Newsletter no 45
Hello once again to all our supporters
In this newsletter
* Progress on the joint industry model for regulating natural health products
* Medsafe's "compliance review"
* Sign the petition
* Where to from here
Industry lead regulatory model
Regular readers of this newsletter will know that the NZ Health Trust has been working for some time now to coordinate a sensible, risk based regulatory system to fill the void created by the demise of the Therapeutic Products Bill.
An extensive consultation process has been carried out with industry and interest groups around New Zealand and the draft model now created has received near unanimous support. This system is designed to provide a "safe harbour" for natural products that meet 4 simple tests;
- Does the product comply with the definition of a natural and traditional health product?
- Does the product manufacturer and distributor have an accepted Risk Management Programme or Good Manufacturing Practice system in place?
- Is the required evidence held for any health claims made?
- Has the product been lodged on the central web based registry?
If the answer to those 4 questions are yes then the product is exempt from both Medicines and Food laws.
Because manufacturers are able to choose from a long list of approved GMP's, they are able to pick the one most appropriate for their product and for the markets they sell into. As an example this means you don't need to comply with Aussie rules if you only sell into Asia.
The model is now reaching a stage where we have been able to have initial discussions with MP's and feedback to date has shown there is strong interest in the work that has been done. So far, however, we have not been able to meet with the Minister to progress this important initiative.
Medsafe's Compliance Review
Those of you in the NHP business will no doubt have heard about the compliance review Medsafe launched shortly after their ANZTPA plan was scuttled. Under this review, teams of auditors have been assessing many natural health products for breaches of the Medicines Act and the Dietary Supplements Regulations. In many cases though, where there are breaches, these are matters that have been openly allowed by Medsafe for many years. Medsafe themselves told the Health Select Committee that current laws were not being enforced because doing so would force a substantial proportion of existing complementary healthcare products off the market. They also said that current Medicines Act rules were not appropriate for use for natural products. We can't help but see their decision to now ruthlessly enforce these very same matters as an act of retaliation against the industry for standing up to them on ANZTPA.
The review seems to be targeting two key areas. Firstly the making of any therapeutic claim (no matter how well established) and secondly the inclusion of any listed "medicine" in a dietary supplement notwithstanding that listed medicine may be something as innocuous as Vitamin B12 or Folate over a very small level. The effect of this is that many products are right now being forced from sale despite any real evidence of public harm being caused by them, and many businesses are threatened with closure. If you have received a letter by Medsafe or had products confiscated then it would be very helpful if you could send us brief details of the circumstances to us.
This is a link to an audio recording from a Radio NZ interview that will give you some idea of the situation;
http://www.nzhealthtrust.co.nz/news.html and click on Natural Health Practitioners under Fire from Medsafe 5th March 08.
Sign the Petition
There has been an important petition created to show the amount of industry concern about Medsafes activities and to call on the House of Representatives to urge the Government to; 1 Stop Medsafe’s harassment of the natural products industry, 2 Begin working with the natural products industry on a NZ regulatory model that will regulate dietary supplements and natural remedies appropriately, and protect consumers at the same time, 3 Legislate to remove natural products from schedule 1 of the medicines act of the 1981 because it is inappropriate to regulate dietary supplements and natural products as if they were high risk medicines, 4 Develop a separate classification and regulation for dietary supplements which allows properly justifiable claims to be made.
All forms will be will be submitted to the Health Select Committee to empower them to make recommendations.
To sign the petition on line; click here
To print the petition for signing your self and as many others as you can; click here
Where to from here
In an election year we see it as unlikely that there will be significant Parliamentary activity on this matter. The actions of Medsafe in the background however are serious and unacceptable. We urge them to instead allow the status quo that has shown a very high level of public safety over the past 20+ years to continue for a little longer while the industry driven regulatory model can be worked through and made a reality. To continue with this review could mean that many long standing and productive businesses are driven out of existence for no good public safety reason.
We are continuing our work with MP's and regulators and as ever welcome any input or assistance from our allies.
Kind Regards
Dave Sloan |
