Saturday, 18 March 2017

Brexit and Homeopathy

Many of laws that relate to homeopathic medicines originate from EU Directives. In fact, UK law contained no references to homeopathy until the EU introduced them. Will have Brexit have any effect on this?

Others have blogged about this too - here and here

Brexit means Brexit
Whatever your opinion on Brexit is, one thing that is very clear is that almost everything is unclear. It's unclear what form it will take. The thorniest question is whether the UK remain a member of the Single Market or negotiate access to it.

Leaving the EU is not the simple process presented by some. 

European Communities Act 1972
It is said by some that leaving the EU is a simple matter of repealing the European Communities Act 1972. This is not the case. It would mean that many laws would no longer have any standing thus creating a huge legal black hole. 

The Great Repeal Bill
The title is a misnomer. It would actually be a Great Incorporation Bill. The idea behind the bill is to incorporate the full language and meaning of (the majority of) EU Directives into UK law where previously laws refer to EU Directives so that the Act 1972 can be repealed and the status quo can be preserved when Brexit actually happens (although not everything can be). The intention is that post Brexit, the process of amending law can begin. However, it is clear that many believe that the Great Repeal Bill offers an opportunity to get rid of EU Directives that they do not like.

The extent to which UK law depends on EU Directives is moot. Various figures are quoted but any existing analysis is likely to be trivial. It's not just a question of searching through legal databases to see which laws contain reference to EU Directives. A specific piece of legislation may make no mention of EU Directives but it may relate to legislation that does.

Nor is the Great Repeal Bill a simple matter of search and replace as this could change the meaning of the law and result in unintended consequences. It will need to done carefully and with much scrutiny.

The Library of the House of Commons has a very good analysis here. It is well worth reading. It makes clear how much is unknown at this stage. One thing that it does not spell out is how long the process of drafting such a bill would take even before it is made law. Nor does it spell out the resources required. How long it would take to pass the bill is unknown. It is entirely possible that the Great Repeal Bill would almost paralyse the drafting and passing of other legislation. The Bill has to come into force as soon as the actual moment of Brexit. That is a very tight deadline.

Whilst it may be tempting to repeal or amend the essence of certain EU Directives from UK law, attempts to so necessarily increase the time and resources required. Various lobby groups are already making noises about repeal/amendment. However, Government has indicated that it would prefer this to occur post-Brexit.

It is not clear is whether the UK will be able to remain within the European Economic Area (EEA) post Brexit as it depends on the "four freedoms". Mainly of those in favour of Brexit oppose Freedom of Movement and it may well prove impossible to remain within the EEA. It wouldn't matter if the UK joined the European Free Trade Association (EFTA) or had a series of bilateral treaties a la Switzerland. It would only be by exception that the UK could be part of the EEA and not have Freedom of Movement and although Brexit negotiations are yet to begin, at the time of writing, an exception is very unlikely to be made.

Being a member of the EEA and having access to the Single Market does require EEA member states to implement EU Directives in their domestic law. This had implications for homeopathic medicines in Norway

Council of Europe
The Council of Europe is not the same as the EU although many are confused about its nature. Although the semi-autonomous European Directorate for the Quality of Medicines falls under the Council's umbrella, it has no important bearing on homeopathic medicines.

Not knowing the form that Brexit will take means that it difficult to predict what effect it would have on UK homeopathy. The most likely scenarios would have little if any impact on the practice of homeopathy but the import/export of homeopathic medicines could be affected.

There is no mechanism for EU wide registration of homeopathic medicines. Registration is at member state level. However, having a product registered in one member state can make the process of registration slightly easier in some ways. This is different from pharmaceutical medicine where a centralised route for marketing authorisation exists via the European Medicines Agency (EMA). As the EMA is based in London, Brexit may cause it to move.

