Friends In High Places

September 1st, 2006 by Ben Goldacre in bad science, homeopathy | 44 Comments »

Some of you may remember this story, about MHRA plans to change regulation of homeopathic remedies, and allow them to make medical claims with no evidence, which I wrote about on the last day of 2005, and which becomes law today.

www.badscience.net/?p=200

Below is the press release from the MHRA. There’s quite a lot about this that raises eyebrows for me. Firstly, the statutory instrument got slipped in to parliament a couple of days before the recess, so nobody could scrutinise it. Secondly, this press release is a bit of an advert for homeopathy, a treatment which, frankly, has had its day: there are meta-analyses examining vast numbers of papers which show it is no better than placebo (the very existence of these papers is still denied by various people in the homeopathy community, including many medics and, bizarrely, the British Homeopathic Association itself).

So the press release talks about how the changes “will enhance consumer confidence with respect to the safety, quality and use of these medicines.” Which is not a good thing for a treatment that doesn’t work.

It also offers to put you in touch with some friendly homeopaths: I fail to see what business that is of the Medicines and Healthcare Products Regulatory Authority.

Lastly, it features a man who makes money making these sugar pills saying that its provisions will “encourage growth in the range of products on the market” as if this is a good thing, and something that a government should be involved in encouraging.

I don’t think I can be bothered to write about it all over again – unless you either (a) think I should or (b) have some good jokes I can steal on the subject – but I thought you might like to see the press release. In the meantime if anyone finds an example of a new homeopathic remedy making a claim to be useful in a condition, do let me know.

The bigger problem in the background is this: the MHRA, and the bodies that came before it, are serious regulatory bodies that are engaged in serious business, checking that medicines are safe, and that pharmaceutical companies do not make unreasonable claims. They brought in the Yellow Card System as a response to things like Thalidomide. And here their credibility is, in my mind, undermined. This change will be exploited by quacks to suggest that their treatments have received tacit endorsement, as has happened many times before.

Anyway [coughs] just remember, back in Dec ’05 you heard it first in Bad Science….

Press release

Embargoed until 00.01 hrs on Friday

1 September 2006

Date: 01 September 2006

Time: 00.01hrs

Subject: National Rules Scheme for homeopathic medicines

Contact: Press Office xxxxxxxxxxxxxxxxxxx
_________________________________________________________________

Improved patient information and greater consumer choice – new rules to regulate homeopathic medicines

The Medicines and Healthcare products Regulatory Agency (MHRA) has today introduced a new scheme to improve and strengthen the regulation of homeopathic medicines in the UK. The National Rules Scheme for homeopathic medicines will enhance consumer confidence with respect to the safety, quality and use of these medicines.

From today, companies will be encouraged to register new homeopathic medicines under this scheme, with the option of re-registering certain existing products. For the first time since Product Licences of Right were issued in 1971, companies will be allowed to include information about the treatment and relief of minor, self-limiting conditions based on the use of the product within the homeopathic tradition. For example, labels may indicate that a product may relieve the symptoms of common colds and coughs, hay fever or chilblains. All homeopathic medicines authorised under the new scheme will have clear and comprehensive patient information leaflets to help consumers use their medicines safely and effectively.

Professor Kent Woods, Chief Executive of the MHRA, said, “This is a significant step forward in the way homeopathic medicines are regulated. Products authorised under the National Rules Scheme will have to comply with recognised standards of quality, safety and patient information.”

Penny Viner, Board Member of the British Association of Homeopathic Manufacturers (BAHM), said, “The British Association of Homeopathic Manufacturers welcomes the coming into force of this new scheme. This long-awaited regulatory development benefits the ever-growing number of users of homeopathic medicine: its provisions will both encourage growth in the range of products on the market, and enhance the consumer’s understanding of their benefits.”

