By Len Monheit
How many times have we heard it - 'The Times they Are a-Changin' or 'just wait until' or the merely a simple 'SOON'. And in the meantime, what's a company to do in an environment that is so uncertain, so dynamic and so filled with potential?
I speak of course, about the international regulatory environment for natural products, herbal medicines and dietary supplements. I use all these terms consciously, as they are an excellent indication of the conundrum facing not only industry, but also legislators and regulators around the world attempting to manage the category, and 'presumably' intending to provide widest access to safe and effective products.
I've used this column in the past to talk about regulations, including topics as diverse as Codex and the EU Supplements Directive, to the 2003 Pan Pharmaceuticals recall of products triggered by an OTC medicine quality issue that has brought herbal medicines quality, safety and efficacy into a critical spotlight in both Australia and New Zealand. In the US, industry awaits FDA's final GMP's with bated breath (we'd have perished long ago if we'd been actually holding our breath), and in Canada, January 2004 marked the beginning of a new regulatory era with the new Natural Health Products Directorate of Health Canada issuing its regulations concerning the category, including product licensing, site licensing, standards of evidence to support claims, Adverse Event Reporting requirements, clinical trial requirements, and the ability (actually need) to make a claim for each product.
So why talk about the regulatory environment now?
Well, in the past few days, the 'sands' of regulatory status may have shifted again, at least in Australia and Canada. Let's deal with Australia first.
As many will recall, in April 2003, contract manufacturer Pan Pharmaceutical had their manufacturing license revoked, triggered by a quality issue regarding an OTC sleep product. In the ensuing weeks, over 1600 products were recalled (around the world) including many Complementary Medicines. Part of the fallout from the investigation was a critical examination of herbal medicine quality and safety issues, leading to the formation of an Expert Committee on Complementary Medicines in the Health System. This committee tabled its report in September of 2003 (http://www.tga.gov.au/docs/pdf/cmreport.pdf ), making 49 recommendations.
Earlier this week, the Australian Therapeutic Goods Administration (TGA), responded to the committee, accepting pretty much all of the committee's recommendations (http://www.tga.gov.au/cm/cmresponse.pdf ), many of which would presumably be applied also to New Zealand, under the trans-Tasman therapeutic products regulatory agency. The commitments proposed by the TGA include:
- ensuring that quality standards for ingredients are introduced and are legally enforceable
- ingredients that raise concerns for teratogenicity are not permitted
- guidelines will be presented to support claims and sponsors will be required to submit evidence consistent with new guidelines for both new and grandfathered products
- an increase in penalties
- special review and considerations for homeopathic remedies
- stepped up enforcement activity and adverse event reporting awareness
- increased education
- better control and regulation of complementary practitioners
- identification of research needs, and the intention to make additional funding available, as well as the identification of centres of excellence, establishment of formal links with international centres, and strategies to encourage innovation and research including data protection and market exclusivity
So what will the net effect of these decisions likely be? At this point, consultation with stakeholders will be required, but it is clear that a process has been initiated that will ultimately tighten the rules and a spotlight has been placed on complementary medicines. It is ironic, once again, that the impetus for all of these activities, was a quality issue involving a product that was not even in the category.
Now cross half the globe to Canada.
We are less than eighteen months into a new regulatory environment and already a serious battle is emerging that could impact the future of natural health products regulation in Canada. Health Canada's Natural Health Products Directorate had proposed a gradual implementation of new regulations over several years, and to date, albeit slowly, products are being licensed and new products, previously not allowed, have begun appearing in the marketplace (melatonin, chromium picolinate to name two). A key deliverable in the new regulations was the ability, and in fact, the requirement, to make a health claim for every natural health product. In order for this to occur, guidelines for claim substantiation had to be crafted (standards of evidence) and worked through.
The regulations themselves were the end product of a several year consultation process across the country, and a response to a series of recommendations (53) made in November 1998. Included in this series of recommendations was a recommendation that the regulations governing natural health products not be as severe as that governing drugs, and that Canada's Schedule A of the Food and Drug Act, established in 1934, containing a list of diseases and conditions for which no advertising or claims could be generated, was archaic, inappropriate and needed to be reviewed and modified. And so the new Directorate, armed with an official response to the 53 recommendations, launched its efforts to provide Canadian consumers with broader access to safe, high quality and effective products.
