Article 1
Submission
in Response to the proposal to Amend Aspects of
New Zealand's Medicines Law
16/12/2002
Table of Contents
Introduction
Prescribing Issues
New Developments Related to Prescribing
Contact Details
About the New Zealand Association of Medical Herbalists
Submission Information
References
Introduction
The New Zealand Association of Medical Herbalists (NZAMH)
is pleased to be able to have input into this Medsafe-generated
discussion document with regard to the Proposals to Amend
Aspects of New Zealand's Medicines Law.
The purpose of this NZAMH submission, while directly commenting
on aspects of the proposed legislative changes, is mainly
to inform Medsafe and the MCC of the desire of NZAMH to
have access to Herbal Medicines that are currently restricted
alongside access to those Herbal Medicines that may be placed
within Class I, II or III of any trans-Tasman or National
legislative framework.
NZAMH will be applying for registered health professional
status under the HPCAB when it is enacted, provisions allowing.
This means that registered Medical Herbalists will be under
the auspices of a registering authority and as such will
be subject to similar regulations and disciplinary procedures
as other registered health professionals who dispense restricted
medicines.
As a direct result of this registration possibility, aspects
of this discussion document are of interest to NZAMH. This
submission addresses questions 1 and 24 alongside briefly
commenting on broader issues of Herbal Medicine regulation
within New Zealand. To a large degree this submission comments
on possible proposed future aspects of Herbal Medicine legislation.
However this does not belittle the content of this submission
and the discussion document allows room for these issues
to be presented and aired at the current time.
Please review this document and discuss the raised issues
further as you see fit.
Prescribing Issues
Question 1: Subject to the enactment of the HPCA Bill,
do you agree that the lists of medicines that can be prescribed
by each profession should be disseminated by the professional
bodies rather than maintained as Schedules of the Medicines
Act?
Answer: It is the opinion of NZAMH that prescribable Herbal
Medicines should be listed with the Medical Herbalists professional
body.
Rationale
The ability of the MCC to satisfactorily and competently
regulate Herbal Medicines has been discussed within the
MCC and published on the Medsafe website during 2001.
Medsafe does not recommend that the proposal to adopt the
MCC proposed framework for the classification of herbal
medicines be adopted at this time for the following reasons:
• MCC expertise is in the practice of medicine and
the practice of pharmacy: Members are not skilled in the
field of herbal medicines
• The consultation process was limited in its effectiveness
and therefore there is no assurance that all relevant information
was considered
• Accepting the recommendations would result in unavailability
of products for which there is no evidence of consumer harm
in New Zealand.
Medsafe recommends that consideration of these classifications
be deferred until the outcome of the government decision
on the Joint Agency proposal is known later in the year.
If the decision is positive, consideration of classification
will be dealt with as part of the pre-implementation process.
An expert committee of Australian and New Zealand members
with knowledge of herbal medicines could be convened for
this purpose.
(Medsafe 2001(a))
This adequately explains the MCC position with regard to
regulation of Herbal Medicines within New Zealand. At present
the Complementary Medicines (and therefore Herbal Medicines)
aspect of the Joint Agency proposal is currently before
Select Committee and will not be reported back for some
months. Until clear direction is received on this issue
definitive decision cannot be made. However, the possibility
of Herbal Medicines being listed with the Medical Herbalist
professional body is a positive development.
Within the HPCA NZAMH Scopes of Practice will include wording
that will encompass the right of Medical Herbalists to utilise
their full materia medica within the extent of New Zealand
law. As such registered Medical Herbalists will desire to
be 'authorised prescribers' for Herbal Medicines that are
currently restricted, or those Herbal Medicines that may
be classed as I, II or III in any trans-Tasman or National
legislation.
To allow for this process to occur the registering authority
to which NZAMH would belong under the HPCA will be instructed
to follow the process of preparing a submission to the New
Prescriber's Advisory Committee (NPAC) under the guidelines
outlined within MOH.
NZAMH is aware that Scopes of Practice are secondary to
legislation and as such wishes to be consulted and involved
in any legislative aspects of Medicines Law with regard
to Herbal Medicines.
New Developments Relating
to Dispensing
Question 24: Should dispensing rights be extended to other
health providers?
Is so who, and should there be restrictions on the medicines
or circumstances of their supply?
Answer: NZAMH requests that registered Medical Herbalists,
registered under the HPCA, be allowed prescribing rights
for all Herbal Medicines that are currently restricted,
or for those Herbal Medicines that may be classed as I,
II or III in any trans-Tasman or National legislation. No
restrictions should be applied on either the medicines or
circumstances of supply.
Rationale
Prescription rights for registered Medical Herbalists with
regard to restricted Herbal Medicines have been discussed
within the MCC and published on the Medsafe website during
2001.
The committee discussed the role of Herbalists and the
need for registration if Herbalists were to be given access
to classified medicines. It was recognised that, without
a registration process, there was no way of distinguishing
between highly-trained, competent Herbalists and those with
inadequate or minimal training.
The Committee supported the establishment of a registration
process for those qualified in the field of herbal and/or
complementary medicines in order to enable access to classified
medicines.
(Medsafe 2001(b))
This statement recognises the competence of adequately
trained Medical Herbalists. It also accepts that some type
of registration system be introduced to allow for Medical
Herbalist access to restricted Herbal Medicines.
As such the HPCA and its registration process fulfils the
requirements as outlined within the previous MCC-issued
statement. This therefore means that registered Medical
Herbalists qualify for prescribing rights for the above-mentioned
Herbal Medicines.
Contact Details
New Zealand Association of
Medical Herbalists
P O Box 12582
Chartwell
Hamilton
www.nzamh.org.nz
About the
New Zealand Association of Medical Herbalists
History
The New Zealand Association of Medical Herbalists (NZAMH)
was formed by a group of practising Herbalists in the 1930's.
In 1983 NZAMH became an Incorporated Society and in 2000
amalgamated with The Aotearoa Herbalists Inc (TAHI - formed
by students at the Waikato Centre for Herbal Studies in
1994) to form a unified national body. Currently NZAMH is
growing rapidly.
Aims:
• To provide a support network for persons engaged
in the practice and study of herbal medicine.
• To act as an advisory body and uphold high standards
of proficiency and conduct.
• To promote, protect, maintain, represent and further
the professional interests of members.
• To represent members in regard to any proposed legislation
concerning herbal medicine and to make submissions to appropriate
authorities on their behalf
• To assist in the promotion of herbal medicine.
• To encourage/provide ongoing professional education
for members.
• To publish and circulate a magazine and any other
material of interest.
Membership Requirements
NZAMH has four classes of membership:
(a) Professional Members who have graduated from herbal
medicine courses at colleges approved by NZAMH or else have
passed examinations set by the New Zealand Natural Health
Practitioners Accreditation Board; and have completed 100
clinic hours with a recognised Herbal College. Annual practising
certificates are issued to professional members once they
show proof of at least 10 hours of continuing education
each year.
(b) Student members are studying herbal medicine at an approved
college.
(c) Associate members are individuals or groups involved
in some aspect of medicinal herbs e.g. growing, producing
or promoting medicinal herbs.
(d) Fellow members are elected by the association to honour
members who have given conspicuous service.
Membership Status
Professional members 141
Student members 43
Associate members 50
Fellow members 3
Submission Information
This submission with regard to the Proposal to Amend Aspects
of New Zealand's Medicines Law has been prepared and approved
by the New Zealand Association of Medical Herbalists dated
06/12/2002
Submission prepared and approved by:
Jeff Flatt ND, MNZAMH
Convenor Political Sub-Committee NZAMH
email: jeffnd@xtra.co.nz
Joan Flynn President NZAMH, M.A.(Hons), Dip Ed, Dip Herb
Med, NZAMH.
