Legislation: Bill 21, Safeguarding Health Care Integrity Act, 2014
Date of Royal Assent: December 11, 2014
Bill 21, Safeguarding Health Care Integrity Act, 2014, was proposed on July 22, 2014, and received Royal Assent on December 11, 2014, although not all provisions are currently in force.
The Bill makes key changes to the oversight of Ontario’s hospital pharmacies, the regulation of healthcare professionals, and enacts theVoluntary Blood Donations Act, 2014. Bill 21 expands the number of situations where mandatory reporting to health profession colleges is required and would allow for circumstances where confidential information can be shared with a hospital or possibly other persons where prescribed in regulation, although no such regulations have yet been published.
We previously reported on Bill 21 in a Pharma in Brief bulletin which can be accessed here.
Enacting the Voluntary Blood Donations Act, 2014
The first part of Bill 21 enacts the Voluntary Blood Donations Act, 2014 (“VBDA”). The purpose of VBDA is to recognize that blood donations are a public resource, that blood donors should not be paid except in exceptional circumstances, and that the integrity of the public and voluntary blood donor system must be protected.
The VBDA prohibits the provision of payments or offering payments to any person, or accepting payment by any person, in return for a donation of blood. However, Canadian Blood Services and individuals who give blood to Canadian Blood Services are exempt from these prohibitions.1 Moreover, these prohibitions do not apply to blood that is given solely for the purpose of research. The VBDA clarifies that blood given “solely for the purpose of research” is blood that is used or intended to be used to manufacture pharmaceuticals derived from blood.2
The VBDA grants broad inspection powers to the Minister of Health and Long-Term Care to ensure compliance with the VBDA. The Minister can appoint inspectors that can enter and inspect, without a warrant, a blood collection facility, a business that owns, operates, franchises, or licenses blood collection facilities, and any place that the inspectors reasonably believe to be a blood collection facility.
Offenders of the VBDA face potentially steep fines. In the case of an individual, for a first offence, the fine is $10,000 for each day or part of a day that the offence occurs or continues, and for a second offence, the fine is $50,000 for each day or part of a day that the offence occurs or continues. In the case of a corporation, the fine amounts are increased 10-fold to $100,000 and $500,000, respectively.3
The VBDA came into force on December 11, 2014 when Bill 21 received Royal Assent. The Lieutenant Governor in Council may make regulations respecting the clarification of the definition of what constitutes “payment” for the purposes of the VBDA, and clarifying the meaning of the phrase “solely for the purpose of research”.
Regulatory oversight of hospital pharmacies
The Bill makes amendments to the Drug and Pharmacies Regulation Act to bring hospital pharmacies under the regulatory authority of the Ontario College of Pharmacists (“OCP”). The amendments allow the OCP to inspect hospital pharmacies to ensure that they comply with regulatory requirements, and require that hospital pharmacies be accredited by the OCP. For the purposes of the Drug and Pharmacies Regulation Act, the definition of a “hospital pharmacy” deems a location in a hospital where drugs are compounded, dispensed, supplied from, or stored to be a pharmacy.
The amendments also grant the OCP the authority to make regulations respecting the standards, operation and inspections of hospital pharmacies.
Reporting requirements for regulated health professionals
Bill 21 expands the regulatory oversight of regulated health professionals by creating mandatory reporting requirements to regulatory colleges of health professionals in Ontario. Specifically, Bill 21 amends the Public Hospitals Act, requiring that the administrator of a hospital prepare and forward a detailed report to the College of Physicians and Surgeons of Ontario where a physician resigns or restricts their practice within the hospital and the hospital administrator has reasonable grounds to believe the resignation or restriction is related to the competence, negligence or conduct of the physician, or the resignation or restriction occurs during the course of, or as a result of, an investigation into his or her competence, negligence or conduct.
The Bill also makes three key amendments to the Regulated Health Professions Act, 1991, specifically:
- A supervisor of a health professional college may be appointed by the Lieutenant Governor in Council, on the recommendation of the Minister of Health and Long-Term Care, where the Minister considers it to be appropriate or necessary.
- Three exceptions are provided to the duty of confidentiality under the Regulated Health Professions Act, 1991, namely: (1) allowing disclosure of information where required, in order to administer certain legislation including, among others, the Food and Drugs Act, the Health Protection and Promotion Act, the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee Act; (2) allowing disclose of confidential information to a public hospital that employs a member of a health profession college that is investigating a complaint against the member; and (3) allowing disclosure of information to a class of people as may be provided for the regulation.
- The Health Professions Procedural Code (Schedule 2 of the Regulated Health Professions Act, 1991) is amended to require an employer who has reasonable grounds to believe that the resignation of a member of a health profession college is related to the member’s professional misconduct, incompetence or incapacity to file a written report with the Registrar of the health profession college.
The amendments to the Drug and Pharmacies Regulation Act, Public Hospitals Act and Regulated Health Professions Act, 1991 are not yet in force.
The author wishes to thank Bobby Leung, articling student, for his help in preparing this pharma in brief.
Link to the Legislation: