UK Ban on Kava Kava Supplement Upheld-EU directive still to be appealed

[Guest guest]

IAHF List: The National Association of Health Stores in the UK just lost a

legal challenge in which they attempted to overturn the UK's ban on Kava.

See the transcript from the hearing below.

On January 30th, attorneys from both ANH and NAHS will be in court at the

same time in a bid to challenge the EU Food Supplements Directive.

ANH and NAHS's lawsuits are separate, yet will be heard concurrently.

Given that NAHS will be using the same third rate lawfirm that just lost the

kava case, this makes it doubly important that more people donate funds to the

Alliance for Natural Health which has retained the best lawfirm in the

European Union to handle their case. Please make your donations via their secure

server at http://www.alliance-natural-health.org

The Crusador Vitamin Company in Orlando, Florida publishes a magazine called

" The Crusador " which just ran a cover story on an interview with me about the

global attack on dietary supplements. I'll be posting it on the IAHF website

in the near future, but if you'd like a copy right away you can call The

Crusador at 800-593-6273

IAHF will be doing at least 4 radio shows in the coming month in an effort to

underscore the extreme global importance of vitamin consumers supporting the

ANH lawsuit to overturn the EU Food Supplement Directive.

Ongoing work to turn IAHF into a membership organization in the coming year

is ensuing. Please forward this to more people. Anyone can sign on to the IAHF

distribution list at http://www.iahf.com If you're new to the list, please

read the Emergency Alert on the website about the ANH lawsuit to overturn the EU

Food Supplement Directive, which has huge global importance to the future

survival of the supplement industry.

Case No. CO/1888/2003

Neutral Citation Number: [2003] EWHC 3133 (Admin).

IN THE HIGH COURT OF JUSTICE

QUEEN'S BENCH DIVISION

Royal Courts of Justice,

Strand, London WC2A 2LL

19 December 2003

Before:

MR. JUSTICE CRANE

- - - - - - - - - - - - - - - - - - - - -

BETWEEN:

(1) NATIONAL ASSOCIATION OF HEALTH STORES

and

(2) JENNIFER ANN SEAGROVE

Claimants

and

(1) SECRETARY OF STATE FOR HEALTH

and

(2) NATIONAL ASSEMBLY FOR WALES

Defendants

- - - - - - - - - - - - - - - - - - - - -

- - - - - - - - - - - - - - - - - - - - -

Mr.Rhodri QC and Mr.Sam Grodzinski (instructed by Irwin )

appeared for the Claimants.

Mr.Philip Sales and Mr. Coppel (instructed by Office of the Solicitor

to the Department of Health) appeared for the Defendant.

- - - - - - - - - - - - - - - - - - - - -

JUDGEMENT

Introductory

1. Kava-Kava is an ancient herbal remedy widely used in the Pacific

region to relieve anxiety. It is derived from the plant species Piper

methysticum. Following concerns about its safety, it was prohibited for

medicinal

purposes by the Medicines for Human Use (Kava-Kava) Prohibition Order 2002 ( " the

Order " ) and as a food by the Kava-Kava in Food (England) Regulations 2002 ( " the

Regulations " ). Both were made on 18 December 2002. The Order applied to both

England and Wales. The Regulations were mirrored in Wales by the Kava-Kava in

Food (Wales) Regulations 2002 made by the National Assembly for Wales ( " the

Wales Regulations " ).

2. It is conceded that the Wales Regulations were flawed for lack of

proper notification to the European Commission. Those Regulations were

therefore

revoked. By consent the Claimants' application against the National Assembly

was withdrawn prior to the hearing.

3. The First Claimant is an association representing 420 stores

supplying health foods. The second Claimant is a successful actress, permitted

to

bring her claim in a representative capacity.

4. Early in the hearing Counsel for the Claimants applied for disclosure

of documentation placed before the Ministers who took the crucial decisions.

I refused the application and with Counsel's agreement am giving reasons in

this judgment. Since these reasons are in part based on authorities relevant

to the issues, I shall deal with those reasons later in this judgment.

The statutory framework

5. It is common ground that products containing Kava-Kava are either

" medicinal products " within the meaning of section 130 of the Medicines Act 1968

or are " food " within the meaning of section 1 of the Food Safety Act 1990 or

in some cases fall within both definitions. A limited number of products

containing Kava-Kava were licensed medicinal products. This case is not

concerned

with those and I understand that Kava-Kava has now been removed from such

products by agreement. This case is concerned with unlicensed medicinal

products.

6. Section 62 of the 1968 Act provides a power to prohibit the sale,

supply or importation of medicinal products. The relevant parts read:

" (1) Subject to the following provisions of this section, the appropriate

Ministers, where it appears to them to be necessary to do so in the interests of

safety, may by order -

prohibit the sale or supply, or the importation of medicinal products of any

description, or falling within any class, specified in the order, or (in such

manner as may appear to them to be sufficient to identify the products in

question) designate particular medicinal products and prohibit the sale or

supply,

or the importation, of those particular products;

…

A prohibition imposed by order under this section may be a total prohibition

or may be imposed subject to such exceptions as may be specified in the order. "

7. Section 85 provides a power to require labelling. The relevant

parts read:

" (1) The appropriate Ministers may make regulations imposing such

requirements as, for any purpose specified in subsection (2) of this section,

they

consider necessary or expedient with respect to any of the following matters,

that

is to say -

(a) the labelling of containers of medical products;

( the labelling of packages of medicinal products;

© the display of distinctive marks on containers and packages of medicinal

products.

(2) The purposes referred to in the preceding subsection are -

(a) securing that medicinal products are correctly described and readily

identifiable;

( securing that any appropriate warning or other appropriate information or

instruction is given, and that false or misleading information is not given,

with respect to medicinal products;

© promoting safety in relation to medicinal products. "

8. The Secretary of State acted at all material times through an

executive agency, the Medicines Control Agency ( " MCA " , now, since 1 April 2003,

the

Medicines and Healthcare Products Regulatory Agency). However, it is common

ground that the Agency is not legally separate from the Department and that

officials of the MCA stood in the same relationship to Ministers as any other

civil servants. When I refer to civil servants it is to these officials.

