By David Skinner, Association Manager, Canadian Homeopathic Pharmaceutical Association
In the global context, Canada is a very small market, but the dynamics are no different than in other large markets like the United States. Above the 49th parallel, there are professional critics of all things falling outside the modern science model of support such as traditional medicines and homeopathic products. There are organizations that pressure the government to remove any product not aligned with a narrow clinical trial interpretation of evidence. And there are constantly changing regulations that influence what types of products people can choose for their own health. But there are opportunities as well.
The palpable paranoia that sometimes accompanies debates around homeopathic remedies often overshadows the fact that in Canada there are nearly five million people who have used homeopathy to help manage their health (the population of Canada is only 37 million). That represents a significant cohort where the proof of real-world effectiveness is self-evident, and that is truly encouraging. For beyond the basic analysis of market opportunity lies an untapped energy to keep homeopathy alive and well. It is this potential for balance that has led to the formation of two homeopathic coalitions: one national and the other in Quebec, where the French language thrives and communications take on an added dimension. These groups were formed out of a desire to support the freedom of therapeutic choice for Canadians and to defend the right to access homeopathy.
The coalitions’ efforts to achieve a balance between critics and supporters in the court of public opinion have been challenging; they also have potential to bring some counterbalance to regulatory pressures that seem to arise like clockwork. All over the world, drug regulators face pressure to eliminate or reduce homeopathic medicine’s footprint in the marketplace. Canada is no different, and over the years there have been many legislative and regulatory events that could have dealt a critical blow to the sector.
Evidence-Based or Science-Based Regulatory Standards?
The ongoing tension between applying strict science, as defined by the “gold standard” of clinical trials, and the use of a broad array of supporting evidence may be observed as influencing the approach to regulating health products. This debate has been accented by cultural shifts in Health Canada, the department of the Government of Canada responsible for national health policy (and likely in other competent regulatory authorities around the world). Once a proud “evidence-based” regulator, new leadership has chosen to drive toward becoming a strictly “science-based” organization. The subtlety of this difference may seem slight to some but to many, this narrowing of the fundamental philosophy of how the government acts can hold devastating consequences. To understand where we are now, a brief glimpse at how we got here may help.
When the Natural Health Product Regulations were introduced nearly 20 years ago, homeopathic products found a new home. The regulations were born from a public demand for greater flexibility in the application of standards of evidence for lower risk health products and that public support persists. In fact, the mission of the government administration for Natural Health Products (NHPs) is “to ensure that Canadians have ready access to NHPs that are safe, effective and of high quality while respecting freedom of choice and philosophical and cultural diversity.” That mission statement, while unchanged, has been supplanted with increased verbiage connected with a science-based evidentiary standard. Without continuous stakeholder pushback toward a broader toolkit of evidence, there is bound to be consequences for many traditional medicines and other health products.
Despite the more inclusive context for lower risk products, there are always attempts to add even more regulatory burden to what is already a highly regulated sector. For example, Health Canada has been developing a Self-Care Framework (SCF) that intends to bring OTC and NHP products into alignment with respect to standards for labeling, quality, and evidentiary requirements. This harmonization effort has, at its core, a principle of applying the same risk-based approaches to all similar health products. There is a potential for applying the standards of evidence required for an Rx-OTC switch to NHPs if this SCF policy is dominated by the noted cultural shift. However, one might easily argue that the broader array of evidence afforded NHPs could also be applied to OTC products. The latter is a preferred direction for most NHP stakeholders, but all can agree that it must be a risk-based system. The risk-based decision framework has become an internationally recognized way to adapt government rules to diverse types of products and is now seen as a regulatory “best practice.”
Upcoming Regulatory Challenges for Homeopathy
The SCF has a critical path extending into 2023, but this year the industry expects to see new NHP regulations that would engender more consistent labelling practices. Starting with a Product Facts Table modelled on the Drug Facts Table already in place for OTCs, the new rules will set out several changes to label content and the way it is executed. Underlying the labelling content proposals is the political imperative for requiring Plain Language Labelling (PLL) on all product packages. Seemingly simple enough, but this is complicated by the inclusion of mandatory fonts and font sizes that put pressure on manufacturers to make changes to packaging that can have large commercial impacts.
Given that Canadian products must label in two languages, a 10% increase in labelling fundamentals could mean a 20% overall impact on label space. Companies must resist increasing package size to accommodate the new rules as the environmental impacts of packaging waste are a real consideration. Similarly, the shelf space issues at retail are intuitively obvious to industry (perhaps less so to regulators). Other labelling challenges are complex but potentially damaging, with repercussions that extend beyond Canada. After all, other regulators can more easily cite government action in another country to support their efforts at domestic change (recalling the Australian “study” and the French government decision on reimbursement).
Looking toward next year, Health Canada expects to re-examine the standards of evidence for all NHPs. They have left this aspect to the end of the critical path, and cynics may infer that it is intended to give the shift from evidence-based decisions to science-based decisions more time to become embedded. Efforts to retain the existing use of Materia Medica and other homeopathic references as the basis for product licenses will have to be strong if the market for Canadian products is to be maintained.
Homeopathic medicines continue to face challenges in many countries. While each country has its own advocacy organizations that hopefully are robust enough to ensure that regulations aren’t devastating to the homeopathic sector, there is an appreciable lack of international foresight and preventative issues management. In virtually every other health sector, there is an international federation where national organizations can come together to share experience, conclusions from environmental scanning, and to develop the necessary plans to manage threats and opportunities. The regulators gather to do exactly this, and it is easily observed that when one country makes a decision, its precedence can lead to regulatory “creep” where another country one-ups that decision and so on until draconian measures are taken and emulated. The homeopathic industry is mature enough to take the next step in its evolution and come together worldwide. Meanwhile, Canada remains dedicated to the need for common-sense regulation based on relative risk and freedom of choice.