May 11 2015 - Press release - The Kooperation deutscher Tierheilpraktikerverbände
The European Commission has tabled a proposal to amend or, to be more precise, replace the existing law on veterinary medicinal products (Proposal for a Regulation of the European Parliament and of the Council on veterinary medicinal products /* COM/2014/0558 final - 2014/0257 (COD) */). Because of the variety of animal species, the legal regulation of veterinary medicinal products is very piecemeal. This has resulted in a variety of supplementary regulations and provisions that render the law very unwieldy and in some respects contradict the rules and objectives of the internal market.
The Kooperation deutscher Tierheilpraktikerverbände, which is an umbrella organization of five professional associations of CAM animal practitioners in Germany, the Fachverband Niedergelassener Tierheilpraktiker and the Ältester Verband der Tierheilpraktiker Deutschlands, issued a joint statement to this proposal:
CAM (Complementary and Alternative Medicine) animal practitioners/Tierheilpraktiker regard themselves as members of a regulated animal health profession. The activities of CAM animal practitioners in Germany are governed by several laws and provisions. In this context, the position of CAM animal practioners is that the reorganization of the veterinary medicinal products legislation and the following core objectives are completely welcome, namely,
- Halting the use of antibiotics in animals, and combatting antimicrobial resistance in humans and animals
- Improving the availability of veterinary medicinal products
- Reducing regulatory burden
- Introducing pharmaceutical-monitoring in the employment of medicinal products in animals
- Stimulating competitiveness and innovation.
A closer examination of the proposal, however, reveals that some of its elements do not reflect the aforementioned objectives. Indeed, according to a strict interpretation, the formulation of significant passages is in complete contradiction to these objectives.
We consider the most important issues:
- The scope of the proposalis problematic because it extends to substances that merely serve to prevent disease or to sustain animal health care by an undue and unjustifiable extention of the meaning of “veterinary medicinal product.”
- Contrary to the proposal’s intended purpose, it will disproportionatley restrict the availability of complementary and alternative drugs for animals.
- The proposal takes in sufficient account of the fact that animals should enjoy as much unrestricted access to a variety of risk-free therapies as humans enjoy. This includes complementary and alternative medical therapies.
- The proposal’s present design contradicts the constitutionally guaranteed freedom of profession according to Art.12 of the German Basic Law, as well as Art. 15 of the EU Charter of Fundamental Rights. To the extent that the proposal’s provisions intend to render the exercise of the profession of CAM animal practitioners or the charging of fees for their services impossible, it might even represent an illegal interference with the right to maintain an established and ongoing business enterprise (Art. 14 Basic Law Germany) and incur liability for damages or compensation.
- With regard to homeopathic remedies, the general ban on the use of medicinal products designed for human use in animals is disproportionate in light of EU regulation 37/2010.
- The proposal contradicts the Council Regulation on organic production and the labelling of organic products, repealing Regulation No 834/2007, according to which treatment with complementary and alternative medicinal products (e.g. phytotherapeutic, homeopathic, and other products) must take precedence over treatment with chemically synthesised allopathic veterinary medicinal products. No large-scale approval of complementary and alternative drugs for animals need be anticipated provided they have already been authorized as medicinal products for human use.
- We are concerned that the provisions requiring manufacturers to establish a pharmaceutical-monitoring system might lead to a conflict of interest.
In accordance with the Council Regulation on organic production and thel abelling of organic products and (EC) No. 834/2007 (Article 14 para. 1 e (ii), Art. 15 para. 1 f (ii)), treatment with complementary and alternative medicinal products (phytotherapeutic, homeopathic, and other products) must have priority over treatment with chemically synthesised allopathic medicinal products. With regard to antimicrobial resistance prevention, this should not only apply to animals of biological-ecological livestock production, but to all the animals.
CAM animalpractitioners (non-veterinarianandveterinarian) employ a widerange of therapeutics. These include homeopathic remedies, phytotherapy, leech, enzyme therapeutics, and so forth. The application of complementary and alternative medicinal therapies must not only be left to physicians and veterinarians, because this would result in a loss of variety of methods as well as in professional restrictions on non-medical therapists.
With respect to risks, if any, in the application of homeopathic remedies, these should be regulated by a so-called “first safe dilution” (the concept of “first safe dilution” or “safe only by dilution”), but not by the introduction of prescription or separate/additional registration/authorization as veterinary medicinal products.