Long-Term Care Home System Strained but Not Broken

Co-authored by Nareh Ghalustians

The Report on the Public Inquiry into the Safety and Security of Residents in the Long-Term Care Homes System (the “Report”) was released on July 31, 2019, with 91 recommendations (the “Recommendations”) for improving the safety and security of residents in Ontario’s long-term care system, and for Ontarians receiving home care services. The Report was released following the Public Inquiry into the Safety and Security of Residents in the Long-Term Care Homes System (the “Inquiry”). The commission to spearhead this Inquiry was established on August 1, 2017, after Elizabeth Wettlaufer pleaded guilty to and was convicted of eight counts of first-degree murder, four counts of attempted murder, and two counts of aggravated assault offences that she committed while working as a registered nurse in various long-term care homes in southwestern Ontario and as a nurse providing home care services in private homes. She has been sentenced to life imprisonment with no parole eligibility for 25 years.

This article reviews Volume 1 of the Report and identifies the mandate of the Inquiry and its key findings and summarizes the Recommendations affecting long-term care homes in Ontario. We anticipate that there will be broader implications across the entire health sector arising from these Recommendations.

Background

The Report was dedicated to the victims and their loved ones. It notes that the regulatory regime that governs the system is not broken and imposes clear standards for long-term care homes, and a rigorous inspection regime to enforce those standards that can be built upon and improved. In that vein, the Report requires the Ministry of Health and Long-Term Care (the “Ministry”)[1] to issue a report by July 31, 2020, describing the steps it has taken to implement the Recommendations coming out of the Report, and to table that report in the Ontario Legislature. In a recent news release, the Ministry stated its intention to meet this deadline.

Mandate

The Report notes that the mandate of the Inquiry was to inquire into the events that led to the offences, circumstances, and contributing factors, and to make recommendations on how to avoid similar tragedies in the long-term care system. The mandate was not to conduct a general review of the long-term care system.

Key Findings

The Report highlights three main findings:

  1. The offences would not have been discovered if Elizabeth Wettlaufer had not confessed.
  2. The offences resulted from systemic vulnerabilities.
  3. The long-term care system is strained, but not broken.

Recommendations

The Report was clear that change is required on a systemic level.

Training

The Report recommends that long-term care home licensees must provide training to administrators and directors of nursing on hiring and discipline of staff, conducting workplace investigations, and on reporting obligations to the Ministry and the College of Nurses of Ontario (the “College”). Recommendation #3 suggests that this training be provided by the Ministry, the College, and the Office of the Chief Coroner/Ontario Forensic Pathology Service.

The Report also recommended that medical directors, attending physicians, and nurse practitioners of long-term care homes receive comprehensive, ongoing training on preventing resident abuse and neglect, a requirement from which they are currently exempted, unlike other staff such as registered nurses.

The Report also adds a specific Recommendation that Medical Directors complete the Ontario Long-Term Care Clinician’s Medical Director course within two years of assuming the role of Medical Director in a long-term care home.

Furthermore, the Report recommends additional training for staff, visitors, and residents about their obligations to report to the Ministry (not just to the long-term care home) regarding suspected abuse and neglect of residents that results in a risk of harm to the resident (see s. 24(1) of the Long-Term Care Homes Act, 2007 (the “Act”)).

Summary of Other Key Recommendations

  • Handling of Medication. Recommendations were made for improving the long-term care home’s medication administration and medication incident reporting systems, and how to use the recommended redesigned institutional Patient Death Record, once it is created.

 

    • Improved medication management in long-term care homes is recommended through a three-pronged approach directed at the Ministry creating new policies, improving the annual quality inspection process, and by long-term care homes modifying and improving the security of rooms in which medications are stored and using technology to support medication management.

 

    • Recommendations are made to the Ministry to permit long-term care homes to use the additional nursing and personal care funding to purchase or upgrade integrated automated medication dispensing cabinets and install cameras and/or glass doors in medication rooms.

 

    • It is recommended that long-term care homes improve their medication incident analyses (required by the Act) and treat the use of glucagon as a medication incident. Medication incidents, under the Act, would have to be reported and reviewed at least quarterly by the long-term care home’s medication management interdisciplinary team, composed of the Medical Director, administrator, director of nursing and personal care, and the pharmacy service provider. More details regarding medication management can be found in Recommendations #74-84 of the Report.