9. Section 2 of the Act established the Medicines Commission ( " the

Commission " ), a body corporate, consisting of experts. Section 3(1) requires

the

Commission to give Ministers advice

" on matters relating to the execution of this Act or the exercise of any

power conferred by it, or otherwise relating to medicinal products, where either

the Commission consider it expedient, or they are requested by the Minister or

Ministers in question, to do so " .

10. Without prejudice to section 3(1), the Commission has by section

3(2) a duty to recommend what committees should be set up under section 4. One

purpose of such a committee may be to give advice with respect to safety and to

collect and investigate information relating to adverse reactions for the

purpose of enabling such advice to be given: section 4(4). Such committees are

expert committees, not part of the Department or of the MCA. The relevant

committee in relation to medicinal products is the Committee on Safety of

Medicines ( " CSM " ).

11. Before making any order of prohibition, the Ministers must (except in

cases of urgency, not relevant here) consult the appropriate committee, or if

for the time being there is no such committee, the Commission: section 62(3).

12. Before making any regulations or order under the Act (except in cases

of urgency) Ministers proposing to do so must consult such organisations as

appear to them to be representative of interests likely to be substantially

affected: section 129(6). Where the Ministers are proposing an order of

prohibition, section 62(5) provides additional requirements:

" (5) If any organisation consulted in pursuance of section 129(6) … have

given notice to the appropriate Ministers of their desire to be heard under this

subsection, or have made representations in writing to those Ministers with

respect to that proposal, then before making the order -

(a) if the organisation have given notice of their desire to be heard, the

appropriate Ministers shall arrange for them to have an opportunity of appearing

before, and being heard by, the Commission; or

( if they have made representations in writing, the appropriate Ministers

shall refer those representations to the Commission,

and, where the organisation have availed themselves of the opportunity of

being heard, or after considering the representations, as the case may be, the

Commission shall report their findings and conclusions to the appropriate

Ministers and those Ministers shall take that report into account in determining

whether to make the order.

13. I turn to the legislation on food safety.

14. The relevant part of section 16 of the 1990 Act, as amended, reads:

" (1) The Secretary of State may by regulations make -

provision for requiring, prohibiting, or regulating the presence in food or

food sources of any specified substance, or any substance of any specified

class, and generally for regulating the composition of food;

…

provision for imposing requirements or prohibitions as to, or otherwise

regulating, the labelling, marking, presenting or advertising of food, and the

description which may be applied to food; … " .

15. The Food Standards Act 1999, section 1, set up the Food Standards

Agency ( " FSA " ), with the main objective of protecting public health from risks

which may arise in connection with the consumption of food.

16. The FSA in facts seeks advice from the Committee on Toxicity of

Chemicals in Food, Consumer Products and the Environment ( " COT " ). It is not a

statutory committee, but has an independent advisory role similar to that of the

CSM.

17. As with medicinal products, the 1990 Act, as amended by the 1999

Act, provides for advice and consultation in connection with the making of food

regulations. By section 48(4A), as amended:

" Before making any regulations … under this Act, the Secretary of State shall

have regard to any relevant advice given by the Food Standards Agency " .

18. As to consultation, section 48, as amended, provides:

" (4) Before making -

any regulations [other than some not here relevant] …;

…

the Secretary of State shall consult such organisations as appear to them

[sic] to be representative of interests likely to be substantially affected by

the regulations … .

(4B) If it appears to the Secretary of State that the Food Standards Agency

has undertaken any consultation with an organisation that he is required to

consult under subsection (4) above, the Secretary of State may treat that

consultation as being effective for the purposes of that subsection as if

undertaken

by him. "

The grounds

19. The Grounds lodged raised various arguments not pursued, as did the

skeleton argument lodged by Counsel for the Claimants. It is clear that the

decisions to prohibit Kava-Kava are considered by some eminent scientists and by

some others, apart from the Claimants, to be unjustified. Those who oppose

the prohibitions consider that Kava-Kava is a beneficial substance and that the

fears about its safety are based on shaky and inadequate scientific

foundations. On the other hand the action taken to prohibit products containing

Kava-Kava appears to be consistent with action taken in at least most of the

other

member states of the European Union. The decisions to prohibit are of course

not ones for the Court to take. Moreover, the Claimants do not pursue any

challenge to the rationality or proportionality of the decisions taken. Thus,

as I

pointed out to Mr.Rhodri QC, the weight of scientific and other

views could become relevant only if I conclude that the procedural challenges

vitiate the Order or the Regulations. If so, I should have to decide whether as

a

matter of discretion the Order or the Regulations should be quashed. In

those circumstances the possibility that a different decision would result could

become relevant. However, although it is necessary to understand the principal

arguments both ways, much of the evidence filed is not relevant to a

consideration of the procedural challenges. A substantive challenge should not

be

mounted under cover of a series of procedural challenges.

20. Partly as a result of amendment which was not opposed and for which I

granted permission, the live challenges can be summarised as follows:

The Order:

(1) the Commission and/or the civil servants failed to inform the primary

decision-maker, Lord Hunt, that (a) a recent, highly authoritative report had

been prepared by one of the leading experts, Professor Edzard Ernst, (

Professor Ernst had presented the findings of the report at the meeting on 7

November

2002 at which the Commission reached the conclusions submitted to the First

Defendant, © the report's findings were wholly inconsistent with the advice

that was given to the First Defendant on the basis of admittedly incomplete and

unsatisfactory data on rare adverse effect reports.

(2) There was a failure to consider or consult on the possibility of

compulsory warnings.

(3) There was a failure to inform consultees of the very limited nature

of adverse reactions, and in particular the fact that only 14 or 15 cases

worldwide since 1990 (none of which was fatal) had the CSM identified as

" probably "

causally linked to the consumption of Kava-Kava.

The Regulations:

(1) Neither the FSA nor Ms Hazel Blears, the Parliamentary Under Secretary of

State with devolved responsibility were made aware of the matters under (1)

above.

(2) Similar to (2) above.

(3)There was the same failure as under (3) above, and a failure to take

account of those matters.

