On October 1, 2012 Ontario Regulation 298/12 “Collection of Pharmaceuticals and Sharps — Responsibilities of Producers” came into effect. It’s not only Ontario’s first extended producer responsibility (EPR) regulation created under the Environmental Protection Act (EPA); it also sets a new and innovative approach to producer responsibility regulation.
Pharmaceuticals comprise a range of products that include drugs as defined in the Food and Drugs Act (Canada) and natural health products as defined in the Natural Health Products Regulations made under the same Act. Sharps are defined as a “…needle, safety engineered needle, lancet or other similar instrument that is designed to puncture the skin of individuals or companion animals for medical purposes.”
Pharmaceutical products are prescribed with the intent to be fully consumed, whereas sharps are single-use products. Both materials pose unique health, safety and environmental risks with end-of-life management.
Historically, this management occurred through the voluntary collection network of retail pharmacies in Ontario that accepted unused/expired medications and used sharps from consumers, and covered the cost of handling and disposal. Because the network was voluntary and without comprehensive coverage, a significant portion of these materials ended up in the municipal hazardous and special waste collection system (and were therefore managed at a cost to taxpayers).
On July 1, 2010, the responsibility and cost for managing these materials shifted to Stewardship Ontario (SO) under the expanded Municipal Household and Special Waste (MHSW) “Phase 2” program as convened under the Waste Diversion Act.
As a result of the eco-fee controversy that arose from the launch of the Phase 2 program, the provincial environment minister cancelled the levying of stewardship fees to producers on July 19, 2010. While the logistics of the SO-administered program remained, program costs were covered by the Ontario government (i.e., taxpayers) for the next 26 months.
In the summer of 2012, with the Ontario government’s commitment to fund the Phase 2 program ending in October of that year, the environment ministry proposed a new regulatory approach to producer responsibility for pharmaceuticals and sharps under the EPA.
The EPA-based regulatory approach is truly unique in that it does not require producers to file stewardship plans. Rather, it sets out some key compliance requirements and leaves it to producers to determine how they discharge their obligations. Specifically the regulation:
• Assigns end-of-life responsibility for waste pharmaceuticals and sharps to individual producers of pharmaceuticals and sharps (i.e., manufacturers, brand owners or importers); in turn;
• Allows a producer to establish and operate such a system on its own or as part of a collective of producers. (Notably, the ministry does not regulate any producer collectives that may form);
• Requires producers to utilize service providers who have EPA environmental compliance approvals for the operation of waste management systems specific to the collection and proper end-of-life management of post-consumer pharmaceuticals and sharps (public waste); and,
• Requires minimum collection coverage (to ensure collections from the approximately 3,000 retail pharmacy locations generating consumer returns of waste pharmaceuticals and sharps), proper handling and management standards, and annual reporting to the ministry regarding collection performance.
In anticipation of the regulation, Health Products Stewardship Association (HPSA) was chosen by industry as the collective, producer-driven national producer responsibility organization. HPSA has led the transition of the SO program to a producer responsibility compliance model under O. Reg. 298/12.
HPSA’s compliance model is highly successful and builds on earlier efforts.
Consider that in the six month period prior to the start of the MHSW Phase 2 program in July 2010, 1,005 retail pharmacies collected pharmaceuticals and sharps voluntarily. By the end of the Phase 2 in October 2012, the number of participating pharmacies almost tripled to over 3,000 as the costs for recovery and end-of-life management of these materials transferred from retailers to SO. By March 2013, 84 per cent of Ontario pharmacies were participating in the HPSA administered program.
Between 2010 and 2011 there was a 32 per cent increase in the amount of material collected at retail pharmacies. 2012 saw an additional 16 per cent increase in collections as pharmacy participation increased and consumer awareness improved. The first nine months of the HPSA producer responsibility program saw a further 10 per cent increase in the collection of sharps and medications.
HPSA plans to aggressively expand the retail collection network and drive more consumer awareness, with the objective of diverting all waste pharmaceuticals and sharps away from municipal collection and disposal systems to their network of retail pharmacies (that are properly equipped to handle and dispose of these materials).
The response by producers to Ontario Regulation 298/12 has been positive and retail pharmacies continue to voluntarily embrace the HPSA administered programs. The successful performance of the programs speaks well for a streamlined approach to producer responsibility that gives producers the flexibility to drive the environmental outcomes the public wants.
Brad Wright is Principal Consultant at Environment and Resources Consulting and has been the consulting lead on the development and implementation of the HPSA’s Ontario producer compliance scheme for pharmaceutical and sharps wastes. Contact Brad at firstname.lastname@example.org