Questions on delimitation in the field of animal health

Unlike human medicine, where new scientific findings have led to a resurgence in the use of medicinal plants in drug treatment in recent years, significantly less recent scientific data and documentation on the effect and dosage of medicinal plants and medicinal plant preparations are available in veterinary medicine. Consequently, in veterinary medicine, what is known about the desired and undesirable effects of medicinal plants is based largely on traditionally handed-down empirical knowledge or on observational studies with animals. In many cases, insufficient consideration is given to the differences that are specific to animal species, while the inadmissibility of directly transferring therapeutic results from humans to different, or even all, animal species is disregarded. Such differences primarily involve the indications for, and dosage, absorption and metabolism of, herbal active substances by animals (e.g. ruminants, omnivores or carnivores). These are compounded by specific intolerabilities for herbal substances within the various animal species and animal groups.

The issue of delimitation is not just a purely theoretical question, since the assignment of a product to the various categories also has far-reaching consequences. Accordingly, the requirements governing manufacturing, processing, advertising, promotion, distribution, dispensing and monitoring of a product are regulated differently in legislation governing animal feed and medicinal products. The authorities responsible for enforcement also differ, as do the measures and sanction options available to them. Last but not least, an authorisation procedure is required for medicinal products. For these reasons, correct classification is crucially important for the manufacturer / distributor of the product.

A product that falls in the overlap between legislation on animal feed and medicinal products is always subject to one of the two laws. However, this does not mean that the product concerned can also actually be marketed as a veterinary medicinal product or animal feed. In fact, it is entirely possible that a product classified as an animal feed and accordingly subject to animal feed legislation cannot be marketed because it does not satisfy the relevant statutory standards governing animal feed. The opposite situation is also conceivable (a veterinary medicinal product cannot be marketed as such because, for example, the applicant was not able to provide the required proof of efficacy in the intended indication and animal species). In isolated cases therefore, products may fall within the scope of legislation on medicinal products or animal feed but fail to satisfy the corresponding requirements, meaning that they cannot be marketed under either set of legislation.

The Swiss Agency for Therapeutic Products, Swissmedic, and the official feed inspection division of Agroscope jointly review the classification criteria. The important factors covered by this review are the purpose and use of the product, the pharmacological and nutritional properties of the ingredients and product promotion¹. Whether a specific product is ultimately classified as a veterinary medicinal product or animal feed must be determined on a case-by-case basis taking account of all factors (composition, manufacture, intended purpose, promotion, presentation, labelling and intended animal species).

Example: A plant cannot be universally classified as a veterinary medicinal product or animal feed. A classification always relates to a single, specific product and takes all factors into account (concentration of the plant in the product, plant or e.g. plant extract, intended purpose, nutritional purpose / nutrient content, presentation, promotional claims/advertising, intended animal species, pet or farm animal etc.) Once the product has been assigned a category and is thus subject to a particular set of legislation, the question then arises as to its marketability under this legislation. It is thus conceivable that the product is classified as an animal feed, but cannot be marketed as such because it does not meet the requirements of animal feed legislation.

¹ Swiss Fed. Admin. Court ruling C-4612/2011 of 29 October 2013

Herbal active substances are herbal substances or herbal preparations.

• Herbal substances are any whole, fragmented or cut plants, plant parts, algae, fungi or lichen in an unprocessed, dried or fresh form. Certain exudates that have not undergone further processing are also considered to be herbal substances
• Herbal preparations are obtained by subjecting herbal substances to processes such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. They include comminuted or powdered herbal substances, tinctures, extracts, fat oils, essential oils, expressed juices and processed exudates.

According to Article 3 (1) of the Animal Feedstuffs Ordinance (FeedO; SR 916.307), animal feed is substances or products, including animal feed additives, whether processed, partially processed or unprocessed, intended for the oral feeding of animals. A complete feed is considered to be a compounded feed which, by virtue of its composition, is sufficient for a daily ration (Art. 3 (2) b FeedO).

By contrast, a supplement is a compounded feed possessing a high content of certain substances, but which, by virtue of its composition, is only suitable for mixing with other animal feed to make up the daily ration (Art. 3 (2) d FeedO).

