Marketing of prescription drugs in Sweden

Is it legal to advertise prescription drugs, RX, in Sweden?

Yes, it is allowed to advertise prescription/RX drugs. However, according to the Swedish legislation it is only permitted to direct the marketing to healthcare professionals, such as doctors, nurses, pharmacists and veterinarians.

The law is intended to promote the effective use of the drug through objective, up-to-date information for those qualified to asses it.

Direct-to-consumer adversing (DTC) for a specific prescription drug or treatment is forbidden by law.

Marketing of non-prescription Drugs, OTC

Advertising for non-prescription drugs, OTC (over the counter), is allowed in Sweden. The information may also be directed to the public under strict rules to safeguard consumer safety.

The advertisement must not mislead the consumer to believe that the drug has other characteristics than those underlying the product’s approval (spmc) at the Swedish Medicines Agency.

It must be clearly stated that the product is a medicine and that the message is in fact advertising. There should also be an invitation to read the full drug information leaflet that accompanies the product.

The Medical Products Agency interprets the pharmaceutical law

The Swedish Medical Products Agency’s regulations on the marketing of medicinal products for human clarify the requirements in the Medicines Act.

Advertising must be supported by the Summary of Product Characteristics

The regulations state, among other things, that the marketing of a drug must comply with the information in the Summary of Product Characteristics (spmc).

Advertising and other information is only allowed to describe the actual characteristics for which the product is registered. Claims about the product’s properties and effects need scientific evidence with references available.

This applies regardless of the advertisement media; website, newspapers, in radio or television commercials.

The Swedish Medicines Agency reviews the advertisement

The Swedish Medical Products Agency (MPA) is the Swedish national authority responsible for regulation and surveillance of the development, manufacturing and marketing of drugs and other medicinal products. Their task is to ensure that both the individual patient and healthcare professionals have access to safe and effective medicinal products and that these are used in a rational and cost-effective manner.

The Medical Products Agency reviews advertising for medicines in all media, such as television, radio, internet, medical journals, newspapers and weekly press. The Medical Products Agency also receives tips from corporations, healthcare professionals and citizens. If the Medical Products Agency assesses that the marketing does not comply with the rules, the responsible company can be contacted and asked to change or terminate the incorrect advertisement.

IGN and NBL examine that pharmaceutical companies comply with the rules

The Information Surveillance Board (Informationsgranskningsnämnden, IGN) and the Committee for Medicinal Products Assessment (Nämnden för Bedömning av Läkemedelsinformation, NBL) also act to ensure that pharmaceutical companies maintain the ethical and objective marketing requirements.

The tasks of the boards are, to continuously review that the pharmaceutical information of the companies is in accordance with good industry practice.

Notifications to IGN may come from other pharmaceutical companies that disagree with the given informatio. Notifications may also come from individuals, healthcare professionals or initiated by IGN themselves.

What if the rules are violated?

A violation of LIF’s ethical rules may result in the pharmaceutical company having to pay a fine to LIF. The fine is based on the degree of violation and can be up to SEK 500,000.

The Medical Products Agency may also announce injunctions and prohibitions associated with a fine.

Education suitable for managers and agencies

With the right knowledge, pharmaceutical companies need not make unnecessary advertising mistakes. Training courses are available to provide knowledge about the rules regarding appropriate marketing of drugs in Sweden. For example the LIF training or IMA course.

A good insight and experience of drug communication is a way to ensure that the information is safe for consumers and patients.

 

Sources and information

Pharmaceuticals Act: http://www.riksdagen.se/en/documents-lags/documents/svensk-forsamlingssamling/lakemedelslag-2015315_sfs-2015-315#K12

Swedish Medicines Agency’s Constitution: https://lakemedelsverket.se/upload/lvfs/LVFS_2009-6.pdf

Pharmaceutical Industry Association, LIF: https://www.lif.se

 

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Due to the regulations on pharmaceutical information, we do not display any cases for prescription drug on our website. If you are interested in seeing any case for RX please contact us: info@fwd.se or 08-441 13 40.