TOPIC:

I've been running variously themed diatribes in my mind for hours now, but it won't help the immediate situation. So for now I'll only make three points and move on to the real issues we need to address.

1) This is about as clear cut an example of Regulatory Capture as I've seen in a long while.

because

2) There can be little doubt that this is taking place due to pressure brought by either the pharmaceutical lobby directly (read that as "Gilead") or by some butt hurt gastro doc or other specialist within the establishment. No member or former poster on this forum would go to these lengths to damage this forum ... (not even the one that immediately pops into your and my mind, Ms. Chester )

3) The current Vice-President* Secretary of State of the United States of America, John #&*%!ng Kerry, is, and has long been, advocating for the entire internet to be placed under the regulatory authority of the United Nations. I'm not even going to bother trying to explain why this would be one of the worst disasters ever to befall mankind.

*I guess I was still too worked up to be thinking clearly.
In my own defense, Biden is completely forgettable ... lol.
Thanks Matt
________________________________________________

On to the immediate issues. I think the solution may be simpler than is being currently contemplated.

James, some immediate questions to explore ...

1) Is WebMD geoblocked in Australia? (or any other website in the US, UK, France, Germany, etc. where medical discussion/promotion are allowed) Does Australia block access to HepMag and its forums and blogs? Are Google searches of such information filtered in Australia as they are in China?

I'm pretty sure the Australian authorities recognize that their authority stops at the border. And I can't imagine them introducing draconian (Chinese) web blocking technologies.

2) Would there be any penalty available to the Australian authorities to punish you if you were to write articles for WebMD or similar sites outside of Australia? (Whether your article itself advocated particular drugs/procedures or if other writers on the site did, or if the site allowed ads to appear ... Gilead's ads are ever-present on most web forums or medical advice sites whenever "Hep C" is put into the search.)

I'm pretty sure any work done outside of their physical authority boundaries are beyond their reach, but this one needs to be determined clearly. Can you, or can you not, produce content for sites outside of Australia that would not be allowed within Australia?

3) Would there be any Australian laws disallowing you to take an ownership interest in WebMD or its parent company? (Or similar sites.)

4) Would there be any Australian laws disallowing you to have a management or other decision making position at WebMD, its parent company, or similar sites?

After determining the answers to those questions the solutions become clear, and likely don't require any form of geoblocking.
_________________________________________

Solutions:

I suspect all that's necessary to remove their authority is
a) to physically place the server outside their reach, and
b) place the ownership vehicle, the corporate entity, outside their authority.

If they can still prosecute you for being the web site manager, then hand off technical authority to some trusted party outside of Australia ... Alsdad maybe.

If they can still get you for having an ownership interest then hand off ownership to some other entity ... maybe Doctors Without Borders ... and require them to leave either you or your hand chosen person in administrative authority of the site.

Really, I don't think Gilead's little gambit here of putting a thumb on Australian regulators is all that bright. I have long suspected that Gilead is run by a bunch of snotty nosed, silver-spoon, Ivy League idiots. You can out maneuver them.

The FixhepC website could be hosted in USA (I think) and then foreign Doctor's offering prescriptions to foreign meds or advice could advertise on that site, so that the site is not involved in commercially promoting illegal generic meds. Ad prices could start very low, based on competitive free market competition , or perhaps free in some sort of "physicians market" section with a "pharma's market section also included. Like an unmoderated, "Craigslist" style version of FixHepC. perhaps using user ratings as a gauge of trustworthiness of suppliers. (?)

Paul-Jarman-facebook wrote: Given that Aussies now have access to PBS meds

Unfortunately I'm not sure that's correct. Depends on the doc. And a few other things.

Big pharma have had their private parts up the TGA for so long that the TGA has forgotten they're there.

