TGA Consultation: Sampling of Consumer Responses

Response

See HC’s response here in pdf.

Response

Submission to the TGA Consultation on future regulation of low risk products

I am writing to ask that you implement Option 1, or if not 1, then Option 2. I strongly
oppose Options 3 and 4. I have read scientific research on homeopathy and find that your consideration of the materials available is incomplete. I find homeopathy of value and feel that it is
my right to have access to it. As well, given my understanding of the research, there is reason to believe that homeopathy is an effective and safe practice as well as one that should be considered because of its reasonable cost.

Yours sincerely, CM

Response

• The TGA’s role is to protect public safety, not to make value
judgements on faulty evidence.
• As homeopathy is the safest option of any medicine
available, I and the wider homeopathic community support Option 1 and/
or Option 2
• To protect my rights and access to homeopathy, I strongly
oppose Options 3 and 4.
ISSUES RAISED BY INDUSTRY BODIES IN RELATION THE
HOMEOPATHIC CONSULTATION
• Homeopathic Medicine is a Traditional medicine used worldwide
recognized by World Health Organisation. On that basis alone it
should be recognized as a therapeutic opAon. Under no
circumstances should Homeopathy be removed as a therapeutic
option.
• The TGA has the ability and discretion to recognize Traditional forms
of medicine and not just evidence based therefore it should conAnue
to do so in the case of Homeopathy.
• The NHMRC report set a higher standard to Homeopathy than the
TGA currently use to assess efficacy and will use in the future to
assess efficacy and therefore should not have been menAoned in this
consultaAon paper as it is misleading and not relevant.
• The NHMRC report is subject to a complaint to the Ombudsman and
therefore should not have been cited in this consultation paper.
• The UK government review cited in consultaAon paper was rejected
by the UK Govt. and therefore should not have been mentioned to
imply validity to its unaccepted conclusion.
• There was a Swiss Report on Homeopathy which stated “There is
sufficient evidence for the preclinical effecAveness and the clinical
efficacy of homeopathy and for its safety and economy compared
with conventional treatment.” – Why was this not included in the
recommendations to give perspective and balance?

– KP

Response

To the Regulatory Reforms Team, Therapeutic Goods Administration,

Banning a modality that helps the body cure illness and also aids in pain management is tantamount to  theft, neglect and ignorant of medicine outside of western medicine.

You will never find a study, case study where a patient has over dosed and died from any form of homeopathy, you will however find countless overdoses from western medicine.

There are claims that homeopathy is pseudoscience and placebo effecting, how  then does a 4 month old baby become calm and regain happiness when they have been screaming in pain from teething – all of a sudden after a mother applies homeopathic teething gel?  That is my own personal experience as a mother of 6

How is this possible? A baby does not understand what this gel is nor what pain relief is.  The proof is outstanding and there is no possible way for these gels or any other product to be harmful.  If you study homeopathy you will find that the products are formed via stimulus and energy -science which your western medicine touts to solely use to maintain their hold on the population- as safe and effective..  There are no chemicals in this medicine unlike western or allopathic medicine.

If any modality needs scrutinising for lethal conduct it is western medicine.

I and the rest of the homeopathic using/ providing community would like to see this type of action taken of the pharmaceutical companies. If health is truly about health and not money then prove it.

This move simply is to get rid of other modalities that do not raise greed and money.

Iam a mother and have also studied medicine and know the difference between a drug and medicine. Homeopathy is a least harm medicine, in comparison with western medicine which should be used as a last resort.

Please research and also use homeopathy before casting judgements and making a false move.  How can anyone possibly remove something they have only ever heard rumours about?

That is not a policy maker. That is a joke.

Be on the right side of history and empathetic .

Regards.

DK

Response

6 May 2017

To whom it may concern

I have been using homeopathy for more than 40 years, on 3 continents, in many countries. I have found it to be extremely effective at times, and less so at others – a fact, that can be easily explained by the very way that homeopathy works.

A therapeutic process that is so completely individual (meaning that the same remedy will not successfully treat the same symptom on many people, because of other factors that make the way patient 1 experiences a condition different from the way patient 2 experiences it) is not suited to the way western medicine sets up their trials.

Yet, while it would be easy to dismiss homeopathy, simply based on these ‘negative’ results in clinical trials, it would be foolhardy to dismiss a system that has been around for hundreds of years and that enjoys full government support in other modern Western societies like Switzerland.

Are those who consider homeopathy quackery suggesting that the Swiss, famous for their straight and no-nonsense approach to the world, sanction treating their ill homeopathically, without good reason?

As it is, homeopathy is barely supported in Australia, making it quite difficult for those of us, who enjoy gentle, non-toxic, effective treatment, to access homeopathic remedies beyond those mass produced to try and fit into the ‘one product helps every patient’ mould.

Pushing homeopaths even further to the fringe of natural therapies will not make homeopathy safer, it won’t protect anyone and it won’t dissuade those who use it. It will, however, take away a low cost, low risk treatment and thereby put more pressure on the Australian medical system by conveying the message that antibiotics really are the only way to treat…

I call on the TGA to adopt option 1 or 2 of their consultation paper regarding the future regulation of homeopathic products.

Yours sincerely,

SP

Response

To whom it may concern

Regarding the TGA vs homeopathy, I believe this is appalling to even begin to
consider regulating this brilliant modality.

Homeopathy has been around since time 1755 and is a highly valid, very useful form
of treatment for many health issues. It has survived since then and the only reason
anything “different” survives is because it works.

Doctors’ appointments are generally very short, they prescribe drugs, many of which
have terrible side effects; a homeopath will spend a long time with a client finding out
lots of things before even considering a homeopathic.

What I object to most is a government body having yet more say in how I live my life
and attempting to determine my choices. I am an adult, I have studied many forms
of healthcare and if I choose homeopathy to treat myself or my family then that is my
right as a human being living in Australia. People are tired of being told what we
have to do to conform to someone else’s idea of what is right. I for one believe
homeopathy needs to be left alone.

MD

Response

6 the May 2017

Submission to the TGA re Homoeopathy Regulation

I wish to express my concern and objection to the potential change of homoeopathy to an un-therapeutic good in Australia.

As a practicing naturopath of 20 years I have seen the safety and effectiveness of homoeopathy in many situations and spent time observing in an Indian hospital where the primary treatment of clients was via homoeopathy. Millions people use homoeopathy world wide. The Swiss did their own independent investigation of the available evidence and as a result of the outcome, incorporated homoeopathy into their public health care system.

The NHMRC report on homoeopathy – currently being reviewed by an ombudsman due to irregularities which indicate bias against finding positive evidence for homoeopathy, is not a sound base for the TGA to make theraeuptic decisions upon.

I sincerely hope that reason, good judgement and true science prevail in this case and homoeopathy remains regulated as a therapeutic treatment available to all Australian’s.

Thank you for your time and considerations

WS

Naturopath ANTA member 3460

Response

To Whom it May Concern,

I strongly believe that Option 1 (Keep homeopathy regulated the way it is)

should be the only option for the future of Homeopathy in Australia.

Options 3 and 4 would be to the detriment of Australian public health and would send Australia back to the dark ages. I strongly oppose these 2 options.

If we are to move forward, Homeopathy needs to be kept as an important modality option for all to be able to access.

Proper unbiased studies need to be undertaken to correct the latest Homeopathic review, as the inaccuracies have since been pointed out about how that was undertaken. It would be unjust to ban Homeopathy in Australia based on this incorrect study.

Again, Option 1 (Keep homeopathy regulated the way it is) should be the only option for the future of Homeopathy in Australia.

Regards,

TA

Response

As an individual who has observed personal beneficial health results with absolutely no side-effects from receiving homeopathy, on and off since the 80’s and regularly for the past two years, I wish to express my support for Option 1 of the four regulatory options for ‘Consultation: Options for the future regulation of ‘low risk’ products’ that is presently under consideration.

My understanding is that the TGA’s role is to protect public safety, not to restrict access to products that in my own experience are completely safe: Products that I wish to maintain the right to freely choose to use, as therapeutic goods and services.

In order to protect my right to access homeopathy, I strongly oppose Options 3 and 4.

Sincerely,

CA

Response

I write with regards to the current TGA consultation on low risk products, and in particular the section of the consultation paper relating to Homeopathic Products (pages 46-49).

Of the four options presented, I strongly support Options 1 and 2, keeping homeopathic products’ regulation as it currently stands and requiring scientific evidence for high-level claims. This approach preserves homoeopathic products as therapeutic goods and brings them into line with other medicines.
I would support Option 3 providing the Traditional use of Homeopathics is acknowledged and preserved, allowing Australians good general access to homeopathics.

I strongly oppose Option 4, declaring homeopathic products not to be therapeutic goods. This option is void for a number of reasons, notably as it is out of step with regulatory frameworks worldwide (including but not limited to the WHO, the UK Government, and the Swiss Government), that homeopathy is formally recognised worldwide as a Traditional medicine, and that many of the citations leading to this option are derived from reports (e.g. the NHMRC report and the UK Science and Technology paper) that are proving unreliable (refer to relevant Ombudsman submission and UK Government dismissal).

Moreover, homeopathic medicines are among the safest, most cost-effective and clinically successful therapeutic goods available to the Australian population. Whilst other governments such as France, Switzerland, India and the UK are increasingly acknowledging and utilising this effective form of therapy, please do not let Australia fall behind by denying our population the benefit of access to Homeopathy.

Please accordingly accept my submission in support of Options 1 and 2.

Thank you and with best regards,

HE

Response

Dear Therapeutic Goods Administration,

I am writing to you to show my concern for the restricted or banded use of homeopathic medicines. STRICTLY “NO” to Option 4.

One must only look at the history of Homeopathy in treating epidemics or the number of successfully treated or assisted cases to understand that this type of medicine is nothing short of remarkable.

As an Australian l want to continue to experience the benefits of this type of medicine as l have done for many years. DO NOT MAKE ANY CHANGES.

Our family has been using homeopathic medicines for over 24years now. Our first experience was in Germany by our families. This has resulted in very few GP visits over this timespan. A remarkable feat to say the least. Yes we do go to the GP if needed but only if required. Everyone needs to experience homeopathy.

The TGA should see that this type of medicine is protected for future use by trained practitioners. I want to continue to visit professionals who are trained and experienced. Make this your priority. Homeopathy is “low risk” medicine to me and my family. We have never had a reaction from taking this type of medicine.

Many countries have spoken out about the effectiveness of homeopathy and how its use has saved many lives. The world is starting to embrace the use and effectiveness of homeopathic medicine. This “low risk” medicine can work beautifully with all other medicines. What more can we ask for?

We must unite with other countries that have already expressed great interest to include this medicine into their health system.

The results will speak for themselves

Regards

PR

Concerned Australian

Response

SUBMISSION TO TGA IN CONSIDERATION OF CLASSIFICATION OF HOMEOPATHIC MEDICINES. 5th May 2017 TO WHOM IT MAY CONCERN

Dear Sir/Madam, Whilst the classification of medicines through the TGA has no direct impact on the provision and use of Veterinary medicines and substances, as a registered veterinary surgeon I am quite concerned about the impact of your decision to reclassify homeopathic medicines in your current review process. As the peak body for therapeutic goods registration to medical professionals in Australia, the actions and decisions of the TGA will filter into other areas that will potentially adversely affect decisions made in veterinary medicines.

