Recently, more and more questions have arisen about where to draw the line between simple information and advertising a medicinal product. Where does information end and advertising begin? What are the criteria for demarcation?
Advertising pharmaceutical products is subject to strict restrictions in Austria. Advertising medicinal products in Austria is governed by the Medicinal Product Act (Arzneimittelgesetz; AMG), the Unfair Competition Act (Gesetz gegen den unlauteren Wettbewerb; UWG), Section 351g paragraph 5 of the General Social Security Act (Allgemeines Sozialversicherungsgesetz; ASVG) and the Austrian Pharmaceutical Industries Association's (Pharmig) Code of Con duct in its current version of 1 July 2009.
The AMG differentiates between direct-to-consumer advertising (DTCA) and advertising to health care professionals.
Direct-to-consumer advertising – advertising or information?
Advertising to the general public medicinal products that are only available with a prescription is currently prohibited in Austria.
DTCA is permitted only in the US and New Zealand. DTCA is controversial world wide. Supporters of DTCA see a potential to foster a sense of patient empowerment and increase their awareness of diseases and available treatments. Critics, however, con tend that advertisements may mislead consumers. Opponents also argue that misinformed patients will demand the most heavily marketed drugs and will not choose products reasonably.
The European Commission believes that, "The time has come to improve the quality of information avail able to patients on medicinal products and that the balance between the benefits and risks of providing information indicates the need for clear rules that apply to information, ensuring its objectivity and avoiding any promotional character." In December 2008, the Commission pro posed a directive on information to the general public about medicinal products subject to medical prescription. According to the proposal, patients should get access to information on medicines and DTCA should remain prohibited for medicinal products only available via prescription. The proposal also tries to provide criteria for distinguishing between information and advertisement.
But is it really possible to establish clear boundaries between advertising and information?
Advertising to healthcare professionals
According to the latest amendment to the AMG, advertising of medicinal products to health care professionals must com ply with the summary of product characteristics (SPC) and may not contain statements or illustrations not compatible with the SPC. Directive 2001/83/EC provides that the advertising of a medicinal product must com ply with the particulars listed in the SPC.
In its decision C-249/09 of 5 May 2011, the ECJ held that advertisements may not be contrary to the information in the SPC, but that it is not required "that all the claims in such advertisements are included in that summary or can be derived from it."
Thus, due to the clarification of the ECJ, the latest amendment to the AMG regarding Art 50a para 3 No 3 AMG has been de facto overruled.
Sale of medicinal products by mail (Versandhandel)
In a recent decision, the Supreme Court of Austria held that pharmacies in the EU may sell medicinal products by mail to Austria if these products are not only available via prescription and are for personal use only. The prohibition in the Austrian AMG is contrary to the free movement of goods under Article 28 of the EC Treaty, if it applies to non-prescription medicines.
So pharmacies in other EU countries may sell (non-prescription) medicinal products by mail to Austria, but under the AMG, Austrian pharmacies may not sell by mail. This discriminates against Austrian pharmacies.
Misleading and comparative advertising
Advertising must be assessed under the provisions of the UWG in Austria. Again, the question arises whether a clear distinction between advertising and information can be made. According to a recent ECJ decision (C-316/09, 5 May 2011), simply communicating information with the assistance of a passive presentation platform should not be considered as advertising.
The future will show whether further provisions can clarify where to draw the line between advertising and information of medicinal products.
"Pharmacies in other EU countries may sell (nonprescription) medicinal products by mail to Austria, but under the AMG, Austrian pharmacies may not sell by mail. This discriminates against Austrian pharmacies.
This article was originally published in the schoenherr roadmap`13 - if you would like to receive a complimentary copy of this publication, please visit: pr.schoenherr.eu/roadmap.
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