(4) The Regulations failed to include exemptions that are contained in the

Order, notwithstanding the fact that the Regulations had no independent

justification and the First Defendant's evidence that a more rigorous approach

is

appropriate for medicinal products than for foods.

The history: medicinal products

21. In August 2000 the MCA received information from Switzerland about a

cluster of cases of possible hepatotoxicity (a destructive or poisonous effect

on liver cells) that might be associated with Kava-Kava use. In October 2001

the German Federal Institute for Drugs and Medical Devices (BfArM) produced a

report based on 30 reported cases of possible adverse hepatotoxic reactions.

The MCA sought advice from the CSM, which met on 12 December 2001.

22. There was before the CSM a detailed paper by Mr. Woodfield.

He noted that there had been no reports of hepatic adverse reactions in the

United Kingdom. The concern was based on the BfArM report, which he annexed.

It is right to note that the evidence was not, and indeed, as I read the

various reports, never has been, undisputed or conclusive. Many of the cases

were

confounded, in other words other medication or substances had been taken. The

principal questions addressed in Mr.Woodfield's report were whether there was

sufficient evidence to support an association between Kava-Kava and hepatic

adverse reaction and what, if any, regulatory action was justified. Those have

continued to be the essential questions which have had to be addressed by all

concerned.

23. In discussing the options for regulatory action, Mr.Woodfield said

" Although warnings could be added to licensed products there is currently no

method to ensure the unlicensed preparations contain similar warnings other

than voluntary agreement with the manufacturers " .

24. And when setting out the possible regulatory action for unlicensed

products, he listed making the ingredient Kava-Kava a prescription-only medicine

( " POM " ), prohibition, and

" Initiate safety variations to add warnings regarding rare hepatic adverse

reactions.

…

Obtain voluntary agreement with manufacturers of unlicensed products to

include warning information about the risks of rare hepatic adverse reactions. "

25. On behalf of the Claimants Mr. QC submits that the

possibility of compulsory warnings was overlooked and that this error continued

thereafter.

26. The CSM noted that many of the reported cases were confounded and

lacking in detail, and that the toxological basis for the hepatotoxic effect was

unclear, but considered that there was " sufficient evidence that Kava-Kava is

hepatotoxic " . They advised voluntary action to remove product use, while

additional data was sought, but said that if voluntary action failed, further

consideration should be given to " the appropriate regulatory mechanism to

achieve

product withdrawal " . The MCA met the First Claimant and other interested

groups. The voluntary suspension of sale of Kava-Kava products was agreed.

27. The CSM convened a Kava-Kava Working Group to assess the evidence,

advise the CSM on risk/benefit balance and consider possible regulatory action.

The Group met on 12 March 2002. They had before them a detailed paper

mainly prepared by Mrs.Leigh . The information available was again

analysed. The first passage just quoted from Mr.Woodfield's report was

repeated,

with the added words:

" However, it is likely that the proposal to add a warning to the label of

Kava-Kava products would have a high uptake given the current level of agreement

with the various associations. In fact some of the association (sic) have

proposed wording for such a warning. "

28. The possible alternatives were not canvassed, but the Group were

supplied with Mr.Woodfield's paper. The Claimants' skeleton argument asserts

that

the Group considered a report from BfArM, but it seems that cannot have been a

report in the form referred to, since that was dated June 2002.

29. The Group noted the options set out in Woodfield's paper. They

concluded that unless further data were submitted which altered the risk/benefit

balance, the prohibition of Kava-Kava in unlicensed products would be the most

appropriate action, rather than making the products prescription only.

30. The full CSM met again on 10 July 2002 and considered a further

report from Mrs.. They clearly did see the June 2002 report from

BfArM.

Mrs. noted that there were now a total of 67 case reports of

suspected hepatotoxicity worldwide. Of these 14 were classified as " probable " ,

29

as " possible " , 19 as " unassessable " and 5 as " unlikely " , according to defined

criteria.

31. The CSM were also presented with a formidable volume of

representations and supporting evidence. Included was a paper by Professor

Ernst and

Dr.Pittler of the Department of Complementary Medicine, School of Postgraduate

Medicine and Health Sciences in the University of Exeter. It was published in

the February 2000 edition of the Journal of Clinical Psychopharmacology,

entitled Efficacy of Kava Extract for Treating Anxiety: Systematic Review and

Meta-Analysis. A meta-analysis is a statistical analysis of a large collection

of

analysis results from individual studies for the purpose of integrating the

findings. They said

" In conclusion, the evidence presented here suggests that kava extract is

relatively safe and more efficacious than placebo in the symptomatic treatment

of

anxiety. Important caveats exist, which prevent firm conclusions. The

findings warrant further and more rigorous investigations of the risk-benefit

relation of kava " .

32. The regulatory options set out by Mrs. were in similar

terms to those in previous such reports. She added

" For unlicensed products, voluntary warnings, would be the only means of

introducing warnings to users. However, 100% coverage would be unlikely to be

achieved, a concern which is supported by the disintegration of the voluntary

agreement not to market Kava-Kava pending investigation of the safety issue.

There would be no means of enforcement other than to then proceed down a

compulsory regulatory route " .

The further discussion does not suggest that a " compulsory regulatory route "

included compulsory warnings.

33. The minutes of the 10 July meeting advised the removal of products

containing Kava-Kava from the market as soon as possible. It is pointed out on

behalf of the Claimants that in referring to the 68 suspected cases, with

three associated with a fatal outcome and six resulting in liver

transplantation,

the CSM made no reference to the fact that only 14 (not including the

fatalities) were classified as " probable " . It is also pointed out that in

discussing

label warnings, there is no indication whether these could be voluntary or

compulsory. However, there is no indication that the CSM considered anything

not in Mrs.'s paper or its annexes.

34. On 25 July the MCA embarked on consultation under section 129(6) of

the 1968 Act. Included in the material sent to consultees were the Proposals,

together with a Draft Partial Regulatory Impact Assessment ( " RIA " ).

