The end to herbal remedies in Europe?

By Siouxsie Wiles 03/05/2011 17


Hidden amongst the hysteria of the royal wedding, the EU Directive on Traditional Herbal Medicinal Products came into force. Actually, it came into force in 2005 but there has been a ‘transitional period’ which ran out at the end of April. The Directive requires traditional, over-the-counter herbal remedies to be made to assured standards of safety and quality and for regulations to be standardised across Europe. This means that manufacturers will have to prove their products have been made to strict standards and contain a consistent and clearly marked dose*.This sounds like common sense to me but herbal practitioners and manufacturers are up in arms saying it will drive them out of business and ‘force’ patients to take Big Pharma products.

I was very sad to see the organisation Avaaz jumping on the band wagon. Their petition, which over 600,000 people have already signed, states:

As concerned EU citizens, we call on the Commission to amend the THMPD Directive, suspending the draconian measures against herbal medicines and removing all barriers to traditional remedies with a long history of use inside and outside Europe. We further call on our governments to refuse to comply with this Directive until it is amended. We have a right to choose among all remedies and medicines that can keep ourselves and our families healthy.

Avaaz, and everyone else I suspect, is blowing this completely out of proportion. Why should such products not be made to appropriate standards of quality control? This is a pro-consumer law that brings the herbal remedy peddlers in line with other industries. No one is signing petitions to stop corn flakes from being manufactured safely, so why should they be any different? It’s not even clear to me if they have to show any efficacy! Now that would be a challenge.

I think the thing that annoys me most of all about the herbal/supplement/vitamin industry is the myth they perpetuate that they are the underdog, fighting against Big Pharma. News flash! Big Herba is a billion dollar industry too, they just don’t have to spend as much of their billions on R&D, quality control or efficacy trials.

So did all unapproved natural remedies disappear from the shelves over the weekend? What do you think! Apparently, unapproved products will be allowed to stay on the shelves until their expiry date. I can’t help but wonder if there might have been some last minute reprinting of labels…

*What this means for homeopathic products is anyones guess…

PS I urge everyone to contact Avaaz and ask them to rethink their campaign.


17 Responses to “The end to herbal remedies in Europe?”

  • It’s a pity but the numbers aren’t really that impressive to my mind, esp. bearing in mind that on-line polls are very readily spammed by advocated rounding up their buddies. ~620,000 votes out of over 8 million members and how many Europeans?

    The poll is ‘leading’ in very unbalanced ways, too.

    We have a right to choose among all remedies and medicines that can keep ourselves and our families healthy.

    I believe the Directive is not blocking people’s rights to choose – it’s blocking seller’s from not meeting standards; nor does it ban products in themselves – it just asks that they met standards of evidence.

    Likewise the “Let’s get to 1,000,000” pitch is leading voters in a way no balanced poll would.

    And so on. Point is, if the poll is inappropriately managed, the results are meaningless.

    (Do the results show how many voted against fighting it, or how many visited the ‘vote’ page, but didn’t vote? I can’t see a way to get them, without registering at least.)

    I’ve touched on this directive a couple of times myself. It’ll be interesting to see the impact. (As a last wrote on it, I hope there are quantitative studies tracking the before and after; you’d think there will be.)

  • I have to disagree with this article, only because its the other side to those saying this new law is all doom. this article suggest all is rosey, I would say we are somewhere in the middle and remember if a herb is not on an approved list, the cost to achieve this will be unachievable unless you are BIG business.
    If you write please research and find a balance, opinion is old hat, we are now a world of free-thinking open-minded beings and picking your stance and bedding in is just unacceptable …
    RR

  • ReikiRebel,
    if we are a in a “world of free-thinking open-minded beings”, then we should be able to make an informed choice on the medicines we take. This directive provides people with evidence that these herbal remedies work and that they have been tested. It is unacceptable for a medicine to not label its ingredients or evidence of proven effect. Not providing these violates informed choice and is unethical. However, if they are able to provide the evidence that they work then there should be no problem.

  • Herbal remedies have been under national quality control rules for a long time. Over the last decade, botanicals and extracts have been gradually included in the European Pharmacopoeia, along with some homeopathic preparation procedures.

    The cost concerns are the same as those raised by NZ producers when Oz and NZ governments tried to merge TGA and Medsafe’s regulatory roles about 5 year ago. NZ herbal producers ran a very effective campaign about the increased compliance costs would kill small producers. Herbal formulating counterparts overseas had coped fine, so it’s the consumers who lost out.