Notes to Editors

1. The MHRA press office can assist you with any queries you have in making contact with homeopathic practitioners. Call ### #### ####

2. The National Rules Scheme for homeopathic medicines was introduced today following a full public consultation in 2005. There was widespread support for the proposals. The summary of responses can be seen at:

www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON1004429&ssTargetNodeId=373

3. Homeopathic medicines in the UK are currently covered by either the Product Licences of Right (PLRs), or by certificates of registration under the Simplified Registration Scheme. PLRs were issued to all medicines on the market when the Medicines Act 1968 was introduced. The National Rules Scheme will build on these existing regulatory frameworks, with a particular emphasis on indications and appropriate labelling and literature.

4. All homeopathic medicines fall within the scope of the Yellow Card Scheme, which will allow patients and healthcare professionals to report suspected side effects to the MHRA. For over 40 years, the Yellow Card Scheme has been the cornerstone of medicines safety monitoring in the UK. Since the Yellow Card scheme was set up, over 500,000 reports of suspected side effects (known as adverse drug reactions) have been completed, enabling the MHRA to identify and take action on a wide range of previously unrecognised medicines safety issues. Adverse effects associated with the use of homeopathic medicines should be reported to the MHRA using the Yellow Card Reporting Scheme. www.yellowcard.gov.uk

5. The MHRA is the government agency that is responsible for ensuring that medicines and medical devices work, and are acceptably safe. We keep watch over medicines and devices, and we take any necessary action to protect the public promptly if there is a problem. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks.

This email and any files transmitted with it are confidential. If you are not the intended recipient, any reading, printing, storage, disclosure, copying or any other action taken in respect of this email is prohibited and may be unlawful.

If you are not the intended recipient, please notify the sender immediately by using the reply function and then permanently delete what you have received.Incoming and outgoing email messages are routinely monitored for compliance with the Department of Healths policy on the use of electronic communications.

For more information on the Department of Healths email policy, click http;//www.doh.gov.uk/emaildisclaimer.htm


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44 Responses



  1. superburger said,

    September 1, 2006 at 2:09 am

    Go after homeopaths hard……..

    They have the veneer of respctability – GP referals, homeopathic hospitals, B S fucking Cs in it. Yet the whole thing is utter bullshit. The performance by Mel Oxley on Newsnight sums up everything that’s wrong with their charade.

    A lot of CAM is obvious bollock and just for the wealthy to indulge themselves in, but state funded homeopathy in 2006 is a disgrace.

  2. jackpt said,

    September 1, 2006 at 3:06 am

    The MHRA looked at the famous Mary Poppins song but forgot about the medicine. On a more serious note, I wonder if one day someone will be sued over the tacit approval of things that don’t work. A homeopathy killed my grandmother legal action. I suppose the get-out will be that homeopathic practitioners were never supposed to be taken seriously. With policy like this it’s going to be very difficult for the public to distinguish.

    Things like this, scare the shit out of me because it is possible that someone could actually try to treat flu with it. Available at Superdrugs and Boots for a mere £4.20… Note it actually says Influenza, not just colds. And it says “Keep out of the reach of children. If symptoms persist or worsen, consult your doctor or homeopath“. A homeopath gains equality with a medical doctor when there’s hints of influenza in the air. I presume products such as this will now get a more official stamp of approval.

  3. lilyburn said,

    September 1, 2006 at 7:23 am

    Does this mean that a pharmaceutical company can re-label one of its medicines as a homeopathic remedy and get it on the market without having to go through the tedious rigmarole of clinical trials? Will that mean more elephant men?
    Maybe the drugs companies could be persuaded to sue the government over this new law distorting competition: GlaxoSmithKline has to go through years of R&D, animal models, clinical trials etc to get a drug onto the market, while Harry Homeopath can knock something up in his kitchen in ten minutes, make untested claims for it and launch it on the market.

  4. JQH said,

    September 1, 2006 at 8:04 am

    Since homeopathic pills consist of nothing but sugar, there’ll be no side effects to report unless the patient is diabetic.Do the MHRA actually moniter drugs to see if they actually work as claimed?

