Natural Health and Supplementary Products Bill

NZHT Submission http://www.nzhealthtrust.co.nz/pdf/nhp/NZHT_submission_NHP_bill_4th_mar_2016.pdf

Mojo Mathers SOP - released 20 March 2013 Supplementary Order Paper.pdf

As reported from the Health Committee on 31 October 2012 Natural Health and Supplementary Products Bill.pdf

Natural Health Products Bill introduced 7th Sept 2011 Natural Health Products Bill.pdf

Media Release
November 21, 2014
Dropping ANZTPA joint regulatory agency a wise decision
Dropping the proposed Australia New Zealand Therapeutic Products Agency (ANZTPA) is a wise decision, says the Medical Technology Association of New Zealand (MTANZ).

read full article on link below

http://www.scoop.co.nz/stories/GE1411/S00128/dropping-anztpa-joint-regulatory-agency-a-wise-decision.htm

Monopolistic/Big Business Strategies

The book entitled "The Ten Day MBA" by Steven Silbiger click here for more info

Decision to abandon ANZTPA welcomed by NZ Health Trust

click here to download media statement pdf

NZ and Australia abandon therapeutic products regulator

New Zealand and Australia have abandoned efforts to establish a joint therapeutic products regulator.
The decision to not go ahead with the Australia New Zealand Therapeutic Products Agency was made after a review of the costs and benefits to both countries, Australian Health Minister Peter Dutton and New Zealand Health Minister Jonathan Coleman said in a joint statement.
read full article here

NZ, Australia abandon joint medicine agency

The New Zealand and Australian governments have abandoned talks to establish a joint agency for regulating medicines. 

Health Minister Jonathan Coleman and his Australian counterpart Peter Dutton announced today that efforts to establish the Australia New Zealand Therapeutic Products Agency (ANZTPA) would be shelved, after a review failed to find adequate cost benefits for either country.
read full article here

Click on each of the PDF documents below

Castalia_Updated_Regulatory_Assessment_NHP_Bill_Sept_2015

Castalia_Regulatory_Assessment_NHP_Bill_March_2014

TDB_report_of_NHP_using_Treasury_Criteria _Sept 2015

TDB_Report_Natural_Health_Product May 2014

A brief history of the evolution of proposed regulation for natural and supplementary health products

1. In 2006 the government proposed a joint regulatory scheme with Australia to regulate natural and supplementary health products: the "Australia New Zealand Therapeutic Products Authority" (ANZTPA) (replacing the Dietary Supplement Regulations 1985 promulgated under the Food Act 1981).
   http://www.nzhealthtrust.co.nz/pdf/Joint_Industry_NTHPs_Bill_Feb_2009.pdf

2. After a period of intense opposition from the NZHT, members of the industry and the general public, the Government decided not to proceed with ANZTPA. 15 October 2009 letter from Dr Jonathan Coleman and Sue Kedgley to Roger Sowry 
   http://www.nzhealthtrust.co.nz/pdf/correspondence to and from the Minister.pdf

3. In response to a request from the Minister of Health (Tony Ryall), members of the natural and supplementary health products industry got together and formulated a joint industry proposal (JIP) for regulation of natural and supplementary health products (N&SHPs).
   http://www.nzhealthtrust.co.nz/pdf/consultation_paper_final.pdf

4. Key features of the JIP are:
   a. establishment of an industry specific regulatory agency (with costs shared between Government and the industry (by way of a levy based on turn-over);
   b. anticipation of the potential overlap between N&SHPs, foods and medicines and provision for N&SHP manufacturers/suppliers to choose the appropriate regulatory framework for N&SHPs (N&SHP, food or medicine);
   c. establishment of a simple on-line notification system for notification of products and ingredients/new ingredients (that are not prohibited ingredients) together with evidence to support safe use and any claims made, with the regulator able to disallow notification (and therefore sale of a product) if the agency has reasonable cause for safety concerns. A key factor in the proposal is the grandfathering of ingredients/products currently on the market.
   d. establishment of appropriate risk-management processes and regulations for the manufacture of N&SHPs.
   http://www.legislation.govt.nz/bill/government/2011/0324/3.0/DLM3984610.html

