Ontario Regulation 298/12 - The Collection of Pharmaceuticals and Sharps - Responsibility of Producers (the "Regulation") made under the Environmental Protection Act (Ontario)[1] came into in force October 1, 2012 with a transition period of three months (i.e. January 1, 2013) and it set out certain requirements that must be met by producers[2] of pharmaceuticals[3] and sharps[4]

When the Regulation was proposed, the Ontario Ministry of the Environment summarized its decision to introduce the Regulation as follows:

The regulation implements an extended producer responsibility (EPR) approach that requires producers of pharmaceuticals and sharps (e.g., manufacturers, brand owners and importers selling in Ontario) to be responsible for the management of the wastes resulting from their products (i.e. unused or expired pharmaceuticals, or used, unused or expired sharps), ensuring that consumers have access to convenient locations to return waste pharmaceuticals and sharps so that these wastes are not improperly disposed in Ontario's land and waterways.

Producers of pharmaceuticals and sharps have indicated a willingness to take responsibility for the end-of-life management of their products. The regulation ensures that these wastes are collected and properly managed and establishes the level-playing field requested by producers of pharmaceuticals and sharps.[5]

Brief summary of the Requirements

In order to comply with the Regulation, pharmaceutical and sharp producers must:

  1. Make publicly available, free of charge and on its website, the location of the collection locations at which the collection of the producer's pharmaceuticals or sharps is available to consumers.
  2. Provide a description of how a consumer should safely store and handle such pharmaceuticals or sharps before bringing it to a collection location. 
  3. Have prepared a report by June 30, 2013 which, among other things, set out the actions taken and outcomes achieved by the producer in order to comply with the Regulation. 
  4. On or before April 1, 2014 and every year thereafter prepare and post an annual report that contains certain information set out in the Regulation.

Health Products Stewardship Association

The Health Products Stewardship Association ("HPSA") is a not-for-profit association with a mandate to perform, on behalf of its members, certain duties required under provincial regulations.

The HPSA asserts that if producers join the HPSA (and pay the applicable membership fees) that the producer will have access to the HPSA programs that facilitate compliance with the requirements of the Regulation. It has produced a document entitled the Ontario Medications Stewardship Plan (the "Stewardship Plan") that sets out how it intends to facilitate compliance.[6]

This article will discuss some of the details of what producers must do in order to comply with the Regulation and what the HPSA has implemented in order to assist its members to meet their requirements under the Regulation.

What Producers Must to do in Order to Comply

1. Make publicly available, free of charge and on its website, the location of the collection locations at which the collection of the producer's pharmaceuticals or sharps is available to consumers.

The producer's website must provide the location of the collection locations at which the collection of the pharmaceuticals or sharps (and the containers in which consumers bring the pharmaceutical or sharp to the collection locations) are provided for.  These collection locations must represent at least 80% of the retail locations in Ontario where the producer's pharmaceuticals or sharps are sold or 80% of all accredited pharmacies in Ontario (whichever is less).[7]  Further there must be at least one collection location in each local municipality in Ontario in which there is a retail location at which a producer's pharmaceuticals or sharps are sold.  The collection sites must be free of charge to the consumer and there can be no limit on the quantity of the pharmaceuticals or sharps that a consumer may bring in for collection.

The HPSA website is directed at the general public and provides information on how to return unused or expired medications in Ontario through its Medication Returns Program.  It also includes a "site locator" function to assist consumers in finding drop off locations for unused or expired medications.  According to the HPSA, their Medication Returns Program currently includes collection locations at 84% of the accredited pharmacies in Ontario.  As part of its membership in the HPSA, a producer may post a link to the HPSA website on the producer's website which will connect consumers to the HPSA Medications Returns Program.  This will bring a producer in compliance with this requirement under the Regulation.  Alternatively, producers are free to make arrangements for the adequate number of collection locations to be available to its consumers in Ontario and post this information on its own website in order to meet its obligations under the Regulation.

2. Provide a description of how a consumer should safely store and handle such pharmaceuticals or sharps before bringing it to a collection location. 

Producers must provide information to consumers on how to safely store or handle its pharmaceuticals or sharps prior to bringing them to a collection location.  This information must be available on the producer's website and in print at each collection location at which the collection of the producer's pharmaceutical or sharp is provided for.  This requirement relates to general handling and storing such as keeping the pharmaceutical or sharp in a secure place and out of reach of children. Given that individual pharmaceuticals will require particular instructions relating to handling, storage (i.e. temperature, avoid light, keep container closed) the Regulation is not intended to capture those specifics.  Each producer is responsible to provide such information as part of its packaging.[8]

3. Prepare a report by June 30, 2013 which, among other things, sets out the actions taken and outcomes achieved by the producer in order to comply with the Regulation. 

This interim report must have included the following:

  1. A description of actions taken and outcomes achieved by the producer in respect of the requirements of the Regulation.
  2. The number of collection locations and the location of each of the collection locations at which collection of the producer's pharmaceuticals are provided for

The report may be prepared on behalf of more than one producer.  If this is done, the report must set out, at a minimum, the following information:

  1. The name of each producer on whose behalf the report is prepared.
  2. A description of actions taken and outcomes achieved by the producers in respect of the requirements of the Regulation.
  3. The number of collection locations and the location of each of the collection locations at which collection of the designated material of the producers is provided for.

This interim report must be publicly available and free of charge on the producer's website for a minimum of one year.

The HPSA prepared, on behalf of its members, an interim report that is posted on the HPSA's website and can be posted on a producer's website.[9] The Interim Report states that the individual members of the HPSA have complied with all of the requirements of the Regulation. 

4. On or before April 1, 2014 and every year thereafter prepare and post an annual report that contains certain information set out in the Regulation

The Regulation requires that the following information be set out in a report each year (the "Annual Report") and made available on a producer's website for at least three years:

  1. The number of collection locations and the location of each of the collection locations at which collection of the producer's pharmaceuticals was provided for during the previous calendar year and a description of any changes that occurred with respect to the number and location of collection locations from the previous calendar year.
  2. The total weight of all of the pharmaceuticals and containers (excluding any containers that were recycled) that were collected at the collection locations during the previous calendar year:
  3. A description of how the producer's pharmaceuticals collected at collection locations was handled and how it was recycled or disposed of during the previous calendar year.
  4. A description of actions taken by the producer during the previous calendar year, their effectiveness and outcomes achieved as part of complying with the Regulation.
  5. A description of any actions taken by the producer during the previous calendar year that exceeded the actions required in order to provide for the collection of the designated material of the producer.
  6. A description of any actions taken by the producer during the previous calendar year that exceeded the actions required with respect to educational and public awareness activities in order to promote to consumers the collection locations and the availability of collection (the minimum requirements being posting the collection information on the producer's website and providing print materials at the collection locations).

The Annual Reports can be prepared on behalf of more than one producer.  The Stewardship Plan indicates that the HPSA plans to produce the required Annual Report for its members and that such a report will include all of the information required by the Regulation.[10]