NEW LAWS – what does it all mean for me?

Last updated on 10th July 2011

Rutland Biodynamics does not given legal advice and therefore what follows here is a personal opinion and only sets out to explain the company’s understanding at the time at which it was written. Law is made by Governments and by Courts, enforced by Governments but, finally only the Courts can give definite interpretations. That is not very practicable from the point of view of most people and so in the early days of the new EC legislation within the UK, manufacturers, practitioners and enforcers have to work together to try to interpret the regulation in the spirit in which it was made. Please consult a suitably qualified specialist for further advice.

There are also inter-continental aspects of medicines legislation which this piece will briefly mention and we will also try to disentangle where we stand in relation to other EC and non EC based practitioners where relevant, but most of this piece applies to UK law, where recent changes have occured.

Several different strands of UK and EC regulation have been woven together over recent months, and the only thing that seems clear at the moment, is that this has led to a great deal of confusion amongst practitioners, the health industry and the informed natural-products using general public. It’s hard for anyone to get a clear consensus of what pattern is yet emerging, what the true intentions behind all of it are and how it affects people at different levels of the chain. Finally, it is too early to know how the Courts would interpret any aspects of the regulation.

The prime pieces of legislation regarding the UK are

* The Traditional Herbal Medicinal Products Directive 2004/24/EC, which came into force on 30 April 2004. (Click here for the Wikipedia link)

* The Medicines Act (UK 1968), as amended and specifically Section 12 (1) which exempts ‘herbal practitioners’ from the general provisions of the Act, but only under certain well defined circumstances.

The general provisions of the Medicines Act, brought in after the 1960s Thalidomide tragedy, were and are to enforce extremely rigorous international protocols of quality assurance on all aspects of the medicines industry. Unintentionally, herbalists were caught by this but, fortunately, they were eventually granted an exemption in 1973 (Section 12 [1]), without which they would be unable to practise. That exemption has not been very rigorously policed, mainly because there was ambiguity regarding who was or was not a ‘herbalist’ and so, in order to protect the herbalists’ profession, further changes are now underway within UK law.

The main intended change which has been occurring recently in the UK due to Directive 2004/24/EC is an extreme tightening of the loopholes used by traders in uncontrolled medicinally active plant materials. The Directive arose from the identification by the EC that European herbalists’ exemptions were being used as a cover under which to supply unsafe materials to unsuspecting members of the public. This even resulted in two deaths in Belgium (some years ago).  In order to frame the legislation to work in the UK situation, it subsequently became necessary for the UK authorities to define, at last, who is, and who is not, a ‘herbalist’. This was something that the 1973 exemption had omitted to do. The phrase that is being used to describe this process is ‘Statutory Regulation’ (SR). So although not part of the EC Directive,  SR has arisen in order to allow UK herbalists to practise following implementation of the Directive.

At Rutland, we see two main effects of this:

(i) Herbalists within the UK will continue to be able to buy our ingredients. Whenever in the future  the SR register is established (informed guesses are now not before 2013), this could mean that it may become necessary for us to be provided with some sort of proof that the practitioner is indeed registered to practise, and

(ii) At the end of April 2011, a considerable tightening of the application of the 1973 exemptions occurred. To get a clearer understanding of what this means, it is helpful to look at what the 1973 rule actually said. The UK government, in the form of the MHRA (Dept. of Health) has published the following guidance on their website.

This is only published as a “Guidance” but we believe that the government is taking the opportunity to affirm that the EC Directive clarifies the UK legislation requiring practitioners to personally make their products only from ingredients (para 21)  and clearly sets out the Agency’s opinion with respect to what are ingredients and what are not (paras 22 and 23). In para 23, the MHRA thus states the following:

What counts as an ingredient and what counts as a product?

Examples of what would be regarded as ingredients are:
• Unprocessed herbal ingredients
• Tinctures or extracts the herbal practitioner buys in bulk in order to blend to make products tailored to meet the needs of individual patients.

Examples of what would be regarded as products are:

• Tablets, capsules and other such pharmaceutical finished dosage forms bought in by the practitioner (whether or not the practitioner sources them in bulk)

• Any medicine the herbal practitioner sources in the form and packaging it is to be supplied to the patient.

