IN THE HIGH COURT OF NEW ZEALAND WELLINGTON REGISTRY

I TE KŌTI MATUA O AOTEAROA TE WHANGANUI-A-TARA ROHE	
CIV-2020-485-000111
[2020] NZHC 433	

BETWEEN	NEW ZEALAND HEALTH TRUST
First Applicant

PROMISIA INTEGRATIVE LTD
Second Applicant	
AND	ATTORNEY-GENERAL
Respondent	

Hearing:	5 March 2020	
Counsel:	L Hansen and N Keating for the Appellant
K Wevers and E Dowse for the Respondent□	
Judgment:	9 March 2020	

JUDGMENT OF DOOGUE J

Introduction

[1]	Artemisia annua (A. annua) is a plant. It has been used for over two thousand years in traditional Chinese medicine.

[2]	The second applicant, Promisia Integrative Limited (Promisia), sells a product called Arthrem. Arthrem contains a supercritical carbon dioxide extract of dried A. annua material in grapeseed oil, and is taken in capsule form. Promisia sells Arthrem as a dietary supplement for supporting the maintenance of joint health and mobility. Arthrem is sold online and in over 800 pharmacies throughout New Zealand. Arthrem is also sold in Australia.

NEW ZEALAND HEALTH TRUST & ORS v ATTORNEY-GENERAL [2020] NZHC 433 [9 March 2020]

[3]	After concerns emerged about Arthrem and the potential detrimental effects of
A. annua extract, the Minister of Health’s delegate Medsafe began internal and external consultations concerning its classification under the Medicines Act 1981 (the Act).

[4]	Medsafe determined that A. annua extract should be classified as a prescription medicine in terms of the definition in s 3 of the Act. As a result, A. annua extract would only be available on prescription from a person authorised under the Act to prescribe medicine. The pharmacies that stock Arthrem could only then supply it to a consumer on presentation of a valid prescription.

[5]	Medsafe intends to publish a notice in the Gazette declaring A. annua extract a prescription medicine.

[6]	Promisia and the first applicant, New Zealand Health Trust (NZ Health) – an independent, charitable educational trust – (the applicants) say Arthrem is a food and a dietary supplement, and not a medicine. Foods are excluded from the definition of a medicine under the Act. The applicants say that Arthrem should therefore not have been classified as a prescription medicine.

[7]	The applicants seek judicial review of Medsafe’s decision and an interim order preventing Medsafe from publishing the notice in the Gazette pending the outcome of the judicial review.

[8]	Medsafe opposes the application for interim relief because it says the applicants’ substantive case for judicial review lacks merit, is not necessary to protect the applicants’ position, and that the risk to the health and safety of the public outweighs other considerations.

Factual overview

[9]	In January 2018, Medsafe was alerted by the Centre for Adverse Reactions Monitoring (CARM) to potential concerns about Arthrem’s effects. CARM is based in Dunedin and is contracted by Medsafe to collect voluntary reports of adverse

reactions to medicines, vaccines, herbal products, dietary supplements and blood products.

[10]	At that time, CARM’s assessment was that the reports they had received suggested a strong possibility of an association between Arthrem and liver toxicity. Liver reactions can be very serious. They can result in the need for liver transplantation or death, if not detected and treated early.

[11]	Accordingly, the Director General of Health approved the issuing of an alert under s 98 of the Act to advise consumers and healthcare professionals of the potential risk of harm to the liver when taking products containing A. annua extract. This was published on 15 February 2018.

[12]	An additional 11 reports were made to CARM following the alert, including one report of cirrhosis of the liver. Of those 11 reports, eight pre-dated the original alert.

[13]	The Director General of Health approved the issuing of a further statement under s 98 and this was published on 27 November 2018.

[14]	CARM continued to receive adverse reaction reports associated with Arthrem notwithstanding the alert communications. Medsafe then formed the view that additional risk mitigation strategies were needed in the interests of public health. Medsafe’s view was that Arthrem was not sufficiently safe that a person should be able to purchase it off the shelf.