For this reason I urge your review committee to reject the option number 4 (below) in this current review Option 4 – Declare homeopathic products NOT to be therapeutic goods. It is clear that this option has no rational basis as a significant and growing body of research and data demonstrates quite clearly that homeopathic medicines ARE therapeutic goods. Classifying them otherwise is failing to recognize the important contribution to health care that these medicines provide to the Australian public. I am more than happy to provide your committee with a body of research that clearly shows homeopathic medicines to be therapeutic goods.

Yours truly, PS

Response

To whom it may concern

My name is Mark O’Brien, editor and publisher of the Byron Body & Soul Guide in Byron Bay, NSW.
In my role as the publisher of a now defunct alternative health magazinea, Here & Now and Kindred
parenting magazine, I sometimes had the pleasure of writing about homoeopathic consultations I received, which I found to be very interesting.

With a background in physiotherapy and coming from a family of doctors I have always been interested in health and the efficacy of various treatments, and I was very impressed with homoeopathy. I am also aware of the placebo affect and am usually very sceptical about alternative therapies.

I have seen my children respond to homoeopathy very quickly, with symptoms of various sicknesses
vanishing within minutes of receiving a homoeopathic treatment. While this can also be attributed to
psychological factors, the virtually instant affect homoeopathics have on pets is irrefutable and undeniable.

Whilst I would not use or recommend homoeopathics for life threatening illnesses I have found it is a very useful treatment method for ailments me and my family and our pets have suffered from.
Many friends also swear by homoeopathics, and trust their practitioner more than doctors.
One of the negatives people focus on with regards homoeopathics is that there is mathematically virtually nothing in the pills or drops. So it works in another way, a way less likely to lead to reactions so prevalent with allopathic medicines.

Being ‘nothing’ means that it cannot be denigrated as there is nothing to denigrate, and obviously cannot do any harm, which is more than anyone can say about pharmacueticals. There is no issue with homoeopathic resistant bacteria either, something that is becoming a big issue. Possibly people using homoeopthics instead of antibiotics for regular illnesses actually postpones the end date of antibiotic efficacy. I think homoeopathy should be freely available to anyone who wants it, and training courses funded by the government like other health related professions are.

Your Sincerely

OM

Response

Please note that: The TGA’s job is to protect public safety, not to
make value judgments or restrict access to safe products Australians
freely choose to use as therapeutic goods.

As an amateur or lay homoeopath (ie studied but not formally qualified
and not in public practise) I still want to use my remedies on myself,
my animals, my garden and any consenting friends and family. I do not
charge for my services nor for the remedies.

As you will know, Homoeopathy is an at least 200 year old practise, and
while a lot of Homoeopaths are not medically-trained A LOT ARE!
Especially overseas in the U.K., India and on the continent.

Effectively banning Homoeopathy will be a retrograde step and endanger
the health of the people who wish to use it.

SE

Response

To Whom It May Concern,

Re: The Therapeutic Goods Administration Consultation on “Low Risk Products”,

I am deeply concerned about any changes in the regulations towards Homeopathy within the regulatory framework of the TGA. The best option in regards to Homeopathy is Option 1 to Keep Homeopathy Regulated The Way That It Is. Any other option will place Australia and its citizens behind the rest of the world in terms of quality Healthcare.

Homeopathy is an extremely safe and effective healing modality that has been in use longer than any pharmaceutical drug. Homeopathic remedies do not come with a list of adverse side effects – for there are none! They are safe for children, the elderly and pregnant women, and are even safe and effective for those with disabilities.

I use Homeopathy for my Special Needs child, as well as the rest of my children, their father and myself. I was thrilled to find a Homeopath, with over 20 years experience, who could help my child, and am pleased with the progress he is making. Compared to other medicines and supplements, Homeopathic remedies are very easy for him to take.

Many countries all over the world, like India, the UK and other European nations, see the value of Homeopathy and have been using it in their Healthcare programs for decades.

Homeopathy was once the most popular healing modality in the Western world also. Many famous American colleges were founded as Homeopathic colleges, such as the Hahnemann Medical College of Philadelphia. In fact, it was the American Institute of Homeopathy, founded in 1844, that was the first national medical society in the U.S. – founded three years before the AMA.

Though some web searches may lead a reader to a different conclusion because there has also been constant opposition to Homeopathy – not due to lack of its ability to heal people – quite the opposite, in fact. Its because of its ability to heal people, that those who are profiting off of more lucrative forms of  therapy are constantly trying to stifle knowledge of its effectiveness and its widespread use. Ample historical evidence can verify this fact.

Since the TGA’s mandate is to “protect the safety of Australian citizens in relation to medicines and treatments” Option 1 – Keep Homeopathy Regulated The Way That It Is , is the only choice when it comes to regulating Homeopathy because, Homeopathy is and remains a “low risk” medicine, and has proven to be completely safe over two centuries worth of Worldwide use.

Many studies have been conducted, however, the real proof is in the “clinical evidence” of people who use Homeopathy, and find relief and healing. If this were not the case, the use of Homeopathy would not have endured.

It should be clear to all those involved, that choosing any option, other than Option 1 would be cause for seriously questioning the motives of those in the position to change, what has been considered, historically and on a global scale, an utterly safe, “low risk” and effective healing therapy.

I urge all those in a position to do so to Keep Homeopathy Regulated The Way That It Is !

Thank you,

BK, BMSc., NC

Response

Dear Sir/Madam,

Whilst the classification of medicines through the TGA has no direct impact on the provision and use of Veterinary medicines and substances, as a registered veterinary surgeon I am quite concerned about the impact of your decision to reclassify homeopathic medicines in your current review process.
As the peak body for therapeutic goods registration to medical professionals in Australia, the actions and decisions of the TGA will filter into other areas that will potentially adversely affect decisions made in veterinary medicines.

For this reason I urge your review committee to reject the option number 4 (below) in this current review

Option 4 – Declare homeopathic products NOT to be therapeutic goods. It is clear that this option has no rational basis as a significant and growing body of research and data demonstrates quite clearly that homeopathic medicines ARE therapeutic goods. Classifying them otherwise is failing to recognize the important contribution to health care that these medicines provide to the Australian public. I am more than happy to provide your committee with a body of research that clearly shows homeopathic medicines to be therapeutic goods.

Yours truly, Dr SC BVSc MPhil Veterinarian Integrative Veterinary Medicine

Response

RE:  TGA Consultation: Options for the future regulation of “low risk” products

I make this submission as someone who has benefitted greatly from the use of Homeopathic medicines for a debilitating illness, which had me crawling around the floor unable to stand up, when allopathic medicine could offer me no help.  Please do not make this form of medicine unavailable to those who need it.

We are a diverse nation of individuals with individual needs.  It is not the ‘one size fits all’ approach that is required here.

There are countries in Europe where Homeopathy has equal status to allopathic medicine In regard to health insurance.  The Swiss Report on Homeopathy says, “There is sufficient evidence for the preclinical effectiveness in the clinical efficacy of homeopathy and for its safety and economy compared with conventional treatment.”

Homeopathy is recognised by the World Health Organisation (WHO) as the most popular and widely used complementary medicine worldwide. Entire communities depend on it for healthcare and the prevention of epidemic disease. That being so, why would the TGA consider restricting the access of Australians to it?

By not recognizing homeopathic remedies as therapeutic goods in Option 4 of the consultation, the TGA will be out of step with other governments, worldwide, who do.

The TGA’s role is to ensure that the products and treatments available to Australians are safe for use – not to decide what the Australian public can and can’t use especially when safety, as with homeopathy, is not an issue.  Australians have the basic right to choose treatments which best suit us.  I firmly believe that Government agencies should not regulate to restrict their access to information about that treatment.

Evidence is easily found re efficacy of homeopathy here:    https://www.hri-research.org/

Millions of people worldwide acknowledge the benefits of homeopathy. It would not be growing at the rate it is if it didn’t work.

  • BG

Response

Homeopathic products

I support Option 1 of the TGA recommendations to retain the status quo, and oppose Options 3 and 4.

Homoeopathic medicines should be given the same opportunity to meet the TGA criteria as other  complementary medicines for traditional or scientific evidence and regulatory monitoring is important to ensure public safety. This includes ensuring that products sold in Australia are manufactured according to Good Manufacturing Practice. Homeopathy is currently one of the safest medicines available and Option One will preserve homeopathic products as therapeutic goods but brings them into line with other medicines. Australians should continue to be free to use homeopathics as therapeutic goods.

I am concerned that if Option 4 was adopted that it would mean that no claims at all could be made for homeopathic products, that professional manufacturing of homeopathics could be impacted and the profession of homeopathy seriously impacted. If Option 4 was adopted it would be contrary to practice in the rest of the world, in particular it would run contrary to regulatory practice in Switzerland where homoeopathy will have the same status as conventional medicine by May 2017 when it comes to health insurance.

I urge the TGA to continue with Option 1.

LC

Homeopath

Response

To whom it may concern, In early 2016 my daughter (Annabel, dob 2/8/12), developed a goblet/mucous cyst on her lower lip. This cyst became extremely large and after 4 or so months did not subside. We consulted our local GP and then visited a paediatric specialist at the Northern Park Private Hospital. At the specialist visit we were advised it was highly unlikely the cyst would recede and to go ahead with surgical removal. We booked in for surgery in January 2017, giving ourselves a few months to consider pre surgical options. Upon consultation with my husband I decided to take Bel for treatment with Dr Isaac Golden, Homeopath in Gisborne. Dr Isaac recommended homeopathic remedies of Phytolacca and Thiosinaminum. After 3 months of twice daily treatment Annabel’s cyst receded to barely noticeable. As of today it’s been roughly 6 months since seeking treatment and we are still very happy with our homeopathy results. Both my husband and I could hardly believe that this treatment worked. I now whole heartedly recommend homeopathy as an alternative health option. Please consider me pro homeopathy.

Many thanks for your time, BM 5/5/2017

Response

To whom it may concern,

I am horrified and deeply confused why the Therapeutic Goods Association are attempting to ban homeopathy!? This is the safest form of health care available! The entire concept is built on minimal dosage! How is it that an identified low risk product is being challenged as a therapeutic good? Isn’t that our right as a consumer to decide on provided it’s safe?!

My understanding of the TGA’s role is to protect public safety, not to make value judgements or restrict access to safe products Australians freely choose to use as therapeutic goods.

This appears to be manipulation and control, a block on natural medicine yet again to push people towards the profit driven pharmaceutical industry only. It’s not acceptable, ethical or reasonable by any standards.

People have the right to choose their preferred method of health care, whether that is abstinence, homeopathy, fishing or Prozac. It’s our choice!

I strongly support Option 1. – Keep homeopathy the way it is.

Regards,

Concerned Citizen.