    For the curious, the definitive herbal monographs were the German Commission E monographs, but some people used the British Herbal Pharmacopoeia. Versions of these are gradually being assimilated into the European and US Pharmacopoeias, usually with some improvements arising from use of modern HPLC, as is also happening with pharmaceuticals.

    By incorporation into Pharmacopoeia, the quality control is improved, and products meet defined standards, as they have in countries like Germany for decades. Pharmacopoeia monographs have very little to do with efficacy, just consistency and safety for consumers.

  • A friend of mine works for an analytical laboratory. He was given a sample of a “male potency” product to analyse by a customer who had purchased it while overseas, and was starting to feel ill.
    To paraphrase my friend the analysis suggested that the “remedy” had been been “scrapped off the ground in a waste battery dump.” Extremely high levels of lead and cadmium.

    I agree with Jared in that I’m all for INFORMED choice for the consumer. This includes the consumer being able to find out
    1) If the product contains what it says it does
    2) Knowing about any interactions it will have with other remedies/medications
    3) Being aware of any possible adverse reactions (which will be dose dependent)

  • ReikiRebel,

    “If you write please research and find a balance, opinion is old hat, we are now a world of free-thinking open-minded beings and picking your stance and bedding in is just unacceptable”

    Perhap you should follow your own advice and provide some research that justifies the stance that you have taken? It seems a bit hypocritical to chastise someone saying that “picking your stance and bedding in is just unacceptable” when this is exactly what you comment is doing.

  • ReikiRebel

    As I understand it, the directive merely requires that herbal remedies now have to be manufactured to a guaranteed quality and the contents have to be stated on the package. I don’t think there’s any requirement to prove they work, just that they are what they say they are.

    Essentially, it means that herbal remedies now have to have a contents label on the container, guaranteeing what is inside.

    You seem to be saying that if you bought a box of herbal remedies, the label states one thing but the contents are something else, you wouldn’t mind?

    If you bought a box of corn flakes but instead it contained peanut butter, you wouldn’t mind?

    All of the foodstuffs in a (New Zealand) supermarket now have to have a contents label and guarantee of quality; even the smallest of food manufacturers have managed to do so with no problems. Why should manufacturers of herbal preparations have any problems doing the same?

    Why don’t you want a guarantee of what’s inside the box you buy? That’s all this directive requires.

  • The testing regime for pharmaceuticals is still significantly more expensive and comprehensive than for foods. That’s not surprising, given that most food is consumed by healthy people, and pharmaceuticals are consumed by people with ailments.

    Testing in accordance with the European Pharmacopoeia monographs is not low cost, as expensive short-lifetime certified chemical standards have to be purchased regularly. They are often only available from the Pharmacopoeia organisation, and methods must be followed diligently using qualified and trained staff and formally-maintained instruments – allow a $1000 / year just to keep the Pharmacopoeia itself up-to-date, and $5,000 – $10,000 a year for a chromatograph. Minimum cost of an in-house laboratory for quality assurance of a limited range of herbal products could probably exceed $100,000/year.

    The obvious solution is for small producers to use contract labs for most of the final product testing, but that process can have obvious pitfalls, and can become quite expensive.

    It’s true that some small producers could be hurt, and consumers will pay more to have improved quality assurance.
    However, some countries have implemented such testing without killing their herbal products industries.

  • See http://tinyurl.com/3behsc5
    “Germany and France: EU Herbal Directive won’t damage us”
    Because they’ve already had these standards in place for some time, the directive will make no difference in these countries. As Bruce Hamilton has already remarked, some countries have already proved that such regulation does not kill herbal products industries.

  • Bruce Hamilton

    My apologies may be due. I used foodstuffs as a comparison, not intending to imply the process was the same.

    My impression was that the directive requires labelling and quality standards of herbal remedies to be somewhere between the standards of foodstuffs and pharmaceuticals.

    I have to admit that I could be completely wrong – I have huge problems following the language used in the directive!

  • Stuart,
    No apologies are due, except perhaps from me. I didn’t mean to suggest your message was misleading. I was just trying to indicate that the testing regimes of the European Pharmacopoeia are neither trivial or cheap.

    Caution – eye-glazing nausea ahead for the unwary, please just skip the rest…

    The relevant section of the directive is probably ” Products should comply with quality standards in relevant European Pharmacopoeia monographs or those in the pharmacopoeia of a Member State.”

    In general, compendial commissions, like the EP and USP, are modern monopolies They have made serious money selling their monographs in a single volume, which are updated every six months at about $500 a hit ( whether online or hardcopy ). and by selling expensive “certified standards” .