[15]	In June 2019, Medsafe made an application to the Medicines Classification Committee (MCC) seeking to have A. annua extract classified as a prescription medicine.1 Medsafe made the classification request not only because of the safety risks associated with the risk of A. annua extract, but also because of the intended use of A. annua extract in the treatment of arthritis and malaria. Medsafe’s view is that arthritis and malaria are not conditions that should be self-diagnosed and self-

1	The Medicines Classification Committee, by virtue of s 9 of the Medicines Act 1981, is empowered to make recommendations to the Minister of Health in respect of the classification of any medicines as prescription medicines, restricted medicines and pharmacy-only medicines.

medicated. This is because, by way of example, there are many different types of arthritis and related conditions which may need to be treated differently.

[16]	The MCC met on 10 October 2019 and recommended that A. annua extract should be classified as a prescription medicine. It published its recommendations and there was then opportunity for objections to be filed. The applicants objected.

[17]	On 20 June 2019 the Secretary of the MCC provided the Group Manager of Medsafe, Mr James, with copies of the objections received and he was asked to make a decision on whether the objections were valid. He reviewed the objections and on
22 January 2020, Mr James decided that he would support the MCC’s recommendation. On 5 February 2020, Mr James advised the objectors of his decision. Following his decision, Medsafe prepared a draft notice for the publication in the gazette. Mr James agreed not to publish the notice pending this hearing.

The law – s 15 of the Judicial Review Procedure Act 2016

[18]	Section 15 of the Judicial Review Procedure Act 2016 provides that the Court may make interim orders in judicial review proceedings if, in its opinion, “it is necessary to do so to preserve the position of the applicant”.2

[19]	The exercise I must undertake can be stated in terms of four questions:3

(a)	Does the applicant have a position to be protected by the order sought?

(b)	How strong is the applicant’s case on the substance of the proceeding?

(c)	What are the effects on each party and third parties of either granting or refusing the application for interim orders?

2	Carlton & United Breweries v Commerce Commission [1986] 1 NZLR 423 (CA);
Easton v Wellington City Council [2010] NZSC 10.
3	Graham Taylor Judicial Review: A New Zealand Perspective (4th ed, LexisNexis, 2018) at 274.

(d)	Considering the nature of (a), the strength of (b), the nature and seriousness of (c), and any other relevant matters, does the balance of justice favour granting the application for interim orders?

Do the applicants have a position to be protected by the order sought?

[20]	It is accepted that for this interim application, NZ Health do not have a position that needs preserving.

[21]	Promisia argues it unquestionably has a position to preserve. Promisia currently sells its dietary supplement Arthrem online and in pharmacies. It will be prevented from doing so in the event that the gazette notice is published.

[22]	Publication of the gazette notice declaring A. annua extract a prescription medicine would have immediate financial consequences for Promisia. It would lose the ability to sell Arthrem it holds in stock. It would lose the ability to manufacture more Arthrem using raw materials it presently stores. It is estimated that this would represent a loss of at least $900,000. If the 800 pharmacies which stock Arthrem could not sell their stocks and Promisia was required to compensate them, this would cost approximately $400,000.

[23]	The evidence contained in the Chief Executive Officer of Promisia Mr de Wit’s affidavits, as set out above, somewhat differs from a market announcement made by Promisia on 14 February 2020 about the decision to classify A. annua extract as a prescription medicine. That announcement states:

On 19 December 2019, the company advised that it is to seek shareholder approval to acquire three aged care facilities and cease operating in the natural products market.

The final decision of the Medicines Classification Committee confirms that the decision to exit the natural products market was correct. This decision will have minimal impact on Promisia as most stock was written off as at 30 June 2019 and the stock retained has been sold.

[24]	Further, a media article from 10 January 2020 reported that as a result of Medsafe’s position, Promisia had decided to reinvent itself as a rest home company. The article quotes the Chairman of Promisia as saying “we’ve got to move on,

frustrating though it has been, because the product was a success”. The irreconcilability between those statements and the affidavit evidence creates some uncertainty about the precise position Promisia seeks to preserve.

[25]	Promisia’s further apprehension is that they would not be able to sell Arthrem lawfully and that it could not be sold under a prescription because it is not an approved medicine. Medsafe says that is not correct. If A. annua extract is classified as a prescription medicine, the effect will simply be that it is only available on prescription from medical practitioners.

[26]	Medsafe argues that although they would certainly expect pharmacies to stop selling Arthrem without a prescription, it is highly unlikely that Medsafe would attempt to formally recall the product. They argue it could still be sold by pharmacies on the presentation of a valid prescription. Whilst that may be correct in theory, I prefer the evidence of Promisia to the effect that it is highly unlikely that consumers would en masse go to their medical practitioners to seek a prescription for Arthrem.