Taken from the TGA website:

www.tga.gov.au/court-action

a list of prosecutions from 2013 through to 2015:


2015
• Conviction for criminal charges for dealing with unapproved therapeutic goods. 
On 3 December 2015, a Melbourne man appeared in the Ringwood Magistrates Court, Victoria on 8 criminal charges relating to dealing with unapproved therapeutic goods:
◦ 6 counts of importing therapeutic goods not included in the Australian Register of Therapeutic Goods (ARTG) contrary to section 19B(4) of the Therapeutic Goods Act 1989 (Cth) (the Act)
◦ 1 count of supplying therapeutic goods not included in the ARTG contrary to section 19B(4) of the Act
◦ 1 count of supplying counterfeit therapeutic goods contrary to section 42E of the Act.
• The Magistrate ordered that in relation to the import charges and supply charges under section 19B, a single penalty be imposed - the man was convicted and fined $1,500.
In relation to the charge of supplying counterfeit therapeutic goods, the man was convicted and fined $500.
The man who now resides overseas voluntarily returned to finalise these matters. He had no previous convictions and entered a guilty plea.
The man was ordered to pay $117 in court costs and he was allowed 3 months to pay. The Magistrate also ordered that all of the imported goods seized by TGA investigators were forfeited.
• On 22 May 2015 the Adelaide Magistrates Court sentenced a 69 year old Adelaide man in relation to the importation of counterfeit erectile dysfunction medicines. The man pleaded guilty to one criminal charge under section 42E (1)(a)(iii) of the Therapeutic Goods Act 1989. The man was convicted and fined $4,000.
The goods seized as evidential material were forfeited to the Commonwealth under section 54 of the Therapeutic Goods Act 1989.
• On 13 February 2015 the Southport Magistrates Court sentenced a man in relation to 24 criminal charges surrounding the manufacture, export and supply of unapproved therapeutic goods under section 19B(4) of the Therapeutic Goods Act 1989. The product, known as Black Salve, is not approved for marketing in Australia and has been the subject of TGA alerts (See Black and red salves in treating cancer and Black salve, red salve and cansema). The man was convicted under the provisions of section 20(1) of the Crimes Act 1914 and released on security of $5,000 and by recognizance that he be of good behaviour for two years. The court ordered the man not to be in possession of restricted chemicals, not to manufacture, promote, advertise or supply Black Salve and that the goods seized as evidential material be forfeited to the Commonwealth under section 54 of the Therapeutic Goods Act 1989.
2014
• 13 June 2014: Following an appeal by the Commonwealth Director of Public Prosecutions, two men were convicted the County Court of Victoria in Melbourne on 13 June 2014. Both respondents had been charged with eight criminal charges relating to their dealing with unapproved, and counterfeit medicines contrary the Therapeutic Goods Act 1989 (Cth) namely;
◦ 2 charges contrary to section 19B (1)(a)(i) (import of unapproved therapeutic goods); and
◦ 2 charges contrary to section 19B (1)(a)(iv) (supply of unapproved therapeutic goods); and
◦ 1 charge contrary to section 35 (1) (carrying out step in manufacture of therapeutic goods while not licensed to do so); and
◦ 1 charge contrary to section 42E (1)(a)(ii) (supply of counterfeit therapeutic goods); and
◦ 1 charge contrary to section 42E (1)(a)(i) (manufacture of counterfeit therapeutic goods); and
◦ 1 charge contrary to section 42E (1)(a)(iii) (import of counterfeit therapeutic goods).
• Both men were released conditionally under paragraph 20 (1)(a) of the Crimes Act 1914 (Cth), that each respondent give security by recognisance of $ 750 and to be of good behaviour for two years.
2013
Outcome of criminal prosecutions, from 1 August 2013
• 13 November 2013 - a company pleaded guilty in the Melbourne Magistrate's Court to the importation and supply of unapproved therapeutic goods contrary to subsection 19B(4) of the Act following an investigation by the Therapeutic Goods Administration. The company entered into an order and recognisance under Subsection 19B(1) of the Crimes Act 1914 with a recognisance of $25,000 on condition the company is to be of good behaviour for 12 months and to pay costs of the prosecution for the offences of $25,000 stayed until 11 February 2014.
• 7 November 2013 - a man was sentenced at the Downing Centre Local Court (Sydney) in relation to supplying counterfeit medicines contrary to section 42E of the Act following an investigation by the Therapeutic Goods Administration. The man was convicted and ordered to perform 350 hours of community service.
• 27 August 2013 - a man pleaded guilty at the Downing Centre Local Court (Sydney) to one count of importing unapproved weight loss medicines contrary to section 19B of the Act following an investigation by the Therapeutic Goods Administration. The man was ordered to pay a fine of $2,000 and to be of good behaviour for 2 years. The medicines seized by the TGA as evidence in the case were forfeited to the Commonwealth for destruction.