MHRA cannot cover all possible circumstances in guidance, as the position will depend on the facts of each case. Bear in mind that some pharmaceutical forms, eg a tincture, could be either an ingredient or a product, depending on the facts of the case.

This has always been our understanding and is the reason why Rutland has always focused on the supply of tinctures to herbalists, as being the major form of ingredient that is legal for practitioners to source (as well as being the most efficient way of getting plant extracts into the body). We believe that creams and ointments are typical of what MHRA describes as being either an ingredient or a product, depending on the facts of the case. Our practitioner creams, supplied in large 450g pots are clearly described and labelled as ingredients. A practitioner may change these in any way upon prescribing to their patient on a one-to-one basis (by putting them in smaller jars, or mixing them with other ingredients) and then they are technically making the ingredient into a ‘product’, which they are allowed them to supply, legally, to the patient. Capsules and tablets are regarded as products in themselves and not ingredients and so supply of these from a manufacturer would now require a licence for the individual product. Lack of such licences will mean that, after April 2011, it is illegal for manufacturers to supply many of those pills and capsules that have until recently been used by practitioners. On making up the ‘product’ on a one-to-one basis, the practitioner can only provide it to that one patient. Technically, it would not be legal to make up a batch of cream and put them on a shelf for sale.

(iii) Rutland Biodynamics is also required as a condition of it’s cGMP certification to exercise due diligence in respect of supply of ingredients outside of the UK. This means that we require assurance from our overseas customers that they are buying our ingredients for purposes legitimate within the jurisdiction into which we supply. As we manufacture under cGMP, our products are legal for use as ingredients in any lawful process anywhere in the world that has a supply agreement with Europe.

Back to the UK situation, many herbalists have shops or stalls (either virtual or real) in which they sell products and, in order to help those who also rely on selling well-made and reliably sourced herbal medicines to the public with integrity, we are steadily building up a retail brand of Traditional Herbal Registrations (THRs) called : English Herbal Medicines (EHM). These are finished ‘products’ with General Sales List ‘actives’ (herbs) that can be legally sold from the shop shelf, market stall or supplied to patients unchanged, because they are licensed for retail sale – within the UK only at present. Unfortunately, because these are fully controlled under the Medicines Act, it is extremely hard and costly for us to develop and the process is tortuously slow. You can click here to be directed to the EHM website.

SUMMARY

In summary therefore, we do not see any change whatsoever regarding the supply to practitioners of bulk ingredients, such as tinctures or bulk creams. Furthermore, we do not see any change in the UK professional practitioner being able to mix or alter these in any way they see fit and to dispense them to their patients on a one-to-one basis.

It is plain that capsules and tablets, however, will have to be licensed from the end of April 2011 and we do see a change occurring in the definition of the UK practitioner by the end of April 2012, although the details of that are unclear so far. Because the dispensing of individual prescriptions by manufacturers is covered under the existing law of “Specials Licensing”, we also understand that, as manufacturers, it is illegal for us to dispense prescriptions on your behalf or to send medicines to your individual patients until (a) you are a registered healthcare practitioner (April2012) and (b) we are granted a “specials licence” . We are not aware of any changes regarding supply of ingredients outside UK, although we are vigilant to prevent our products being used other than as permitted in the jurisdiction into which they are supplied.

Finally, it has always been legal for herbalists to grow and make their own medicines for supply to their patients and this is not affected in any way at all. The sale of such medicines to anyone other than directly to their patients (by putting up for sale to members of the public, or to a shop or to other herbalists ) is, however, now controlled by the Medicines Act.

In order to assure the practitioner of a supply of herbal ingredients now and in the future, as the main grower of herbalists ingredients in the country, Rutland Biodynamics went through the extreme pain and expense of developing, achieving and maintaining over the past 6 years, it’s MHRA MIA licence (no. 28255). This is not only your assurance of a ‘legalised future’ but also your present assurance that every batch of all our products have been made under a battery of quality assurance protocols and have been put through a battery of quality control tests.


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