Fw: ANZTPA needs more legal scrutiny

[Guest guest]

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Dear Health Freedom Advocate,

 

Below is an article weighing up the legal issues that have muddied the

ANZTPA. For those of you who are wondering, the ANZTPA is part of a plan by

the Australian TGA to control and regulate New Zealand's health industry via

a treaty. It is our understanding that a treaty such as this would require a

referendum certainly when NZ is about to surrender part of their sovereignty

but neither the Australian Government or the NZ government seems to be

interested what the people think, they are more interested in what the

corporations and big multinationals think.

 

After reading the below summary from Ian Cunliffe one can not help wonder

why the ANZTPA is moving ahead at all and how can each government vote into

existence a regulatory frame work only to have the TGA fill in the blank

spaces (Rules and the Orders) later....isn't this like letting the wolf look

after the sheep?

 

You will also see that the TGA are trying to assume powers to create laws

once the domain of the Governor General, very interesting indeed. A law unto

themselves.

 

And why would some of our big players here in our own health industry give

the TGA an open cheque book to do as they will? Please read on....

 

 

ANZTPA needs more legal scrutiny

http://www.pharmainfocus.com.au/opinion.asp?opinionid=161

 

The proposed trans-Tasman therapeutic products regime it is likely to throw

up constitutional, legal and regulatory issues, and deserves more attention

from lawyers argues Ian Cunliffe.

 

Ian Cunliffe is a regulatory and commercial lawyer with Norton White in

Melbourne. He has worked extensively in the pharmaceutical industry for 12

years.

 

Merits review

Pharma in Focus (18-24 June) quoted " legal experts " as expressing

uncertainty about the merits review system for the new regime. However the

draft legislation which was released some weeks ago for public comment makes

clear that:

 

* the Administrative Appeals Tribunal is the body which will provide merits

review

* only AAT members will be members of the Australian merits review

* the following decisions will be subject to merits review:

* refusal of applications for approval of products

* amendments, suspensions and revocations of such approvals; and

* other matters specified by the Rules.

 

Admittedly, until we see all the Rules, we will not know how much further –

if at all – merits review will go beyond refusal of applications for

approval of products; and amendments, suspensions and revocations of such

approvals.

 

Many uncertainties

But there are other issues with and uncertainties about the proposed

trans-Tasman therapeutic products regime. Numerous key elements of the new

regime - much to be supplied by the Rules and the Orders - are not yet

available. The way the scheme will operate in practice will become clearer

as those major parts of the jigsaw are added.

 

Rules and Orders will have the force of law as if they were regulations.

 

Normally, regulations are made by the Governor General in Council. That is a

well-tested procedure with in-built safeguards. By contrast, the procedure

that the draft legislation will apply is untested.

 

The following matters amongst others are apparently to be prescribed by the

Rules:

 

- determining what are therapeutic products

- determining what are therapeutic uses

- classification of therapeutic products for access control purposes

- regulating manufacture, supply, import, export and promotion

- providing for recognition in Australia of regulatory approvals from other

countries

- prescribing rules for the promotion and representations of therapeutic

products

- prescribing record keeping and notification requirements.

 

Parliamentary accountability

This draft legislation’s regime for parliamentary scrutiny and disallowance

departs from the usual requirements:

 

- Rules and Orders can be disallowed only in whole – not in part.

Accordingly, if e.g., a set of 100 Rules or the entire Medicines or

Advertising Rule, are tabled, the parliament is put in the dilemma of

rejecting or allowing the lot. The parliament can’t just reject one or two

objectionable rules.

 

- Disallowance does not prevent the disallowed Rule or Order from being

immediately remade.

 

- Rules and Orders can incorporate other materials by reference, even

materials as they are updated from time to time – an example would be to

incorporate the contents of the website of the new Australia New Zealand

Therapeutic Products Authority as that website is changed from time to time.

 

Even intergovernmental schemes confined to the Commonwealth, States and

Territories are dogged by loss of real parliamentary accountability: the

ministers of each jurisdiction will commonly tell anybody pressing for

reforms to the scheme that it can’t be changed without all jurisdictions

agreeing; and refuse to take responsibility for administrative shortcomings

because this or that government – effectively no government – really

controls the monster.

 

There are signs already of that with the proposed regime – both the New

Zealand Government and the Australian have been defending their failure to

remedy shortcomings on the basis that they are not in control.

 

Information at risk

The draft legislation allows information to be publicly released without the

need for a formal application. That gives nearly total discretion to publish

any information at all. There is no counter-balancing requirement that

commercial in confidence material must not be released without the owner’s

consent.

 

The draft legislation also allows information to be publicly released to

Commonwealth authorities and departments, where the ANZTPA is reasonably

satisfied that the authority or department will use the information for

performing the functions or exercising the powers of that department or

authority. That is a very low threshold. It would justify large amounts of

information being given to the taxation authorities, and to Commonwealth

authorities which may be commercial rivals – for example CSIRO or R & D

corporations doing joint ventures with industry competitors.

 

Officers could also be excused from civil liability for releasing

therapeutic product information, even for deliberate wrongdoing.

 

''Balance'' in advertising

The draft legislation creates an offence for publishing an advertisement

which is not " truthful or balanced " .

 

In such a context balance is a very slippery and subjective concept. The

concept of balance is not appropriately the basis for a criminal offence.

The criminal sanctions law does not require ads for Telstra or Ford or

government or political ads to be balanced. They do not require Alan Jones

or Neil Mitchell to be balanced. Indeed, the concept of a truly balanced ad

is both odd and objectionable.

 

Ian Cunliffe

 

 

 

Michael Bending

Alliance for Health Freedom Australia

http://www.ahf-au.org

'All that is required for evil to prevail is for good men to do nothing'

- Edmund Burke (1729-1797), British writer and politician -

 

 

 

 

 

 

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