Health Canada Notice on Dental Laboratories

DIAC responds forcefully to Health Canada’s proposed licensing of Canadian dental labs.

 

March 24, 2008 Via Email Attachment

Ms. Sarah Chandler
A/Head, Regulatory and Scientific Section
Device Licensing Services Division
Medical  Devices Bureau
Health Canada                                                       

RE: Health Canada Notice on Dental Dispensers (Notice)

Dear Ms. Chandler:

The Dental Industry Association of Canada (DIAC) has numerous concerns about the proposed Notice regarding the rules governing “dispensers” and manufacturers in the design and construction of custom dental appliances in Canada.

We will attempt to enumerate our concerns. However, in the interests of fairness, we wish to reiterate our request during our meeting of July 17, 2007 that all stakeholders, including the widening group implied by the proposed Notice, receive an opportunity – a public stakeholder meeting – to chart the repercussions through the various flows of goods to ensure that the “greater public interest” is actually being served in a cost-effective manner applied across the entire playing field.

In the interim, please note that any reference to the implied effect on stakeholders not represented by DIAC is not exhaustive nor has our opinion been sanctioned by any of those stakeholders.

DIAC’s Representation

The Dental Industry Association of Canada (DIAC) is an industry trade association that represents the commercial interests of manufacturers, dealers, service providers and dental laboratories who provide goods and services to the various dental professions in Canada. Although our Code of Ethics and Conduct requires our member companies to certify their compliance with all federal, provincial and local laws, regulations and ordinances, we have no regulatory authority to make that determination. We can only discipline our members based on determinations already made by a competent court or regulatory authority.

Executive Summary

DIAC welcomes and respects Health Canada’s concern about manufacturers of custom dental devices who do not operate under the supervision of a “dispenser” as defined in the Notice.

However, we also believe that adding to the regulatory burden of dental laboratories that already operate under the supervision of a “dispenser” only makes it harder for them to compete with those foreign and domestic operations that do not comply with either the provincial governing bodies or with Health Canada regulations.


July 14, 2008 Via Email Attachment

Ms. Sarah Chandler
A/Head, Regulatory and Scientific Section
Device Licensing Services Division
Medical  Devices Bureau
Health Canada                                                       

Dear Ms Chandler:

We recognize Health Canada’s concern about ensuring compliance with Medical Device Regulations while not encroaching on Provincial responsibilities and the principles of fair competition as embodied in the Competition Act. This is not a task to be envied and we assure you of our continued cooperation throughout the process.

The Commercial Dental Laboratory Group of DIAC is also in a quandary. All of our member dental laboratories are located in Provinces where dental technicians are regulated professionals and all our laboratory members are properly supervised by licensed dental technicians. In these circumstances, if they do any sub-contracting among themselves, they would be subject to both Health Canada and Provincial regulations under the proposed Notice, while their competitors would only have to comply with Health Canada regulations – what we see as a penalty for compliance.

At the very minimum, all of the regulated Provinces already have a standard of practice which prohibits licensed dental technicians from sub-contracting to dental laboratories that are not supervised by (their own Province’s) licensed dental technicians. Although there is a Mutual Recognition Agreement among the regulated Provinces, it tends to be directed towards licensing and mobility issues (Fairness) rather than inter-provincial trade.

Some Provincial regulators have a standard, or are contemplating a standard, that would prohibit dental technicians from accepting a prescription from a laboratory without a supervising licensed dental technician.

As for dentists, only Quebec has regulations that prohibit them from prescribing to dental laboratories without the supervision of a licensed dental technician. The other Provinces rely on their disciplinary procedures to prevent dentists from committing acts which they know, or should know, are beyond their training and expertise and which may compromise their patients’ safety.

So the issue becomes “how does Health Canada regulate the spirit of the Medical Devices Act” within a mish-mash of potentially conflicting Provincial Regulations?

Towards our own concerns we would add two more issues.

How does Health Canada regulate the spirit of the Medical Devices Act without disadvantaging the dental laboratories that are already in compliance with Provincial regulations?

How does Health Canada regulate the spirit of the Medical Devices Act without consequent challenges to these regulations under the Competition Act?

Although we recognize that Health Canada is only attempting to plug a hole in Provincial regulation that prevents the Provinces from regulating activity outside their jurisdiction, we also recognize that the licensing of dental laboratories and their products under the Medical Devices Act may be viewed by the Competition Bureau as sufficient to protect the public interest, and that such a viewpoint would undermine the Provincial regulator’s ability to continue regulating within the Province.

This, in turn begs the question as to why Provincial Regulation would continue to be needed at all, and whether such licensing would impose a sufficiently onerous double regulatory burden on dental laboratories that are already supervised by regulated dental technicians, and whether such a condition would give rise to a challenge under the Competition Act. The Competition Bureau has already ruled that Regulations which restrict the practice of health professionals must be shown to be in the “overriding public interest” in order to be sustained. How can something be in the overriding public interest in one Province but not another?