[27]	On 7 February 2019, Promisia was served with nine charging documents relating to offences against the Act. Two of those charges allege that Promisia sold a new medicine before the consent or provisional consent of the Minister of Health to distribution of that medicine had been notified in the Gazette, and seven charges related to advertising in that same context.

[28]	Promisia applies to this Court to stay the prosecutions referred to in [27] in the District Court and to hear those prosecutions in this Court. I consider the preferable course is for Promisia to seek an  adjournment  of  those  proceedings  in  the  District Court, pending the outcome of the judicial review proceedings in this Court.

[29]	In summary, I am satisfied that for the purpose of this application Promisia does have a position to protect.

How strong is the applicants’ case on the substance of the proceeding?

Decision to classify – ultra vires or not?

[30]	The applicants say Medsafe’s decision was ultra vires because their power to classify a substance as a prescription-only medicine is limited to substances which meet the definition of medicine in s 3 of the Act. They say Arthrem is a food as defined in s 9 of the Food Act 2014 – namely that it is plant material intended for human consumption. Promisia says it makes no claim that Arthrem has a therapeutic purpose. The relevant parts of the Food Act are set out below:
9	Meaning of food
(1)	In this Act, unless the context otherwise requires, food—
(a)	means anything that is used, capable of being used, or represented as being for use, for human consumption (whether raw, prepared, or partly prepared); and
(b)	includes—
(i)	seeds, plants, or plant material intended for human consumption, including seeds that are intended to be sprouted and consumed as sprouts, but not other seeds, plants, or plant material intended for planting; and
…
(c)	does not include—
…
(iii)	any substance that—
(A)	is used only as a medicine or is a controlled drug or psychoactive substance;
…

[31]	Medsafe says that A. annua extract meets the definition of medicine in s 3(1)(a) of the Act because A. annua extract is a substance sold for administering to human beings for a therapeutic purpose and achieves its principal intended action on the human body by pharmacological means. The relevant parts of the Act are set out below:4
3	Meaning of medicine, new medicine, prescription medicine, and restricted medicine
(1)	In this Act, unless the context otherwise requires, medicine—

4	I note that s 3(1)(c)(ii) of the Medicines Act 1981 has not been updated to reflect replacement of the Food Act 1981 with the Food Act 2014.

(a)	means any substance or article that—
(i)	is manufactured, imported, sold, or supplied wholly or principally for administering to 1 or more human beings for a therapeutic purpose; and
(ii)	achieves, or is likely to achieve, its principal intended action in or on the human body by pharmacological, immunological, or metabolic means; and
(b)	includes any substance or article—
(i)	that is manufactured, imported, sold, or supplied wholly or principally for use as a therapeutically active ingredient in the preparation of any substance or article that falls within paragraph (a); or
(ii)	of a kind or belonging to a class that is declared by regulations to be a medicine for the purposes of this Act; but
(c)	does not include—
(i)	a medical device; or
(ii)	any food within the meaning of section 2 of the Food Act 1981; or
…
(vi) any substance or article of a kind or  belonging to a  class that is declared by regulations not to be a medicine for the purposes of this Act.

Statutory interpretation

[32]	The ultimate issue will likely turn on whether Arthrem is meant for administering to human beings for a “therapeutic purpose”. The relevant part of the definition for the purposes of this application is found in s 4 of the Act:

4	Meaning of therapeutic purpose

In this Act, unless the context otherwise requires, therapeutic purpose means any of the following purposes, or a purpose in connection with any of the following purposes:

(a) preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for, a disease, ailment, defect, or injury; or

…

[33]	So, what does Arthrem claim to be used for? The applicants’ submissions say that it is for “joint support”. The bottle Promisia markets Arthrem in describes the product as a “Joint Support Formula”. It says it is a “dietary supplement” which “[m]ay help to support normal healthy function, flexibility and mobility in stiff, and

worn or damaged joints”. It explains that it is clinically tested and has been shown to maintain and support healthy joints.

[34]	Promisia’s website in Australia contains similar claims. Promisia say the website is geo-blocked in New Zealand and available only to consumers in Australia. It was obviously available to consumers in New Zealand at some point in time and is useful for present purposes. On the front page of the website there is a claim that Arthrem is a “natural dietary supplement for supporting the maintenance of joint health and mobility”. This claim of supporting the maintenance of joint health and mobility is repeated often.