5. In April 2009 the National Party and the Green Party announced that they would work together to develop a regulatory system for natural health products that is specific to New Zealand. Dr Jonathan Coleman (the Associate Minister of Health) and Sue Kedgley (Green Party MP) met with the industry group to discuss the JIP in May 2009 and in October 2009 wrote to the industry group indicating broad support for the proposals outlined in the JIP.
   http://www.nzhealthtrust.co.nz/pdf/Summary_of_Submission_New_Zealand_Health_Trust_and_New_Health_NZ_24_February_2012.pdf and http://www.nzhealthtrust.co.nz/pdf/New%20Zealand_Health_Trust_and_New_Health_NZ_Submissions_24_February_2012.pdf

6. In 2010 the Ministry of Health consulted on a proposed Natural Health Products Bill. Cabinet approved development of the Bill on 7 December 2010 and the Natural Health Products Bill was introduced into Parliament on 7 September 2011. The Bill introduced bore little resemblance to the JIP (contrary to a commitment from Government that it would). NZHT made comprehensive submissions on the Bill in February 2012 and appeared before the Health Select Committee in support of these submissions in March 2012.
   including: letter from NZHT to Minister Ryall dated 24 September 2012 and letter Minister Ryall to NZHT dated 6 November 2012
   http://www.nzhealthtrust.co.nz/pdf/correspondence to and from the Minister.pdf

7. In summary, NZHT's key concern was that the Bill did not resemble the JIP. It appeared rushed and incomplete, did not include appropriate principles and purpose clauses, was lacking processes that reflect the principles of natural justice, gave the regulator powers that were far too wide and did not provide for sensible transition. Many of definitions and processes in the Bill were unclear and un-workable.
   http://www.nzhealthtrust.co.nz/pdf/Natural Health Products Bill report back 31 October 2012.pdf

8. NZHT followed up these submissions with on-going correspondence and meetings with both the Minister of Health and Ministry officials in an attempt to align the Bill with the JIP and make it workable.
   http://www.nzhealthtrust.co.nz/pdf/Bullet%20points%20amended%20billv4.pdf

9. The Health Select Committee reported back on the Bill on 31 October 2012. Many of NZHT's original concerns remained. Some issues raised by NZHT had been dealt with but in other respects this version of the Bill was much worse than the original version. A significant and risk disproportionate change was made to the notification process introducing pre-approval processes for health benefit claims about named conditions.
   http://www.nzhealthtrust.co.nz/pdf/correspondence to and from the Minister.pdf

10. NZHT provided the Ministry of Health with a position paper outlining in some detail the key changes, problems and unintended consequences of the amended Bill and on 17 December 2012 NZHT wrote to the Minister of Health outlining those concerns.
    http://www.nzhealthtrust.co.nz/pdf/correspondence to and from the Minister.pdf

11. NZHT representatives met with the Minister to discuss those concerns and then continued to engage with officials in an effort to resolve matters. Some minor amendments were agreed to but NZHT was unable to progress the important issues – in particular the change from a risk-proportionate notification regime to a pre-approval regime (for claims about named conditions), and delays in consultation on the the ingredients list, the manufacturing code and the approach to be taken to fees. On 1 November 2013 NZHT wrote to the Minister again expressing those concerns in detail.
    http://www.nzhealthtrust.co.nz/pdf/Update Letter to Hon Tony Ryall 1 Nov 2013.pdf

12. In early 2014, NZHT commissioned a regulatory assessment of the Bill from Castalia Ltd. Castalia concluded that there was little evidence of a problem or gap in the existing regulatory landscape for N&SHPs, that the proposed regulatory regime does not include adequate principles or objectives to guide the regulatory process and that the costs of the proposed regulation are potentially large. Castalia concluded that the strongest form of legislation commensurate with the risks associated with the natural health products industry is a disclosure regime with black-list features (as opposed to the mixed notification/pre-approval regime proposed).

13. At the same time NZHT commissioned a cost-benefit analysis of the Bill from TDB Advisory Ltd. TDB concluded that there is little or no evidence that adverse health consequences N&SHPs are a major problem in New Zealand under the current regime and that the costs of implementing the regime and that the costs of the proposed regime would be significant and likely to increase over time. TDB's conclusion is that there does not appear to be a compelling case for moving from the current regulatory regime for N&SHPs.

14. TDB notes that a significant problem with the current regime (the Dietary Supplement Regulations 1985) is that it is somewhat outdated and is not being adequately enforced but that this could be rectified with revision and enforcement on a basis proportionate with the risks and benefits. TDB also raises the question of the appropriate location of responsibility for regulating N&SHPs. The Bill proposes a separate unit within the Ministry of Health. TDB notes that the Ministry of Primary Industries is a better fit given that the N&SHP sector is primary-industry based, export oriented and relatively low-risk.
    

Hello NHP colleagues,

You will most likely be aware that the Bill to regulate Natural Health Products has been reported back from the Health Select Committee with its amendments and has been substantially changed from the first draft which bore little resemblance to the fully agreed Joint Industry Proposed Bill.

Attached for your information is a copy of documents that set out NZHT's position on the Natural Health & Supplementary Products Bill as amended by the select committee.  (We have identified six key issues (set out in detail in the key issues table and summarized in the bullet point key issues document.  The remaining document (bullet points amended bill) provides an overview of all issues with the amended Bill.  The Bill is not the Joint Industry Proposal (JIP) but we have consistently made submissions to the Minister and officials in line with the principles of the JIP and these bullet points reflect the Trust's view of how the spirit of the JIP could be achieved within the framework of the Bill.  There is no political willingness to scrap this Bill and draft a “JIP” Bill.  The reality is that we have to work with the current Bill and try and fix it (as opposed to pursuing a complete change of approach i.e. the JIP in the form we originally suggested).

Key issues v5.pdf

Bullet point key issues.pdf

Bullte points amended billv4.pdf

We have also identified the Trust's bottom line (these items have a red-arrow in the “bullet point amended bill” document) i.e. the minimum changes required to make the Bill work consistent with the principles agreed to in the JIP.  

The Trust has provided Minister Ryall with this document and advised that without these changes the Trust will not be able to support the Bill.  The Minister has indicated a willingness to look at our concerns and we are currently working through this with officials however at present we have no firm commitment to change.  We have been told that the Minister and officials consider that there is strong industry support for the Bill in its current form but we do not believe this is the case and would like to bring that to his attention.

We urge that any company or person that supports the Trust's position write to the Minister outlining that support.  You may have different items that you wish to "red flag".  It may be helpful to attach the bullet points (as the Minister has a copy of these) and refer to these when making any comments.  You may wish to suggest changes – for example, you may have a view that the Schedule does not encompass all appropriate categories of substances and you may wish to suggest additions to that Schedule.

The Bill has now had its second reading (see http://legislation.govt.nz/bill/government/2011/0324/latest/DLM3984610.html?src=qs) and we understand it will be before the House shortly for the third reading.  This will be the last opportunity for changes to the Bill to be made (by supplementary order paper or amendment) so it is important that any correspondence to the Minister is received as soon as possible.

Please email Hon Tony Ryall (t.ryall@ministers.govt.nz) and follow up with a letter to the Minister, Private Bag 18888, Parliament Buildings 6160.  We would be grateful if you could copy us in on any correspondence.

If you have received this email but are not the relevant person to deal with this issue, please pass on to the relevant person within your organization.

Please feel free to send this email and attachments on to your industry colleagues.

