Bill 21, Safeguarding Health Care Integrity Act, 2014

Bill 21 2014

An Act to safeguard health care integrity by enacting the Voluntary Blood Donations Act, 2014 and by amending certain statutes with respect to the regulation of pharmacies and other matters concerning regulated health professions

Her Majesty, by and with the advice and consent of the Legislative Assembly of the Province of Ontario, enacts as follows:

Contents of this Act

   1.  This Act consists of this section, sections 2 and 3 and the Schedules to this Act.

Commencement

   2.  (1)  Subject to subsections (2) and (3), this Act comes into force on the day it receives Royal Assent.

Same

   (2)  The Schedules to this Act come into force as provided in each Schedule.

Same

   (3)  If a Schedule to this Act provides that any provisions are to come into force on a day to be named by proclamation of the Lieutenant Governor, a proclamation may apply to one or more of those provisions, and proclamations may be issued at different times with respect to any of those provisions.

Short title

   3.  The short title of this Act is the Safeguarding Health Care Integrity Act, 2014.

 

Schedule 1
Voluntary Blood Donations Act, 2014

Purpose

   1.  The purpose of this Act is to provide for recognition of the following principles:

    1.  Within Ontario's health care system, blood donations are viewed as a public resource‎.

‎    2.  Blood donors should not be paid, except in exceptional circumstances.

    3.  ‎The integrity of the public, voluntary blood donor system in Ontario must be protected.

Definitions

   2.  In this Act,

"blood" means human blood, and includes whole blood and blood constituents; ("sang")

"blood collection facility" means a place where blood is taken or collected from the human body; ("établissement de collecte de sang")

"compliance order" means an order made under section 5; ("arrêté de conformité")

"inspector" means an inspector appointed under section 4; ("inspecteur")

"Minister" means the Minister of Health and Long-Term Care, or, if another Minister has been assigned responsibility for this Act under the Executive Council Act, that Minister; ("ministre")

"offer to provide", without restricting the ordinary meaning of the expression, includes to offer by means of advertising in any media; ("offrir de fournir")

"payment" means, subject to the regulations, remuneration, compensation or consideration of any value and of any kind, and includes reimbursement for time, travel, commitment or expenditures of any kind; ("paiement")

"personal information" includes personal information as defined in the Freedom of Information and Protection of Privacy Act and personal health information as defined in the Personal Health Information Protection Act, 2004; ("renseignements personnels")

"record" includes a record that contains personal information; ("dossier")

"regulations" means regulations made under this Act; ("règlements")

"restraining order" means an order made under section 6. ("ordonnance de ne pas faire")

Payment for blood prohibited

   3.  (1)  No person shall,

  (a)  provide payment to any individual in return for the giving of blood by that individual, either directly or indirectly; or

  (b)  offer to provide payment to any individual in return for the giving of blood by that individual, either directly or indirectly.

Same, donor

   (2)  No individual shall accept any payment in return for the giving of his or her blood, either directly or indirectly.

Exemption, Canadian Blood Services

   (3)  Canadian Blood Services and the individuals who give blood to Canadian Blood Services are exempt from subsections (1) and (2).

Non-application, blood for research

   (4)  Subsections (1) and (2) do not apply with respect to blood that is given solely for the purpose of research.

Clarification

   (5)  For greater clarity, in applying subsection (4), blood is not given "solely for the purpose of research" if it is used or intended to be used, directly or indirectly, in whole or in part, for the manufacture of pharmaceuticals derived from blood.

Inspectors

   4.  (1)  The Minister may appoint inspectors for the purposes of this Act.

Inspection

   (2)  For the purpose of determining whether this Act is being complied with, an inspector may, without a warrant, enter and inspect,

  (a)  a blood collection facility;

  (b)  any business premises of a company that owns, operates, franchises or licenses one or more blood collection facilities; and

   (c)  any place that the inspector reasonably believes is being used as a blood collection facility.

Time of entry

   (3)  The power under this section to enter and inspect without a warrant may be exercised only during the regular business hours of the blood collection facility, business premises or place.

Dwellings

   (4)  The power to enter and inspect under this section shall not be exercised to enter and inspect a place or a part of a place that is used as a dwelling.

Use of force

   (5)  An inspector is not entitled to use force to enter and inspect a blood collection facility, business premises or place.

Identification

   (6)  An inspector conducting an inspection shall produce, on request, evidence of his or her appointment.

Powers of inspector

   (7)  An inspector conducting an inspection may,

  (a)  examine records or anything else that is relevant to the inspection;

  (b)  demand the production of a record or any other thing that is relevant to the inspection;

   (c)  remove a record or any other thing that is relevant to the inspection for review, examination or testing;

  (d)  remove a record or any other thing that is relevant to the inspection for copying;

  (e)  in order to produce a record in readable form, use data storage, information processing or retrieval devices or systems that are normally used in carrying on business in the place;

   (f)  take photographs or make any other kind of recording; and

  (g)  question a person on matters relevant to the inspection.

Written demand

   (8)  A demand under this section that a record or any other thing be produced must be in writing and must include a statement of the nature of the record or thing required.

Obligation to produce and assist

   (9)  If an inspector demands that a record or any other thing be produced under this section, the person who has custody of the record or thing shall produce it and, in the case of a record, shall on request provide any assistance that is reasonably necessary to interpret the record or to produce it in a readable form.

Records and things removed from place

   (10)  A record or other thing that has been removed for review, examination, testing or copying,

  (a)  shall be made available to the person from whom it was removed on request and at a time and place that are convenient for the person and for the inspector; and

  (b)  shall be returned to the person within a reasonable time, unless, in the case of a thing that has been subject to testing, the thing has been made unsuitable for return as a result of the testing.

Copy admissible in evidence

   (11)  A copy of a record or other thing that purports to be certified by an inspector as being a true copy of the original is admissible in evidence to the same extent as the original and has the same evidentiary value.

Obstruction

   (12)  No person shall hinder, obstruct or interfere with or attempt to hinder, obstruct or interfere with an inspector conducting an inspection, refuse to answer questions on matters relevant to the inspection or provide the inspector with false information on matters relevant to the inspection.

Compliance orders

   5.  (1)  Where the Minister believes, on reasonable grounds, that a person who owns or operates a blood collection facility is not complying with the prohibition under subsection 3 (1), the Minister may make an order requiring the person to correct the non-compliance.

Evidence of compliance

   (2)  A person to whom a compliance order is directed may, within 14 days of service being effected, provide the Minister with evidence that the person is, in fact, in compliance with the prohibition.

Reconsideration

   (3)  Where a person has provided evidence under subsection (2), the Minister shall consider the evidence, and may either affirm the compliance order or rescind it in consequence, and have the person served with the affirmed order or notice of the rescission.

Compliance

   (4)  A person to whom a compliance order, or an affirmed compliance order, as the case may be, is directed shall comply with it according to its terms.

Service

   (5)  A document under this section is sufficiently served if it is served on the owner or operator of the blood collection facility or a person employed or apparently employed at the facility.

Proof of service

   (6)  A certificate of service made by the person who served a document under this section is evidence of the service of the document on the person served and its receipt by that person if, in the certificate, the person who served the document,

  (a)  certifies that the copy of the document is a true copy of it;

  (b)  certifies that the document was served on the person; and

   (c)  sets out in it the method of service used.

Copy of order

   (7)  In a prosecution for failing to comply with a compliance order, a copy of the order that purports to have been signed by the Minister is evidence of the order without proof of the signature.

Non-application of SPPA

   (8)  The Statutory Powers Procedure Act does not apply with respect to compliance orders.

Restraining orders

   6.  (1)  If it appears to the Minister that a person is not complying with this Act or the regulations or a compliance order, the Minister may apply to the Superior Court of Justice for an order directing the person to comply, and, upon the application, the court may make the order that the court thinks fit.

Same

   (2)  Subsection (1) applies in addition to the power to issue compliance orders, and may be exercised whether or not such an order has been issued.

Must comply

   (3)  A person to whom a restraining order is directed shall comply with it according to its terms.

Appeal

   (4)  An appeal lies to the Divisional Court from a restraining order.

Personal information

   7.  (1)  The Minister and an inspector may directly or indirectly collect personal information, subject to any requirements or conditions provided for in the regulations, for purposes related to the enforcement of this Act.

Use of personal information

   (2)  The Minister and an inspector may use personal information, subject to any requirements or conditions provided for in the regulations, for purposes related to the enforcement of this Act.

Disclosure of personal information

   (3)  The Minister and an inspector may disclose personal information, subject to any requirements or conditions provided for in the regulations, for purposes related to the enforcement of this Act.

Offences

   8.  (1)  Every person who contravenes a provision of this Act is guilty of an offence and on conviction is liable,

  (a)  in the case of an individual,

           (i)  for a first offence, to a fine not exceeding $10,000 for each day or part of a day on which the offence occurs or continues, and

          (ii)  for a second or subsequent offence, to a fine not exceeding $50,000 for each day or part of a day on which the offence occurs or continues; and

  (b)  in the case of a corporation,

           (i)  for a first offence, to a fine not exceeding $100,000 for each day or part of a day on which the offence occurs or continues, and

          (ii)  for a second or subsequent offence, to a fine not exceeding $500,000 for each day or part of a day on which the offence occurs or continues.

