Tuesday, 6 December 2016

Regulation in Eire

Irish law relating to homeopathic medicines is similar to UK law. This is not surprising given a lot of it comes from EU Directives. However, Irish law is structured differently. The situation in Eire is potentially more problematic than in UK.

Recognition of Homeopathy
The situation regards the recognition of homeopath is largely the same as in the UK. As a partly common law jurisdiction, Eire does not prohibit the practice of homeopathy but does not it recognise it or its practitioners. A lay homeopath in Ireland has no special status. They are just another member of the public. Medically qualified homeopaths are recognised because of their qualifications and registration.

Medicines Regulation
Eire, like the UK, implemented EU Directive 92/73/EEC which was replaced by 2001/83/EC. Both are long documents. Article 13 of the later states
1. Member States shall ensure that homeopathic medicinal products manufactured and placed on the market within the Community are registered or authorised in accordance with Articles 14, 15 and 16, except where such medicinal products are covered by a registration or authorisation granted in accordance with national legislation on or before 31 December 1993. In case of registrations, Article 28 and Article 29(1) to (3) shall apply.
This also imposes the duty on Member States to ensure that unregistered or unauthorised homeopathic medicines are not placed on the market. In the case of Eire, these duties fall to the Healthcare Products Regulatory Agency. This Directive also provides an exemption for medicines prepared in a pharmacy under certain conditions.

In terms of Irish legislation the Medicinal Products (Control of Placing on the Market) Regulations 2007 is a good place to start. Irish legislation is a little hard to follow as it comes in multiple regulations.

PART 2 AUTHORISATION AND CERTIFICATION FOR PLACING ON THE MARKET
Requirement for an authorisation or certificate to place a medicinal product on the market.
6. (1) Subject to the provisions of these Regulations, a person shall not place a medicinal product on the market unless such product is the subject of—
(a) a marketing authorisation,
(b) a Community marketing authorisation,
(c) a certificate of registration, or
(d) a certificate of traditional-use registration,
and, in each case, such authorisation or certificate is for the time being in force.
(2) A person shall not in the course of a business carried on by him, sell, supply, manufacture, or procure the sale, supply or manufacture or have in his possession a medicinal product unless he or she has reasonable cause to believe that the product was or is intended to be—
(a) placed on the market in compliance with paragraph (1), or
(b) placed on the market in another EEA State in accordance with the corresponding provisions as required by that State pursuant to the 2001 Directive.

A certificate of registration is for homeopathic medicines.

Authorisation of homeopathic medicinal products under national rules.
11. (1) Notwithstanding the provisions of Regulations 9 and 10 insofar as those provisions relate to the requirements for pre-clinical tests and clinical trials, the Board may grant a marketing authorisation in respect of a homeopathic medicinal product other than a product referred to in Article 14.1 of the 2001 Directive.
(2) For the purposes of obtaining an authorisation in accordance with this Regulation and subject to paragraph (3), the applicant shall demonstrate to the satisfaction of the Board—
(a) that the product is a homeopathic medicinal product which conforms with the principles and characteristics of homeopathy as practised in the State;
(b) that the indication sought is appropriate to such a homeopathic medicinal product;
(c) that any such indication shall be suitable for use without the intervention of a registered medical practitioner for diagnostic purposes or for prescription or for the monitoring of treatment;
(d) that the efficacy of the product shall be established on the basis of evidence that the particular class of homeopathic medicinal product has been in use in the State as a homeopathic treatment for the indication sought; and
(e) that the safety of the homeopathic medicinal product has been established in the manner set out in paragraph (3).
(3) For the purpose of this Regulation and subject to subparagraph (4), the safety of the homeopathic medicinal product shall be demonstrated—
(a) by reference to relevant published literature or original data having regard to the proposed route of administration and the dilution involved; or
(b) in the case of stocks derived from substances commonly used in food, by means of a statement setting out the homeopathic nature of the product and the absence of any change to the route of exposure for the substance concerned; or
(c) in the case of an active principle used in allopathic medicinal products, by establishing that the dilution of the stocks is at least 1 in 10,000 of the mother tincture or not more than one hundredth of the smallest dose of the said active principle as used in allopathy; or
(d) by establishing that the medicinal product contains not more than one part per 10,000 of the mother tincture.
(4) In regard to the active principles referred to in subparagraphs (3)(c) and (d), the Board may refuse to grant an authorisation where it is satisfied that the active principle concerned is toxic and as such would present concerns in regard to the safety of the product. For the purposes of this subparagraph, the Board may publish and update from time to time a list of the substances that it considers to be in this category.
(5) A homeopathic medicinal product that is placed on the market on foot of a marketing authorisation granted in accordance with this Regulation shall, in addition to compliance with the requirements of Regulation 16 (relating to labelling and package leaflets), be presented in such a manner as to show—
(a) that the product is a homeopathic medicinal product in respect of which an authorisation has been granted in accordance with this Regulation;
(b) that any evidence of efficacy on the part of the product has not been based on the outcome of clinical trials;
(c) that use of the product is only intended for the symptomatic relief of the condition to which the indication specified relates; and
(d) that the user is advised to consult a doctor or other healthcare professional if the symptoms persist.

