EMERGENCY FORUM, BRUSSELS, 21st June to save herbal medicine: be there or view on internet
The Alliance for natural Health, the European Parliament CAM Interest Group and other campaign groups will be in the European Parliament in Brussels to question European regulators, along with concerned Members of the European Parliament (MEPs), over how they are handling herbal products in Europe. The questions will be raised in an emergency forum organised by Greens MEPs.
But this is your chance to ask your own questions! If you can make it to Brussels, please be there. It would be amazing to stuff the seminar room full of concerned citizens to really show European regulators the extent and depth of concern.
If you can get to the European Parliament in person next Tuesday for around midday in readiness for a 13:00h start, you will need to register by sending your full name, address, your passport number and date of birth to michele.rivasi@europarl.europa.eu and satu.hassi@europarl.europa.eu by 16:00h Central European Time, Friday 17 June 2011. It would be wonderful to see as many of you there as possible! Access to the European Parliament can be gained via the Altiero Spinelli entrance on Rue Wiertz 60, B-1050 Brussels (see ASP on map).
If you can't be there, you'll be able to watch the debate live between 13:00-16:00h Central European Time via the following livestream link:
http://greenmediabox.eu/live/thmpd/
We know this is very short notice - but this is an emergency conference, and the scheduling, venue and details have only just been agreed and received by us, which is why we have wasted no time getting this out to you.
Please get this message out as widely as possible to all those you know in Europe (and beyond of course for those who want to view the livestream) who are as concerned as we are.
Showing posts with label European Herbal Directive. Show all posts
Showing posts with label European Herbal Directive. Show all posts
Thursday, June 16, 2011
Sunday, June 12, 2011
European ban of herbal remedies - UK
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
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
Thursday, April 28, 2011
A BLACK DAY FOR FREEDOM IN EUROPE, A SHAMEFUL DAY FOR THE EUROPEAN UNION
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: www.spectator.co.uk Allergic to Freedom Why is Europe taking up arms against herbal remedies? (12.03.2011)
2. Daniel Hannan: www.spectator.co.uk Allergic to Freedom Why is Europe taking up arms against herbal remedies? (12.03.2011)
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: www.spectator.co.uk Allergic to Freedom Why is Europe taking up arms against herbal remedies? (12.03.2011)
2. Daniel Hannan: www.spectator.co.uk Allergic to Freedom Why is Europe taking up arms against herbal remedies? (12.03.2011)
Wednesday, February 16, 2011
GOOD NEWS FOR HERBAL MEDICINE IN THE UK
There are good news from England in the fight to preserve the freedom to prescribe herbal remedies. As a background, herbal practitioners have been fighting to obtain a derogation from the upcoming European Directive so that they would be able to prescribe unlicensed remedies. This derogation revolved around them being statutorily registered: we have now obtained this.
The UK Secretary of State for Health has made an announcement today about regulation of herbal medicine practitioners. The issue of whether or not practitioners of acupuncture, herbal medicine and traditional Chinese medicine should be statutorily regulated has been debated since the House of Lords Select Committee report on Complementary and Alternative Medicine in 2000.
The Health Professions Council (HPC) has now been asked to establish a statutory register for practitioners supplying unlicensed herbal medicines. The proposal is, following creation of this register, to make use of a derogation in European medicines legislation (Article 5 (1) of Directive 2001/83/EC) that allows national arrangements to permit those designated as "authorized healthcare professionals" to commission unlicensed medicines to meet the special needs of their patients.
Accordingly, a scheme would be created enabling registered practitioners to commission unlicensed herbal medicines to meet the special needs of their individual patients. Safeguards for the public would be provided by a combination of professional regulation and linked medicines regulation, for example, to safeguard manufacturing standards.
If practitioner regulation is in place for the purposes of creating an Article 5(1) scheme this also opens the way to reform Section 12 (1) of the Medicines Act 1968. Under Section 12 (1), practitioners may prepare unlicensed herbal medicines on their own premises for use following consultation with individual patients. It is intended to move to the position that only registered practitioners would be able to operate under Section 12 (1) after regulation of practitioners is in place.
A formal consultation exercise will take place on specific legislative proposals for establishing the register and proposed reforms of medicines legislation later in 2001.
I think we all owe the European Herbal Practitioners Alliance (EHPA) and its chairman Michael McIntyre a huge debt of gratitude. In particular, Michael McIntyre has been fighting tirelessly for the past 10 years in defence of herbal medicine in England and Europe.
