to apply for other groups of HCPs to attend information meetings which concern treatment of prescription medicinal products.
At the same time, the Agency has also proposed a new guideline which provides assistance on the interpretation for when a statement relating to human health or disease does not directly or indirectly refer to medicinal products, and thus falls outside the scope of the rules of advertising, cf. section 13-1 second paragraph letter c.
By providing guidelines, the Agency clarifies whether they consider statements as advertising or solely information related to human health or disease. The proposal thus opens for a pharmaceutical company to inform the general public and patients on therapeutic indications where they market medicinal products, provided that the material is in compliance with the guidelines.
Several requirements for the interpretation of when a statement falls outside the scope of pharmaceutical advertising are found in the consultative document. In short, the following criteria apply for the information:
- precise: the information must be medically correct, easy to understand and adjusted for the general public
- up-to date: all printed material shall be dated and medically up-to-date
- verifiable: references to professional literature or other scientific sources must be included
- adequately comprehensive: the information must provide all the most important aspects with a disease and not only selected aspects
- balanced and fair: the presentation of the disease or the consequences shall not raise unnecessary concern, the presentation of the management of the disease shall be balanced and correct, focus on risk factors must be balanced, and the presentation shall not improperly emphasise the need for treatment
- readable: the language must be easy to understand with a suitable design
- source identified: all printed material shall name the company as originator, but the company shall not be the main focus of the presentation
Furthermore, it is a criterion that there are no indications that treatment with medicinal products is available. It is also emphasised that the requirements apply regardless of technological platforms or media.
The proposed action from the Agency is likely both an effort to provide clearer rules in a rather challenging field for the pharmaceutical industry, as well as an effort to redirect the Agency's work resources from management of application towards supervision of promotional material. The action will likely lead to an increase in disease awareness campaigns from the pharmaceutical industry. It is expected that the Agency will monitor such campaigns closely to assure compliance.
While the initiative from the Agency to allow pharmaceutical companies to make statements concerning therapeutic indications of within their commercial interest areas will be welcomed by the industry, the proposed requirements are still rather strict. It remains to be seen if the final guidelines are more comprehensive. The descriptions of the requirements mentioned in the proposal are ambiguous at best, and further clarification is desired.
The deadline for submitting comments to the proposal is set to 2nd October 2014.