Our Proposed Solution

A laboratory, as a question of fact, is supervised by a licensed and regulated professional dental technician, or it is not.  Invoices from the laboratory have a valid stamp from a licensed dental technician, or they do not. The license and the stamp can be easily verified with the relevant regulatory college of dental technicians.

Health Canada should develop an “Application for Dispenser’s Exemption from the Medical Devices Act” requiring all licensed dental technicians to apply for a dispenser’s exemption from the Medical Devices Act. The Applications would name and cover the facilities under supervision.

Health Canada Regulations could include the inspection of dental laboratory facilities exempted under the supervision of licensed dental technicians to ensure they are, or remain in compliance.

Dental laboratories under the supervision of licensed and regulated dental technicians would be granted this “dispenser’s exemption” provided only that their respective Provincial Regulations included a Standard of Practice requiring the use of only those inputs which have a valid Product License issued by Health Canada. This places the responsibility for supervising the use of licensed products directly with the body that regulates the activity; and removes the regulation of the activity from those bodies not willing to provide the required standards, supervision and discipline.

Sub-contracting between licensed and regulated dental technicians, within and between regulated Provinces, would remain exempt. A simple extension of the logic (in 4 above) implies that the sub-contractor is using inputs licensed under the Medical Device Regulations (or he/she wouldn’t be exempt) and that the sub-contracted appliance meets the standards of the Provincial regulator for safety and efficacy (or he/she wouldn’t be licensed). The proof lies in the technician’s stamp on the inter-laboratory invoice.

Provincial regulators would still be free to restrict inter-provincial sub-contracting among dispensers in the Provinces governed by their Mutual Recognition Agreement. This is the exclusive domain of the Provincial regulators, and Health Canada should not insert itself into a possible “overriding public interest” dispute between the Provincial regulators or between their respective regulations and the Competition Act. In so far as Health Canada is concerned, both laboratories are supervised by an exempt dispenser. 

Dental laboratories, foreign or domestic, within and between regulated jurisdictions or unregulated jurisdictions that do not operate under the supervision of an Exempt Licensed and Regulated Dental Technician (Dispenser) would be required to obtain a Health Canada Product License for each of the distinct medical devices that they manufacture and/or sell under their own name. They would also be required to obtain an Establishment License for the inputs that they use to manufacture medical devices. It is irrelevant whether these inputs constitute a raw material, a sub-contracted partial device or a completed device.  The unsupervised laboratory is nonetheless receiving a medical device as defined by the Medical Devices Act.

Under Medical Device Regulations, trade in medical devices (sub-contracting) between dental laboratories would be governed by the status of the laboratory receiving the goods.

“Exempt” laboratories (see No. 5 above) would not require either an Establishment License or product licenses. Because they are supervised by “dispensers” approved by Health Canada, all inputs they receive either as a raw material or under sub-contract are already licensed or exempted by Health Canada, or they would not have been approved. As professionals, they are subject to discipline if they purchase raw materials or inputs that are not licensed or that are not processed by another (recognized) licensed and regulated dental technician.

Provincial regulators would still be free to restrict the sub-contracting of medical devices to unsupervised laboratories even if the sub-contractor has a Medical Device License. This is the exclusive domain of the Provincial regulator and there is no need for Health Canada to insert itself into a possible “overriding public interest” dispute between the Provincial regulations and the Competition Act. In so far as Health Canada is concerned, the sub-contracting technician has met his/her burden by ensuring that all the inputs were manufactured either under license or under exempt supervision.

“Non-exempt” laboratories would be required to obtain a Product License and an Establishment License for all products which they subcontract; the former because they are selling a device under their own name and the latter because they are using inputs that are themselves medical devices. Medical devices sub-contracted to “exempt” laboratories would be deemed to have a Medical Device License if they are accompanied by a stamped invoice, but they can not be resold in whole or as an input without a valid Medical Device License. An Establishment License in this case is not sufficient since the device is being resold as the laboratory’s own product.

Provincial regulators would remain free to restrict sub-contracting from “non-exempt” laboratories to “exempt” laboratories even if the contractor has a valid Establishment License and a valid Product License for the device. This is the exclusive domain of the Provincial regulator and there is no need for Health Canada to insert itself into a possible “overriding public interest” dispute between the Provincial regulations and the Competition Act. In so far as Health Canada is concerned, both laboratories have met their burden by ensuring that all full or partial devices have been manufactured under license and/or under the supervision of an “exempt” dispenser.

It is unfortunate that dental technology is a provincially regulated labour activity as well as a federally regulated manufacturing process that may come into conflict with each other and with the Competition Act.

Nonetheless, medical devices are being manufactured inside and outside the country in jurisdictions which do not meet the requirements of a “dispenser” designation. It is those specific cases that the Medical Device Regulations should address without making matters less competitive for those technicians (and the laboratories they supervise) who already meet the Provincial requirements.

Sincerely yours,

Bernie Teitelbaum

Executive Director
On behalf of the Commercial Dental Laboratory Group