Regards

Dave Sloan

NZ Health Trust
PO Box 34057
Fendalton
Christchurch 8540
NEW ZEALAND

Medicines Amendment Bill

http://www.legislation.govt.nz/bill/government/2011/0345/latest/DLM4096106.html

Summary of Submission New Zealand Health Trust and New Health NZ 24 February 2012
( Click here for PDF )

New Zealand Health Trust & New Health NZ Submissions 24 February 2012
( Click here for PDF )

Attached was the
Joint Industry NTHPs Bill Feb 2009
( Click here for PDF )

Natural Health Products Bill

http://www.legislation.govt.nz/bill/government/2011/0324/latest/DLM3984610.html

Make a submission

http://www.parliament.nz/en-NZ/PB/SC/MakeSub/a/1/4/50SCHE_SCF_00DBHOH_BILL11034_1-Natural-Health-Products-Bill.htm

Legislative Analyst by John McSoriley BA LL.B, Barrister, This Digest was prepared to assist consideration of the Bill by members of Parliament. It has no official status.
http://www.parliament.nz/NR/rdonlyres/11E3FB9C-3445-45BD-A523-CF131303E548/201630/1927NaturalHealthProducts1.pdf

Regulatory impact statement
http://www.health.govt.nz/about-ministry/legislation-and-regulation/regulatory-impact-statements/development-natural-health-products-bill

Please find link to discussion document regarding the latest round of consultation on mandatory fortification of bread with folic acid:

www.nzfsa.govt.nz/consultation.

Please feel free to pass this email on to anyone in your organisation who you feel may be interested in making a submission.  Submissions close on 12 August 2009.
The Government is aware that there is significant public interest in this issue and has decided to consult on three options relating to the fortification of bread with folic acid.

The Government’s preferred option is to amend the New Zealand (Mandatory Fortification of Bread with Folic Acid) Food Standard to delay its commencement until 31 May 2012. A deferred commencement date would for allow for the planned 2011 review of the Australian standard to be completed. The outcome of this review would provide valuable information for the Minister to drawn on to decide how to proceed at that time.

As the mandatory standard is due to commence on 27 September 2009, the timeframe in which consultation can occur is very short. We appreciate the difficulties that the short timeframe may cause some submitters but it is important that any decisions are made before the current commencement date. All submissions will be given full consideration before making a final decision. 

Yours sincerely

Carole Inkster
Director, Policy

Click here
"Proposed Natural and Traditional Health Products Bill"
44 page PDF

Click here for "Executive Summary"
2 page PDF

The New Zealand Food Safety Authority is proposing to update the regulations surrounding food-type dietary supplements. The proposed changes will bring the laws surrounding the manufacture and sale of these food-type dietary supplements into line with the Australia New Zealand Food Standards Code.

New rules proposed for food-type dietary supplements
http://www.nzfsa.govt.nz/publications/media-releases/2008/2008-08-01-supplemented-food-standard.htm

Proposed changes to the dietary supplement regulations
http://www.nzfsa.govt.nz/policy-law/consultation/supplemented-food/

Proposed Standard for Supplemented Food
http://www.nzfsa.govt.nz/policy-law/consultation/supplemented-food/discussion-doc/index.htm

Draft New Zealand Food (Supplemented Food) Standard 2008
http://www.nzfsa.govt.nz/policy-law/consultation/supplemented-food/draft-standard/index.htm

Public Health Bill

2nd oral submission to the Health Select Committee re the Public Health Bill in AK by NZ Health Trust Click here for the PDF

1st written submission to the Health Select Committee re the Public Health Bill by NZ Health Trust click here for the PDF

Public Health Bill click here for the PDF 4MB - Feb 2008
visit the website below.
http://www.legislation.govt.nz/bill/government/2007/0177-1/latest/versions.aspx

Original July 1998 public health Bill discussion document click here

Proposed Changes to the Regulation of Dietary Supplements

Visit NZFSA wbsite
click here to download the NZFSA proposal info in PDF
click here to download the PDF document from Medsafe letter advising of changes

information from Medsafes website to the above proposed changes

• COMET (Complementary Medicines Transition Database)

• Joint Agency complementary medicine issues

• Are you a sponsor of a complementary medicine?

