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February 2008
| Feature |
| Regulation in trouble as world leader faces political storm |
The world's leading regulatory agency, the US Food and Drug Administration is under extreme pressure from a US Congress that thinks it isn't doing its job properly. What does this mean for regulatory agencies around the world that often take the FDA's lead, including Australia's TGA? » full report |
August 2007
An overview of the last 12 months:
The Trans Tasman merger has stalled, and looks like taking quite some time yet to be implemented. Much of this is due to the NZ Parliament being unable to ratify the transitional legislation required. The NZ Health Trust has been actively involved in this issue.
On the 16th August, 2007 the Therapeutic Godos Amendment Bill 2007 was passed, extending the October 4th deadline relating to the transition period for Australian manufacturers to comply with the new Medical Devices Register. What this means is that as long current manufacturers have an effective application for inclusion, or effective application for conformity assessment, lodged with the TGA by October, 2007, they will still be able to sell & market their products, past this deadline, until a final decison has been made by the TGA about their application.
The TGA are in the process of producing a Recognition Agreement between the TGA & Health Canada for mutual recognition of conformity assessment procedures for medical devices, which specifically relates to quality management systems and the ISO13485 International Standard. Working towards a MRA with Canada is facilitating the ongoing global harmonisation of the regulatory environment for medical devices.
July 2006
It's been some time since we added any new material to this page, however we would urge ALL members to take the time to visit the NEW Trans Tasman Therapeutic Products Agency site that is the planned body to replace the Australian TGA and New Zealand's Nedsafe, after the proposed merge in 2007.
Of particular interest is the devices page .
There has been much angst especially from the New Zealand people regarding this proposed merger, and as yet the NZ parliament has not ratified the treaty signed by Annette King, in 2003. Unlike Australia, where the deal was set in motion with barely a ripple of public knowledge, politicians and the public continue to block the progrees of a Bill through the NZ Parliament, and there have been a significan number of timeframe setbacks for the implementation of the Australia New Zealand Therapeutic Products Authority (ANZTPA).
The latest date given is now mid 2007, and if the NH Health Trust has anything to do with it, this Bill will never be passed ! A news article dated June 21st 2006 outlines the ongoing struggle.
September 2005
On 7 September 2005 the Senate, on the recommendation of the Selection of Bills Committee, has referred the provisions of the Therapeutic Goods Amendment Bill 2005 to the Senate Community Affairs References and Legislation Committees for inquiry and report by 28 October 2005.
The terms of reference for this committee in relation to the Therapeutic Goods Amendment Bill 2005 are to examine the provisions of the Bill relating to new enforcement options for the TGA and to:
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Identify if the Bill provides sufficient detail on the scope of alleged breaches to which infringement notices may apply, on the use of alternatives to court proceedings, and the extent to which the processes of investigation of offences will be in line with procedural fairness (including the use of media during investigations and prosecutions);
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Ascertain if the Bill adequately accommodates differences between registrable and listable goods;
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Examine inequity implications for Australian based manufacturers due to the non-applicability of the civil penalty regime to foreign entities; and
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Examine the need for ad hoc appeals mechanism against the imposition of an infringement notice and a fine under the civil penalties regime currently included in the Guidelines, to be included in the Regulations to preserve the appeal mechanism and prevent arbitrary variations and application.
The Committee invites written submissions on the Bill which should be lodged with the Committee by Wednesday, 5 October 2005. The Committee prefers to receive submissions electronically as an attached document - email: community.affairs.sen@aph.gov.au – otherwise by fax (number 02 6277 5829).
The Committee intends to hold a public hearing on the Bill on Friday, 14 October 2005.
August 2005
As of the 24th August, the Therapeutic Goods Advertising Code 2005 took effect. The ABEA would urge all members and non member Practitioners to review the following sections:
- Section 4: General Principles (pages 5 - 7)
- Section 5: Prohibitions (page 7)
- Appendix 6: Prohibited, Restricted and Permissible Representations (pages 17 - 18)
Click here to read this document.
As of the 19th August, the TGA has released a brief overview to the transitional arrangements for medical devices under the Trans Tasman Agency. These arrangements will allow for a transition "Interim Product Licence" which will be valid for a period of three years, however re-establishment of the manufacturing licence must be gained after two years. Following commencement of the Trans Tasman scheme, anyone who supplies a medical device without the relevant interim licence will be potentially exposing themselves to enforcement action by the Agency. Click here to read this document.