Complaint is again made on behalf of the Claimants that both documents, in

referring

to the 68 suspected cases, gave no breakdown and in particular made no mention

that only 14 were classified as " probable " . The Draft RIA set out the options

in a similar way to Mrs.'s paper for the July meeting and said

" Voluntary warnings would be the only means of introducing warnings for

users. It is unclear whether there would be full compliance with voluntary

arrangements. There would be no sanctions or means of enforcement. There would

be

no means for the public to determine whether they were at risk. On the basis

of the CSM's advice this option would represent an insufficient response to the

risk " .

35. 51 responses were received. One was from the First Claimant, which

attached two papers, one from Professor Waller, Professor of

Pharmacology and Toxicology at the University of Illinois, dated 15 February

2002, the

other from Dr.Mathias Schmidt dated November 2001. Both analysed and

considered the available evidence. Professor Waller expressed the opinion that

" on

currently available information … kava when take in appropriate doses for

reasonable periods of time has no scientifically established potential for

causing

liver damage " . However, he took the view that the medical community and the

public should be made aware that certain prescribed drugs, excessive alcohol and

pre-existing liver disease or hepatitis with compromised liver function are

conditions that may preclude any kava consumption. Dr.Schmidt took the view

that when reactions were examined in detail BfArM's classification of causality

linked to kava was to a large extent incomprehensible and arbitrary.

36. The Claimants also point to a report from the Scientific Committee

on Kava Toxity (Professor Arnold Beckett, a medicinal chemist and clinical

pharmacologist, and others), dated January 2002 and submitted by the Institute

for

Optimum Nutrition. That Committee considered that there was very little of

real substance in the original 30 cases to support the view that Kava-Kava had

a negative risk-benefit profile. They considered that any potential risk for

toxicity for Kava-Kava could easily be mitigated by warning labels. They

suggested an appropriate warning label.

37. In addition a group of 17 German professors and doctors, described

as " Commission E " , all members of BfArM, signed a statement in July 2002

disagreeing with the German decision that medical products containing Kava-Kava

should be withdrawn. Kava-Kava had previously been available only on

prescription in Germany and the Commission E members considered that certain

recommendations about use and dosage were sufficient.

38. The CSM met again on 16 October 2002. As usual, a paper was

prepared, by Mrs. and Judith . They said

" No substantial new evidence to support the continued sale and supply of

Kava-Kava has been provided during the course of the consultation. Of the

responses received from the UK herbal sector there is a general trend which

considers

the proposed action to be out of proportion with the level of risk.

The low number of cases and potential confounding factors features [sic]

highly, however, these issues have been previously discussed in detail by the

Committee and the Working Group and do not represent new evidence " .

39. These comments are criticised by the Claimants as not rebutting the

contents of the reports submitted. I do not consider that the comments were

unjustified, in the sense that the reports submitted examined in detail the

individual cases reported, rather than providing new evidence. In any event,

however, the paper annexed the First Claimant's response in full, together with

the reports of Professor Waller and Dr.Schmidt and the statement from Commission

E.

40. The regulatory options were stated in similar terms to those in

previous papers, with no mention of compulsory warnings.

41. The minutes of the CSM stated that they had been provided with a

summary of responses. They endorsed their previous position, that Kava-Kava

should be prohibited in unlicensed medicines. They criticised the responses

from

the herbal sector, although " of good quality " , as avoiding discussion of the

risk-benefit balance, and as overlooking the strong temporal balance of the

cases and the evidence obtained from dechallenge and rechallenge. The reference

to the temporal balance and to dechallenge and rechallenge is essentially to

evidence about when symptoms occurred in relation to the taking of Kava-Kava,

the cessation of taking it, and the resumption of taking it.

42. The Claimants submit that these criticisms of the responses from

the herbal sector do less than justice to the evidence submitted. In my view

that submission has merit, at least so far as the response from the First

Claimant is concerned; such matters were dealt with in the material submitted by

the

First Claimant.

43. On 7 November the Commission met. A relatively short paper was

submitted to the Commission, but annexed were previous reports and minutes,

including the October paper prepared for the CSM. The Commission was invited to

consider what advice should be given to Ministers. No mention was made of

compulsory warnings. The reference to warnings said

" A number of major interest groups in the herbal sector consider a voluntary

warning to be the most appropriate regulatory action. It is also pertinent

that some also acknowledge there may be an issue over the effectiveness of

voluntary action in this area " .

44. The minutes of the meeting record that the Commission considered all

the written evidence and an oral presentation made by representatives on

behalf of the British Herbal Medicines Association. " It discussed the options

available in considerable detail and gave its advice at Annex A " .

45. The advice, which is relatively short, was to ban Kava-Kava in

unlicensed medicines under section 62 of the 1968 Act, other than for external

use.

They concluded that there was a risk in rare cases of hepatotoxicity

associated with the use of medicines containing Kava-Kava, which might be

severe.

They stated that the hepatotoxic effect was unpredictable and that no specific

factors relating to an increased risk with specific preparations, doses or

groups of susceptible patients could be identified. Again the 69 (sic)

suspected

adverse reaction reports worldwide were referred to, with 4 relating to fatal

cases and 6 requiring liver transplants, but mentioning that only 16 cases had

been classified as " probable " . In discussing medical supervision and

warnings, the Commission said

" The Commission considered that medical supervision of the use of Kava-Kava

(POM status) would not necessarily permit safe usage of these products due to

the unpredictable nature of the reactions. The Commission also considered the

inclusion of warning information on unlicensed medicines containing Kava-Kava

would not be sufficient to make the use of these products safe … " .

46. One of the members of the Commission present at the meeting on 2

November was Professor Ernst. On 2 November he had sent to the MCA an up to

date

meta-analysis of kava extract (referred to as the " Cochrane Collaboration

Review " , a reference to a respected process of review), prepared in conjunction

with Dr.Pittler. The Synopsis read

" Systematic literature searches were conducted to assess the evidence for or

against the effectiveness of kava extract for treating anxiety. Twenty-one

potentially relevant double-blind, placebo-controlled RCTs [randomised,

controlled trials] were identified. Eleven trials met the inclusion criteria.

The

meta-analysis of six trials suggests a significant differential treatment effect

for the total score on the Hamilton Anxiety Scale in favour of kava extract.

