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Delegated Legislation Committee Debates

Kava-Kava in Food (England) Regulations 2002 and Medicines for Human Use (Kava-Kava) Prohibition Order 2002

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Fifth Standing Committee on Delegated Legislation

Thursday 30 January 2003

[Miss Ann Widdecombe in the Chair]

Kava-kava in Food (England) Regulations 2002

8.55 am

Tim Loughton (East Worthing and Shoreham): I beg to move,

    That the Committee has considered the Kava-kava in Food (England) Regulations 2002 (S.I., 2002, No. 3169).

It is good to see you in the Chair, Miss Widdecombe, at this early hour set by our new Thursday morning sitting arrangements. I should like to explain why my right hon. and hon. Friends and I have prayed against the two motions.

First, I want to make it clear that I am neither a user of nor an expert on kava-kava, though I am less ignorant now than I was a week ago, when I was swamped with representations from many health bodies and users of kava-kava who are greatly alarmed at the prospect of the substance no longer being available in this country. It has been available for many years and is used by many thousands, if not hundreds of thousands, of people throughout the world as a treatment for a range of conditions such as anxiety and ailments affecting the bladder and digestive tracts.

I am no medical expert and cannot say whether the substance has beneficial effects. Suffice it to say that enough people who use it obviously believe that it does. We have to rely on medical professionals who advise the Government. However, before we go along with this extreme action, we need to be sure that the medical advice is soundly based on medical science and is not influenced by other factors that undermine the soundness of that science. We are in Committee today to challenge the Minister to justify the findings on which the regulations, which we have prayed against, are based.

The Government are keen on banning things, except, as reported in the newspapers, sex in public, but I shall not travel down that road. Before banning a substance, we need to be wholly convinced that it is the right action to take. Other courses of action, such as voluntary label warnings, are available to the Government. With St. John's wort, for example, people who may have liver problems are warned of the potential risks, so that they can make an informed choice about whether to begin or continue using it.

Kava-kava is the subject of today's Committee debate, but it is not the only substance with which we are concerned, because the measure has ramifications for many hundreds of other substances that people use daily to help with various conditions. Kava-kava could be the tip of the iceberg. How many other

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substances could fall foul of similar diktats by the medical authorities without justification according to the full rigours of medical science?

I received a learned paper, one of many, from Professor Waller of Illinois university, who is an internationally renowned expert on the subject, so we must take his comments seriously. More importantly, however, we must be convinced that the medical authorities that advise the Government have taken on board such comments.

The best way to approach the matter is to put a series of questions to the Minister. Concerns were raised at the timing of this statutory instrument. The day before the House rose for the Christmas recess, it was sneaked—if I dare use that word—into the business of the House. Fortunately, that did not go unnoticed, which is why we were able to pray against it. It has been brought to the Committee so that the Minister can justify it.

What science has established a link between liver problems and kava-kava? Can the Minister comment on the number of people who would ordinarily be expected to have some degree of liver impairment, irrespective of what substances, such as kava-kava, they may take? For the number of cases in which liver problems are associated with kava-kava how great is the incidence of such problems occurring naturally? How great is the incidence of liver problems that are either genetic or occur through taking other substances?

Can the Minister comment on the number of people who have contracted severe liver problems and the number who have died from liver disease in the past few years? Is that figure a constant; is the trend improving or is it worsening? Are other factors at work which could account for those few cases, which we shall look at later, in which the finger of blame has been pointed at kava-kava? Are we looking at all the possible causes or are we simply saying that kava-kava must be responsible for a person's demise?

The Medicines Control Agency has referred to only four cases in the UK. Can the Minister assure us that those people were not taking other supplements that may have affected their condition, either singly or in combination with kava-kava? Without going into great detail, I gather that one person studied was an 87-year-old, who took kava-kava as a supplement in his tea, who died in his sleep. That is not a strange occurrence for an 87-year-old. How sure is the agency that there is a direct link with kava-kava in that case? What has it recommended as the level of concentration of kava-kava that may be deemed dangerous?

Can the Minister estimate what proportion of the United Kingdom population regularly takes kava-kava supplements, either as a medicine or as a food? How does that figure compare with European countries, especially Germany and Switzerland? Much of the judgment on kava-kava seems to have been based on cases in those countries. How many cases of hepatotoxicity have been reported in the UK in the past few years?

