In the last newsletter I covered briefly the Canadian Government trying to pass a bill known as Bill C51. According to the interpretations of the bill, it would remove all supplements from over-the-counter availability, by only allowing Medical Doctors to prescribe them as they see fit.
Around a million Canadians made their feelings known about Bill C-51, an amendment introduced by the Harper government to the Canadian Food & Drugs Act. The mass opposition to this Bill forced the Canadian Parliament to call off the second reading last Friday. The Bill, having been successfully through its first reading on 8 April 2008, is apparently now in hiatus. Hooray for mass protest! The Bill was going to create a new category called 'therapeutic products' which would throw natural health products—or what is termed ‘therapeutic foods’—into the same category as synthetic pharmaceutical drugs. It would also have given Canadian authorities obscene powers to raid premises, confiscate products—with no reasons given. It would scare the small, somewhat fragile and fragmented natural products industry into submission—an industry that is the life line for millions of consumers who prefer to maintain their freedom of choice in all aspects of healthcare by using non-toxic natural products rather than toxic chemical drugs to manage their health
Well done Canada the world fully appreciates your fantastic work in stopping the proponents of C-51 who have been steering the government-corporate machine that is hell-bent on removing our ability to freely access un-patented, natural products.
We have since been informed by our Canadian sources that although Bill C-51 did not make it to its second reading the authorities are planning to introduce C-52. The intent of this Bill is designed for something entirely different. It is intended to protect consumers from unsafe products and chemicals, such as pesticides. It is not directly concerned with natural health products; however we are informed that should any amendments be made to schedule 1 of Bill C-52 this Bill could be applied to natural health products overnight, removing from public access safe and effective products.
Simply put any carefully orchestrated amendments to this legislation could take away individual rights in the name of safety.
The Canadian, Australian and New Zealand governments have been surreptitiously supporting the direction of the Codex Alimentarius Commissions nutrition committee, which is involved in developing international guidelines and standards on ‘safe’ nutrient levels which are pitifully low because of a misapplication of scientific risk assessment.
These worldwide regulations are effectively designed to heavily restrict free access to safe effective dietary supplements and leave only ludicrously low global levels, sanctioned by these governments.
If the Canadians, Australian’s and Europeans want bureaucrats to tell them what to do, that’s their business. Governments around the world are privatising their responsibilities by transferring their elected responsibilities to Trans National Corporations run by un-elected bureaucrats.
New Zealanders deserve better, can think for themselves, make their own decisions and certainly do stand up when there is a threat to their most personal and historical right to choose which is being superceded or suspended by laws that reflect corporate financial interests. When health freedom reflects the interests of the corporate sector like nothing we have ever seen before, with the threat of losing our perennial right to choose the foods, herbs or medication at the hands of non government, non-democratic corporately owned organisations, its time for us all to take a stand!
On another note, recently there was a report published in the British newspaper The Sunday Telegraph stating that there should be measures put in place to stamp out poor practice among herbalists who did not understand the risks of the potent substances they were dealing with nor recognise symptoms that required urgent medical attention.
According to the authors of the Department of Health report, patients are being harmed when given preparations that have been wrongly labeled, contaminated, cut with toxic substances such as lead, mercury and arsenic, and several of these preparations have interfered with conventional medicine. According to the report there are approximately 2000 herbalists working in Britain and the authors claim there is limited scientific evidence to support over 4,000 years use of effective herbal remedies.
The report confirms that the lucrative so called complementary medicines market in Britain is worth £200 million annually. The report proposes that any new student studying in the complementary medicine field of herbal medicine or acupuncture has to study for an honours degree, and existing practitioners without qualifications would have two years to submit applications demonstrating their experience and knowledge. All would be required to pass tests in English. Apparently the British government has already promised to regulate the so-called complementary medicine field, and will now consider the report
Professor Michael Pittilo, chairman of the steering group that wrote the report, said it was "desperately important" that ministers acted with speed.
Many alternative medicines will remain unregulated, subject only to voluntary codes of practice. Therapists who practice in such diverse disciplines as reflexology, shiatsu, homeopathy and aromatherapy are left to choose whether to register with the Complementary and Natural Healthcare Council.
A number of self styled medical experts have spoken out against the honours degree proposal and have been openly critical of natural health care therapies.
Government regulated mainstream medicine is the leading cause of death, in England and the developed world and is failing miserably, littered with 'bad' science and is a system in crisis in which the public have lost faith.
It is well recognised that orthodox western medicine causes expected side effects and iatrogenesis (drug induced death) and thousands of these unnecessary deaths are considered "normal". When one person has a side effect from a natural healthcare remedy or therapy, the media with banner headlines proclaims that the public must be protected.
In reality, the medical profession needs to put their own house in order before endeavouring to dictate the regulation of natural therapies that have proven to be effective for thousands of years.
Who Is Regulating the Regulators?
According to Don Benjamin, past Australian Commonwealth Scientific and Research Organisation (CSIRO) researcher and spokesman for the Australian Cancer Information & Support Society (CISS) "it would be a good idea if orthodox health practitioners supply much of what they claim to provide. About 15% of orthodox medical interventions are proven to be beneficial, meaning that 85% are not”.
In the cancer field, where Don Benjamin has the most expertise on the statistical front, he says "less than 6% are proven to be beneficial, meaning that about 94% are unproven using the standard levels of proof that orthodox medicine requires of natural health care practitioners, such as randomised controlled trials”.
Despite volumes of existing scientific evidence, countless scientific studies, peer review journal articles and credible expert opinions in worldwide support of natural healthcare therapies, skeptics and members of the flat earth society claim that the apparent benefits gained by using natural healthcare methods are merely a result of the "placebo effect" – a patient's expectation that the treatment will work – which they say is heightened by the elaborate procedures involved.
Proponents of today’s so called “scientific medicine” which has almost no resemblance to genuine science at all need to conduct unbiased research before making statements which are ill informed opinions and contrary to fact. The truth is conventional medicine is almost entirely justified by truly bad science. Is there any government agency or media reporting on the thousands of cases of patients dying from the horrendous side effects of legally prescribed pharmaceutical drugs?
These unnecessary deaths are never fully investigated reported or publicised, nor are the episodes of medical misadventure that occur when a patient is admitted to hospital for a minor operation and fails to come out alive.
No one is regulating the regulators and ensuring that they perform for the optimum benefit and enhanced health status of the population.
There is a critical need for in depth unbiased studies to determine as to what percentage of patients are actually cured by our present medical system and if the failure in our health care system is due to medical practice or regulatory methodology.
Compliance with the 1981 Medicines Act.
I encourage you all to read the article following this report entitled “Notice to all Practitioners” which clearly outlines members responsibilities should you be approached by government officials or receive a letter or email from Medsafe or the Commerce Commission.
On a lighter note, in closing let me urge all of you to be thankful for life in this country. It may not always be perfect, but in my opinion, it far exceeds any other country around the world. After all - we are the first country to see the sun and as such must always be awake and ahead of the rest of the world – regardless of the advertisement for Mainland Cheese.
References: The evidence for Don Benjamin’s research is accessible as submission #15
http://www.aph.gov.au/Senate/committee/clac_ctte/cancer/submissions/sublist.htm
or visit website www.ciss.org.au
Notice to all Practitioners
WARNING — WARNING — WARNING —
Take special note of “The Bottom Line and Most Important” at the end of this article.
MEDICINES ACT COMPLIANCE
Therapeutic Claims: Guidance on Compliance with the Medicines Act 1981
(Format and Emphasis Added)
These guidelines are intended to provide advertisers and distributors with a practical interpretation of some aspects of current Medicines Legislation to assist them in ensuring that their products and advertising comply with relevant legislation.
If the intention is to market products as dietary supplements, herbal remedies, nutraceuticals, cosmeceuticals, or cosmetic creams or balms rather than medicines, it is important to ensure they cannot be considered to be medicines as defined in the Medicines Legislation.
