I received a letter this morning from the Rt Hon. John Bercow MP informing me of a recent update regarding herbal medicine from the Rt Hon Andrew Lansby MP, Secretary of State for Health at the Department of Health.
It says, When the European Directive 2004/24/EC takes full effect at the end of April 2011 it will no longer be legal for herbal practitioners in the UK to source unlicensed manufactured herbal medicines for their patients.
What does this mean for us? The consumer who relies on some of these amazingly clever little herbs to stay healthy?
The letter goes on to state “the government wishes to ensure the public can continue to have access to these products. In order to achieve this, while at the same time complying with the EU law, some form of statutory regulation will be necessary and I have therefore asked the Health Professions Council (HPC) to establish a statutory register for practitioners supplying unlicensed herbal medicines. This will ensure that practitioners meet specified registration standards. This will be underpinned by a strengthened system for regulating medicinal products. This approach will give practitioners and consumers continued 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 manufacturerd herbal medicines to meet individual patients needs.
So we’re going to have a UK permit scheme that regulates the supply and allows access to unlicensed herbal medicines – what does that mean for all our herbal practitioners and all the companies who currently sell medicines in health food shops and over the internet?
The letter goes on to explain: The HPC is an established and experienced statutory regulatory body with the necessary experience to successfully establish and maintain a statutory register. Subkject to parliamentary approval, all herbal practitioners who wish to supply unlicensed herbal products will be required by law to register with the HPC. Once prepared, the UK Health Departments will consult jointly on draft legislation, providing practitioners and the public the opportunity to comment. Subject to Parliamentary procedures, we will aim to have legislation in place in 2012.
Until the new arrangments 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 MJHRA’s normal approach, the action taken will be proportionare and will target products which pose a public health risk. 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.
Bear with me, it’s a very long letter and I don’t want to miss out anything important, so we continue…
The 2009 consultation also looked at practitioners of acupunture. The practice of acupuncture is not affected by the EU Directive and, therefore, compliance is not required. I am confident that acupuncturists have their own voluntary regulatory measures in place which are sufficiently robust. Additionally, local authorities in England have powers to regulate the hygiene of the practice of acupuncture, to protect against the risk of transmission of certain infectious diseases. Similar measures are also in place in Scotland, Wales and Northern Ireland.
Andrew Lansby finishes by saying: I am pleased to say that this decision marks a significant milestone. I am confident that this is the right decision, benefitting both practitioners and the public who use herbal medicines.
THE END.
So who and what will be effected? Acupuncture will remain unchanged and not effected by this new legislation, but what about homeopathy? Will we see the end of certain herbs on our shelves? Will some practitioners be forced out of business? Is this legislation good or bad? Will the industry now be safer? I guess at this stage it’s still pretty vague. We still don’t know exactly what the new arrangements will be, nor what the new guidelines will regulate and restrict. What do you think? A positive move forward as Andrew Lansby CBE believes? Or bad news for herbal practitioners and herbal remedy users nationwide?
I just bought some supplements, echinacea etc.and prices seem to have gone up by loads. Anyone else noticed this?
I am not sure about vitamins etc, but herbal medicines will have to be licensed, if they are to continue to be available in shops after 30th April. The process of licensing a herbal product is costly. I have seen figures quoted in the region of £50,000 to £100,00, plus £12,000 to £15,000 for each product. If a manufacturer is making 30 products, that is a cost of something like £400,000 to £500,000
Hi David. Gosh that is expensive isn’t it? It will surely force some manufacturers out of the market and have a knock on effect for consumers.
The effect will undoubtedly be that some herbs will be more difficult to buy from shops, and it will more difficult to bring new herbs to the market, particularly those with little or no history of traditional use in market. Although public choice will be reduced, public safety will be increased.
However, registered i.e. qualified herbalists will continue to have access to unlicensed herbs, which they will be able to prescribe and supply to their patients, following a consultation. Up until now, anyone could practice as a herbalist. Although incidence of clients being harmed are rare, when they have occured, they have usually happened when unqualified people have dispensed herbs, or when people have self medicated with herbs.
The net effect of the new regulations should therefore be that the public will continue to have access to the herbs they want, but through a qualified herbalist, who will be responsible for making sure that the herb is suitable for individuals, taking into account their medical condition, medications etc.
Hi David. Thanks for commenting. It will be really interesting to see if any studies are conducted to actually prove that herbal medicine works, and works well, without the side effects of man made drugs. I can see there will be some definite positive outcomes from these new regulations and perhaps it will even mean the herbalists and herbalism are taken more seriously and also used as part of referral by NHS etc.
The THMPD (April 2011) does not stop herbalists from having access to unmanufactured herbal medicines, it only stops them having access to manufactured products that do not have a new traditional registration and ‘specials’ mixes ordered by a herbalist from a third party.
Herbalists can still order and mix up their own herbal medicines, under 2dc 12(1) of the 1968 Medicines Act.
Unfortunately the pro SR herbalists have mislead the Government. Once (if) herbalists become state regulated then the MHRA will change sec 12(1) and unregistered herbalists will then be totally without their herbs!!!
THMPD was enacted into UK law in 2005 with a breaking in period lasting til April 2011, this will see hundreds of herbal medicines taken from our shelves due to the expense of applying for a license. The pro SR herbalists have known about this law for some time and at first welcomed it!!!!!
this whole process benefits the pharmaceutical companies who have raged against natural medicine for years, they will be the ones who can afford the licences and will now begin to introduce their own form of herbal medicines, containing god-knows-what, does anyone know if we can grow our own at home from seed? thanks