No limitation

   (2)  Section 76 of the Provincial Offences Act does not apply to a prosecution under this section.

Provincial Judge required

   (3)  The Attorney General or an agent of the Attorney General may, by notice to the clerk of the Ontario Court of Justice, require that a provincial judge preside over a proceeding in respect of an offence under this Act.

Publication re convictions

   (4)  If a person is convicted of an offence under this Act, the Minister may publish or otherwise make available to the general public the name of the person, a description of the offence, the date of the conviction and the person's sentence.

Compliance order not necessary

   (5)  A person may be prosecuted under this section whether or not a compliance order or a restraining order has been previously made with respect to the subject matter of the prosecution.

Certificates

   (6)  In any prosecution or other proceeding under this Act, a certificate of an analyst stating that the analyst has made an analysis of a sample and stating the result of that analysis is evidence of the facts alleged in the certificate without proof of the signature or the official character of the person appearing to have signed the certificate.

Protection from liability

   9.  No action or other proceeding shall be commenced against the Minister or anyone acting under the authority of the Minister for anything done in good faith in purported compliance with this Act.

Regulations, Minister

   10.  The Minister may make regulations exempting persons from this Act or any provisions of this Act, subject to any conditions that may be provided for in the regulations.

Regulations, Lieutenant Governor in Council

   11.  The Lieutenant Governor in Council may make regulations,

  (a)  defining any word or expression used in this Act but not defined in the Act;

  (b)  clarifying the definition of "payment" in section 2 and specifying what things do or do not constitute payment for the purpose of the Act;

   (c)  further clarifying the meaning of "solely for the purpose of research" as used in section 3;

  (d)  specifying requirements or conditions in respect of the collection, use or disclosure of personal information by the Minister or an inspector under this Act;

  (e)  for carrying out the purposes, provisions and intent of this Act.

Related Amendments

Laboratory and Specimen Collection Centre Licensing Act

   12.  (1)  The definition of "laboratory" in section 5 of the Laboratory and Specimen Collection Centre Licensing Act is repealed and the following substituted:

"laboratory" means, subject to any exclusions provided for in the regulations,

  (a)  an institution, building or place in which operations and procedures for the microbiological, serological, chemical, hematological, biophysical, immunohematological, cytological, pathological, cytogenetic, molecular genetic or genetic examination, or such other examinations as are prescribed by the regulations, of specimens taken from the human body are performed to obtain information for diagnosis, prophylaxis or treatment, and

  (b)  any other institution, building or place that may be provided for in the regulations; ("laboratoire")

   (2)  The definition of "specimen collection centre" in section 5 of the Act is repealed and the following substituted:

"specimen collection centre" means a place where specimens are taken or collected from the human body for examination to obtain information for diagnosis, prophylaxis or treatment, and any other place that may be provided for in the regulations, but does not include,

  (a)  a place where a legally qualified medical practitioner is engaged in the practice of medicine or surgery,

  (b)  a place where a registered nurse who holds an extended certificate of registration under the Nursing Act, 1991 is engaged in the practice of nursing,

   (c)  a place where a member of the College of Dietitians of Ontario is engaged in the practice of dietetics,

  (d)  a place where a member of the College of Midwives of Ontario is engaged in the practice of midwifery,

  (e)  a laboratory that is established, operated or maintained under a licence under this Act, or

   (f)  a place that is excluded from this definition by the regulations; ("centre de prélèvement")

   (3)  Section 8 of the Act is amended by striking out "instituted against the Director" and substituting "instituted against the Minister or the Director".

   (4)  Section 9 of the Act is amended by adding the following subsections:

Blood collection facilities

   (7.1)  Despite subsections (2) and (4), where an application is made for a licence to establish, operate or maintain a laboratory or a specimen collection centre which will operate as a blood collection facility within the meaning of the Voluntary Blood Donations Act, 2014 and the Minister states in writing to the Director that it is not in the public interest to issue such a licence, section 11 shall not apply and the Director shall not issue the licence to the applicant and shall give written notice to the applicant of the refusal and of the Minister's statement.

Same

   (7.2)  In making a decision in the public interest in subsection (7.1), the Minister may consider any matter the Minister regards as relevant including, without being limited to, the principles set out in the Voluntary Blood Donations Act, 2014.

   (5)  Subsection 9 (8) of the Act is amended by adding the following clause:

  (e)  any other ground for refusal that is prescribed in the regulations exists.

   (6)  Clause 9 (17) (e) of the Act is amended by adding "or any other Act or law relevant to the operation or maintenance of a laboratory or specimen collection centre" at the end.

   (7)  Subsection 9 (17) of the Act is amended by striking out "or" at the end of clause (f), by adding "or" at the end of clause (g) and by adding the following clause:

  (h)  any other ground for revoking or refusing renewal that is prescribed in the regulations exists.

   (8)  Subsection 16 (1) of the Act is amended by striking out "5 to 18" and substituting "5 to 17".

   (9)  Subsection 16 (3) of the Act is amended by striking out "5 to 18" and substituting "5 to 17".

   (10)  Subsection 16 (4) of the Act is amended by striking out "and probable".

   (11)  The Act is amended by adding the following section:

Restraining orders

   17.  (1)  If it appears to the Director that a person is not complying with this Act or the regulations, the Director may apply to the Superior Court of Justice for an order directing the person to comply, and, upon the application, the court may make the order that the court thinks fit.

Same

   (2)  Subsection (1) applies in addition to any other procedures that may be available to the Director, whether or not the Director has exercised his or her rights under such procedures.

Compliance

   (3)  A person to whom an order under subsection (1) is directed shall comply with it according to its terms.

Appeal

   (4)  An appeal lies to the Divisional Court from an order made under subsection (1).

   (12)  Section 18 of the Act is amended by adding the following clauses:

(a.1) excluding institutions, buildings or places from the definition of "laboratory" in section 5, and providing for additional institutions, buildings or places that are laboratories for the purposes of that definition;

(a.2) providing for additional places that are specimen collection centres for the purposes of the definition of "specimen collection centre" in section 5, and excluding places from that definition;

(a.3) prescribing grounds for the purposes of subsections 9 (8) and 9 (17);

   (13)  Subsections 22 (1) and (2) of the Act are repealed and the following substituted:

Offences

   (1)  Subject to subsection (2), a person who contravenes any provision of this Act or of the regulations is guilty of an offence and on conviction is liable,

  (a)  for a first offence, to a fine of not more than $25,000 for each day or part of a day on which the offence occurs or continues or to imprisonment for a term of not more than 12 months, or to both;

  (b)  for a subsequent offence, to a fine of not more than $50,000 for each day or part of a day on which the offence occurs or continues or to imprisonment for a term of not more than 12 months, or to both.

Same, corporation

   (2)  A corporation that is convicted of an offence under subsection (1) is liable to a fine of not more than $50,000 for each day or part of a day on which the offence occurs or continues for a first offence and to a fine of not more than $200,000 for each day or part of a day on which the offence occurs or continues for a subsequent offence.

Health System Improvements Act, 2007

   13.  Section 18 of Schedule P to the Health System Improvements Act, 2007 is repealed.

Regulated Health Professions Statute Law Amendment Act, 2009

   14.  Subsection 12 (2) of the Regulated Health Professions Statute Law Amendment Act, 2009 is repealed.

Trillium Gift of Life Network Act

   15.  (1)  Section 10 of the Trillium Gift of Life Network Act is amended by striking out "other than blood or a blood constituent".

   (2)  Section 10 of the Act is amended by adding the following subsections:

Blood

   (2)  Despite anything else in this Act or the regulations, blood and blood constituents shall not be considered to be tissue or part of a body for the purposes of subsection (1).

Voluntary Blood Donations Act, 2014

   (3)  Subsection (2) shall not be construed as authorizing anything that is prohibited by the Voluntary Blood Donations Act, 2014.

Commencement and Short Title

Commencement

   16.  The Act set out in this Schedule comes into force on the day the Safeguarding Health Care Integrity Act, 2014 receives Royal Assent.

Short title

   17.  The short title of this Act set out in this Schedule is the Voluntary Blood Donations Act, 2014.

 

Schedule 2
Amendments respecting the regulation of pharmacies and other matters concerning regulated health professions

Drug and Pharmacies Regulation Act

   1.  Subsection 1 (1) of the Drug and Pharmacies Regulation Act is amended by adding the following definitions:

"hospital" means a hospital within the meaning of the Public Hospitals Act or a private hospital within the meaning of the Private Hospitals Act; ("hôpital")

"hospital patient" means a patient within the meaning of the Public Hospitals Act or the Private Hospitals Act; ("malade d'un hôpital")

"hospital pharmacy" means a location that is deemed to be a pharmacy by virtue of section 119; ("pharmacie en milieu hospitalier")

"institutional pharmacy" means a premises that is deemed to be a pharmacy by virtue of section 120; ("pharmacie en milieu institutionnel")

   2.  Subsection 118 (1) of the Act is amended by striking out the portion before clause (a) and substituting the following:

Application of the Act

   (1)  Subject to sections 119 and 120, this Act does not apply to,

.     .     .     .     .

