This apparent contradiction is very worrying in its implications, both for transparency in policymaking and for the practice of herbalism in the UK. In this article, we highlight some of the contradictions as well making our own comments. The comments are clearly attributed and bold is used only for emphasis.
The Minister’s position
The statement by Andrew Lansley MP, Secretary of State for Health, gives the strong impression that the government is giving herbalists what most of them wanted: state recognition as “authorised health-care professionals”. This will allow them to continue prescribing unlicensed herbal medicines as they have since 1968, no longer under an exemption in UK law (Section 12(1) of the Medicines Act 1968), but rather under an exemption in European Union (EU) medicines law (Article 5(1), Directive 2001/83/EC).
The crucial phrases of Mr Lansley’s statement are as follows:
Minister:“When the European Directive 2004/24/EC takes full effect in April 2011 it will no longer be legal for herbal practitioners in the UK to source unlicensed manufactured herbal medicines for their patients.”
ANH Comment: When the Traditional Herbal Medicinal Products Directive (THMPD) is fully implemented on 1 May 2011, it will replace a second exemption in UK law, Section 12(2) of the 1968 Medicines Act, which has permitted the sale of manufactured herbal medicines in shops or online. The MHRA has long intended to make this change. Apparent confusion over the distinctions in UK law regarding herbal prescribing and manufactured herbal remedies, and of how EU law affects these UK exemptions, has led to the recent media disinformation on the topic.
Minister:“This Government wishes to ensure that the public can continue to have access to these products.”
ANH Comment: The use of “these products” would tend to suggest that the very same products the consumer used to buy that were produced under the Section 12(2) exemption will now be available via practitioners only. So far, so good: this would be exceptionally good news for consumers and practitioners, and also for manufacturers and suppliers. At this point, it looks like the MHRA under the new Coalition government is prepared to come to a more generous and realistic arrangement than was ever proposed under the previous Labour government.
Minister: “In order to achieve this, while at the same time complying with EU law, some form of statutory regulation will be necessary and I have therefore decided to ask the Health Professions Council to establish a statutory register for practitioners supplying unlicensed herbal medicines. This will ensure that practitioners meet specified registration standards. Practitioner regulation will be underpinned by a strengthened system for regulating medicinal products. This approach will give practitioners and consumers continuing access to herbal medicines. It will do this by allowing us to use a derogation in the European legislation to set up a UK scheme to permit and regulate the supply, via practitioners, of unlicensed manufactured herbal medicines to meet individual patient needs.”
ANH Comment: “…continuing access” would seem to suggest no loss in choice. It is highly significant that the Minister has used the term “manufactured herbal medicines” – surely these should include herbal medicines currently sold under the Section 12(2) exemption, to which he referred above? It is possible that he was referring only to the concept of compounding herbal remedies onsite, which has been allowed for herbalists under the Section 12(1) exemption. Logically, his use of the term “manufactured” dismisses this possibility, as it implies some sort of industrial process – but then, we are talking about politicans here.
Minister:“The four UK Health Departments will consult jointly on the draft legislation once it is prepared. This will give practitioners and the public the opportunity to comment. Subject to Parliamentary procedures we will aim to have the legislation in place in 2012.”
ANH Comment: Statutory regulation fully up and running by 2012? Well that’s a little quicker than some of us thought, given the heel-dragging that has occurred over nearly the last 20 years to get this agreed. History will inform us in due course, in any event.
Minister: “Until the new arrangements are in place the Medicines and Healthcare products Regulatory Agency (MHRA) will continue to take appropriate compliance and enforcement action where products are in breach of the regulatory requirements. In line with the MHRA's normal approach, the action taken will be proportionate and will target products which pose a public health risk.”
ANH Comment: This isn’t bad news. We’re used to seeing the MHRA going after products that are perfectly safe, so at least this priority seems to be the right way around. We’ll have to remind the MHRA of the Minister’s wording if the MHRA start targeting products that are patently safe.
Minister: “Guidance issued by the MHRA makes clear their view that, where practitioners hold stocks of unlicensed products on 30 April 2011 that legally benefited from transitional arrangements under the European Directive, the practitioner can continue to sell those existing supplies to their patients.”
ANH Comment: This would suggest that all stocks of products currently sold under Section 12(2) can be ‘sold through’. It also means manufacturers who hold stock of products exempted under Section 12(2) would do well to put that stock into the hands of practitioners by 30th April 2011. And after this time, the Minister has made quite clear (above) that sales of unlicensed manufactured products will be able to continue via registered practitioners. The government’s proposals really do seem to neatly work around the threat to off-the-shelf herbal medicines represented by the THMPD. Things are looking up…
Minister: “I am pleased to say that this decision resolves a long-standing issue, to the benefit of both practitioners and the public who use herbal medicines.”
ANH Comment: This is half true, but the Minister omits to say that retailers will be the big losers, and that consumers who want to avoid or who cannot afford practitioners’ fees will also lose out. Let alone consumers outside the UK, who will not receive any benefit from what is a uniquely UK-based decision to statutorily regulate herbalists.
Contradictions from the MHRA
All of this would be unreservedly positive for practitioners and patients alike, were it not for some ominous signs coming from the MHRA. Close examination of the MHRA’s statement gives the strong impression that the political spinmeisters have been in action: the Minister issuing a positive, reassuring piece for the media to run with, while the MHRA, responsible for actually implementing the laws, prepares something rather different. Whether by accident or by design, the two stories do not gel.
