What is the legal status of ambroxol and/or bromhexine in the uk?

dear community of folks interested in parkinson’s disease,

i have checked and neither ambroxol nor bromhexine seem to be listed in any of the uk official registries of drugs that can be used in health care. (but perhaps i did not search correctly?)

however, they are easily available over the counter (or perhaps even on the shelf without needing an assistant to hand them over the counter?) in many countries in europe.

what is the reason for this difference?

is it legal for someone in the uk to order ambroxol or bromhexine from businesses located across the channel? is it legal for the buyer? is it legal for the seller? is it legal for the buyer in the uk to then hand the drug to someone else (e.g., their partner) to use?

thanks for any helpful information you can provide on any one of the questions above!

with my best wishes,

joe

Hi Joe, there is at least one drug trial on at the moment for ambroxol. They have to go through due process before a drug can be approved for use for PD, I believe
Neil

thanks, @NeilT. sorry, i should have made clear that i am aware that it hasn’t been approved (anywhere in the world) for parkinson’s.

i’m wondering about the legal status of trying to use it in the uk now. i’ve seen lots of messages from people saying they’re trying ambroxol in the uk anyway, ordering it from wild-and-crazy places like … germany. (who knows, perhaps they have a really bad cough and they’re using ambroxol for its approved (but only outside the uk) purpose.) are these people all lawbreakers? if it is a crime, what level is it? if someone who has difficulty with the computer keyboard asks their partner to order some “german cough medicine”, is this legally a conspiracy? is there a prison wing where the dangerous ‘parkies’ are held?

Hi @parkiejoe , :wave:t5:

Welcome to the forum. :slightly_smiling_face:

Apologies for my delayed response; however, I wanted to clarify a few things with my colleagues before I responded to you.

Here’s some news on ambroxol we shared earlier in the year. While past trials have shown promise, there is still more research needed to show if ambroxol can be a safe and effective treatment for Parkinson’s. This includes safe testing of dosages and frequencies. We have also searched for any evidence on bromhexine and can’t find anything robust to say it’s a safe potential treatment for people with Parkinson’s

Therefore we don’t recommend anyone take any medications without a prescription. If you have any questions, please contact our research mailbox at [email protected]

I hope this helps.

Best wishes,
Reah
Forum Admin

@Reah, thanks very much. i’m sorry, i should have made it clear that i would be completely surprised to find parkinson’s uk recommending using a drug that has not been approved in the uk and that i was not asking about that at all.

my question is solely about the legality of people in the uk using ambroxol or bromhexine. because many people have reported on this forum that they are interested in using it or already are using it by ordering it from far-away countries like germany, i guessed that some people who read this forum might have some knowledge about the relevant uk law.

does anyone on this forum know what the legal situation is? how many minutes/hours/days/months/years/decades can you be sent away for if you get caught ordering “german cough medicine”, especially if it is in large quantities?

Hi @parkiejoe, :wave:t6:

We’ve sought some advice from a pharmacist on this and they’ve shared this.

Technically, this would be an unlicensed and unproven drug, as the clinical trials are still ongoing. As part of the trial they test dosage, formulation and suitability around gender, age and comorbidities. Drugs on clinical trials may not make it to full licensing and if they do, they may not be suitable for everyone, due to various drug interactions etc. So, in addition to potentially being illegal, such drugs may not be safe.

We would always encourage anyone who doesn’t feel their medication is working
to speak to their prescriber.

Best wishes,
Reah

@Reah thanks for your message.

i’m not quite sure why my question seems to be unclear to everyone. i am not asking about whether taking ambroxol is advisable, recommended, suitable, etc. i am only asking whether it is a crime (perhaps the word should be “offense”?) for a person P to engage in the following actions:

  • from within the uk, ordering ambroxol from a supplier outside the uk, to be delivered by post or parcel service, for P’s own personal use, or for the use of a member of P’s immediate family who lives in the same household as P.

note that this is a separate question from whether it is a crime for a person Q outside the uk to supply the ambroxol via post or parcel service to the person P mentioned above. it might well be a crime for Q but not for P, because laws are often like that.

I have been looking through the The Human Medicines Regulations 2012 for hints as to whether the activities of the person P above are a crime. for example, i found this at 17.(6):

Paragraph (1) does not apply to a person who imports a medicinal product for administration to himself or herself or to any other person who is a member of that person’s household.

but it is very hard to figure out the scope of this exemption.

i would have guessed that because there are many people at this forum who report importing and using ambroxol, that hopefully one of them might know.

has anyone here worked out the legality of this?

thanks for any help you can provide!

best wishes,

joe

Hi @parkiejoe, :wave:t5:

Your question needs specialist legal advice which I’m afraid we’re not able to provide. However you might want to write to the Medicines and Healthcare products Regulatory Agency who may be able to give you an answer.

Best wishes,
Reah

Parkiejoe,
Did you ever get an answer to this?

@Jellywoman,

no i haven’t had energy to pursue it. there does seem to be a genuine exception for importing the drug for yourself, but i don’t know if another law would still make it illegal. for example, if person X in the uk convinces person Y outside the uk to send them some ambroxol, is this act by person Y an offence against uk law and then person X’s act becomes inciting person Y to commit an offence which might be an offence itself. someone with uk legal training would need to check for various possibilities like this.

i had been hoping with my original posting that someone else might have done the necessary legal checking. but if someone has, they are not posting their knowledge here.

best wishes,

joe