Before a drug or natural therapy can be approved by the “regulator” — the TGA — it must have a sponsor whose job is to pay the license fee, fill out the paperwork, and prepare safety and efficacy reports. These can be overseas because we no longer require local trials for new drugs. Drug companies are happy to develop new drugs and sponsor the applications because they have 25 years to get their money back from the patent which gives them exclusive rights to the product’s profits. After that, a product can be ‘generic’ or off-patent and any pharma company can make it.
Natural products such as cannabis and Aboriginal medicine from native plants cannot be patented which means nobody can afford to act as a sponsor. The result is the only thing doctors can prescribe are patented or ‘generic’ pharmaceutical drugs.
I asked why there is not an office of the consumer advocate who can sponsor natural therapies like Cannabis and Albicidin (a natural antibiotic). Instead, the TGA chose to speak about their program to re-purpose pharmaceutical drugs that have already been approved for different uses. This answer really shows the pharmaceutical mindset our health administrators have. The legislation needs to be changed to give natural products a path to market.
Transcript
Senator ROBERTS: Thank you. That leads to another point. It opens it up from this one. We have a system that says that, unless a product has a sponsor, it will never be approved. This isn’t the TGA system. They don’t write policy. This is a department and minister problem. There are multiple studies on the efficacy of medicinal cannabis for some conditions, and yet they’re not listed in schedule 4. There are 150 substances in Aboriginal medicine, yet only two have been commercialised, because natural products, even with postprocessing, can’t be approved by your system, because, without a patent, nobody will sponsor the product. Minister, why is there not a public advocate within the department that can bring natural remedies to the people under poison schedules 2, 3, 4 under the PBS where appropriate?
Senator McCarthy: I will refer to the department.
Prof. Lawler : As you highlighted and as we’ve discussed previously, the act does require a sponsor to bring medicines for evaluation. There are a number of reasons for this, and not least among them is the fact that, once a medicine is listed on the Register of Therapeutic Goods, there is a need for postmarket surveillance, pharmacovigilance, and safety and quality assurance, so it’s obviously very important that there be a point of accountability for these medicines. We are undertaking some work in terms of a repurposing initiative, and I will ask Mr Henderson to speak to that. It is about ways in which some of the medicines that are currently on the market can be used in other ways and how that might extend beyond the current sponsorship arrangements.
Mr Henderson : As part of the last budget, the government approved funding of roughly $10 million over four years for the TGA to initiate a repurposing program for medicines. The context or the objective of that program is to incentivise sponsors—and non-pharmaceutical sponsors as part of that as well—to come forward with submissions to the TGA for medicines that are predominantly used off label. They are registered on the ARTG, the Australian Register of Therapeutic Goods, but for indications for which it may not have been feasible for low-population groups or niche population groups to have had a sponsor come forward in the past, so we’re looking to implement a program where we incentivise through waiving fees associated with the regulatory fees and charges as well as through working closely with our colleagues in the reimbursement space in relation to processes through the PBAC, pharmaceutical benefits and fee waivers.
Senator ROBERTS: Thank you. So there may be some hope.
CHAIR: We will return to this after the break.
I am so glad you are in Parliament. It is very true that natural alternative’s to Pharmaceuticals are being denied a place in Australia. The alternative industry overseas is worth 200 billion and we are not part of it. Yes the herbs that First Nation people used should be investigated but I am afraid the powers that be will never let it happen.
The medical and pharma industry have done this for decades. You cant patent anything from nature , so the go after any doctor promoting natural treatments. Dr Ernst Krebs was an Honourary Doctor and lived with the Hunzakut tribes of the Himalayas for seven years , studying why they were one of the longest living people on the planet , no cancers, illness was rare and never even an appendecitis within the community. Krebs dicovered a food group consumed from Apricots. The kernels contained a Vitamin that came to be known as Nitrilocide. Vit B17. In small quantity this seed had anti cancer properties. It later was used in a drug called laetrile. It would have cost the Rothchild/ Rockefeller AMA /pharma and the medical establishment 100’s of billions a year in profits from Chemo , Radiation and surgeries. They went after Krebs, labelling him a quack and did everything to debunk the use of B17. Making it illegal to promote its use as an anti cancer food. They did the similar thing to Nurse Caisse . A medically qualified Nurse that used Native american treatments to save 1000’s of lives over a 40 year time frame at her clinic with Essiac. Also Dr Hoxley in the US ended up leaving and starting a metabolic therapy clinic in Mexico to treat cancer patients. The list goes on. Any threat to the big pharma piggy bank and they will destroy you. Author and investigative journalist Phillip Day has uncovered some of the most disguting practices of the medical industry over 40 years. Definitely a collection of books worth reading. Australian Toxicologist and natural medicine practioner Eve Hillary wrote ,Children of a toxic harvest well over 20 years ago. We need to be aware of what is being put theough the food chain.
A year ago I heart problem and given amiodarone. after 10 days I collapsed. The cardiologist was no longer available! This drug is banned in some countries!
Before Christmas I was diagnosed with cardiomyopathy. My GP told my wife there was a good chanced of my dying in the near future. I then over a period of 3 months saw three differnent heart specialists. Each prescribed something different.
The side effect were making me ill. I took myself of them and started to feel a bit better.
I then put myself n 6 grams of vitamin C. A month later I took a rigorous medical to see if I was saft to drive. The doctor could find noting wrong with me !! This amazed him as he had seen my past medical history.
A very cheap treatment cured me.
Vitamin C also cures cancer. I have many testimonies to confirm this.
Billions of dollars could be saved if the big Pharma could be exposed and corrupt bureaucrats1
Well done I’m glad you recovered.. Yes I had massive doses of liposomal vit c for cancer & never would touch quacks ever again.
Best wishes.