By Mark Land, AAHP President
David Skinner of the Canadian Homeopathic Pharmaceutical Association recently wrote that there is a need for an international coalition of homeopathic associations. He makes this recommendation based the perceived need to monitor and respond to the international implications of actions taken by individual regulators. David speaks of “regulatory creep,” a phenomenon whereby regulatory authorities accelerate implementation of mechanisms of control in response to the actions of colleague agencies.
There are multiple associations of regulatory authorities, including the International Conference of Drug Regulatory Authorities, (which is sponsored by the World Health Organization) and the Canada-United States Regulatory Cooperation Council. There is also a memorandum of understanding between Health Canada, US FDA, and Mexico on scientific and regulatory fields of health. It is worth the time to browse the proceedings of these initiatives.
There have been attempts in recent years to gather the international homeopathic community around regulatory topics. These conferences were attended by representatives of health authorities as well as scientists in the field. Different speakers addressed the current pharmacopeia structures in various countries, variance in pre-market approval process, regulatory frameworks for homoeopathic medicines, labelling requirements, safety requirements, marketing approaches, and good manufacturing practices. Debates focused on quality control testing, stability of intermediate stocks, shelf life of finished products, pre‑market approval process, and labelling, and they shed light on regional differences in regulation. The conclusion was to reconvene to discuss specific topics.
David speaks of blunting the impact of draconian regulatory measures implemented by an unapproachable regulatory authority. There is a bit of pessimism in that thought, in that it assumes brittle engagement with regulators. To my delight, he recovers buoyancy in the next sentence by saying, “The homeopathic industry is mature enough to take the next step in its evolution and come together worldwide.”
I agree with David that if the homeopathic community was to abdicate from engagement with health authorities on unresolved scientific and regulatory issues facing homeopathy, we would expect a creep toward models designed for other categories of healthcare products. I depart from David on the launching-point, however. Instead of limiting our aims to protecting in-place systems to which industry has adapted, we should also consider the aims and perspectives of regulatory authorities: principally, the protection and advancement of public health. With these aims, we place ourselves in the same conversation with our health authority colleagues.
An international coalition is more possible today than even a few years ago. David states, “All over the world, drug regulators face pressure to eliminate or reduce homeopathic medicine’s footprint in the marketplace.” Another way to think about this is that regulatory authorities are addressing public health issues related to the populations they serve. That said, several factors—including the globalization of homeopathy, the recent de-reimbursement of homeopathic medicines in France, and the implications of Canada’s Self Care Framework—may act as the springboard necessary to catalyze momentum behind an international coalition. This is a topic I will take up with the AAHP Board in upcoming meetings.