    Maybe the answer is for some manufacturer of homeopathic nostrums to be sued under the Trade Descriptions Act.

  5. DeeTee said,

    September 1, 2006 at 8:54 am

    Ben, I agree you should not let this matter drop unchallenged.
    Michael Fitzpatrick was correct on the BBC this morning when he said that they have just “given a Kite mark for the Emperor’s new clothes, or rather the Prince of Wales’ new clothes”.

    I concurr with the suggestion that as soon as we see manufacturers putting medical claims on their individual homeopathic products that we make a complaint to the ASA under the Trades descriptions Act.

    What also galls me is that the MHRA seem to suggest that because their public consultation was broadly in favour of the new national rules scheme for homeopathy that this somehow confers legitimacy. What next? – Consultation exercises on the medical benefits of astrology, or Lourdes water?

  6. MostlySunny said,

    September 1, 2006 at 9:28 am

    I don’t believe it – has this world gone MAD?

  7. apothecary said,

    September 1, 2006 at 9:40 am

    it was very interesting to listen to the “debate” on Today this morning. Others have rehearsed the problems with “balance” in the meeja (imagined interview – “come come, Mr Churchill, that’s surely a reasonable point Herr Hitler makes about Poland”).

    But, dear Jackpt – antiviral (ie neuraminidase inhibitor) therapy for flu is not all that effective (see the evidence in the NICE TAs – enormous NNTs. And not insubstantial NNHs). And come the inevitable pandemic, there may not be much to choose in efficacy between sugar pills and Tamiflu. My antipandemic plans rely less on drug therapy and more on a provisions and a tent to hide in the middle of the Yorkshire Moors for quite a few months. Perhaps HMG could have saved a packet by stocking up on the Nelson product! That should surely have appealed to the NLDP which is New Labour’s natural home.

  8. evilgenius said,

    September 1, 2006 at 9:47 am

    Hello everybody long time reader, 1st time poster.

    Grr. I personally feel that homeopathic medicines should be licensed and manufactured under GMP and that their safety should be monitored. But the idea of making statements about usage… This is an amazing piece of double think.

    Kent Woods states:
    “Products authorised under the National Rules Scheme will have to comply with recognised standards of quality, safety and patient information.”

    The important omission here is efficacy. Without a test for efficacy claims cannot and should not be made.

    From the MHRA website :
    “Safety, quality and efficacy are the only criteria on which legislation to control human medicines is founded. ”

    Also my understanding of the Homeopath point of view is that the individual patient has to be treated and the prescription tailored to them. A homeopathic remedy therefore has only vague indications for use.

  9. sfluendy said,

    September 1, 2006 at 9:58 am

    Yes, but back to the MHRA. There was a consultation on the proposals. It received 32 responses and a large majority supported the plans.

    snipurl.com/vrsm

    Perhaps instead of sitting round and telling eachother how right we all are and how stupid homeopathy is, it would be more sensible to send reasoned responses to these things.

    Now that the law is through, is there any scope for taking any action? I note the actual responses are not published. Why not?

    And is ‘anthroposophic’ medicene any better than homepathic? Something to do with uber-nutter Rudolf Steiner, I believe. Anyway, MHRA are concerned with giving it a level playing field against homepathic remedies.

    Perhaps if we were to come up with a new form CAM based on the healing spirit of the Flying Spaghetti Monster (a satirical response to teaching of creationism in US schools, m’lud) it would also get a level playing field.

  10. Evil Kao Chiu said,

    September 1, 2006 at 10:01 am

    Unless it’s the thin end of the regulatory wedge and they are moving towards proper regulation once the fraudulent little buggers have got used to the concept.

    That’s too optimistic, isn’t it? Sorry…

  11. Zephya said,

    September 1, 2006 at 10:18 am

    Adverse affects ?

