Thursday, April 28, 2011


On 1 May 2011, the European Directive on Traditional Herbal Medicinal Products 2004/24/EC will come into force. This Directive has far-reaching (negative) consequences for acupuncturists, herbalists, the herbal medicine industry and consumers of herbal medicine. Quite simply, this is a draconian Directive that limits our freedom to use herbal medicines as practitioner and consumers. Make no mistake, contrary to what our bureaucrats are telling us, this Directive has nothing to do with the protection of the consumer: it has everything to do with the desire and need of Eurocrats to regulate and control.

In this age of the Internet when high-quality information is readily available, the consumer is perfectly able to satisfy him- or herself about the standard of quality controls and efficacy of a particular herbal remedy. For example, hundreds of clinical studies on herbal medicines are available online.

The main motivation for this draconian European Directive is the European political and administrative class’s pathological need to regulate. In the European mindset, anything that is not “regulated” is assimilated to “illegal”. The European bureaucracy needs to regulate to justify their existence and paradoxically, we, the victims of this legislation, are even paying their salaries through taxation. Have you heard that the European Commission has asked for an increase of 5% in their annual budget? At a time when all over Europe (and especially in Ireland, Greece and Portugal) populations are suffering under a regime of economic “austerity” and drastic cuts!

The second reason for the ban is, sadly the lobbying by the powerful drug companies. Hannan says: “Whenever an apparently absurd law of this kind emanates from the EU, ask yourself cui bono — whose interest does it serve? In this case, there is no mystery: the directive was openly lobbied for by large pharmaceutical companies, which saw an opportunity to put their smaller rivals out of business. Not for the first time, big corporations have used the EU to push through rules which national assemblies would never have countenanced. MPs were left in no doubt about how their constituents viewed the proposal. But Brussels fonctionnaires are invulnerable to the ballot box: the EU was designed, in the aftermath of the second world war, precisely to shield them from public opinion”.1

When asked why we need this Directive, regulators churn out always the same trite things: some Chinese herbal remedies contain undeclared medicinal drugs, some have high levels of heavy metals, etc. This is true (although the percentage of above remedies is a tiny proportion of the total), but there are already existing laws against such practices. Such practices could easily be stamped out using existing legislation without this draconian European legislation. In fact, the result of this legislation will be the exact opposite of what it purports to do. A tiny minority of companies will probably continue selling remedies that are already illegal while many reputable herbal companies who do not, and never have, used such practices will be driven out of business. Moreover, as in usual European style, each country will do what they want, we will have the absurd situation that consumers in one country will be able to buy unlicensed herbal remedies online from another European country: hardly a desirable outcome.

By the way, do you know that the long delay (7 years) in the implementation of this Directive was deliberate? Hannan says: “The ban was voted through the European Parliament seven years ago but, as so often, Eurocrats built in a delay, knowing that national ministers were far more likely to agree to an unpopular measure that would blow up in the laps of their successors”. Indeed, in the UK, the Directive was approved by the Blair Labour Government and it has now blown up in the face of Cameron’s Coalition Government.

Why do we need such Directive?
• Six million people in Britain have visited a herbalist at some point in the past two years
• Two million regularly use alternative treatments as a first resort
• Herbal remedies account for just 0.4% of reported adverse reactions.

In theory, the EU Directive sounds reasonable. It is not “banning” herbal medicines: it is “merely” establishing rules for their “licensing”. In practice however, the licensing requirements are such that no remedy with multiple ingredients (such as Chinese or Ayurvedic medicines) can get a licence because it is impossible to meet the criteria for registration.

Secondly, cost. The licensing of each remedy would cost about between € 50,000 and € 100,000 Euro ($ 74,000-148,000) which is therefore impossible to bear for the overwhelming majority of herbal suppliers. Therefore, the practical effect of this legislation is indeed to ban herbal remedies (and, by the way, increase unemployment).

The result of this Directive is that:
• A third-party dispensary service (Product Supplier) can no longer make up individualised raw and powdered prescriptions, batches of pills or capsules
• Patent herbs will no longer be available to any practitioners, whether state regulated or not and will disappear from the UK/ European market. Over-the-counter herbal remedies also will not be available to consumers
• Only health professionals who are statutorily regulated can prescribe or sell “finished” unlicensed medicines and even that is up in the air in the UK

It is ironic that such restrictions on the use of herbal medicines are being introduced at the same time as more and more powerful and dangerous previously prescription medicinal drugs are being de-regulated and sold over the counter without prescription. Such drugs cause a 100 times more side effects and adverse reaction than herbal remedies. This proves that the European Directive has nothing to do with protection of the consumer.

In my opinion, we should fight this European Directive tooth and nail on political rather than medical grounds because that is what this Directive is inspired by. We can argue for the next 10 years that herbal remedies are intrinsically safe but the regulatory authorities will always come back with the same old excuses: undeclared drug ingredients, heavy metals, the one patient who got liver failure years ago, St John's Wort induces cytochrome P450, etc.

It is also a losing battle to argue the medical case with regulatory authorities (although necessary and we should continue doing that) because they are not elected and have a vested interest in “regulating” and “licensing”. By contrast, politicians are elected and all they are interested in is being re-elected. They are therefore more sensitive to the political case: we should tell them en mass that we are not going to vote for them if they do not scrap this Directive.

Why should Eurocrats decide what I can and cannot take for my health? It is a fundamental issue of freedom and we should demand our freedom!

It is ironic that this freedom-killing European Directive is coming into force on 1 May, the day when traditionally the peoples of Europe celebrate freedom and workers’ rights…

1. Daniel Hannan: Allergic to Freedom Why is Europe taking up arms against herbal remedies? (12.03.2011)

2. Daniel Hannan: Allergic to Freedom Why is Europe taking up arms against herbal remedies? (12.03.2011)