Ban on natural remedies in the EU

[gregorach]

If I was to grow garlic for personal treatment and consumption and also to sell as garlic powder for it's antibacterial properties in what way would a certificate aid me in doing so?

The problem with this sort of reasoning is that, whilst you may be both competent and trustworthy (or maybe not - I don't know you), there are lots of other people out there who are neither. The certificate allows you to demonstrate your competence and trustworthiness to your customers.

Caveat emptor is not generally felt to be sufficient consumer protection in any other department of commerce, so why should it be acceptable in this one, in which a mistake could potentially be fatal?

[MKG]

The main issue with this ban, and indeed is a ban...

Damn! - hours of research and I obviously missed it. You'll have to give me a clue, Radu - what, precisely, has been banned?

Mike

[Radu]

MKG - for one "every plant with therapeutic indications will have to be with withdrawn from sale after the 30th of April 2011, all over Europe" but also as I was trying to convey through the different examples of this type of action, the main issue is that this type of regulation does not support local small scale producers but the multinationals and as a result it puts a ban on these small producers (such a nasty term anyway when one has a connection with the land s/he's working and the life teaming around him/her). A ban can be as direct as a law that states that any alcohol sale or consumption is illegal in the whole of the USA or as subtle as regulations that make it too hard to work within such a system.

And I don't know what you mean by competent or trustworthy gregorach (do I need to be an expert in anything to be reflective and opinionated?) but you couldn't have put the issue better: why does one need a certificate to know his neighbor is trustworthy or competent? And if we're talking about something that escapes our sphere of immediate knowledge what is wrong with trusting another small scale producer/consumer in the same conditions as yourself?

Fatal herbal medicine? If one is to eat 2 kilos of chamomile or one too many cloves of garlic before going to bed something nasty could happen but I still doubt fatal. I am not concerned about the, such as nasty as the multinationals, synthesis and concentrated so called alternative medicine but how regulations such as these affect the very small scale peasants such as I like to think of myself in the future.
"Caveat emptor is not generally felt to be sufficient consumer protection in any other department of commerce" - As I said I am not an expert of law and see no need for such a discussion as such when the examples of the works of such "protection" can be seen either in the dumspters of the world and the emergence of a new trend of freeganism over what is seen as unfit for consumption or in the shelves of the same supermarkets who sell products that are still safe for consumption but which in turn are the root cause of such ridiculous terms as "obesity epidemic", premature deaths or pain ridden lives brought about by cardivascular diseases or diabetes. My advice would be to not get caught up in the details and legal terms. And I think I've said all I had to say in regards to this subject. I wish you a good day as we are experiencing now here in Luxembourg, either outside or in the mind and heart.

[MKG]

MKG - for one "every plant with therapeutic indications will have to be with withdrawn from sale after the 30th of April 2011, all over Europe"

This is absolutely untrue, though. There has been no such call and, even if attempted, it would prove impossible to put into effect or police. Such sweeping statements do not help to gain support for an issue.

Mike

[gregorach]

And I don't know what you mean by competent or trustworthy gregorach (do I need to be an expert in anything to be reflective and opinionated?) but you couldn't have put the issue better: why does one need a certificate to know his neighbor is trustworthy or competent?

If it's your neighbour, then no, you don't, and no EU law can stop you anyway. The law cannot effectively control private sales, so there's no point worrying about that - I seriously doubt they're going to be sending in the SWAT teams over this. There's plenty of "herbs" which you're not even legally allowed to posses, yet nobody who wants them has much trouble getting hold of them...

What I mean by "trustworthy and competent" is simply the question of whether you actually know your chamomile from your digitalis, and whether or not you're actively trying to defraud people by selling them chalk and telling them its flour. Once you start getting into commercial sales, frequently over the internet, you can't take such things for granted. As it currently stands, I could sell home-made tincture of belladonna (on a commercial scale) as a herbal remedy for indigestion, and if I don't take great care in preparation, it could easily kill people.

If you're genuinely not aware that there are many plants which are potentially deadly, I'd seriously advise you to educate yourself more thoroughly before getting too carried away with your home herbalism. Especially with the Umbelliferae - there's some really nasties in that family.