Member Political Sub-Committee NZAMH.
Vanessa Hart Vice-President NZAMH, Dip Herb Med, MNZAMH.
Member Political Sub-Committee NZAMH.
Phil Rasmussen MPharm, MPS, Dip Herb Med, MNIMH, MNZAMH,
NHAA.
Member Political Sub-Committee NZAMH.
Isla Burgess Dip PE, Dip Tchg, Dip Herb Med, MNZAMH, MNHAA.
Member Political Sub-Committee NZAMH.
James Hart ARICS, Dip Herb Med, MNZAMH.
Member Political Sub-Committee NZAMH.
References
Medsafe (2001(a)). Minutes of the December 2001 Medicines
Classification Committee Meeting. (Online) http://www.medsafe.govt.nz/Profs/class/
mccMin [Accessed 24 Jun 2002]
Medsafe (2001(b)). Minutes from the 26th MCC Meeting December
2001. (Online). http://www.medsafe.govt.nz /Profs/class/mccMin11
Dec01 .htm [Accessed April 20th 2002].
Article 2
Kate McConnell - Medsafe
18th April 2008
Dear NZAMH Members.
Many thanks Phil for your comments (NHC members - I have
attached these at the bottom for your interest.) It helps
not to get too hyped up about things before talking with
and clarifying the situation with those people who are knowledgeable
about the legislation. It can take a while to sort out fact
from fiction.
I had a long chat yesterday with Sarah Reader from Medsafe
and I hope I am now able to present the current issues a
little more clearly. Please note that the final paragraph
of my email to the yahoo group on 13th April was incorrect.
Yes, Medsafe is clamping down on companies selling natural
products and bringing them in line with our current NZ legislation;
in particular with regarding to the advertising of therapeutic
products that have not been approved as medicines. (See
section III.)
It is important to begin with how it is for us as Medical
Herbalists.
I. Natural Health Practitioners
As Medical Herbalists, nothing for us has changed. We continue
to practice within the specifically granted exemptions under
the Medicines Act 1981. Medsafe would like us to be aware
of these exemptions and be clear about what we can and can't
do. A document has been prepared for us and is awaiting
approval. In the meantime, here are some brief points:
1. Medical Herbalists are allowed to supply general sales
medicines in a consultative capacity. We are not restricted
in what we can say about a remedy, or what we write on a
remedy, as long as it is in a consultative capacity with
our clients.
That is, we can prepare, blend or formulate a general sales
medicine for supply to a patient and label products with
information regarding its therapeutic use, as long as the
label meets the requirements of the Medicines Regulations
1984.
(Section 4 of the Medicines Regulations outlines the labelling
requirements. There is also additional information in Medsafe
published guidelines http://www.medsafe.govt.nz/regulatory/guidelines.asp.
However the pertinent information does have to be located
so Medsafe will prepare a guidance document for us).
2. We cannot display retail products that are labelled so
as to imply a therapeutic purpose to the consumer, unless
those products have been approved as medicines. We also
cannot display product advertising that would imply the
product has a therapeutic purpose.
3. We cannot advertise methods to treat diseases or conditions
in Schedule 1 of the Medicines Act. This includes the common
cold, arthritis, psoriasis, menstrual disorders, cancer,
obesity, sexual impotence ...
This is an amendment to what we had previously understood,
so you are able to advertise services, but not methods or
products. There is possibly some clarification on this yet
to come from the Fair Trading Act.
II Proposed amendments to the Dietary Supplements Regulations
These have been approved by Cabinet and are now being drafted
for final approval.
This affects companies producing supplemented foods, dietary
supplements or complementary medicines. If you wish to retail
a product, this is for you.
i. to exclude food-type dietary supplements from coverage
under the DSR and instead regulate them as supplemented
foods - initially under an interim Standard and later under
a Joint Standard developed through the Food Standards Australia
New Zealand process;
ii. require sponsors of therapeutic-type dietary supplements
to enter details about their products into a database to
be administered by the Ministry of Health (Medsafe); and
iii. transfer responsibility for administration of therapeutic-type
dietary supplements
from NZFSA to the Ministry of Health.
What does this mean?
It means that "supplemented foods" will now be
regulated under a new code or Standard and taken out of
the Dietary Supplements Regulation (DSR).
Therapeutic-type dietary supplements will now be known
as complementary medicines and will stay under the amended
Dietary Supplement Regulations and be administered by Medsafe.
The DSR continues to be legislated under the Food Act.
Foods and dietary supplements are regulated by the Food
Act 1981 and herbal remedies by the Medicines Act 1981.
Food regulation is performed by a joint, Trans-Tasman agency.
In NZ we have another set of regulations so oral products
can be foods, dietary supplements or medicines.
To work out whether your product is a food or a medicine,
Medsafe has prepared a tool: the food-medicine interface
tool. That is, it provides an interface between the Food
Act and the Medicines Act. There is a guidance document
accompanying the tool that explains how to separate supplemented
foods from therapeutic-type dietary supplements.
The original food-medicine interface tool was created for
the joint agency. It is still used in this format by the
Australian TGA and therefore is useful for NZ companies
who wish to enter the Australian market.
http://www.medsafe.govt.nz/regulatory/CompMed/GuidanceTool.asp
However the NZ regulatory environment is different so the
following document was created to help people understand
how to use the food-medicine interface tool in our current
regulatory environment.
http://www.medsafe.govt.nz/regulatory/CompMed/FoodMedicineInterface.asp
It can still be difficult to separate some products that
are at the interface of the legislation. Medsafe also have
a food-medicine interface working group that the product
owner can contact; they will give an opinion on which regulatory
system covers the product and will advise on a specific
issue. You can access the working group by emailing Sarah
Reader mailto:Sarah_Reader@moh.govt.nz
For example:
To determine the regulatory system for herbal teas the product
owner can use the food-medicine interface tool to determine
if their product is a food or not. If it is determined that
the product is not a food, then the product owner would
need to decide if the product is a dietary supplement or
a medicine.
Some herbal teas are beverages (foods), some are dietary
supplements (a subset of foods) and some are herbal remedies
(medicines). Which one a specific product is depends on
the presentation (i.e. how does the product owner position
the product in the market).
III What is the process for getting a product approved
as a medicine?:
The Medicines Act regulates products that are administered
to a human for a therapeutic purpose. There are specific
definitions for herbal remedies, cosmetics, related products
and Natural Therapists plus the Act contains all the legislation
for medicines.
The guidance documents for applying for approval to distribute
a medicine are located at http://www.medsafe.govt.nz/regulatory/guidelines.asp.
We have three different routes to approval which are linked
to the type of product and its intended use.
Related products are products that are cosmetics, dentifrices
or foods with a secondary therapeutic purpose. Dietary supplements
that are primarily used to provide nutritional support and
have a secondary therapeutic purpose are "related products".
Lower -risk medicines include general sales medicines and
some pharmacy-only medicines. They contain well known ingredients
and are used for diseases and conditions that are self-manageable.
Homoeopathic and herbal remedies for a specific therapeutic
purpose are usually lower-risk medicines.
High-risk medicines are those that contain a new chemical
or biological entity (i.e. there is no history of use that
can be used to help in the safety assessment) or contain
prescription medicines. High-risk medicines also include
those that treat or prevent diseases and conditions not
suitable for self-management.
The above definitions are very general as there are exceptions.
As the information required varies on a case -by-case basis
we prefer a product owner to discuss their specific product
with us so that we can advise on the most appropriate approach.
For all categories the product owner will need to provide
evidence of safety, quality and efficacy. Again this depends
on the product and its purpose. Safety data requirements
are less if the product has a long history of use. Similarly
efficacy evidence is dependent on the therapeutic purpose.
