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New Academy statement on homeopathic products
The Royal Swedish Academy of Sciences has made a critical statement concerning a report from the Swedish Medical Products Agency (MPA) on homeopathic products. The Agency's report is based on an EU Directive on Medicinal Products which gives Member States the possibility to impose national directives on preclinical studies and clinical trials for the approval of homeopathic products as medicinal products.
The Agency proposes the incorporation of anthroposophical homeopathic products in the Swedish directive on medicinal products, which the Academy opposes as it would run counter to several of the fundamental principles regarding medicinal products and evidence-based medicine. The minimal administrative gains of such a decision do not in any way compensate the negative effects of the message this would convey, namely that medicinal products need not be evidence-based and that even totally implausible preparations may be called medicinal products.
For the general public as well as in the medical products directive, the term 'medicinal product' (in Swedish: 'läkemedel' = healing substance) is associated with substances that (alone or in combination) have been found to have clear effects to cure, relieve or diagnose disease or symptoms of disease, and have been examined in controlled trials regarding safety. If the term 'medicinal product' is used also for products that lack scientifically documented effects, this may over time lead to very serious consequences for the use of such products and may lead to both excessive and insufficient use. The Royal Swedish Academy of Sciences therefore opposes using the term 'medicinal product' for substances that lack scientifically documented effects.
If any anthroposophical product might be considered to have effects justifying its use for treatment of disease, it should be evaluated by the same standards as other candidate drugs.