To some, the new regulations were much too drug-like. To others, the ability and need to make claims was a dream come true. To still others, Health Canada's inability to gear up quickly enough, or anticipate the demand for resources and license processing was an alarm bell of lack of understanding and preparation. Many adopted a 'wait and see' attitude, others took advantage of the market limbo and introduced products 'pending NPN#'. (Natural Products Numbers assigned upon review and approval of product license by the Directorate) To add to the confusion, other federal government bodies, including the Health Canada inspectors, Canadian Food Inspection Agency and the RCMP all had to deal with a situation in flux, and yet at the same time, try to enforce a dynamic market. Whatever the cause, evidence of a punitive attitude and lack of understanding of regulatory implications has led to product seizures, lawsuits and a feeling of victimization on the part of many natural products companies, especially the smaller ones, already fearful of massive cost escalations as a cost of compliance.
Despite the fact that currently there are no user fees for the registration process, an examination of the resources consumed by the process has made it obvious that they are not far away. And lumping these costs on top of the cost of compliance, factor in relatively little intellectual property protection, and the stated fear for the 'little guy' and for cost of innovation, expressed repeatedly at consultation meetings, appears quite legitimate.
What about Schedule A?
This list of diseases, which includes diabetes, arthritis and cancer is a major issue of contention. Despite being part of a process the government calls 'legislative renewal', and despite consultations on the subject over several years, Schedule A remains intact and unchanged since 1934, like an ancient icon preventing an organization from moving forward and competing intelligently in the modern era. Moreover, there is no indication that it will be modified any time soon, so as it stands, claims involving any of the listed disease states are absolutely taboo, despite sound science which contends that natural health products support, augment, assist, prevent and in general make better, these disease states.
Into this contentious environment, enter Bill C-420. Introduced last parliament, this Bill passed second reading in Canada's House of Commons, (Debate: http://www.parl.gc.ca/38/1/parlbus/chambus/house/debates/034_2004-11-29/HAN034-E.htm#OOB-1038861 ) and has now been introduced into this session of parliament. (National Post article on Canada.com: http://www.canada.com/national/nationalpost/news/story.html?id=f2574c07-90ec-48b2-9969-7a08b1884701 )
Bill C-420 is a bill to amend Canada's Food and Drug Act, that would, if passed, undo much of the new regulations governing natural health products. The Bill's supporters note the outdated food and Drug Act, and claim that the bill would modernize the regulatory environment which some claim is cautious and even punitive, largely by placing the products under the 'Food' category. The Bill also proposes to 'deal with' Schedule A in short order. Opponents of the bill argue that they need time for the new regulations to come into effect, the cost of undoing these regulations and changing them would be enormous, and that the consultative process which led to these regulations involved consumer feedback which indicated that safety and product quality were critical priorities and Bill C-420 would inadequately deal with these issues - if at all.
Lost in all this debate might be the fact that the ability to make claims and the type of claims permitted, is construed as a significant victory by many in the natural health products sector. By virtue of the claims substantiation process, and the product licensing system, companies even have an opportunity to make unique, rather than generic claims. Although it remains to be seen exactly what the ultimate impact will be, the potential exists for this to both grow and further legitimize the entire category, especially since so much sound science exists. I can't help but wonder whether, if, as Bill C-420 enjoys further success in Parliament, this important milestone might not be undone as potentially these products get shifted to being regulated 'like foods'.
No system is perfect. Perhaps the best efforts would be on pushing for clarification of Canada's Codex stance and implications of codex decisions on the Canadian marketplace, and more importantly, completing the 'legislative renewal process' as it relates to Schedule A, immediately, if not sooner. It seems to me that if Schedule A is quickly revised and the rules altered, without that argument in their quiver, supporters of C-420 would lose a lot of their momentum. And more importantly, Health Canada would appear at least a bit responsive to reasonableness.
In the midst of all this, what's a company to do?
They can start by keeping current on the news and regulatory climate, actively manage their vendors and supply chain to the highest possible standards, and ensure their manufacturing and compliance practices pose minimal or absolutely no risk - in short, smart and responsible business practices.