 

    • Recommendation #19 recommends that the Ministry expand the nursing and personal care funding envelope and permit long-term care homes to use these funds to pay for a broader spectrum of staff including porters, pharmacists, and pharmacy technicians.

 

    • Recommendation #76 goes further to recommend that long-term care homes use this funding to engage a staff pharmacist and/or pharmacy technician. The Report also recommends that the licensees use this new funding for training, education, and professional development of all staff, including the backfilling of positions for staff attending training. Further, the Report recommends that licensees be permitted to use the expanded or new funds for annual membership fees in AdvantageOntario and the Ontario Long-Term Care Association.

 

  • Agency Nurses, Service Providers, and the Role of the Ministry. Specific Recommendations are made regarding long-term care homes’ use of agency nurses (Recommendations #11-13); home care service provider obligations (Recommendations #14-18); and the role of the Ministry (Recommendations #19-31).

 

  • LHINS/Ontario Health, College, Coroner, and Ministry Recommendations. Recommendations #32-39 are directed toward Local Health Integration Networks (“LHINs”) and providers and coordinators of home care services, and thereby to Ontario Health, once it takes over this role. One of the Recommendations is for the LHINs to adopt a common electronic events reporting system and to train staff and service providers on its use. Recommendations #40-49 are directed to the College and Recommendations #50-61 to the Office of the Chief Coroner/Ontario Forensic Pathology Service. Recommendations #62-63 suggest an expanded leadership role for the Ministry and improved communication with the LHINs/Ontario Health.

 

  • Health Care Serial Killer Phenomenon. Building awareness of the “healthcare serial killer” phenomenon is addressed in Recommendations #64-73 (a phenomenon used to describe murders committed by individuals working as health care professionals). The Inquiry heard evidence that 90 healthcare serial killers have been convicted in the USA, Canada, and Western Europe since 1970, but the phenomenon has been documented since the 1800s.

 

  • Number of Registered Staff. It is recommended that the Ministry conduct a study to determine the adequate levels of registered staff in the long-term care homes on each of the day, evening, and night shifts, table the study in the legislature by July 31, 2020, and increase funding accordingly (Recommendation #85).

 

  • Detecting Deaths. Suggestions for improving the detection of intentionally caused resident deaths are covered in Recommendations #86-91.

Conclusion

The Report highlights the dedication and commitment of individuals working in the long-term care system under pressure and with limited resources. The Report highlights improvements that were implemented by stakeholders during the Inquiry and prior to the release of this Report, including the formation of a working group on medication management systems in long-term care homes, and the increase in the amount of information available from the College about nurses’ employment history, and stakeholder-led initiatives that predated the Inquiry, such as a medication safety pilot project and the clinical support tools program.

The Report expresses hope that the Inquiry and the Report can rebuild Ontarians’ shattered trust in the long-term care system.

[1] The Government of Ontario recently divided this Ministry into two, appointing a separate Minister of Long-Term Care in addition to what is now called the Ministry of Health. This blog post uses the language of the Report, which references both Ministries jointly.

Understanding the Regulatory Framework of OTN’s eConsult

The use of virtual care, also called telemedicine, is growing in Ontario. The June 2019 Devlin Report on Ending Hallway Medicine referred to the Ontario Telemedicine Network’s eConsult program as a success story that could be built upon in the pending realignment of the healthcare system.[1]

What is telemedicine? How are electronic consultations remunerated? Do these services meet regulatory requirements? If you need advice about the practise of telemedicine, or related privacy issues, please contact spalter@ddohealthlaw.com or sgrauer@ddohealthlaw.com.

This blog explores telemedicine, electronic consultations and related regulatory issues.

What is telemedicine?