This is roughly the same as the National Rules scheme in the UK.

SCHEDULE 1 EXEMPTIONS FROM THE AUTHORISATION AND CERTIFICATION REQUIREMENTS OF REGULATION 5
2. The provisions of paragraphs (1) and (2) of Regulation 6 shall not apply to the sale or supply of a medicinal product in response to a bona fide unsolicited order, formulated in accordance with the specifications of a practitioner for use by his individual patients on his direct personal responsibility, in order to fulfil the special needs of those patients, but such sale or supply shall be subject to the conditions specified in paragraph 3.
3. The conditions referred to in paragraph 2 are that—
(a) the medicinal product is supplied to a practitioner or for use in a pharmacy under the supervision of a pharmacist, in accordance with paragraph 2;
(b) no advertisement or representation relating to the medicinal product is issued with a view to it being seen by the general public in the State and that no advertisement relating to the product, by means of any catalogue, price list or circular letter is issued by, at the request or with the consent of, the person selling the product by retail or by way of wholesale dealing or the person who manufactures it, and that the sale or supply is in response to a bona fide unsolicited order;
(c) the manufacture of the medicinal product is carried out under the supervision of such staff and such precautions are taken as are adequate to ensure that the product is of the character required by and meets the specifications of the practitioner who requires it;
(d) written records as to the manufacture in accordance with subparagraph (c) are made and maintained and are available to the Board on request;
(e) if the medicinal product is manufactured in the State, or imported into the State from a third country, the product—
(i) is manufactured or imported by the holder of a manufacturer’s authorisation which relates specifically to the manufacture or import of the medicinal product to which paragraph 2 applies; or
(ii) has been manufactured or imported as an investigational medicinal product by the holder of a manufacturing authorisation granted by the Board in respect of such products under Regulation 37 of the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 or Regulation 8 of the Medicinal Products (Control of Manufacture) Regulations 2007; and
(f) the medicinal product is distributed by way of wholesale dealing by the holder of a wholesaler’s authorisation or by the person who has manufactured or imported the product, being the holder of a manufacturer’s authorisation which relates specifically to the manufacture or importation of the medicinal product concerned.
4. (1) Subject to the following subparagraphs, the provisions of paragraphs (1) and (2) of Regulation 6 shall not apply to anything done—
(a) by a practitioner which relates to a medicinal product specially prepared by him, or to his order, for administration to one or more of his patients, and consists of procuring the manufacture of a stock of the product with a view to administering it to such patients; or
(b) in a pharmacy and is done there by or under the supervision of a pharmacist, and consists of procuring the manufacture of a stock of medicinal products with a view to dispensing them in accordance with paragraph 2.
(2) The exemption conferred by subparagraph (1) shall not apply to procuring the manufacture of medicinal products unless those products are to be manufactured by the holder of an authorisation referred to in Article 40 of the 2001 Directive which relates specifically to the manufacture of the medicinal products to which paragraph 2 applies.
(3) The exemption conferred by subparagraph (1) shall not apply to anything done by a practitioner in relation to a stock held by him or her of such medicinal products in excess of 3 litres of fluid and 1 kilogram of solids of all medicinal products to which that subparagraph relates.

