Tenor
On the defendant’s appeal, the judgment of the 4th Chamber for Commercial Matters of the Regional Court of Cologne – 84 O 285/17 – handed down on May 4, 2018 is amended and restated as follows
The action is dismissed.
The plaintiff is ordered to pay the costs of the legal dispute in both instances.
This judgment is provisionally enforceable. The plaintiff may avert enforcement by providing security in the amount of 110% of the enforceable amount. 110 % of the enforceable amount, unless the plaintiff provides security in the amount of 100 % of the amount to be enforced prior to enforcement. of 100 % of the amount to be enforced.
The appeal is not permitted.
Reasons
I.
The plaintiff is the known competition center. It has active legitimacy within the meaning of Section 8 para. 3 No. 2 UWG.
The defendant operates a pharmacy through which he offers vaccines, among other things. He advertised these to doctors with a catalog “A Vaccines”. The catalog contained an order form with which the doctor could order “service articles” / application aids – cannulas size 18 (1 pack / 100 pcs.) – free of charge in addition to the vaccines. 18 (1 pack / 100 pcs.), cannulas size 16 (1 pack / 100 pcs.), injection plasters (1 pack / 100 pcs.), alcohol swabs (in a practical box), cannula collector (1.5 L). The pharmacy retail price of these items was between €2.22 and €3.22, and their total value was around €13.00.
The plaintiff claims that this advertising violates Sections 3, 3a UWG in conjunction with Section 7 para. § 7 Abs. 1 HWG and §§ 299a, 299b StGB. In response to a corresponding warning, the defendant agreed to issue a declaration to cease and desist with a penalty clause, but only with regard to the ordering of vaccine doses that are subject to the regulations of the German Drug Price Ordinance. The plaintiff rejected this as insufficient; such a declaration to cease and desist would be meaningless because – which is undisputed – the vast majority of vaccines are not price-bound.
The plaintiff has applied,
I. to order the defendant to cease and desist, subject to the avoidance of a fine of up to € 250,000.00 to be determined by the court for each case of infringement, and in the event that this cannot be collected, alternatively imprisonment for up to 6 months, or imprisonment for up to 6 months,
to advertise vaccines with the granting of “service items” as shown below:
II. order the defendant to pay him € 267.50 plus interest in the amount of 5 percentage points above the respective base interest rate since 19.01.2018.
The defendant has applied,
dismiss the action.
The defendant argued that the promotional gifts were permissible as they were only items of low value. The value limit of €1.00 set by the BGH did not apply in this case, as it did not concern prescription drugs and healthcare professionals were addressed. The wording “please select” makes it clear that the doctor can only select one service item per order process. The low-value limit applies to each individual medicine prescribed. In addition, any influence on doctors as healthcare professionals was simply ruled out.
By judgment dated 04.05.2018, to which reference is made for further details pursuant to Section 540 para. 1 ZPO, the Regional Court granted the claim as requested. The value limit of € 1.00 set by the Federal Court of Justice for benefits to consumers was also to be applied to members of the professional community.
With its appeal, the defendant complains of a violation of the law. The Regional Court failed to recognize that, in the absence of an abstract risk of improperly influencing the doctors addressed, there was already no inadmissible advertising gift under § 7 HWG. In the case of vaccine doses with a value – undisputed in this respect – of € 1,553.00 to € 4,879.00, no corresponding risk emanates from the low-value service items offered. The decision of the Higher Regional Court of Stuttgart referred to by the Regional Court was not transferable to the present case. The decisive factor for the value of the benefit was not the pharmacy retail price, but the normal purchase price from the wholesaler pp. of €1.86 to €2.70. Furthermore, it was a matter of commercially available accessories; the granting of such low-value application aids as an addition to the vaccine doses was within the scope of reasonable commercial practice. Finally, the case law of the ECJ on the inapplicability of fixed pharmaceutical prices to foreign mail-order pharmacies must be taken into account, as a result of which benefits of up to € 30.00 disguised as cash discounts are also granted by the applicant without objection. In this respect, the understanding of low value seems to have changed; it is obviously no longer € 1.00, but significantly higher.
The defendant claims,
set aside the judgment of the Regional Court of Cologne dated 04.05.2018, Ref.: 84 O 285/17, and dismiss the action.
The plaintiff requests,
dismiss the appeal.
He defends the contested decision.
II.
The admissible appeal is well-founded.
The plaintiff authorized to sue pursuant to Section 8 para. 3 No. 2 UWG has no entitlement to injunctive relief under Section 8 para. 1, §§ 3, 3a UWG, neither in conjunction with §§ 299a, 299b StGB. §§ Sections 299a, 299b StGB nor in conjunction with. § Section 7 HWG as market conduct regulations within the meaning of Section 3a UWG.