For related products and lower-risk medicines this evidence
can be in the form of peer reviewed articles such as scientific
papers or published in text books. It does not necessarily
have to include clinical studies.
All manufacturers need to demonstrate a quality assurance
programme of manufacture that adheres to the principles
of good manufacturing practice. Manufacturers will need
approval from Medsafe prior to a product application being
lodged. Again we encourage product owners to enter into
dialogue as soon as possible.
The fee for an evaluation also varies depending on the
approval process to be undertaken and is proportional to
the amount of data that will need to be assessed. We have
initiated a fees review and expect to announce changes in
March 2009.
So the process in brief is as follows:
Make an application; talk to Medsafe.
What do you want the product to do?
Provide evidence of efficacy, this includes anything you
wish put on your label or in written advertising.
Evaluation by Medsafe
Recommendation to the Minister
Any queries please talk to Sarah Reader, at Medsafe on
0800 266 380.
I hope this all helps.
Kind regards
Kate McConnell
Kate McConnell, B.Sc; Dip.App.Sci, MNZAMH
President New Zealand Association of Medical Herbalists
katemcc@paradise.net.nz
Hi all,
I agree with Kate, that there's a lot of misleading information
going around about this issue presently.
After hearing Sarah Reader from Medsafe and someone from
NZFSA speak to industry meetings on 2 occasions now about
the DSR, and a brief 1:1 chat with her, while I'm still
somewhat confused about some issues (mainly the difference
between a 'Dietary Supplement' and a 'Herbal Remedy'), what
is clear is that Medsafe are continuing to regard herbs
and products dispensed by natural health practitioners to
patients in the context of a consultation, as very different
from those advertised (eg through websites) and sold more
openly in the public domain. This is, in fact, what the
current (but yes, hopelessly outdated!) legislation requires.
What Sarah said at the Natural Products NZ annual summit
in Rotorua last week, was that once a practitioner consultation
has occured, practitioners are able to dispense or sell
products with names/labels implicating therapeutic benefits
(eg 'Eczema Cream'; 'Sleeping mixture'). Such titles as
well as circulation of promotional literature/info on websites
& in magazine ads etc which clearly suggests a product
has a therapeutic action, are not, however, legal for non-licenced
natural products sold without a practitioner consultation,
under current legislation.
I agree that these regs are far from ideal and we need more
appropriate ones asap. Medsafe also recognise this, but
are bound by the current regs, have several new staff now
employed in the buildup to ANZTPA, and undoubtedly know
that little further progress towards the successor to ANZTPA
will occur until some time after this year's election.
What the dramatically increased surveillance/policing activities
of Medsafe do have the potential to achieve, however, is
reinforcement of the differences between purchasing herbal
medicines over the counter or through someone's website,
and receiving these after a proper individualised consultation.
In this sense, us as medical herbalists whose practices
should be based primarily on consultations rather than selling
products in the public domain, could in fact stand to benefit
from these 'changes'.
By the way, my experience with numerous Medsafe staff over
recent years and again with Sarah recently, is that they
are now well aware of the need for a practitioner-only schedule
of herbal medicines, and are fully supportive of our pathway
towards registration as a profession.
Phil Rasmussen
MPharm; Dip Herb Med; M.P.S.; M.N.I.M.H.; M.N.Z.A.M.H.;
M.N.H.A.A.
Harvest Natural Health Centre
407 Richmond Rd
Grey Lynn
Auckland
New Zealand
tel (09) 376 0174
fax (09) 828 0039
Article 3
New Zealand Association of Medical Herbalists
(1983) Inc. Submission to the Health Select Committee
Examining the Health Practitioners Competence Assurance
Act (HPCA)
NZAMH requests an oral hearing to present the contents of
this submission to the Health Select Committee.
In the first instance please contact either of the following
for confirmation of this request.
Jeff Flatt
Convenor - Political sub-committee
New Zealand Association of Medical Herbalists
5 Napier Tce
Napier
Ph: 06 834 3953
email: jeffnd@xtra.co.nz
James Hart
Member - Political sub-committee
New Zealand Association of Medical Herbalists
PO Box 864
Cambridge
email: herbs@hnpl.net
If Jeff or James are unavailable please contact the following.
Joan Flynn
President
New Zealand Association of Medical Herbalists
418 Thames Coast Road
RD 5
Thames
Ph: 07 868 2988
email: jflynn@paradise.net.nz
Table of Contents
Introduction
Costs Incurred Due to the HPCA
Membership of Registering Authorities
Practising Outside of the HPCA
Quality Assurance Activities
NZAMH Contact Details
About the New Zealand Association of Medical Herbalists
Submission Information
References
Introduction
The New Zealand Association of Medical Herbalists (NZAMH)
is pleased to be able to present this submission, in reference
to the Health Practitioners Competence Assurance Bill (HPCAB),
to the Health Select Committee.
NZAMH is a professional association representing Medical
Herbalists within New Zealand. The members of NZAMH have
opted to request for registration under the HPCAB, and as
such the NZAMH political sub-committee has dutifully prepared
and presented this submission to the Health Select Committee
as part of this registration analysis and application process.
NZAMH and the HPCAB
The HPCAB is a legislative document that recognises the
ongoing changes in models of care and health care delivery
within the Health System (Page 2 explanatory note). Medical
Herbalism is an example of a profession that is involved
within these impending changes in health delivery (Budd
2001). The HPCAB allows for new professions to be regulated
under Order in Council. NZAMH fulfils the criteria required
for inclusion under the HPCAB (Clauses 111/112) and as such
will apply for registration under the HPCAB when it is enacted
(Health Practitioners Competence Assurance Act - HPCA).
Within the HPCAB NZAMH has identified several key aspects
of the proposed legislation that it feels is worthy of discussion
and investigation. These are costs related to registering
authorities and the disciplinary tribunal, the membership
of registering authorities, practising outside of the HPCA
and quality assurance activities. We look forward to your
review and comments on these issues.
Costs Incurred Due to the HPCA
Introduction
Of significant concerns to all of those within NZAMH (and
much of the broader CAM community within New Zealand) is
the annual costs that will arise as a result of registration
under the HPCA legislation. The two components of the Bill
that generate most of this concern are the Registering Authorities
and the Disciplinary Tribunal. This section discusses these
two components and offers possible solutions to the costings
issues generated by these components.
Costs Incurred Due to Registering Authorities
NZAMH is an Association that has a small membership with
140 professional members currently paying $200.00 annual
fee. If Medical Herbalists are registered they will likely
find the possible increased annual fees of $1200.00 (pages
37/38 explanatory note) difficult to meet. This figure would
equate to a 600% fee increase and as such is likely to lead
to a reduction in professional members due to valid financial
concerns. This is highly counter-productive for the Association.
Many NZAMH members work part-time, run households and practice
concomitant modalities. This can be seen where Naturopaths
are members of NZAMH as a result of their Medical Herbalism
training. As these members are multi-disciplined and therefore
belong to separate associations there is the very real possibility,
under the HPCA, of considerable expense for these members
due to the presence of separate registering authorities
for these individuals' distinct chosen modalities. If fees
become prohibitively high, members may choose to leave the
involved Associations. This is a situation that no single
Association wants to see occurring.
Within Australia 5 CAM organisations have been granted
$100.000 each from the Department of Health and Aged Care
to assist with registration processes (Khoury 2001). The
recent White House Commission on Complementary and Alternative
Medicine Policy has stated that the US Federal Government
should offer assistance with regard to the issue of registration
and regulation of practice for CAM (White House Commission
on CAM Policy 2002). It is possible that prohibitively high
Registering Authority fees may create the need for similar
financial assistance here in New Zealand if CAM is to be
regulated.