Telemedicine is the use of communications technology to provide clinical patient care, or to assist in the provision of such care, at a distance. Various technologies may be used, including telephones (land lines and mobile devices), electronic mail, video-conferencing, audio-conferencing, remote monitoring and telerobotics.[2] The improvement of access to medical services for patients in rural communities, via telemedicine services facilitated by the Ontario Telemedicine Network (OTN), has been reported in the literature.[3]

The Ontario Telemedicine Network facilitates various telemedicine programs[4] including:

  • eConsult – electronic consultations between primary care providers and specialist physicians in respect of a specific patient
  • eCare – applications or devices that monitor patients, or to allow patients to self-monitor in their own homes
  • eVisit – real-time video visits with patients.

This blog entry will focus on e-Consult, electronic consultations between health care providers.

Electronic consultations

The OTN eConsult is a service that lets a referring provider, such as a family physician or nurse practitioner, consult with a specialist physician over a secure hub provided by OTN, without requiring the patient to visit the specialist (in person or virtually). The referring provider sends the clinical question, along with relevant patient information such as patient/family history, history of the presenting complaint and (where indicated) laboratory and diagnostic test results, to the specialist. The specialist reviews the records and answers the clinical question, provides a consultation report and may request that the patient be referred.[5] In tele-dermatology, a referrer (including a specialist) can send digital images to a consulting dermatologist and receive a response within five days.[6] In tele-ophthalmology, patients are referred by their family physician to an OTN tele-ophthalmology site where their retina is scanned and the image is uploaded to an ophthalmologist for assessment, diagnosis and/or treatment recommendations while the referring provider coordinates follow-up care.[7]  Physicians can apply for access to the secure OTN hub and the eConsult service at https://support.otn.ca/en/form/otnhub-sign-form-ocfp-members.

The Ontario Telemedicine Network’s 2017-2018 annual report indicates that during that time period 33,643 electronic consultations took place, including tele-dermatology and tele-ophthalmology, and resulted in 78% referral avoidance.[8] Electronic consultations save time and money for patients who avoid a visit to the specialist.

Who pays for electronic consultations?

Under the eConsult program, there is no charge to the patient. Both the referring physician or nurse-practitioner, and the consultant physician, can bill OHIP for telemedicine services if certain conditions are met.[9] All physicians billing OHIP for telemedicine are required to complete a form to be registered as a telehealth provider with the Ministry of Health. The OTN website also indicates that consultants may be remunerated through another route via funding provided by the Ministry of Health.[10] Physicians are permitted to bill for services provided at sites outside the OTN network but only if the service is eligible for remuneration through OTN/the provincial telemedicine program and the site has been certified by OTN; it is unclear whether this remuneration occurs through OHIP or otherwise through the Ministry.

Regulatory requirements

Regulatory requirements for physicians providing medical services to patients vary somewhat across provinces and territories. Similarly, the requirements for physicians providing telemedicine services also vary across Canada. The College of Physicians and Surgeons of Ontario’s telemedicine policy states that it applies to CPSO-registered physicians, regardless of where the physician or patient is physically located when the telemedicine service is provided.[11]

Under the CPSO telemedicine policy, CPSO-registered physicians providing medical services via telemedicine, including consultations with other providers, are required to ensure that telemedicine is in the best interests of the patient, and that the physician’s regulatory and legal obligations, including the standard of care, can be met. Physicians are also required to ensure that the patient is accurately identified, and that the patient information obtained via telemedicine is reliable and of sufficient quality. Providers must also protect the privacy and confidentiality of their patients’ personal health information and ensure that the technology platform is secure.

How does a physician ensure that such security and technical requirements are met? According to the CPSO policy, physicians can do so by using the sites in the OTN network, or OTN certified sites, or by checking with a privacy expert.[12]

What happens if a physician is located outside of Ontario?

Under the CPSO telemedicine policy, if the consultant is outside of Ontario, but the referring provider is inside of Ontario, the Ontario referrer is expected to take reasonable steps to ensure him/herself that the consultant is appropriately licensed in his or her jurisdiction of practice and should alert the patient, via the use of a form, that the consultant may or may not be licensed to practise medicine in Ontario. If the referring provider is located outside of Ontario, and is not registered with the CPSO, the CPSO may report that provider’s actions to his or her local medical regulator, and reimbursement from OHIP may not be available to the provider.

A national telemedicine framework?

