NAHS Loses Kava Lawsuit in UK- Underscores Importance of ANH Challenge to EU FSD

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

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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

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

Mr.Rhodri Thompson QC and Mr.Sam Grodzinski (instructed by Irwin Mitchell) appeared for the Claimants.

Mr.Philip Sales and Mr.Jason Coppel (instructed by Office of the Solicitor to the Department of Health) appeared for the Defendant.

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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;
(b) the labelling of packages of medicinal products;
(c) 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;
(b) 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;
(c) 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
(b) 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 Thompson 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, (b) 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, (c) 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.Richard 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.Thompson 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 Henderson. 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.Henderson. They clearly did see the June 2002 report from BfArM. Mrs.Henderson 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.Henderson 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.Henderson'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.Henderson'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 Donald 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.Henderson and Judith Thompson. 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.John'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.Henderson 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.Richard 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(c), 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 requisitioning 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.Thompson 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 jurisprudence, in the regulatory context, cited by Mr.Thompson 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.Henderson 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,
John C. Hammell, President
International Advocates for Health Freedom
556 Boundary Bay Road
Point Roberts, WA 98281-8702 USA
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