Switzerland: Limited Swiss Pre-Approval Requirement For Pharmaceutical Advertising

Abstract

The Swiss Agency for Therapeutic Products ("Swissmedic") changed its practice regarding the requirement of pre-approval of advertising for certain categories of medicinal products in print as well as in audiovisual media. Since January  1st, 2017, pre-approval is only required for advertising those analgesics, sleeping drugs, sedatives, laxatives and anorectics with a potential for abuse and addiction.

Current pre-approval requirements depending on media channel

Switzerland is not part of the European Union and regulates advertising independently. Advertising pharmaceuticals to the public in Switzerland is only allowed for medicinal products available without prescription (art. 2 para 1(b) of the Swiss Federal Act on Medicinal Products and Medical Devices). In case of violations of advertising regulations, Swissmedic can, among other measures, seize advertising material, temporarily or permanently prohibit advertising for certain products and impose fines of up to CHF 50'000 or CHF 100'000 if committed in professional capacity.

Before 2014, Swiss law required pre-approval by Swissmedic of public advertising for three categories of drugs through certain media channels (art. 15(a) and (c), art. 23 para. 1 of the Swiss Ordinance on Advertising for Medicinal Products):

  • Print as well as audiovisual advertising for analgesics, sleeping drugs and sedatives, laxatives and anorectics ("sensitive medicinal products");
  • Ads on the radio, on TV or in movie theatres for medicinal products in supply category C (e.g. certain dosages of ibuprofen, hydrocortisone, codeine, certain flu and cough drugs, nose sprays etc.), which products can be supplied only by pharmacies and after technical advice from (regulated) medical staff; and
  • Ads on the radio, on TV or in movie theatres for medicinal products in supply category D (e.g. certain dosages of paracetamol, certain eye drops etc.), for which products the required technical advice does not necessarily have to be provided by medical staff.

The Swiss Federal Administrative Court found the pre-approval practice to be too strict and expressly limited the scope of the requirement for advertising of sensitive medicinal products to those products with a potential for abuse and addiction (Decision no. C-2220/2010 from November 4, 2013). This decision was aimed at advertising in print media, on the internet and through electronic displays as well as through audiovisual media. As a consequence, Swissmedic limited the scope of mandatory approval accordingly in 2014 for said media channels. The separate pre-approval requirements for ads on the radio, on TV or in movie theatres for pharmaceuticals in categories C and D remained unchanged.

Advertising regulation to become less media-dependent

In 2016, Swissmedic decided to adjust its pre-approval practice entirely, arguing that consumers tended to increasingly search for information on pharmaceuticals online and that the mandatory pre-approval of radio, TV and movie theatre spots for products in categories C and D was therefore no longer adequate (either). Mandatory pre-approval for ads in print as well as in audiovisual media is now limited to the group of sensitive medicinal products with potential for abuse and addiction.

Consumer protection demands for more regulation online

Swiss law does generally not require pre-approval of advertising, thus, the requirement under pharmaceutical advertising law was already very particular compared to the rest of Swiss advertising law. Consumer protection organizations fear that the limitation of the requirement may increase the risk of misleading advertising. Acknowledging that online search for information has become more common, they demand stricter regulation of online advertising instead. Their main argument is the stronger disciplinary effect of the pre-approval requirement on advertisers and authorization holders compared to the post-control regimes in pharmaceutical advertising regulation and unfair competition law.

Upcoming changes in advertising regulation

Besides this short-term adjustment, the Swiss regulator is currently working on redrafting the requirements for information on pharmaceuticals, their supply categories as well as reorganizing market surveillance in this field. Changes in the Federal Law have already been adopted by the Swiss parliament, but the relevant provisions of the more detailed ordinances need to be adjusted. Updates on advertising regulations for medicinal products can be expected in 2017/2018. 

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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