I am not concerned about the, such as nasty as the multinationals, synthesis and concentrated so called alternative medicine but how regulations such as these affect the very small scale peasants such as I like to think of myself in the future.

I'll tell you how regulations such as these affect the "very small scale peasants": not at all. Seriously, they're not going to be kicking your door in looking for your chamomile tea.

[greenorelse]

Here's what my local herb nerd has to say:

As of 30th April an EU directive concerning the sale of herbal products (e.g. echinacea, ginseng, valerian etc) in shops will come into force. This directive is called the Traditional Herbal & Medicinal Products Directive (THMPD) Directive 2004/24/EC. Most people are blissfully unaware of this but it was actually drawn up in 2004 and is due to be fully-implemented in 10 days' time.

The general public and indeed, most MEPs are unaware of this because no vote was ever taken on it: it was brought in by an EU sub-committee and so it by-passed the usual process of debate and vote.

Under this new legislation, all herbal products on the market must now have a THMPD licence if they are to be continued to be sold after 30th April.

What's the problem with the licences?
There are numerous problems. I'll out-line the biggest ones.

The cost of the licences. E80,000-E150,000 per product! Most herbal companies are small and have a wide-range of herbal products that they sell small amounts of. I guaruntee you that there isn't a herbal company in the world that can afford to licence it's full range of herbal products in every country in the EU.
Despite being an EU regulation, anyone wanting to apply for a licence must apply and pay for it in every EU country that they wish to sell the product in.
The cost of implementation: Even if a company can raise the cash to apply for the licence, the criteria that the companies need to meet in order to conform to the terms of the licences are similar to those of pharmaceutial standards i.e. the costs are very high to upgrade to standards that are totally unnecessary and inappropriate for herbal remedies. (Pharamceutical drugs are new compounds that haven't existed in the wrold before and so need to be rigorously tested. Herbs are not: they are far closer to foods and we already have vast amounts of safety info regarding them from our history of using herbs as foods and medicines).
Evidence of therapeutic use. A company applying for a licence has to produce evidence that the herb has been used therapeuically. However historical and traditional evidence is not acceptable, only scientific research papers. The majority of info about herbs comes from a history of traditional use (millenia of traditional use in fact!). Many herbalists and herbal companies would love to have scientifc research papers to validate the traditional uses of herbs and learn more about how they work. However, the reality is that such research is extremely costly and is far beyond the reach of the herbal companies and practitioners. Natural remedies cannot be patented so do not generate huge profits. Pharmaceutical drugs can and do.
No product that contains a blend of herbs can receive a THMPD licence. This means that Chinese and Ayuvedic herbal products cannot be licenced because they are pre-blended.
I could go on......

What does this mean?
Compared to the number of herbal products currently for sale in shops, very few THMPD licenses have been applied for. In the UK about 180 licences have been applied for and to date only 79 have been approved. To see the list of approved products click this link http://gaia-health.com/articles401/0004 ... list.shtml

In Ireland so far only about 30 licences have been applied for.
This means that most herbal products will no longer be available for sale in shops. Recent estimates expect that 80-90% of the current range of herbal products sold in shops will disappear. In most EU countries these products will disappear after 30th April. In Ireland shops will be allowed to sell off any remaining stock purchased before 30th April so this means that the products will gradually reduce and fully disappear by the end of 2011 after which date the Irish Medicines Board will no longer allow shops to sell unlicensed products.

Chinese and Ayuvedic Herbal blends will totally disappear from shops. Because the THMPD has been written from a pharmaceutical rather than a herbal perspective, the regulation does not allow for products that contain a blend of herbs (such as Chinese and Ayuvedic remedies) to receive a licence. To date not one single Chinese or Ayuvedic product has been approved for a THMPD licence.

There are also serious negative economic consqeuences. If shops have a far smaller range of herbal products for sale then it is likely that their turnover will go down and some shops could well go out of business. This would also impact on couriers and wholesalers who would have less work too. And this at a time when Ireland is already in a desperate financial struggle.