Response

Dear Sir/Madam

I am extremely concerned that the future of homeopathy in Australia is at risk. It is vital that this effective, low-risk and popular modality continue to be regulated as it currently is.

I am also very concerned that the TGA’s decision-making is informed by the highly flawed NHMRC report about the effectiveness of homeopathy. The complaint to the Ombudsman asking that this report be rescinded is required reading for all TGA law-makers. See https://www.hri-research.org/resources/homeopathy-the-debate/the-australian-report-on-homeopathy
Despite all the fuss and skeptical nonsense in the media today about homeopathy, TGA law-makers need to be aware that it continues to thrive. Why? Because it provides an effective alternative. Most people inherently know or feel that pharmaceuticals are unnatural and ‘wrong’ for them, especially in the long-term. There are severe deficiencies in conventional medicines’ armamentarium, particularly for the management of chronic disease. The amount of money wasted due to non-compliance with drugs is a universal scandal. The unscrupulous behaviour of drug companies is another. I know this because I practised as a pharmacist in both community and hospital settings, and also in regulatory and professional support roles for almost 30 years.

The general public, now much better-informed than in previous decades, has a rapidly-growing lack of faith in doctors and what they can offer. Homeopathy fulfils a much-needed role and needs to be integrated into the conventional healthcare system. The result would be vastly lower costs and happier, healthier patients. Finally I would like to remind the TGA that its role is to protect public safety, not to make value judgments or restrict access to safe products that Australians freely choose to use as therapeutic goods. Yours faithfully CJ

Response

To whom it may concern,

I have grown up with homeopathy in my life since my mother discovered it through researching ways to help my older brother with autism. It saved his future as it allowed him to have a much more ‘normal’ life, and hence he is now fully independent and secure with a job.
My childhood was difficult due to the autism but with the aid of homeopathy, my brother’s behavioral problems eased away. Homeopathy also saved my relationship with my brother. Without it, his behavior would have continued to stop us from getting close.

Homeopathy is a medicine that works. I use it regularly on my horse and on myself and I have seen the results first hand. All my life I have suffered from severe headaches. Conventional medicine has never helped, it was always a ‘band-aid’ and my headaches would always return, the same with cold sores. With homeopathy, all of this changed. I no longer suffer from either of these.  And these are just two examples, of the many that I have.

There are scientific studies behind it, countless success stories, no side-effects. Why take away the free choice that Australians have over their bodies? This is meant to be a country where we have the freedom to express our beliefs, concerns and freedom over our own bodies. Why is this being taken away?

I’ve worked closely with homeopathy for nearly a year now and I know the difference between something fraudulent and something honest, pure, and reliable. Take away a medicine that has no side effects and heals people at the deepest roots of themselves, take away our freedom, and it will be sending a very bad message about what it means to be a human being living in Australia (a DEVELOPED country).

Homeopathy should be left alone the way it is. Or even made easier to access. Our health is our choice. No one has the right to dictate what we eat, what we drink, or how we heal our own bodies. Just look to all the other countries who strongly support homeopathy. You can’t deny it’s truth if you open your eyes to it.

Yours sincerely,

AR

Response

Dear Sir/madam,
I would like to submit my comments on the ‘Options for the Future Regulation of
Low Risk Products’.
Reading through the Options for Low Risk products I will discuss Option 4.
The TGA with other world drug regulating authorities considers homeopathic
remedies to be in the category of “low-risk” medicines. There is no reason for that
position to change. I do not want, and other consumers and users of homeopathy,
do not want the following to happen in Australian medicine –
* Self-help information about Homeopathy and the symptoms and ailments it
treats, restricted.
* Homeopathic prescribers to be stopped from providing that information, or
prescribing remedies.
* Regulations designed for high-risk medicines applied to Homeopathy which is
considered a “low-risk” medicine.
* Consumer and user access to Homeopathic remedies restricted.
* Changes to the regulations that would inhibit, restrict, or deny the importation,
exportation, or manufacture of Homeopathic remedies by homeopathic
manufacturers and pharmacies.
The following points are important to take into account when deciding on this
review;
1) Homeopathy is recognised by the World Health Organisation (WHO) as the
most popular and widely used complementary medicine world-wide. Entire
communities depend on it for healthcare and the prevention of epidemic disease.
Why is the TGA considering restricting the access of Australians to it?
2) The recent Swiss Report on Homeopathy says, “There is sufficient evidence for
the preclinical effectiveness in the clinical efficacy of homeopathy and for its safety
and economy compared with conventional treatment.” That being the case, why did
the TGA exclude this favourable report from its consultation paper ?
3) Why would the TGA consider removing the access of Australians to
homeopathic information and products when, based on the evidence, the TGA’s
Swiss counterpart has given homeopathy the same status as conventional
medicine in regard to health insurance?
4) By not recognising homeopathic remedies as therapeutic goods in Option 4 of
the consultation, the TGA will be out of step with other world-wide governments
who do.
5) Safety: there is no evidence to suggest that homeopathic medicines have
harmed or contributed to the death of anyone. Homeopathy should not therefore be
restricted by regulations used for “high-risk” pharmaceutical drugs.
Australians have the basic right to choose treatments which best suit them.
Government agencies should not regulate or restrict access to information about
that treatment. The TGA’s role is to ensure that the products and treatments
available to Australians are safe for use. Its role is not to decide what the
Australian public can and can’t use especially when safety, as with homeopathy, is
not the key issue.
For all of the above reasons, Option 4 of the consultation should not be adopted.
Option 1 is the best way to proced now.
Thank You for your time.
signed : GR
FOOTNOTE: Please take this into account when discussing and considering my
submission….
Dr George Wang is an Asst. Professor at the Columbia University Medical Centre
and adjunct Professor at John Hopkins School of Medicine in the USA. He wrote
the following in an article on The Conversation in 2017;
“ The World Health Organisation defines health as ‘a state of complete physical
mental and social well-being and not merely the absence of disease or infirmity’.
Disease treatments in conventional medicine primarily rely on the use of
medicines or invasive interventions to treat the dysfunctional body parts. It
generally does not address the health of the whole person at the root level. To
achieve truly successful health care we need to emphasise the primacy of healing
the whole person on a fundamental level. Research has shown that such an
integrative medicine approach – one that considers the mid-body connection,
lifestyle choices, social and environmental influences, individuality of body
constitution, and the therapeutic relationship – not only yields good health
outcomes, but is cost effective as well. “
For these reasons the use of homeopathy in the Australian medical context, a
medicine that addresses issues of the whole person and integrates all influences
of the person who is reporting to the practitioner as ill, is one that is not ‘high risk’
and deserves to be a part of the medical options available in Australia.

Response

To Whom it May Concern
Homeopathic Goods and Practice
As a concerned Australian Citizen and practitioner of Homeopathy I would strongly
appose any legislation that curtails, limits or bans the practice of Homeopathy and the
manufacture or distribution of homeopathic products.
Homeopathy is the only medical practice that does not rely on animal testing, is the
second most used modality worldwide and has been proved over the last 250 years to
not only much safer than conventional medicine, but also more efficacious in epidemic
conditions.
There is no possible justification for legislating against the use of homeopathy except to
bolster the pecuniary interests of drug companies.
I trust that Australian sensibility will prevail and homeopathy will be specifically
protected from any future legislation that may impact on its use, manufacture or
prescription

LA

Response

 

11 May 2017 Hello My submission concerns the Consultation: Options for the future regulation of ‘low risk’ products’ being undertaken by the Therapeutic Goods Administration. As a consumer I believe that homeopathic remedies offer viable treatment options to modern health problems. This view is supported by the TGAs Swiss counterpart in its own report. With reference to key reports used to inform this consultation I trust that findings and recommendations from the NHMRC report are being evaluated rigorously for merit or lack thereof. Issues involving conflict of interest, bias and fairness must be investigated thoroughly in order to present the findings as reliable. My key concerns in restricting access to homeopathy are: 1. Right to choose. I have a right to choose adequate and affordable health care. My family have all benefitted from use of homeopathic remedies for colds, ear infections (on occasion diagnosed by my gp if i was unsure but treated effectively with homeopathy) hayfever, fever, reactions to insect bites, emergency situations (non life threatening in most cases). Having trained as a registered nurse I would rather reach for homeopathy than paracetamol or ibuprofen for my asthmatic children because it works and there are no adverse side effects noted. Again on occasion we have used one of the above for pain relief. We use inhalers and antibiotics when necessary and will continue to do so. However I have found that early intervention with a less invasive remedy markedly reduces our reliance on an overburdened public health system and decreases the need for expensive over the counter products with the unnecessary extras that are often contained within. A bit of lactose in a homeopathic remedy is the least of my worries compared with the alternatives. 2. Safety. Given that these products are already considered low risk with no evidence (that i am aware of) linking them to harm or death in the Australian population (as opposed to readily available OTC products such as paracetamol for example) how can the TGA justify restricting the current status? What does it expect to achieve? Why does the homeopathic industry need to prove itself to a higher standard than other therapies? 3. Research based evidence. Please refer to the Homeopathic Research Institute for case studies and large population studies with positive results. The UK recently chose not to ban prescription of homeopathic medicines and funds NHS homeopathic treatments to the tune of 4 million pounds annually. There is a plan there to study its efficacy rather than dismiss it outright. Why is this not considered in Australia prior to proposing radical changes? I therefore: Oppose options 3 and 4 of the TGAs proposed options. I strongly support the existing access to homeopathy treatments and products with rights to remain as they are for prescribing practitioners and students of homeopathy courses. The fact that there is a registering body (AROH) setting standards for accreditation and requiring practitioners to fulfill competencies that protect the public must surely satisfy the safety aspect as much as any other health profession.
Regards TR

Response

To Whom It May Concern,

Submission to the TGA re Homoeopathy Regulation

I have a degree in Health Science (Complimentary Medicine) so I understand the NEED for a balance of available treatments between Western Medicine & Complimentary alternatives for people that can aid in the treatment & recovery of conditions & ailments.

I wish to express my concern and objection to the potential change of homoeopathy to an un-therapeutic good in Australia.

Homeopathics at its best are seen in children, they are unbiased in what they report back to you when they are in pain or feeling unwell or emotional. When you see a child of 2 years old throwing a tantrum there is no drug you can give them for an occasional emotional episode as children have, however my use of Homeopathy with my own children & my families children for tantrums, teething, bumps from falls has been close to miraculous & instantaneous. Homeopathy works & it would be an unimaginable loss to not have access to this wonderful product.

I have seen it work time and time again for myself & my family. I have to ask myself if Homeopathy is good enough for the Queen to use, why is it not good enough for us? Australians are open minded sensible individuals in a country that is diverse & ever changing. We need to have these options available to us.

Therefore I strongly support Options 1 and 2, keeping homeopathic products’ regulation as it currently stands and requiring scientific evidence for high-level claims. This approach preserves homoeopathic products as therapeutic goods and brings them into line with other medicines.

