Prohibition of Selling Medical Devices with Reward Points - Prohibition of Sales: Medical Devices with Repayment Rewards are Banned
In a recent ruling, the German Federal Court of Justice (BGH) declared that the offering of Payback points for the purchase of hearing aids is illegal. This decision sheds light on the complex legal framework surrounding promotional gifts in Germany, particularly in relation to medical devices.
The Medicinal Products Advertising Act (HWG) strictly regulates advertising and promotional activities related to medicinal products, including prescription and over-the-counter medicines. However, medical devices, such as hearing aids, are not covered by the HWG, but rather by the Medical Devices Regulation (MDR) and the Medical Devices Act (MPG).
While the HWG does not apply to medical devices, it is crucial to note that promotional gifts, such as Payback points, may still be subject to professional ethical guidelines, competition law, or sector-specific regulations.
The BGH's ruling stems from a complaint filed by the Competition Center, who argued that Payback points were legally prohibited promotional gifts. The court further clarified that promotional gifts, such as Payback points, are only permitted as trivialities of little value, objects of such little value that they exclude a relevant unsolicited influence on the addressees of the advertising.
In this case, the value of Payback points for hearing aids exceeded the value limit set by the BGH, making them illegal. Customers could redeem these points for cash, rewards, vouchers, or donations.
Amplifon, a hearing aid retailer with over 600 stores in Germany, was offering Payback points for the purchase of hearing aids. The crediting of Payback points created an incentive for further purchases of medical devices, a practice the BGH aims to exclude to make it easier for consumers to compare prices.
The BGH explained that advertising for a range of products can be product-related. However, they rejected the argument that Payback points were similar to the two percent instant discount commonly offered by pharmacies. The BGH stated that this incentive was not intended by the legislator.
In conclusion, while promotional gifts, including Payback points, for medical devices such as hearing aids are not legally prohibited under the Medicinal Products Advertising Act (HWG), they may still be subject to other laws or professional guidelines. A full legal assessment should consider these factors to ensure compliance. For medicinal products, even minor benefits above €1 are strictly prohibited under the HWG.
- The ruling by the German Federal Court of Justice (BGH) emphasizes that promotional gifts, such as Payback points, for medical devices, even though not explicitly prohibited under the Medicinal Products Advertising Act (HWG), may still be subject to professional ethical guidelines, competition law, or sector-specific regulations.
- Under the Medical Devices Regulation (MDR) and the Medical Devices Act (MPG), science, medical-conditions, health-and-wellness, therapies-and-treatments, including hearing aids, are not covered by the HWG, but their promotion might still abide by the value limit stipulated in community law, such as the trivialities of little value rule, to avoid any unsolicited influence on consumers and ensure fair competition.