On July 22, 2014, Ontario's Minister of Health and Long-Term Care introduced Bill 21, Safeguarding Health Care Integrity Act, 2014. If passed as proposed, the legislation will prohibit payments or other forms of compensation to individuals who donate blood. The legislation makes it an offence not only to pay or offer to pay for blood but also for blood donors to accept such payments. Bill 21 also provides for the inspection and accreditation of hospital pharmacies by the Ontario College of Pharmacists, expands the ability of health profession colleges to share information with hospitals (or others as set out in the regulations) and expands mandatory reporting requirements to health profession colleges in certain situations following a member's resignation or voluntary restriction of his/her activities.
Bill 21 is a combination of two previously proposed bills: Bill 178, the Voluntary Blood Donations Act which was introduced in March 2014, and Bill 117, the Enhancing Patient Care and Safety (Statute Law Amendment) Act1 which was introduced in October 2013. Both Bills 117 and 178 died on the order paper when the Ontario legislature dissolved earlier this year.
Summary of the proposed legislation
Prohibitions against paid blood donations
The first part of Bill 21 enacts the Voluntary Blood Donations Act, 2014 (VBDA) which prohibits:
- providing or offering to provide payment to any individual in return for giving blood or blood constituents; and
- accepting payment, either directly or indirectly, in return for the giving of blood.
The VBDA provides for certain exemptions and exclusions. Canadian Blood Services and its donors are exempt from the payment prohibitions. In addition, the prohibitions against payment do not apply to blood given solely for the purpose of research (as long as the blood is not used or intended to be used for the manufacturing of pharmaceuticals derived from blood).
The VBDA provides for the inspection of blood collection facilities and associated business premises (for the purposes of determining whether the VBDA is being complied with) and corresponding enforcement powers. Contraventions of the VBDA by an individual would be subject to fines of up to $10,000 for a first offence and up to $50,000 for a second or subsequent offence upon conviction. Contraventions of the VBDA by corporations would be subject to fines up to $100,000 for a first offence and up to $500,000 for a second or subsequent offence upon conviction. In all cases, the fines are applicable to each day, or part of a day, that the offence occurs.
Hospital pharmacy regulation and information sharing
Schedule 2 of Bill 21 expands the authority of the Ontario College of Pharmacists (College) to inspect, oversee and issue certificates of accreditation for pharmacies within both public and private hospitals, in addition to community pharmacies by amending the Drug and Pharmacies Regulation Act. The proposed amendments bring hospital pharmacies into Ontario's regulatory framework for pharmacies and, among other changes, provide the College with the ability to conduct regular inspections of such pharmacies in order to monitor compliance and enforce regulatory requirements (in the same way that the College monitors compliance of community pharmacies).
In addition, Bill 21 proposes amendments to the Public Hospitals Act that would require hospitals to report to the College of Physicians and Surgeons of Ontario cases where a physician resigned from the medical staff of a hospital or restricted practice within a hospital and the hospital believes that the resignation or practice restriction is related to the competence, negligence or conduct of the physician. Similar amendments are also proposed to Ontario's Health Professions Procedural Code (Code) to require reports to an Ontario health profession college where a member of that college resigns or voluntarily restricts their practice and there is reason to believe that the resignation or restriction is related to professional misconduct, incompetence or incapacity of the member.
Bill 21 also expands the exceptions to the confidentiality requirements under the Regulated Health Professions Act, 1991 to include disclosure of confidential information for the administration of the Health Protection and Promotion Act and for prescribed purposes to a public hospital where a health profession college is investigating a complaint about one of its members to whom the hospital has granted privileges or who the hospital employs, or to certain other persons where a health profession college is investigating a complaint about one of its members or where the information was obtained by an investigator conducting an investigation under the Code and as provided in the regulations.
Status of Bill 21
Bill 21 received first reading on July 22, 2014. We will continue to monitor the status of Bill 21 and report on its status.
Link to Bill 21
1 The Enhancing Patient Care and Safety Act was previously reported in a Pharma in Brief bulletin which can be accessed here.
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