    How about consumers losing hard-earnered money to charlatans who sell “remedies” that they know don’t work beyond a placebo effect? The price per kilo of homeopathic sugar will be above gold, the price per litre of water (aka a homeopathic solution) more than the costliest champagne.

    How about serious illnesses developing because mumbo-jumbo remedies delayed effective treatment by real medicine ?

    Public demand is no justifcation for allowing bogus medical claims – this measure brings the entrire regulatory system into disrepute.

  12. Cargo Cult said,

    September 1, 2006 at 10:28 am

    I’m trying to figure out how best to overdose on a homeopathic medicine. Should I be consuming more, or fewer, of these sugar pills?

    … More seriously, is there any legally-required testing to check the maximum safe dosage of medical products, placebo or otherwise?

  13. MostlySunny said,

    September 1, 2006 at 10:49 am

    Ben – I think the general consensus is that you have to take them down to China Town…

  14. wewillfixit said,

    September 1, 2006 at 10:51 am

    Although I agree that this does undermine the credibility of the MHRA, nothing much will actually change. At the moment, although there are no claims of what is “supposed” to treat what on the the actual homoeopathic remedy, places like Boots, I’m pretty sure, just display a booklet nearby with a guide to homoeopathy and what remedies to use for what condition nearby.

    I think they should be allowed to display the conditions supposedly treated by their remedy, on the proviso that they replace it with the following disclaimer “If you are stupid enough to believe that homoeopathy works, you might like to know that this remedy is traditionally used for X”

  15. evilgenius said,

    September 1, 2006 at 10:55 am

    sfluendy;
    You’re right of course. I was just in a bad mood: The tube. The points from the consulation document that interested me were:
    “The main reservations related to the effectiveness of homoeopathic products, and their claims for efficacy.”
    “Wording on the label must not mislead patients into thinking that the product has had efficacy proven by clinical trials.”

    I was interested by the first point; how much was this taken into account? The second point suggests that perhaps the only thing that can be done is to complain about misleading labelling of efficacy on a case by case basis. of course a slightly reworded caveat would probably cover that.

    Evil K.C., Benylin (or robbitussin or meltus) for chesty cough is probably the best example of a medicine which basically doesn’t work but has a PL number. There are also plenty of medicines that can be prescribed on the NHS which were never (and will never be) proven to be effective.

    Cargo Cult; I’m not to sure but I’d suggest that LD50 values for the constituents would for the basis of any toxicological assessment.

  16. le canard noir said,

    September 1, 2006 at 11:01 am

    If I was the society of homeopaths, I would be furious about this. Who this really benefits are people like Boots and Holland and Barrett (and Kim Wilde). They display their smarties without chocolate without any indication of ‘what they are for’. Now they will be able to do so. Thus, homeopathy will become much more a ‘pick up and go’ product.

    The SoH obviously want to promote those long ‘holistic’ ‘individualised’ consultations, that maximise the ‘complex intervention’ required for the treatment to work (or the placebo effect to kick in). Their members rely on this to charge their fees for doling out sugar. Picking up those pills in boots will obviously allow people to self-’medicate’. .

    I hope that the placebo effect will be so weak from these poducts taken in this manner that people come to see them as useless. Maybe I am guilty ot wishful thinking here.

  17. Wonko said,

    September 1, 2006 at 11:01 am

    Leaving aside (as the government has done) the obvious distinction between homeopathic remedies and medicines – that homeopathic remedies don’t work while medicines do – is there anything else that distinguishes them? They are both manufactured substances designed to treat illness. They are both often based on the chemical composition of naturally occuring substances.

    Now most of us would, hopefully, believe that being effective and being (relatively) safe are rather important characteristics of medicines. However, since the government and its regulator do not, why stop at homeopathy? Why not open the way for the herbalists to hawk their (sometimes life-threatening) products as medicines without the need for clinical trials?