Adverse events reported in the review trials were mild, transient and

infrequent. These data imply that kava extract is superior to placebo as a

symptomatic treatment of anxiety. Further and more rigorous investigations into

the

effectiveness and safety of kava extract would be welcome " .

47. The Reviewers' conclusions were:

" Compared with placebo, kava extract appears to be an effective symptomatic

treatment option for anxiety. The reviewed data suggest that kava is safe for

short-term treatment. Given the recent reports of adverse events, kava should

not be taken concomitantly with hepatoxic drugs or over longer periods of

time. Further rigorous investigations, particularly into the safety profile of

kava are required " .

48. It is clear that the criticisms made by the CSM of the consultees'

responses could not be levelled at the meta-analysis. However, although the

minutes do not record the discussion, a discussion of about an hour took place

at

the meeting of the Commission, during which Professor Ernst advanced his

views. He opposed the advice to prohibit Kava-Kava. It is not entirely clear

whether Professor Ernst's latest meta-analysis was before the Commission, but he

is described by the First Defendant as having talked to his paper and there can

be no doubt that he must have referred to the conclusions in it. It is clear

that the Commission did not accept Professor Ernst's view about prohibition.

And it must be said that the meta-analysis did not contain an unqualified

view that Kava-Kava was safe.

49. The Order was made on 18 December. It prohibited the sale, supply

or importation of any medicinal product consisting of or containing Kava-Kava

or an extract from Kava-Kava. The prohibition was subject to certain

exceptions, to certain of which I shall return.

50. The relevant RIA was also published on 18 December, signed by Lord

Hunt. There is reference to 69 suspected cases and to the assertion that in 15

cases it was probable that Kava-Kava caused the adverse reaction. The listed

options were similar to those set out before, but the following passage was

included:

" Voluntary warnings would be the only means of introducing warnings for

users. Compulsory warnings are not thought a realistic proposition due to

weaknesses in the regulation of unlicensed herbal medicines. There would be no

means

for the public to determine whether they were at risk of an idiosyncratic or

unpredictable reaction to Kava-Kava. It is unclear whether there would be full

compliance with voluntary arrangements. There would be no sanctions or means

of enforcement to ensure warnings are provided. On the basis of the advice

of the CSM and MC this option would represent an insufficient response to the

risk " .

51. Evidence has been filed on behalf of the First Defendant from Ms

Raine, Director of the Post-Licensing Division of what is now the MHRA. It is

necessary to set out her evidence in relation to consideration of compulsory

warnings and to whether Professor Ernst's second report and his oral

contribution

to the meeting on 7 November.

52. She states in her first statement that the Agency was at all times

aware that there were relevant statutory powers for the enforcement of

labelling requirements. She refers to the action taken in 2000 in relation to

St.'s Wort, where voluntary labelling of unlicensed products was reinforced

by a

compulsory revision of patent information for certain licensed products.

However, I must point out that that is not the same as compulsory labelling of

the

unlicensed products.

53. Ms Raine also points out that there were objections to the efficacy

of labelling, whether voluntary or compulsory. The reported reaction was

idiosyncratic and serious; hence warnings would not enable patients to identify

the risk or any symptoms.

54. As to particular difficulties affecting compulsory warnings, Ms

Raine points out that there are no specific regulatory requirements for

unlicensed

medicines setting out what packaging or labelling (if any) is required.

Hence it would have been extremely difficult to formulate a general warning or

label requirement. That seems to be the basis of the second sentence in the

passage on warnings in the RIA.

55. In her recent, third witness statement Ms Raine states that colleagues

attending the March and July 2002 meetings do not recall any specific

discussion of compulsory labelling; discussion of labelling was about the

effectiveness of warnings to the public to enable them to decide whether they

were at

risk.

56. As to Professor Ernst, Ms Raine confirmed in her first statement

that Professor Ernst had made a " presentation " to the Commission on 7 November

2002, although she did not state what his view had been. In her second

statement she noted that she had been present and that the discussion lasted an

hour

and 5 minutes. There was further general discussion later before a decision

was reached and although no formal vote was taken, it was clear that a large

majority of the Commission supported the advice given. She states that it is

the Commission's practice to give a single, unified statement of advice to

Ministers.

57. Ms Raine also states that the detailed deliberations of the

Commission have never been previously disclosed, partly because that would be a

criminal offence under section 118 of the 1968 Act, partly because

confidentiality

promotes the free exchange of views and partly because it would undermine the

role of the Commission in providing unified advice to the Secretary of State.

58. It is not crucial to decide whether Ms Raine is correct in these

assertions. I note, however, that section 118 provides for the disclosure of

information " in the performance of [a person's] duty " . It may on some future

occasion require to be decided whether a single, unified advice is necessary and

how far confidentiality is required in this context.

59. As to what happened within the MCA, Ms Raine explains that the 2002

Ernst Review was passed to both Mrs. and to Simon Day, a statistician

in the Licensing Division. She states that the MCA's view was that the new

Review did not rebut the previous view of the MCA and the CSM that, on balance,

and having regard to the spontaneous case reports, hepatotoxicity is a rare

adverse effect of Kava-Kava. She adds some information about the material

placed before Lord Hunt, in a submission by Mr. Woodfield, the Group

Manager of Herbal Policy in the MCA. The 2002 Review was not placed before Lord

Hunt, but there was included an explanation that Professor Ernst had opposed the

prohibition and had contributed to a lengthy discussion at the Commission's

meeting. Professor Ernst's objections to the prohibition were summarised. The

fact that of 69 adverse reactions reports, 15 had been classified as probable

was explained; indeed the broad breakdown was provided.

The history: food

60. On 12 July 2002 the FSA was supplied with the advice from the CSM

that Kava-Kava should be prohibited in medicines. The FSA proposed that

products containing Kava-Kava should be removed from the market on safety

grounds and

sought the advice of the COT. A paper (a Food Risk Assessment) was prepared

by the secretariat of COT for its meeting on 23 July 2002. The views of the

CSM were summarised. The 68 suspected cases were categorised. The

inadequacies in the available information were canvassed and the paper

concluded:

" In absence of a clear understanding of the hepatotoxicity, including its

mechanism and relevant patient and exposure characteristics, it is not possible

to exclude hepatotoxicity arising from food uses of kava kava. The information

provided since December 2002 (sc. 2001) provides further evidence that

consumption of kava kava may cause hepatotoxicity " .