Regards

LT

Response

TGA Submission – Options for the future regulation of ‘low risk’ products
This submission is made in support of homeopathic medicines as safe and effective complimentary medicines for therapeutic use.
Of the four regulatory options under consideration, I would like to request that the TGA consider adopting Option 1 or Option 2 and strongly oppose Option 3 and Option 4.
Homeopathics, around the world, are considered safe and effective low-risk medicines. As concluded by Bornhoft et al. (2006) in a review of the effectiveness, safety and cost-effectiveness of homeopathy in general practice, the effectiveness of homeopathy can be supported by scientific and clinical evidence and professional and adequate application be regarded as safe.
Here are a few statements from scientific studies on homeopathics that I would like to draw your attention to:
– Homeopathics can be an effective and non-inferior alternative to conventional and other complementary medicines (Derasse, Klein & Weiser, 2005; Haidvogle et al. 2007; Riley et al. 2001), may be significantly better tolerated (Adler et al. 2009) and in some cases, found to be superior (Wustrow 2004).
– Homeopathic treatment results in clinical, measurable improvement of illnesses and health concerns (Jacobs et al. 2008; Steinsbekk et al. 2005; Weatherley-Jones et al. 2004)
I would also like to point out that if the TGA is struggling to collate appropriate, peer-reviewed, scientific articles on the safety and efficacy of homeopathics, that can be used to support the inclusion of homeopathics as a safe, complementary medicinal treatment option, www.greenmedinfo.com has collated over 100 abstracts on homeopathic research.
I am concerned that the TGA is basing the review of homeopathics on a report that is currently being investigated for complaints of serious irregularities and so is basing policy decisions on science omission.
Personal Story
I am a mum to a young toddler. I started using professionally and self-prescribed homeopathics as part of our home first-aid kit after I had a very positive experience with a homeopathic product, Rescue Remedy, when my son had a cold. He was irritable, crying, restless and becoming inconsolable at night time because of his blocked nose interfering with normal breathing and breastfeeding. Aromatherapy chest rubs, vaporizers and herbal nasal decongestants were providing only minimal relief. After trying these remedies and not having much improvement, my friend offered Rescue Remedy (we were traveling and staying at her place). On three consecutive occasions that night, after receiving a few drops of Rescue Remedy on his forehead, he stopped crying, rolled over and went back to sleep. I found it to be such an
incredible and immediate response! It was so astounding for me because he stopped crying so immediately, during the application of rescue remedy, even when a breastfeed couldn’t calm him! Sleep and recovery from the cold was then easy and I have included homeopathics as a go-to remedy for health concerns for our family ever since. I am continuing to learn about the incredible amount of scientific and clinical evidence in support of the efficacy and safety of homeopathics and believe that homeopathics offer a substantially safer, primary-care option for treating illnesses and health concerns than pharmaceuticals. There is MUCH scientific and clinical evidence to be found on the harmful and negative impacts of pharmaceutical medicines and treatments. For this reason, I believe that homeopathics offer a safer alternative for the primary treatment of illnesses and health concerns and ask that the TGA ensure that homeopathic products and treatments remain available to Australians as therapeutic medicines.
References
Adler, U.C., Paiva, N.M.P., Cesar, A.T., Adler, M.S., Molina, A., Padula, A.E. & Calil, H.M. 2009. Homeopathic Individualized Q-potencies versus Fluoxetine for Moderate to Severe Depression: Double-blind, Randomized Non-inferiority Trial. Evid Based Complement Alternat Med. PMID: 19687192
Bornhöft, G., Wolf, U., von Ammon, K., Righetti, M., Maxion-Bergemann, S., Baumgartner, S., Thurneysen, A.E. & Matthiessen, P.F. 2006. Effectiveness, safety and cost-effectiveness of homeopathy in general practice – summarized health technology assessment. Forsch Komplementmed. 13 Suppl 2:19-29. PMID: 16883077
Derasse, M., Klein, P. & Weiser, M. 2005.0The effects of a complex homeopathic medicine compared with acetaminophen in the symptomatic treatment of acute febrile infections in children: an observational study. Explore. 1(1):33-9. PMID: 16781498
Haidvogl, M., Riley, D.S., Heger, M., Brien, S., Jong, M., Fischer, M., Lewith, G.T., Jansen, G. & Thurneysen. A.E. 2007. Homeopathic and conventional treatment for acute respiratory and ear complaints: a comparative study on outcome in the primary care setting. BMC Complement Altern Med. PMID: 17335565
Jacobs, J., Jiménez, L.M., Malthouse, S., Chapman, E., Crothers, D., Masuk, M. & Jonas, W.B. 2008. Homeopathic treatment of acute childhood diarrhea: results from a clinical trial in Nepal. J Invest Dermatol. 128(10):2429-41. PMID: 10784270
Riley, D., Fischer, M., Singh, B., Haidvogl, M. & Heger, M. 2001. Homeopathy and conventional medicine: an outcomes study comparing effectiveness in a primary care setting. J Altern Complement Med. 7(2):149-59. PMID: 11327521
Steinsbekk, A., Fønnebø, V., Lewith, G. & Bentzen, N. 2005. Homeopathic care for the prevention of upper respiratory tract infections in children: a pragmatic, randomised,
controlled trial comparing individualised homeopathic care and waiting-list controls. Complement Ther Med. 13(4):231-8. PMID: 16338192
Weatherley-Jones, E., Nicholl, J.P., Thomas, K.J., Parry, G.J., McKendrick, M.W., Green, S.T., Stanley, P.J. & Lynch, S.P.J. 2004. A randomised, controlled, triple-blind trial of the efficacy of homeopathic treatment for chronic fatigue syndrome. J Psychosom Res. 56(2):189-97. PMID: 15016577
Wustrow, T.P.U. 2004. Alternative versus conventional treatment strategy in uncomplicated acute otitis media in children: a prospective, open, controlled parallel-group comparison. Int J Clin Pharmacol Ther. 42(2):110-9. PMID: 15180172

WN

Response

Greetings

I subscribe to the news letters and love the articles.

I understand the urgent need to vote in Australia to keep homeopathy alive.  The petition does not accept anyone else, other than Australians.

I think it is important to keep this practice of Homeopathy alive as it produces much good for humans and animals alike.  I request the government review and consider maintaining it.

I hope that my humble voice may be heard from far away. Homeopathy is very old and international, and I think it would be a sad day to ban it in the 21st Century!

Warm regards

PJJ

Response

I have been a regular user of Homoeopathic medicines for myself and my
children, for nearly 40 years. During this time, I have had RARE contact with
Doctors or Hospitals, consulting either a Professional Homoeopath or using
remedies myself as First Aid.

I have always found the medicines to be both SAFE and Effective They help the
body to heal the underlying causes of Dis-ease, unlike Allopathic drugs, which not
only suppress symptoms but can create very toxic side effects, causing them to be
one of the leading causes of death in the Western world.

The TGA and all Government Departments being part of the “Australian Government”.
are all Private Foreign Corporations registered with the American Securities Exchange in
Washington DC. As such, it has NO legal authority over me, being a Free Man and Woman
on the Land.I have every right to decide for myself, what I put into my body, for which
I take full responsibility.
I have thus NO CONTRACT with the TGA
Homoeopathy must left regulated as it currently is, ie NO 1
I definitely say NO to No 4

India has fully embraced Homoeopathy as has Switzerland
Why then does the TGA endorse flawed UK “Science”?

Yours Sincerely
GM

PS The British Royal Family has traditionally used Homoeopathy. Surely
the Queen at 90 and still reigning, must be testimony to its effectiveness?

Response

Gisborne Homeopathy
CJ Dip Hom
TGA submission on the regulation of low risk products
Dear Sir/Madam
I am extremely concerned that the future of homeopathy in Australia is at risk. It is vital that this effective, low-risk and popular modality continue to be regulated as it currently is.
I am also very concerned that the TGA’s decision-making is informed by the highly flawed NHMRC report about the effectiveness of homeopathy. The complaint to the Ombudsman asking that this report be rescinded is required reading for all TGA law-makers. See https://www.hri-research.org/resources/homeopathy-the-debate/the-australian-report-on-homeopathy
Despite all the fuss and skeptical nonsense in the media today about homeopathy, TGA law-makers need to be aware that it continues to thrive. Why? Because it provides an effective alternative. Most people inherently know or feel that pharmaceuticals are unnatural and ‘wrong’ for them, especially in the long-term. There are severe deficiencies in conventional medicines’ armamentarium, particularly for the management of chronic disease. The amount of money wasted due to non-compliance with drugs is a universal scandal. The unscrupulous behaviour of drug companies is another. I know this because I practised as a pharmacist in both community and hospital settings, and also in regulatory and professional support roles for almost 30 years.
The general public, now much better-informed than in previous decades, has a rapidly-growing lack of faith in doctors and what they can offer. Homeopathy fulfils a much-needed role and needs to be integrated into the conventional healthcare system. The result would be vastly lower costs and happier, healthier patients. Finally I would like to remind the TGA that its role is to protect public safety, not to make value judgments or restrict access to safe products that Australians freely choose to use as therapeutic goods. Yours faithfully CJ

Response

To whom it may concern,

My family have been using homeopathy for several years for the treatment of many illnesses including colds, sore throats, hormonal imbalance, hayfever and ear aches, to name a few. My children, including when they were babies, had great success with homeopathy. Examples include:

Noses dried up without the use of cold and flu medicines or 100 tissues.

Ear aches stopped without Nurofen or Panadol.

Following birth, taking Sepia to help with my own hormonal mood swings and anxiety.

My husband who had been sneezing for at least 15 years first thing in the morning and last thing at night experienced great relief using Nat Mur for his hayfever. Incidentally, his sneezing has now been reduced by 95% due to this treatment.

We have also treated our cat homeopathically for epilepsy with greater success than with conventional medicine. Whilst one can trick themselves into believing that a remedy is working (placebo effect), you cannot trick a cat. We have noticed that our cat is much less skittish and is more like himself when he was younger (prior to starting epileptic symptoms).

I have seen firsthand the benefit of homeopathy and would respectfully ask you to continue to allow homeopathy to be used in Australia.

Yours faithfully,

OD

Response

TGA Submission
Options for the future regulation of low Risk products
Homeopathic Products
I choose Option 1 or Option 2
I have used homeopathic products personally in my family with myself, my husband and my children for over 20 years and have found them to be most beneficial for a non-toxic alternative to conventional medications whose side effects worry me.
There have been no adverse effects of homeopathic products to my knowledge and I would like to be able to still use them and be able to purchase them for my own use. Alternatives to high risk medications are few and far between and Homeopathic preparations are in my opinion a good alternative to someone wanting to avoid potential toxic and high risk alternatives.
I hope that we can continue to have this choice in australia

HS

Response

I am surprised to hear that some new restrictions are being considered for controlling the use of homeopathy in Australia. I do not know the present status of homeopathy there but I know the position in India as a citizen and as a convert to this system of treatment after experiencing the benefits for myself and the family.