Because the composition, presentation and promotion of a product determine whether or not it is categorised as a medicine, it is important that companies make sure that their marketing strategy does not change the intended categorisation of their product to medicine. This is because it is illegal to advertise or, with the exception of a few particular circumstances, supply a medicine that has not been approved for supply in New Zealand.
The Medicines Act 1981 is the legislation that defines and regulates medicines. In simple terms, a medicine is a product that is supplied and used for a therapeutic purpose. The term therapeutic purpose is defined in section 4 of the Medicines Act and includes (but is not limited to):
a) Treating or preventing disease (including colds, influenza and parasites)
b) Treating hair loss
c) Assisting with general ailments such as pain and inflammation
d) Effecting contraception
e) Altering the shape, structure, size or weight of the human body
f) Preventing or interfering with the normal operation of a physiological function
The term disease is further defined in the Medicines Act and includes any injury, ailment, deformity, disorder or adverse condition of body or mind.
In many cases a therapeutic purpose may be stated or implied in advertising material prepared for the product or on labels attached to the product. These are referred to as therapeutic claims. Other factors that can imply a therapeutic purpose include pictures, the product's name or a product category statement at the retail outlet.
Therapeutic claims often include the following statements or combinations of words:
Relieves, prevents, treats a disease, or symptoms of a disease, or a disease state, increases, improves, enhances a physiological condition or function, decreases, retards, or slows the onset of a normal physiological condition or function.
A therapeutic claim may also be made using the following statement types:
References to method of treatment e.g. apply to affected area.
Mentioning that the product or any of its ingredients has been used traditionally for a therapeutic purpose.
Using testimonials or personal statements that refer to the product having a therapeutic effect. Information articles about disease prevention or other therapeutic purposes that includes a brand name of a product or an advertisement for a product on the same or facing page.
Informational websites with links to a product:
• Quoting research or clinical trials.
• Claims that the product assists in weight loss.
• Claims that the product cures or prevents hair loss.
• Claims that the product is an alternative to a medicine or group of medicines.
The following terms generally indicate a therapeutic purpose for a product:
• Apply to the affected area…
• Relieves the symptoms of…
• Temporary relief of...
• Assists in the treatment of…
• May be useful for...
Examples of Therapeutic Claims
The following are examples of claims for a therapeutic purpose (this is not an extensive list).
• Relieves arthritis or relieves the pain associated with arthritis.
• Relieves the symptoms of colds and flu.
• Prevents winter viruses.
• Treats eczema.
• Soothing for burns and scalds.
• Accelerates the healing of cuts and grazes.
• Useful for cancer, diabetes, Alzheimer's Disease
• Has anti-tumour, anticancer, antifungal, antiviral properties.
• Boosts immunity.
• Heart medicine.
• A natural form of Viagra.
Assists with rapid weight loss (refer to Medsafe's Guidelines for Weight Management / Weight Loss products.
Therapeutic claims only form part of a product's presentation. The implication of a therapeutic purpose could be achieved or enhanced by accompanying pictures or even the product's name. It is important to check all promotional material to ensure that there are no references to a therapeutic purpose. Promotional material includes any written or spoken words (including radio and video material), product labels, product leaflets/instructions, in-store sales materials, websites, newsletters and direct promotion.
The addition of the qualifier may before the therapeutic claim or use of statements such as not intended to imply a therapeutic purpose do not negate a therapeutic claim.
Dietary Supplements and Cosmetics
Claims made for a product should be consistent with the relevant legislation. If the product is intended to be marketed as a dietary supplement, any advertising must be consistent with the definition of a dietary supplement included in the Dietary Supplement Regulations 1985.
Products that are applied topically and are intended to be cosmetics need to comply with the Group Standard for Cosmetic Products (available from ERMA NZ, www.ermanz.govt.nz). In addition any claims must be consistent with the definition of a cosmetic in the Medicines Act.
