Pharmaceutical Industry Should Prepare for Individual Producer Responsibility

The uncertainty among producers within the waste diversion industry in Canada over the coming change from an industry-funded organization (IFO) fee-based model to an individual producer responsibility (IPR) regime for “brand holders” has principally focused upon those various regulated waste streams at the centre of mandatory diversion, such as waste electronics and electrical equipment (WEEE) or used tires – the latter as test case for a circular economy IPR program in North America set for next year.

Easily overlooked is the pharmaceuticals diversion programs, legally mandated in the Canadian provinces of British Columbia, Manitoba, Ontario and Prince Edward Island, with voluntary programs in the remaining 6 other provinces.  To date, the programs have consisted of the indirect funding of take-back facilities at point-of-purchase locations such as pharmacies.  Little more has been required of the pharmaceutical industry and the programs today seem almost quaint in the rough and tumble world of waste / waste diversion.

 Increased Regulatory Concern Over PhACs

The cited need for pharmaceutical diversion programs lies with the increasing attention paid to the harmful effects of pharmacologically-active compounds (PhACs) in the environment, including their endocrine disrupting impacts in groundwater, surface water, soil and even drinking water.

In British Columbia, a successful Medications Return Program voluntary drop program has been operational since 1999. In contrast, Ontario’s ill-conceived Orange Drop program, covering drugs, lasted only weeks before its discontinuance in 2010, which was replaced two years later by Ontario Regulation 298/12, mandating facilities, but not outcomes,  for the collection of both pharmaceuticals and sharps.

Since that time, concerns over endocrine disruptors have only increased, with Environment Canada placing increasing numbers of them on the Toxic Substances List, and raising real questions as to whether the pharmaceutical and health product industry should be doing more to ensure drugs are truly being diverted from waste streams.

IPR to Directly Obligate Pharmaceutical Industry

As part of the IPR overhaul of waste diversion in Ontario, oversight is being placed with an (emboldened) Resource Productivity and Recovery Authority, given the mandate to ensure resource recovery achieves the goals for environmental protection as articulated in the February 2017 Waste-Free Ontario Strategy.

It is only a matter of time before the diversion of unused pharmaceutics and health products in Ontario are brought under the Authority’s jurisdiction, with its mandate to achieve verified diversion rates for recovery-regulated waste streams.

Pharmaceutical Diversion Targets Coming?

The IPR model will obligate producers to divert a discounted equivalency of the waste-producing materials introduced into Ontario.  For tires, it may be 9 tires diverted and reprocessed for every 10 sold, implicitly recognizing the shrinkage within the lifecycle of the product.  While the numbers for pharmaceuticals will be different, there is still a diversion percentage which can discerned and made into concrete diversion obligations for pharmaceutical brand owners.

Waste Diversion as Industry Friend, Not Foe

Given the growing concerns over PhACs, the pharmaceutical industry may wish to view waste diversion as the least disruptive stage in a drug lifecycle in which to make tangible gains in the reduction of dispersion of PhACs (as well as more effectively removing harmful drugs and sharps from potential public access).  The alternatives, applied earlier in the lifecycle of a drug such as at the product development or dispensing stages, may well be more difficult to swallow.

Jonathan D. Cocker heads the Firm’s Environmental Practice Group in Canada and is an active member of firm Global Consumer Goods & Retail and Energy, Mining and Infrastructure groups. Mr. Cocker provides advice and representation to multinational companies on a variety of environment, health and safety matters, including product content, dangerous goods transportation, GHS, regulated wastes, consumer product and food safety, extended producer responsibilities and contaminated lands matters. He appears before both EHS tribunals and civil courts across Canada. Mr. Cocker is a frequent speaker and writer on EHS matters, an active participant on EHS issues in a number of national and international industry associations and the recent author of the first edition of The Environment and Climate Change Law Review (Canada chapter) and the upcoming Encyclopedia of Environmental Law (Chemicals chapter).