• Hot Topics - Herbal, Traditional and Complementary Medicines

• Permitted Ingredients List Project

• Guidance tool for assessing the appropriate regulatory coverage for products at the food-medicine interface

Dietary Supplement Regulations 1985 click here to read the regulations PDF

Medicines Act 1981 click here to read the Act

The review of fees payable under the Medicines Act 1981 and the Misuse of Drugs Act 1975 has been completed.  See below for documents relating to the fees review. 
The revised schedule of fees is effective from 21 August 2006 click here

or use these two direct links below to the relevant info pages

1. Revised schedule of application fees for consent, applying to the various types of applications and notifications (effective from 21 August 2006) click here
   
2. Schedule of New Fees for all Licences under the Medicines Act 1981
   and the Misuse of Drugs Act 1975 click here

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration (FDA) Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

click here to read the 815 page PDF or right click and save target as to download it

Minority report by Green party

We oppose the bill because we believe it will reduce New Zealander’s access to many dietary supplements and traditional medicines, reduce consumer choice, increase compliance costs of natural health products and result in the closure of many small New Zealand businesses. We also have serious constitutional concerns with the proposed regulatory regime, which we believe will undermine the sovereignty of our Parliament. read the PDF

Therapeutic Products and Medicines Bill (103-1) (15 June 2007)

The Government Administration Committee has examined the Therapeutic Products and Medicines Bill. We have been unable to reach agreement and therefore cannot recommend that the bill be passed.

Govt Admin Committee report released today click here for the PDF

NZFSA Discussion Document

NZFSA now wants to progress the development of new regulations to cover complementary foods and has produced a new discussion paper called
Proposed Changes to the Regulation of Dietary Supplements (pdf, 107KB 21 Pages) which explains how the new regulations might work.

Visit NZFSA website page for all info

The closing date for submissions is Wednesday, 29 March 2007.

Please send your submission to:
Trish Ranstead, Policy Group
New Zealand Food Safety Authority
PO Box 2835, Wellington – New Zealand
Facsimile: (04) 463 2583
Email: policy@nzfsa.govt.nz

7th Feb 07 -Therapeutic Products and Medicines Bill submission from NZ Health Trust / New Health NZ presented to the Government Administration Committee.
NZ Health Trust / New Health NZ Submission 1 PDF 26 pages 141k

Draft ANZTPA Rules
Consultation documents released

23 May 2006

Documents detailing the proposed joint regulatory scheme for the new Australia New Zealand Therapeutic Products Authority (ANZTPA) have been released for public consultation.

Submissions are being welcomed on the proposed regulatory scheme or "draft Rules" for medicines and medical devices; a description of the proposed Grouping Order for medicines; draft guidelines on transition provisions for product licensing; the key components of the draft Administration Rule; and the consultation document on the proposed fees and charges.

The closing date for submissions on the consultation documents is 15 August 2006.

• Download a copy of the consultation document - draft Medicines Rule (pdf,489kb)
  
• Download a copy of the consultation document - description of the proposed Grouping Order for medicines (pdf,53kb)
  
• Download a copy of the consultation document - draft guideline on transition provisions for product licensing (pdf,133kb)
  
• Download a copy of the consultation document - draft Medical Devices Rule (pdf,754kb)
  
• Download a copy of this consultation document - draft administration Rule (pdf,330kb)
  
• Download a copy of this consultation document - proposed fees and charges (pdf,353kb)
  
• Medicines Manufacturing Principles (pdf,45kb)
  
• Plain English Guide on the proposed regulatory scheme outlined in the draft Rules (pdf,417kb) is also available to provide context and assist readers' understanding of the key features of the regulatory proposals.

For more information go to Govt website ;
 http://www.anztpa.org.nz/consult/consdocs1.htm

REPORT BY OCEANIA HEALTH CONSULTING
January 2005

REVIEW OF THE NEED FOR FURTHER REGULATION OF EXTEMPORANEOUS COMPOUNDING.

See item 2 The present legislative Framework in Australia and 2.1 Constitutional Limitations of the Therapeutic Goods Act, of this report showing a very real example of why the TGA is so keen for the trans tasman body - nothing to do with NZ - more about removing their constitutional inability to regulate sole traders and natural persons.

This report demonstrates that the TGA wants to extend its control to all Territories and states to cover natural people and reach into pharmacists and hospital controls, all of which are currently outside their domain.