  18. Mojo said,

    September 1, 2006 at 12:25 pm

    lilyburn said:
    “Does this mean that a pharmaceutical company can re-label one of its medicines as a homeopathic remedy and get it on the market without having to go through the tedious rigmarole of clinical trials?”

    The MHRA don’t seem to have updated their page about registration of homoeopathic medicines yet (it still says that they must make no therapeutic claims), but it does say that homoeopathic medicines must be sufficiently dilute to ensure their safety, i.e sufficiently dilute to have no effect at all, so I don’t think this route would be open to any product that actually does anything.

  19. jackpt said,

    September 1, 2006 at 1:03 pm

    Apothecary, in the event of a flu pandemic I shall be playing immune system roulette, which has all kinds markers like human leukocyte antigens, and stuff ;-). Plenty of soup too. While the Nelson’s product doesn’t specifically discourage the the use of medicines it worries me that people won’t take things like paracetamol because they believe the homeopathic medicine will help fight a fever. I suppose at best they could dissolve the tablets in a litre of water, add a little salt, and have an effective electrolyte booster. A £4.20 DIY sports drink, and worse than soup. The MHRA announcment is scary. There should be a law against it.

  20. CdrJameson said,

    September 1, 2006 at 1:17 pm

    Homeopathy? Obvious cobblers, and clearly no better than placebos.

    But is that A Bad Thing?

    After all, placebos are far, far, more effective than doing nothing.

    If there’s nothing medically useful my doctor can do for me, isn’t it better to walk away with a prescription for some mumbo jumbo that, perhaps subconsiously, I think may help, than nothing at all?

    Surely a useful bit of doublethink, a beneficial self-deception. Homeopathy is clearly one of the safest placebo therapies, as it’s just water. If it’s hounded out of town , where else can I go to get a reliable and diverse supply of placebos?

    eh? Eh? EH?

    Or something.

  21. Gilbert said,

    September 1, 2006 at 1:27 pm

    Perhaps the public could be encouraged to carry cards saying “In case of emergency use only homeopathic medicines”. Supply ambulance crews with a range of sugars and waters, then wait 10 years for the gene pool to improve.

  22. jackpt said,

    September 1, 2006 at 1:32 pm

    CdrJameson: The problem isn’t with placebos, the problem is that homeopathy often portays itself as a serious alternative to mainstream medicine. In many cases that may not be a problem (things that will probably clear up by themselves eg colds), but with things like malaria, and flu that’s risky. Giving an official nod increases the perception that there *must* be something to homeopathy because it has an official stamp. Some people will make the mistake to rely on homeopathy, or other unproven treatment, and have very negative outcomes.

  23. MostlySunny said,

    September 1, 2006 at 1:48 pm

    I think we need to get over this obsession with “wellness” “well being” etc which is has warped the idea of what it means to be healthy.

  24. Robert Carnegie said,

    September 1, 2006 at 2:10 pm

    I may look a fool myself for harping on about the strength of a homeopathic remedy name printed on paper and carried in the pocket – said by Wikipedia to be actual prescribing practice by courtesy of www.homoeopathica.org.nz/editorial_00.htm and www.medicinegarden.com/Homeopathy/Paper%20Remedies.html (page no longer exists, site re-organised, by all means dig) – but if this is legitimate, then could you put a scrupulously genuine Paper Remedy into your column for the benefit of readers? And what’s more you’re a real doctor.

    Apparently the criterion is that someone somewhere in the world is already doing it and calling it homeopathy?

  25. Robert Carnegie said,

    September 1, 2006 at 2:17 pm

    And is it true that homeopathy does not recognise diseases? Influenza is a disease, therefore a homeopathic remedy cannot treat influenza? Cannot even be “for the symptoms of influenza”, because on Planet Homeopathy, influenza doesn’t even exist? Conversely, if it treats influenza then it isn’t a valid homeopathic remedy and we’ve got ‘em?