61. The minutes of the COT noted the paper, but apparently the COT

expressed no view and gave no advice.

62. On 25 July 2002, the same day as the parallel consultation by the

MCA, the FSA embarked on its consultation process, circulating a Partial RIA.

The 68 suspected cases were referred to, without being categorised. Four

options for action were set out, not including any reference to labelling.

63. Forty responses were received, many not supporting prohibition.

Among the responses was one from Food Standards Australia and New Zealand, where

there is a long history of Kava-Kava use. That agency was reviewing its

actions, but it is clear that compulsory labelling formed part of the regulatory

action.

64. The FSA advised prohibition. The Regulations were made on 18

December 2002. Complaint was made that the RIA was not published until 23

January

2003, but it now appears that it was signed by Ms Hazel Blears on 18 December.

There is extensive reference to the CSM's conclusions. The 68 suspected cases

were not referred to in terms. It was stated that the evidence does not

justify treating Kava-Kava in foods differently from Kava-Kava in medicines.

The

same four options were set out as in the Partial RIA, but the full RIA added

" Initially we also considered a fifth option - that of allowing Kava-Kava

foods to remain on the market provided the labels carried a warning statement.

However, we dismissed this course of action as unworkable because it is not

possible to construct a warning that would provide adequate protection of public

health. This is due to the unpredictability of adverse reactions and due to

the fact that it is not possible to identify patient or product characteristics

that would result in greater risk to health " .

65. There is no evidence before the Court about what information was

provided to her, although of course she saw and signed the Full RIA.

The Order and Regulations

66. The Order prohibits the sale, supply or importation of any medicinal

product consisting of or containing Kava-Kava. There are certain exceptions,

for example where the product is for external use only and to cover those

authorised to sample or examine products. The exception requiring attention by

me is that contained in article 3©, covering certain products in transit that

are being or are to be exported to a Contracting Party to the Agreement on

the European Economic Area, other than the United Kingdom.

67. The Regulations prohibit the sale, possession for sale or

importation of any food consisting of or containing Kava-Kava. The exemption

in the

Order relating to goods in transit to be exported is not mirrored in the

Regulations.

The Carltona principle and connected matters

68. The first three of the grounds raises the issue of how ministerial

decisions are taken and to what extent the court should investigate who took

the decision and on what information. The same issue arose on the Claimants'

application for further disclosure.

69. The starting point is Carltona v. Commissioners of Works [1943] 2

All ER 560. The Court of Appeal were considering a challenge to a requ

isitioning order of the Commissioners of Works, who in fact never met and where

the

decision had in fact been made by an assistant secretary. At 563 Lord Greene MR

said:

" In the administration of government in this country the functions which are

given to ministers (and constitutionally properly given to ministers because

they are constitutionally responsible) are functions so multifarious that no

minister could ever personally attend to them. To take the example of the

present case no doubt there have been thousands of requisitions in this country

by

individual ministries. It cannot be supposed that this regulation meant that,

in each case, the minister in person should direct his mind to the matter.

The duties imposed upon ministers and the powers given to ministers are

normally exercised under the authority of the ministers by responsible officials

of

the department. Public business could not be carried on if that were not the

case. Constitutionally, the decision of such an official is, of course, the

decision of the minister. The minister is responsible. It is he who must

answer before Parliament for anything that his officials have done under his

authority, and, if for an important matter he selected an official of such

junior

standing that he could not be expected competently to perform the work, the

minister would have to answer for that in Parliament. The whole system of

departmental organisation and administration is based on the view that

ministers,

being responsible to Parliament, will see that important duties are committed to

experienced officials. If they do not do that, Parliament is the place where

complaint must be made against them " .

70. I was referred to Wade and Forsyth, Administrative Law (8th

edition), where the authors, after citing Carltona, say at pages 325-6:

" Consequently many ministerial powers are exercised by officials who recite

'I am directed by the Minister', 'the Minister is of the opinion', and so

forth, when in reality they are acting on their own initiative. If the proper

official is acting in his capacity as such, his assumption of ministerial

authority is lawful. This doctrine is assumed to extend equally to legislative

powers, since it is common practice for officials to issue statutory regulations

under powers vested in their ministers.

Strictly speaking there is not even delegation in these cases.

Delegation requires a distinct act by which the power is conferred upon some

person not

previously competent to exercise it. But the authority of officials to act

in their ministers' names derives from a general rule of law and not from any

particular act of delegation. Legally and constitutionally the act of the

official is the act of the minister, without any need for specific authorisation

in advance or ratification afterwards. Even where there are express statutory

powers of delegation they are not in fact employed as between the minister and

his own officials. Such legal formalities would be out of place within the

walls of a government department, as is recognised by Parliament's practice of

conferring powers upon ministers in their own names " .

71. In Bushell v. Secretary of State for the Environment [1981] AC 75,

at 95, Lord Diplock said:

" … Discretion in making administrative decisions is conferred upon a minister

not as an individual but as the holder of an office in which he will have

available to him in arriving at his decision the collective knowledge,

experience

and expertise of all those who serve the Crown in the department of which,

for the time being, he is the political head. The collective knowledge,

technical as well as factual, of the civil servants in the department and their

collective expertise is to be treated as the minister's own knowledge, his own

expertise " .

72. It follows that information available to officials involved in

advising a minister is information that can properly be said to be information

taken

into account by the minister. It was submitted by Mr. QC that this

would mean that information known to any official in the department can be said

to be known to the minister taking a decision. I do not think that follows.

If on a challenge to a decision, it were to be asserted that the Secretary of

State took into account such information, when in fact no official involved in

the matter knew of it, that would in my judgment be an inaccurate assertion.

Nor, for example, would it be an accurate assertion if the relevant

information was buried in a file but not in fact considered by any official

involved in

the matter. However, it does not follow that the court will in the ordinary

way investigate whether such an assertion is accurate.