What manner of logic allows the TGA to categorise FixHep C as something they should go after and waste my tax payments along the way?


J.

"I've been running variously themed diatribes in my mind for hours now, but it won't help the immediate situation"
Love it. Very economic. It quietens my mind.
The thing about being flexible and out manouvering the regulations is it is distracting, and demanding, and they can change, and there may be other strict liability ones we are not yet aware of, probably up someone's sleeve. Definitely more complainants, exactly as you outline, and I think the disgruntled specialists you mention are the most dangerous.
Because it is not just internet law that is at stake, it is medical license, risk etc, that boxing clever might not be enough to protect. Complete retrenchment is a good look for a while at least.
There should be noise but it should, now, be guarding not exposing James further.

Paul-Jarman-facebook wrote:
On a more serious note Dr Freeman has created a wonderful resource to assist with treating Hep C and to aid in the procurement of safe and reliable meds to treat this virus for people worldwide. Given that Aussies now have access to PBS meds it's only logical that Fixhepc has become more relevant to overseas sufferers. The ball is in and has for some time been in the court of our overseas members I guess when it comes to furthering the cause that the Doc has started.

Cheers

Paul, thank you for an excellent summary of the situation.


EVERYBODY, as Dr James' link in the opening post of this thread points out:

Fixhepc.com itself has been transferred to Myanmar

fixhepc.com/tga

So for those outside of Australia, effectively nothing changes as long as you keep supporting, developing and expanding it. FixHepC will continue its important role of providing information and support to HCV patients and their supporters worldwide.

It is true that from 15th June 2016 Australians won't be able to access it from Australian IP addresses. This is not an ideal situation but necessary to retain the information already available while ensuring that the original founders of the site are not open to legal liability.

Yes, we should and will protest but please don't doubt that we will continue the main purpose of the site which is the support of HCV patients and spread of information regarding affordable HCV treatments worldwide.

Too true, excellent point, ignore my earlier election rabble rousing, TGA is an Australian thing but you are absolutely right, ball is in our court now and the structure remains unchanged.

Couple of thoughts:
- on this forum people talk about how to legally import REAL medication and the forum developed "protection skills" against scam or fake medication.
- the legal importation is possible because of Art. 60 fron TRIPS and not because of other laws (which perhaps would forbid it)
- forums by definition are places where people exchange ideas and information including Howtos, Wheretos, Who, etc
- through the current laws that are "known" by TGA, the message was the activity here should be changed so that advertise, etc, will no longer exist. But, as long as the current medical systems are not able to supply medicines to the patients, is there any higher law that allows people to discuss and share information about possible treatments? Usually, there exist cases when country laws are overridden by international laws. Freedom of speech or something similar?


RHF

It would be great if the advice accumulated here regarding treatment and patient experiences was available separately from the Buyer's Club and generic supply topics. It would be a herculean task to sift through what is posted here already though. A lot of the knowledge contained here is helpful and some is invaluable for people contemplating or undergoing treatment irrespective of where they source the medication.
Perhaps someone with website skills could set up a forum in Australia just to provide treatment info without links to generic supply (ozhepcsupport.com?) and some of us here with Tx experience could join to kick it off. As I see it, the TGA's main issue is the actual connection to supply of generics.

And just a thought on sabrecat's post above, all those prosecutions by the TGA appear to be for snake oil or counterfeit snake oil. This appears to be unprecedented action against medication that is approved for use in Australia.

Hi Sonix,

"This appears to be unprecedented action against medication that is approved for use in Australia".

Certainly is, I think.

I got into the generics after reading a Sydney Morning Herald article last year - the joining this site is coincidental to that. Maybe they should prosecute the SMH too?

The real shame is the I suppose, unintended consequences of this threat - people like me who use this site to dip in and out of a support system that costs the government nothing will now miss out. Of course unintended consequences come when things are not thought through.

Compare me to somene using the PBS:

Me - paid for my DAA's and use a forum to get support.

Person on the PBS - government pays mega $thousands and I suppose they will need a Medicare funded Mental Health Plan to get ongoing support if they want someone to talk to? Or maybe fund themselves a trip overseas so they are not breaking the law when they log on to FixHepC??

The Red Cross left me for dead when they infected me with Hep C; can't remember the TGA being about offering any support anytime after that.

These people have nothing I want and nothing to offer me. Well pleased if they just went away.

Jeff.

This post has 2 area: “Reflection area” and “Joke area”.
Feel free to read (or not read at all) whichever you like.

---

Reflection area

---

1. COGITO ERGO SUM
I make the following self-statement for those who are not aware, but also for those who are already aware: I AM A PERSON!

And because I am a person, I, like EVERYONE else, have the following rights:
- Everyone has the right to freedom of thought, conscience and religion; this right includes freedom to change his religion or belief, and freedom, either alone or in community with others and in public or private, to manifest his religion or belief in teaching, practice, worship and observance.

- Everyone has the right to freedom of opinion and expression; this right includes freedom to hold opinions without interference and to seek, receive and impart information and ideas through any media and regardless of frontiers.

-(1) Everyone has the right to freedom of peaceful assembly and association.
- (2) No one may be compelled to belong to an association.
(Art. 18,19,20 from the Universal Declaration of the Human Rights - www.un.org/en/universal-declaration-human-rights/ )

2. Since I joined the peaceful assembly/association/community FIXHEPC (called it as you want), I enjoyed reading the blogs and forum messages, which I consider as opinions and expressions of other persons. In particular, I do like to read the opinions of the person named JAMES FREEMAN (did you noticed he is NOT signing his messages as Dr. James Freeman?).
And because I am also a person, I DO think on what James Freeman writes. Sometimes I do agree with him, sometimes I do not agree with him and I really like that I have and use this freedom to make my own opinion.
If I think more on James Freeman, I think he is acting accordingly to the Art.1 from the Universal Declaration of the Human Rights, as a human being “endowed with reason and conscience and should act towards one another in a spirit of brotherhood.”

3. The FIXHEPC Disclaimer – shall I say more ?

EXCEPT AS EXPRESSLY STATED IN AN AGREEMENT BETWEEN YOU AND FIXHEPC, ALL CONTENT, SERVICES, PRODUCTS AND SOFTWARE PROVIDED ON THIS WEB SITE ARE PROVIDED "AS IS" WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED. FIXHEPC AND ITS SUPPLIERS AND LICENSORS DISCLAIM ALL WARRANTIES, EXPRESS OR IMPLIED INCLUDING, WITHOUT LIMITATION, THOSE OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. YOU ARE SOLELY RESPONSIBLE FOR THE APPROPRIATENESS OF THE SITE, ITS CONTENT, AND THE PRODUCTS AND SERVICES OFFERED BY FIXHEPC ON THE SITE FOR YOUR INTENDED APPLICATION AND USE. FIXHEPC DOES NOT WARRANT THAT THE SITE, ITS CONTENT, OR THE PRODUCTS AND SERVICES IT OFFERS ON THE SITE MEET YOUR REQUIREMENTS. SUBJECT TO THE TERMS OF ANY AGREEMENT BETWEEN YOU AND FIXHEPC, ITS SUPPLIERS AND LICENSORS SHALL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, SPECIAL, CONSEQUENTIAL, INCIDENTAL, OR PUNITIVE DAMAGES, EVEN IF FIXHEPC, ITS SUPPLIERS OR LICENSORS HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. CERTAIN STATE LAWS DO NOT ALLOW LIMITATIONS ON IMPLIED WARRANTIES OR THE EXCLUSION OR LIMITATION OF CERTAIN DAMAGES. IF THESE LAWS APPLY TO YOU, SOME OR ALL OF THE ABOVE DISCLAIMERS, EXCLUSIONS, OR LIMITATIONS MAY NOT APPLY TO YOU, AND YOU MIGHT HAVE ADDITIONAL RIGHTS. -