    …things to do today: print a sheet of self-adhesive labels for a dozen different bottled homeopathic remedies, and casually drop the sheet near the pharmacy counter in Boots.

  26. stever said,

    September 1, 2006 at 2:23 pm

    probably too late Ben, but i say run with it. its totally fuckig ridiculous.

    regards what can be done – a judicial review could be undertaken if there are sufficient grounds – strikes me that there might well be in thjis case but youd need some heavy duty legal bods and a pile of money. en.wikipedia.org/wiki/Judicial_review
    Its strikes me that several important principles have been violated here – which could provide grounds. Also the consultation proceedure seems pretty lame – had anyone here heard of it? which stakeholders was it sent to. the statutory instruments BTW dont require scrutiny. the bill gets scrutinised and passed the statutory instruments are the detail that is decided after the event.

    The regulatory impact assessment (on the consultation page linked above)is also well worth a read. This is the document that is required to be produced by the relevant department for any new proposed legislation

    “Its role is to perform a detailed evaluation of the potential impacts of this new regulation and establish whether it would have the desired impact. For instance, it is useful to identify potential side effects or unforeseen extra costs associated with this new regulation. It also helps to clarify the cost of enforcement of the regulation. In general, a RIA is created by an independent team of experts hired by the regulation body.” (wiki)

    The RIA itself seems pretty wiffy to me – id be interested to know who was responsible for it.

  27. Ben Goldacre said,

    September 1, 2006 at 3:11 pm

    mm i just didnt think i could write about the exact same thing twice. this is the entertainment industry after all. anyway it’s all over the media today, so in some respects our work is done.

    www.badscience.net/?p=200

  28. clairebio1 said,

    September 1, 2006 at 4:31 pm

    What irritates me is that tje NHS spends money on homeopathy. Let people buy OTC sugar pills and water out of their own pockets by all means but why should my taxes fund homeopathy while other NHS services suffer chronically from underinvestment? Perhaps we should campaign for the OTC homeopathic remedies to be taxed so that some of the cost of running NHS homeopathic hospitals can be recouped (can’t see New Labour closing them) and spent on cash starved, unglamourous areas like mental health.

  29. glutam9 said,

    September 1, 2006 at 4:42 pm

    Glad the flying spaghetti monster has made an appearance. I thought of something along those lines. Ive emailed the MHRA to ask why just homeopathy and not any other old rubbish people care to dream up.. I can see they may have legal trouble in the future if they deny similar rites to other groups of products with similar unproven/disproven levels of efficacy.

    Where does Evan Harris live, I want to live in his constituency…..

  30. Ben Goldacre said,

    September 1, 2006 at 4:50 pm

    oxford west and abingdon. he is a well clever bloke.

  31. AndrewT said,

    September 1, 2006 at 5:21 pm

    Regarding whether anyone can set up their own homeopathic nonsense, unfortunatly, it is not so simple. i met a very senior mhra bod at a conference, and naturally i made him talk about homeopathy. the key criteria is that biobliometiric data is now valid data. that is, if people have written it down in the past, mhra can approve it. so if you want to make your own fancy dan sugar pills, you need to write about them for 10 years, claim literature, and then bingo, onto the market properly. there may be political reasons why they choose to licence certain products…

    he deliberatley said absolutely nothing incriminating against this policy, but his body language suggested he was deeply unhappy with this state of affairs. it was this that lead me to believe that mhra are not that independent of governmental (whoever that may be) policy, and are not that happy about that either. therefore does mhra deserve the kicking people want to seem to give it?

  32. sfluendy said,

    September 1, 2006 at 5:39 pm

    hmm this bibliometric thing is interesting.
    It was pointed out to me that quite a lot of highly useful drugs would never have made the pharamcists’ counters if they had gone through modern testing procedures.
    Aspirin springs to mind. Yes, yes, i know it’s a wonder drug but it’s also dangerous with loads of contra-indications.

    I suppose this past claims things could cut both ways.

