Federal Constitutional Court of Germany

11/16/2022 | Press release | Distributed by Public on 11/16/2022 02:37

Veterinary prescription requirement Prescription requirement for the use of human non-prescription homeopathic remedies in animals is unconstitutional

Veterinary prescription requirement Prescription requirement for the use of human non-prescription homeopathic remedies in animals is unconstitutional

Press Release No. 92/2022 of 16 November 2022

Order of 29 September 2022
1 BvR 2380/21, 1 BvR 2449/21

In an order published today, the First Senate of the Federal Constitutional Court held that § 50(2) of the Veterinary Medicinal Products Act (Tierarzneimittelgesetz - TAMG) of 27 September 2021 violates Art. 2(1) and Art. 12(1) of the Basic Law (Grundgesetz - GG) and is void to the extent that the provision requires a prescription by a veterinarian for the use of registered, non-prescription human homeopathic remedies in animals other than livestock.

The complainants are veterinary healers and homeopathic practitioners who treat animals with highly diluted, non-prescription homeopathic remedies intended for human use. According to § 50(2) TAMG, which was newly included as part of the Act and took effect on 28 January 2022, the complainants may only use such human homeopathic remedies in animals when prescribed or dispensed by a veterinarian.

Insofar as the prescription requirement applies to the use of non-prescription human homeopathic remedies, § 50(2) TAMG violates the complainants' occupational freedom (Art. 12(1) GG). In addition, it violates the general freedom of action (Art. 2(1) GG) of the complainant who also treats her own animals. The interference with fundamental rights resulting from the provision is disproportionate. The legislator did not strike an appropriate balance between the affected interests, given that the likelihood of impairments to animal welfare and harm to animal or human health is low and can be further lowered by imposing an obligation on affected persons to provide proof of theoretical knowledge in the area of veterinary medicine.

Facts of the case:

As the law stood until 27 January 2022, the use of any human non-prescription medicinal product in animals other than livestock by non-veterinarians was permitted without restriction. Since 28 January 2022, § 50(2) TAMG provides that human medicinal products may only be used in animals if prescribed or dispensed by a veterinarian; they must then be used in accordance with the veterinarian's instructions. This requirement also extends to the use of highly diluted, non-prescription human homeopathic remedies in animals.

The complainants have been working as self-employed animal healers or homeopathic practitioners for many years. They mainly treat dogs and cats, but also horses and some other pets. They almost exclusively apply classical homeopathy, using highly diluted human homeopathic remedies that must be licensed but are not subject to prescription for human use. One of the complainants also treats her own dogs and horses with these remedies when needed.

The complainants challenge § 50(2) TAMG, asserting a violation of their occupational freedom under Art. 12(1) GG. The complainant who treats her own animals also asserts a violation of her general freedom of action under Art. 2(1) GG.

Key considerations of the Senate:

A. The constitutional complaints are admissible to the extent that the complainants assert a violation of Art. 2(1) GG (general freedom of action) and Art. 12(1) GG (occupational freedom).

It is true that the Veterinary Medicinal Products Act also implements and enforces legal acts of the European Union (cf. § 1(3) TAMG). However, given that the provision at issue, to the extent challenged here, does not implement binding EU law, the Federal Constitutional Court has jurisdiction to review § 50(2) TAMG. The provision does not implement fully harmonised EU law on the basis of an implementation order, nor does it serve to adapt German legislation to binding EU law.

B. The constitutional complaints are well-founded.

I. § 50(2) TAMG results in disproportionate interference with the occupational freedom protected by Art. 12(1) GG of the complainants who work as animal healers or homeopaths.

1. To the extent that § 50(2) TAMG requires a prescription by a veterinarian for the use of non-prescription human homeopathic remedies in animals, it interferes with the complainants' occupational freedom.

2. This interference is not justified under constitutional law.

a) The prescription requirement does pursue a constitutionally legitimate purpose. The legislative materials state that the legislation in question serves to continue § 57a of the former version of the Medicinal Products Act (Arzneimittelgesetz - AMG) and adapts it to the requirements of EU law; these stated purposes by themselves do not constitute a valid basis for the challenged provision. In this case, ensuring the safety of medicinal products by preventing medication errors does not constitute a legitimate purpose either, since there are no sufficiently reliable findings that the use of highly diluted human homeopathic remedies in animals poses a risk to animals, humans or the environment.

