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Simplified authorisation Insights into complementary and herbal medicines

When it comes to the authorisation of medicines, the three requirements of quality, safety and efficacy are repeatedly mentioned. Do these requirements also apply to complementary and herbal medicines (CHMs)? We asked Martin Ziak, Margot Spohn and Bilkis Heneka from the CHM Team at Swissmedic. What is the status of CHMs in Switzerland, how do the requirements for CHMs differ from those relating to synthetic medicinal products, what are the various dispensing categories and how does the future look for complementary and herbal medicines?

The basics

Complementary and herbal medicines are very popular and widespread in Switzerland, accounting for almost 20 percent of the 8,000 or so authorised medicines with an indication. To this can be added a further 11,000 authorised complementary medicines without an indication and used for individual therapy. Many complementary and herbal medicines are assigned to dispensing category D and have consequently become an important mainstay for druggists. The latter have also made an active and necessary contribution by raising people's awareness of these medicines", explains Martin Ziak, Head of the CHM division at Swissmedic.

Simplified authorisation

Basically, the requirements applicable to synthetic medicinal products also apply equally to complementary and herbal medicines: Quality, safety and efficacy must be guaranteed. "However, the latter can be authorised in a simplified procedure according to the Ordinance on Complementary and Herbal Medicinal Products", explains Martin Ziak. "As evidence of safety and efficacy, the applicant can refer to published literature data, for example scientific publications."

"These medicines can be authorised in a simplified procedure according to the Ordinance on Complementary and Herbal Medicinal Products."
Martin Ziak

The active substance

Margot Spohn explains some of the relevant issues: "Complementary and herbal medicines often contain several active substances. Over 2,000 different starting materials exist in homeopathy, each of which can be used to prepare numerous potencies. The key question that arises here is whether combining active substances is justifiable. For example, certain substances may not be combined from the homeopathic standpoint." The situation is different for herbal medicines: "In contrast with synthetic medicinal products, herbal medicines do not contain any pure substances as active ingredients, but rather mixtures with many substances, for example herbal extracts or essential oils. This is a particularly complex situation, and one that plays a crucial role in the authorisation of herbal medicines", explains Bilkis Heneka.

Bilkis Heneka und Martin Ziak — Bilkis Heneka and Martin Ziak

Dispensing category

Key factors are the indication, the dosage and the dosage form – most complementary and herbal medicines are classified in dispensing category D. This means that they are available for self-medication, as supportive treatment or for relieving symptoms. "Only a small number of complementary and herbal medicines require a prescription", says Martin Ziak: "One example is Sativex, a mouth spray used in multiple sclerosis – because of the indication, this product is available only on prescription. As active substances, this medicine contains two cannabis extracts. Since the THC content exceeds 1 percent, the medicine is also subject to the Narcotics Act." Another example: mistletoe preparations used in anthroposophic medicine. These are used to support a cancer treatment or as homeopathic medicinal products containing potentially toxic substances at a low potency – i.e. they are only slightly diluted.

Differentiation

For medicinal products, a health claim may be made only if it has been reviewed and approved by Swissmedic. This does not apply to nutritional supplements, which do not fall within Swissmedic's remit. One feature that differentiates them from nutritional supplements, is that medicinal products display a Swissmedic "vignette" and a five-figure authorisation number on the packaging. To illustrate the difference, tea is perhaps the best example: If a curative effect is stated, for example "for the relief of mild gastrointestinal symptoms", this is classified as a medicinal tea and must therefore satisfy the requirements of the Therapeutic Products Act.

Developments

Margot Spohn, Bilkis Heneka and Martin Ziak all agree: "The Swiss public is very interested in herbal and complementary medicines, and this trend is also monitored with interest by politicians." Nevertheless, the number of authorisations of the corresponding medicines, particularly herbal medicines, has declined in recent years. It is often for market-related reasons that marketing authorisation holders decide to drop a medicine. The authorisation requirements have remained unchanged following the revision of the Therapeutic Products Act in 2019; in other words, simplified authorisation is still possible for these medicines. Furthermore, the fees for these medicines are much lower compared to those for synthetic medicinal products, and have only been moderately raised for CHMs. However, it is primarily the competition from nutritional supplements and medical devices that presumably discourages the authorisation of complementary and herbal medicines. The fact that the marketing authorisation holders are, in many cases, small and medium-sized companies also has to be taken into account.

Heilkräutergarten Albinen — Photo taken in the herb garden in Albinen, Valais

The team

Martin Ziak has a doctorate in biochemistry and conducted basic medical/biological research at the University Hospital of Zurich and worked as a lecturer. He has worked at Swissmedic since 2009, initially as a unit head and, since 2015, as head of the CHM division. Margot Spohn is a biologist and used to work in the authorisation and quality assurance department of a manufacturer of complementary and herbal medicines. Since 2002, she has been working in various roles at Swissmedic for CHMs and has been involved in all developments relating to CHMs.

Bilkis Heneka has a doctorate in biology and used to work in the production department of a manufacturer of complementary medicines. Since 2004, she has worked at Swissmedic as a Quality Assessor for CHMs. In 2018, she also assumed the role of deputy head of department. A total of 12 specialists work in the CHM division. During an average working day they deal, for example, with authorisation and variation applications for CHMs and address the associated issues. In addition to the day-to-day business, great importance is attached to interactions with stakeholders, other authorities and the public.

Differences

As active substances, herbal medicinal products contain one or more herbal substances or preparations derived from these, which involve multi-substance mixtures obtained from plants or defined plant parts. Examples: dried and fragmented plants or plant parts, tinctures, dry extracts, essential oils.
Complementary medicines are based on a particular therapeutic approach based on complementary medicine, for example homeopathy, anthroposophic medicine or Asian medicine. They are manufactured according to the specifications of the respective school of therapy, and the indications are determined accordingly. The active substances can be herbal, mineral, chemical or animal in nature and are used in concentrated form or in dilutions of differing strengths (potentised according to homeopathic principles).