By Mark Land, AAHP President
The content in our June 2022 newsletter on regulation turned out quite different than I imagined when we discussed it at an editorial planning committee meeting several months ago. I envisioned the regulatory issue to include several articles from authors around the world, each outlining the regulatory framework for homeopathic medicines in their country or region of the world. We got something different but, in many ways, more interesting.
When I read the articles for this issue together at the same time a theme emerged. It goes something like this: there are forces of change within and outside of homeopathy that are pushing at the edges of current regulatory and clinical frameworks. The articles in this issue are examples of those forces at work. I can’t resist a geological metaphor. Tectonic plates move constantly. Pressures build imperceptibly beneath the surface and eventually erupt in one way or another.
We are passengers on a tectonic wave with little input at the scale of a continent, let alone the world. Homeopathy has been a little bit like that: practitioners, manufacturers, and consumers of homeopathic medicines working in isolation within the clinical and regulatory frameworks of their part of the world. Our authors speak about the implications of change for homeopathic medicine, both at GMP and GCP levels.
Steve Mann in his article writes about the implications of Brexit on GMP operations in the now more complicated cross-border environment between the UK and the EU. In this scenario, manufacturers struggle to find practical ways to deal with the impact of duplicative regulatory requirements caused by UK’s exit from the EU. Robbert van Haselen, on the other hand, makes a proposal that aims to upset the status quo related to risk versus clinical evidence. In his article, Robbert recommends a man-made seismic shift that takes advantage of a gap in clinical frameworks.
In his article, David Skinner of the Canadian Homeopathic Pharmaceutical Association (CHPA) reports on the evolution of the regulation of homeopathic medicines over the past 30 years. There, CHPA has worked with Health Canada to shape the regulatory environment over that time.
Overall, one may perceive an impatience within the homeopathic community to define a regulatory path forward that is responsive to the needs of all stakeholders. This issue is a step toward a global discussion on the regulation of our products.