In India, this is not an occult tradition like astrology or palmistry but a well established   medicinal system with state support and with many approved medical colleges turning out graduates every year . It has established its presence in remote rural areas and all the metros of this country. It not only helps in curing patients without side effects but is also kind on their pockets !!  While the traditional Western system of medicine referred to as allopathy has its strengths in life threatening situations [ to keep the patient alive in an emergency] , it has not succeeded in reversing diseases of a chronic nature—the medicines work only to suppress symptoms and give temporary relief. Homeopathy has proved itself in many countries in this area especially.

I appreciate that all medical systems need control to prevent misuse or charlatans taking over. It would be a retrograde step for the people of Australia to deny the use of Organised Homeopathy and its accepted practices . These practices are good for the people of the country. Please consider this before imposing embargos !!

I am told that 4 options are being considered. I have seen the list and would strongly support Option 1.  I have never been in Australia but I feel that the people there should not be denied the use of something beneficial , by Governmental action .

SVS

Response

May, 10th 2017

To Whom It May Concern,

I am writing to you to let you know that I do not agree with your intention to change anything about the status that homeopathic products hold in our country. As with all medicines or therapeutic products, some work extremely well for a patient, some may not have as much of an effect and in a very scientific way that can be due to many reasons, first of all the remedy itself not being selected well. That happens just as much in allopathic medicine and with pharmaceutical drugs, however, while people yearly get injured and made sicker in our main health modality of Allopathy (numbers as you know are in the thousands), homeopathy comes along as a safe alternative or adjuvant for large numbers of people. Please, do not discount the fact that there are numerous people that have been helped and are continuing to be helped. Homeopathics even work where other medicines, especially toxic pharma drugs, don’t help. I have seen it in my own life and family and I am deeply grateful for this modality and being able to use it with good judgement.

I understand that there is an issue if people use alternative medicines without good judgement or advice. There is no wonder drug nor a wonder modality where one size fits all,, which is why I believe Australia needs proper bridges of ALL the modalities of medicine working in collaboration. There is not one modality that has all the answers, and that includes Allopathic Medicine as well as homeopathy. Neither should ever be portrayed that way. That is why we consult and prescribe individually. That’s what the GP should do as much as any other health practitioner, including the homeopath.

If you remove the option of homeopathy from our disposal I am afraid there will be more of a health crisis in our country, because you fail to realise how valuable it is and what place it has in our health system. Do investigate into the many people that have tried everything (and that usually means ALL the allopathic options) and arrive at homeopathy just to find help, relieve or even complete healing. What study does anyone need to prove that? Absolutely none! If someone is made well or improve in their condition there is no reason to say it can’t be because there is no scientific paper that says so.

I am an advocate against changing the status of homeopathy in our country. And I am backing my claims up with many proofs, including what happens in countries like India, Cuba and Switzerland. You are obliged to look into ALL evidence and ALL TRUTHS and not take one report by one organisation (however truthful or lacking in accuracy it may be) and investigate an action because of its erroneous conclusions.

I urge you to serve the people of Australia well and do not assume taking away our right to use a long-standing proven form of medicine from our disposal. The list of harm in homeopathy is shorter than a kindergarten child can count their numbers. If there is need for an adjustment in the way specific therapies are marketed or portrayed that sounds lke your duty and an important one. But cutting into our ability to access a long-standing, proven health modality is absolutely a wrong direction.

Sincerely,

  1. B.

Response

Online Submission in regards to the ‘ Consultation: Options for the future regulation of ‘low risk’ products’

To whom it may concern,
I have grown up with homeopathy in my life since my mother discovered it through researching ways to help my older brother with autism. It saved his future as it allowed him to have a much more ‘normal’ life, and hence he is now fully independent and secure with a job.
My childhood was difficult due to the autism but with the aid of homeopathy, my brother’s behavioral problems eased away. Homeopathy also saved my relationship with my brother. Without it, his behavior would have continued to stop us from getting close.
Homeopathy is a medicine that works. I use it regularly on my horse and on myself and I have seen the results first hand. All my life I have suffered from severe headaches. Conventional medicine has never helped, it was always a ‘band-aid’ and my headaches would always return, the same with cold sores. With homeopathy, all of this changed. I no longer suffer from either of these. And these are just two examples, of the many that I have.
There are scientific studies behind it, countless success stories, no side-effects. Why take away the free choice that Australians have over their bodies? This is meant to be a country where we have the freedom to express our beliefs, concerns and freedom over our own bodies. Why is this being taken away?
I’ve worked closely with homeopathy for nearly a year now and I know the difference between something fraudulent and something honest, pure, and reliable. Take away a medicine that has no side effects and heals people at the deepest roots of themselves, take away our freedom, and it will be sending a very bad message about what it means to be a human being living in Australia (a DEVELOPED country).
Homeopathy should be left alone the way it is. Or even made easier to access. Our health is our choice. No one has the right to dictate what we eat, what we drink, or how we heal our own bodies. Just look to all the other countries who strongly support homeopathy. You can’t deny it’s truth if you open your eyes to it.

Yours sincerely,
A.R

Response

CONSULTATION: OPTIONS FOR THE FUTURE REGULATION OF ‘LOW RISK’
PRODUCTS
Submission by: T.M Phd, DipHom, FCIS
INTRODUCTION
I support Option 1 in the consultation paper, namely to maintain the status quo for regulation
of homeopathic products.
Homeopathy has an unusually long recorded history of therapeutic effects The track-record of a
core group of medicines goes back more than 200 years. The effects of these medicines have
been systematically recorded and collated in various ways over that period, most recently
through scientific investigation.
The sections that follow outline the reasons why homeopathic medicines should be regarded as
having therapeutic effects, essentially due to the wide variety of different forms of evidence of
those effects.
EVIDENCE OF EFFECTS
Overview
It is common in quality assurance in other contexts to place reliance on the concept of
‘triangulation’. The concept of triangulation is a powerful one and yields more reliable findings
than reliance on one form of evidence alone. Essentially the objective is to find different forms
of evidence that are aligned, all pointing to the effectiveness of a process or intervention but
from different perspectives.
In the case of homeopathy, we can cite the combination of:
• ‘provings’, in which generations of homeopaths have laid the foundations of the materia
medica through trials of the ‘primary effects’ (i.e. the initial adverse effects) of
homeopathic medicines, corresponding to the symptoms being treated
• the work of master practitioners/scholars, who aggregated the evidence from provings
and clinical experience into the materia medica and repertories used as the basis for
prescribing
• high quality case studies such as those on the site: Homeopathy 4 Everyone.
Homeopathic Medicine & Homeopathy Remedies
• observational studies of large numbers of homeopathic patients with one or many
different conditions and the outcomes of their treatments, not contrasted with a control
group
2
• randomized controlled trials (RCTs) of which many hundreds have been published in the
peer-reviewed scientific literature, many of them positive.
• studies of the effects of homeopathic medicines on other biological systems, such as the
growth rates of plants and animals
• other animal studies
• studies on the physical structure of homeopathic medicines.
Clinical Evidence
The recorded clinical effects have been collated in works such as Frans Vermeulen’s The
Concordant Materia Medica (Vermeulen 2003).
A well-regarded example of a series of positive RCTs includes the series of RCTs on
homeopathic treatment for childhood diarrhea (Jacobs et al 2003).
Some examples follow of the concordance between recorded clinical experience and
contemporary research.
Homeopathy has been show to produce major improvements in injuries. For example, the
homeopathic literature has shown Natrum sulphuricum to be effective in brain injuries for at
least the last 100 years (see entry in Vermeulen 2003). In 1999 the effectiveness of
homeopathic treatment for brain injuries was also demonstrated in a trial by Chapman et al.
There were small numbers of patients in the trial (common in unfunded trials), but the
combined forms of evidence are persuasive.
There is a similar mix of evidence showing that homeopathic Symphytum can accelerate the
healing of fractures. Clinical experience has been recorded and aggregated again for over 100
years (Vermeulen 2003). In addition, there is a positive randomised controlled trial (Sharma,
Sharma and Sharma 2012). Further work is now being undertaken by the Homeopathy
Research Institute: Can homeopathic medicines accelerate fracture healing?
The most rigorous and comprehensive systematic review of all the RCTs to date by Mathie et al
(2014) found reliable studies that were positive for homeopathy, although the effect sizes
reported were small. The overall conclusions were cautiously positive and consistent with the
position that homeopathic medicines have therapeutic effects.
To this, we can add observational studies of large numbers of homeopathic patients and the
outcomes of their treatments. For example, the study on all patients treated with homeopathy
at the Lucca hospital over seven years Rossi et al (2009) found that 74% reported at least
moderate improvement.
These are only examples of the material body of evidence available for the effectiveness of
homeopathic medicines. Further substantive evidence is outlined at the following sites:
• National Center for Homeopathy Research Library
3
• Research – The Faculty of Homeopathy
• Research – European Committee for Homeopathy
• Homeopathy Research Institute (HRI): Current projects
In 2015, the National Health and Medical Research Council reached unfavourable conclusions
on the basis of a selective sample of RCTs, but these conclusions have been rebutted by the
Homeopathy Research Institute. The full version of HRI’s analysis is not yet public, but a short
summary is available from: https://www.hri-research.org/wp-content/uploads/2016/02/HRIResponse-
to-NHMRC-Information-Paper.pdf
Mechanism of Action
The Faculty of Homeopathy has summarised the current status of research on the properties of
homeopathic medicines (with 16 scientific references)
(http://facultyofhomeopathy.org/research/basic-science-research/) as follows:
[One possible} mechanism is suggested by the results of research on molecular clustering in
water solutions, which has shown that as a solution is made more and more dilute, very
stable and larger ‘clumps’ of material develop in dilute solutions rather than in more
concentrated solutions. This means that residual molecular clusters of the original
substance might be present in homeopathic dilutions. Succussion might also be responsible
for creating very tiny bubbles (nanobubbles) that could contain gaseous inclusions of
oxygen, nitrogen, carbon dioxide and possibly the homeopathic source material.
A recent meta-analysis evaluated 67 in-vitro biological experiments in 75 research
publications and found that high-potency effects were reported in nearly 75% of all
replicated studies; however, no positive result was stable enough to be reproduced by all
investigators. One example of a series of in-vitro experiments in homeopathy is the model
of the allergic response to antibody using the human basophil degranulation test. The
earliest study reported inhibition of degranulation with ultra-molecular dilutions of anti-
IgE. These initial experiments did not prove to be reproducible. Subsequent studies using a
modified method, and using ultra-molecular dilutions of histamine, have shown positive
results however. These findings have been reproduced in several independent laboratories,
as well as in a multi-centre series of experiments.
Bell et al (2012) developed a comprehensive model of the actions of homeopathic medicines on
biological systems, based on integrating the findings of 247 scientific papers.
While the research into possible mechanisms of action is incomplete, it is material and
indicative. The development of sophisticated models for the actions of homeopathic medicines
makes it increasingly difficult to dismiss homeopathy on a priori grounds.
4
CONCLUSION
The other options given in the consultation paper are not appropriate.
Exemption from listing would lower quality controls on the manufacture of homeopathic
medicines, as the consultation paper acknowledges.
Declaring homeopathic medicines not to be therapeutic goods would be a polemical position,
which flies in the face of the evidence accumulated over 200 years. The only justification for
such an extreme position would be that homeopathic medicines are not distinguishable from
water and therefore must be inactive on first principles. This position is inconsistent with the
status of the current research on this issue referred to above.
The final paragraph of this section of the consultation paper concludes:
In the event that Option 4 (or a version thereof) is the supported way forward and the
TGA were to no longer regulate homoeopathic products, then a new definition for what
a ‘homoeopathic’ product represents must be developed. Further consideration should
be given to defining the term with reference to concentrations, so that concentrated
preparations remain within the purview of the therapeutic goods regime.
This represents a logical contradiction. It makes no sense to declare that homeopathic
medicines are not therapeutic goods and then seek to keep some of them within the
therapeutic goods regime. There is no distinction in homeopathy between the effects of
products manufactured with low dilutions and those manufactured with high dilutions.
Therapeutic effects have been observed at all levels both in the clinical and in the scientific
literature. This distinction would have no basis in the scientific literature on the effects of
homeopathic medicines, and no other therapeutic regime in the world has made such a
distinction.
The profile of evidence on homeopathic medicines is not consistent with the profile of
evidence for other substances that lack any clinical effects. It is only consistent with
substances that do have therapeutic effects.