On the 17th of August, Mr Christopher Pyne, (Parliamentary Secretary to the Minister for Health and Ageing), presented a bill for an Act to amend the Therapeutic Goods Act 1989. This bill aims to increase dramatically the penalty units and civil convictions for breaches against the act. This bill aims to amend the Therapeutic Goods Act 1989 to provide the Therapeutic Goods Administration with additional sanctions and enforcement options for dealing with suppliers and manufacturers who fail to comply with regulatory requirements including product and manufacturing standards, including: introduction of a tiered offence regime and civil penalties for breaches; providing for infringement notices, enforceable undertakings and strict liability offences; and extending territorial jurisdiction in certain circumstances. Also makes a consequential amendment to the Therapeutic Goods Amendment (Medical Devices) Act 2002.
Click here to view Mr Pyne's second reading of the bill, click here to view the Explanatory Memorandum that accompanies this bill or click here to view the Therapeutic Goods Amendment Bill 2005. Due to the structure of the current parliament, there is little that anyone can do about the passage of the document through the House of Representatives or the Senate.
The ABEA would urge all interested parties to discuss this issue with their local Liberal / National member of parliament to make them realize the draconian nature of these amendments and the potential flow on effects this will have on the industry.
May 2005
On the 10th May 2004, Christopher Pyne (Australian Parliamentary Secretary for Health) and Annette King (New Zealand health Minister) met in Adelaide and appointed an expert committee to oversee to establishment of standards for therapeutic products under the new Trans Tasman Agency. Click here to read this document.
January 2005
In a nutshell, as of the 4th October, 2004,the Therapeutic Goods ( Excluded Goods Order) of 1998 (the Order), was repealed and replaced with the Therapeutic Goods (Excluded Goods) Order No.1 of 2004. A document was released by the TGA in the 3rd week of September 2004 as a reminder to all stakeholders of the impending closure of the two year transition period for Excluded Devices. Click here to read this document.
In order to remain on the ARTG (Australian Register of Therapeutic Goods) after 4 Oct 2007, the manufacturers of each device will have successfully applied to have their device "included" in the register prior to this date.
The "Office of Devices, Blood & Tissues" within the TGA is the responsible government department. http://www.tga.gov.au/devices/devices.htm
Each application will involve "Conformity Assessment Procedures" involving:
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Compliance with "Essential Principles" [documented in Schedule 1, Part 1 of the Therapeutic Goods (Medical Devices) Regulations 2002]; and
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A choice of procedures involving either Verification, Production Quality Assurance, or Product Quality Assurance.
For the overseas-manufactured bio-energetic computers that we use, the manufacturer will generally have to supply documentation from their own regulatory bodies attesting to their compliance, safety, quality, indications, and so on. They will have to demonstrate that their product has a "post-production monitoring system" responsive to any problems that arise with their "medical devices".
Also important in the process is the "intended purpose" for the device specified by the manufacturer, the level of risk to those using the device and the degree of invasiveness in the human body.
Up until now, EAV/CEDS devices have been considered low risk, and harmless and were categorized on the simple basis that they were safe, of good quality and had something to do with health. In 1998, an order de-listing these devices from the ARTG was put through without any consultation with the alternative medical industry. CEDS devices have remained de-listed ever since, until now.
Should the CEDS devices fail to be successfully "included" in the new ARTG, there are a number of options mentioned on page 17 of the GDN7 for unapproved medical devices:
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Apply for access as a part of a proper Clinical Trial (which would have to have ethics committee approval);
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Apply under the Special Access Scheme (SAS) on behalf of individual patients who want access to the device;
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Apply to become an Authorized Prescriber to use this device.
There is a document discussing this called "Access to Unapproved Therapeutic Goods In Australia" (www.tga.gov.au/docs/html/sasinfo.htm)
TGA Consultants
For those sponsors and manufacturers needing a hand to navigate their way through the maze of technical jargon,we can recommend several consultants with extensive TGA background and experience.
QLD - Bren Milsom based on the Gold Coast. Click here to view his web site. He can be contacted 07 5522 4880 or email bmilsom@advantagempc.com.au
NSW - Leo Barnes of Lindfield, NSW. He can be contacted on leo.barnes@ihug.com.au or 02 8904 0092 , PO Box 294 LINDFIELD NSW 2070.
SA - Kea Dent of Kea Dent & Associates. Mb : 0411 101 392 Fax : 08 8172 1614 kdent@senet.com.au
The Future...