Since a daily ration is defined (Art. 3 (4) d FeedO) as the total quantity of animal feed that an animal of a particular species, age group and performance requires each day, on average, in order to cover all of its nutritional requirements, a product is considered to be an animal feed if it provides the body with substances that ensure its normal development and functioning. It serves to maintain the physiological status of animals.

Animal feed may not be promoted as a therapeutic product (see the "Therapeutic promotional claims" glossary on the Agroscope website at www.afk.agroscope.ch; see "Feeds or veterinary drugs" under the heading "Therapeutic promotional claims: List of disallowed formulations"). Claims of any kind that ascribe properties of prevention, diagnosis, treatment or cure of illnesses to an animal feed are forbidden (Feedstuffs Book Ordinance; FsBO; SR 916.307.1; Art. 6 (3) a).

Anyone who manufactures or places on the market animal feed in violation of the legal requirements (FeedO, FsBO) is liable to imprisonment or a fine of up to 40,000 Swiss francs (Agriculture Act, AgricA SR 910.1 Art. 173).

Medicinal products – and this definition also applies to veterinary medicinal products – are defined in Article 4 (1) a of the Therapeutic Products Act (HMG; SR 812.121) as products of chemical or biological origin which are intended to have, or are promoted as having, a medicinal effect on the human or animal organism, in particular in the diagnosis, prevention or treatment of diseases, injuries and handicaps. When interpreting this definition, it is important to understand the criterion "intended to have ... a medicinal effect on the ... animal organism".

The intended purpose of a veterinary medicinal product is its medical effect on the animal's organism in the course of the diagnosis, prevention and treatment (including the cure and alleviation) of diseases. This purpose may be objective (i.e. a product that by the very nature of its active substances can only be used for its medical effect) or subjective (i.e. the intended purpose that the manufacturer or distributor primarily attributes to its product).

Accordingly, whether a product is classified as a medicinal or veterinary medicinal product is determined by its composition on the one hand and its predominant intended purpose on the other. The expectations of the averagely informed consumer must be taken into account when evaluating the predominant intended purpose. Does this person perceive a product as a therapeutic product by virtue of its presentation, promotional claims and advertising statements? Anything that might influence the expectations of an averagely informed consumer is taken into account.

Also regarded as veterinary medicinal products are herbal substances or preparations whose pharmacological properties clearly outweigh their nutritional properties. N.B.: Since pharmacological effect is dependent on dosage, the content of the plant as a proportion of the total content of the product is taken into account when classifying a product.

Ready-to-use veterinary medicinal products with herbal active substances that are destined to be placed on the market must be reviewed and authorised by Swissmedic beforehand (Art. 9 (1) TPA). Anyone who applies for marketing authorisation for a veterinary medicinal product must demonstrate the quality, safety and efficacy of the veterinary medicinal product, possess a licence to manufacture, import or conduct wholesale trade in veterinary medicinal products and have a registered address, registered office or a branch office in Switzerland (Art. 10 (1) a-c TPA).

Under Article 86 TPA, anyone who manufactures, places on the market, prescribes, imports, exports or trades in a foreign country medicinal or veterinary medicinal products that are subject to authorisation without possessing the necessary authorisation or licence, or in violation of other provisions of the Therapeutic Products Act is liable to imprisonment or a fine of up to 50,000 Swiss francs.

Products presenting a primarily physical effect and that are used on humans for therapeutic purposes are considered to be medical devices. The said devices include implants, pacemakers, syringes, cannulae and catheters. Moreover, this category also includes products for oral or topical
use but with a purely physical effect.

The definition of a medical device could in fact also be applied in the veterinary sector. However, article 2, paragraph 2 of the Therapeutic Products Act states that such products might be excluded from the scope of the said act. The Federal Council applied this provision in specifying that the Ordinance on Medical Devices applies to products for human use only.

Inversely, this means that these products are not subject to the Therapeutic Products Act if they are used on animals. Consequently, they are also not therapeutic products.

Since the legislation on therapeutic products does not apply, the relevant, usual legal provisions are thus applicable: for example the law on product safety, on power and electricity, on chemicals or on animal feed. The extent and content of the declaration must therefore be in line with the relevant
provisions.
In particular, products marketed as animal feed or chemicals (biocides) may not present any therapeutic health claim, since these claims are specifically forbidden in the corresponding legal basis.

Therapeutic health claims in the veterinary sector are thus exclusively reserved for authorised medicinal products with a pharmacological effect.