A claim that the product will help or support the body's normal physiological processes and function may be acceptable.
Some examples include
• For strong bones and teeth
• Contains antioxidants
• Supports the immune system
• Moisturises the skin
• Supports a healthy heart
• Aids the digestive system/aids digestion
Further Information
A copy of the relevant legislation can be found at www.legislation.govt.nz or may be purchased from Bennett’s Bookshops.
The Advertising Standards Authority publishes its codes of practice and guidance on complying with these on their website www.asa.co.nz.
Further advice can be obtained from the Therapeutic Advertising Pre-vetting System (TAPS) which pre-vets advertising material prior to publishing. TAPS attracts a fee. TAPS also publishes guidelines on the Association of New Zealand Advertisers website www.anza.co.nz.
Advice can also be obtained from a regulatory affairs consultant. A list of consultants is published on the Medsafe website www.medsafe.govt.nz. Information on the process for applying for consent to market a product as a medicine can be found in the Regulatory Section of the Medsafe website
Compliance Witch Hunt
Medsafe has allocated millions of dollars for the establishment of investigative and persecution compliance teams consisting of Medsafe Investigators and have also, it appears, involved the Crown Law Office and the Commerce Commission as part of their persecution task force. Both of these agencies have been conducting fishing expeditions in an endeavour to trap Dietary Supplement resellers and practitioners. Internet websites, advertising and pamphlets are the primary target for these teams to begin the process of building a case. The cases that have been presented to date have, it appears, originated without any complaint from consumers or as far as we can determine any other source.
Disrepute
Every claim entered into against the Health Industry by these agencies regardless of the outcome serves the purpose of bringing the Industry into disrepute and will be used by Medsafe as the cornerstone for a campaign to convince Parliamentarians that stronger legislation is required to control the situation.
This in itself is a prime reason for all of our practitioners to review all their promotion and advertising materials to ensure that it is in line with the Therapeutic Claims, Guidance on Compliance with the Medicines Act as set out above.
Liability Insurance
While Chartered Practitioners are covered by liability insurance this does not necessarily mean that they are covered for willfully breaching the 1981 Medicines Act and its subsequent amendments and regulations. The Insurance Company may well cover the legal cost but not necessarily cover any fines imposed for breaching the Medicines Act. These fines can be as much as $60,000 or more dollars, which will be the responsibility of the Practitioner.
Please re-read the above paragraph and fully understand that if you create this type of offense then you will individually be the person paying for that offence, and ignorance of the law under an Act is not an acceptable excuse in any court. It does appear that all other civil liabilities will still be payable by our Insurer.
Remember at all times that the words used in all Acts have their own defined meaning and that this meaning may differ from everyday standard use and that it is this official definition that is recognised by the Courts and not what you may perceive the word or words to mean in common usage.
The Bottom Line
Very simply, if a Practitioner breaches the Medicines Act, the Practitioner is responsible for any and all fines due by breaching the Act. If you carefully read the guidelines set out above you will realise that even the spoken word can constitute a breaching of the Act, even a private discussion between you and a client can in the wider sense be construed as a claim. This likewise includes telephone discussions and radio and television interviews.
We appear to be reaching the ludicrous situation where the only claim that we as health practitioners are able to make is that our practice of (modality name), etc is designed to assist the client to endeavour to promote their own health, wellness, vitality and life style changes.
Most Important — Practitioners Beware.
If at any time you as a practitioner are approached by a Government official or receive a letter or an email from Medsafe or the Commerce Commission you must contact the Charter Office immediately and report the situation — regardless as to how innocuous and friendly the initial approach is.
There are Charter representatives that are fully conversant with your obligations under the insurance program and more importantly the steps that need to be correctly undertaken to achieve a satisfactory resolution to the witch hunting expedition entered into by government agencies.
Failure to contact the Charter is a breach of the insurance contract and more importantly the answering of even one email without your representatives’ guidance could result in heavy fines.
Take Care Out There…..
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