If the UK does not manage to negotiate some sort of trade deal with the EU/EEA, there could well be tariffs applied to homeopathic medicines. Being outside of a customs union does also increase costs because of the administrative requirements. Whilst manufacturing homeopathic medicines would appear to be a profitable business overall, some markets are less profitable than others. UK manufacturers may find it unprofitable to do business in certain EU member states and the reverse could be true as well. 

Good Manufacturing Practice (GMP) certification could become a problem. At the moment, the Medicines and Healthcare product Regulatory Agency (MHRA) conducts GMP inspections which are recognised by the EU. They do cost money. Unless the UK made a mutual recognition agreement with the EMA, exporting to the EU would require GMP inspection by another EU regulator and vice versa. The cost could be passed onto consumers but...

The regulations relating to homeopathic medicines are couched in terms of them being defined by the method of preparation as documented in EU/EEA member states' pharmacopoeias which basically means the French and German ones. There was a UK homeopathic pharmacopoeia produced by the Faculty of Homeopathy but it has not been updated in many years. It is also very difficult to get hold of. However, not all homepathic medicines are prepared by the general methods. Which is permissable if a monograph exists in a homeopathic pharmacopoeia that desribes the method for a particular product. There is nothing to prevent regulations referring to the homeopathic pharmacopoeias of other countries as validation but it's hardly "taking back countrol".

The veterinary cascade also makes reference to products licensed in other EU/EEA member states but given the uncertainty in where homeopathic products fit in the cascade, it is moot whether there are any implications.

Amendments to Law

It is not clear what amendments UK homeopathy would want. Which is very similar to the situation back in 2012 when the consolidation of medicines regulation took place. Some of the issues that upset UK homeopathy have nothing to do with EU Directives or even legislation, for example, the Advertising Standards Authority (ASA).

It is very unlikely that Government would consider amendments to the law regarding homeopathy a priority. In reality, the use of homeopathy in the UK is very low. There are no votes in it. Whilst it might be thought that CAM groups working together might have a better chance of lobbying Government, different groups have often very different goals. 

Regulating homeopathic medicines in a similar way to medicines could be seen as giving some "official" status to homeopathy as a whole. That it has unfortunate consequences regarding legal supply is conveniently ignored. UK homeopathy might wish for a different system of regulation of homeopathic medicines - for example, a system that licenses manufacturers rather than products. Given the nature of homeopathic medicines i.e. that they are inert lactose and/or sucrose pillules (barring contamination, etc) it would be more expedient to de-recognise them as medicines and treat them as food. But that loss of status is difficult for UK supporters of homeopathy to swallow and could open up the homeopathic medicines market to almost anyone. EU Directives forced recognition of homeopathic medicines onto the UK, so Brexit would allow a change to how they are treated. 

"Official" recognition seems very important to some of UK homeopathy. Recognition of the practice of homeopathy would doubtless involve statutory regulation. This has nothing to do with EU Directives. Indeed, variations in who is allowed to practice medicine across member states demonstrate this quite clearly. In some countries such as France only doctors etc are permitted to practice medicine, in others anyone can (subject to certain restrictions) and then in Germany, there is recognition of Heilpratik.

Marketing claims for homeopathic medicines - and by extension - homeopathic services are legally restricted by both medicines and consumer protection law. Whilst both certainly do incorporate EU Directives, both existed in a similar form before the UK joining the then Common Market. In fact, it could be argued that UK law strongly influenced certain EU Directives. Arguments for special treatment of homeopathic products and services in law fail on the basic principle of natural justice. It would create a bias in law in favour of homeopathy. Which would also be anti-competitive. It is extremely unlikely that any Government would seek to dilute consumer protection post Brexit. A reversion to caveat emptor is very unlikely. It would be seen as a very regressive step - consumer protection is one of the hallmarks of more advanced nations. Something that may need pointing out to US readers is that in the EU and other countries, the advertising of prescription medicines to the public is totally forbidden. As is the promotion of any medicine that is not licensed/registered.

Brexit is extremely unlikely to have any significant effect on the Advertising Standard Authority (ASA) or any other voluntary self regulatory body. Best practice is different from the law.

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