[35]	The website’s frequently-asked-questions page also provides some guidance. One such question is “Can I take Arthrem with other medications?”. The phrase “[o]ther medications” does seem to imply—though not determinatively—that Arthrem is considered to be a medication itself. There is also a claim that Arthrem is well- tolerated when taken with a number of “concomitant medications”. This would seem to suggest to an ordinary reader that Promisia considers Arthrem is a medication rather than a food.

[36]	I consider these claims fall squarely within s 4(a) of the meaning of therapeutic purpose. The relevant verbs in s 4(a) are “preventing”, “alleviating”, “treating”, “curing”, and “compensating for” and the relevant nouns are “ailment”, “defect”, or “injury”.

[37]	“Joint health and mobility” suggests an ailment, defect, or injury such that the joints are in some way not healthy or mobile. “Supporting the maintenance of” falls within preventing, alleviating, treating, or curing those joint conditions. The product has no utility other than support for joints—which would only be required for treating or preventing a joint condition.

[38]	Thus, in my view there is a strongly arguable case that Arthrem is a medicine and Medsafe were within their statutory power to deem it so.

[39]	Turning to the meaning of food. Plant extracts are not included in the definition. Perhaps this is because the extracting of substances from within a plant materially could change the nature of the substance.

[40]	The supercritical CO2 extraction process used for Arthrem’s extract uses specific pressures and temperatures to allow CO2 molecules to attach to the desired extract molecules. I was not provided with any evidence one way or the other as to whether this method of extraction fundamentally changes the nature of the substance, as, for example, extracting opium from opium poppies obviously does. This is also critical as to whether or not Promisia can successfully argue that Arthrem is a dietary supplement within the definition of s 2A of the Dietary Supplements Regulations 1985.

[41]	I expect it is the intention of the parties to provide this critical evidence to the Court when the substantive judicial review is heard, however for present purposes it appears to me that Medsafe has a more than arguable case to defend the claim its decision was ultra vires.

Additional grounds for judicial review of Medsafe’s decision: bias and a lack of true consultation

[42]	The applicants allege that Mr James of Medsafe has acted as judge and jury in his own case. They refer to the fact that Mr James has been instrumental in every regulatory action Medsafe has taken against Promisia, including a recent prosecution against them. They say he initiated the application to reclassify, he rejected the applicants’ objections to the classification process, and then proceeded to make the decision. In summary, they say he did not exercise his statutory decision-making power fairly.

[43]	They say this is directly analogous to a pharmaceutical company applying to the MCC for a recommendation to reclassify a prescription medicine as a pharmacy- only medicine, and then the same company making the ultimate decision to reclassify its own product. This analogy fails for three primary reasons – first that Mr James is the only person delegated by the Minister able to make these decisions, second that

Medsafe and Mr James have no private commercial interests to protect, and third that Medsafe has a duty to protect the public.

[44]	Whilst Medsafe made the application, it was the MCC who made the recommendation in respect of the classification. The MCC is comprised of nominees of professional bodies – all of whom are independent experts in clinical practice. Mr James was not a member of this committee.

[45]	The process for changing the legal qualification of a medicine in New Zealand is set out in a guidance document published by Medsafe.5 There are nine phases. On the evidence available to me and for the purpose of considering interim relief, it appears to me that the statutory process was properly followed by Medsafe and that therefore if Mr James correctly applied the relevant statutory criteria the judicial review on this point has a limited chance of success.

Material errors of fact in the MCC’s recommendation

[46]	Counsel for the applicants pointed to six alleged material errors of fact in the MCC’s recommendation.

[47]	Three of these relate to the definition issue at the heart of the ultra vires argument. Two relate to information as to what has occurred in Australia with Arthrem sales. One appears to overlook the effect of s 29 of the Act.

[48]	On my limited acquaintance with this matter I do not consider it is seriously arguable that any of the alleged errors of fact are so material to the outcome of the decision that the decision should be set aside.

Unreasonableness

[49]	The applicants allege unreasonableness and irrationality in Medsafe’s decision. They rely here on the lack of causation argument which I deal with elsewhere.

5	How to change the legal classification of a medicine in New Zealand (Ministry of Health, Guidance document, March 2019).

