TOPIC:

CAREFUL fitz! Ya never know who's watching

Exactly fitz, their only interest is in the money.

If it is necessary for this site to begin operations overseas, I would like to make the suggestion that it is based (server location) in a country that does not honor Gilead's patent. If this site were based in USA, I think there would also be big problems. If it was registered in Bangladesh (under someone else than Dr. Freeman) and located on a server in China, then I think the governmental frustration level will be clearly off the charts. Gilead would be just besides themselves in grief.

No doubt the team here saw this possibility, and prepared accordingly by relocating the site to Myanmar (Burma).

My appreciation and admiration for their dedication to the process and cause of eliminating Hepatitis C worldwide is beyond words.

The purpose of the site after all is not to stick a finger in the eye of big pharma, but to provide a public forum for, facilitate resources, and provide peer support for people who are in sincere need of lifesaving medication.

Greedfighter wrote: If it is necessary for this site to begin operations overseas, I would like to make the suggestion that it is based (server location) in a country that does not honor Gilead's patent. If this site were based in USA, I think there would also be big problems. If it was registered in Bangladesh (under someone else than Dr. Freeman) and located on a server in China, then I think the governmental frustration level will be clearly off the charts. Gilead would be just besides themselves in grief.

Says it all. In Australia for me to maintain my right to information and the freedom to express myself about a condition I have, and a condition that entities like the TGA have not cared a damn about in regard to me, we have to look at going 'off shore'.

I get your point about not using the USA - it is in the grip of big companies and too much of a risk. We need to try other options a bit more open to free communication; I put forward the case for North Korea.

Where is the Minister in all this. The "LAW"!. Baloney!

Where I work here in NSW, there is an example in respect to Financial Management Orders during Mental Health Review Tribunal Hearings. One Act says they have to be made, virtually by stint of someone being mentally unwell, while another says distress to the patient and other supports have to be considered. The onus is then on the MHRT to exercise its discretion for the best interests of the patient.

The tone of the letter is that 'I can do this to you because you are a private person and not a government entity, and you cannot do anything about it'.

Unfortunately, I agree with another poster that the recipient(s) of this threat are in the gun and it would be best if they don't risk themselves. Appears we are back to being a convict settlement.

Yours


Jeff

It seems to me that Fixhepc only became a problem for the authorities when the DAA's were listed on the PBS. We have laws in this country prohibiting pushing of legal drugs to patients possibly to ease the burden on the system. Imagine a system where this wasn't the case and the manufacturer could advertise the shit out of their product which would place a larger burden on the taxpayer. In this case it would be a good thing as the meds work for most but with many other drugs it would be a bunfight which is probably why they leave it up to the medical profession to prescribe meds to patients free from interference. It relys on their honesty and integrity but opens the way for some unscrupulous ones to engage in Payola I guess.

We have a good law that has snared an open and honest information sharing entity whilst trying to protect us from a bunch of dodgy bastards.

cheers

Precisely Paul. There is no discretion and there is good public reasons for that. The law can't envisage all the situations it will be applied to. We know ourselves what an unusual situation this is, what an unusually good doctor James is, and what an unusual health peer support and advice forum this is. That the TGA regs captures that is unfortunate, not incompetent or sinister. Complainants are a different matter.
The reason they have strict liability is to avoid any wrangling and to create a situation that is clear to everyone in it- no defence. Sounds terrible, but think in terms of workplace safety: too bad if the boss wasn't there, if they told their worker not to do something- if something happens, it is still the bosses fault because something has happened so they must not have done enough. No argument, no buck passing.
In other scenarios it is what we mostly want the law to achieve. No High Court Judge can get off drink driving any more by saying they were called to an emergency, because it is strict liability - alcohol in breath, driving- there is no more to the story no matter who you are.
In fact, the TGA are exercising the only discretion they have, which is to give a warning/time period for compliance.

