Thursday, 22 December 2016

Norway and Homeopathy

Currently, Norway has no specific legislation relating to homeopathic medicines. This is will change and will have major implications for Norwegian lay homeopaths.

Norway and the European Union
Although Norway is not a member of the EU, it is a member of the European Economic Area. In short, Norway implements much of EU law in order to gain access to the European Single Market. It has some key exemptions though that relate to fisheries and agriculture.

Regulatory Background
Norway does permit the practice of alternative therapies by the non-medically qualified although this is a recent innovation. Lov om alternativ behandling av sykdom mv (Law on Alternative Treatment etc) is the law in question. Fortunately, Google Translate does a very good job of turning it into English.

The key point about this law is that it prohibits the non-medically qualified from  -

  • Performing treatments or interventions that carry a serious health risk
  • Treatment of communicable diseases (although it does permit treatment to alleviate symptoms there of or side effects of conventional treatment - but only a medical professional can treat the disease itself.
  • Treatment of serious conditions and diseases (although, again, alleviation etc are permitted)
Where Norwegian law differs from UK law is that it makes doing any of the above a criminal offence, carrying possible fines and prison sentences. It also regards a patient not seeking proper treatment as the fault of the non-medical practitioner as well as making ignorance of putting a patient at danger inadmissible as a defence.

There are also restrictions on advertising which can only be a factual description of the business.

Norwegian medicines law does make mention of homeopathic medicines. Lov om legemidler m.v. (legemiddelloven) (Law on Medicinal Products, etc (Medicines Act)) is the main law but it doesn't explicitly mention homeopathy. Forskrift om rekvirering og utlevering av legemidler fra apotek (Regulations relating to the requisition and provision of medicines from pharmacies) mentions homeopathic medicines very briefly to say that they must carry a statement that the effects of the medicine are not "considered" or "rated". It talks in terms of homeopathic medicines that are available without prescription.

Forskrift om legemidler (legemiddelforskriften) (Regulation on Medicinal Product (Medicinal Products Regulations)) is probably the most important law. It came into force in January 2010. Again, Google Translate does a very good job of making sense of it. Some of it is very familiar, which is unsurprising. A cursory examination of the references reveals reference to EU Directives.

The law requires medicines to have a Marketing Authorisation. There are exceptions. The most important from the perspective of this article are -

  • Magistral formulas - medicines compounded by a pharmacy on according to a specification provided by a customer (although the nature of that customer is not clear ie medical professionals only?)
  • Officinal formulas - medicines compounded by a pharmacy in accordance with a pharmacopoiea for dispensing to customers of the pharmacy only.
  • Homeopathic medicines - providing them meet specific requirements.

This law allows the import of homeopathic medicines into Norway as long as they are registered in another EEA member country for a period of seven years. It also creates a Simplified Scheme for the registration of homeopathic medicines in the same manner as EU regulations. Norway does not have any homeopathic medicine manufacturers itself.

It places restrictions on the advertising of homeopathic medicines. As no claims are permitted, essential only flat lists are permitted.

Although the law provides exemptions for doctors and dentists to obtain medicines other than authorised/registered in Norway, in the case of homeopathic medicines it only allows those registered in other EEA member states.

It's also worth pointing out that Norway takes a strong line on the personal importation of medicines - effectively only allowing what is authorised/registered in Norway . Medicines can be seized and destroyed.

What is about to happen?
The seven year period is about to expire on 12/01/2017. The Statens legemeddelverk (SLV) will publish a list of homeopathic medicines registered up to that point. After a three month transition period, anything not on that list will not be permitted to be sold. How many registered homeopathic medicines will be on that list is unknown. Whilst the registration fees are set at a nominal level, the preparation of documentation is onerous (even if SLV will accept English). Norway is a small market and homeopathy is much less common than some other EEA member states. It does not seem likely that many products will be registered.

The supply of homeopathic medicines could be restricted to a handful of products. This has implications for both lay and medical homeopaths. It could make practice very difficult if not impossible.

Update 03/04/2017
The SLV has now published the list of registered homeopathic medicines. 
Hom√łopatiske legemidler tillatt omsatt etter 1.7.2017 - laveste fortynningsgrad
Is what you mean to look at. The associated news item states that these will be the only permitted homeopathic medicines in Norway come the 1st July 2017.

The number, 420 (excluding variations in potency) is surprisingly high - more than the UK. As applications for registration can be made in Danish, Swedish and English, it's no surprise to see products from a Swedish manufacturer, but Austrian and German? It's not known what language their submissions were made in. It may be the case that those manufacturers had already prepared dossiers for registration in other countries (e.g. Denmark and Sweden, both of which are bigger potential markets than Norway) they could simply reuse them. What is telling is that Boiron could not be bothered to register any products. Nor could any of the UK manufacturers. Perhaps Brexit and being outside of the Single Market represented too much risk for them? Speculation is pointless.

Further analysis of the list is required and the SLV do need to be asked some questions but in general, homeopathy practitioners should be happy with the outcome. 






4 comments:

  1. A tragedy for the ordinary citizen. It is totally an initiative created by the pharma/ medical community to control the use of safe remedies and make a sick world that they can manipulate with bad drugs that are dangerous and proven so. Just awful.

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  2. No, you are completely wrong. It transcribes an EU Directive into Norwegian law that was the result of lobbying by the big French and German homeopathic medicines manufacturers. It suits them very well even if it doesn't suit others. It imposed recognition of homeopathic medicines onto countries that had no tradition of homeopathy.

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  3. Hi, I'm 'den hud' (glocid.com) who asked you on Twitter about regs today. Thanks for your reply and looking forward to your findings on USA laws. You're correct about Federal vs State conflicts. A starting point might be New Mexico's Unlicensed Health Care Practice Act http://nmcaamp.org/nm-legislation/ . I'm retired and no longer hold a license so it suits me just fine. But what I'm puzzling over is not 'practice' but marketing regs. After studying this byzantine mess a few days, I decided to (temporarily) pull my human meds off the Ultras page 'til I get a better view. Better safe than sorry. What do you make of Criteria 6 and 9 here http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm103340.htm ? I'll keep checking back- thank you.

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  4. Thank you for the comment.

    It's the complexity of Federal vs State that has kept me from writing about US regulation. Marketing regs do vary from State to State but there are regulations at the Federal level. Who can practice medicine is even more confusing as it is regulated at a State level and the laws can be contradictory and confusing. For example, in some States only doctors can practice medicine but medicine is defined as what doctors do!

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