TAMG – the new Veterinary Medicinal Products Act

Update from 14.09.2022

The German Veterinary Medicine Act (TAMG) has been in force since 28 January 2022

Since 28 January 2022, Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on Veterinary Medicinal Products which repeals Directive 2001/82/EC has applied to veterinary medicinal products in the European Union. At a national level, this prompted the German legislator to adopt a Veterinary Medicine Act, TAMG, as a separate and independent law. According to the explanatory memorandum of the Bundestag (printed matter 19/28658), the aim is to ensure a high level of protection in the use of veterinary medicinal products and medicinal products for human use in animals, because these may have an impact on the food chain, the quality of foodstuffs of animal origin, the environment, animal health and also on public health, through the emergence and spread of antibiotic resistance. Regulation (EU) 2019/6, which is also applicable, further restricts, among other things, the use of antibiotics in animals in order to limit the emergence and spread of antibiotic resistance.

1. Changes to the previous legal position

a) Changes compared to the German Medicinal Products Act (AMG)

Before the introduction of the TAMG, veterinary medicine law was codified at national level in the Medicinal Products Act (AMG). The new legislation now separates the regulations for human and veterinary medicines into two independent specialised laws which is a great relief for veterinarians and for animal owners in the application of the legislation. However, a change contained in the new Section 50 (2) TAMG has attracted much criticism:

“Animal owners and other persons who are not veterinarians may only use prescription-only veterinary medicinal products and veterinary technical products as well as medicinal products in accordance with section 2 (1), (2) and (3a) of the Medicinal Products Act on animals if

1.  they have been prescribed or dispensed by a veterinarian with whom the animals are being treated, and
2. and the use is in accordance with a veterinary treatment instruction handed out by the veterinarian for the case in question.”

According to the wording of the legislation, all medicinal products for human use according to Section 2 (1), (2) and (3a) AMG are covered by the veterinary proviso. This means that animal health practitioners and animal owners are prohibited from using non-prescription and registered human homeopathic medicines and that this will be punished as an administrative offence according to Section 89 (2) no. 5, (6) TAMG. In its order of 24 January 2022 (case no. 1 BvR 2380/21), the Federal Constitutional Court rejected the application for a temporary injunction pursuant to section 32 (1) of the BVerfGG. In its reasoning, it stated that no reasons of particular weight were substantiated for the issuance of a temporary injunction. The especially high hurdles of interim legal protection in the area of constitutional complaints have not been reached. An interim injunction represents a considerable encroachment on the original competence of the legislature and is therefore to be applied very restrictively. It remains to be seen whether the norm will remain in the main decision of the Federal Constitutional Court.

b) Changes in the law on advertising of medication

Previously, veterinary medicinal products, like medicinal products, were subject to the Medication Advertising Act (Heilmittelwerbegesetz, HWG), which laid down the requirements for permissible advertising of (veterinary) medicinal products. With the introduction of the TAMG, the HWG was amended and veterinary medicinal products were removed from its scope of application (Section 1 (1) HWG). Since 28 January 2022, the provisions of Arts. 119-121 of the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) apply to the advertising of veterinary medicinal products. These are (so far) conclusive. In the TAMG, no further regulations were made regarding the advertising of veterinary medicines. It is noticeable that the regulations of the Veterinary Medicinal Products Regulation do not require any compulsory information like Section 4 HWG and are overall rather more general. The main point here is that the advertising must not be misleading. Exactly how the company implements this in its advertising remains a decision for the company itself. A special feature applies to veterinary medicinal products subject to prescription according to Art. 120 of the Veterinary Medicinal Products Regulation, as in this case advertising may only be made to veterinarians and persons who are authorised to supply veterinary medicinal products according to national law.

Outlook

The TAMG continues with the national antibiotic minimisation concept of the 16th amendment of the Medicinal Products Act unchanged in order to significantly reduce the use in livestock farming. However, at least according to the Federal Ministry of Food and Agriculture (BMEL), there is still a need for improvement. There could therefore still be amendments to the law to further minimise antibiotics. It remains to be seen whether the TAMG will also contain detailed regulations on advertising requirements, as one of the aims of the TAMG was to make the marketing of veterinary medicinal products more efficient.

Authors: Dr. Daniel Tietjen, Katharina Hölle