The UK Secretary of State for Health has made an announcement today about regulation of herbal medicine practitioners. The issue of whether or not practitioners of acupuncture, herbal medicine and traditional Chinese medicine should be statutorily regulated has been debated since the House of Lords Select Committee report on Complementary and Alternative Medicine in 2000.
The Health Professions Council (HPC) has now been asked to establish a statutory register for practitioners supplying unlicensed herbal medicines. The proposal is, following creation of this register, to make use of a derogation in European medicines legislation (Article 5 (1) of Directive 2001/83/EC) that allows national arrangements to permit those designated as "authorized healthcare professionals" to commission unlicensed medicines to meet the special needs of their patients.
Accordingly, a scheme would be created enabling registered practitioners to commission unlicensed herbal medicines to meet the special needs of their individual patients. Safeguards for the public would be provided by a combination of professional regulation and linked medicines regulation, for example, to safeguard manufacturing standards.
If practitioner regulation is in place for the purposes of creating an Article 5(1) scheme this also opens the way to reform Section 12 (1) of the Medicines Act 1968. Under Section 12 (1), practitioners may prepare unlicensed herbal medicines on their own premises for use following consultation with individual patients. It is intended to move to the position that only registered practitioners would be able to operate under Section 12 (1) after regulation of practitioners is in place.
A formal consultation exercise will take place on specific legislative proposals for establishing the register and proposed reforms of medicines legislation later in 2001.
I think we all owe the European Herbal Practitioners Alliance (EHPA) and its chairman Michael McIntyre a huge debt of gratitude. In particular, Michael McIntyre has been fighting tirelessly for the past 10 years in defence of herbal medicine in England and Europe.
Thursday, December 9, 2010
APPEAL TO EUROPEAN HERBAL PRACTITIONERS
I would like to remind all European herbal practitioners of the looming dangers of the European Union (EU) “Directive” called “Directive on Traditional Herbal Medicinal Products” (THMPD) coming into force in April 2011. This “directive” (note the Soviet-style sound of this word) is the greatest threat to herbal medicine. The EU Directive (formulated and enforced by the unelected and unaccountable European Commission) sets new over-the-counter (OTC) standards adopted in April 2004 with requirement for full implementation by April 2011. In the UK this will replace S12(2) of 1968 Medicines Act for OTC products (see below).
The Traditional Herbal Medicinal Products Directive (THMPD) comes fully into force in April 2011. After this time, only herbal medicines that have been registered under the scheme will be available EU-wide. For a wide range of herbal products, especially those from non-European traditions such as Ayurveda and traditional Chinese medicine, the requirements of the scheme are either impossible to meet or are prohibitively expensive. In many cases, both constraints apply so the result is that virtually no herbal medicines from these traditions have been registered. These products will effectively be banned after April 2011. The ban will also effect medicinal herbs in food supplements, which are used by many thousands of people across Europe to help maintain their health.
The Directive has the following aims:
- Aims to ensure correct identification of medicinal plants and adoption of Good Manufacturing Practice (GMP) by suppliers and manufacturers.
- Requires that OTC herbals demonstrate 30 years safe use for registration, 15 years of which within the EU.
- Monographing herbal safety and efficacy by the European Medicines Evaluation Agency Committee on Herbals.
- Permits limited medicinal claims on THMPD products
Problems with THMPD:
- Cost of licensing high.
- Cost of quality assurance also high.
- Quality control guidelines not workable for multi-herb complexes. This now has been recognised but now no applications for multi-herb complexes will be accepted until this is sorted out. The time for all this is running out as Section 12(2) products must be withdrawn from the market from April 2011 when the THMPD is fully implemented.
In the UK, herbal practitioners have been free to practise their art since the times of Henry VIII:
“Be it ordained established and enacted by authority of this present parliament, that at all time from henceforth, it shall be lawful to every person being the King’s subject, having knowledge and experience of the nature of Herbs, Roots and Waters… to practise, use and minister in, and to any outward swelling or Disease, any Herbs, Ointments, Baths, Pulters and Emplaisters, according to their Cunning, Experience and Knowledge … without suit, vexation, trouble, penalty or loss of their goods.”
The Herbalists’ Charter ordained by Henry VIII, 1543.
In 1968 the UK Medicines Act was enacted:
- Provides legal basis for the supply and sale of herbal medicines.
- Herbal medicines exempt from licensing.
- SI 2130 specifically allows powerful herbal medicines to be prescribed by herbalists.