   3.  The Act is amended by adding the following sections:

Hospital pharmacies

   119.  (1)  Despite anything else in this Act, where drugs are compounded, dispensed or supplied for hospital patients by a hospital in premises located in a hospital, the primary location or locations in the hospital where drugs are compounded, dispensed or supplied from, together with any other location in the hospital where drugs are stored or supplied from and any other location prescribed in regulations made under subsection (2), is deemed to be a pharmacy for the purposes of the following provisions of this Act, subject to the regulations and to any necessary modifications:

    1.  Section 139.

    2.  Section 140.

    3.  Section 140.1.

    4.  Section 143.

    5.  Section 148.

    6.  Section 148.1.

    7.  Section 148.2.

    8.  Section 148.3.

    9.  Section 148.4.

  10.  Section 160.1.

  11.  Section 161.

  12.  Section 162.

  13.  Section 162.1.

  14.  Section 164.

  15.  Section 165.

  16.  Section 166.

  17.  Section 167.

Regulations

   (2)  The Lieutenant Governor in Council may make regulations prescribing locations for the purposes of subsection (1).

Institutional pharmacies

   120.  (1)  The Lieutenant Governor in Council may make regulations,

  (a)  designating premises in or associated with one or more health or custodial institutions as institutional pharmacies;

  (b)  providing that any or all provisions of this Act apply with respect to institutions designated under clause (a), subject to the modifications, if any, provided for in the designating regulation.

Same

   (2)  Where a premises has been designated in regulations described in subsection (1), the premises is deemed to be a pharmacy for the purposes of the provisions of this Act provided for in those regulations, subject to the regulations and to any necessary modifications.

Not pharmacies for other purposes

   121.  (1)  Hospital pharmacies and institutional pharmacies are not pharmacies, and the operators of hospital pharmacies and institutional pharmacies are not operators of pharmacies, for the purposes of any other Act or regulation, except,

  (a)  as may be explicitly provided for in the other Act or regulation, with reference to this section; or

  (b)  as may be provided for in regulations made under subsection (2).

Regulations

   (2)  The Lieutenant Governor in Council may make regulations,

  (a)  providing that hospital pharmacies are pharmacies for the purposes of one or more other Acts or regulations, and providing for those Acts or regulations;

  (b)  providing that institutional pharmacies are pharmacies for the purposes of one or more other Acts or regulations, and providing for those Acts or regulations;

   (c)  providing that operators of hospital pharmacies are operators of pharmacies for the purposes of one or more other Acts or regulations, and providing for those Acts or regulations;

  (d)  providing that operators of institutional pharmacies are operators of pharmacies for the purposes of one or more other Acts or regulations, and providing for those Acts or regulations;

  (e)  governing who is the operator of a hospital pharmacy or institutional pharmacy for the purposes of this section.

   4.  The Act is amended by adding the following section:

Contact person, hospital/institutional pharmacies

   146.1  (1)  Every hospital or institution in which a hospital pharmacy or an institutional pharmacy is operated shall designate a contact person for the hospital pharmacy or institutional pharmacy, and file notice of the designation with the College in accordance with the regulations.

One contact person or several

   (2)  For greater certainty, a hospital or institution may designate a different person as the contact person for every hospital pharmacy or institutional pharmacy for which it must designate a contact person, but is not obliged to do so.

   5.  (1)  Subsection 161 (1) of the Act is amended by adding the following clauses:

(l.1)  establishing one or more separate classes of certificates of accreditation with respect to pharmacies, hospital pharmacies or institutional pharmacies, setting terms, conditions and limitations with respect to such classes, and requiring compliance with those terms, conditions and limitations;

(l.2)  respecting the operation of hospital pharmacies and clarifying the application to hospital pharmacies of the provisions set out in section 119;

(l.3)  respecting the operation of institutional pharmacies and clarifying the application to institutional pharmacies of the provisions of this Act that apply to them by virtue of their designating regulations;

   (2)  Section 161 of the Act is amended by adding the following subsections:

Circulation

   (5)  A regulation shall not be made under subsection (1) unless the proposed regulation is circulated to every person who holds a valid certificate of accreditation at least 60 days before it is approved by the Council.

Same

   (6)  Subsection (5) does not apply to a regulation if the Minister required that the Council make the regulation under clause 5 (1) (c) of the Regulated Health Professions Act, 1991.

Exception

   (7)  Despite subsection (5), the Council may, with the approval of the Minister, exempt a regulation from the requirement that it be circulated or abridge the 60-day period referred to in subsection (5) to such lesser period as the Minister may determine.

   6.  Section 166 of the Act is amended by adding the following subsection:

Exception, hospital pharmacies

   (3)  A director of a corporation operating a hospital pharmacy is not liable for an offence by virtue of subsection (1), and may not be proceeded against under subsection (2).

   7.  The Act is amended by adding the following section:

Notice to Minister

   166.1  Where the College or a committee of the College proposes to take action under section 140 or any other provision of this Act and the action will involve a hospital pharmacy or an institutional pharmacy, the College or committee shall,

  (a)  give notice of the proposed action to the Minister in writing before taking the action; and

  (b)  provide the Minister with any information the Minister requests with respect to the action.

Public Hospitals Act

   8.  Section 33 of the Public Hospitals Act is amended by striking out "or" at the end of clause (b), by repealing clause (c) and by substituting the following:

   (c)  a physician resigns from a medical staff of a hospital or restricts his or her practice within a hospital and the administrator of the hospital has reasonable grounds to believe that the resignation or restriction, as the case may be, is related to the competence, negligence or conduct of the physician; or

  (d)  a physician resigns from a medical staff of a hospital or restricts his or her practice within a hospital during the course of, or as a result of, an investigation into his or her competence, negligence or conduct,

.     .     .     .     .

Regulated Health Professions Act, 1991

   9.  Subsection 5.0.1 (1) of the Regulated Health Professions Act, 1991 is repealed and the following substituted:

College supervisor

   (1)  The Lieutenant Governor in Council may appoint a person as a College supervisor, on the recommendation of the Minister, where the Minister considers it appropriate or necessary.

   10.  Clause 36 (1) (d) of the Act is repealed and the following substituted:

  (d)  as may be required for the administration of the Drug Interchangeability and Dispensing Fee Act, the Healing Arts Radiation Protection Act, the Health Insurance Act, the Health Protection and Promotion Act, the Independent Health Facilities Act, the Laboratory and Specimen Collection Centre Licensing Act, the Ontario Drug Benefit Act, the Coroners Act, the Controlled Drugs and Substances Act (Canada) and the Food and Drugs Act (Canada);

(d.1) for a prescribed purpose, to a public hospital that employs or provides privileges to a member of a College, where the College is investigating a complaint about that member or where the information was obtained by an investigator appointed pursuant to subsection 75 (1) or (2) of the Code, subject to the limitations, if any, provided for in regulations made under section 43;

(d.2) for a prescribed purpose, to a person other than a public hospital who belongs to a class provided for in regulations made under section 43, where a College is investigating a complaint about a member of the College or where the information was obtained by an investigator appointed pursuant to subsection 75 (1) or (2) of the Code, subject to the limitations, if any, provided for in the regulations;

   11.  Subsection 43 (1) of the Act is amended by adding the following clauses:

(g.1) prescribing purposes and providing for limitations for the purposes of clauses 36 (1) (d.1) and (d.2);

(g.2) providing for classes of persons for the purposes of clause 36 (1) (d.2);

   12.  Subsection 85.5 (2) of Schedule 2 to the Act is repealed and the following substituted:

Same

   (2)  Where a member resigns, or voluntarily relinquishes or restricts his or her privileges or practice, and the circumstances set out in paragraph 1 or 2 apply, a person referred to in subsection (3) shall act in accordance with those paragraphs:

    1.  Where a person referred to in subsection (3) has reasonable grounds to believe that the resignation, relinquishment or restriction, as the case may be, is related to the member's professional misconduct, incompetence or incapacity, the person shall file with the Registrar within 30 days after the resignation, relinquishment or restriction a written report setting out the grounds upon which the person's belief is based.

    2.  Where the resignation, relinquishment or restriction, as the case may be, takes place during the course of, or as a result of, an investigation conducted by or on behalf of a person referred to in subsection (3) into allegations related to professional misconduct, incompetence or incapacity on the part of the member, the person referred to in subsection (3) shall file with the Registrar within 30 days after the resignation, relinquishment or restriction a written report setting out the nature of the allegations being investigated.

Commencement

Commencement

   13.  This Schedule comes into force on a day to be named by proclamation of the Lieutenant Governor.

 

EXPLANATORY NOTE

This Explanatory Note was written as a reader's aid to Bill 21 and does not form part of the law.  Bill 21 has been enacted as Chapter 14 of the Statutes of Ontario, 2014.

