GoogleLegislation Affecting UK Homeopathy (Part 1)
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by Louise Mclean, LCCH, MHMA.  (Updated 22 September 2012)

Without Prejudice

PART 1

In October 2011, the MHRA published a Public consultation MLX 375  Consolidation and Review of UK Medicines Legislation  The relevant clauses are 4.17, 4.21, 4.25, 4.26, 4.32, 4.39, 6.35, 6.36, 10.19 and 10.20.

The consultation closed in January 2012 and amendments to the Medicines Act 1968 are being considered by the MHRA and may be decided as early as the end of this month and consolidated by July 2012 in accordance with the wishes of the EU which want UK legislation 'harmonised' this year.

The problem is that there are clauses in the Medicines Act 1968 which are not favourable to homeopathy and the reason for the recent furore, is that these clauses might be enforced in order to comply with EU directives which take precedence over UK law.

As Britain is a full EU Member State, 170,000 pages of EU law have to be adopted into UK law and this has been ongoing for some time.  Some of these laws have badly impacted on our natural health therapies and practices.

We saw it with the EU Food Supplements Directive which was transposed into UK law in 2003,  limiting the sale of vitamins and food supplements.  Go into a health food store and you find that bit by bit, ever since 1992 when Britain signed the Maastricht Treaty putting the EU in charge of our Public Health, hundreds of excellent products have been removed, companies folded and chains like Holland & Barrett have simply reformulated their products to comply.

Then the EU Nutrition & Health Claims directive which prohibited natural health products making any health claims on their labels.  This has currently been impacting on natural health practitioners' websites where they are no longer allowed to say that products or homeopathic medicine can treat disease.  In an interview the author conducted with Dr. Robert Verkerk of the Alliance for Natural Health in 2005, he said that 'it will severely impact on what companies can say to consumers and what practitioners can say to patients' and 'any communication about the benefits or health claims of a product would become illegal'.  'Unless your product is licensed as a medicine, you are not allowed to talk about its benefits'.

After that we have recently had the EU Herbal Directive which limited the supply of herbal products.  One wonders if the EU plans to regulate Nature itself (since herbs grow freely in the countryside)!!

The real problem for homeopathy started when it was legally classified as a 'medicinal product' under an amendment in EU Directive 2004/27/EC to the  EU Human Medicinal Products Directive 2011/83/EC .  A vital concession was lost whenthis amendment was adopted forcing homeopathic medicines to be defined as medicinal productsand regulated under the EU Human Medicinal Products Directive EU Directive 2011/83/EC in the same way as pharmaceutical medicines.

The amendment is in Article 1, 1). of EU Directive 2004/27/EC, which defines a 'medicinal product' as:
2.  Medicinal product:
(a) "Any substance or combination of substances presented as having properties
for treating or preventing disease in human beings."

(b)  "Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis"

In the interview with Dr. Robert Verkerk mentioned above, he said: 'There are a number of pieces of other EU regulation that could pose very serious problems for natural health practitioners. One of them is the Human Medicinal Products which passed into European Law in 2004.  It is designed to control pharmaceutical products but has such a wide definition, it can affect virtually any product it chooses.  The definition basically includes any substance or combination of substances used to correct, modify or restore physiological functions that exert an immuniological, metabolic or physiological function of the body. The second aspect of the Human Medicinal Products Directive is that it has a provision that allows it to trump any other piece of European Law. If for example something fits as a food supplement, it would also fit as being a drug under this Directive. So that gives the regulators a big gun to more or less choose at will whatever product they want and call it a drug.'  ('medicinal product')

 Since 1971 when the Medicines Act came into force, homeopathy had been regulated in the UK in three ways. Firstly in 1971 remedies were regulated under the Product Licences of Right (PLRs) which allowed them to state indications on the label. Then in 1992 under EU directive 92/73/EC the Simplified Registration Scheme was introduced, which did not allow indications for use.  It did not protect homeopathic medicines, although this was never enforced.

The third method of regulation introduced on 1st September 2006 was the National Rules Scheme in order to regularise these inconsistencies and allow homeopathic products to show indications 'for the relief or treatment of mild, self-limiting conditions'. Companies were encouraged to register (licence) new products under this scheme and re-register any existing PLR products, as the MHRA planned to scrap the old system of Product Licences of Right altogether.  The problem was only a fraction of remedies were registered.

 

Only a limited number of homeopathic medicines have actually been registered (licensed) because in order to register them, large batches and lots of paperwork were required for each one.  Since 2004, homeopathy has been classified as a 'medicinal product' and the EU and MHRA do not want unlicensed medicinal products.