  33. clairebio1 said,

    September 1, 2006 at 5:50 pm

    Regarding possible harm from homeopathy, Asthma UK claims that most asthma deaths are preventable and many are due to failure to comply with prescribed medications – chiefly inhaled steroids. I wonder has anybody ever tried – or is it possible – to find out how many of these dead asthmatics were discouraged from using these medications by homeopaths? In the case of adult deaths, you can argue it’s their choice, but every year there are a certain number of child deaths, recorded as asthma. To lose a child is unspeakably awful but to lose one, and then to be told it might have been relatively easily preventable, must be unbearable.

  34. neoteny said,

    September 1, 2006 at 8:11 pm

    According to today’s Times:

    “The MHRA has now taken advantage of a new EC Directive to amend the way homoeopathic products are sold. The changes were introduced by way of a statutory instrument.

    The new regulations say: “An application for a national homoeopathic product is not required to comply with the requirement to submit the results of pre-clinical tests and clinical trials.””

    What on earth is the EC doing? I wonder whether complying with this directive is optional?

  35. neoteny said,

    September 1, 2006 at 8:49 pm

    Further to the above regarding the EC directive, here is a link to the statutory instrument: www.opsi.gov.uk/si/si2006/20061952.htm , where an explanatory note states that::

    “These Regulations make amendments to the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (“the 1994 Regulations”), which implement the provisions of Directive 2001/83/EC on the Community code relating to medicinal products for human use (“the 2001 Directive”)[5] relating to marketing authorisations, to introduce a new scheme for applications for such authorizations for certain homoeopathic medicinal products. Article 16(2) of the 2001 Directive permits Member States to introduce in their territory specific rules for pre-clinical tests and clinical trials of such products.”

    The full text of Directive 2001/83/EC can be found here:
    pharmacos.eudra.org/F2/eudralex/vol-1/CONSOL_2004/Human%20Code.pdf

  36. tom p said,

    September 2, 2006 at 12:14 am

    Neoteny – complying with European directives is not optional. They have to be implemented into national legislation, and as long as the intention of the directive is implemented, then that’s sufficient, it can be done in one or in many pieces as has happened here, otherwise the European Commission will take the government who has not (or has partially) implemented the directive to the european court of justice.

    This happened to Germany with a dfferent part of this directive and Germany lost hands down (no link, but I work for an agency of the commission).

    To be fair to the MHRA (something I’m loth to do since I used to work there), this is not their fault at all, and the press release and Kent’s quotes are them putting the best possible spin on something they *really* don’t want to do. The Times’ use of the phrase ‘The MHRA has now taken advantage of a new EC Directive…’ is disingenuous. The UK governement has implemented the directive and the MHRA is doing what it’s supposed to, which is doing the practical bits of enacting UK and EU legislation within the UK. The government has actually taken as long as they realistically could in getting around to this. 2001/83 was supposed to be fully implemented into national legislation by 31 October 2005, and other parts of the directive have been in place in the UK since way before then. At least they dragged their heels on it.

    If you want anyone to blame, blame the Germans. They *heart* their homeopathy and it will’ve been their lobbying that got the relevant articles into Directive 2001/83/EC. If you want to blame someone closer to home, then try our parliamentary system which didn’t properly scrutinise the legislation and reject these clauses long before 2001.

    Sorry for the long post

  37. Bob O'H said,

    September 2, 2006 at 9:25 am

    “If you want anyone to blame, blame the Germans. ”

    Hiw should the Daily Mail react to this? Bash woo, or bash the Germans? Quandries like these show how difficult tabloid journalism can be.

    Bob

  38. Dean Morrison said,

    September 2, 2006 at 3:42 pm

    Seems to mean you could interpret the directive in whatever way you want to – the rules for states with a ‘homeopathic tradition’ can be different for example (do we count as a having a homeopathic tradition?)