 

Schedule 1
Voluntary Blood Donations Act, 2014

It is made an offence to pay or offer to pay blood donors for blood, and for blood donors to accept such payments.

Inspection and enforcement provisions are provided for, including compliance orders.

Related amendments are made to other legislation.

Schedule 2
amendments respecting the regulation of pharmacies and other matters concerning regulated health professions

The Drug and Pharmacies Regulation Act is amended to allow premises associated with hospitals and health and custodial institutions to be considered "pharmacies" for the purposes of certain provisions of the Act.  Related amendments are also made.

The Public Hospitals Act is amended to require a hospital administrator to prepare and forward a detailed report to the College of Physicians and Surgeons where a physician resigns or restricts his or her practice and there is reason to believe the resignation or restriction is related to his or her competence, negligence or conduct, or if the resignation or restriction takes place during the course of, or as a result of, an investigation into his or her behaviour.

The Regulated Health Professions Act, 1991 and the Health Professions Procedural Code are amended. Among the amendments:

    1.   The Lieutenant Governor in Council, upon the recommendation of the Minister of Health and Long-Term Care, may appoint a person as a supervisor of a health profession college where the Minister considers it to be appropriate or necessary to do so. The Bill removes the existing requirement that the Minister must additionally be of the opinion that the college's Council has failed to comply with a requirement previously issued to the college's Council by the Minister. 

    2.   Additional exceptions are created to the existing duty of confidentiality under the Act, including,

            i.  for the purposes of administering the Health Protection and Promotion Act,

           ii.  where the disclosure is to a public hospital that employs or that provides privileges to a member of a college, where the college is investigating the member, subject to any limitations in the regulations,

          iii.  disclosure to additional classes of persons provided for in regulations, subject to any limitations to be prescribed in those regulations.

    3.   The Health Professions Procedural Code is amended to provide that where a college member resigns, or voluntarily relinquishes or restricts his or her privileges or practice, a person such as an employer who has reasonable grounds to believe that the resignation, relinquishment or restriction, as the case may be, is related to the member's professional misconduct, incompetence or incapacity, shall file with the Registrar within 30 days after the resignation, relinquishment or restriction a written report setting out the grounds upon which the person's belief is based. This requirement also applies if the resignation or restriction takes place during the course of, or as a result of, an investigation into allegations related to the college member's behaviour.

Bill 21 2014

An Act to safeguard health care integrity by enacting the Voluntary Blood Donations Act, 2014 and by amending certain statutes with respect to the regulation of pharmacies and other matters concerning regulated health professions

Her Majesty, by and with the advice and consent of the Legislative Assembly of the Province of Ontario, enacts as follows:

Contents of this Act

   1.  This Act consists of this section, sections 2 and 3 and the Schedules to this Act.

Commencement

   2.  (1)  Subject to subsections (2) and (3), this Act comes into force on the day it receives Royal Assent.

Same

   (2)  The Schedules to this Act come into force as provided in each Schedule.

Same

   (3)  If a Schedule to this Act provides that any provisions are to come into force on a day to be named by proclamation of the Lieutenant Governor, a proclamation may apply to one or more of those provisions, and proclamations may be issued at different times with respect to any of those provisions.

Short title

   3.  The short title of this Act is the Safeguarding Health Care Integrity Act, 2014.

 

Schedule 1
Voluntary Blood Donations Act, 2014

Purpose

   1.  The purpose of this Act is to provide for recognition of the following principles:

    1.  Within Ontario's health care system, blood donations are viewed as a public resource‎.

‎    2.  Blood donors should not be paid, except in exceptional circumstances.

    3.  ‎The integrity of the public, voluntary blood donor system in Ontario must be protected.

Definitions

   2.  In this Act,

"blood" means human blood, and includes whole blood and blood constituents; ("sang")

"blood collection facility" means a place where blood is taken or collected from the human body; ("établissement de collecte de sang")

"compliance order" means an order made under section 5; ("arrêté de conformité")

"inspector" means an inspector appointed under section 4; ("inspecteur")

"Minister" means the Minister of Health and Long-Term Care, or, if another Minister has been assigned responsibility for this Act under the Executive Council Act, that Minister; ("ministre")

"offer to provide", without restricting the ordinary meaning of the expression, includes to offer by means of advertising in any media; ("offrir de fournir")

"payment" means, subject to the regulations, remuneration, compensation or consideration of any value and of any kind, and includes reimbursement for time, travel, commitment or expenditures of any kind; ("paiement")

"personal information" includes personal information as defined in the Freedom of Information and Protection of Privacy Act and personal health information as defined in the Personal Health Information Protection Act, 2004; ("renseignements personnels")

"record" includes a record that contains personal information; ("dossier")

"regulations" means regulations made under this Act; ("règlements")

"restraining order" means an order made under section 6. ("ordonnance de ne pas faire")

Payment for blood prohibited

   3.  (1)  No person shall,

  (a)  provide payment to any individual in return for the giving of blood by that individual, either directly or indirectly; or

  (b)  offer to provide payment to any individual in return for the giving of blood by that individual, either directly or indirectly.

Same, donor

   (2)  No individual shall accept any payment in return for the giving of his or her blood, either directly or indirectly.

Exemption, Canadian Blood Services

   (3)  Canadian Blood Services and the individuals who give blood to Canadian Blood Services are exempt from subsections (1) and (2).

Non-application, blood for research

   (4)  Subsections (1) and (2) do not apply with respect to blood that is given solely for the purpose of research.

Clarification

   (5)  For greater clarity, in applying subsection (4), blood is not given "solely for the purpose of research" if it is used or intended to be used, directly or indirectly, in whole or in part, for the manufacture of pharmaceuticals derived from blood.

Inspectors

   4.  (1)  The Minister may appoint inspectors for the purposes of this Act.

Inspection

   (2)  For the purpose of determining whether this Act is being complied with, an inspector may, without a warrant, enter and inspect,

  (a)  a blood collection facility;

  (b)  any business premises of a company that owns, operates, franchises or licenses one or more blood collection facilities; and

   (c)  any place that the inspector reasonably believes is being used as a blood collection facility.

Time of entry

   (3)  The power under this section to enter and inspect without a warrant may be exercised only during the regular business hours of the blood collection facility, business premises or place.

Dwellings

   (4)  The power to enter and inspect under this section shall not be exercised to enter and inspect a place or a part of a place that is used as a dwelling.

Use of force

   (5)  An inspector is not entitled to use force to enter and inspect a blood collection facility, business premises or place.

Identification

   (6)  An inspector conducting an inspection shall produce, on request, evidence of his or her appointment.

Powers of inspector

   (7)  An inspector conducting an inspection may,

  (a)  examine records or anything else that is relevant to the inspection;

  (b)  demand the production of a record or any other thing that is relevant to the inspection;

   (c)  remove a record or any other thing that is relevant to the inspection for review, examination or testing;

  (d)  remove a record or any other thing that is relevant to the inspection for copying;

  (e)  in order to produce a record in readable form, use data storage, information processing or retrieval devices or systems that are normally used in carrying on business in the place;

   (f)  take photographs or make any other kind of recording; and

  (g)  question a person on matters relevant to the inspection.

Written demand

   (8)  A demand under this section that a record or any other thing be produced must be in writing and must include a statement of the nature of the record or thing required.

Obligation to produce and assist

   (9)  If an inspector demands that a record or any other thing be produced under this section, the person who has custody of the record or thing shall produce it and, in the case of a record, shall on request provide any assistance that is reasonably necessary to interpret the record or to produce it in a readable form.

Records and things removed from place

   (10)  A record or other thing that has been removed for review, examination, testing or copying,

  (a)  shall be made available to the person from whom it was removed on request and at a time and place that are convenient for the person and for the inspector; and

  (b)  shall be returned to the person within a reasonable time, unless, in the case of a thing that has been subject to testing, the thing has been made unsuitable for return as a result of the testing.

Copy admissible in evidence

   (11)  A copy of a record or other thing that purports to be certified by an inspector as being a true copy of the original is admissible in evidence to the same extent as the original and has the same evidentiary value.

Obstruction

   (12)  No person shall hinder, obstruct or interfere with or attempt to hinder, obstruct or interfere with an inspector conducting an inspection, refuse to answer questions on matters relevant to the inspection or provide the inspector with false information on matters relevant to the inspection.

Compliance orders

   5.  (1)  Where the Minister believes, on reasonable grounds, that a person who owns or operates a blood collection facility is not complying with the prohibition under subsection 3 (1), the Minister may make an order requiring the person to correct the non-compliance.

Evidence of compliance

   (2)  A person to whom a compliance order is directed may, within 14 days of service being effected, provide the Minister with evidence that the person is, in fact, in compliance with the prohibition.

Reconsideration

   (3)  Where a person has provided evidence under subsection (2), the Minister shall consider the evidence, and may either affirm the compliance order or rescind it in consequence, and have the person served with the affirmed order or notice of the rescission.