Critically the definition of a "practitioner" is given as "a registered dentist or a registered medical practitioner".


4 Exemptions from the requirement that medicinal products be licensed

4. The provisions of article 3 shall not apply as respects —
(a) the sale of a medicinal product by a person lawfully keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons under the Pharmacy Acts, 1875 to 1977 where such sale is carried out and the product is extemporaneously compounded by or under the supervision of a pharmacist for such particular sale;
(b) the importation or sale of a medicinal product by or to the order of a registered medical practitioner or registered dentist for the treatment of a patient under his care;
(c) the importation of a medicinal product by any person for his own personal use, not being an importation resulting directly from a mail order advertisement directed to members of the public;
(d) the importation or sale of a medicinal product solely for the purpose of its being exported;
(e) the manufacture or importation of a medicinal product which is intended for use in the conducting of a clinical trial, in accordance with a permission granted under section 4 of the Control of Clinical Trials Act, 1987 (No. 28 of 1987).

(a) would appear to grant an exemption to pharmacies. The meaning is not entirely clear. It could be read as applying only to transactions that take place in a pharmacy. The Regulations 1998 do not provide a definition of "medical prescription" but it could be understood as a prescription provided by a registered medical practitioner.

8 Homeopathic medicinal product

8. (1) The Board may grant or renew a certificate of registration in respect of any homoeopathic medicinal product which satisfies the conditions set out in sub-article (2) to any person who makes application in writing for such certificate and for such purpose the information, documents, samples and other material required by the Board shall be as specified in the Third Schedule.
(2) Subject to sub-article (3), the conditions to be met for the purpose of registration under sub-article (1) are that the homoeopathic medicinal product shall be such that-
(i) it is intended to be administered orally or externally;
(ii) no specific therapeutic indication appears on the labelling of the product or in any information relating thereto; and
(iii) there is a sufficient degree of dilution to guarantee safety.
(3) The homoeopathic medicinal product shall not be considered to have a sufficient degree of dilution to guarantee safety if -
(i) in the case of a medicinal product containing an active principle the presence of which in an allopathic medicinal product would, by virtue of the Medicinal Products (Prescription and Control of Supply) Regulations, 1996 (S.I. Nos. 256 and 309 of 1993), require the presentation of a prescription issued by a registered medical practitioner in order that the said product may be supplied, if it contains either more than one part per 10,000 of the mother tincture or more than one hundredth of the smallest dose of the said active principle as used in allopathy, or
(ii) in any other case, if it contains more than one part per 10,000 of the mother tincture.
(4) The registration referred to in sub-article (1) shall be subject to the conditions specified in the Fourth Schedule.
(5) Unless sooner revoked by the Board, the aforementioned registration shall normally remain in force for a period of five years and may be renewed on application made by the holder thereof not later than three months before the date of expiry of the certificate concerned.
(6) The provisions of Articles 5 and 9 shall apply to homoeopathic medicinal products to which this article relates as if the references in those articles to efficacy and therapeutic efficacy had been omitted.
Which is the equivalent of the UK Simplified Scheme.

The Problem
It would appear that the supply to and by lay homeopaths of unregistered homeopathic remedies in Eire is of dubious legality.

There would appear to be no pharmacy that compound homeopathic medicines and even if there were, it seems unlikely that they could supply lay homeopaths.

There appears to be one manufacturer of homeopathic medicines in Eire. New Vistas Healthcare and it has the most curious website. It restricts access to certain product listings to those registered with the site. There is an application form on the site which includes the curious wording.
Approved users are able to access the secure Practitioner Support section. Approved users will also be able to access the full product range on the online shop. All customers wishing to buy products need to be approved as legally we are only permitted to ship to an end user who is under the guidance of a trained therapist or a qualified and approved professional themselves.
This would appear not to be the case. It would appear that they can only supply registered medical practitioners.

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