@Paul: I am not clear what it means in Australia to have a drug listed on the PBS scheme. Does it mean that branded as well as generic medication are allowed to be sold in AU?
I've seen that Sofosbuvir for instance is listed in PBS, so I assume that people who need it, can take it, of course, based on doctor's prescription.
In my view, the fact that Sofosbuvir is listed in the PBS simply means that it is already acknowledged by the medical world and the health care system that Sofosbuvir does cure hepatitis C.
Talking and spreading the news about Sofosbuvir should therefore not be an offense, at least not in AU.

Let's assume for a moment that we no longer talk about Hep C. Let's take another illness, like depression. I just run a quick Google search some minutes ago and I found out that a drug called “Mirtazapine” is used to treat depression and that in Australia you need the doctor's prescription. I was relieved ( … or “offended” in TGA's words ) to see that in Australia there are plenty of forums where people do speak about depression, describe their experiences, talk about how they feel, they ask for advice and people are sharing their advices and they do talk also about medication, one of this being the so called “Mirtazapine”. Shall I consider that all these websites are doing advertisements for prescription-only medication that treat the depression? Would this imply that in Australia there is a habit of people to become offenders of the TGA rules/ laws, etc? OMG ! (I'll try to make another joke here: Through the lenses of TGA, how should older people talk with young people or children regarding the "process of manufacturing" children? Shall they speak about S.X or shall they say a nice story about the stork delivering the baby at the door ?)

If fixhepc will be banned in Australia because of the (questionable) “advertisements” being made for medication known already that it does cure Hep C, what will come next? Forbidding the websites for depression, then those for heart problems, then those for kidney problems, etc.... With other words, TGA is ensuring that in the near future there will be no more medical discussions (they will be forbidden!). Isn't this a kind of inquisition within the medical world?

If I might reply to your first question, PBS stands for Pharmaceutical Benefits Scheme. Meds on the PBS are subsidised but the government. The DAAs were put on the PBS in early March.
The TGA action is a witch hunt pure and simple.

I am shocked, saddened and very angry that this has happened. Difficult to get my head around why someone as wonderful as James Freeman can be subjected to this nonsense. I credit not only James and the generics but also the many friends I have made on the forum, getting me through a very difficult time in my life. My son is somewhat of a computer "geek" so I'm sure he will find ways around it all for me.

I agree that even though the medication is now listed on the PBS there will be very few people like I was (not sick enough to be treated) that will miss out.

I think I have said before on this Forum that I have no time nor faith in ANY politician or some of our Government bodies and this has only cemented that belief more.

Lynne-Francis-facebook wrote: I think I have said before on this Forum that I have no time nor faith in ANY politician or some of our Government bodies and this has only cemented that belief more.

I saw Bronwyn Bishop at our local shopping centre today ,fund raising with the salvos. My eyes still feel violated.

Taken and abridged from - www.health.gov.au/internet/ministers/pub...el-yr2015-ley063.htm

Just read the red bit below to get my issue; perhaps the TGA should.

Pharmaceutical Benefits Scheme to be reformed
Australians will benefit from cheaper medicines, a more competitive pharmacy sector and greater investment in new medicines and patient support services.

27 May 2015

Australians will benefit from cheaper medicines, a more competitive pharmacy sector and greater investment in new medicines and patient support services as part of a “balanced” package of pharmaceutical reforms announced by the Abbott Government today.

Minister for Health Sussan Ley today announced the Government’s Pharmaceutical Benefits Scheme (PBS) Access and Sustainability Package of reforms following months of constructive consultations and robust negotiations across the entire pharmaceutical supply chain, including consumers, pharmacists, medicines manufacturers, wholesalers and doctors.

Ms Ley said this “hand in glove” approach had enabled the Government to put together a reform package that struck the “right balance” between supporting the needs of consumers, industry and taxpayers.

“Throughout the Government’s negotiations with the entire pharmaceutical supply chain we have had consumers at the core of our negotiations and I think this shines through in the sensible measures we’re delivering,” Ms Ley said.