Compliance

   (4)  A person to whom a compliance order, or an affirmed compliance order, as the case may be, is directed shall comply with it according to its terms.

Service

   (5)  A document under this section is sufficiently served if it is served on the owner or operator of the blood collection facility or a person employed or apparently employed at the facility.

Proof of service

   (6)  A certificate of service made by the person who served a document under this section is evidence of the service of the document on the person served and its receipt by that person if, in the certificate, the person who served the document,

  (a)  certifies that the copy of the document is a true copy of it;

  (b)  certifies that the document was served on the person; and

   (c)  sets out in it the method of service used.

Copy of order

   (7)  In a prosecution for failing to comply with a compliance order, a copy of the order that purports to have been signed by the Minister is evidence of the order without proof of the signature.

Non-application of SPPA

   (8)  The Statutory Powers Procedure Act does not apply with respect to compliance orders.

Restraining orders

   6.  (1)  If it appears to the Minister that a person is not complying with this Act or the regulations or a compliance order, the Minister may apply to the Superior Court of Justice for an order directing the person to comply, and, upon the application, the court may make the order that the court thinks fit.

Same

   (2)  Subsection (1) applies in addition to the power to issue compliance orders, and may be exercised whether or not such an order has been issued.

Must comply

   (3)  A person to whom a restraining order is directed shall comply with it according to its terms.

Appeal

   (4)  An appeal lies to the Divisional Court from a restraining order.

Personal information

   7.  (1)  The Minister and an inspector may directly or indirectly collect personal information, subject to any requirements or conditions provided for in the regulations, for purposes related to the enforcement of this Act.

Use of personal information

   (2)  The Minister and an inspector may use personal information, subject to any requirements or conditions provided for in the regulations, for purposes related to the enforcement of this Act.

Disclosure of personal information

   (3)  The Minister and an inspector may disclose personal information, subject to any requirements or conditions provided for in the regulations, for purposes related to the enforcement of this Act.

Offences

   8.  (1)  Every person who contravenes a provision of this Act is guilty of an offence and on conviction is liable,

  (a)  in the case of an individual,

           (i)  for a first offence, to a fine not exceeding $10,000 for each day or part of a day on which the offence occurs or continues, and

          (ii)  for a second or subsequent offence, to a fine not exceeding $50,000 for each day or part of a day on which the offence occurs or continues; and

  (b)  in the case of a corporation,

           (i)  for a first offence, to a fine not exceeding $100,000 for each day or part of a day on which the offence occurs or continues, and

          (ii)  for a second or subsequent offence, to a fine not exceeding $500,000 for each day or part of a day on which the offence occurs or continues.

No limitation

   (2)  Section 76 of the Provincial Offences Act does not apply to a prosecution under this section.

Provincial Judge required

   (3)  The Attorney General or an agent of the Attorney General may, by notice to the clerk of the Ontario Court of Justice, require that a provincial judge preside over a proceeding in respect of an offence under this Act.

Publication re convictions

   (4)  If a person is convicted of an offence under this Act, the Minister may publish or otherwise make available to the general public the name of the person, a description of the offence, the date of the conviction and the person's sentence.

Compliance order not necessary

   (5)  A person may be prosecuted under this section whether or not a compliance order or a restraining order has been previously made with respect to the subject matter of the prosecution.

Certificates

   (6)  In any prosecution or other proceeding under this Act, a certificate of an analyst stating that the analyst has made an analysis of a sample and stating the result of that analysis is evidence of the facts alleged in the certificate without proof of the signature or the official character of the person appearing to have signed the certificate.

Protection from liability

   9.  No action or other proceeding shall be commenced against the Minister or anyone acting under the authority of the Minister for anything done in good faith in purported compliance with this Act.

Regulations, Minister

   10.  The Minister may make regulations exempting persons from this Act or any provisions of this Act, subject to any conditions that may be provided for in the regulations.

Regulations, Lieutenant Governor in Council

   11.  The Lieutenant Governor in Council may make regulations,

  (a)  defining any word or expression used in this Act but not defined in the Act;

  (b)  clarifying the definition of "payment" in section 2 and specifying what things do or do not constitute payment for the purpose of the Act;

   (c)  further clarifying the meaning of "solely for the purpose of research" as used in section 3;

  (d)  specifying requirements or conditions in respect of the collection, use or disclosure of personal information by the Minister or an inspector under this Act;

  (e)  for carrying out the purposes, provisions and intent of this Act.

Related Amendments

Laboratory and Specimen Collection Centre Licensing Act

   12.  (1)  The definition of "laboratory" in section 5 of the Laboratory and Specimen Collection Centre Licensing Act is repealed and the following substituted:

"laboratory" means, subject to any exclusions provided for in the regulations,

  (a)  an institution, building or place in which operations and procedures for the microbiological, serological, chemical, hematological, biophysical, immunohematological, cytological, pathological, cytogenetic, molecular genetic or genetic examination, or such other examinations as are prescribed by the regulations, of specimens taken from the human body are performed to obtain information for diagnosis, prophylaxis or treatment, and

  (b)  any other institution, building or place that may be provided for in the regulations; ("laboratoire")

   (2)  The definition of "specimen collection centre" in section 5 of the Act is repealed and the following substituted:

"specimen collection centre" means a place where specimens are taken or collected from the human body for examination to obtain information for diagnosis, prophylaxis or treatment, and any other place that may be provided for in the regulations, but does not include,

  (a)  a place where a legally qualified medical practitioner is engaged in the practice of medicine or surgery,

  (b)  a place where a registered nurse who holds an extended certificate of registration under the Nursing Act, 1991 is engaged in the practice of nursing,

   (c)  a place where a member of the College of Dietitians of Ontario is engaged in the practice of dietetics,

  (d)  a place where a member of the College of Midwives of Ontario is engaged in the practice of midwifery,

  (e)  a laboratory that is established, operated or maintained under a licence under this Act, or

   (f)  a place that is excluded from this definition by the regulations; ("centre de prélèvement")

   (3)  Section 8 of the Act is amended by striking out "instituted against the Director" and substituting "instituted against the Minister or the Director".

   (4)  Section 9 of the Act is amended by adding the following subsections:

Blood collection facilities

   (7.1)  Despite subsections (2) and (4), where an application is made for a licence to establish, operate or maintain a laboratory or a specimen collection centre which will operate as a blood collection facility within the meaning of the Voluntary Blood Donations Act, 2014 and the Minister states in writing to the Director that it is not in the public interest to issue such a licence, section 11 shall not apply and the Director shall not issue the licence to the applicant and shall give written notice to the applicant of the refusal and of the Minister's statement.

Same

   (7.2)  In making a decision in the public interest in subsection (7.1), the Minister may consider any matter the Minister regards as relevant including, without being limited to, the principles set out in the Voluntary Blood Donations Act, 2014.

   (5)  Subsection 9 (8) of the Act is amended by adding the following clause:

  (e)  any other ground for refusal that is prescribed in the regulations exists.

   (6)  Clause 9 (17) (e) of the Act is amended by adding "or any other Act or law relevant to the operation or maintenance of a laboratory or specimen collection centre" at the end.

   (7)  Subsection 9 (17) of the Act is amended by striking out "or" at the end of clause (f), by adding "or" at the end of clause (g) and by adding the following clause:

  (h)  any other ground for revoking or refusing renewal that is prescribed in the regulations exists.

   (8)  Subsection 16 (1) of the Act is amended by striking out "5 to 18" and substituting "5 to 17".

   (9)  Subsection 16 (3) of the Act is amended by striking out "5 to 18" and substituting "5 to 17".

   (10)  Subsection 16 (4) of the Act is amended by striking out "and probable".

   (11)  The Act is amended by adding the following section:

Restraining orders

   17.  (1)  If it appears to the Director that a person is not complying with this Act or the regulations, the Director may apply to the Superior Court of Justice for an order directing the person to comply, and, upon the application, the court may make the order that the court thinks fit.

Same

   (2)  Subsection (1) applies in addition to any other procedures that may be available to the Director, whether or not the Director has exercised his or her rights under such procedures.

Compliance

   (3)  A person to whom an order under subsection (1) is directed shall comply with it according to its terms.

Appeal

   (4)  An appeal lies to the Divisional Court from an order made under subsection (1).

   (12)  Section 18 of the Act is amended by adding the following clauses:

(a.1) excluding institutions, buildings or places from the definition of "laboratory" in section 5, and providing for additional institutions, buildings or places that are laboratories for the purposes of that definition;

(a.2) providing for additional places that are specimen collection centres for the purposes of the definition of "specimen collection centre" in section 5, and excluding places from that definition;

(a.3) prescribing grounds for the purposes of subsections 9 (8) and 9 (17);

   (13)  Subsections 22 (1) and (2) of the Act are repealed and the following substituted:

Offences

   (1)  Subject to subsection (2), a person who contravenes any provision of this Act or of the regulations is guilty of an offence and on conviction is liable,

  (a)  for a first offence, to a fine of not more than $25,000 for each day or part of a day on which the offence occurs or continues or to imprisonment for a term of not more than 12 months, or to both;

  (b)  for a subsequent offence, to a fine of not more than $50,000 for each day or part of a day on which the offence occurs or continues or to imprisonment for a term of not more than 12 months, or to both.