Let’s now have a look at what the MHRA said in a little more detail:
MHRA: “The proposal is, following creation of this register, to make use of a derogation in European medicines legislation (Article 5 (1) of Directive 2001/83/EC) that allows national arrangements to permit those designated as “authorised healthcare professionals” to commission unlicensed medicines to meet the special needs of their patients.”
ANH Comment: The vital word here is “commission”: this implies that, rather than be able to prescribe unlicensed herbal medicines as they have in the past, herbalists will have to somehow work with manufacturers to produce the herbal medicines their patients need. The MHRA may, in fact, have signalled the end of onsite prescribing. Optimistically, this could mean that herbalists will retain the right to compound and prescribe herbal remedies onsite, providing they use starting materials that are certified to pharmaceutical Good Manufacturing Practice (GMP) standards. However, it may mean that the MHRA wishes to introduce a system of ‘magistral prescriptions’. Magistral prescriptions can be commissioned by medical doctors elsewhere in the EU, although not by herbalists, who are not recognised as “authorized health-care professionals” under EU law in EU member states other than the UK. UK herbalists already make use of a ‘specials’ scheme that is somewhat similar to magistral prescriptions, whereby third-party suppliers are involved in supplying individualised prescriptions.
Herbalists would then be obliged to commission a GMP-certified pharmacist or manufacturer to make products for individualised prescriptions. Also, other than these ‘commissioned’ herbal medicines, herbalists will not be able to prescribe herbal medicines that are not THMPD-registered, which will be illegal and withdrawn from sale. This is like asking a drug company to make tailored herbal medicines for you; you know you’re going to have to pay more – a lot more. Ask any German doctor who prescribes magistral formulae!
The implications of magistral prescriptions
Costs to the herbalist will rise, thereby increasing consultation and prescription charges
Lower socio-economic groupings will be struggle to afford access to herbal medicine
The convenience and efficiency of onsite prescribing will be lost, a tradition that has existed in England since the time of eminent herbalist and botanist Nicholas Culpeper in the 17th century
Health stores will largely be excluded from the regime by being limited to selling a narrow range of THMPD-registered products. Their roles as important community hubs for consumer advice and sale of reasonably priced and diverse herbal remedies will be lost
But we just can’t tell at the moment, so we had best await clarification from the MHRA. The key question is: will it allow the same in-clinic compounding of herbs as has been allowed under the Section 12(1) exemption? Or is it trying to covertly bring in the painfully expensive magistral formula system used in continental Europe?
MHRA:“If practitioner regulation is in place for the purposes of creating an Article 5(1) scheme this also opens the way to reform Section 12(1) of the Medicines Act 1968. Under Section 12(1), practitioners may prepare unlicensed herbal medicines on their own premises for use following consultation with individual patients. It is intended to move to the position that only registered practitioners would be able to operate under Section 12 (1) after regulation of practitioners is in place.”
ANH Comment: This text does not mention Section 12(2) of the 1968 Act at all, and drops the term “manufactured” used by the Minister in favour of the more customary concept of in-clinic compounding, as described by the phrase “prepare unlicensed herbal medicines on their own premises”. Even more interesting, the MHRA is no longer talking about “commissioning” as it did when it was referring to the powers bestowed on “authorised healthcare professionals” granted through EU medicines law (above).
Brilliant! Not only do we see contradictions between the Minister and the MHRA, but now the MHRA appears to contradict itself in its own official statement. No wonder that confusion abounds over the issue of the THMPD and statutory regulation of herbalists, is it? And while people are confused, they are far less able to organise effectively and react appropriately.
Of course, we hope that our fears are unfounded, and that the actual legislation enacting statutory regulation simply maintains the exemption that has been available to herbal practitioners since 1968. Unfortunately, the MHRA’s response in its accompanying Frequently Asked Questions is not encouraging:
Q:"Does this announcement have an impact on the way MHRA implements the European Directive on traditional herbal medicinal products (2004/24/EC)?"
A:"No. The Directive (2004/24/EC) has full effect in the UK as in other Member States. The UK implemented the Directive in 2005. The transitional period under the Directive will end on 30 April 2011. From this date, all manufactured herbal medicines placed on the market must have either a traditional herbal registration or a marketing authorisation (MA). The MHRA has published guidance on its website about the transitional arrangements that apply under the Directive. This guidance continues to apply in full."
No indication here that the new exemption will include “manufactured” herbal medicines as defined in Section 12(2), and which were at first glance referred to by Andrew Lansley MP in his Ministerial statement.
Is the wool being pulled over our eyes?
What’s going on here? One would assume that Andrew Lansley, as Secretary of State for Health and the MHRA’s ultimate boss, is the man to believe on matters of forthcoming legislation. Unfortunately, recent experience in the case of water fluoridation gives reason to believe that policy statements from Ministers are all too often sacrificed on the altar of political expediency.
The laws that will institute statutory regulation have not been written yet, and much can change between now and then. Witness the fluoride case, where a stone-cold promise that local residents would have the final say on whether their water would be fluoridated was quietly written out of the eventual laws. We hate to say it, but the same could be happening here: the government has released a loudly trumpeted statement, apparently meeting the herbalists’ long-standing demands and heading off a grassroots revolt over the availability of herbal medicines. In the meantime, the ‘confused’ UK media sows more disinformation to throw people off the scent.
We must all be supremely vigilant to ensure that the final shape of statutory regulation is recognisable from the broad sketch we were given by the Minister last month. That’s clearly what the people want, it’s what herbalists want, and it’s what we need to fight for every step of the way.