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I also want to ask the Minister a few questions about the timing of the Government's presentation of this prohibiting order. When did they receive the conclusions from the Committee on Safety of Medicines and the Medicines Commission which linked kava-kava to cases of liver toxicity? If there was a delay between that date and the date on which the order was presented to Parliament, what caused it?

Can the Minister tell the Committee about the consultation process that took place last year? The issue has been under discussion for a long time, leaving much uncertainty among businesses that market kava-kava, most of whom co-operated on a voluntary withdrawal while the consultation was taking place. How many responses to the consultation proposing the prohibition of kava-kava did the Medicines Control Agency receive? What proportion of them were in favour of a ban and what proportion against? What steps did the agency take fully to research the evidence supporting the use of kava-kava which was submitted by the interested organisations, and what subsequent discussions have taken place with those organisations?

Did the Government or the agency set any criteria for the investigation into kava-kava by the CSM and the Medicines Commission? If so, what were those criteria? Were they asked by the Government to provide a definitive answer as to whether they thought that there should be a ban on kava-kava, or was it just their advice that was sought? In what form were the conclusions given by the CSM and the MC to the agency and to Ministers? The MCA's press release, issued on 20 December 2002, stated that there have been four reports of liver toxicity in the UK thought to be due to consumption of kava-kava. Has any progress been made in confirming whether the problem in those cases was caused by consumption of kava-kava? Can the Minister give us more information about those cases?

The MCA's question and answer document No. 25 states:

    ''Each case of suspected hepatoxicity associated with Kava-kava received has been assessed for causality using standard criteria. The latest case is still being assessed. No cases have been identified with a causality classification of 'certain'. However, 15 cases are considered to have a 'probable' relationship with Kava-kava and 30 were considered to have a 'possible' causal relationship with it. The other cases were either unassessable or considered unlikely to be related to Kava-kava usage. The strongest causality relationship related to the 'probable' cases.''

How certain does the MCA have to be to recommend a ban on a substance because a link has been proven? Can the Minister tell us whether all those assessments were carried out in the United Kingdom? Is there any precedent for a product being prohibited despite the fact that no cases have been identified with a causality classification of ''certain''? Was the decision to prohibit the use of kava-kava made using evidence of the product as it is sold and used in Britain or was it, as I suspect, based on evidence gathered from other European countries, especially Germany and Switzerland? If evidence from other countries was used in the CSM's deliberations, what adjustments were made for the suggested differences in the type of product on sale in Britain and elsewhere?

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In a written answer last October the Minister stated that the MCA had

    ''requested information from the herbal sector about unlicensed remedies containing Kava-kava which had been on the market prior to the voluntary agreement. The information provided was insufficiently comprehensive to enable a detailed comparison with products on the German market.''—[Official Report, 29 October 2002; Vol. 391, c. 748W.]

What consideration has she given to the point made by the National Institute of Medical Herbalists that the prohibition fails to take into account the distinction between the use of over-the-counter concentrated standardised extracts and the traditional herbal preparations that herbal practitioners prepare specifically to meet the needs of their customer?

The statutory instrument states that kava-kava shall not be prohibited where the product is the subject of a product licence, marketing authorisation or homeopathic certificate of registration. Can the Minister confirm that all the products containing kava-kava which were granted such a licence, authorisation or certificate before the CSM's inquiry will now be subject to a review of their authorisation or licence for use? Will manufacturers of kava-kava products that are not currently licensed be able to apply for a marketing authorisation licence or certificate of registration?

If a product is unavailable in one country, that will not necessarily prevent British consumers from buying it from another country via the internet, mail order or another means. What measures have the Government taken to warn consumers about the safety risks that are attached to the consumption of kava-kava? If the Government ban kava-kava in the UK, where will it still be possible to buy it? Other EU and non-EU European countries are easily accessible to UK consumers. Which of them will still make kava-kava products available to their population and to visitors from the UK and other countries?

I have asked many detailed questions without the aid of any supplements or additives. The Minister produced a bottle of the product under discussion, and it had a lot of information on it. She also has a lot of advisers, and she received many representations during and after the consultation. She is therefore eminently equipped to answer all my questions within the next two hours and 15 minutes—the period available to us. I look forward to hearing a detailed and lengthy response.


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