However after the Medicines Act is revised, it may mean that ALL homeopathic medicines will need to be licensed and as there around 3,500 of them, according to insiders at the homeopathic pharmacies, this would be hugely expensive and not viable.  In fact about 98% of homeopathic medicines are not licensed.  However remedies bought in Boots, Holland & Barrett and Weleda and Nelson's remedies from health shops are the licensed ones and will not be affected.  They can still be purchased freely, though in the limited range, as they are available by what is termed 'general sale' in the Medicines Act.

So due to the fact that the majority of remedies are unlicensed, it would then become illegal to dispense them in any way - make up or prescribe them, as well as order them by phone or on the internet.  They would not legally be allowed to go through the postal system.  They would only be allowed to be dispensed face to face at a registered homeopathic pharmacy or by a local pharmacy.

It is Clause 10 of the Medicines Act 1968 that is worrying the homeopathic pharmacies, as they are concerned these clauses in the Act might be enforced and they want 10(4)(a) to be changed by giving an exemption to homeopathic medicines, which would enable them to carry on business posting orders to practitioners and to the public.  Requests for this change to clause 10(4)(a) to the MHRA have apparently been met with 'no comment' and assurances that there will be no policy change for homeopathy.  Insiders have said there will be no change to Section 10 and it will remain in force in the new  Human Medicines Regulations 2012   though its terms are contained in other clauses.

(1) Subject to the next following subsection, the restrictions imposed by sections7 and 8 of this Act do not apply to anything which is done in a registered pharmacy, a hospital [a care home service] or a health centre and is done there by or under the supervision of a pharmacist and consists of—
(a) preparing or dispensing a medicinal product in accordance with a prescription given by a practitioner, or
(b) assembling a medicinal product provided that where the assembling takes place in a registered pharmacy—
(i) it shall be in a registered pharmacy at which the business in medicinal products carried on is restricted to retail sale or to supply in circumstances corresponding to retail sale and the assembling is done with a view to such sale or supply either at that registered pharmacy or at any other such registered pharmacy forming part of the same retail pharmacy business.

(3)Those restrictions do not apply to the preparation or dispensing in a registered pharmacy of a medicinal product by or under the supervision of a pharmacist in accordance with a specification furnished by the person to whom the product is or is to be sold or supplied, where—
(a)the product is prepared or dispensed for administration to that person or to a person under his care

(4)Without prejudice to the preceding subsections, the restrictions imposed by sections 7 and 8 of this Act do not apply to anything which is done in a registered pharmacy by or under the supervision of a pharmacist and consists of—
(a)preparing or dispensing a medicinal product for administration to a person where the pharmacist is requested by or on behalf of that person to do so in accordance with the pharmacist's own judgment as to the treatment required, and that person is present in the pharmacy at the time of the request in pursuance of which that product is prepared or dispensed, or
(b)preparing a stock of medicinal products with a view to dispensing them as mentioned in subsection (1)(a) or subsection (3) of this section or in paragraph (a) of this subsection;

These are the restrictions referred to in Section 10 above which are imposed by sections7 and 8 of the Medicines Act1968:
(2)Except in accordance with a licence granted for the purposes of this section (in this Act referred to as a “product licence") no person shall, in the course of a business carried on by him, and in circumstances to which this subsection applies,—
(a) sell, supply or export any medicinal product, or
(b) procure the sale, supply or exportation of any medicinal product, or
(c) procure the manufacture or assembly of any medicinal product for sale, supply or exportation.

[F1(2A)The restrictions imposed by subsection (2) of this section shall not apply where the medicinal product concerned is a homoeopathic medicinal product in respect of which a certificate of registration has been granted. (licence)

2)No person shall, in the course of a business carried on by him, manufacture or assemble any medicinal product except in accordance with a licence granted for the purposes of this subsection (in this Act referred to as a “manufacturer’s licence”).
(7)In this section any reference to distribution of a product by way of wholesale dealing is a reference to
(a)selling or supplying it, or
(b)procuring, holding or exporting it for the purposes of sale or supply, to a person who receives it for the purposes of—
(i)selling or supplying it, or

(ii)administering it or causing it to be administered to one or more human beings, in the course of a business carried on by that person.