Costs Incurred Due to a Single Disciplinary Tribunal
NZAMH understands the rationale of a Single Disciplinary
Tribunal within the HPCA and in principle is in full support
of this for all registered health professions. However,
the issue of costs associated with this Tribunal requires
discussion.
Within the HPCA it has been stated that current Registration
Authorities have expressed concern at the likely costs of
the Single Disciplinary Tribunal which will be passed on
to their members (page 40 explanatory note). This statement
clearly outlines a point of common ground between most Health
Associations.
Disciplinary Tribunal costs imposed upon a Registering
Authority as is outlined in Clause 99 and Clause 100 would
create substantial financial strain upon a small association
such as NZAMH due to modest membership and limited fiscal
ability.
Without a greatly increased membership and/or substantial
financial input the possibility of disciplinary action under
HPCA legislation does create a situation where financial
risk becomes too high for the Association. This aspect of
the HPCA makes the economic aspect of registration for NZAMH
prohibitive.
A Possible Solution to the Costs Incurred Due to Registering
Authorities and the Disciplinary Tribunal. The Concept of
a 'CAM Council'
The establishment of a CAM multi-disciplinary Registering
Authority may be an effective measure that would assist
with easing the financial burden associated with the registration
and disciplinary processes as described within the HPCA.
The New Zealand Charter of Health Professionals has expressed
interest in this concept and from the NZAMH point of view
this type of authority may be desirable. A body such as
a "CAM Council" would be an example of this.
This 'CAM Council' could be effective in fulfilling the
Registering Authority criteria and any costs that may arise
due to Complaints Investigation Committees and/or a Single
Disciplinary Tribunal. This Council could serve to regulate
those CAM therapies that fulfil the criteria for registration
as outlined within Clause 112.
This Council could serve as the Registering Authority for
the New Zealand equivalent of the 'Big 5' as is discussed
within the recent United Kingdom Lords Report on CAM. (House
of Lords Select Committee 2000). An added bonus with this
concept is that this Council would oversee individual Scopes
of Practice that overlap to a relatively large extent.
NZAMH feels that this type of Council may be highly effective
and is definitely worthy of serious consideration.
Membership of Registering Authorities
Clause 116 outlines registering authority membership. Schedule
3 discusses these registering authorities in depth. Within
both this clause and schedule there is no reference to who
shall belong to the membership of the registering authorities.
NZAMH seeks clarification as to the representation of the
profession under registration and regulation within the
structure of these registering authorities. It is of concern
to NZAMH that the herbal medicine profession may have inadequate
representation and may therefore be to under-represented
within this situation.
NZAMH is aware that the Minister appoints members of the
registering authorities (Clause 116 paragraph 1). At present
NZAMH is a non-registered association and as such the Minister
is unlikely to have a substantial amount of knowledge as
to the epistemologies and practice patterns of medical herbalists.
As this may well be the case NZAMH has concerns that, due
to this low level of exposure and therefore reduced knowledge,
the Minister may inadvertently appoint individuals that
are not representative of medical herbalists or the profession
to which they belong.
NZAMH requests that the membership of the registering authorities
contains at least 60% of individuals that are fully qualified
representatives of the association that is to be registered.
This would then mean that the registering authority becomes
truly characteristic of the profession that it holds quite
some degree of authoritative power over.
At present this issue of registering authority membership
is a situation that is unclear and as such requires clarification.
Practising Outside of HPCA
Clause 7 paragraph 2 describes false claims made as to
the ability to practise a health discipline. NZAMH would
like to clarify this situation with regard to medical herbalists
that are competent and in receipt of practising certificates
who therefore fulfil criteria to be registered within a
registering authority but who choose, for whatever authentic
reason, to practise outside such legislation.
This situation could arise where practitioners who prefer
to practise part-time would deem the financial outlay involved
with registering under the HPCA prohibitive. For an individual
who does not secure substantial income from their work the
cost/benefit ratio does not work in their favour. Therefore
these people may choose to practise outside of any registration
body.
NZAMH wishes to allow these individuals to remain as members
of the association and practice within a separate register
from that associated with the HPCA. NZAMH requires some
form of clarification that Clause 7 paragraph 2 does not
exclude such individuals from practising within their chosen
career under the membership of their current association.
Quality Assurance Activities
Appointment of the person responsible for Quality Assurance
Activity (Clause 53 paragraph 3) states that the minister
may appoint a person who is sufficiently independent of
the health practitioners whose services are to be assessed
or evaluated within a quality assurance context. It is assumed
that this clause is stipulated to ensure a degree of impartiality
when undertaking quality assurance activities. Therefore
conflict of interest is avoided. Reasons such as these make
this section of the HPCA totally valid and reasonable.
From the point of view of NZAMH this section raises questions
with regard to epistemologies and the understanding and
acceptance of distinct practice methods. As medical herbalists
practice in an holistic manner it would be of importance
that any person appointed for quality assurance tasks with
regard to medical herbal practice should have an understanding
of holistic medical practice methods.
The appointment of the individual undertaking quality assurance
activity would ideally be undertaken in consultation with
the registering authority involved. Appointing a person
who has no knowledge or understanding of holistic practice
would be seen as unjust to those being assessed. This could
then create a situation where differing epistemologies can
create irrevocable points of difference that assist no-one
in the task at hand. As such this is a situation that must
be avoided at all costs.
NZAMH queries whether Clause 53 paragraph 3 (b) accounts
for any situation such as that which is outlined above.
Contact Details
New Zealand Association of
Medical Herbalists
P O Box 15313
Tauranga
www.nzamh.org.nz
About the
New Zealand Association of Medical Herbalists
History
The New Zealand Association of Medical Herbalists (NZAMH)
was formed by a group of practising Herbalists in the 1930's.
In 1983 NZAMH became an Incorporated Society and in 2000
amalgamated with The Aotearoa Herbalists Inc (TAHI - formed
by students at the Waikato Centre for Herbal Studies in
1994) to form a unified national body. Currently NZAMH is
growing rapidly.
Aims:
• To provide a support network for persons engaged
in the practice and study of herbal medicine.
• To act as an advisory body and uphold high standards
of proficiency and conduct.
• To promote, protect, maintain, represent and further
the professional interests of members.
• To represent members in regard to any proposed legislation
concerning herbal medicine and to make submissions to appropriate
authorities on their behalf
• To assist in the promotion of herbal medicine.
• To encourage/provide ongoing professional education
for members.
• To publish and circulate a magazine and any other
material of interest.
Membership Requirements
NZAMH has four classes of membership:
(a) Professional Members who have graduated from herbal
medicine courses at colleges approved by NZAMH or else have
passed examinations set by the New Zealand Natural Health
Practitioners Accreditation Board; and have completed 100
clinic hours with a recognised Herbal College. Annual practising
certificates are issued to professional members once they
show proof of at least 10 hours of continuing education
each year.
(b) Student members are studying herbal medicine at an approved
college.
(c) Associate members are individuals or groups involved
in some aspect of medicinal herbs e.g. growing, producing
or promoting medicinal herbs.
(d) Fellow members are elected by the association to honour
members who have given conspicuous service.
Membership Status
Professional members 141
Student members 43
Associate members 50
Fellow members 3
Submission Information
This presentation to the Health Select Committee examining
the Health Practitioners Competence Assurance Act has been
prepared and approved by the New Zealand Association of
Medical Herbalists dated 01/02/2003
Presentation prepared and approved by:
Jeff Flatt ND, MNZAMH
Convenor Political Sub-Committee NZAMH.
email: jeffnd@xtra.co.nz
James Hart ARICS, Dip Herb Med, MNZAMH.
Member Political Sub-Committee NZAMH.
Joan Flynn President NZAMH, M.A.(Hons), Dip Ed, Dip Herb
Med, MNZAMH. Member Political Sub-Committee NZAMH.
