Supervision of pharmaceutical marketing

Supervision of pharmaceutical marketing, text 1/2

Supervision of marketing promotes the correct and safe use of medicines

According to the Medicines Act, pharmaceutical marketing must encourage the appropriate use of medicines. Marketing must not be inappropriate or attract the general population to use the medicine unnecessarily. Fimea supervises pharmaceutical marketing in accordance with the norms in the Medicines Act and Decree. The marketer is expected to be familiar with the norms in force in Finland.

Principles of compliant pharmaceutical marketing infographic. A text alternative is available below the infographic.

EN Normienmukaisen lääkemarkkinoinnin periaatteet -tekstivastine (Lääkemarkkinoinnin valvonta)

- Legal target group
  - The marketing of prescription medicines is carefully targeted only at those entitled to prescribe or supply the medicine.
- Balanced information content
  - The benefits and risks of the medicine are presented in a balanced and truthful way, in line with the summary of product characteristics.
- Reasonable hospitality
  - Hospitality towards health care professionals is of modest economic value.
- Transparent marketing
  - Acceptable marketing is easily identifiable as advertising. It does not hide its commercial purpose or mislead.

Supervision of pharmaceutical marketing, text 2/2

Fimea provides guidance

Fimea provides guidance on the norm compliance of pharmaceutical marketing to all stakeholders, such as companies, pharmacies, authorities, health care professionals and private individuals. The guidance is advisory and is not an approval or a binding position. More advice can be found under Advice on appropriate pharmaceutical marketing and Frequently asked questions (in Finnish). You can also request guidance using the contact form.

Anyone can report inappropriate pharmaceutical marketing

The supervisory process may be initiated on Fimea’s own initiative or based on an initiative submitted to Fimea. The initiative can be submitted by anyone, such as a health care professional, a company representative, a private individual or another authority. The initiative should describe in sufficient detail the suspicion of a non-compliant advertisement or action. The initiative can be submitted to the registry by e-mail or via the contact form.

Fimea supervises marketing under the Medicines Act and the Medicines Decree

Key aspects of supervision in pharmaceutical marketing include the information content, legal target group and the moderation of hospitality. Supervision takes place after-the-fact.

Fimea sends a notice or request for clarification to the marketer, such as a marketing authorisation holder or a pharmacy, concerning marketing suspected to be non-compliant. The recipient has the opportunity to submit a response, based on which further measures are decided on. After this, the processing of the matter is often closed with Fimea’s reproachful or guiding summary letter. If the processing proceeds to a ban on marketing, the marketer is consulted before the decision is made.

In addition to authority supervision, pharmaceutical marketing is supervised under pharmaceutical companies’ self-monitoring of pharmaceutical marketing. More information on pharmaceutical companies’ self-monitoring on the Pharma industry Finland website.