1. the defendant has not violated the provisions of §§ 299a, 299b StGB. Since pharmacists do not belong to the group of offenders of § 299a StGB (see Fischer, StGB, 65th ed., § 299a para. 5), the defendant himself can only have committed the offence of § 299b StGB, which corresponds to the mirror image of § 299a StGB. The offense in Section 299b StGB is the offering, promising or granting of a corrupt advantage on the basis of an unlawful agreement. The advantage must therefore be accepted, promised or granted in return for a future unfair advantage, and the perpetrator must have the intention to enter into such an agreement; it is not sufficient to offer a benefit to induce general goodwill without reference to a specific advantage/grant of advantage in competition with competitors (see Fischer, StGB, 65th ed., § 299b, § 299a para. 6, § 299 para. 22 et seq.). Such an unlawful agreement has neither been conclusively demonstrated by the plaintiff nor is it otherwise apparent.
2. the defendant also did not violate § 7 HWG.
a) When interpreting the HWG, Directive 2001/83/EC on the Community code relating to medicinal products for human use must be taken into account, as this aims to achieve complete harmonization in the area of advertising for medicinal products for human use and conclusively regulates the cases in which member states may issue deviating regulations. With regard to the – in this case – specialist group advertising, Section 7 HWG essentially implements the European regulation in accordance with the directive. According to § 7 para. 1 sentence 1 HWG, it is not permitted to offer, announce or grant benefits or other promotional gifts or to accept them as a healthcare professional unless one of the exceptions in Section 7 para. 1 sentence 1 nos. 1 to 5 HWG applies. Art. 94 of the Directive prohibits any financial or material benefits other than bonuses to persons authorized to prescribe and dispense medicinal products, unless they are of low value and relevant to medical or pharmaceutical practice. The directive is based on a strictly economic concept of benefits: It covers material benefits of any kind that are not matched by a full consideration. The exceptions to the prohibition are to be interpreted narrowly in accordance with general principles of interpretation and with a view to the intended comprehensive shielding of economic incentives for the preferential prescription or dispensing of medicinal products. Low value can only be assumed if an influence on prescribing and dispensing behaviour appears to be ruled out from a standardized perspective due to the low market value. Cumulatively, i.e. even in the case of low value, the advantages must be relevant for medical or pharmaceutical practice (see Mand/Rektorschek, Wertreklame für Arzneimittel, WRP 2015, 429, 430 f.).
According to the case law of the Federal Court of Justice (see WRP 2014, 847 – Testen Sie Ihr Fachwissen, juris para. 14 f.; WRP 2012, 1517 – DAS GROSSE RÄTSELHEFT, juris para. 29; see also Köhler in: Köhler/Bornkamm/Feddersen, UWG, 36th ed., Section 3a para. 1.230, with further references), Section 7 para. 1 HWG is intended to counter the abstract risk of improper influence emanating from value advertising because and to the extent that it is capable of arousing an economic interest in the prescription or dispensing of medicinal products. In this context, the individual influence of the recipient of the benefit must be taken into account.
b) According to these principles, an advertising gift within the meaning of § 7 para. 1 sentence 1 HWG, however, this is to be assumed both according to § 7 para. 1 no. 1 HWG as well as according to § 7 para. 1 No. 3 HWG.
aa) The term “promotional gift” is to be interpreted broadly and generally covers all free monetary benefits granted in connection with the advertising of medicinal products (see BGH WRP 2011, 1590 – Arzneimitteldatenbank, juris para. 15; Brixius in: Bülow/Ring/Arzt/Brixius, HWG, 4th ed., Section 7 para. 16). The defendant offers application aids worth at least € 1.86 as a free addition to the vaccine doses.
According to the case law of the Federal Court of Justice (WRP 2014, 847 – Testen Sie Ihr Fachwissen, juris-Tz. 14 f.), the existence of a promotional gift also depends on whether offering, announcing or granting it creates at least the abstract risk of improperly influencing the advertising addressee. The fundamental prohibition of value advertising is only intended to prevent sales promotion practices that are likely to arouse an economic interest in the prescription or dispensing of medicinal products among healthcare professionals. The advertising complained of must therefore be able to cause the addressee to change his or her behavior when advising customers in an unobjective manner, especially with regard to the advertising gift in their favor.