Phil Rasmussen MPharm, MPS, Dip Herb Med, MNIMH, MNZAMH,
MNHAA. Member Political Sub-Committee NZAMH.
Isla Burgess Dip PE, Dip Tchg, Dip Herb Med, MNZAMH, MNHAA.
Member Political Sub-Committee NZAMH.
Vanessa Hart Vice-President NZAMH, Dip Herb Med, MNZAMH.
References
Budd S (2001). Complementary Health. A Consumer Led Trend.
New Zealand General Practitioner. 12 Dec:16.
House of Lords Select Committee (2000). Complementary and
Alternative Medicine. Chapter 5. Regulation. (Online). http://www.publications.parliament.uk/pa/ld199900/
ldselect/dsctech / 123/12301.htm [Accessed Nov 10th 2002].
Khoury R (2002). Australian Traditional Medicine Society.
Regulatory News. Government Grants $0.5 Million for GST-Free
Registration System. (Online). http://www.atms.com.au/news/
govt_grant_gst-free.htm [Accessed May 20th 2002].
White House Commission on Complementary and Alternative
Medicine Policy. (2002). Executive Summary. (Online) http://www.whccamp.hhs.gov/es.html.
[Accessed Sept 8th 2002].
Article 4
New Zealand Association
of Medical Herbalists (1983) Inc
Submission to the Health Select Committee
Inquiry into the Proposal to Establish a trans-TasmanAgency
to Regulate Therapeutic Goods
NZAMH requests an oral hearing to present the contents of
this submission to the Health Select Committee.
In the first instance please contact the following for confirmation
of this request.
Jeff Flatt
Convenor - Political sub-committee
New Zealand Association of Medical Herbalists
5 Napier Tce
Napier
Ph: 06 834 3953
email: jeffnd@xtra.co.nz
If Jeff is unavailable please contact the following.
Joan Flynn
President
New Zealand Association of Medical Herbalists
418 Thames Coast Road
RD 5
Thames
Ph: 07 868 2988
email: jflynn@paradise.net.nz
Table of Contents
Executive Summary
Introduction
Legislation of Herbal Medicine Worldwide
An Appropriate Regulatory Framework
The Issue of Risk and Herbal Medicine
Compliance Costs for the Herbal Medicine Industry
Herbal Medicine and National Identity
Contact Details
About the New Zealand Association of Medical Herbalists
(NZAMH)
Submission Information
References
Executive Summary
Overview
This select committee submission document contains pertinent
excerpts from the recent New Zealand Association of Medical
Herbalists (NZAMH) submission to Medsafe with regard to
the trans-Tasman Agency to Regulate Therapeutic Goods.
Also incorporated within this document are comments on
the issues raised within the terms of reference for this
select committee inquiry.
This information concisely summarises the predominant issues
that are seen as vital to the phytomedicine industry within
New Zealand with regard to the trans-Tasman Agency proposal.
These issues are of importance to phytomedicine producers
and practitioners, as well as the public, in a myriad of
ways.
The New Zealand Association of Medical Herbalists has concerns
that there is the very real potential to induce severe deleterious
consequences as a result of the legislative concepts proposed
within the trans-Tasman Agency document. As such NZAMH is
pleased that this select committee inquiry has been called
and that issues of concern are investigated in a manner
that is exempt from the regulatory bodies involved with
any such legislative undertakings.
The contents of this document address concerns that are
also applicable to any national New Zealand legislation
that may be enacted within the future. Thank you for your
examination of this document. We look forward to your review.
The Pertinent Issues
• NZAMH wishes to partake in all complementary medicines
legislative processes.
• Legislation for complementary medicines based on
risk is an issue that can be managed within New Zealand,
and as such New Zealand has the ability to create its own
national legislation with regard to complementary medicines.
• The Phytomedicine industry requires representation
on any legislative Agency.
• There is likely to be the need to acknowledge the
registered status of Medical Herbalists within any legislation.
• Registered Medical Herbalists will require access
to all classes of herbal medicine (I, II & III), or
both the white and black listings, within any legislation.
• The issue of extemporaneous compounding and dispensing
requires clarification.
• Options for regulation aside from the proposed legislation
are available.
• There must be a thorough economic review of the
impact of any legislation on the phytomedicine industry
and associated services.
• There must be full disclosure of all costs incurred
as the result of any legislation.
• The Phytomedicine industry within New Zealand will
require assistance with the issue of cost-recovery.
• Further discussion is required on the topic of GMP
and how this will be applied to phytomedicine producers.
• There must be suitable access to the listing process
for New Zealand native phytomedicines.
• The Phytomedicine industry within New Zealand has
a national identity that must be maintained.
Overleaf is an example as to how these issues can be integrated
into a regulatory framework that could be suggested as contributing
to an alternative to that proposed within the trans-Tasman
Agency discussion document.
An Alternative Regulatory Framework
This proposal and its poignant elements is a synergy of
various aspects of this submission. It is not a definitive
alternative to the work of Medsafe and TGA, as their proposal
discusses many important issues. This is a theoretical proposition
that explores options.
Aspects of the NZAMH Alternative Proposed Regulatory Framework
An appropriate regulatory framework for herbal medicines
within New Zealand could be based upon the existing scheduling
system. Any risk control could be ensured by some form of
good manufacturing practice, professional prescription of
herbal medicines, adequate knowledge dissemination and ethical
marketing practices. The regulatory authority would ideally
involve a national legislative framework that consults fully
with all stakeholders, has a Medical Herbalist within its
committee, acknowledges the registered status of Medical
Herbalists and therefore allows Medical Herbalists extemporaneous
as well as full prescribing and dispensing rights for their
medicines, and acknowledges the national identity of all
those who use herbal medicines within New Zealand.
This type of Agency is likely to field lower fiscal outgoings
and therefore reduce the cost-recovery aspect of any regulatory
authority (this is the predominant source of fear for many
stakeholders). It would be operated within New Zealand and
would have input from those that would be directly affected
by its operations.
Obviously this type of proposal requires extensive review.
However, it does clearly show that stakeholders affected
by the trans-Tasman Agency discussion document consider
other options aside from those proposed as workable.
Introduction
Medsafe and TGA have been in active discussion on the topic
of harmonisation with regard to medicines legislation between
Australia and New Zealand for several years, as was outlined
at a recent stakeholder meeting in Wellington (Medsafe 2002a).
As a stakeholder and undoubtedly one to be affected by any
such legislative changes NZAMH feels that several points
need to be raised and addressed.
NZAMH is aware of the world wide swing towards the regulation
of complementary medicines and in particular phytomedicines.
NZAMH is also conscious of the fact that irrespective of
whether or not the trans-Tasman proposal is successful,
there will be regulation placed on complementary medicines
and phytomedicines within New Zealand in the future.
Within this submission NZAMH has outlined points that are
echoed throughout the phytomedicine community in the western
world. These are calls for freedom of choice with regard
to public and practitioner access to phytomedicines, the
strong desire for bureaucratic legislators to enter into
active, equitable and transparent dialogue with phytomedicine
representative groups, the need for those in legislative
capacities to review, critically analyse, critique and receive
information on all scientific phytomedicines studies with
adequate knowledge and without bias, the equal representation
on any lawmaking bodies and the fair and just imposition
of reasonable and manageable costs on to the New Zealand
phytomedicine industry.
These issues are addressed within this submission in the
order of international and national legislation, an appropriate
regulatory framework, herbal medicine and risk, compliance
costings and national identity.
Legislation of Herbal Medicine
World Wide
Discussion
International legislation of complementary medicine is
an issue that is addressed throughout the trans-Tasman Agency
discussion document, particularly in Appendix 3: International
Approaches to Regulation of Complementary Medicines and
Dietary Supplements (Pg 167). While the current legislative
changes are adequately referred to within the discussion
document, NZAMH would like to present some comments on this
legislative process.
