Gifts and Promotional Items in the Pharmaceutical Sector: Section 7 of the German Pharmaceutical Advertising Act (HWG) in Current Case Law (2025/2026)

In 2025 and 2026, the Federal Court of Justice and several Higher Regional Courts ruled on the limits of permissible gratuities and promotional gifts in the pharmaceutical sector. Three issues were central to these rulings: the value threshold for a “trifle of negligible value,” the distinction between cash discounts and promotional gifts, and the application of EU law in cross-border scenarios. Recent case law has established a consistent and practical framework in this regard.

1. Section 7 HWG

Under Section 7(1) HWG, it is prohibited to offer, announce, or grant gifts and other promotional items (goods or services), or to accept them as a member of the professional community.

Exceptions apply under certain conditions, such as when the gratuities or promotional gifts are items of negligible value that bear a permanent and clearly visible designation of the advertiser or the advertised product—or both—or when they are small items of negligible value. The terms “gifts” and “promotional items” are not intended primarily to address different scenarios, but rather to ensure the provision’s comprehensive scope. The difference between items of minor value and small items of minor value lies in the labeling requirement for the first category.

Furthermore, gifts and other promotional items that are provided in the form of a specific monetary amount—or an amount calculated in a specific manner—or a specific quantity of identical goods—or a quantity calculated in a specific manner—are also permissible.

2. The 1 EUR Threshold as the Central Benchmark

In its ruling of July 17, 2025 (“PAYBACK,” Case No. I ZR 43/24), the Federal Court of Justice clarified that, in the context of consumer advertising involving promotional gifts in the healthcare sector, the value threshold for low-value trinkets is 1.00 EUR.

The decision was based on a bonus system in which purchases—including those related to hearing aids—were rewarded with PAYBACK points. The Federal Court of Justice classified these points as promotional gifts within the meaning of Section 7(1) of the German Advertising Act (HWG). The decisive factor is a broad definition of a gift that encompasses any benefit of monetary value which, from the recipients’ perspective, does not appear to be in exchange for consideration.

In interpreting the exception for “gifts of negligible value,” the Senate focuses decisively on the purpose of the provision: Only those benefits that practically rule out any undue influence on the consumer’s purchasing decision are permissible. Against this backdrop, the Federal Court of Justice (BGH) sets the threshold at 1.00 EUR, thereby confirming a strict, clearly defined value-based de minimis threshold.

At the same time, the decision is based on an absolute approach: Permissibility is not determined by a relative ratio to the purchase price, but solely by the amount of the gift. This prevents higher-value “trinkets” from becoming permissible as the value of the goods increases.

3. Promotional Gift vs. Cash Discount: A Clear Legal Distinction

The “Gutscheinwerbung II” ruling of November 6, 2025 (Case No. I ZR 182/22) provides further key clarification. Here, the Federal Court of Justice (BGH) clarifies the scope of the exception under Section 7(1), first sentence, No. 2, subparagraph a of the German Advertising Act (HWG).

According to this, only price reductions that take effect immediately and are expressed as a specific monetary amount are exempt. This includes, in particular, classic immediate discounts that are deducted directly from the invoice amount.

However, the following are not exempt:

• vouchers for future purchases,
• benefits for the purchase of other products,
• gifts in kind or memberships, and
• variable bonuses (e.g., “€2.50 to €20”).

These benefits constitute promotional gifts and are therefore subject to the general prohibition under § 7(1) HWG, unless they can be classified as items of negligible value.

The key legal distinction lies in the purpose of the measure:

A preferential cash discount reduces the price of the specific medicinal product being purchased, whereas promotional gifts provide an additional incentive outside the scope of that specific purchasing decision. From the perspective of the law, the latter creates a risk of undue influence.

4. E-Prescription Vouchers as Prohibited Promotional Gifts

The Higher Regional Court of Karlsruhe (judgment of December 9, 2025 – 14 U 49/25) applies these principles to digital distribution models.

The case involved a €25 voucher for redeeming an e-prescription via an app. The voucher could be applied during the same ordering process, with any remaining balance typically used for OTC products.

The court classified the measure as an impermissible promotional gift:

• The €1 limit is significantly exceeded.
• This is not merely a price discount on the prescription drug.
• Rather, it creates a targeted incentive to purchase additional products.

The Higher Regional Court emphasizes that such a mechanism is likely to unduly influence purchasing decisions and, in particular, to encourage the purchase of unnecessary medications.

5. Expanded Scope of Application: Medical Devices and “Triangular Arrangements”

In its ruling of February 5, 2026 (Case No. 3 UKl 1/24), the Hanseatic Higher Regional Court of Hamburg confirmed the broad scope of Section 7 HWG in accordance with previous case law.

The provision covers not only pharmaceuticals, but also:

• medical devices (in this case: hearing aids) as well as
• diagnostic procedures (in this case: hearing tests), even if these are offered free of charge.

Of particular practical relevance is the classification of “customer-referral” programs:

The granting of vouchers to existing customers for referring new customers also constitutes a prohibited promotional gift. Unfair influence is also present when the economic benefit accrues to a third party.

This clearly encompasses typical referral models and other customer incentive systems in the healthcare sector.

6. EU Law and Price Fixing

The “Arzneimittel-Check” decision (Federal Court of Justice, July 17, 2025 – I ZR 74/24) has an EU law dimension.

The BGH held that the former regulation on fixed drug prices (Section 78 AMG, old version) must not be applied to mail-order pharmacies based in other EU member states, as it violates the free movement of goods.

The assessment of the current legal framework (Section 129 SGB V), however, remains open.

Regardless, one thing is clear: The German Law on the Advertising of Medicinal Products (HWG) continues to apply in parallel and is, in principle, also applicable to cross-border scenarios. Even if price-related restrictions are limited under EU law, the provisions on promotional gifts retain their independent significance.

Conclusion for Practice

Case law from 2025/2026 further clarifies the scope of § 7 HWG:

• 1.00 EUR threshold: This remains the decisive and strictly applicable threshold for low-value promotional items.
• Cash discount vs. promotional gift: Only direct, amount-specific price reductions on the specific medicinal product are permitted.
• Vouchers and bonus systems: Generally considered impermissible promotional gifts if they exceed 1.00 EUR.
• Broader scope of application: This also covers medical devices, services provided free of charge, and third-party incentive systems.
• EU law: It imposes limited restrictions on fixed pricing in specific cases but generally leaves the law on promotional gifts unaffected.

For companies in the life sciences industry, this means: Customer benefits may generally only take the form of genuine immediate discounts. Any benefit granted beyond this—regardless of its specific form—carries a significant legal risk.