Anthroposophic substances will no longer be given special treatment in the pharmaceutical legislation in Sweden. Every since 1993, fake treatments made by proponents of anthroposophy could be used without having any evidence of safety or efficacy, and they could even be injected.
Now, the Swedish government has decided to remove this and force anthroposophy proponents to put their substances through the standard approval or registration pipeline. However, the exemption will first be extended for two years, then there will a transition period for three years and only after a total of five years will they be forced to show that their substances are safe and effective (if they want them to be treated like real medication) or just safe (if they want to settle for homeopathy registration and be denied the possibility of making efficacy claims). This is a welcome development and arguably a small victory for science-based medicine, but it could have been done faster. In the end, it is a reluctant compromise.
What is anthroposophy and anthroposophic substances?
Anthroposophy is a weird mix between pseudoscience and mysticism that was founded by Rudolf Steiner in the late 1800s and has since infiltrated medicine, agriculture and education.
Anthroposophic substances are products made by anthroposophy proponents that typically do not have any evidence for efficacy and safety. Often, these involve homeopathic dilutions and due to an exemption in the Swedish law since 1993, these are given a sales permit and can circumvent normal regulations that cover real medication (approval) or fake treatments that have been shown to be pharmacologically harmless (registration). This special treatment will now end and anthroposophy will be treated like other fake treatments and require at the very least evidence of safety.
What is the Vidar Clinic?
The Vidar Clinic is a medical facility located in Järna, which is the heart of Swedish anthroposophy. They are often anti-vaccine and regularity treat patients with real medical problems with fake treatments. They have even gone so far as to spread dangerous misinformation about vaccines and autism, as well as encourage parents to spread measles rashes over the entire body of the infected child.
What does the current pharmaceutical law says about anthroposophic substances?
The current pharmaceutical law called Läkemedelslag (2015:315) has a special exemption for anthroposophic products that had to be renewed on a regular basis. Here is how the 1st paragraph of the 5th chapter of this law explains the requirements for selling pharmaceuticals (my translation, bold heading in original, my bold in the second instance):
5th ch. Requirements for selling of pharmaceuticals
1 § A pharmaceutical product can, if nothing else is stated in the third section, be sold only after it
1. is approved or registered for sale according to 4th ch. 2, 4, 5 or 9 §,
2. is covered by an admission or a recognition or a registration for sale that has been announced in another ESS country according to 4th ch. 6 or 7 §, or
3. is covered by a permit for sale according to 4th ch. 10§ second section.
An anthroposophic substance can be sold only after it is covered by a permit for sale according to 4th ch. 10 § first section.
Pharmaceuticals that are manufactured at a pharmacy for a specific patient, a specific animal or a specific livestock can be sold without such approvals, registrations or admissions provided in the first section 1 and 2.
So what is this special permit in 4th ch. 10 § first paragraph? Here is the relevant section (my translation, bold in original):
Permit for sale in other cases
10 § If there are special reasons, a permit for sale of an anthroposophic substance that is not provided in 4 § be given.
The 4§ covers very diluted homeopathic substances that are given orally or topically (and for which no therapeutic effect is claimed), but this 10 § can cover anthroposophic substances that do not fulfill those requirements, such as substances that can be injected. This paragraph will change on 2017-01-01 for an unrelated reason, but it will not affect this section.
So far, this exemption has been renewed 13 times. But this new decision will change everything….probably…after 5 years.
What does this government decision mean?
The Swedish government decided today to phase out this special treatment of anthroposophic substances over a period of several years. The gist of their decision is this:
(1) Current exemption will be extended for two years.
(2) After two years, a transition period will begin for another three years.
(3) After the transition period has ended, anthroposophic substances will be treated like any other substance: either be approved as a normal pharmaceutical (requires evidence of safety and efficacy) or be registered as homeopathy (requires evidence of safety).
What this will mean in practice is that the special treatment of anthroposophic substances that was enacted in 1993 will be gone after 5 years, and they will be treated like the rest.
Scientific skeptics, and most scientists and doctors, might have wanted to get rid of anthroposophic substances and all fake treatments altogether and that all products that have the government’s seal of approval should have evidence of efficacy. This decision does not satisfy this goal, but it is a moderate victory against nonsense. Sure, it is only about the removal of special treatment for anthroposophic substances, it will require approval in the Swedish parliament and it will take five years to complete. But it is a victory nonetheless.
References and further reading:
Paues, H. (2016). Femårig omställningsperiod för antroposofiska medel. Regeringskansliet. Accessed: 2106-06-30.
Lövtrup, M. (2016). Antroposofiska nekas särreglering. Läkartidningen. Accessed: 2106-06-30.
Kjellberg, C. (2016). Dispensen för antroposofiska medel försvinner. Dagens Medicin. Accessed: 2106-06-30.
Manzoor, A. (2016). Ingen gräddfil för antroposoferna. Dagens Nyheter. Accessed: 2106-06-30.