The European Directive on herbal medicines (which effectively bans all industrially-produced herbal remedies) came into force on 1 May 2011 and it looks like the UK is “dutifully” enforcing it. I wrote the letter below to the Department of Health in answer to an anodyne letter from them re-stating the usual points (undeclared pharmaceuticals in some herbal remedies, etc.), in turn received after writing to Mr Cameron and Mr Lansley.
Let us not give up the fight. Let us bring the fight to our elected representatives, not the regulatory agencies. It is them who are ultimately responsible for legislation and they who need to be elected by us. It is them who impose on us the taxes that are used to design, implement and enforce the very legislation that takes our freedom away. Even if they will not repeal the legislation, they can adopt a very “European” solution and that is to quietly ignore it as many European countries do with most European regulations.
June 3, 2011
Customer Service Centre
Department of Health
Richmond House
79 Whitehall
London SW1A 2NS
Dear Sirs,
European Directive on Herbal Medicines
Thank you for taking the time to reply to my letter addressed to Mr Cameron and Mr Lansley. I would like to make a few comments if I may.
1) Firstly, I would like to say that my letter to Mr Cameron made a political point rather than a medical one. We do not need yet another mammoth European Directive meddling into our affairs and I was urging Mr Cameron to reject it especially since he said he does not want to delegate more powers to the EU.
2) You mention the fact that some herbal remedies have been found to contain undeclared pharmaceutical substances as a reason to have the European Directive on Herbal Medicines. With respect, this Directive has nothing to do with that problem. The addition of undeclared pharmaceutical substances to herbal remedies is of course illegal and the MHRA already has the power to stop that practice: we do not need a European Directive for that.
3) Whenever the issue of the European Directive is raised, the MHRA brings up the same issues that are essentially UK issues: so why do we need a European Directive for that?
4) Your letter mentions the licensing of herbal remedies and that sounds very re-assuring. The problem is that no remedy with multiple ingredients (such as Chinese or Ayurvedic ones) can be licensed; so this seems to me like discrimination against Chinese and Indian herbal remedies.
The second problem is cost: the criteria for licensing are such that the cost of registration (per remedy) is extremely high, 50,000 Euros and upwards. That puts it out of reach of most herbal companies, especially those who would need to register many different remedies. Therefore, while the THMD sounds “reasonable”, it is effectively banning herbal medicines and significantly curbing the freedom of the public to choose the treatment they want.
You may say that the MHRA has a duty to “protect” the public, but what if they do not want to be protected and would rather prefer to decide for themselves which treatment they want? Especially in this Internet age, the public are quite capable of “protecting” themselves and make their own decisions about the suitability of a particular treatment. For example, some years ago the Government was trying to convince the public that GM foods are safe and yet the public overwhelmingly made up their own mind about that and rejected GM foods.
5) It seems totally irrational to punish many good herbal companies with excellent quality controls and high quality of products because a very small minority of companies have added undeclared pharmaceutical substances to herbal remedies. This is equivalent to the police forcing all drivers to register at a very high cost simply because a few drivers speed. If I can make a prediction it is this: the THMD will not raise the standard of herbal remedies on the market because it will put out of business very many good companies with quality products and some of the rogue companies that have been adding undeclared pharmaceutical substances will probably continue doing so.
6) In this Internet age when information is readily available, the public does not need to be “protected” by some nanny agency; moreover, what if they do not want to be “protected” and prefer to keep the freedom to choose the treatment they want? I recently got an email from a woman with ovarian cancer undergoing chemotherapy. She had been taking a herbal remedy to minimize the side-effect of chemotherapy with good results. This has now been banned and she cannot have it any longer. Do you not think that she would rather keep the freedom to choose a remedy that is helping her than be “protected” by you? Indeed Mr Richard Woodfield himself is reported as saying (according to the Daily Express): “There are lots of herbal medicines with only partial evidence of efficacy. The consumer is perfectly able to decide for themselves whether or not they wish to take them.”
7) What is so upsetting about this European Directive is that it a gross infringement of our freedoms. We are always told this Directive is aimed at the “protection of the consumer” but it is not so: it has nothing to do with the protection of the consumer and everything to do with the need of regulatory agencies to “regulate” and the need of the bloated European bureaucracy to “regulate” in order to justify their existence. Indeed, such regulatory agencies are also responsible for licensing of medicines and, presumably, licenses are granted after extensive safety studies and clinical trials. And yet, thousands of people die each year from adverse reactions to drugs and, after such safety studies, many drugs have to be withdrawn from the market (see Vioxx). Which is the greater threat to public health: herbal remedies or medicinal drugs? How does the MHRA “protect” the public in this case?
8) There are grave reports about the European Medicine Agency. European MEPs have refused to sign off the European Medicines Agency's accounts, citing "grave" concerns. The MEPs are worried about the Agency’s lack of independence from pharmaceutical companies. The Nordic Cochrane Centre accuses the Agency of working to protect pharmaceutical profits. In a damning indictment of the EMA, of the type many people had despaired of ever witnessing in the closed environment of the European Parliament, an overwhelming majority of MEPs – 637 to 4! – voted not to sign off the EMA’s accounts.
Yours sincerely,
Giovanni Maciocia