Response

Dear Sirs/Madams,

Myself, my husband & our 2 children (4 & 7) would be greatly disadvantaged, & completely devastated, if homeopathy were banned, or even restricted, partially or otherwise, in Australia. We only consume pharmaceutical products in case of emergency, as homeopathic remedies have resolved countless health issues & benefited us more than words can say (here). Our children have NOT had to consume anti-biotics, thanks to & solely due to the miracle of homeopathy. I appeal to you to investigate ALL testimonials/studies, before even remotely considering this completely unnecessary legislature. It is completely unjust & inequitable that BIG PHARMA are trying to destroy this proven form of healing & health care (We may only represent a minute percentage of the population, but I would like to think that we DO count). They (our children) are now healthy, happy, balanced children who have survived & even thrived with this method, so I appeal to you, particularly those of you who have children… PLEASE don’t ban homeopathy… or you will undermine our entire family’s health & well-being (and an entire nation of individuals, particularly parents, who rely & depend on this safe & non-invasive [see the countless, clinical double-blind studies] form of health care & management).

Thank you, Mrs S.K

Response

To whom it may concern,
I have been a classical homeopathy practitioner for over 20 years,
much to the satisfaction of many patients. My concern is that with
a change in regulations in Australia, patients in Australia won’t be
able any more to benefit from this gentle and safe and evidence
based healing method.
I would like to refer you hereunder to a the Swiss HTA report on
homeopathy, that may inspire you to reconsider changing the
regulations in Austria, and keep allowing people to prescribe, buy
and use homeopathic remedies.
Sincerely,
Rivka Klein-de Graaf
The Swiss HTA report on homeopathy
A Health Technology Assessment report1 was commissioned by the Swiss health
authorities to inform decision-making on the further inclusion of homoeopathy in the list of
services covered by statutory health insurance.
According to the authors, their report “confirms homoeopathy as a valuable addition to
the conventional medical landscape – a status it has been holding for a long time in
practical health care.“
To quote the report’s official conclusion:
“There is sufficient evidence for the preclinical effectiveness and the clinical efficacy of
homeopathy and for its safety and economy compared with conventional treatment.”
For a short overview of the Swiss report, see HRI Spring 2012 research article.
Swiss report findings
· The evidence from laboratory studies and clinical research shows that homeopathy is
effective, and homeopathy as practised in Switzerland is cost-effective and safe.
· 20 of 22 systematic reviews of clinical trials showed a positivedirection of evidence
in favour of homeopathy.
· Strongest evidence of effectiveness was found for Upper Respiratory Tract
Infections and Allergic Reactions (URTI/A).
29 studies identified, 24 of them showing positive results.
· Report discredits the Lancet 2005 meta-analysis by Shang et al.2 (the only
comprehensive systematic review ever to conclude that homeopathy works no better
than placebo). To quote the Swiss report authors,“…. we can say with certainty that the
Shang et al 2005 study does not prove that homeopathy has no effect”.
Swiss report key facts
· HTA is a well-recognised research method used to assess real-world effectiveness,
safety and cost-effectiveness of treatments e.g. for the UK’s National Health Service.
· Report was commissioned by Swiss Federal Office for Public Health (BAG).
· Report summarised the findings of a seven-year review of the evidence on homeopathy,
conducted as part of a wider ‘Program of Evaluation of Complementary Medicine (PEK).
· 2006 – Short summary of the report,3 concluding that homeopathy is clinically effective
and safe, is published in a scientific journal in German.
· 2009 – Public referendum in Switzerland supports inclusion of homeopathy and other
complementary and alternative medicines in the list of treatments covered by Swiss
public health insurance, with 67% voting in favour.
· 2011 – English translation of the full HTA report1 published in booklet form bringing wider
awareness to the report’s endorsement of homeopathy.
· 2011 – Swiss government decides that homeopathy will be covered by public health
insurance from 2012 until the end of 2017 as part of a temporary scientific evaluation
plan to determine whether state coverage should be made permanent.

G.R

Response

To Whom it May Concern
Homeopathic Goods and Practice
As a concerned Australian Citizen and practitioner of Homeopathy I would strongly
appose any legislation that curtails, limits or bans the practice of Homeopathy and the
manufacture or distribution of homeopathic products.
Homeopathy is the only medical practice that does not rely on animal testing, is the
second most used modality worldwide and has been proved over the last 250 years to
not only much safer than conventional medicine, but also more efficacious in epidemic
conditions.
There is no possible justification for legislating against the use of homeopathy except to
bolster the pecuniary interests of drug companies.
I trust that Australian sensibility will prevail and homeopathy will be specifically
protected from any future legislation that may impact on its use, manufacture or
prescription.

L.A

Response

I say No to the proposed TGA Option 4 Consultation because this is a blatant disregard for individual rights, my rights. I refer to rights that are mine, to be able to choose what best suits me and how I choose to go about the whole process. I do not want to be relegated to a position of being subjected to everyone else’s views and opinions on my health and welfare because I believe I am smart enough to work things out for myself. Furthermore, I am appalled at life’s present directions where individuals have so lost their ability to think for themselves that we now believe we have to save them from their own decisions. At what point, I ask, does responsibility rest with the individual?

I believe TGA’s role is to advise, provide information, offer assistance where requested but never, take the role of parent. Independently, TGA’s work is about preventing harmful substances being made available, yes, but this does not require action on Homoeopathy which is particularly harmless. So let’s get the details correct. Misguided individuals, not prepared to take responsibility for their own lives, may want to be pandered to and treated like children, but I am not such a one.

I have experienced both ends of the spectrum with a parent that was so totally blinded by scientific, modern medicine that she chose to ignore the complete uselessness of drugs in her treatment and preferred to die, as I see it now, in a most uncomfortable manner. This was the beginning of my own turning towards Homoeopathy, though at the time I didn’t realise this fact.

When my own daughter was becoming a drugged toddler for a simple case of Glue ear and continuous ear infections, I became desperate and this was the point at which I really did turn to Homoeopathy and I have never looked back. I have not used pain killers, nor antibiotics and no other form of drug for myself since then. My daughter is married with her own child and she prefers following allopathic treatment and I believe this to be her right. True Homoeopathy requires skill, time and patience, which is not a fit for her life style, however for myself, after more than 20 years I know that I cannot return to that form of medicating where the cause is ignored in preference to the ailment. It’s almost a case similar to that of bad parenting, by reinforcing the negative and ignoring the positives. I have seen Homoeopathy work quickly and effectively on children who cannot possibly have agendas such as we adults do. I know this works and what is more, harmlessly, so I cannot understand why such products can be thought of as harmful, unless by harmful there is a reference to lost business to drug companies.

In summation, I would like to stress that as a nation we owe it to our population to have the benefit of both realms. There are proper times for allopathic Medicine and then there are times for complimentary. Both have their uses and both need encouragement.

In view of this belief, I would appreciate open access to all self-help information on symptoms, ailments and treatments, on Homeopathy.

Homeopathic providers, free to provide information, on prescribing Homeopathic remedies.

Recognition of Homeopathic remedies as being harmless and therefore ridiculous to be considered for grouping with high risk medicines.

Consumer and user access to be simple and easily available

Encouragement for importation, exportation or manufacturing of homeopathic remedies by pharmacies and manufacturers via relaxed regulations

Question those seeking to restrict homeopathy for their agenda and not allow personal agendas to influence decisions on health by encouraging antagonistic complaints.

All together, these are my reasons why Option 4 of the consultation should not be adopted

H.A

Response

NO  NO  NO  to Option 4

The day to day life and the future of my family has been greatly enhanced and “saved” by discovering and using homeopathy for the past 18 years.  From treating autism like symptoms, ADHD,  colds, croup, flu, stings, bites, bruises, pain, cramps, varicose veins, grief, etc etc etc. After the ongoing experiences of years and expenses of conventional medicine and treatments that only masked not fix the health issues Homeopathy is a God send.

Just one example is my 21 year old son who was diagnosed with Autism, ADHD at age 2 is now happily completing a mechanic apprenticeship, he has a relatively normal life not because of Ritalin, dexamphetamine, anti depressants etc which made him like a zombi but because of Homeopathy.

Another is when my 3 year old daughter was hiding in a bush and came out screaming, she had close on to 40 wasp stings all over her back, legs and arms – within minutes of treating her with Homeopathy her pain and distress disappeared.

Homeopathy is used successfully world wide including whole communities and should be encouraged and not taken away from people as a choice of treatment. We have a right to choose what treatment we take on. My own research of information and using Homeopathy with success means this method is my choice , I do not want access restricted or worse having it banned because of misguided thought processes wanting to changes regulations.

I ask you who benefits if  Option 4 gets passed???  It definitely will NOT be us – the everyday people – individuals, families, communities.

Please TGA be fair, thorough and unbiased – Homeopathy is safe and successful as a health choice. We have a right to access this choice.

Option 1 is the right option – do the right thing for us, the people.

W.T

Response

Dear TGA,

May I remind you that the TGA’s role is to protect public safety, not to make value judgments or restrict access to safe products such as those dispensed by Homeopaths across Australia.

Australians freely choose to use Homeopathy to cure illness and resolve disease in the body.

I refer to the suggested changes you are attempting to make to place Homeopathy under a changed therapeutic goods act.

Homeopathic products and remedies are mentioned on Page 46-49 of the Consultation Paper.

TGA: Four regulatory options under consideration

Option 1 – Keep homeopathy regulated the way it is.

Option 2 – Keep it the way it is but require scientific evidence for high level claims.

Option 3 – Exempt homeopathy from listing.

Option 4 – Declare homeopathic products NOT to be therapeutic goods.

Pay special attention to Option 4 – “Declare homeopathic products NOT to be therapeutic goods.”