- The term “herbalist” not defined.
The implementation of the EU THMPD would supercede this Act and would have particularly dire consequences from a medical, social, economic and political point of view as it would at a stroke abolish a freedom that has existed in England since 1543.
I therefore urge European herbal practitioners to support the organizations that are working very hard to oppose or at least mitigate the THMPD before April 2011.
European Herbal and Traditional Medicine Practitioners Association (EHPA): http://www.ehtpa.eu/
Association for Natural Health (ANH): http://www.anh-europe.org/
European Benefyt Foundation: http://www.benefyt.eu/
DAO DE JING
Chapter 30 (partial)
Whoever relies on the Tao in governing men
does not try to force issues
or defeat enemies by force of arms.
For every force there is a counterforce.
Violence, even well intentioned,
always rebounds upon oneself.
Chapter 60 (partial)
Governing a large country
is like frying a small fish.
You spoil it with too much poking.
Center your country in the Dao
and evil will have no power.
Chapter 75
When taxes are too high,
people go hungry.
When the government is too intrusive,
people lose their spirit.
Act for the people's benefit.
Trust them; leave them alone.
Translation by S Mitchell
The Traditional Herbal Medicinal Products Directive (THMPD) comes fully into force in April 2011. After this time, only herbal medicines that have been registered under the scheme will be available EU-wide. For a wide range of herbal products, especially those from non-European traditions such as Ayurveda and traditional Chinese medicine, the requirements of the scheme are either impossible to meet or are prohibitively expensive. In many cases, both constraints apply so the result is that virtually no herbal medicines from these traditions have been registered. These products will effectively be banned after April 2011. The ban will also effect medicinal herbs in food supplements, which are used by many thousands of people across Europe to help maintain their health.
The Directive has the following aims:
- Aims to ensure correct identification of medicinal plants and adoption of Good Manufacturing Practice (GMP) by suppliers and manufacturers.
- Requires that OTC herbals demonstrate 30 years safe use for registration, 15 years of which within the EU.
- Monographing herbal safety and efficacy by the European Medicines Evaluation Agency Committee on Herbals.
- Permits limited medicinal claims on THMPD products
Problems with THMPD:
- Cost of licensing high.
- Cost of quality assurance also high.
- Quality control guidelines not workable for multi-herb complexes. This now has been recognised but now no applications for multi-herb complexes will be accepted until this is sorted out. The time for all this is running out as Section 12(2) products must be withdrawn from the market from April 2011 when the THMPD is fully implemented.
In the UK, herbal practitioners have been free to practise their art since the times of Henry VIII:
“Be it ordained established and enacted by authority of this present parliament, that at all time from henceforth, it shall be lawful to every person being the King’s subject, having knowledge and experience of the nature of Herbs, Roots and Waters… to practise, use and minister in, and to any outward swelling or Disease, any Herbs, Ointments, Baths, Pulters and Emplaisters, according to their Cunning, Experience and Knowledge … without suit, vexation, trouble, penalty or loss of their goods.”
The Herbalists’ Charter ordained by Henry VIII, 1543.
In 1968 the UK Medicines Act was enacted:
- Provides legal basis for the supply and sale of herbal medicines.
- Herbal medicines exempt from licensing.
- SI 2130 specifically allows powerful herbal medicines to be prescribed by herbalists.
- The term “herbalist” not defined.
The implementation of the EU THMPD would supercede this Act and would have particularly dire consequences from a medical, social, economic and political point of view as it would at a stroke abolish a freedom that has existed in England since 1543.
I therefore urge European herbal practitioners to support the organizations that are working very hard to oppose or at least mitigate the THMPD before April 2011.
European Herbal and Traditional Medicine Practitioners Association (EHPA): http://www.ehtpa.eu/
Association for Natural Health (ANH): http://www.anh-europe.org/
European Benefyt Foundation: http://www.benefyt.eu/
DAO DE JING
Chapter 30 (partial)
Whoever relies on the Tao in governing men
does not try to force issues
or defeat enemies by force of arms.
For every force there is a counterforce.
Violence, even well intentioned,
always rebounds upon oneself.
Chapter 60 (partial)
Governing a large country
is like frying a small fish.
You spoil it with too much poking.
Center your country in the Dao
and evil will have no power.
Chapter 75
When taxes are too high,
people go hungry.
When the government is too intrusive,
people lose their spirit.
Act for the people's benefit.
Trust them; leave them alone.
Translation by S Mitchell
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