QUEEN'S BENCH DIVISION
London WC2A 2LL
B e f o r e :
|(1) NATIONAL ASSOCIATION OF HEALTH STORES|
|(2) JENNIFER ANN SEAGROVE||Claimants|
|(1) SECRETARY OF STATE FOR HEALTH|
|(2) NATIONAL ASSEMBLY FOR WALES||Defendants|
Smith Bernal Wordwave Limited, 190 Fleet Street
London EC4A 2AG
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Official Shorthand Writers to the Court)
Mr.Philip Sales and Mr.Jason Coppel (instructed by Office of the Solicitor to the Department of Health) appeared for the Defendant.
Crown Copyright ©
The statutory framework
"(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."
"(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."
"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".
"(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.
"(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; …".
"Before making any regulations … under this Act, the Secretary of State shall have regard to any relevant advice given by the Food Standards Agency".
"(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."
(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.
(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
"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".
"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."
"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."
"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".
"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.
"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".
"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".
"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".
"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 …".
"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".
"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".
"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".
The history: food
"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".
"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".
The Order and Regulations
The Carltona principle and connected matters
"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".
"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".
"… 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".
"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".
Ground (1) (Order and Regulations): failures to inform the decision-makers
"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".
Ground (2) (Order and Regulations): failure to consult about compulsory warnings
"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  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  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".
Ground (3) (Order and Regulations): failure to inform consultees
Ground (4) (Regulations only): inconsistency with the Order