Genesis of Current Legislative Environment
It is obvious, upon study of the differing legislative
processes, that much of the lawmaking derived for complementary
medicines arises from two separate issues. These are perceived
public safety and market control. These concepts appear
to have arisen from the United Nation's Codex Alimentarius
Commission, alongside the WTO and the push for 'harmonisation'
of world trade. The complementary medicines market is huge
with $US7 billion spent in America in 1997, $A621 million
in Australia in 1996, and roughly UK580 million pounds in
the United Kingdom per annum (Budd 2001). In the view of
some of our members the present legislative measures appear
to be aimed at the control of this market, under the guise
of public safety.
The above paragraph points towards motivations with regard
to legislative actions and the elements included within
regulatory frameworks. It also assists to explain the genesis
of the trans-Tasman Agency discussion document.
International Trends in the Regulation of Herbal Medicine
Products
The World Health Organisation is the predominant international
organisation that is actively researching guidelines for
the legislation of herbal medicine worldwide (WHO 2001)
and it is interesting to note that in Africa and Asia traditional
medicines (also termed complementary/alternative medicines)
are being integrated into state funded health care programmes
(Budd 2001). This appears to be the development of a type
of 'world practice'. Within the first world the situation
is actually not too dissimilar, with a type of 'world practice'
also being attempted as a result of impending professional
and complementary medicines legislation.
By and large there are significant moves afoot throughout
the western world with regard to regulation of complementary
medicines, and in particular herbal medicines. It is logical
that New Zealand should seek to follow this trend, and NZAMH
acknowledges this reality. However, the manner with which
this is undertaken and executed is of prime importance.
The NZAMH Position with Regard to Regulatory Processes
NZAMH is acutely aware of the need to partake in the legislative
process to ensure just action. National herbal representative
organisations in affected countries (i.e. European Herbal
Practitioners Association [EHPA] in the EU and National
Herbalists Association of Australia [NHAA]) are in active
dialogue with legislative groups with regard to herbal medicine
legislation. NZAMH, as the national body representative
of Medical Herbalists within New Zealand is interested in
this process and wishes to be an involved party in any legislative
changes that have the potential to impact on New Zealand
herbal medicine practice.
An Appropriate
Regulatory Framework
Discussion
NZAMH is of the opinion that there is sufficient knowledge
and talent within New Zealand to create a national regulatory
framework for complementary medicines. The requirement for
a Australia/New Zealand regulatory authority, such as is
postulated within the trans-Tasman Agency proposal is regarded
as unnecessary.
Integrity of Any Regulation
The trans-Tasman Agency discussion document contains information
that needs to be upheld with the highest integrity if any
proposed regulatory system is to be viewed in good faith
and not regarded as a fait accompli that is passing through
to legislation without serious consideration of stakeholder
concerns. The following quote from the document is vital
within this context.
The regulatory framework should be designed to manage the
risks in a way that is efficient and cost-effective, does
not impose inappropriate compliance costs on the industry,
and does not unnecessarily restrict the range of products
consumers are able to access.
(Medsafe 2002 (b):90)
This statement considers the administration, enforcement
and power of the proposed Joint Agency. How these aspects
of the Agency will function and be seen to function will
determine the integrity of the Agency (in fact any Agency,
regional, national or otherwise).
To adequately address the concerns of stakeholders with
regard to the previously quoted areas will require considerably
more extended consultation and ken than is currently outlined
within the trans-Tasman Agency discussion document.
National as Opposed to Regional Regulation
NZAMH does not regard the homogenisation of national regulation
into regional or international context necessary as a pre-requisite
to consumer safety. New Zealand does have the ability to
enact a national legislative framework that may well serve
the local industry in a more effective manner than any regional
framework. This is not an example of protectionism but a
statement with regard to the ability of New Zealand to be
capable in its own regulatory processes.
The national implementation of a regulatory system for
complementary medicines within New Zealand is a possibility
if the trans-Tasman Agency does not proceed. The recognition
of New Zealand's ability to successfully regulate these
products should be acknowledged.
There has been the public admission that there are aspects
of the TGA, and its complementary medicines regulatory arm,
that require some degree of alteration (Medsafe 2002a).
The fact that this type of statement has been made is an
indication that the adoption of Australia's regulatory framework
may not necessarily be in the best interests of the New
Zealand complementary medicines industry.
Consultation Between NZAMH and Regulatory Agencies
Medsafe (and its sub-agency the Medicines Classification
Committee or MCC) is the regulatory agency that is involved
with medicines' legislation. This agency and its actions
has a direct impact on members of NZAMH. Medsafe is also
the author of the New Zealand arm of the trans-Tasman Agency
proposal.
NZAMH has made previous submissions to Medsafe in response
to the possible scheduling of pyrrolizidine alkaloid containing
phytomedicines (Rasmussen 2000, Baillie 2001, Fisher 2001).
In response to these submissions, presumably alongside other
factors, Medsafe and the Medicines Classifications Committee
(MCC) have publicly made the admission that they are not
qualified to schedule phytomedicines. This has been worded
as follows:
Medsafe does not recommend that the proposal to adopt the
MCC proposed framework for the classification of herbal
medicines be adopted at this time for the following reasons:
• MCC expertise is in the practice of medicine and
the practice of pharmacy: Members are not skilled in the
field of herbal medicines
• The consultation process was limited in its effectiveness
and therefore there is no assurance that all relevant information
was considered
• Accepting the recommendations would result in unavailability
of products for which there is no evidence of consumer harm
in New Zealand.
Medsafe recommends that consideration of these classifications
be deferred until the outcome of the government decision
on the Joint Agency proposal is known later in the year.
If the decision is positive, consideration of classification
will be dealt with as part of the pre-implementation process.
An expert committee of Australian and New Zealand members
with knowledge of herbal medicines could be convened for
this purpose.
(Medsafe 2001)
Suitably qualified representation of Medical Herbalists
in the legislative process in NZ is lacking and at times
communication and subsequent consultation to this sector,
by those who formulate legislation that directly affects
the sector, has been sparse.
It is notable that the Medicines Control Agency (MCA) within
the UK as well as legislative bodies within the EU consult
with the European Herbal Practitioners Association (EHPA)
prior to implementing legislation. An analogous situation
occurs within Australia where the National Herbalists Association
of Australia (NHAA) is consulted on issues pertaining to
phytomedicine legislation. Unfortunately NZAMH has not been
viewed as a consultative body within New Zealand and as
such has generally been neglected on issues of medicines'
classification.
NZAMH has grave concerns that within New Zealand the exclusion
of those suitably qualified and working daily with phytomedicines
will continue under a trans-Tasman Agency agreement proposal,
although the opposite has been promised (see Medsafe 2001
quote above). Within the TGA in Australia the National Herbalists
Association of Australia (NHAA) has a member present on
the Complementary Medicines Evaluation Committee (TGA 2002).
NZAMH would like to nominate a representative for an equal
position within any Joint Agency. This also applies to any
local Agency.
There are individuals within the New Zealand phytomedicine
industry that are adequately qualified and skilled for such
a position. NZAMH would like to enter into dialogue on this
issue when appropriate.
Due to the nature of the content of the trans-Tasman Agency
discussion document those that formulate legislation have
now been willing to enter into a degree of dialogue on the
matter. This is a recent development here in New Zealand
and is encouraging and does need to continue at each and
every opportunity.