Breach of s 21 of the New Zealand Bill of Rights Act 1990

[50]	The applicants allege that the decision to classify amounts to a prohibition on the sale and distribution of products that up until now have been lawfully sold and used, and that this is an unreasonable seizure of property contrary to s  21 of the  New Zealand Bill of Rights Act 1990 (NZBORA).

[51]	At this stage of proceedings, it appears to me that it is not a prohibition, rather it is a restriction: a patient would still be able to obtain A. annua extract with a prescription from a medical practitioner.

[52]	The respondent submits it is difficult to see how an argument that product regulation constitutes property seizure could succeed. I agree.

Conclusion on strength of applicants’ case on the substance of the proceeding

[53]	Overall and in answer to the question, I am of the view there are compelling arguments to counter those of the applicants in respect of the substantive proceeding.

What are the effects on each party and third parties of either granting or refusing the application for interim orders?

[54]	I have dealt with the effects on the applicants earlier. I turn now to the effects on third parties.

General public

[55]	Case law confirms that public repercussions are relevant to the exercise of the Court’s discretion.6 In particular, concern about the safety of members of the public  is a paramount consideration. In International Heliparts NZ Ltd v Director of Civil Aviation, Gendall J stated that:7

The safety interests to the public weigh heavily on my mind. They fall squarely within the “repercussions, public or private” referred to by Cooke J as he then was in Carlton & United Breweries v Minister of Customs… the public interest consideration is of vital importance to the interim application…

6	Carlton & United Breweries Ltd v Minister of Customs [1986] 1 NZLR 423, (1986) 2 TCLR 7 (CA) at [9].
7	International Heliparts NZ Ltd v Director of Civil Aviation [1997] 1 NZLR 230 at 237.

[56]	Following that dicta, Chisholm J observed in O’Malley v Jones that:8

In [International Heliparts], which has reasonably close parallels to the matter in consideration, Gendall J concluded that where public safety is in issue the Court cannot afford to take any risks. Again, I agree. On the available information it would be most unwise for this Court to override the Director’s concerns about aviation safety arising from the reported behaviour of the plaintiff.

[57]	In this case, Promisia says there are no credible safety risks to the public. First, the applicants say that more than 1,000 scientific papers have been published on this herb. No papers in relation to harmful effects on the liver have been published in the peer-reviewed scientific literature. Further, they say there are no reports to the European Medicines Agency of adverse reactions to products containing A. annua; and in a 48-year period only five cases that potentially related to a liver condition were reported to the comparable regulatory authority in Australia.

[58]	Secondly, the applicants say that Medsafe has only identified a potential risk, not a known or established risk, and that there is no proof of causation between ingesting Arthrem and damage or injury to the liver.

[59]	Medsafe submits that the approach in International Heliparts and
O’Malley v Jones applies here because the evidence establishes that having
A. annua extract available for patient self-selection poses a health and safety risk to the public due to a risk of liver toxicity, and that this risk outweighs the modest benefits associated with A. annua extract.

[60]	The decision to classify A. annua extract as a prescription medicine removes it from patient self-selection and ensures the involvement of healthcare professionals. The consequence of delaying the notice in the gazette would be to leave the substance available until the substantive judicial review can be determined with the concomitant risk to the public.

[61]	Medsafe claims that regulatory intervention does not require proof of causation. Requiring evidence to that standard would make it impossible for health

8	O’Malley v Jones HC Christchurch CP64/02, 8 November 2002 at [27].

authorities to responsibly manage risks to public health and safety. Medsafe has given evidence about how Medsafe approaches risk assessment. In particular, risk assessment requires consideration of the balance of benefits and risks and the condition the medicine is intended to treat. For example, tolerance of risk will be higher for medicines intended to treat a life-threatening condition than for a condition such as a cold. In this case, Medsafe’s view was that the risk of harm to the liver with the use of products containing A. annua extract outweighs the modest benefits of supporting joint health.

[62]	I have been referred to extensive material by all parties to support their respective positions.

[63]	The most recent pharmacological article directly on point is “Suspected Hepatoxicity with a Supercritical Carbon Dioxide Extract of Artemisia annua in Grapeseed Oil Used in New Zealand”.9

[64]	Promisia relied on this article to establish its primary submission that there is no established causation, but issued caution about reliance on the article for two reasons. First, that two of the four authors were Mr James of Medsafe and Mr Tatley of the New Zealand Pharmacovigilance Centre of the Dunedin School of Medicine which operates CARM. Secondly, they cautioned that the study did not employ methodologies as robust as other studies provided to the Court.