What we think it means
We expect that people will still be able to obtain herbs from consultations with herbal practitioners. In the UK Herbal Practitioners are in the process of being recognised by the goverment. This recognition as health care professionals will allow them to continue to prescribe herbs to their patients after the THMPD comes into force on 30th April. Practitioners in Ireland hope that something similar will come in here too. You can find your nearest herbalist on my website http://www.theherbalhub.com under the Herbal Directory section.

What this won't mean
So much confusion has arisen from this situation that some emails and petitions have been circulating saying that all courses and books on herbal medicine and all medicinal plants will be banned. I'm delighted to inform you that this is NOT true. So, after the 30th April it will still be legal to:
Buy books on herbal medicine
Attend courses on herbal medicine and remedy-making
Grow medicinal herbs
Prepare your own remedies from medicinal herbs (it would just be illegal to sell them unless you apply for a THMPD licence)

and here's another petition for you to sign:

http://www.gopetition.com/petition/39757.html

[MKG]

Good post, greenorelse - and a pretty balanced viewpoint from your "herb nerd". This bit was disarmingly honest (a rarity in discussions such as this, although I've read it before) ...

"What this won't mean
So much confusion has arisen from this situation that some emails and petitions have been circulating saying that all courses and books on herbal medicine and all medicinal plants will be banned. I'm delighted to inform you that this is NOT true. So, after the 30th April it will still be legal to:
Buy books on herbal medicine
Attend courses on herbal medicine and remedy-making
Grow medicinal herbs
Prepare your own remedies from medicinal herbs (it would just be illegal to sell them unless you apply for a THMPD licence)"

Just one small thing - the last point is in error. It would be illegal to sell such products (without a licence) as a third-party supplier. It would most certainly not be illegal to prepare your own remedies (as a herbalist), prescribe them (as a herbalist) and supply them, in return for payment, to a patient who agrees to the treatment.

To be perfectly frank, anyone who buys and re-supplies third-party material for human consumption without knowing what they are actually buying and supplying should be spending time behind bars. If anyone can convince me that such knowledge is attainable without regulation, then I'm up for it. I've seen no such evidence yet. Simply because I sell a consignment of stuff labelled "Tincture of Mint" does not mean that there's nothing else in there - or even mint in there. In the days when the original supplier was someone from the next village, a swift smack in the mouth would have sorted any problems. When the original supplier is in China, my alarm goes off.

Yes, regulation (and consequent inspection) means expense for third-party suppliers. Yes, that lets in the "Big Pharma" companies. No, small garden-shed producers will not be able to afford full licencing and will go out of business. Yes, welcome to the real world. Is there any good reason why I should trust the word of a herbalist I've never met before? Or that of a solicitor? (There I go again). Or anyone else? People, when faced with profit, will do the most amazing things. Risking my health is not one of those things which I'm prepared to allow. I would love to live in a society in which I felt that people, overall, were basically honest and trustworthy. Unfortunately, I don't. My experience tells me that if I saunter through life trusting lots of people I don't know to do things for me about which I know nothing, I will be well and truly screwed. Deservedly so.

Having worked through several applications of swingeing regulation in my working life, I can see the logic behind it. Sometimes, I agree, it goes well over the top - that usually gets worked out within the first few years of regulatory control. Most times, there are casualties. Those casualties, however, are almost always borderline operators. It's the way of the commercial world (and let's not pretend that the world isn't commercial). Got a good product? Marketable? Can't afford to get into mainstream production? Go to the bank. Go to a Dragon's Den denizen. Go to your family. That's how it's done, and that's how it's always been done.

Herbalists - those people who genuinely want to help other people - are not threatened in any way by this legislation. Those who are threatened will be, in the great majority of cases, bandwagon-jumpers and crooks. I don't want to spend a part of my life arguing for the rights of such creatures.

Mike

[Green Aura]

http://www.heraldscotland.com/news/home ... s.17295890

And so it starts. No evidence that any products they sell are ineffective, dangerous or anything else - they simply can't afford to comply with the legislation.

[gregorach]

http://www.heraldscotland.com/news/home ... s.17295890

And so it starts. No evidence that any products they sell are ineffective, dangerous or anything else - they simply can't afford to comply with the legislation.