This includes measures that will see: the price of medicines discounted for patients and improved access to new medicines; greater certainty for medicines manufacturers via a five year strategic agreement; and an additional $2.8 billion investment in supporting pharmacy and primary care.

Ms Ley said stakeholders recognised the need to deliver a more sustainable PBS to ensure the Government could continue to list new medicines, with the package also proposing total efficiencies of $6.6 billion over five years across the entire pharmaceutical supply chain.

“The Abbott Government has doubled the number of drug listings for consumers since coming to office when compared to Labor – a significant investment of almost $3 billion in just over 18 months.

“In fact, this Government is now delivering an average of about 30 new and amended drug listings for patients each month compared to an average of just eight under Labor.

“Yet, with taxpayers expected to invest at least $50 billion in the PBS over the next five years, we are ensuring with this package that spending on existing medicines is as efficient as possible so we can invest in new drugs for the future as well.”

Ms Ley said it was important to note a number of the measures delivering savings for taxpayers were also saving money for consumers because both would pay less for medicines.

For example, removing ‘originator’ brands from price calculations could save some consumers up to 50 per cent off the price of medicines and taxpayers $2 billion over five years.

The proposal to allow pharmacists to discount the price of medicines by up to $1 per script could also save some pensioners over $40 per year while, also delivering the Government about $400 million worth of efficiencies over five years.

Ms Ley said savings delivered through the package over the next five years would support the Government’s ability to continue to list new medicines into the future.

The Government is currently considering almost $2.5 billion worth of new drugs for listing, with another 15 meetings of the independent Pharmaceutical Benefits Advisory Committee expected over the next five years.

“The reality is the expectation of the community to list new drugs – some worth hundreds of millions of dollars at a time - will only continue to increase over the next five years.

“This reform package is designed to be a sensible start that focuses on longer-term structural reform to enable ongoing investment in new medicines while ensuring they remain affordable for patients and taxpayers.”

Pharmaceutical Benefits Scheme Access and Sustainability Package:

The Abbott Government is proposing a Pharmaceutical Benefits Scheme Access and Sustainability Package over the next five years (2015-2020), including:
• $18.9 billion Sixth Community pharmacy Agreement.
• A Strategic Agreement with Generic Medicines industry Association (GMiA).
• $6.6 billion worth of proposed efficiencies throughout the PBS supply chain.
• $2.8 billion additional direct investment across the pharmacy sector
• - Note: This $2.8 billion investment is in addition to PBS investment that will occur over the next five years, including the $2.5 billion worth of new drugs currently being considered by the Government for listing.
• An in-principle Strategic Agreement with Medicines Australia is also being progressed.
Key measures within the package:
• Changes to price disclosure arrangements applied to those medicines subject to competition (F2), which will see the price of generic medicines for consumers reduce as much as 50 per cent from October 2016. This will be done by removing the ‘originator’ brand version of the drug from pricing calculations. These cheaper medicines prices will also see taxpayers paying less, delivering $2 billion worth of efficiencies for taxpayers between October 2016 and the end of the agreement that will assist the Government’s capacity to continue to list new medicines.
• The ability for pharmacists to offer consumers a discount of up to $1 per script on the price on the PBS co-payment. This could see a concessional patient’s co-payment drop from $6.10* to $5.10* and deliver someone who used 40 scripts a year an annual upfront saving of up to $40. It will also apply to non-concessional patients, who pay a co-payment worth $37.70*. This measure will also drive greater competition in the pharmacy sector and deliver efficiencies of more than $360 million over the next five years. *these are 2015 prices for co-payments, which are indexed each year.
• A $20 million awareness campaign to support the increased use of ‘biosimilar medicines’ by patients, pharmacists and specialists. Biosimilars are complex biological medicines that are approved by the Therapeutic Goods Administration as an alternative to an existing brand. The increasing use of biosimilar medicines is also expected to deliver efficiencies of $880 million over five years.
• A doubling of investment in pharmacy-run primary care programmes of up to $1.26 billion. New and existing programmes will also now be scrutinised by the Government’s expert Medical Services Advisory Committee to improve transparency and ensure programmes are evidence-based and cost-effective.
• Better targeting the premium-free dispensing incentive to apply only when there is a premium charged for another brand of the same medicine. This will deliver efficiencies of $560 million over five years, better support the uptake of generic medicines, and further reduce the cost of these medicines for consumers and taxpayers.
• $1.5 billion investment in a new handling and infrastructure fee for pharmacists. This will restore pharmacist remuneration to average levels provided under the previous 5th Community Pharmacy Agreement and provide greater certainty by delinking remuneration from the variability of price disclosure. Instead of applying a mark-up percentage on medicines, pharmacists will now receive a set transparent fee.
• More efficient spending on F1 formulary medicines (those protected by patents), with a five per cent reduction in the price taxpayers pay for on-patent medicines that have been listed for five years or more on the PBS. This is expected to deliver efficiencies of about $1 billion to ensure new F1 medicines can be listed for patients as well. This is the first time changes have been made to F1, with price disclosure and other past changes only applying to F2 (those medicines subject to competition).
• Closing loopholes around the way combination drugs – where two separate drugs are combined to create a new patented drug – are subsidised under price disclosure reductions. This will deliver proposed efficiencies of $610 million over five years.
• An independent review of pharmacy remuneration and location rules to be undertaken during the first two years of the new 6th Pharmacy Agreement.
• The removal of some comparatively low-cost over-the-counter medicines from the PBS, many of which can be bought for below the price of the PBS concessional co-payment ($6.10). For example, in 2013-14, there were 6.7 million scripts for paracetamol issued on the PBS costing taxpayers about $70 million. This measure is expected to deliver $500 million in efficiencies over five years and will allow PBS funding to be focussed on listing essential high cost medicines which would otherwise be unaffordable for consumers. Decisions on which over-the-counter medicines this measure will be based on advice from the independent expert Pharmaceutical Benefits Advisory Committee.
• Extending the existing safety net 20 day rule to a broader range of PBS medicines to promote the quality use of medicines, discourage waste and reduce the quantity of unused medicines in the community. This is expected to deliver efficiencies of $475 million over five years.

PBS is the government subsidy scheme for drugs. They first need to be approved for use in Australia by the TGA after which they are allowed to be prescribed although will only be available at full retail price until PBS listing. For instance sofosbuvir was approved in 2014 but not listed on PBS until March 2016.
It is not legal to sell generic drugs until after the patent expires, but it is legal to import 3 months supply of drugs that are TGA approved for personal use only.
Where the TGA got it's knickers in a knot, they somehow think FixHepC is advertising and supplying generic drugs. It's a bit of a stretch as the site is really just making available information to facilitate patients to organise their own supply.

I just found an interesting book named "THE GLOBAL POLITICS OF PHARMACEUTICAL MONOPOLY POWER" (available at apps.who.int/medicinedocs/documents/s20963en/s20963en.pdf ) which has 160 pages and was written in 2009. It deals with the AIDS case and provides interesting information about the challenges, issues, politics for treating people having AIDS with affordable medicines.
It does provide also nice highlights about TRIPS and the DOHA DECLARATION.

Maybe it will not respond to the issue of the fixhepc website, yet, I believe it helps in developing a better understanding about politics, BIG Pharma, doctors looking for an affordable cure and the patients.

P.S. I only read the first 20 pages and I am attracted about what I read so far. I look forward to continue the lecture

Best Regards,
RHF

Since we do have the right to freely share our opinions, here are 3 thoughts addressed to:

1. @Dr. Freeman -> as reply to his message "Sorry" -- no need to say Sorry !! At least not to those whom you helped and will be helped based on the great work you did so far !!!



2. @Those who think that generic HCV medication is not working or does not represent a viable solution to treat Hep C:



3. @Those who might question the truth about Fixhepc



Cheers
RHF