However, the existence of an abstract risk cannot be denied solely with regard to the low value of the advertising gift when interpreted in accordance with the Directive, as this point may only be taken into account in the context of the exception rule of Section 7 para. 1 No. 1 HWG may be taken into account. Otherwise – contrary to EU law – the low value of the advertising gift alone and a related unsuitability to arouse an economic interest in the distribution of the advertised medicinal product among healthcare professionals could lead to exclusion from the scope of application of the advertising ban, although the law cumulatively requires that the advertising gift is relevant to medical or pharmaceutical practice (see Mand/Rektorschek, Wertreklame für Arzneimittel, WRP 2015, 429, 434). In the present case, it is therefore sufficient to establish the abstract risk of improperly influencing the advertising addressee that it cannot be ruled out that in individual cases a doctor who actually needs slightly less than 100 vaccine doses will nevertheless order more, e.g. to receive a new cannula collector free of charge, and that it cannot be ruled out that this doctor will then change his advice to patients, e.g. regarding a flu vaccination.
bb) Small items of low value are exempt from the ban on promotional gifts for healthcare professionals if – as here – they are intended for use in medical practice, Section 7 para. 1 sentence 1 no. 1, 2nd case, sentence 2 HWG. Low-value small items are items of such low value that a relevant improper influence on the advertising addressees appears to be excluded, such as, in particular, small gifts that are an expression of general customer friendliness. Prior to the entry into force of the new version of the HWG, which has prohibited any promotional gifts for price-linked medicines since 13.08.2013, the BGH set the value limit for prescription medicines at €1.00 per preparation, inter alia on the grounds that, in the absence of price competition, even smaller gifts can easily enter the consumer’s consciousness and thus cause the consumer to react in a benefit-maximizing manner (see BGH WRP 2013, 1590 – Rezept-Prämie, juris para. 9; BGH WRP 2013, 1587 – Rezept-Bonus, juris para. 20). Against the background of this reasoning, whether the value limit of €1.00 is at all transferable to non-prescription drugs and specialist advertising (cf. e.g. Mand in: Gröning/Mand/Reinhard, Heilmittelwerberecht, Stand Januar 2015, § 7 Rn. 185, 186), can be left open, since in any case the special feature that the advertising gift is only granted for the order of at least 100 vaccine doses must be taken into account here. Even if the value limit were not to be set at € 1.00 for each vaccination dose and therefore at € 100.00 in total, and even if the order form were to be interpreted in accordance with the plaintiff’s opinion in such a way that all five service items listed can be ordered free of charge when ordering 100 vaccination doses, a value of the promotional gift of (maximum) € 13.00 would be inappropriate in view of the high purchase price of (at least) € 1.553.00 would be unsuitable to justify an increased interest on the part of the targeted doctors to preferentially obtain, advertise or dispense the remedies in question. With an advertising gift worth (at most) 0.8% of the value of the goods, life experience suggests that a relevant influence on the prescribing and dispensing behavior of doctors can be ruled out.
cc) Also exempt from the ban on value advertising are advertising gifts that consist of customary accessories to the goods, Section 7 para. 1 No. 3 HWG. The application aids are accessories because they are assigned to the main service for a specific purpose (see Gröning in: Gröning/Mand/Reinhard, Heilmittelwerberecht, January 2015, Section 7 para. 236). When vaccinating, the use of alcohol swabs, cannulas, injection patches and cannula collectors is indispensable; the service items “serve” the vaccine as the main service.
The free inclusion of service items when ordering 100 vaccine doses – cannulas and injection patches in packs of 100 each – is to be regarded as customary in the trade within the meaning of Section 7 para. 1 No. 3 HWG. Customary in the trade does not mean a trade usage within the meaning of Section 346 HWG. Rather, the accessory must merely be within the scope of reasonable commercial practice. The standard is open to new forms of arrangement that are not yet common practice, but whose establishment corresponds to commercial practice (see Gröning in: Gröning/Mand/Reinhard, Heilmittelwerberecht, Stand Januar 2015, § 7 Rn. 237, m.w.N., u.a. on BGH NJW-RR 1991, 1191; see also Senate GRUR-RR 2016, 424 – Fahrdienst zur Augenklinik II, juris-Tz. 31). Irrespective of the lack of distribution to date, when ordering vaccines with a total value of at least € 1,553.00, the addition of vaccination accessories with a maximum value of € 13.00, i.e. less than 1% of the purchase value, is within the scope of reasonable commercial practice, especially since the free service is not highlighted by the defendant as a special feature of his offer. The selection list reads less as an advertising measure than as a checklist for the accessories required for vaccination.
The fact that the defendant only supplies the application aids free of charge from an order quantity of 100 vaccination doses and not also for smaller quantities in correspondingly smaller quantities does not prevent them from being assessed as commercially available accessories. Cent articles such as cannulas, injection patches and alcohol swabs are not sold in individual packaging, but only in larger containers, so that it is objectively and economically obvious to include the application aids only from a corresponding order quantity.
III.
The decision on costs is based on section 91 para. 1 ZPO, the decision on provisional enforceability is based on Sections 708 No. 10, 711 ZPO.
The judgment concerns the transfer of generally recognized principles of interpretation and application of the law to an individual case, so that there is no reason to allow an appeal pursuant to Section 543 para. 2 ZPO to allow an appeal on points of law.
Value in dispute for the appeal proceedings: € 22,000.00.