Note that their problems are attributed to "a fall in sales and increased costs to license products in line with EU law." (My emphasis). Later in the article the liquidator says:

There have been issues with a downturn in trade and a number of long-term leases on some of the other clinic locations. We are using the liquidation procedure as part of a larger restructure to allow a business to continue.

"The legal entity of Napiers the Herbalist Ltd, which is the one in provisional liquidation, has ceased trading. A number of the individual practitioners have got together and set up a new company and they are going to continue to provide the service to their clients. The business will continue, but just in a slightly different format.

From reading the article, I really don't think it's at all clear that their problems really stem from this legislation. Lots of business are having a tough time of it at the moment. What is clear is that the practitioners are still practising. You can still buy exactly the same herbal remedies from exactly the same people, just under a slightly different business structure.

[Green Aura]

Yup. How much of the downturn can be contributed to them not being able to sell OTC items we'll never know. In a downturn those seeking 1:1 treatments will surely dwindle. Unfortunately the article is, as usual too brief, but makes clear links to the legislation.

[gregorach]

Unfortunately the article is, as usual too brief, but makes clear links to the legislation.

Well, yeah, but whether that's because it's a good analysis of the situation or just a convenient journalistic hook into a well-established narrative (c.f. bendy bananas etc.) we'll never really know.

[MKG]

I think the last paragraph of the article says it all ...

"Dee will continue trading from the original shop at Bristo Place, which Duncan Napier began back in 1860, as well as the Glasgow shop. She will continue to see patients and run the clinics and dispensaries. She will continue to make up special mixtures and provide unique and personal health care options."

That suggests to me that it isn't the legislation at all which she has suffered from, otherwise it would still apply and she wouldn't be running the business even in a reduced form.

Mike

[Green Aura]

Actually that's the bit that suggests otherwise, Mike.

make up special mixtures and provide unique and personal health care options."Mike

This is the 1:1 part of the business. The over the counter recipes, like the original Napiers Cough Mixture mentioned earlier that are now banned unless she can afford the £kkkkkkks (OK, slight exaggeration there )

These are the items that probably help keep the business ticking over in harder times.

[MKG]

You've got me stumped now, GA - it says that she will CONTINUE to do that Oh - sorry. I see what you are saying now. But it's precisely those over-the-counter remedies which NEED to be controlled. I have no idea how that cough medicine was made, nor from what it was made, despite any labelling claiming whatever they like to claim. They may even make it to the highest possible standards, but how would I know what testing they carry out on their bought-in ingredients? However, she is STILL allowed to sell it to a patient who visits her specifically for a consultation, as it's her own company which makes it.

From the MHRA ...

"Current requirements
Section 12(1) is commonly referred to as the 'herbalist exemption' and permits unlicensed remedies to be made up and supplied by a practitioner to meet the needs of an individual patient following a one-to-one consultation...

Section 12(1) remedies are not subject to a regime of specific safety or quality requirements. There are no restrictions in terms of those who operate under the regime. Anyone - irrespective of qualifications or experience - can practise herbal medicine and, after making a diagnosis and forming a judgment about the treatment required, can make up and supply an unlicensed herbal medicine...

Proposals for reform
Proposals for reform of Section 12 (1) are being developed alongside the DH led work on regulation of the herbal medicine profession.

On 16 February 2011, a DH announcement was made about regulation of practitioners.

The Health Professions Council (HPC) will establish a statutory register for practitioners supplying unlicensed herbal medicines."

Which all seems common sense to me. The only thing which has an outright ban is the manufacture or supply of unlicensed herbal medicinal products for over-the-counter sale or sale to a third party. A herbal practitioner (soon to be a qualified herbal practitioner) can prescribe (and charge for) any legal herbal material in any mixture to treat specific conditions after a personal consultation.

I wouldn't want to visit an unqualified doctor who prescribed an unregulated treatment. Nor would I want to buy a self-prescribed proprietary treatment unless I was confident that it had been manufactured under a strict safety regime. Why should I want to change that common-sense stance merely because it's "herbal"?

Mike