    Botanicals have been in pharmacopeia for decades ( and were dominant in the the early 20th editions ), and analysts must use and have access to the latest edition when testing to any monograph. Over the last few years, botanicals and extract monographs that were in national pharmacopeia/documents ( such as for German Commission E ) have been transferred to the EP. Many firms had already meet the strict national standards, but some smaller firms in other EU nations didn’t.

    The inevitable result of moving to EP/USP is a significant increase in compliance costs, just because the methods are more expensive to implement, and equipment has to be qualified and maintained to more stringent standards.

    There are not different levels of methods, eg instruments for testing foods, veterinary, botanicals, and pharmaceuticals require the same investments in maintenance, calibration, and qualifications, as well as staff trained for each method.

    Another example is the US Food Chemicals Codex, which was published by the National Academies Press every five years. From memory about US$150 + $50 per six month supplement. The USP took over, and it is now US$500 every two years with the six month supplements also more expensive. The updated monographs also specify certified standards from USP.

    It’s not as if US food chemical were harming people because of inadequate chemical monographs or controls, but the “over abundance of caution” mentality prevailed, as well as the USP management seeing another captive market to exploit.

    Food chemical testing was cheaper and adequate, but the quality systems are becoming more like pharmaceuticals, with the concomitant increase in costs that must be passed onto the consumer. Most companies will make the transition, especially if already selling in markets with good controls like Germany.

    Other firms will find solutions for the analytical costs, except for places like NZ, where vested-interest lobby groups have been effective it preventing further regulation.

  • At ReikiRebel,

    The neutraceutical industry is in fact as Siouxsie pointed out a multi-billion dollar industry. Big Herba has megabucks they could and should be putting towards high quality research and ensuring quality of product. They are not because they have not had to, and so make more profit by not doing it. Could this change?

    Remember most drugs investigated by drug companies turn out to be unsafe or not effective after many many millions have been spent on them. We are all impressed with the incredible profits made on viagra or prozac but forget how much has been lost on the other thousand potential drugs developed at the same time. Many companies go under because they weren’t lucky enough to strike gold.

    Herbal products are often not sold for much less, and the companies don’t spend that money on R+D. There is massive profit there. It is no wonder many companies do not want to have to prove the dosage in the bottle, nevermind whether their product works, requiring a high quality trial design (with the very real possibility that some don’t work or are harmful).

    But there are real advantages to a company that shows their product, their extract to be beneficial in a quality trial – they can register the benefit, patent their extract and plaster it on the bottle. Then they have a point of difference.

    It is likely that many neutraceuticals have physiological effects. Why wouldn’t we all like to be able to walk into the health food store and see honest representations of what they are? It is possible that these laws are the beginning of a seachange towards neutraceuticals investigated and marketed with rigor closer to drugs, though I’m not holding my breath.

  • I’m try remember to come back to this, but the aims do mention efficacy, even though they appear to have passed the buck on this (dropped the ball, etc., depending on your view). I’ve written a short draft of a post on this, but haven’t time to verify a few points. It seems to me that there is a lot of confusion over the wider aims of the Directive, and to my reading that the aim don’t appear to be being met by the recommendations offered. (It seems to me that actions recommended are self-contradictory with the aims if you examine the logic.)

  • Efficacy only has to be plausible based on historical use ( 30 years +? ), and is not required to be determined – unless it’s not plausible. If no pharmaceutical claim is made, a safe product may be alternatively registered as a food.

    The Directive is much more about consistent and safe products across Europe to facilitate cross-border trade. This will also facilitate competition and reduce national monopolist pricing.

    Pharmacopoeia monographs try to identify and control active ingredients to ensure products from different suppliers can be used and substituted safely by consumers. They are the basis of most generics. It’s less expenisve to make and test a generic if an approved mongraph exists. The aim is to facilitate trade of herbals as a commodity, and is an update of an earlier directive.

    One relevant section is …
    “(e) the data on the traditional use of the medicinal product are sufficient; in particular the product proves not to be harmful in the specified conditions of use and the pharmacological effects or efficacy of the medicinal product are plausible on the basis of long-standing use and experience. ”

    Efficacy is very expensive to determine, but all new drugs ( including new herbals ), or registration of off-label applications of approved drugs, will require full testing for registration,

  • Efficacy only has to be plausible based on historical use ( 30 years +? ), and is not required to be determined – unless it’s not plausible.

    Surely if you think through this it’s at odds what they stated their aims to be, to provide “the necessary guarantees of their quality, safety and efficacy” for consumers.

    One relevant section is…

    (Just so you’re aware: I’ve already read quite a bit on this. As you’d expect I’ve read the Directive, several times & the obvious associated material.)

    The passage that you cite is one of reason I find their aim and their recommended actions at odds with eachother.

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