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)