Limited Swiss Pre-Approval Requirement For Pharmaceutical Advertising

Author:Ms Delia Fehr-Bosshard (VISCHER AG)
Profession:Global Advertising Lawyers Alliance (GALA)
 
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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...

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