    Look at his carefully:

    (7) The concepts of harmfulness and therapeutic
    efficacy can only be examined in relation to each
    other and have only a relative significance
    depending on the progress of scientific
    knowledge and the use for which the medicinal
    product is intended. The particulars and
    documents which must accompany an
    application for marketing authorization for a
    medicinal product demonstrate that potential
    risks are outweighed by the therapeutic efficacy
    of the product.

    (8) Standards and protocols for the performance
    of tests and trials on medicinal products are an
    effective means of control of these products and
    hence of protecting public health and can
    facilitate the movement of these products by
    laying down uniform rules applicable to tests and
    trials, the compilation of dossiers and the
    examination of applications

    —————–

    semms to me that they could have insisted on trials to prove efficacy if thay had wanted to.

  39. TB said,

    September 2, 2006 at 8:11 pm

    Suggest Tom P reads it. Directives contain guidance about which must be implemented and which can be decided by national governments. In this case, the implementation of homeopathy rules was optional as Neoteny says. MHRA came up with six options to government and highlighted the one they thought best (that was the one just implemented). The six options included doing nothing.

  40. Delster said,

    September 4, 2006 at 11:31 am

    well i’ve come into this a bit late but looking through all the previous comments i don;t think anybody has picked up on this one yet. In Ben’s posting of the release section 5 says

    “5. The MHRA is the government agency that is responsible for ensuring that medicines and medical devices work, and are acceptably safe. We keep watch over medicines and devices, and we take any necessary action to protect the public promptly if there is a problem. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks.”

    Surely the key sentance here is the first one which say’s “ensuring that medicines and medical devices work, and are acceptably safe”

    Now nobody can argue that the sugar pills are safe (unless your diabetic maybe?) as they effectivly have no active ingredients but i’m fairly sure they could be hung out to dry on the first bit about them having to work…….

  41. prescience said,

    September 6, 2006 at 5:43 am

    Ben,

    Please don’t drop this one.

    What next – the MHRA enhancing consumer confidence in bear gall bladders, tiger penises and rhinoceros horns?

    I agree with sfluendy: we should get the noodly appendage of the flying spaghetti monster (www.venganza.org (and that’s a url worth translating into English)) endorsed by the MHRA as valid therapy for, well, everything really.

  42. three tigers said,

    September 12, 2006 at 1:26 pm

    I loved this part of the press release the most

    “…treatment and relief of minor, self-limiting conditions…”

    I think the “clue” for all those with more money than sense (users of homeopathy, traditional chinese quackery, etc) is the term “self-limiting”. Hint: these things get better on their own!

    Interestingly, here in Switzerland which is a hot-bed of homeopathy and other related clap-trap (German influence perhaps), homeopathy has just stopped being supported by the basic obligatory part of our heath insurance. So now at least you have to pay for it yourself or include CAM in your optional-extras cover.

  43. tom p said,

    September 19, 2006 at 12:48 pm

    Dean
    That bit is from the whereas (and not even the bit about homeopathy), which is just a preamble accepting the basic criteria.
    It’s in the articles that you have to look to see what must be done

    Elsewhere in the whereas, you should see #22. For articles, see #13 – #15, specifically #13.2:
    “Member States shall establish a special simplified registration procedure for the homeopathic medicinal products referred to in Article 14.”

    Interestingly, in article 14, which defines the products for which this simplified registration procedure is available, it states
    “no specific therapeutic indication appears on the labelling of the medicinal product or in any information relating thereto”

    This contrasts, at least for me, with the MHRA’s press release:
    “… companies will be allowed to include information about the treatment and relief of minor, self-limiting conditions based on the use of the product within the homeopathic tradition. For example, labels may indicate that a product may relieve the symptoms of common colds and coughs, hay fever or chilblains”.

    I think I’ll have a word with some friends in the commission, since a few of them are around today, about whether or not they think the 2 are compatible.

    TB – suggest you stop being such a sarky git when you don’t know what you’re talking about

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