In most provinces, practising telemedicine across borders requires that the practitioner confirm that s/he is complying with the licensing requirements of one or both jurisdictions. Given that Canada has provincial regulatory requirements for the practice of telemedicine by physicians that are not harmonized, the Federation of Canadian Medical Regulatory Authorities is exploring a national telemedicine license for physicians to support the provision of telemedicine across all Canadian provinces and territories.[13]

Watch this blog space for updates. If you have questions, contact the author:  spalter@ddohealthlaw.com.

 

[1] Premier’s Council on Improving Healthcare and Ending Hallway Medicine, A Healthy Ontario: Building a Sustainable Health Care System, June 2019, available at https://files.ontario.ca/moh-healthy-ontario-building-sustainable-health-care-en-2019-06-25.pdf, pages 20-21.

[2] Telemedicine Policy. College of Physicians and Surgeons of Ontario. December 2014. Available at: https://www.cpso.on.ca/Physicians/Policies-Guidance/Policies/Telemedicine

[3] O’Gorman, L.D., Hogenbirk, J.C. and Warry, W. Clinical Telemedicine Utilization in Ontario over the Ontario Telemedicine Network. Telemed J E Health. 2016 Jun 1; 22(6): 473–479.

[4] Such programs include teledermatology, telepyschiatry, teleophthalmology, telestroke, emergency services, critical care and others. More information about these program is available at https://otn.ca.

[5] See https://otnhub.ca/patient-care/#econsult

[6] See https://otnhub.ca/patient-care/teledermatology/

[7] See https://otn.ca/innovationcentre/teleophthalmology/

[8] Ontario Telemedicine Network 2017-2018 Annual Report. Available at: https://otn.ca/wp-content/uploads/2017/11/otn-annual-report.pdf

[9] See the Schedule of Benefits, March 1, 2016, available at http://www.health.gov.on.ca/en/pro/programs/ohip/sob/physserv/sob_master20181115.pdf

[10] According to the OTN website, supra note 4, remuneration is available through the Ontario eConsult Centre of Excellence, which is housed at the Ottawa Hospital, in partnership with the Bruyere Research Institute and various regional and delivery partners including the OTN, OntarioMD, eHealth Ontario, the South East Academic Medical organization and the Champlain BASE (Building Access to Specialists through eConsultation).

[11] CPSO telemedicine policy. Supra note 1.

[12] CPSO telemedicine policy. Supra note 1.

[13] College of Physicians and Surgeons of British Columbia. Registrar’s message: Telemedicine and licence portability―the future of medical regulation in Canada. College Connector Volume 7. No. 2. March/April 2019.    https://www.cpsbc.ca/for-physicians/college-connector/2019-V07-02/01

 

What is Virtual Care?

Virtual care, or telemedicine, is the use of communications technology to provide clinical patient care, or to assist in the provision of such care, at a distance. It includes communications technologies such as telephones (land lines and mobile devices), electronic mail, text messaging, video-conferencing, audio-conferencing, remote monitoring, internet-based tools and telerobotics. The June 2019 Devlin Report on Ending Hallway Medicine referred to several of the Ontario Telemedicine Network programs as innovative successes that could be built upon in the pending digitization and realignment of Ontario’s health care system.[1]

 

The Ontario Telemedicine Network website[2] provides or links to many different types of virtual care, which can be broken down into 3 basic types:

  1. eCare: applications or devices used to monitor patients, or to allow patients to self-monitor; such applications or devices may be sourced via innovative procurement together with the MOHLTC and the LHINs
  2. eVisit: real time video visits with patients, usually initiated by the health care provider
  3. eConsult: secure electronic consultations between health care providers about a specific patient

 

Virtual care services require registration by the physician to use OTN infrastructure.  Other infrastructure may be used if approved by OTN. The following chart identifies different types of virtual care solutions, most of which are provided by OTN or available through the OTN website.

[1] Premier’s Council on Improving Healthcare and Ending Hallway Medicine, A Healthy Ontario: Building a Sustainable Health Care System, June 2019, available at https://files.ontario.ca/moh-healthy-ontario-building-sustainable-health-care-en-2019-06-25.pdf, pages 20-21.