Same, corporation

   (2)  A corporation that is convicted of an offence under subsection (1) is liable to a fine of not more than $50,000 for each day or part of a day on which the offence occurs or continues for a first offence and to a fine of not more than $200,000 for each day or part of a day on which the offence occurs or continues for a subsequent offence.

Health System Improvements Act, 2007

   13.  Section 18 of Schedule P to the Health System Improvements Act, 2007 is repealed.

Regulated Health Professions Statute Law Amendment Act, 2009

   14.  Subsection 12 (2) of the Regulated Health Professions Statute Law Amendment Act, 2009 is repealed.

Trillium Gift of Life Network Act

   15.  (1)  Section 10 of the Trillium Gift of Life Network Act is amended by striking out "other than blood or a blood constituent".

   (2)  Section 10 of the Act is amended by adding the following subsections:

Blood

   (2)  Despite anything else in this Act or the regulations, blood and blood constituents shall not be considered to be tissue or part of a body for the purposes of subsection (1).

Voluntary Blood Donations Act, 2014

   (3)  Subsection (2) shall not be construed as authorizing anything that is prohibited by the Voluntary Blood Donations Act, 2014.

Commencement and Short Title

Commencement

   16.  (1)  Subject to subsection (2), the Act set out in this Schedule comes into force on a day to be named by proclamation of the Lieutenant Governor.

Same

   (2)  Sections 13 and 14 come into force on the day the Safeguarding Health Care Integrity Act, 2014 receives Royal Assent.

Commencement

   16.  The Act set out in this Schedule comes into force on the day the Safeguarding Health Care Integrity Act, 2014 receives Royal Assent.

Short title

   17.  The short title of this Act set out in this Schedule is the Voluntary Blood Donations Act, 2014.

 

Schedule 2
Amendments respecting the regulation of pharmacies and other matters concerning regulated health professions

Drug and Pharmacies Regulation Act

   1.  Subsection 1 (1) of the Drug and Pharmacies Regulation Act is amended by adding the following definitions:

"hospital" means a hospital within the meaning of the Public Hospitals Act or a private hospital within the meaning of the Private Hospitals Act; ("hôpital")

"hospital patient" means a patient within the meaning of the Public Hospitals Act or the Private Hospitals Act; ("malade d'un hôpital")

"hospital pharmacy" means a location that is deemed to be a pharmacy by virtue of section 119; ("pharmacie en milieu hospitalier")

"institutional pharmacy" means a premises that is deemed to be a pharmacy by virtue of section 120; ("pharmacie en milieu institutionnel")

   2.  Subsection 118 (1) of the Act is amended by striking out the portion before clause (a) and substituting the following:

Application of the Act

   (1)  Subject to sections 119 and 120, this Act does not apply to,

.     .     .     .     .

   3.  The Act is amended by adding the following sections:

Hospital pharmacies

   119.  (1)  Despite anything else in this Act, where drugs are compounded, dispensed or supplied for hospital patients by a hospital in premises located in a hospital, the primary location or locations in the hospital where drugs are compounded, dispensed or supplied from, together with any other location in the hospital where drugs are stored or supplied from and any other location prescribed in regulations made under subsection (2), is deemed to be a pharmacy for the purposes of the following provisions of this Act, subject to the regulations and to any necessary modifications:

    1.  Section 139.

    2.  Section 140.

    3.  Section 140.1.

    4.  Section 143.

    5.  Section 148.

    6.  Section 148.1.

    7.  Section 148.2.

    8.  Section 148.3.

    9.  Section 148.4.

  10.  Section 160.1.

  11.  Section 161.

  12.  Section 162.

  13.  Section 162.1.

  14.  Section 164.

  15.  Section 165.

  16.  Section 166.

  17.  Section 167.

Regulations

   (2)  The Lieutenant Governor in Council may make regulations prescribing locations for the purposes of subsection (1).

Institutional pharmacies

   120.  (1)  The Lieutenant Governor in Council may make regulations,

  (a)  designating premises in or associated with one or more health or custodial institutions as institutional pharmacies;

  (b)  providing that any or all provisions of this Act apply with respect to institutions designated under clause (a), subject to the modifications, if any, provided for in the designating regulation.

Same

   (2)  Where a premises has been designated in regulations described in subsection (1), the premises is deemed to be a pharmacy for the purposes of the provisions of this Act provided for in those regulations, subject to the regulations and to any necessary modifications.

Not pharmacies for other purposes

   121.  (1)  Hospital pharmacies and institutional pharmacies are not pharmacies, and the operators of hospital pharmacies and institutional pharmacies are not operators of pharmacies, for the purposes of any other Act or regulation, except,

  (a)  as may be explicitly provided for in the other Act or regulation, with reference to this section; or

  (b)  as may be provided for in regulations made under subsection (2).

Regulations

   (2)  The Lieutenant Governor in Council may make regulations,

  (a)  providing that hospital pharmacies are pharmacies for the purposes of one or more other Acts or regulations, and providing for those Acts or regulations;

  (b)  providing that institutional pharmacies are pharmacies for the purposes of one or more other Acts or regulations, and providing for those Acts or regulations;

   (c)  providing that operators of hospital pharmacies are operators of pharmacies for the purposes of one or more other Acts or regulations, and providing for those Acts or regulations;

  (d)  providing that operators of institutional pharmacies are operators of pharmacies for the purposes of one or more other Acts or regulations, and providing for those Acts or regulations;

  (e)  governing who is the operator of a hospital pharmacy or institutional pharmacy for the purposes of this section.

   4.  The Act is amended by adding the following section:

Contact person, hospital/institutional pharmacies

   146.1  (1)  Every hospital or institution in which a hospital pharmacy or an institutional pharmacy is operated shall designate a contact person for the hospital pharmacy or institutional pharmacy, and file notice of the designation with the College in accordance with the regulations.

One contact person or several

   (2)  For greater certainty, a hospital or institution may designate a different person as the contact person for every hospital pharmacy or institutional pharmacy for which it must designate a contact person, but is not obliged to do so.

   5.  (1)  Subsection 161 (1) of the Act is amended by adding the following clauses:

(l.1)  establishing one or more separate classes of certificates of accreditation with respect to pharmacies, hospital pharmacies or institutional pharmacies, setting terms, conditions and limitations with respect to such classes, and requiring compliance with those terms, conditions and limitations;

(l.2)  respecting the operation of hospital pharmacies and clarifying the application to hospital pharmacies of the provisions set out in section 119;

(l.3)  respecting the operation of institutional pharmacies and clarifying the application to institutional pharmacies of the provisions of this Act that apply to them by virtue of their designating regulations;

   (2)  Section 161 of the Act is amended by adding the following subsections:

Circulation

   (5)  A regulation shall not be made under subsection (1) unless the proposed regulation is circulated to every person who holds a valid certificate of accreditation at least 60 days before it is approved by the Council.

Same

   (6)  Subsection (5) does not apply to a regulation if the Minister required that the Council make the regulation under clause 5 (1) (c) of the Regulated Health Professions Act, 1991.

Exception

   (7)  Despite subsection (5), the Council may, with the approval of the Minister, exempt a regulation from the requirement that it be circulated or abridge the 60-day period referred to in subsection (5) to such lesser period as the Minister may determine.

   6.  Section 166 of the Act is amended by adding the following subsection:

Exception, hospital pharmacies

   (3)  A director of a corporation operating a hospital pharmacy is not liable for an offence by virtue of subsection (1), and may not be proceeded against under subsection (2).

   7.  The Act is amended by adding the following section:

Notice to Minister

   166.1  Where the College or a committee of the College proposes to take action under section 140 or any other provision of this Act and the action will involve a hospital pharmacy or an institutional pharmacy, the College or committee shall,

  (a)  give notice of the proposed action to the Minister in writing before taking the action; and

  (b)  provide the Minister with any information the Minister requests with respect to the action.

Public Hospitals Act

   8.  Clause 33 (c) of the Public Hospitals Act is repealed and the following substituted:

   (c)  a physician resigns from a medical staff of a hospital or restricts his or her practice within a hospital and the administrator of the hospital has reasonable grounds to believe that the resignation or restriction, as the case may be, is related to the competence, negligence or conduct of the physician,

   8.  Section 33 of the Public Hospitals Act is amended by striking out "or" at the end of clause (b), by repealing clause (c) and by substituting the following:

   (c)  a physician resigns from a medical staff of a hospital or restricts his or her practice within a hospital and the administrator of the hospital has reasonable grounds to believe that the resignation or restriction, as the case may be, is related to the competence, negligence or conduct of the physician; or

  (d)  a physician resigns from a medical staff of a hospital or restricts his or her practice within a hospital during the course of, or as a result of, an investigation into his or her competence, negligence or conduct,

.     .     .     .     .