73. I agree with the passage at paragraph 66 of the judgment of

Mr.C.Lockhart-Mummery QC, sitting as a Deputy High Court Judge, in Best v.

Secretary of

State for the Environment [1997] EWHC Admin 226. The court was considering

whether the knowledge of a letter seen by an employee in the post-room of the

department, but not at the relevant time communicated to the Secretary of State

or to any civil servant responsible for advising the Secretary of State,

could be imputed to the Secretary of State. The learned judge said:

" It appears to me from this passage [the words immediately following the

passage cited above] that Lord Diplock is confining the doctrine of imputed

knowledge to those civil servants who have responsibility for receiving the

information, considering it and advising the minister thereon. It is, thus, the

knowledge of responsible officers which is imputed to the minister " .

Disclosure

74. I am prepared to accept that if there is reason to doubt the assertion

that a particular factor has been taken into account, the Court may

exceptionally inquire further into the decision-making process within a

department.

Moreover, if, as here, the department chooses to reveal part of the

decision-making process, the Court will have regard to such evidence. Such

evidence may

give rise to questions calling for an answer. Only exceptionally is it

appropriate for the Court to exercise its power to order disclosure. That is

consistent with the words of Lord Clyde in Air 2000 Ltd. v. Secretary of State

for

Transport (No.2) 1990 SLT 335 at 341, of the Divisional Court in R. v. Secretary

of State for Foreign and Commonwealth Affairs, ex parte World Development

Movement Ltd. [1995] 1 WLR 386 and of the Court of Appeal in R. v. Secretary of

State for Education, ex parte S [1995] ELR 71.

75. Ms Raine has explained how far Professor Ernst's views were considered

by the civil servants and how far those views were passed on to Lord Hunt.

In my judgment her evidence on these matters is more than adequate for the

purposes of the present proceedings. There is no reason to doubt what she says

on

these matters. I saw and still see no good reason for ordering further

disclosure.

Ground (1) (Order and Regulations): failures to inform the decision-makers

76. Before dealing with this ground I must refer to European ju

risprudence, in the regulatory context, cited by Mr. QC.

77. In Alpharma v. Council of the European Union [2002] ECR II-3495 the

European Court said:

" 183. It follows, as Alpharma has rightly submitted, that a scientific

assessment carried out as thoroughly as possible on the basis of scientific

advice

founded on the principles of excellence, transparency and independence is an

important procedural guarantee whose purpose is to ensure the scientific

objectivity of the measures adopted and preclude any arbitrary measures " .

78. The Court went on to find that only in exceptional circumstances

should Community institutions adopt a preventative measure withdrawing an

authorisation without obtaining an opinion from appropriate scientific

committees.

What was criticised was reliance on the views of a Standing Committee rather

than the competent scientific committee. In the present case the

decision-makers accepted the advice of the relevant scientific committees.

79. I do not accept that the " principles of excellence, transparency and

independence " are to be imported, as the test to be applied, into a

consideration under English law of the decisions in the present case.

80. In Artegodan GmbH and others v. European Commission [2002] ECR

II-4945 the Court of First Instance was considering the vital role of the

relevant

scientific committee and the role of the Commission. I do not ultimately find

in that decision anything to assist me in this case. The distinction was

drawn between the formality of the committee's scientific opinion and the

Commission's exercise of its discretion. In the present case the

decision-makers

accepted the advice of the relevant scientific committees.

81. The complaint is in essence that Lord Hunt was not informed about

Professor Ernst's 2002 Review or the extent of his opposition to the proposal to

prohibit. However, the evidence indicates that this Review and his opposition

were considered by responsible civil servants. Although Lord Hunt was not

provided with the Review, he was told of Professor Ernst's opposition and

provided with a summary of the Professor's objections. It is not submitted that

Lord

Hunt should have read the Review, only that he should have been aware of its

existence. In my judgment what was provided for him was both adequate and

appropriate.

82. As to the Regulations, there is no evidence as to whether Professor

Ernst's 2002 Review or the extent of his opposition were taken into account by

the FSA or by Ms Blears. It would have been possible, consistently with the

principles of law, to have asserted that these were taken into account. I shall

assume for the purposes of this judgment that they were not. However, the

FSA and in turn the Department clearly relied on the CSM's conclusions. In my

view they were entitled to do so. If the decision to prohibit Kava-Kava in

medicines was lawful, it was in my view rational to conclude that foods should

not be treated differently. In other words, if Kava-Kava was not to be

permitted in medicines even under medical supervision, there was in reality no

room

for permitting it in food. If I am wrong in this conclusion, and if the assumed

failure to take into account Professor Ernst's Review and opposition renders

the making of the Regulations procedurally flawed, I should refuse to quash

the Regulations. There is no reason to suppose that if these matters had been

specifically considered, the decision would have been different. The reasons

are the same: once the conclusion about Kava-Kava in medicines had been

reached, the conclusion about Kava-Kava in foods became for practical purposes

inevitable.

Ground (2) (Order and Regulations): failure to consult about compulsory

warnings

83. I accept that there is no legal obligation on a decision-maker to

consult on all possible options. In R. v. Worcestershire Health Council, ex

parte

Kidderminster and District Community Health Council [1999] EWCA Civ 1525,

Lord Justice Simon Brown said (at page 5 of the transcript):

" If, as is clearly established (and is, in any event, only plain commonsense)

an authority can go out to consultation upon its preferred opinion, per

O'Connor LJ [in Nichol v. Gateshead Metropolitan Borough Council [1988] LGR 435,

456] or with regard to " a course it would seek to adopt if after consultation it

had decided that that is the proper course to adopt " per Woolf LJ [in R. v.

Hillingdon Health Authority, ex parte Goodwin [1984] ICR 800, 809] then it

seems to me plain that it can choose not to consult upon the less preferred

options. It does not, in other words, have to consult on all possible options

merely because at some point they were developed, crystallised, canvassed and

considered " .