At this point of time it appears that Option 4 is the TGA’s preferred option.*

(*The TGA’s dependence on the flawed NHMRC Report on Homeopathy, which is currently being reviewed by an ombudsman because of IRREGULARITIES, and the equally flawed UK Science and Technology Report that was ultimately rejected by the UK Parliament, indicates a potential bias by the TGA: the TGA has shown a preference for these questionable reports while omitting the positive Swiss Homeopathy in Healthcare Report from its consultation.)

I OPPOSE OPTIONS  2, 3 and most importantly option 4 as this will impact upon the freedoms of Australians to use Homeopathy or be dispensed homeopathic remedies.

Australians have been given very little notice of this alteration to the TGA Act and this short process of consultation should be illegal. You have kept it from the media and this is wrong on many levels.

You do not have the right to take homeopathy options away from Australians.

Yours, Z.H

Response

I feel the TGA would be making a big mistake by selecting Option 3 or 4. The TGA is there to protect safety of medicines and treatment, not to restrict access to safe medicines.

Homeoprophylaxis is considered by the TGA and drug companies around the world as low risk medicine, so there is no need to change that now. The WHO recognises Homeopathy as the most popular and widely used complementary medicine used worldwide.

Homeopathy is a great complimentary treatment that has been proven to be effective in treating many ailments.

I believe Australians have the basic right to choose treatments which best suit them and government agencies should not regulate to restrict their access to information about that treatment, especially when safety is not an issue, in the case of homeopathy.

I oppose and say No to Option 3 and 4 of this proposal.

Sincerely, M.B

Response

To: Australian Government
Health Department
Therapeutic Goods Administration
Re “No” to Option 4, “Yes” to Option 1

Dear Sir / Madam
I want to express my absolute disbelief at the attempt to review the basic
human freedom , and right to choose the method of health and healing that
the individual considers appropriate.
My son suffered from chest infections for over 2 years, and nothing the GP
could prescribe made any difference, he just had to live with the condition,
that is until we tried Homeopathy. He was actually skeptical and didn’t think it
would make any difference. However after a few weeks he one day became
aware of the fact that he didn’t have the symptoms and it became clear he was
healed.
Why would anyone take away the available means for a child to be healed?
On the human side that would be criminal, on the economic side it would be
akin to corruption, because the government would then have to subsidise the
alternative treatment, namely a pharmaceutical company product.
Let’s look at who the winners are in this battle:
The government? – No.
The Homeopaths? – Definitely not
The People ? – Clearly Not
The Drug Companies – who else – the money trail tells all
Respectfully begs the question, what are the motives of the Department?

Regarding the practice of Homeopathy, there is no evidence of harm or risk
whatsoever to justify even having an option 4 to ban homeopathics. They are
in fact a very safe alternative complimentary medicine used for nearly over 300
years including a history of homeopathic hospitals worldwide that were very
successful until forced to close. Unlike prescription drugs that “contributed to
330 of the state’s 420 overdose deaths in 2015.” there has never been any
evidence to suggest homeopathics harm or contribute to death.
Coroners report into pharmaceutical drug overdose :
http://mobile.abc.net.au/…/pharmaceutical…/7300036…
Could the energies of the TGA be prioritised to take on dangerous drugs and
their dealers ie manufacturers.
In a world plagued by the proliferation of chemicals, unclean air, pollutants,
and nutrient deficient soils, all contributing to weakened immune systems in
the population, please don’t take away even 1 positive form of remedy that
counter balance the above negatives.
And even if you, in your world , have not experienced Homeopath’s life giving
properties and have beliefs that would negate its validity, consider our positon,
honour our freedoms as fellow humans.
Today you have a choice to stand for the life crushing regulation of a harmless
product, or take the democratic high road and support the freedoms of the
people in the face of corporate self interest.
You choose your children’s tomorrow.
I urge you to choose Option 1 , and say “No” to Option 4.
I welcome your response
Sincerely
D.H

Response

Dear Sir/Madam,

I would like to express my concern regarding the proposed changes to the regulations governing Homeopathic Medicines in Australia.

I am a huge advocate of Homeopathic Medicines which I have used with great success to treat a variety of ailments and conditions since I was a child.  I believe that conventional medicine is also very important & I work as a Registered Nurse. I have found over my life that often Homeopathy is able to help where conventional medicine is limited.

For example, as a child I had poorly controlled asthma despite trying a multitude of different inhaled & oral therapies prescribed by my GP & Respiratory Specialist. I was treated at the Homeopathic Hospital in Glasgow, Scotland where they were able to manage my asthma so effectively that I was able to return to school & live a full life including participating in sport.

More recently, I was diagnosed with Hashimotos Disease, an Auto-Immune Thyroid condition, which is very debilitating. The conventional medical treatment for this condition is oral Thyroxine, and while it did successfully reduce some of my symptoms, I was left with many symptoms which did not improve. By using Homeopathic & Naturopathic medicines, I have successfully regained control of my health. Prior to using these treatments, I found it very hard to function on a daily basis, which was very challenging with a young family.

I have also used Homeopathic Medicine for many other issues, including during childbirth & to manage ailments such as croup in my children. This choice allowed me to avoid exposing my babies to highly potent drugs, helped my body to recover quickly& to avoid giving corticosteroids to my children and therefore avoid their horrible side-effects.

My understanding is that the TGA’s role is to protect public safety. I believe that if the TGA adopts it’s proposal to “declare homeopathic products NOT to be therapeutic goods”, then it will not be protecting my safety or my right to choose homeopathy, in the same way that I can choose to take conventional medicines.

I am extremely alarmed that the TGA is considering making a decision on this issue based on the  NHMRC Report on Homeopathy, which I believe is currently being reviewed by an ombudsman because of irregularities, and the UK Science and Technology Report which was rejected by the UK Parliament. The TGA also appears to have omitted evidence from the Swiss Homeopathy in Healthcare Report. Surely any decision should consider all the available evidence & a decision be deferred if that evidence is under scrutiny.

I believe that homeopathy is very safe, & an extremely useful alternative to conventional medicine. I am very much in favour of keeping homeopathy regulated the way it is (option 1) but would also accept option 2, along with the wider homeopathic community.

To protect my rights and access to homeopathy, I strongly oppose Options 3 and 4.

Yours sincerely, T.J

Response

TO WHOM IT MAY CONCERN

Homeopathy has been a part of my family since before my first child was born in 2000.  On many occasions in the last 18 years, I have found it to be extremely effective and at no stage have I ever had any adverse side-effects.

The current TGA Consultation process concerns me greatly that both myself and my family will not be able to receive the same level of treatment that I have been accustomed to over the last 18 years.

At the very least, I would ask that the TGA choose the regulatory OPTION 1 or 2, allowing homeopathic products to continue to be sold within Australia.

I am vastly opposed to Option 4 being implemented into Australia, a country where the people should be able to have the right to choose their preferred avenue of healthcare.

The TGA has a role to protect our safety in relation to medicines and treatment, not to restrict our access to safe medicines, as is the case with homeopathy.  The current stand is that the TGA and every drug regulating authority around the world considers homeopathic remedies to be “low-risk” medicines.  I see know reason for this position to be changed for the future.

I look forward to seeing the TGA listen to the Australian people and understand that we do know what medical treatment works best for us, by choosing Option 1 or 2 in the TGA Consultation process and NOT OPTION 4.

Regards, B.J

Response

To the TGA in regards to proposed changes to the status of Homeopathy in Australia and Homeopathic remedies. I am 32yrs old and currently studying
Homeopathy and Naturopathy and Chinese Medicine, I am writing to you as I am extremely concerned that I may not be able to work in my chosen holistic career field once my studies are completed and feel Option 4 threatens my future and that of my 7 children.

My Personal testimony
..I have used many different homeopathic remedies over the years with my own children. I have been able to treat severe Croup Respiratory infections with Aconite, Spongia and Hepar Sulph, Teething tantrums with Chamomilla and Pulsatilla, Bumps and bruises and assist in the rapid healing of multiple sports injuries via the use of Aconite, Arnica and Hypericum. Gastroenteritus with Ippeccac and Nux Vom. Coughs with Arsen Alb and Ant Tart. Mastitus with Aconite and Phyttolacca and many other illnesses and complaints. Homeopathy has always sped up the healing processes and shortened significantly the duration of the complaints. Often only one pill is needed for rapid change and health to return. I do not know where I would be without Homeopathics!
Homeopathy is recognised by the World Health Organization (WHO) as the most popular and widely used complementary medicine worldwide. Entire communities depend on it for healthcare and the prevention and often treatments of epidemic diseases and to minimise the duration and spread of viral infections. That being so, why would the TGA consider restricting the access of Australians to it? In my experience homeopathic Products like Brauer Childrens Cold, cough, Calm and teething relief, Stomach Calm and IBS Eze sprays are popular because they work and treat where no conventional drug works as they are used for viral infections or fevers or clingy sick toddler behaviours to which anti-biotics do not help. These actually work and help. I implore you not to
take away parents rights to ease their childrens ailments or conditions.
(The Swiss Report on Homeopathy says, “There is sufficient evidence for the preclinical effectiveness in the clinical efficacy of homeopathy and for its safety and economy compared with conventional treatment.” That being the case, why did the TGA exclude this favourable report from its consultation paper yet refer to two negative reports, one of which is currently before an Australian ombudsman for bias and irregularities, and the other, already rejected by the UK Parliament?)
We should be provided with access to more information not less and required to receive more in depth information during consultations via Qualified Homeopaths. It does not make sense to take away an individuals right to making an informed choice as to whether or not to use homeopathics.
By not recognizing homeopathic remedies as therapeutic goods in Option 4 of the consultation, the TGA will be out of step with other governments, worldwide, who do. Why is there a double standard in regulation of conventional drugs, herbs and non- conventional medicines or remedies?
Why is it expected that homeopathy has to provide a much higher standard of evidence than that set for other therapies or medicines – conventional or complementary? And why are clinical and controlled trials ignored and importantly evidence and endorsement of use and safety of homeopathics from Governments around the world not accepted or taken seriously?

The right to choose and Safe products..
As Australians we should have the basic right to choose treatments which best suit us or our children . As there are no legitimate safety concerns with homeopathy as it is diluted so much that there should not be any reason for the TGA to be concerned about its use or promotion and rather it should be endorsed as it actually fullfills the Hippocratic Oath “First Do No Harm” something the majority of Pharmaceutical conventional drugs do not adhere to. Government
agencies should not regulate or restrict access to vital information about safe alternative treatment options, therapies or medicines. Just like we have the right to choose what food we eat, what schools our children attend, what surgery we agree to, where we live, and what religion we subscribe to, and what intervention or therapy we use for ourselves or our children. I believe we should have the right to accept or reject both conventional treatments and medicine and non-conventional treatments and medicines. Especially, in the case of Homeopathics which have been proven to be harmless and actually may be of benefit to restoring the body back into correct balance and health. Homeopathy is used worldwide and many other countries rely on it for treating and controlling
epidemics and for general health management, many other governments acknowledge the benefits of homeopathy. Why put a ban on something that actually works and helps heal the patient from the inside out instead of just a band-aid approach. Studies into concern of over use of Panadol or Ibuprophen in children showed if children are given too much panadol it can be dangerous, have multiple short and long term side-effects and in rare cases be fetal. See below
(http://www.abc.net.au/health/features/stories/2014/10/30/4118124.htm this should be a reason to endorse side-effect free and safe homeopathics as an non- conventional option for Parents to use.
Its about having a choice in our healthcare and that of our children. Not everyone chooses to use Homeopathy but for those that do and have tried everything else to no avail and finally had success with Homeopathy, their right to use it and learn more about it should not be taken away from them!
Unlike prescription drugs which have serious documented side-effects Homeopathic remedies are safe. I personally have found them extremely effective where no other treatments have worked. They are safe and have no side effects. There are no known or suspected contraindications or drug interactions between homeopathic and conventional medications. Homeopathy should not be restricted by regulations used by “high-risk” drugs when even the TGA classes them as low risk.