Complementary Medicines Legislation Changes and their Impact
on the Clinical Practice
of Medical Herbalists
The proposed legislative changes outlined in the trans-Tasman
Agency discussion document would have effects on the professional
practice of Medical Herbalists. Before any legislation is
passed into law it is imperative that consultation is undertaken
to determine the impact of such legislation on the chosen
careers of herbal medicine practitioners. Currently no such
undertaking has occurred.
Access to Phytomedicines
NZAMH professional members, as of the time of submission
of the trans-Tasman Agency document, are non-registered
health professionals. Even though NZAMH will be applying
for registration under the upcoming Health Practitioners
Competence Assurance Act (HPCA), at this point in time there
is no absolute guarantee that Medical Herbalists will be
registered under the HPCA when it comes into force.
Currently there is no legislative access to scheduled phytomedicines,
and it is of concern to NZAMH that several phytomedicines
may be restricted from use due to listing (class II and
III) as a result of the trans-Tasman discussion document.
NZAMH would appreciate some written verification within
any trans-Tasman (or national) agreement that states registered
Medical Herbalists (under registering legislation such as
HPCA, or any other registering legislation) would have access
to prescribe and dispense phytomedicines within class II
and class III.
The Medicines Classifications Committee has discussed this
issue with regard to restricted herbal medicines and the
registration status of Medical Herbalists.
The committee discussed the role of Herbalists and the
need for registration if Herbalists were to be given access
to classified medicines. It was recognised that, without
a registration process, there was no way of distinguishing
between highly-trained, competent Herbalists and those with
inadequate or minimal training. The Committee supported
the establishment of a registration process for those qualified
in the field of herbal and/or complementary medicines in
order to enable access to classified medicines.
(Medsafe 2001)
Extemporaneous Compounding and Dispensing
(The purpose of the addition of this section is to seek
absolute legislative clarification on this aspect of the
trans-Tasman Agency legislation. NZAMH is aware that a similar
exemption exists within the current New Zealand Medicines
Act and Regulations and is interested in seeing this important
aspect of regulation retained).
Professional members of NZAMH are practising Medical Herbalists
and as such are actively involved in the sourcing, formulating,
extemporaneous compounding and dispensing alongside post-sale
surveillance of products that will be affected by any legislative
changes outlined within this discussion document.
NZAMH is aware that Australian practitioners are exempt
from certain regulatory restrictions that exist within the
TGA legislation. This is in reference to two aspects.
Firstly:
Item 6 of Schedule 5 exempts medicines from inclusion
under listing ("white list") within the Australian
Register of Therapeutic Goods (ARTG). This states:
Medicines (other than medicines used for gene therapy)
that are dispensed, or extemporaneously compounded, for
a particular person for therapeutic application to that
person.
and secondly:
Item 4 of Schedule 8 within the Therapeutic Goods Regulations
exempts certain individuals from the requirement of a GMP
licence. This states:
Herbalists, nutritionists, naturopaths, practitioners of
traditional Chinese medicine or homoeopathic practitioners
engaged in the manufacture of any herbal, homoeopathic or
nutritional supplement preparation
providing the preparation is for use in the course of his
or her business, and
a) the preparations are manufactured on the premises that
the person carrying on the business occupies, and that he
or she is able to close so as to exclude the public
b) the person carrying on the business
i) supplies the preparation for administration to a particular
person, after consulting with that person
ii) uses his or her own judgement as to the treatment required
Within the trans-Tasman discussion document released by
Medsafe Table 6 Product Licensing Processes for Prescription
and OTC Medicines (pg 46) outlines an exempt ruling for
extemporaneously compounded medicines.
There is also a brief description under the title Exempt
Complementary Medicines (Pg 97).
NZAMH assumes that these are an example of both Item 6 of
Schedule 5 of the ARTG and Item 4
of Schedule 8 of the Therapeutic Goods Regulations. At present
this is not definitively clear and
NZAMH seeks absolute written clarification with regard to
the exempt status of practitioners of
phytomedicines from both GMP and what is currently termed
ARTG.
The Issue of Risk and Herbal Medicine
Discussion
The issue of risk to consumers is an interesting aspect
of complementary medicines legislation. Up to this point
in time the natural medicines industry within New Zealand
has been self-regulatory.
The Rise of Risk-Based Regulation
Any risk-based legislation must be founded in fact. As
a rule herbal medicines are safe (hence a GRAS scheduling)
and those that are not deemed safe are either already scheduled
appropriately or should be. Currently this schedule is formed
from sound evidence. There have been isolated incidences
of adverse reactions due to complementary medicine ingestion,
and these are outlined in the New Zealand Ministry of Health
website (MOH 2002). There have also been a number of articles
written on the topic of adverse reactions and drug interactions
involving herbal medicines in the international literature,
many bemoaning the lack of any legislative framework to
adequately address this issue. As a result of this risk
is viewed as a legislative rationale.
The Risk Management Approach to Regulating Complementary
Healthcare Products
While the concept of risk-based evaluation of complementary
medicines has obvious merits how this approach is to be
implemented in practice is a contentious issue.
Admittedly there have been incidences of adverse reactions
to selected complementary medicines. However careful scrutiny
of the documented evidence in most cases clearly points
to either lack of adequate manufacturing standards of the
products concerned, incorrect pharmacognosy or incorrect
prescription practices. (Laliberte and Villeneuve 1996,
Frasca et al 1997, Haseqawa et al 1997).
Also, the efficacy of many of the adverse events reporting
and studies can be brought into question as often methodologies,
internal and external validity and bias are issues that
are not adequately addressed (for an example of a poorly
conducted study of this type please refer to Shaw et al
1997). It would be an interesting exercise for legislators
and herbal practitioners to sit side by side and investigate
each study for efficacy on these issues as a way of testing
the hypothesis of risk-based medicines regulation with regard
to complementary medicines, and in particular herbal medicines.
It seems that utilising the system as currently proposed
to enact a risk-based legislative intervention is questionable.
A valid point that can be raised here is the fact that adverse
events with regard to complementary medicines pale into
insignificance alongside adverse events to pharmaceuticals.
This is a situation that requires acknowledgement.
Risk and Herbal Medicines - Current NZ Situation
Currently with regard to herbal medicines, those plants
with known higher toxicity profiles are deemed to have high
risk. At present these phytomedicines are scheduled under
the Medicines Act 1981 and as such are restricted. Examples
include Ephedra sinica, Bryonia spp, Atropa belladonna,
Rauwolfia serpentina and others. This can be referred to
as a "black" list. Herbs that are not presently
restricted within New Zealand and are low risk are deemed
as GRAS, which can be referred to as a "white"
list.
The suggested change from the current New Zealand scheduling
system to the proposed trans-Tasman Agency system potentially
leads to a 'guilty until proven innocent' type mentality
within the regulatory agency and public eyes, whereas most
herbal medicines currently marketed are safe and should
continue to be available.
An example of this in action is the recent moves by Medsafe
to restrict pyrrolizidine alkaloid containing herbs such
as Comfrey and Coltsfoot. These have been the subject of
submissions by NZAMH (see page 9) and currently no definitive
decision has been made with regard to these. The NZAMH submissions
clearly showed negligible risk with relation to these herbs
if properly prescribed and administered, as has been acknowledged
by the Medicines Classifications Committee within Medsafe.
Risk and Herbal Medicines - Proposed trans-Tasman Agency
Situation
Human health hazards related to herbal medicine are separated
into intrinsic and extrinsic risk (Drew and Myers 1997).
This separation has been adopted within the listing system
of the TGA and the subsequent proposed Joint Agency as is
outlined in Table 7 on page 102 of the trans-Tasman Agency
discussion document.