[2][2] https://otn.ca/


Regulating Internet Sales of Prescription Eyewear in Canada

Introduction

With the explosion of internet sales of prescription eyewear, a new threat exists to traditional optometry and opticianry.  On-line retail sales have skyrocketed since 2000. Business models permitting the dispensing of prescription eyewear, whether glasses or contact lenses, must include the involvement of an optician or optometrist in accordance with Ontario law and the law of most (but not all) Canadian provinces. Many on-line retailers use a business model that complies with provincial law and they dispense prescription eyewear.

BC Case Law

However, some business models do not comply with provincial regulations. Companies involved in such enterprises have been challenging provincial regulations across Canada over the past decade.  An early court decision in British Columbia found that a business model that violated the regulations had to be revised to comply with existing law. The court granted the injunction requested by the applicant college of opticians, but suspended the operation of the injunction for six months, finding no harm or urgency to the retailer’s customers. This suspension gave the retailer time to craft a business model to comply with the regulations and to seek legislative change to accommodate their business model[1].  During those six months, in early 2010, the British Columbia government changed how it regulates opticians, permitting dispensing of repeat prescriptions without the involvement of a regulated eye care professional. The lucrative business model could continue in compliance with BC law.

Quebec Case Law

In 2014, in a similar application involving the same on-line retailer based in British Columbia, the Quebec Superior Court ruled, in accordance with the Quebec Civil Code, that the sale of the prescription eyewear occurred in B.C., rather than Quebec, and therefore did not violate Quebec law that required the involvement of an optician or optometrist[2]. The Quebec optometry regulator was unsuccessful in its appeal to the Quebec Court of Appeal[3] and the Supreme Court of Canada[4].

Association Position Statements

In 2014 the Canadian Association of Optometrists issued position statements about internet dispensing and online eye exams, cautioning that on-line sales of prescription eyewear can compromise patient care[5]. In May of 2018 the Association indicated that “prescribing in the absence of a comprehensive eye exam poses a risk to the public of substandard care”,[6] and it documented the steps to be taken to protect optometrists.

Where are we in Ontario?

What is the situation in Ontario today? In 2018, regulators in Ontario continue to argue, in accordance with the current law, that professional standards and the public interest require that only opticians or optometrists be permitted to dispense prescription eyewear, whether they are involved on-line or in a bricks and mortar location; their guidance documents concerning internet dispensing reflect this position.  Concurrently, internet retail sales of prescription eyewear continue to skyrocket.

In January of 2018, pursuant to an application for an injunction filed in 2016, an Ontario court found that the Ontario law applies to companies that dispense prescription eyewear to Ontario residents without the involvement of an optician or optometrist, despite the fact that the company operates out of British Columbia[7]. The court granted the regulators’ request for an injunction to prevent the company from dispensing products in Ontario without the involvement of an optician or optometrist.  The court noted that policy change is the domain of the provincial legislature, and it is for the province to determine whether the landscape should be shifted.

Competition Bureau Weighs In

In the summer of 2018, the Competition Bureau weighed in. After reviewing Canadian, American and European reports showing that internet dispensing facilitated access for thousands of Canadians living in remote locations, and benefitted Canadians by ensuring competitive prices, the Bureau concluded that Canadian regulators should consider whether less restrictive measures can be created to permit on-line dispensing, while concurrently maintaining patient health and safety. The Bureau argues that doing so would “help to ensure that the Canadian economy benefits from innovative, high quality products and services and the lowest possible prices”, and would give enhanced access to consumers in remote areas.  The Bureau argues that regulations should be modernized so as not to inhibit legitimate forms of competition that benefit consumers and the economy. [For the Bureau’s report see http://www.competitionbureau.gc.ca/eic/site/cb-bc.nsf/eng/04377.html].

Conclusion

Whether or not the Ontario government weighs in on the matter remains to be seen, as legislative change would be required to permit the legal operation of Essilor’s current business model as described in the injunction order. For now, the legal landscape in Ontario preserves the legislative scheme that firmly entrenches the dispensing of prescription eyewear as part of an act that carries with it a risk of harm, and requires the involvement of an optician or optometrist, rather than a retail endeavour.  Future directions remain to be seen.