[65]	The article provides compelling evidence of a causal inference of liver damage by ingesting Arthrem and another A. annua extract products marketed as GO-Arthri (GO-Arthri is no longer marketed).

[66]	In summary, twenty-nine reports of hepatoxicity were assessed. Twelve were assessed as having a “probable” causal relationship with A. annua extract. Thirteen were assessed as having a “possible” causal relationship. One report was considered “unlikely” and three were “unassessable”.

9	Ruth Savage and others “Suspected Hepatoxicity with a Supercritical Carbon Dioxide Extract of Artemisia annua in Grapeseed Oil Used in New Zealand” (2019) 10 Frontiers in Pharmacology 1.

[67]	The harm ranged from mild increases in hepatic enzymes to severe hepatitis, including one case of cirrhosis of the liver. Just over half of the patients presented with jaundice. Recovery or improvement on stopping A. annua extract was reported in 27 cases, although in some cases recovery took several months.

[68]	The authors observed:10

Few reports included information that suggested alternative explanations for the hepatic events. Causality assessment supported a “probable” or “possible” causal relationship for 12 and 13 reports, respectively. While the proportion of “probable” reports is only 41%, this is usual for initial safety signals because of the limitations of examining data retrospectively. Most of the “possible” reports had missing data for causality assessment rather than equally likely alternative causes for hepatic disorders.

[69]	It is interesting to note that the literature also supports underreporting of adverse reactions following use of herbal remedies. This is because individuals who use herbal remedies do not seek professional advice if they experience adverse effects and use of herbal remedies is often not disclosed to healthcare professionals. Thus, lack of reporting is not necessarily synonymous with safety.

[70]	Eight of the users in the sample required hospitalisation for liver injury. Diagnostic processes required multiple blood tests, ultrasound scans and other costlier and invasive procedures including two liver biopsies.

[71]	Given Arthrem’s benefits are said to be easing joint pain, they do not outweigh the potential harm to consumers who may need to undergo hospital admissions for investigation of liver damage – not to mention the financial implications both for the users and for the health service. The additional observation of QT prolongation (a form of cardiac arrythmia) in association with A. annua extract products adds further weight in finding for the respondents.

[72]	On the evidence provided to me I have formed the view that while it cannot be said causation has been established between ingestion of Arthrem and other products containing A. annua extract and liver damage, a very strong causal inference to that effect can be justified on the current scientific evidence.

10	At 4.

[73]	Where a decision is based on risks to public health and safety, it is evident from the cases that interim relief should not be entertained unless, at a minimum, there is good reason to doubt that such risks exist. The applicants have not met that threshold.

[74]	On the available information to me it would be most unwise for me to override Medsafe’s concerns about the safety of this product.

Consequences on third parties

[75]	The applicants assert that there are effects on other third parties including:

(a)	If A. annua extract becomes a prescription medicine, it becomes an offence to possess it. As well as Promisia, customers and pharmacies in possession of Arthrem or A. annua extract products are exposed to risks of prosecution.

(b)	Other parties supplying A. annua extract products will be stopped from doing so.

[76]	In respect of the first ground, I do not consider there is significant likelihood of prosecution of consumers or pharmacies for being in possession of Arthrem. The defence of reasonable excuse would be available in any case where, at the time consumers and pharmacies had come into possession of Arthrem, it had not been classified as a prescription medicine.11

[77]	In respect of others supplying A. annua extract products, the law affords them the same rights to establish any need for relief and I have insufficient evidence before me on which to assess their positions.

Does the balance of justice favour granting the application for interim orders?

[78]	The second applicant does have a position to preserve.

11	Medicines Act, s 43.

[79]	The grounds the applicants rely on for judicial review do not appear to be strong.

[80]	I find that on balance the risk to the health and safety of the public outweighs the interests of the applicants and that the gazette notice should be published – advising that Arthrem is now classified as a prescribed medicine.

[81]	If the outcome of the application for judicial review is ultimately successful, damages appear to be easily identifiable and the second applicant can claim compensation for any economic loss arising.

Result

[82]	The application for an interim order preventing publication of the gazette notice declaring A. annua extract a prescription medicine pending determination of the judicial review is dismissed.

[83]	Costs are awarded to the respondent on a schedule 2B basis.

Doogue J

Solicitors:
Crown Law, Wellington Bartlett Law, Wellington