(Only currently covers 3 of the 8 being NSW, Tasmania, but to a lesser degree Victoria)
Read the PDF by clicking here 31 pages

Complementary and alternative medicines (including traditional Māori treatments) used by presenters to an emergency department in New Zealand: a survey of prevalence and toxicity

Tonia Nicholson

5,880 presentations at Waikato A&E and not a single presentation due  to Complementary medicines...!

"Additionally, during the relatively short period over which this study was conducted (7 weeks) there were no presentations to the Emergency Department with adverse effects associated with the use of  CAM."

http://www.nzma.org.nz/journal/119-1233/1954/

SO WHERE IS THE PROBLEM AND WHY IS LABOUR PUSHING SO DESPERATLY FOR TGA/ANZTPA??

Regulation of Non-prescription Medicinal Products

No. 18

Year: 2004/2005
Tabled: Thursday, 16th December 2004
Audit Type: Performance Audit
Agency: Department of Health and Ageing
Theme: Legislative and/or Administrative Compliance

Summary
The Therapeutic Goods Administration (TGA), a division of the Commonwealth Department of Health and Ageing, is responsible for the regulation of the manufacture and supply of therapeutic goods. The objective of the audit was to assess the TGA's regulation of non-prescription medicinal products. In particular, it reviewed the TGA's systems, procedures and resource management processes used to approve new manufacturers, monitor ongoing manufacturer and product compliance with mandated requirements, and manage non-compliance. The audit made 26 recommendations designed to improve the transparency, quality and reliability of regulatory decisions taken by the TGA and improve its accountability mechanisms by enhancing its management information systems.

Available downloads:

Audit Report 18 (Adobe PDF 830Kb)
Audit Brochure 18 (Adobe PDF 128Kb)

TGA proposed fees & charges increase
The TGA have announced that their already heavy fees are to be increased again on 1 July this year.  Plus, they claim that the complementary medicines sector has been under charged for its share of costs by about 11%.  This gives a clear picture of where the fees are heading and what NZ businesses could expect under the proposed joint regime.

Australian Government
Industry Briefing Reg Issues Bill 2005

A report by NZ Health Trust on the Australian Therapeutic Goods Amendment Bill 2005

The Amendment Bill is currently set to be introduced to the Australian Parliament and if passed would bring into force a regime of penalties and enforcement actions which would give the TGA unheralded and almost unbridled power. read more on PDF...

How The Bill Would Increase Penalties for Natural Medicines (Natural Health Products)
Click here to view A table of existing and propsed penalties relating to Natural Medicines by Mike Browning - this has not been checked by NZHT, however if you read the PDF below you will see the penalty units associated to each offence. 1 penalty unit = AU$110

Australian Government Therapeutic Goods Amendment Bill 2005
(107 Pages)

Just how close should Australia & New Zealand get?
Closer Economic Relations (CER) is put on notice

Amy Adams, Simon Mortlock Partners & New Zealand Health Trust Speech to the 14th National Health Summit , Sydney 26 October 2004

A proposal for a trans Tasman agency to regulate therapeutic products

Dietary Supplement Regulations 1985

Complementary Medicines links

• COMET (Complementary Medicines Transition Database)

• Joint Agency complementary medicine issues

• Are you a sponsor of a complementary medicine?

• Hot Topics - Herbal, Traditional and Complementary Medicines

• Permitted Ingredients List Project

• Letter to Industry on planned changes to the Dietary Supplements Regulations 1985 and regulatory compliance

• Guidance tool for assessing the appropriate regulatory coverage for products at the food-medicine interface

Medicines Act 1981 click here to read the legislation

The review of fees payable under the Medicines Act 1981 and the Misuse of Drugs Act 1975 has been completed.  See below for documents relating to the fees review. 
The revised schedule of fees is effective from 21 August 2006 click here

or use these two direct links below to the relevant info pages

1. Revised schedule of application fees for consent, applying to the various types of applications and notifications (effective from 21 August 2006) click here
   
2. Schedule of New Fees for all Licences under the Medicines Act 1981
   and the Misuse of Drugs Act 1975 click here