The above article does not constitute legal advice.  If you need legal advice, feel free to contact me at spalter@ddohealthlaw.com.

 

[1] College of Opticians of British Columbia v. Coastal Contacts Inc. 2009 BCCA 459 (CanLII) at paragraph 33.

[2] Ordre des optometrists du Quebec v.  Coastal Contacts Inc. 2014 QCCS 5886 (CanLII).

[3] Ordre des optometrists du Quebec v.  Coastal Contacts Inc. 2016 QCCA 837 (CanLII).

[4] Ordre des optometrists du Quebec v.  Coastal Contacts Inc. 2017 CanLII 442 (SCC).

[5] https://opto.ca/sites/default/files/resources/documents/cao_position_statement_-_internet_dispensing.pdf

[6] https://opto.ca/sites/default/files/resources/documents/internet_dispensing_en_may_2018.pdf

[7] College of Optometrists et al v. Essilor Group Canada Inc., 2018 ONSC 206 (CanLII).

Progressing Toward the Regulation of Psychotherapy in Ontario

The regulation of psychotherapy has been more than 10 years in the making but significant strides have been made recently toward full implementation.  Further to the Minister of Health and Long-Term Care’s direction in December of 2017, the College of Registered Psychotherapists of Ontario created a draft regulation identifying therapy modalities that its members could use when providing psychotherapy services. The proposed regulation (under the Psychotherapy Act) was released in April and comments are due by June 15, 2018. The draft regulation is available here: https://www.ontariocanada.com/registry/view_posting.jsp;jsessionid=mAnot1q4ZrYdoGo6sV7mSaT?language=en&postingId=27366

There are six categories of treatment modalities identified in the proposed regulation and they are fairly broad. In order to give some additional clarity to the regulation, and further to the Minister’s direction, the CRPO conducted a public consultation about its draft policy identifying activities that do not fall within the controlled act of psychotherapy. The draft policy is available here: https://www.crpo.ca/wp-content/uploads/2018/03/CRPO-CATG-Consultation-Documents_Consultation-Draft.pdf

Psychotherapists who are not currently registered with an RHPA or social work college whose members are permitted to practise psychotherapy must determine whether their practice falls within one of the broad prescribed modalities identified in the draft regulation; if yes, the practitioner must take steps to become registered with a college permitting such practice (such as the CRPO) or they must take steps to restrict their practice.

In order to provide additional guidance to currently unregulated psychotherapists to help them determine whether they are providing the controlled act of psychotherapy, and therefore whether they need to take steps to register before December of 2019, the CRPO also released a self-assessment tool for providers.  A link to the self-assessment tool is found here https://www.crpo.ca/wp-content/uploads/2018/03/CRPO-CATG-Consultation-Documents_Consultation-Draft.pdf

Prior to the CRPO’s public consultation about the draft regulation, the Health Professions Regulatory Advisory Council reported to the Minister about clarifying the meaning of the controlled act of psychotherapy. That report, entitled “The Therapeutic Relationship as the Cornerstone of Psychotherapy” was released to the public in March of 2018 and is available on the Council’s website.

The CRPO regulation and policy represent a significant move forward toward comprehensive regulation of psychotherapists in Ontario.

For more information, contact Simmie Palter @ spalter@ddohealthlaw.com

Health Sector Payment Transparency Act, 2017

Status

Schedule 4 of Bill 160 enacts the Health Sector Payment Transparency Act, 2017 (the “Act”). On December 12, 2017, the Act received Royal Assent, but has not yet been proclaimed in force.

Purpose of the Act

The purpose of the Act is to require the reporting of information related to financial relationships that exist within Ontario’s health care system. The purpose is also to enable the collection, analysis and publication of that information in order to, among other things:

  • strengthen the transparency to sustain and enhance patients’ trust in both the health care system and health care providers, and
  • allow patients to make informed decisions about their health care by providing them with access to information.

The Act is similar to the Physician Payments Sunshine Act found in the United States and is the first of its kind in Canada. The Act calls attention to the financial relationship between the medical industry (such as pharmaceutical and medical device companies) and those involved in the health care sector (individuals and organizations) – it creates a regime that requires mandatory disclosure of private sector payments to health professionals. As part of Bill 160, the Strengthening Quality and Accountability for Patients Act, 2017, the Act aims to enhance transparency, accountability, and the quality of care across the health care sector.