Having said all this, you should be aware that the New Zealand and Australian Governments have agreed to establish a trans-Tasman therapeutic products agency. In principle the plan was that from 1 July 2005 the joint agency would replace the Australian Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). http://www.tgamedsafe.org/
It will be interesting to observe the lead up to this transition, and what ramifications, if any, it may have upon our industry, in terms of re-listing or continuing current listings of devices. ( NOTE : on the 9th February 2005 Christopher Pyne, the new Parliamentary Health Secretary, announced a deferral of implementation until 1st July 2006. (Click here to read)
According to verbal conversations had with the TGA, as of the 20th January, 2005, the regulatory transition for those importers who are already up to standard and included in the ARTG, will only be a relatively small administrative procedure to transfer to the new “Product Licence” that is proposed under the new scheme, and the procedure is outlined in the initial proposal document from 2002
http://www.jtaproject.com/Downloads/Key%20Documents/june02.pdf
Specifically, pages 146 onwards relates to what happens to pre-existing inclusions on the ARTG. It states that essentially it will only be an administrative process to be issued with the new “Product License” rather than a re-application all together.
As an aside. there is a quite vocal NZ group called the NZ Health Trust that are making their thoughts about the Trans Tasman Harmonization felt. Visit their web site www.nzht.co.nz and bring yourself up to speed on all their latest news.
The TGA site outlining the overview of this project http://www.tga.gov.au/tta/index.htm is extensive and we believe you would benefit from reading this site thoroughly and being aware of the proposed changes that lie ahead, especially relating to the advertising codes.
It is well worth your time to read the minutes of the final stakeholders meeting (Version 11) held in November 2004, as they will now form the basis of the final draft of the Trans Tasman Advertising code, which the Interim Advertising Council (IAC) will decide upon.
Further TGA guidance document links
Guidance Document 1: An Overview of the New Medical Devices Regulatory System
http://www.tga.gov.au/docs/pdf/devguid1.pdf
Guidance Document 2: Application Audits
http://www.tga.gov.au/docs/pdf/devguid2.pdf
Guidance Document 3: Conformity Assessment Procedures
http://www.tga.gov.au/docs/pdf/devguid3.pdf
Guidance Document 4: Clinical Evidence Requirements for the Inclusion of Medical Devices in the Australian Register of Therapeutic Goods
http://www.tga.gov.au/docs/pdf/devguid4.pdf
Guidance Document 5: The Declaration of Conformity
http://www.tga.gov.au/docs/pdf/devguid5.pdf
Guidance Document 7: The Use of Medical Devices in Alternative Therapies
http://www.tga.gov.au/docs/pdf/devguid7.pdf
Guidance Document 8: Advertising Medical Devices
http://www.tga.gov.au/docs/pdf/devguid8.pdf
Guidance Document 11: Postmarket Activities
http://www.tga.gov.au/docs/pdf/devguid11.pdf
Guidance Document 12: Conditions on Conformity Assessment Certificates Issued by the Therapeutic Goods Administration
http://www.tga.gov.au/docs/pdf/devguid12.pdf
Guidance Document Number 20: Obligations and Responsibilities of Medical Device Sponsors and Manufacturers
http://www.tga.gov.au/docs/pdf/devguid20.pdf
Guidance Document 22: The Essential Principles for Medical Devices
http://www.tga.gov.au/docs/pdf/devguid22.pdf
Guidance Document 25: Classification of Medical Devices
http://www.tga.gov.au/docs/pdf/devguid25.pdf
Guidance Document 35: Device – Medicine Boundary Products
http://www.tga.gov.au/docs/pdf/devguid35.pdf
Medical Device Essential Principles Checklist
http://www.tga.gov.au/devices/epcheck.pdf
It is envisaged that most of these guidance documents will remain, in the most part, intact through the transition to the new joint regulatory body now beginning in July 2006.
AFEM will keep you posted as to the latest news on this situation so that everyone is kept up to date on the transitional process. This also includes keeping you up to date with the ramifications of the new advertising code, which at this stage may mean some reasonably important changes in the way that you advertise your devices or services within the Complementary Healthcare community.
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Last Updated: February 25, 2008
Contact Federation of Energy Medicine
Post: PO Box 446 BELLINGEN NSW 2454
Phone: +61 2 6655 9400 Fax: +61 2 6655 9411
Email: info@energymedicine.org.au
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