Regulated Health Professions Act, 1991

   9.  Subsection 5.0.1 (1) of the Regulated Health Professions Act, 1991 is repealed and the following substituted:

College supervisor

   (1)  The Lieutenant Governor in Council may appoint a person as a College supervisor, on the recommendation of the Minister, where the Minister considers it appropriate or necessary.

   10.  Clause 36 (1) (d) of the Act is repealed and the following substituted:

  (d)  as may be required for the administration of the Drug Interchangeability and Dispensing Fee Act, the Healing Arts Radiation Protection Act, the Health Insurance Act, the Health Protection and Promotion Act, the Independent Health Facilities Act, the Laboratory and Specimen Collection Centre Licensing Act, the Ontario Drug Benefit Act, the Coroners Act, the Controlled Drugs and Substances Act (Canada) and the Food and Drugs Act (Canada);

(d.1) for a prescribed purpose, to a public hospital that employs or provides privileges to a member of a College, where the College is investigating a complaint about that member or where the information was obtained by an investigator appointed pursuant to subsection 75 (1) or (2) of the Code, subject to the limitations, if any, provided for in regulations made under section 43;

(d.2) for a prescribed purpose, to a person other than a public hospital who belongs to a class provided for in regulations made under section 43, where a College is investigating a complaint about a member of the College or where the information was obtained by an investigator appointed pursuant to subsection 75 (1) or (2) of the Code, subject to the limitations, if any, provided for in the regulations;

   11.  Subsection 43 (1) of the Act is amended by adding the following clauses:

(g.1) prescribing purposes and providing for limitations for the purposes of clauses 36 (1) (d.1) and (d.2);

(g.2) providing for classes of persons for the purposes of clause 36 (1) (d.2);

   12.  Subsections 25 (5) and (6) of Schedule 2 to the Act are repealed and the following substituted:

Complainant to be informed

   (5)  The Registrar shall give a complainant notice of receipt of his or her complaint and a general explanation of the processes of the College, including the jurisdiction and role of the Inquiries, Complaints and Reports Committee and the power of the Registrar to make a determination that it is not reasonable to believe that the allegations contained in the complaint, if established, could constitute professional misconduct, incompetence or incapacity on the part of the member, together with a copy of the provisions of sections 28 to 29.

Notice to member

   (6)  Except where the Registrar makes a determination referred to in subsection (7), the Registrar shall give the member, within 30 days of receipt of the complaint or the report,

  (a)  notice of the complaint, together with a copy of the provisions of sections 28 to 29, or notice of the receipt of the report;

  (b)  a copy of the provisions of section 25.2; and

   (c)  a copy of all available prior decisions involving the member unless the decision was a determination under subsection (7) or a decision to take no further action under subsection (11) or under subsection 26 (5).

No selection of a panel

   (7)  Despite subsection (1), the chair of the Inquiries, Complaints and Reports Committee shall not select a panel of the Committee to investigate a complaint where the Registrar has determined that it is not reasonable to believe that the allegations contained in the complaint, if established, could constitute professional misconduct, incompetence or incapacity on the part of the member.

Notice

   (8)  Where the Registrar has made a determination referred to in subsection (7), the Registrar shall, within 30 days of having received the complaint, give the complainant and the member who is the subject of the complaint notice of the Registrar's determination.

Request for review by Inquiries, Complaints and Reports Committee

   (9)  Where, within 30 days of receiving notice under subsection (8), the complainant makes a request in writing to the Registrar seeking a review of the Registrar's determination, the chair of the Inquiries, Complaints and Reports Committee shall select a panel of the Committee to review the Registrar's determination.

Notice

   (10)  Where a panel of the Inquiries, Complaints and Reports Committee has been selected under subsection (9), the panel shall give the complainant and the member notice that a review has been requested.

What a panel may do

   (11)  A panel selected under subsection (9) may do one of the following:

    1.  Confirm the Registrar's determination under subsection (7), in which case no further action shall be taken by the Inquiries, Complaints and Reports Committee with respect to the complaint.

    2.  Refer the complaint to the chair to select another panel of the Inquiries, Complaints and Reports Committee, with different members, to investigate the complaint in accordance with subsections (1) to (4).

Notice to complainant and member

   (12)  A panel that has made a decision under subsection (11) shall give notice of the decision to the complainant and member within 14 days of making the decision.

Notice to member where reference to another panel

   (13)  Where a panel of the Inquiries, Complaints and Reports Committee has referred a complaint to the chair under paragraph 2 of subsection (11), the Registrar shall give the member, within 14 days of the complaint having been referred to the chair,

  (a)  notice of the complaint, together with a copy of the provisions of sections 28 to 29, or notice of the receipt of the report;

  (b)  a copy of the provisions of section 25.2; and

   (c)  a copy of all available prior decisions involving the member unless the decision was a determination under subsection (7) or a decision to take no further action under subsection (11) or under subsection 26 (5).

   13.  Subsection 25.2 (1) of Schedule 2 to the Act is amended by striking out "subsection 25 (6)" at the end and substituting "subsection 25 (6) or (13)".

   14.  Subsection 26 (2) of Schedule 2 to the Act is repealed and the following substituted:

Prior decisions

   (2)  A panel of the Inquiries, Complaints and Reports Committee shall, when investigating a complaint or considering a report currently before it, consider all of its available prior decisions involving the member, including decisions made when that committee was known as the Complaints Committee, and all available prior decisions involving the member of the Discipline Committee, the Fitness to Practise Committee and the Executive Committee, unless the decision was a determination by the Registrar under subsection 25 (7) or was a decision to take no further action under subsection (5) of this section or under subsection 25 (11).

   15.  Section 28 of Schedule 2 to the Act is amended by adding the following subsection:

Not affected by referral

   (2.1)  A referral to the chair under paragraph 2 of subsection 25 (11) does not affect the time requirements under this section.

   16.  Subsection 29 (2) of Schedule 2 to the Act is repealed and the following substituted:

Request for review

   (2)  The complainant or the member who is the subject of the complaint may request the Board to review a decision of a panel of the Inquiries, Complaints and Reports Committee unless,

  (a)  the decision was made under subsection 25 (11);

  (b) the decision was to refer an allegation of professional misconduct or incompetence to the Discipline Committee; or

   (c)  the decision was to refer the member to a panel of the Inquiries, Complaints and Reports Committee under section 58 for incapacity proceedings.

   17.  Subsection 85.5 (2) of Schedule 2 to the Act is repealed and the following substituted:

Same

   (2)  Where a member resigns, or voluntarily relinquishes or restricts his or her privileges or practice, a person referred to in subsection (3) who has reasonable grounds to believe that the resignation, relinquishment or restriction, as the case may be, is related to the member's professional misconduct, incompetence or incapacity, shall file with the Registrar within 30 days after the resignation, relinquishment or restriction a written report setting out the grounds upon which the person's belief is based.

Same

   (2)  Where a member resigns, or voluntarily relinquishes or restricts his or her privileges or practice, and the circumstances set out in paragraph 1 or 2 apply, a person referred to in subsection (3) shall act in accordance with those paragraphs:

    1.  Where a person referred to in subsection (3) has reasonable grounds to believe that the resignation, relinquishment or restriction, as the case may be, is related to the member's professional misconduct, incompetence or incapacity, the person shall file with the Registrar within 30 days after the resignation, relinquishment or restriction a written report setting out the grounds upon which the person's belief is based.

    2.  Where the resignation, relinquishment or restriction, as the case may be, takes place during the course of, or as a result of, an investigation conducted by or on behalf of a person referred to in subsection (3) into allegations related to professional misconduct, incompetence or incapacity on the part of the member, the person referred to in subsection (3) shall file with the Registrar within 30 days after the resignation, relinquishment or restriction a written report setting out the nature of the allegations being investigated.

Commencement

Commencement

   18.  This Schedule comes into force on a day to be named by proclamation of the Lieutenant Governor.

 

This reprint of the Bill is marked to indicate the changes that were made in Committee.

The changes are indicated by underlines for new text and a strikethrough for deleted text.

 

______________

 

 

 

EXPLANATORY NOTE

Schedule 1
Voluntary Blood Donations Act, 2014

It is made an offence to pay or offer to pay blood donors for blood, and for blood donors to accept such payments.

Inspection and enforcement provisions are provided for, including compliance orders.

Related amendments are made to other legislation.

Schedule 2
amendments respecting the regulation of pharmacies and other matters concerning regulated health professions

The Drug and Pharmacies Regulation Act is amended to allow premises associated with hospitals and health and custodial institutions to be considered "pharmacies" for the purposes of certain provisions of the Act.  Related amendments are also made.

The Public Hospitals Act is amended to require a hospital administrator to prepare and forward a detailed report to the College of Physicians and Surgeons where a physician resigns or restricts his or her practice and there is reason to believe the resignation or restriction is related to his or her competence, negligence or conduct, or if the resignation or restriction takes place during the course of, or as a result of, an investigation into his or her behaviour.