84. While I do not doubt Ms Raine's assertion that the MCA was aware of

the possibility of compulsory labelling and the RIA indicates that it had been

considered, the fact is that in none of the papers presented to the CSM or the

Working Group or the Commission, had the option of compulsory labelling been

mentioned. As I read the way the options were set out, they must have appeared

to be a complete list. The statement, for example in the consultation

document, that " Voluntary warnings would be the only means of introducing

warnings

for users " , would in my judgment inevitably lead consultees to believe that the

only possible kinds of warnings were voluntary. It was most unlikely in the

circumstances that consultees would go to the legislation themselves. The

same applies to members of the Committee, the Working Group and the Commission.

For such information about the legal options, they would naturally rely on the

MCA. I consider that in the context the statement was misleading and wrong.

85. There has been no attempt in the evidence to explain why, of all the

major options, compulsory warnings were not mentioned and indeed by implication

indicated not to be possible. There is no evidence that compulsory warnings

had been considered and ruled out, while leaving voluntary warnings as an

option. There is no reason to suppose that there was any intention to mislead.

The conclusion must be that although the MCA was aware of compulsory labelling,

that option had been overlooked when papers were prepared for the

consultation.

86. I accept that many of the objections to voluntary warnings applied

equally to compulsory warnings: for example, the perceived difficulty in

constructing meaningful warnings. Nevertheless, a legal requirement for

warnings

did, arguably, remove or reduce in importance one objection.

87. For these reasons I have reached the conclusion that the consultation

process in relation to Kava-Kava in medicines was procedurally flawed.

Although some of the arguments relating to voluntary labelling applied to

compulsory

warnings, consultees should have been given an opportunity to comment on

compulsory warnings. I shall consider whether a remedy is appropriate, in the

light of my conclusions on the other grounds.

88. In relation to Kava-Kava in food, strictly the consultation was

carried out by the FSA, not the MCA. The FSA are not parties to these

proceedings.

However, no point has been taken about their absence and the arguments have

been put forward by the Defendant.

89. Labelling did not form part of the consultation process by the FSA.

The RIA indicates that labelling had been dismissed as unworkable, although it

is not clear when. The implication is that the FSA had ruled it out before

consultation. I do not consider that any irrationality has been demonstrated in

reaching this conclusion. Consultees were not misled in the way they were in

relation to warnings about Kava-Kava in medicines. I do not find any

procedural flaw in the consultation about Kava-Kava in food.

Ground (3) (Order and Regulations): failure to inform consultees

90. This ground can be dealt with shortly. The central thrust of this

complaint is that the consultees, although told of 67 " suspected " cases of

adverse reactions, were not told that of these only 14 or 15 were " probable " .

In

relation to the Regulations, it is said that this was not taken into account in

the making of the decision. However, this is tantamount to alleging that

consultees and decision-makers should have been told: " There are 14 or 15

probable

cases of adverse reactions and 52 or 53 other suspected cases " . That would

have been a stronger, rather than a weaker, argument for prohibition.

91. I realise that there are detailed definitions of " suspected " ,

" probable " and the other categories, conveniently to be found at paragraph 3.2.1

of

the report of Mrs. to the meeting of the CSM on 10 July 2002. However,

consideration of these definitions does not lead to a different conclusion.

92. Neither consultees nor decision-makers were misled in any material way

by the omission of a breakdown of the 67 cases.

Ground (4) (Regulations only): inconsistency with the Order

93. It is clear that the Regulations do not include certain exemptions

that are included in the Order. These relate principally to goods in transit.

94. The submission on behalf of the Claimants is that the principle of

proportionality requires that a restriction on a right conferred by Community

law

should not go beyond what is necessary to achieve the objective in question,

here the protection of public health. It is submitted that if exemptions

could be granted for Kava-Kava in medicines, there is no basis for omitting such

exemptions for Kava-Kava in food.

95. Counsel for the Defendant advances in a supplementary skeleton

argument the proposition that if there were ever to be a prosecution for breach

of

the Regulations in relation to food in transit, any defendant could rely on

Community law to claim that his rights under Community law were being infringed.

I acknowledge, without finding it necessary to set them out, that arguments to

this effect could be advanced. In my judgment this is not a satisfactory

answer to the problem, if a problem exists. If the Regulations are flawed, a

potential defendant should not be faced with having to defend himself on a

prosecution and very possibly in an appeal process.

96. No reason for omitting an exemption in relation to food in transit has

been advanced. I accept the Claimants' submission.

97. I also accept that the flaw cannot be remedied by severance on the

principles set out in DPP v. Hutchinson [1990] 2 AC 783. The Court cannot write

in an exemption.

98. The principal argument advanced on behalf of the defendant is that

this ground is academic and that there is no evidence that the Claimants, or

indeed anyone else, have been adversely affected by the absence of an exemption.

There is indeed no such evidence. Moreover, the Secretary of State has

undertaken to reconsider the matter of the exemption in the Regulations.

99. Although I accept that this ground is not based on any demonstrated

difficulty for the Claimants or anyone else, I do not consider that I should

regard it as academic and decline to express my view, since the matter has been

argued. However, these considerations are highly relevant to whether any

remedy should be granted. I propose to accept the undertaking by the Secretary

of

State to reconsider the matter of exemption. I point out that no attempt has

been made to advance any reason for the omission of the exemption. I invite

submissions on whether in these circumstances it is appropriate even to grant a

declaration, since I am inclined to the view that an expression of my view is

sufficient.

Conclusions

100. I have rejected grounds (1) and (3) in relation to both the Order and

the Regulations. I reject ground (2) in relation to the Regulations. I have

already expressed my conclusions on ground (4).

101. There remains the question whether any remedy should be granted for

the flawed consultation process (ground (2)) in relation to the Order. I have

come to the conclusion that none should be granted. The decision was reached

not to make medicines containing Kava-Kava a prescription-only medicine. In

other words, the decision was taken that use of such medicines under medical

supervision was not sufficient protection for the public. That decision is not

the subject of any substantive challenge. If such medical supervision was

insufficient, it follows that warnings, even compulsory, would be insufficient.

For Health Freedom,

C. Hammell, President

International Advocates for Health Freedom

556 Boundary Bay Road

Point , WA 98281-8702 USA

http://www.iahf.com

jham@...

800-333-2553 N.America

360-945-0352 World

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