Page 25 - Summer 18

Vote on amendments to EU Regulation on Veterinary Medicines by Petra Weiermayer
’In March 2016, the EU parliament voted on our amendments to the EU Regulation on Veterinary Medicines.
The amendments would have made it possible to use all homeopathic medicinal products registered for human use also in animals as first line treatment in every single country within the EU. Unfortunately, in December 2017 the negative vote of the Council of the EU on our proposed amendments was announced. We managed to talk to many who were involved in the negotiations between the EU parliament, Council of the EU, and EU commission. We were allowed to make our case and were given good feedback from these exchanges. Unfortunately, there were too many countries (representatives of the national health ministries) that were against our amendments. During the negotiations, it was therefore decided to leave the difficult subject of the regulation of the use of (human) homeopathic medicines registered according to EU Directive 2001/83 in animals to national governments in order to be able to finalise the new Veterinary medicines regulation (May 2018).
This returned the regulation of the use of registered (human) homeopathic medicinal products in animals to the national level. This can be seen as a small victory and shows there is sufficient support for homeopathy in the EU decision bodies. Otherwise the use of 'homeopathic medicinal products registered for humans' in animals could not be allowed on national level because an EU regulation is direct law and no national additions or different interpretations would be possible. For now, there are three case scenarios:
• Countries with the national law saying homeopathy (registered homeopathic remedies) does not fall under the cascade or where the cascade does not exist. Homeopathy can be used as first line therapy.
• Countries with national law saying homeopathy (registered homeopathic remedies) falls under the cascade. Homeopathy cannot be used as first line therapy, BUT, because, according to the EU organic farming regulation saying that homeopathy should be used as first line therapy there is a contradiction between the national law and the EU organic farming regulation. This is valid for farm animals from organic farms.
• Countries with national law saying nothing about the use of registered homeopathic remedies. In this case
homeopathy cannot be used as first line therapy as it is not stated within the EU Regulation on Veterinary Medicines that homeopathy (registered homeopathic remedies) does not fall under the cascade, BUT according to the EU organic farming regulation saying that homeopathy should be used as first line therapy there is a contradiction between the national law and the EU organic farming regulation. This is valid for farm animals from organic farms.
It is recommended to get in contact with the ministries and agencies in each country and tell them about the contradiction of the national law with the EU organic farming regulation. If the national law is saying that homeopathy falls within the cascade, or if the national law does not say anything about homeopathy and the cascade, tell them the wording of the EU organic farming regulation and that homeopathy (registered homeopathic remedies) should be legally out of the cascade.
This is the link to the EU Regulation 2018/848 on Organic Farming in all languages: https://eur-lex.europa.eu/legal- content/EN/TXT/?qid=1530178702491&uri=CELEX:32018 R0848
The important wording in the EU Regulation 2018/848 on Organic Farming can be found at Attachment II, Part 2: 1.5.2.3.! Please read also: 1.5.2.2. + 3.1.4.2
1.5.2.3.: Feed materials of mineral origin authorised pursuant to Article 24 for use in organic production, nutritional additives authorised pursuant to Article 24 for use in organic production, and phytotherapeutic and homeopathic products shall be used in preference to treatment with chemically synthesised allopathic veterinary medicinal products, including antibiotics, provided that their therapeutic effect is effective for the species of animal and for the condition for which the treatment is intended.
Fortunately, it was managed to keep this wording of preferred use of homeopathy in the EU Regulation on Organic Farming, this might be due to our great lobbying for homeopathy. This EU Regulation was finalised in May this year.
This is the link to the EU Regulation COM(2014)0558 on Veterinary Medicines in all languages which is in working progress: https://eur-lex.europa.eu/legal- content/EN/TXT/?qid=1530180158016&uri=CONSIL:ST_ 9763_2018_ADD_1_COR_1. The English version can be found at the website of IAVH.
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