4. Looking at the TGA letter, it does not say “fixhepc is promoting ”, rather it says “fixhepc appears to promote” through the lenses of some laws that are valid in Australia.

My view here is that laws are subject to interpretation and in cases when people interpret it differently, a judge is required to see on which side the justice is.

My conclusion:
Fixhepc is a MEDIA where people express and share information, experiences, knowledge, questions → and based on the human rights, people do have the right to express their views. Each visitor (see the disclaimer) is also informed and warned about fixhepc liability, limitations, etc. Based on these circumstances, I consider questionable the way in which TGA evaluated the material available on fixhepc as being “advertisment”.

---

A KIND OF JOKE AREA

---

Some weeks ago I was reading the blogs from Greg Jeferrys (most of you probably know who he is ). In one of them he was talking about sex, drugs and youth and I was thinking: “OMG, this man MUST be judged. He promotes things like sex, drugs, by talking about them, these are completely forbidden by some (obscure I would say ) laws of my country. Oh yes, we should do that!”. But later on, I was thinking, amused, about the face of the judge who would have listen to me, claiming that Greg Jeferrys (or anyone else) should be punished because of speaking about those words .

---

Final thought: The human beings from today are HOMO SAPIENS, this means that apart from air, water & food, we need more in our development. One of the things we need is INFORMATION, as information is included in what is called, EDUCATION.

How would the world look like if people would be denied the access to information ?!?

Cheers,
RHF

Hey RHF,
I'm not certain that there is a clear delineation between the "Reflection area" and the "Joke area" Thus the title "A Kind of Joke Area" eh?
Well said on ALL accounts. Loved it.

Cheers back to ya!
MMK

Hi MMK,

thank you, to be honest, these days I am no longer sure whether to say jokes or not .

The more I think on this Fihxepc case, the more I see it very close to the case of Giordano Bruno being burned at the stake for having own opinions (and .... true - as Earth indeed moves around the Sun).
So, in the Fixhepc case, people do get cured with affordable medication and after they decide to obtain it on legal ways.
They do so a RIGHT thing, using other's opinions / information (from fixhepc or other websites).
What next? Shall TGA or any other authority start to "fry" people? Perhaps this is what the children of our children will learn in 100 years from now: in 2016 some australians were fried because they knew and spoke about how people can be cured of Hep C.....

RHF

The laws in Australia seem a bit wacky to me.

The country allows the sale of generic DAA's via the compounding pharmacies. Then why aren't more doctors advising patients of this choice?

Sadly, I don't believe a 'humanitarian' cure is the goal for big pharma.

In order to maintain revenue streams, the rate of infection must necessarily remain significantly higher than the cure rate.

For big pharma, the problem with the new DAAs is that the cure rate is nearly 100%. If access were not strictly limited by keeping the price onerously high, it is conceivable that Hepatitis C could be virtually wiped out world wide within a few years, and that would be very bad indeed for the business of profiteering.

Frankly I think if we were seeing 96% cure rates for HIV, rather than for HCV, the worldwide outcry for universal access would be deafening, and overwhelming.