However, the legislator pursues the legitimate purpose of ensuring quality in diagnosing and treating animals. The challenged provision serves to promote animal welfare and human and animal health to the extent that it prevents misdiagnosis and treatment errors by non-veterinarians. While the legislator failed to clearly state this in the legislative materials, it is a clearly reasonable purpose to which the Federal Government referred in its statement regarding the constitutional complaints.

b) The prescription requirement is suitable and necessary under constitutional law to achieve the legislative purpose. However, it is not proportionate in the strict sense.

aa) The interference with occupational freedom is considerable. The provision affects the main occupational activity of animal healers and homeopaths practising classical homeopathy, who almost exclusively use highly diluted, non-prescription homeopathic remedies intended for human use. Continuing their work in this area is virtually impossible.

bb) This interference must be balanced against the considerable interests of animal welfare and animal and human health, which merit protection. Animals are to be protected from physical pain, suffering and harm resulting from misdiagnosis and treatment errors by non-veterinarians. Enhancing animal welfare is a very important interest of the common good, given that the Constitution itself requires the legislator, in Art. 20a GG, to enact suitable provisions to protect animals.

cc) That being said, the likelihood of an impairment to the interests of the common good pursued in this case is not very high; it can be further lowered by imposing an obligation on animal healers and homeopaths to provide proof of knowledge in the area of veterinary medicine.

(1) The Animal Welfare Act (Tierschutzgesetz - TierSchG) and the Protection Against Animal Diseases Act (Tiergesundheitsgesetz - TierGesG) contain various conduct and reporting requirements, with non-compliance subject to punishment; these, at least in more serious cases, may in part lower the likelihood that misdiagnosis and treatment errors by animal healers and homeopaths will impair animal welfare interests or harm animal or human health.

(2) The legislator itself does not consider the likelihood of impairment to the relevant protected interests of the common good to be very high, because in general, risks to these interests posed by many other animal treatment methods are accepted.

The treatment of animals by animal healers and homeopaths can involve certain risks to animal welfare and animal and human health, given that persons without a license to practise medicine cannot guarantee the same high standards for diagnosis and treatment as a veterinarian. However, these risks are not unique to the off-label use of human homeopathic remedies.The same risks exist with regard to, for instance, the use of non-prescription veterinary medicinal products (such as veterinary homeopathic remedies) or alternative treatment methods (such as phytotherapy), for which neither the Veterinary Medicinal Products Act nor other legislation sets out a prescription requirement. Rather, persons without specific education or training are permitted to use these products and therapies for various treatment methods without restriction. In this respect, the legislator does accept the risk that animals might be misdiagnosed or treated incorrectly and that infectious diseases transmissible to humans might remain undetected or be treated improperly.

(3) Above all, the likelihood that animal welfare interests or animal or human health are impaired can be further lowered by limiting the use of non-prescription human homeopathic remedies in animals by persons without a medical license to those who provide proof of the knowledge to determine when a veterinarian needs to be consulted.

dd) In light of the above,requiring a veterinarian's prescription for the use of non-prescription human homeopathic remedies in order toensure diagnostic and treatment quality is not appropriate. The risks, which are not substantial, can be further reduced by imposing an obligation to provide proof of theoretical knowledge in the area of veterinary medicine. At the same time, these risks must be weighed against a serious interference with occupational freedom, as the provision - to the extent challenged here - considerably restricts the ability of animal healers, whose work is essentially limited to the treatments used in classical homeopathy, to continue their occupation. The burdens imposed on the fundamental rights holders are not in reasonable proportion to the benefits to the common good.

II. To the extent that the provision also requires pet owners to obtain a veterinarian's prescription in order to use non-prescription human homeopathic remedies, § 50(2) TAMG results in disproportionate interference with their general freedom of action (Art. 2(1) GG).

The interference with the general freedom of action of persons who - like one of the complainants - treat their own animals with classical homeopathic remedies is not justified. The prescription requirement, to the extent that it also affects those who treat their own animals, serves the legitimate purpose of ensuring diagnostic and treatment quality. It is suitable and necessary to achieve this purpose. However, the provision is not proportionate in the strict sense.

It is true that the interference resulting from the provision is less severe because the affected persons in this case do not have to give up their source of income or choose a new occupation. However, the requirements imposed by the Animal Welfare Act, which, at least in more serious cases, already lower the likelihood of an impairment to animal welfare interests and of harm to animal or human health, are even stricter for pet owners.