Requirements of the Act

The Act requires a “payor” to report to the Minister of Health and Long-Term Care (the “Minister”) information related to a “transfer of value” provided to a “recipient”, whether directly or indirectly through an intermediary. Intermediaries and affiliates may also be required to make reports, if requested by the Minister. The Act describes a payor as any of the following persons if the person provides a transfer of value to a recipient:

  1. A manufacturer that sells a medical product under the manufacturer’s own name or under a trade-mark, design, trade name or other name or mark that is owned or controlled by the manufacturer and that fabricates, produces, processes, assembles, packages or labels the product, even if those tasks are performed by someone else on the manufacturer’s behalf.
  2. A person who fabricates, produces, processes, assembles, packages or labels a medical product on behalf of a manufacturer described in #1.
  3. A wholesaler, distributor, importer or broker that promotes or facilitates the sale of a medical product.
  4. A marketing firm or person who performs activities for the purposes of marketing or promoting a medical product.
  5. A person who organizes continuing education events for members of a health profession on behalf of a manufacturer described in #1.
  6. A prescribed person or entity.

Note other relevant definitions:

  • “Transfer of value” means a transfer of value of any kind, including a payment, benefit, gift, advantage, perquisite or any other prescribed benefit.
  • “Recipient” means a prescribed person, as per the regulations, that receives a transfer of value from a payor.

The Act requires the following information to be reported:

  1. The name of the parties to the transaction.
  2. The source of the transfer of value (if requested).
  3. The parties’ respective business addresses.
  4. The date of the transfer of value.
  5. The transfer of value’s dollar value (or its approximate dollar value, if it is a non-monetary transfer of value).
  6. A description of the transfer of value (including reasons).
  7. Any other prescribed information.

The Act also requires the Minister to analyse the information that is reported for the purposes of health system research and evaluation, planning, and policy analysis. The Minister is allowed to disclose the information reported at least once in a calendar year. Furthermore, the Act establishes a framework for inspections and other compliance mechanisms.

Draft Regulations

In February 2018, draft regulations under the Act were published by the Ontario Government. Details found within the draft regulations include, among other things:

  • a list of 31 persons/entities that constitute recipients, including regulated health professionals; hospitals under the Public Hospitals Act and the Private Hospitals Act; psychiatric facilities under the Mental Health Act (subject to exceptions); a not-for-profit entity that operates a family health team or community mental health and addiction services; a licensee under the Long-Term Care Homes Act, 2007; a College under the Regulated Health Professions Act, 1991; a board member, director, trustee, officer, appointee, employee, or agent of a prescribed entity within this definition; etc.
  • a list of 24 items that are considered reportable transfer of values under the Act, such as cash or cash equivalents, honoraria, compensation for services, rebates and discounts, membership fees, supplies and equipment, food and beverages, travel and accommodation, personal gifts, royalties, etc.
  • the definition of intermediary – a person or entity is deemed to be providing or facilitating a transfer of value on behalf of a payor if the transfer of value originates from the payor (irrespective of whether the payor directs how the transfer of value is to be used by the intermediary or is aware of the identities of the recipients at the time the transfer of value is provided to the intermediary)
  • the monetary threshold for reporting a transfer of value set at $10 or more, and other exceptions to reporting requirements
  • other reporting requirements related to the classification of the transfer of value
  • new entities under the definition of payor, including community pharmacies and laboratories
  • the manner and frequency of reporting – every payor must report to the Minister every year, no later than June 30 in any year after 2019 for the previous calendar year.

Penalties

Penalties will be imposed on individuals and corporations for contravening the Act for each day or part of a day on which the offence occurs or continues to occur. These will range from $10,000-$25,000 for individuals and $50,000-$100,000 for corporations. However, a defence of due diligence is applicable in cases where all reasonable steps were taken to prevent the contravention, or at the time of the contravention, the person had an honest and reasonable belief in a mistaken set of facts which, if true, would have resulted in there not being any contravention.