Sections 7 and 8 of the Medicines Act 1968 are now listed as  Sections 17 & 18 of the  Human Medicines Regulations 2012 

 

Only the five approved homeopathic pharmacies (or a registered pharmacist of an ordinary chemist) could dispense homeopathic medicines, so according to 10(4)(a), to purchase them you would have to physically go to the homeopathic pharmacy to obtain them face to face, which would be highly inconvenient for most people.  It would be possible to go to an ordinary pharmacy and ask them to order remedies from a homeopathic pharmacy.  The pharmacist would earn commission on the sale but may not agree with the prescription and has the legal right to say no or suggest what they believe to be a more appropriate medicine.  They might refuse if they don't believe in homeopathy and they have a responsiblility to ask what the patient is taking it for, as well as entitled to give their own advice.  According to one top level source, approximately 60% of pharmacists are not necessarily against homeopathy, 20% aren't sure and 20% don't believe in it at all.

In January 2011 the MHRA was discussing the abolition of the Non Orthodox Practitioner (NOP) scheme which allowed practitioners to make up remedies for patients.  (See clauses 27-33).  Very few practitioners had applied for the licences costing £457 and it had not been stringently enforced.

So most alarmingly of all, homeopathic practitioners may have no legal status to prescribe and this could be underpinned in the revision of the Medicines Act, making it illegal for them to either make up a remedy or prescribe one.  They will in effect be breaking the law by practising medicine without a licence and by holding and prescribing unlicensed homeopathic medicines.

The problem is that in all of this legislation, there is no place for an unregistered health professional to prescribe a 'medicinal product'.  Only doctors, dentists, nurses, supplementary prescribers, pharmacists, optometrists, community practitioner nurses can legally prescribe.

Under Part 16  and regulaton 279 of the Human Medicines Regulations 2012   an inspector is legally entitled to enter your property to check whether unlicensed medicines are being manufactured. 6.20 (page 46)  'We have replaced the term "prepared" that was used in a few of the exemptions in the Medicines Act 1968 with "manufactured", as we believe the terms covers the making of any product'  http://www.mhra.gov.uk/home/groups/es-policy/documents/websiteresources/con132058.pdf

 
InEU Directive 2004/27/EC which amends the original EU Directive 2011/83/EC, in Article 107, 77 it says:-

77).  The competent authority may also carry out unannouncedinspections at the premises of manufacturers of active substances used as starting materials, or at the premises of marketing authorisation holders whenever it considers that there are grounds for suspecting non-compliance with the principles and guidelines of good manufacturing practice referred to in Article 47. These inspections may also be carried out at the request of a Member State, the Commission or the Agency.

Homeopathy should NEVER have been regulated along with pharmaceutical medicine and then none of this would have applied.

According to Clause 15 of the Medicines Act 1968, the UK Health Ministers will have the final say about changes to the Act.  We just have to hope they will have the power to help us, even though we are effectively being ruled from Brussels.

15. Provision for extending or modifying exemptions.
(1)The appropriate Ministers may by order provide that sections 7 and 8 of this Act shall have effect subject to such exemptions (other than those for the time being having effect by virtue of sections 9 to 14 of this Act) as may be specified in the order.
(2)Any exemption conferred by an order under the preceding subsection may be conferred subject to such conditions or limitations as may be specified in the order.
(3)The appropriate Ministers may by order provide that any of the provisions of sections 9 to 14 of this Act specified in the order shall cease to have effect, or shall have effect subject to such exceptions or modifications as may be so specified.
(4)No order shall be made under subsection (3) of this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament.

Legislation Affecting UK Homeopathy (Part 2)

 

This Petition attracted 23,000 signatures but is now closed.

 

Further invaluable links and Lady Medea gives background history:

EU Tolls Death Knell for UK Natural Health Practitioners

Lady Medea —November 2008

 

UK Moves to Cripple Homeopathy & Eliminate non-Allopathic Homeopaths

Homeopaths are to be sidelined as the UK moves to limit availability of homeopathic medicines. This is a call to action to protect access to homeopathy!

by Heidi Stevenson

5 February 2011
http://www.gaia-health.com/articles351/000399-uk-cripple-homeopathy.shtml


Back Door Attack on Homeopathy: Speak Out Now, Or Lose Your Freedom
May 19, 2012
(Pages 1to 3)

 

Regulating homeopathic remedies like pharmaceuticals
because they’re both medicines would be like regulating water the same way as alcohol, since they’re both liquids.
May 29, 2012

 

Vocal Opponents of Natural Medicine Fight On
By Lady Medea, BSc in Holistic Nutrition [High Hons]
December 07, 2007

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