Consequently within the trans-Tasman Agency discussion
document there are 4 types of risk clearly identified. These
are:
• risks associated with the ingredients used within
the product
• risks associated with product quality
• risks associated with inadequate consumer access
to information
• risks associated with the claims made about a product
These can be described more simply as being largely attributable
to:
• adulteration
• pharmacognosy/lack of GMP compliance
• education/lack of registered Medical Herbalist status
• integrity/poor policing of current legislation
When these categories are explained in a more simplified
manner then the solutions to any problems that these categories
may pose also become simplified. These solutions are discussed
on the following pages.
NZAMH is opposed to the concept of risk-based legislation
based upon the system outlined within the trans-Tasman Agency
discussion document.
There are anomalies in this method due largely to the concept
of products or individual phytomedicines being classified
as 'unsafe until proven safe', while the scientific and
traditional usage literature is clearly better aligned with
the existing concept of a black list of restricted products
with established inherent risks and a white list of those
herbal medicines that are safe for use.
NZAMH is in support of the development of a third listing
(medium intrinsic risk - class II), for compounds which
do not sit comfortably within either GRAS or its antipode,
but which are useful and safe therapeutic agents when used
only by suitably qualified and registered practitioners.
Such a third schedule would enable the appropriate classification
for herbal medicines such as those containing pyrrolizidine
alkaloids (e.g. Comfrey and Coltsfoot), which are presently
in the 'too hard to legislate' basket.
In the context of a trans-Tasman Agency agreement all of
the risk categories, and subsequent legislation for these
risk categories, are to be placed upon an industry by those
outside the industry that have little to no working knowledge
of the products that they are legislating. For many within
the herbal medicine arena this is an anathema.
Risk and Herbal Medicines - A Possible Solution
This situation of herbal medicines and risk can be resolved
by registered herbal practitioners having the ability to
prescribe these 'neither-scheduled-nor-GRAS' products, and
where these products are to be sold there are registered
practitioners available to correctly prescribe. This is
a circumstance that may soon arise as a result of the impending
Health Practitioners Competence Assurance Act (HPCA). Medsafe
has also requested a situation similar to this (see page
12).
NZAMH would therefore like to suggest the following.
When reviewing the situation here in New Zealand it appears
that the problems associated with adverse events and potential
risks from complementary medicines could be resolved with
professional prescription practices and registration of
competent practitioners, the establishment of a third schedule
for herbal medicines with higher risk, and a revised form
of Good Manufacturing Practice as opposed to blanket medicines
legislation and listing. (The issue of GMP is briefly discussed
within the section discussing compliance costs).
The solution to any perceived risk-related problems with
herbal medicines could involve the screening of foreign
and locally produced products alongside the registration
and competency assurance of prescribing practitioners. In
other words quality control and safe prescribing practice.
This would very effectively reduce perceived risk to negligible
levels as well as being efficient and cost-effective, low
in compliance costs and non-restrictive of products available
to consumers, thereby fulfilling the objectives of any regulation.
The blanket legislation of all complementary medicines
based on the type of risk analysis system proposed seems
to be a rather poor method of dealing with the present need
to competently regulate herbal medicines.
Compliance Costs for the
Herbal Medicine Industry
Discussion
NZAMH has amongst its members producers of products that
will be directly affected by any legislative changes outlined
within the trans-Tasman Agency discussion document. With
the prospect of imposed compliance costs on the industry
forcing the closure of smaller producers the possibility
of a monopoly occurring where Australian registered producers
may control the New Zealand market is a distinct likelihood.
It is obvious to NZAMH that due to experience, population
numbers, financial ability and other factors, the Australian
phytomedicine manufacturing industry is in a much stronger
position than its counterparts within New Zealand. The Australian
industry is already GMP registered, already has products
on TGA listings, is generally better resourced and is much
more knowledgeable of TGA legislation than most producers
in New Zealand. Therefore this Australian industry has an
advantage that can only be accentuated by any trans-Tasman
legislation that opens the New Zealand market to Australian
manufacturers.
The imposition of GMP upon producers is also an issue that
requires discussion. GMP is a wide ranging concept open
to interpretation by the regulatory agency and auditors
as to the various levels of quality control and standards
that should be met.
NZAMH is concerned that the interpretation and initial
requirements of GMP are applied at a level which will not
entail prohibitively high additional costs to the local
industry, and lead to a large number of companies going
out of business as occurred in Australia upon the introduction
of the TGA legislation there some years ago. Further consultation
with appropriate industry representatives on this point
is required.
Phytomedicine manufacturing in New Zealand is a small fledgling
industry and, at this stage of its genesis, requires a degree
of support to succeed and be suitably competitive in any
trans-Tasman situation. To this end NZAMH would like to
suggest shared cost recovery for a period of time until
the local manufacturing industry can perform to a higher
degree.
Professional members of NZAMH utilise native phytomedicines
within their professional practices. Should any new system
proceed, the introduction of NZ native phytomedicines into
class I is an important issue for the future of NZ native
phytomedicine manufacture and dispensation. The available
literature on traditional use of native phytomedicines within
New Zealand is relatively small and this should be taken
into account when application is made to the class I schedule.
In the case of Australian indigenous phytomedicine a similar
argument can be made.
If this class I scheduling does not occur, to then have
native phytomedicines scheduled within the trans-Tasman
proposal there would be the need to place them within Class
II or Class III. If this was to be the case then cost recovery
by industry with regard to New Zealand native phytomedicines
would be a significant issue. NZAMH deems it of importance
that there is provision for NZ native phytomedicines to
be kept within NZ and cost recovery assistance be granted
to protect this valuable national asset.
Herbal Medicine and National Identity
This section is written with the intention of expressing
the NZAMH view of the New Zealand phytomedicine industry
and national identity with respect to herbal medicines.
In touching on these subjects by no means does NZAMH purport
to be representative of Rongoa Maori herbal medicine practitioners
within this writing. This section is purely a comment on
the wider issues of national prescription practices.
Discussion
New Zealand does not have an absolutely identical tradition
to Australia with regard to the use and prescription of
phytomedicines. Cultural differences and aspects of national
and indigenous use of plant products impact on the prescribing
traditions within both countries.
National Traditions
With regard to the practice of Medical Herbalism within
New Zealand and the subsequent use of herbal medicines,
in relation to any postulated Australia/New Zealand harmonisation
legislation, it is interesting to review comments made by
Lord Hunt in the UK.
The possibility of a Directive on traditionally used medicines
is now on the European agenda. The MCA is actively progressing
the debate in Europe by preparing discussion papers for
a working group of the European Commission and interested
Member States.....
We would expect any Directive (on traditional herbal medicines)
which emerged to provide considerable flexibility for Member
States. This would allow Member States to reflect their
own national traditions within regulatory arrangements based
on clear European and national parameters to protect public
health. We also wish to promote the single market where
feasible for those traditional herbal remedies which are
in widespread use across the Community.
(Hunt 2000)
The discussion on the possible directive described above
contains markedly similar thought processes to the legislation
described throughout Part F of the trans-Tasman Agency discussion
document (Regulation of Complementary Healthcare Products
89-110). An important point to note is the comment on national
traditions. This concept can be analogous to the New Zealand/Australia
situation and NZAMH feels that this is a topic that requires
discussion between the various involved parties.
To blithely place the New Zealand use of herbal medicines
within an Australian context and legislative framework appears
to be neglectful of the depth of issues of nationality that
surround the use of herbal medicine within New Zealand.
On discussion with NZAMH members, most do simply not want
to be regulated from outside of their own country.
On the topic of Rongoa Maori it appears to NZAMH that the
placement of Treaty of Waitangi issues alongside Rongoa
Maori and herbal medicine use is an issue that is yet to
be fully addressed within complementary medicines legislation
as it is discussed within the trans-Tasman document. Obviously
this is an area that requires considered input, investigation
and discussion by all of those involved.
Contact Details
New Zealand Association of
Medical Herbalists
P O Box 12582
