By Robbert van Haselen, Chair, HPCUS Clinical Documentation Committee; Director, World Integrated Medicine Forum
We currently live in an increasingly polarized world, and this is also reflected in the regulation of Homeopathic Medicinal Products (HMPs). Whilst there are common principles, such as ensuring the quality and safety of medicinal products, regulatory frameworks for homeopathic and conventional medicinal products are distinct in most countries of the world. To a certain extent this is justified; conventional and homeopathic medicine both have their peculiarities as therapeutic systems, and this should be reflected in the standards. However, when it comes to standards for clinical effectiveness, there is only one dominant narrative: that of demonstrating efficacy of a particular medicinal product for a particular indication in randomized clinical trials. However, most agree that this framework is inappropriate if HMPs are prescribed or sold without an indication, and not always appropriate nor economically viable for HMPs that are sold/prescribed with an indication claim.
For HMPs without an indication, there is a simple solution: as long as the product is safe and manufactured in accordance with a nationally recognized pharmacopoeia, it can be allowed on the marketplace. In the European Union, this is for instance reflected in the simplified procedure for the registration of HMPs without an indication (Article 14.1 of the EU directive). This solution effectively devolves the responsibility of identifying the appropriate indication to the practitioner and is appropriate in the context of individualized prescribing. However, it gets more complicated when therapeutic claims are made as part of marketing authorizations, and this brings us back to the polarized worldview: In most countries, therapeutic claims for HMPs are — in the absence of clinical trial data — at best allowed to be very “weak,” accompanied by “downgrading qualifiers,” and only for “low risk” indications. For example, "product x is traditionally used for the relief of a runny nose." The latter is almost more of a descriptor than a claim. Whilst this approach has proven, and is proving to be, useful, it is largely a risk-based approach: effectiveness claims referring to the “treatment” of “diseases” are not allowed, unless the benchmarks as defined for conventional medicines are met.
So the situation in most countries is as follows: on the one hand there is a homeopathic niche, where HMPs are allowed on the market without indication, or for vague low risk indications; on the other hand, there is the treatment of disease with effectiveness standards similar to those for the therapeutic use of New Chemical Entities. This raises the question: is there a possible “third way”?
First, I would like to address the “why” question: some may argue that the current polarized status quo, is perfectly okay and appropriate. I believe we need to look for a third way because the current status in many countries does not do justice to the full and true potential of homeopathy as a therapeutic system for treating diseases, and not just “relieving” minor illnesses and conditions. Apart from this, the current framework forces the homeopathic sector to operate in a niche that is decreasing in size in many countries.
This brings me to the complex question what the third way could look like for the homeopathic sector. As a prerequisite for this, a shift from the current predominantly “risk-based” framework to a “risk-effectiveness based” approach will be needed. Such a framework will need to involve the stratification of risk associated with the effectiveness claim into “risk tiers”. For instance, the WHO and Australian Therapeutic Goods Administration proposed a three-tiered system for therapeutic claims:
- Low (e.g., for relief of symptoms without reference to a disease),
- Medium (e.g., for aiding the management of a named disease), and
- High (e.g., treatment or cure of a specific disease).
It needs to be said up front that the effectiveness standards for high risk tier claims should be very similar to those for conventional medicines. So, the aim is not to propose lower homeopathic quality standards for the same type of high risk tier therapeutic claims. On the other side of the spectrum, effectiveness standards for low risk tier claims could be largely based on standards currently in place in various countries for claims related to traditional use of HMPs. The latter includes traditional and/or other authoritative literature on the clinical use of such products. Taking into consideration the high threshold for high risk tier claims, and the relatively well-established threshold for low risk-tier claims, the third way would involve trying to establish an appropriate standard for medium risk tier claims. This is where, in my opinion, the main opportunities for the future lie.
However, establishing an appropriate effectiveness standard for medium risk tier claims as a complement to the established standard for high risk tier claims will be no easy feat. Such a standard would require high quality comparative studies and could also include other types of studies that substantiate the plausibility of an effect. Contrary to the situation in high risk tier indications, high quality, prospective, comparative, non-randomized studies could be considered as well. Again, it needs to be emphasized that such a standard would be a complement, rather than an alternative to, existing homeopathic as well as conventional effectiveness standards.
Key guiding principles behind a risk-effectiveness framework for HMPs would be that:
- risk on a sliding scale should be accompanied by evidence on a sliding scale, and
- the use of the HMP is compatible with homeopathic principles.
Some groundwork on grading the plausibility of a therapeutic effect based on a multitude of evidence types has been done in Europe. Some groundwork has also been done by the HPCUS; its Clinical Data Guideline for monograph submissions elaborates on the role and quality assessment of different types of clinical evidence.
Most countries around the world are faced with similar challenges around the development of appropriate effectiveness standards for HMPs. Further collaborative work on a modern and proportionate risk-effectiveness framework for HMPs is clearly needed. This will help to ensure that HMPs are available for the increasing numbers of patients that seek safe, sustainable, and effective healthcare solutions.