I leave this letter in your hands for your careful consideration, Respectfully Yours,
B.J

Response

As a strong supporter of homeopathic remedies who has benefited from them many times, I strongly oppose Options 3 and 4 of the regulatory options currently under consideration by the TGA in relation to homeopathy.

Homeopathy is a low risk complimentary medicine, used safely worldwide. The role of the TGA is to protect our safety in relation to medicine and treatments, not to restrict access to medicines which are considered ‘low-risk’ not only by themselves, but by every drug regulating authority around the world.

Use of homeopathy in my day to day life has helped with everything from small ailments and injuries sustained by my children, to supporting my elderly mother with a quick and trouble free recovery from her recent total knee replacement. The nurses at the hospital just could not understand why she was the only patient with absolutely no bruising or redness within a few days of this invasive operation.

Please do not restrict our access to this safe and elegant complimentary medicine. I strongly oppose anything which will lessen the availability of the remedies to anyone who chooses to use them on their own, or alongside allopathic medical treatments.

Thank you. R.C

Response

By K.L, her husband and daughter:

Dear Sir/Madam,

I am concerned about my Rights to use whatever Natural Therapies I want to. I don’t think it’s the TGA’s job to limit Australian’s Freedom of Choice.

Unfortunately, the information to be used by the TGA will no doubt be based on NHMRC reporting, a flawed and biased source.

I prefer OPTION 1, of those available. At least it leaves Homeopathy available, with limited restrictions. The other options are open to further regulation.

I can’t understand why, when Sweden and Switzerland, for example are moving towards homeopathy, (and Brazil, India, Germany, Portugal, Belgium already recognize it…. And don’t forget Great Britain.. in fact ask the Queen if her family uses it), Australia seems to be lagging behind 15 years again and is moving away from it. Anything that keeps the Medicare bill minimized should be embraced with enthusiasm, and encouragement.

My concern is that there is little funding for research to justify homeopathy, so that is seen, by many, as proof that it doesn’t work. Drug companies with their huge budgets, and warped findings, and lobbyists can win out over centuries of experience and empirical evidence.

…..

The upcoming ruling regarding Natural Medicine is very disturbing.

My family has used homeopathy as its main healing form for my whole life, and I AT LEAST WANT THE OPTION OF USING IT IF I WANT TO.

There is no real reason to make it unavailable; it is safe and if the correct remedy is used, extremely effective, often where nothing else will work.

OPTION 1 is the only one I feel OK about preferring, as it leaves it available, under reasonable guidelines.

With the medical profession mostly only able to use drugs, or surgery, please leave the ordinary people free to use homeopathy, or herbs or any natural therapies they choose (and just trust them to make reasonable choices most of the time)

….

RE Homeopathy ruling by TGA.

I have used homeopathy for 40 years and as a Naturopath (38Years) and Pharmacy Assistant (17 years), it has been my go-to modality for effective healing, especially for acute health issues.

Countries such as Belgium, German, Hungary, Portugal, Russia, Great Britain, and more recently Switzerland and Sweden recognize homeopathy, while in India and Brazil, Mexico and Pakistan and Great Britain it forms part of the national health system.

WHEN IS AUSTRALIA GOING TO WAKE UP TO THIS SIMPLE MEANS TO REDUCE THE MEDICAL BLOWOUT?

With the NHMRC report under dispute, and the powerful lobbying of the Drug companies warping the picture, at least leave Australians free to choose Homeopathy if they want to. It’s not as if it is dangerous……. like so many drugs are!
OPTION 1 PLEASE.

Response

To whom it may concern,

I just wanted to write to let you know that I am concerned that out of the options proposed it seems to me that Option 4 of the TGA Consultation will restrict homeopathic information and remedies, and my access to them.

As far as I was aware the proper regulatory place of the TGA is for them to protect my safety in relation to medicines and treatment, not to restrict my access to safe medicines.

It must be said that the TGA, and every drug regulating authority around the world, considers homeopathic remedies to be “low-risk” medicines – there has been no evidence-based or scientifically supported reason for that position to change now.

Homeopathy is a known, trusted and highly respected practice here in Australia, as well as many other places around the world.

I, and other consumers and users of homeopathy, do not want to see regulations change to restrict the availability of self-help information about homeopathy and the symptoms and ailments it treats.

I also do not want Homeopathic prescribers to be stopped from providing that information, or prescribing homeopathic remedies.

I further believe that regulations designed for high-risk medicines should not be applied to homeopathy which, by the TGA’s own description, is a “low-risk” medicine; this would be unnecessary and an actual overreach of the purpose of these regulations which were never intended to be applied to “low-risk” medicine.

Restricting consumer and user access to homeopathic remedies is also of great concern to me, as are changes to the regulations that would inhibit, restrict, or deny the importation, exportation, or manufacture of homeopathic remedies by homeopathic manufacturers and pharmacies and changes in the current regulations that would either encourage or make it easier for those antagonistic, or with vested interests in industries opposed to homeopathic treatements, to lodge vexatious complaints about homeopaths for providing information and remedies for my well-being.

For the above reasons, Option 4 of the consultation should NOT be adopted.

Further points I would like to make are that

 

  • Homeopathy is recognised by the World Health Organization as the most popular and widely used complementary medicine worldwide. Entire communities depend on it for healthcare and the prevention of epidemic disease.

This is so, and so it is improper that the TGA would consider restricting the access of Australians to it, and makes me question what the possible reason could be for the TGA to propose such a move.

 

  • The Swiss Report on Homeopathy says, “There is sufficient evidence for the preclinical effectiveness in the clinical efficacy of homeopathy and for its safety and economy compared with conventional treatment.”

This is the case! I find it interesting, and actually disturbing, that the TGA saw fit to exclude this favourable report from its consultation paper yet chose to refer to two negative reports, one of which is currently before an Australian ombudsman for bias and irregularities, and the other, already rejected by the UK Parliament. Again this brings questions to mind of the suitability of the TGA to make sound rulings and regulations in these matters.

In whose best interest is the TGA acting if it will refer to questionable and irregular studies, or those rejected outright by the UK, and refuse to include a report that is not currently being investigated for bias and irregularity whatsoever? A very serious question with very serious implications!

 

  • Why would the TGA consider removing the access of Australians to homeopathic information and products when, based on the evidence, the TGA’s Swiss counterpart has given homeopathy the same status as conventional medicine in regard to health insurance?

Why indeed? These are questions that beg answers and don’t at all look good for the credibility and reliability of the TGA as an unbiased and suitable regulatory body.

 

  • By not recognizing homeopathic remedies as therapeutic goods in Option 4 of the consultation, the TGA will be out of step with other governments, worldwide, who do.

Some questions that MUST be investigated and answered comprehensively and appropriately are:

Why does the TGA draw from a report being investigated for complaints of serious irregularities, some of which include:

  • conflicts of interest,
  • bias and absence of fairness,
  • the withholding of important information and commentary from the Australian public, and
  • the expectation that homeopathy should meet a much higher standard of evidence than that set for other therapies or medicines – conventional or complementary?

The TGA’s role is to ensure that the products and treatments available to Australians are safe for use. It is not to arbitrarily decide what the Australian public can and can’t use especially when safety, as with homeopathy, is not an issue.

Australians have the basic right to choose treatments which best suit them. Government agencies should not regulate to restrict their access to information about that treatment.

In referring to the flawed NHMRC report, the TGA says regulating homeopathic products as part of evidence-based medicine will be an “issue”. The inference is that the NHMRC report is correct and there is no evidence for homeopathy. A significant and growing body of evidence is available for those prepared to look, the Homeopathic Research Institute is but one source among many. Why does the TGA ignore this in favour of flawed reports?

Whilst a growing rate of use does not directly correlate to efficacy, the fact that millions of people worldwide acknowledge the benefits of homeopathy does seem to suggest that these people, at least, believe in its efficacy; add to this its often stated “low risk” status and it seems ludicrous, or perhaps corrupt? that the TGA would seek to hinder access to its use.

Option 4 threatens the very practice of homeopathy, as is perhaps the very intent of the TGA? I think it is an interesting question to consider who will pay the student HECS debts if practitioners can no longer work in the area of their training; will the government? Will the government compensate them for loss of their chosen profession due to government regulatory shut down of their industry?

Unlike prescription drugs which “contributed to 330 of the state’s 420 overdose deaths in 2015” in Victoria alone, there is no evidence to suggest that homeopathics have harmed or contributed to the death of anyone! (http://www.abc.net.au/news/2016-04-05/pharmaceutical-drugs-in-nearly-80pc-of-victorian-overdose-deaths/7300036).

It is my firm and well considered opinion that Homeopathy should not be restricted by regulations intended to be applied to “high-risk” drugs. Option 4 is no option, it must be dismissed!

D.L

Response

Re Planned Changes to Homeopathy
I am writing this letter as I am completely dismayed and very distressed by the thought of not being able to access the advice of a trained homeopath or be able to use homeopathic remedies.
I am at a complete loss to understand what motivation the ‘powers that be’ at the TGA would have for suggesting Option 3 or Option 4. I would have thought that the purpose of the TGA would be for the protection of the public, but to consider removing the safest of any medicine available from public use seems outrageous.
My family has received great benefits from the use of homeopathy, from the reversal of extreme depression (and saving of a marriage) to quick relief of the pain of ear infections, sore throats etc of grandchildren, and many others.
I strongly object to Option 3 or 4 being implemented in any form and would only support option 1.
I am happy to be contacted about this matter should the need arise.
Yours Sincerely
R.V

Response

To whom this may concern

I am proposing I know on behalf of 1000’S of other Australia’s to continue to have access to Homeopathic medicine in Australia and to still be able to choose my own form of adjunction healthcare.

I have been using these medicines for the past 11 years as a family and have seen the benefits from homeopathy especially when treating my children for sickness and it has prevented them from getting more unwell and possibly having to go down the road of a few operations if I had not use homeopathic medicines.

We as Australians should be able to have the options of alternate medicines for our families and not have those rights taken away to choose what we know is best and beneficial for our own families and their long term health.

I strongly support option 1 and are strongly not in favor of option 4

Regards

M.

 

 

 

 

 

 

 

 

 

 

 

 






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