Updates in the ethical rules – how are pharmaceutical companies affected?

At the end of September this year, several updates to the Ethical Rules for the Pharmaceutical Industry in Sweden (LER) entered into force. The rules are binding on member companies of the Swedish Association of the Pharmaceutical Industry (Lif). While the rules have previously been updated at relatively frequent intervals, a longer period has now passed since the last amendments were made. In this article, Setterwalls summarises the changes and their impact on pharmaceutical companies.

No minimum information requirement in patient materials for prescribed medicinal products
LER states requirements regarding what information must be provided to the public in written medicinal product information, known as “minimum information” or “mandatory information” (Sw. minimiinformation). In the new version of LER, patient brochures and other types of aids distributed by healthcare professionals to patients who have been prescribed a prescription-only medicinal product are excluded from this requirement.  As a result, the new version only specifies the minimum information that must be provided in advertising for over-the-counter medicinal products to the public. According to Lif, the rationale is that the purpose of patient brochures and other aids is to support the patient in their treatment and not to market a medicinal product—they are provided to patients who have already been prescribed the product. Therefore, the materials do not constitute advertising, and they are distributed by healthcare professionals.  However, Lif states that essential information for patients should still be included in patient brochures and other aids, along with a clear instruction to read the package leaflet carefully.  A product logo may appear to a moderate extent in such materials to help patients recognise their medicinal product.  The update is to be implemented when the material is reprinted, or by 29 September 2026 at the latest.

This change may simplify the way patient brochures and similar materials for prescribed medicinal products are developed.

Only marketing materials to be provided as statutory copies
The Swedish Pharmaceutical Industry’s Information Examiner Committee (IGN) part of Lif is tasked with monitoring the commercial information about medicinal products provided by companies, and reviewing and assessing potential rule violations.  To enable IGN to perform this function, pharmaceutical companies must submit to IGN new marketing materials (such as brochures, advertisements, invitations, mailings, commercial films, or information on websites), or previously submitted marketing materials, including material updates. In prior versions of LER, companies were instructed to submit up-to-date medicinal product information.

LER has now been amended to clarify that only marketing materials—and not materials where the purpose is not to market medicinal products—are to be submitted to IGN. The reason for the update was that Lif was receiving a significant volume of material that was not for marketing purposes.

The aim of the change is to clarify which materials must be submitted to IGN.

Extended reporting period for collaborations
Collaborations between healthcare or organisations/interest groups/the general public and pharmaceutical companies are subject to a requirement for public disclosure. As a result, rules require collaborations to be published in Lif’s cooperation database. In the past, collaborations had to be reported once the agreement had been signed, and no later than on the day on which the project or activity commenced. In many cases, IGN has found companies to be in breach, where reporting was only provided after commencement.

Under the new rules, the reporting period is extended to no later than three months after the start of the project. According to Lif, the change is warranted because the purpose of reporting is transparency regarding the activities of companies, but many have found it difficult to report on the same day because of varying internal processes, for example. The change is therefore considered necessary. It constitutes a relief for companies and should make them better able to meet transparency requirements.

How transfers of value are to be disclosed
Direct and indirect transfers of value made by a pharmaceutical company to, or for the benefit of, a recipient must be documented and publicly disclosed by the company. Reporting must be carried out according to a template annexed to LER.

Lif is a member of the European Federation of Pharmaceutical Industries and Associations (EFPIA). EFPIA has introduced new reporting requirements and, accordingly, LER has been amended to comply. This means that the structure in EFPIA’s “Template of the methodological note structure” must be used. The publication must also include a summary of the methods used for the report. This applies as of 2026 to disclosures of transfer of values from 2025.

Furthermore, the report shall, as a minimum, be searchable by recipient name, and downloadable. This will be mandatory from the publication in 2027 regarding disclosure of transfer of values from 2026.

The changes mean that pharmaceutical companies must revise their procedures in this area.

Removal of the chapter regarding bribes
It may also be noted that LER previously included a chapter regarding bribes that referenced the Swedish Penal Code, where Lif stated that such matters are subject to public prosecution and are not to be handled within the pharmaceutical industry’s system of self-regulation. Lif has removed this chapter on bribery precisely because sanctions are not handled within the pharmaceutical industry’s system of self-regulation.

Conclusion
The majority of the changes are designed to facilitate compliance for member companies through modernisation and clarification. It is now up to pharmaceutical companies to update their internal procedures, both to benefit from and comply with the new requirements.