Importance of Regulations for Advertising Medicines and Medical Devices

Healthcare regulations safeguard public health by ensuring accurate information and ethical marketing. They prevent misleading claims, promote responsible advertising, and require scientific evidence for product claims. This empowers patients with reliable information and protects them from misuse of medications. Regulations also ensure fair competition within the industry.

1. Which laws apply when it comes to promoting medicines and medical devices?

1.1 Medicines

Medicinal Products Act (2015:315)
Medical Products Agency Regulations (LVFS 2009:6)
Marketing Practices Act (2008:4)
Swedish Radio and Television Act (2010:696)

1.2 Medical Devices

Regulation (EU) 2017/745 (MDR)
Regulation (EU) 2017/746 (IVDR)
Marketing Practices Act (2008:4)

2. Are there any additional legislative frameworks or self-regulatory codes of conduct?

2.1 Medicines

Ethical Rules for the Pharmaceutical Industry (LER): Not legally binding but considered to reflect good practice by Swedish courts.

2.2 Medical Devices

Swedish Medtech Guidelines and Regulatory Codes: Apply to member organizations of Swedish Medtech, including provisions on advertising. Violations may lead to warnings, reprimands, or exclusion from the association.

3. What licenses, approvals, or fees are required for advertising medications and medical devices?

3.1 Medicines

Approval for sale is required for advertising medicines to both the general public and healthcare professionals. Advertising unapproved medicines is prohibited under the Medicinal Products Act, Chapter 12, Section 1.

3.2 Medical Devices

There are no specific licenses, approvals, or fees required under Swedish law for advertising medical devices.

4. Does Swedish law govern the advertisement of prescription and over-the-counter medications differently?

Prescription-Only Medicines: Generally prohibited from advertising to the public, except for vaccination advertisements.
Over-the-Counter Medicines: Permitted with certain rules and restrictions.

5. What are the primary limits on promoting drugs and medical devices to the public?

5.1 Medicines

Advertising of over-the-counter medicines must clearly indicate that the communication constitutes advertising and that the product is a medicinal product. The content must not encourage harmful or inappropriate use or discourage people from seeking appropriate treatment.

Advertising must not be directed at children and must promote appropriate use through up-to-date, factual, balanced, and non-misleading information. All advertising must comply with good marketing practices.

Under the Marketing Practices Act, advertising must not be misleading or aggressive and must comply with good marketing practices.

5.2 Medical Devices

According to Article 7 of the MDR and IVDR, advertising medical devices must not:

Ascribe functions or properties the device does not have
Create a false impression regarding treatment, diagnosis, functions, or properties
Fail to inform users of likely risks associated with intended use
Suggest uses other than those stated in the intended purpose

6. What are the primary limits on promoting drugs and medical devices to healthcare professionals?

6.1 Medicines

Advertising to healthcare professionals must comply with the Medicinal Products Act and the Marketing Practices Act. Additional restrictions apply to the supply of samples.

Samples of prescription-only medicines may only be provided to authorized prescribers
Samples of non-prescription medicines may only be provided to authorized pharmacy personnel
Supplying samples to unauthorized professionals is prohibited

Sample supply must meet strict conditions, including written orders, authorization checks, limited quantities, smallest package size, proper labeling, and inclusion of the SmPC.

Medicines classified as narcotics may not be provided as samples.

6.2 Medical Devices

Advertising to healthcare professionals must comply with MDR, IVDR, and the Marketing Practices Act.

According to Swedish Medtech guidelines, gifts must relate to professional practice, benefit patients, and be of nominal value. Product samples may only be provided to healthcare institutions and only to the extent necessary for evaluation.

7. What is the required information for advertisements directed only at healthcare professionals?

7.1 Medicines

Name of the medicine
Dosage form and strength (if applicable)
Generic names of active ingredients
Balanced description of characteristics, indications, and pharmacological group
Warnings and restrictions
Manufacturer or representative contact details
Year of publication or most recent update
Date of SmPC compilation or review
Prescription status (POM or OTC)
Status within the benefits system
Reference to fass.se

7.2 Medical Devices

Advertisements must inform users or patients in a manner consistent with the device’s intended purpose, in accordance with Article 7 of the MDR and IVDR.

8. What information must be included in public-facing advertisements?

8.1 Medicines

Proprietary and generic name (if applicable)
Guidance for proper use and necessary warnings
Clear invitation to read the package leaflet
Manufacturer or representative contact information
Year of publication or last update
Recommendation to consult a physician when treating conditions requiring professional diagnosis

8.2 Medical Devices

Advertisements must provide information aligned with the intended use of the device, in accordance with Article 7 of the MDR and IVDR.

9. Are there any constraints on data used to support promotional claims?

Medicines

Marketing must be up-to-date, factual, and balanced. Scientific references must not be misleading and must accurately reflect study scope, execution, and conclusions.

Contradicted or refuted studies must be cited with caution
Statistical validity must be clear in comparisons
Quotations and data must be accurately reproduced

Medical Devices

Scientific data must not mislead consumers or create false impressions regarding effectiveness or purpose.

10. Are there any rules governing comparative advertising?

Medicines

Comparative advertising must be factual, balanced, and up-to-date. Advertising to the general public must not claim superiority or equivalence.

Medical Devices

Comparisons must not be misleading
Products compared must fulfill the same purpose
Characteristics must be objective, verifiable, and relevant
No confusion, denigration, or unfair exploitation is permitted

11. Internet and social media advertising

Advertising prescription-only medicines to the general public online is prohibited.

All advertisements must clearly indicate promotional intent and identify the responsible company.

12. Oversight bodies and legal consequences

Regulatory Authorities

Swedish Medicinal Products Agency (MPA)
Swedish Consumer Agency (CA)

Sanctions

Prohibitive injunctions with conditional fines (up to SEK 1,000,000)
Market disruption fees (SEK 10,000 to 4% of annual turnover)
Potential MDR/IVDR fines up to SEK 100,000,000
Industry fines up to SEK 500,000 under LER rules

13. Are there any future developments in Sweden?

The upcoming EU Artificial Intelligence Act is expected to introduce strict requirements for AI-based medical devices classified as high risk.

How can OMC help?

Professional review of marketing and advertising materials with reports
Support in obtaining authority approvals where required
Translation of marketing materials by a professional translation agency certified with ISO 17100