IP, IT & Life Sciences

Advertising of Medicinal Products in Austria - Recent Developments

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?

Introduction

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 Con­duct 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 world­wide. Sup­port­ers of DTCA see a poten­tial to fos­ter a sense of patient empow­er­ment and increase their aware­ness of dis­eases and avail­able treat­ments. Crit­ics, how­ev­er, con­tend 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 avail­able 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 pro­posed 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 health care professionals

Accord­ing to the lat­est amend­ment to the AMG, adver­tis­ing of med­i­c­i­nal prod­ucts to health care pro­fes­sion­als must com­ply 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 com­ply 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 (non-prescription) medicinal products by mail to Austria, but under the AMG, Austrian pharmacies may not sell by mail. This discriminates against Austrian pharmacies.

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