June 20, 2016 Ministry of…

June 20, 2016

Ministry of the Environment, Conservation and Parks

Subject: Comments on Regulations for Recycling of Electrical and Electronic Equipment (EEE) and Batteries under the Resource Recovery and Circular Economy Act, 2016

Dear Minister Phillips,

Medtech Canada (formerly MEDEC) is the national association representing the medical technology industry in Canada. Our association advocates for achieving patient access to leading edge, innovative technology solutions that provide valuable outcomes. Our members are committed to providing safe and innovative medical technologies that enhance the quality of patient care, improve patient access to health care, and help enable the sustainability of our health care system. The medical technology industry in Canada employs over 35,000 Canadians in approximately 1,500 facilities across the country.

We are submitting comments on the Draft Regulations for Electrical and Electronic Equipment (EEE) and Batteries under the Resource Recovery and Circular Economy Act, 2016.

The medical technology industry offers a broad range of supplies, devices and equipment, many of those powered by electricity, including by battery. They include, for example, ambulatory pressure monitors, blood glucose monitors, portable vital signs monitors, handheld surgical power tools and large pieces of equipment with back-up power. These products can be used in several settings ranging from hospitals, to long-term care facilities, to private clinics, and to patient’s homes and ambulances.

Based on our understanding of the Draft Regulations, medical technology suppliers (manufacturers and distributors) will be subject to a number of obligations because they will fall into either or both of the following categories:

Large and small equipment producer
Battery producers

Both Draft Regulations refer to materials “marketed to consumers in Ontario”, the term “consumers” defined in the Act as “a person who obtains the product for the person’s own use”. It is not clear if the ICI channel (Industrial, Commercial, and Institutional) is meant to be included or excluded from the Draft Regulations.

Nonetheless, Medtech Canada assumes that the institutional sales channel (public and private healthcare facilities) will be included for the application of the Draft Regulations as will be medical devices and equipment sold to persons as consumers (through retail channels).

This means that most medical technology producers will be subject to the following obligations:

Category: Small and Large equipment
Obligations:
• Promotion and Education (Part V)
• Registration (Part VI)
• Reporting, Auditing and Record Keeping (Part VII)
(Electrical and Electronic Equipment Regulation)

Category: Producer of more than 4 tonnes of small rechargeable batteries, Producers of more than 8 tonnes of large batteries, Producers of more than 2½ tonnes of small single use batteries (yearly periods)
Obligations:
• Collection (Part III)
• Management (Part IV)
(Batteries Draft Regulation)

Category: All battery producers
Obligations:
• Promotion and Education (Part V)
• Registration (Part VI)
• Reporting, Auditing and Record Keeping (Part VII)
(Batteries Draft Regulation)

With regards to EEE, Medtech Canada’s view is that the anticipated volume of Designated Materials produced by our industry is relatively small compared to consumer products, and given the nature of the products involved and the main setting for their usage, they normally do not end up in a landfill after reaching the end of their useful life.

Producers, especially for large equipment, do have practices aimed at recycling, refurbishing and otherwise valorize parts and older equipment. Hospitals typically do not dispose of this equipment like ordinary waste.

Medtech Canada strongly recommends that producers of both small and large medical equipment should be excluded from the Draft Regulations based on the reality that these pieces of equipment are not a problem in terms of waste diversion. They are already effectively managed at end of life through terms negotiated and agreed upon by the OEMs and end users (i.e. service and leasing agreements). Essentially, there is no evidence that this equipment is ending up in landfills and therefore should not be regulated (even with limited obligations) due to the expected significant administrative burden and costs associated with the registration, reporting, and promotion and education that would not result in increased environmental benefit or protection.

With regards to Batteries, we also respectfully ask that medical technology products i.e. licensed by Health Canada be carved out of the Draft Regulations on the basis that none of the producers will likely reach the 2½ tonnes threshold. It seems to us that in the context of an effort to reduce administrative burden and red tape for Ontario business that imposing additional costs and obligations for very little if any environmental impact is not effective. It also raises concerns for trade, with niche producers having to raise their costs of doing business in Ontario or deciding to exit the Ontario market, at the detriment of Ontario patients.

Before imposing additional regulatory burden and costs on producers of our sector, Medtech Canada strongly recommends that a proper regulation impact analysis be made beforehand and our association will certainly be glad to collaborate.

In the absence of such impact analysis Medtech Canada recommends caution and exclusion of medical technology producers and their products from both Draft Regulations.

Sincerely,

Medtech Canada