The Regulated Health Professions Act, 1991 and the Health Professions Procedural Code are amended. Among the amendments:

    1.   The Lieutenant Governor in Council, upon the recommendation of the Minister of Health and Long-Term Care, may appoint a person as a supervisor of a health profession college where the Minister considers it to be appropriate or necessary to do so. The Bill removes the existing requirement that the Minister must additionally be of the opinion that the college's Council has failed to comply with a requirement previously issued to the college's Council by the Minister. 

    2.   Additional exceptions are created to the existing duty of confidentiality under the Act, including,

            i.  for the purposes of administering the Health Protection and Promotion Act,

           ii.  where the disclosure is to a public hospital that employs or that provides privileges to a member of a college, where the college is investigating the member, subject to any limitations in the regulations,

          iii.  disclosure to additional classes of persons provided for in regulations, subject to any limitations to be prescribed in those regulations.

    3.   Procedures are put in place to deal with instances where the Registrar of a College determines that it is not reasonable to believe that the allegations contained in a complaint against a member could, if established, constitute professional misconduct, incompetence or incapacity on the part of the member.

    4.   The Health Professions Procedural Code is amended to provide that where a college member resigns, or voluntarily relinquishes or restricts his or her privileges or practice, a person such as an employer who has reasonable grounds to believe that the resignation, relinquishment or restriction, as the case may be, is related to the member's professional misconduct, incompetence or incapacity, shall file with the Registrar within 30 days after the resignation, relinquishment or restriction a written report setting out the grounds upon which the person's belief is based. This requirement also applies if the resignation or restriction takes place during the course of, or as a result of, an investigation into allegations related to the college member's behaviour.

Bill 21 2014

An Act to safeguard health care integrity by enacting the Voluntary Blood Donations Act, 2014 and by amending certain statutes with respect to the regulation of pharmacies and other matters concerning regulated health professions

Her Majesty, by and with the advice and consent of the Legislative Assembly of the Province of Ontario, enacts as follows:

Contents of this Act

   1.  This Act consists of this section, sections 2 and 3 and the Schedules to this Act.

Commencement

   2.  (1)  Subject to subsections (2) and (3), this Act comes into force on the day it receives Royal Assent.

Same

   (2)  The Schedules to this Act come into force as provided in each Schedule.

Same

   (3)  If a Schedule to this Act provides that any provisions are to come into force on a day to be named by proclamation of the Lieutenant Governor, a proclamation may apply to one or more of those provisions, and proclamations may be issued at different times with respect to any of those provisions.

Short title

   3.  The short title of this Act is the Safeguarding Health Care Integrity Act, 2014.

 

Schedule 1
Voluntary Blood Donations Act, 2014

Purpose

   1.  The purpose of this Act is to provide for recognition of the following principles:

    1.  Within Ontario's health care system, blood donations are viewed as a public resource‎.

‎    2.  Blood donors should not be paid, except in exceptional circumstances.

    3.  ‎The integrity of the public, voluntary blood donor system in Ontario must be protected.

Definitions

   2.  In this Act,

"blood" means human blood, and includes whole blood and blood constituents; ("sang")

"blood collection facility" means a place where blood is taken or collected from the human body; ("établissement de collecte de sang")

"compliance order" means an order made under section 5; ("arrêté de conformité")

"inspector" means an inspector appointed under section 4; ("inspecteur")

"Minister" means the Minister of Health and Long-Term Care, or, if another Minister has been assigned responsibility for this Act under the Executive Council Act, that Minister; ("ministre")

"offer to provide", without restricting the ordinary meaning of the expression, includes to offer by means of advertising in any media; ("offrir de fournir")

"payment" means, subject to the regulations, remuneration, compensation or consideration of any value and of any kind, and includes reimbursement for time, travel, commitment or expenditures of any kind; ("paiement")

"personal information" includes personal information as defined in the Freedom of Information and Protection of Privacy Act and personal health information as defined in the Personal Health Information Protection Act, 2004; ("renseignements personnels")

"record" includes a record that contains personal information; ("dossier")

"regulations" means regulations made under this Act; ("règlements")

"restraining order" means an order made under section 6. ("ordonnance de ne pas faire")

Payment for blood prohibited

   3.  (1)  No person shall,

  (a)  provide payment to any individual in return for the giving of blood by that individual, either directly or indirectly; or

  (b)  offer to provide payment to any individual in return for the giving of blood by that individual, either directly or indirectly.

Same, donor

   (2)  No individual shall accept any payment in return for the giving of his or her blood, either directly or indirectly.

Exemption, Canadian Blood Services

   (3)  Canadian Blood Services and the individuals who give blood to Canadian Blood Services are exempt from subsections (1) and (2).

Non-application, blood for research

   (4)  Subsections (1) and (2) do not apply with respect to blood that is given solely for the purpose of research.

Clarification

   (5)  For greater clarity, in applying subsection (4), blood is not given "solely for the purpose of research" if it is used or intended to be used, directly or indirectly, in whole or in part, for the manufacture of pharmaceuticals derived from blood.

Inspectors

   4.  (1)  The Minister may appoint inspectors for the purposes of this Act.

Inspection

   (2)  For the purpose of determining whether this Act is being complied with, an inspector may, without a warrant, enter and inspect,

  (a)  a blood collection facility;

  (b)  any business premises of a company that owns, operates, franchises or licenses one or more blood collection facilities; and

   (c)  any place that the inspector reasonably believes is being used as a blood collection facility.

Time of entry

   (3)  The power under this section to enter and inspect without a warrant may be exercised only during the regular business hours of the blood collection facility, business premises or place.

Dwellings

   (4)  The power to enter and inspect under this section shall not be exercised to enter and inspect a place or a part of a place that is used as a dwelling.

Use of force

   (5)  An inspector is not entitled to use force to enter and inspect a blood collection facility, business premises or place.

Identification

   (6)  An inspector conducting an inspection shall produce, on request, evidence of his or her appointment.

Powers of inspector

   (7)  An inspector conducting an inspection may,

  (a)  examine records or anything else that is relevant to the inspection;

  (b)  demand the production of a record or any other thing that is relevant to the inspection;

   (c)  remove a record or any other thing that is relevant to the inspection for review, examination or testing;

  (d)  remove a record or any other thing that is relevant to the inspection for copying;

  (e)  in order to produce a record in readable form, use data storage, information processing or retrieval devices or systems that are normally used in carrying on business in the place;

   (f)  take photographs or make any other kind of recording; and

  (g)  question a person on matters relevant to the inspection.

Written demand

   (8)  A demand under this section that a record or any other thing be produced must be in writing and must include a statement of the nature of the record or thing required.

Obligation to produce and assist

   (9)  If an inspector demands that a record or any other thing be produced under this section, the person who has custody of the record or thing shall produce it and, in the case of a record, shall on request provide any assistance that is reasonably necessary to interpret the record or to produce it in a readable form.

Records and things removed from place

   (10)  A record or other thing that has been removed for review, examination, testing or copying,

  (a)  shall be made available to the person from whom it was removed on request and at a time and place that are convenient for the person and for the inspector; and

  (b)  shall be returned to the person within a reasonable time, unless, in the case of a thing that has been subject to testing, the thing has been made unsuitable for return as a result of the testing.

Copy admissible in evidence

   (11)  A copy of a record or other thing that purports to be certified by an inspector as being a true copy of the original is admissible in evidence to the same extent as the original and has the same evidentiary value.

Obstruction

   (12)  No person shall hinder, obstruct or interfere with or attempt to hinder, obstruct or interfere with an inspector conducting an inspection, refuse to answer questions on matters relevant to the inspection or provide the inspector with false information on matters relevant to the inspection.

Compliance orders

   5.  (1)  Where the Minister believes, on reasonable grounds, that a person who owns or operates a blood collection facility is not complying with the prohibition under subsection 3 (1), the Minister may make an order requiring the person to correct the non-compliance.

Evidence of compliance

   (2)  A person to whom a compliance order is directed may, within 14 days of service being effected, provide the Minister with evidence that the person is, in fact, in compliance with the prohibition.

Reconsideration

   (3)  Where a person has provided evidence under subsection (2), the Minister shall consider the evidence, and may either affirm the compliance order or rescind it in consequence, and have the person served with the affirmed order or notice of the rescission.

Compliance

   (4)  A person to whom a compliance order, or an affirmed compliance order, as the case may be, is directed shall comply with it according to its terms.

Service

   (5)  A document under this section is sufficiently served if it is served on the owner or operator of the blood collection facility or a person employed or apparently employed at the facility.

Proof of service

   (6)  A certificate of service made by the person who served a document under this section is evidence of the service of the document on the person served and its receipt by that person if, in the certificate, the person who served the document,

  (a)  certifies that the copy of the document is a true copy of it;

  (b)  certifies that the document was served on the person; and

   (c)  sets out in it the method of service used.

Copy of order

   (7)  In a prosecution for failing to comply with a compliance order, a copy of the order that purports to have been signed by the Minister is evidence of the order without proof of the signature.

Non-application of SPPA

   (8)  The Statutory Powers Procedure Act does not apply with respect to compliance orders.

Restraining orders

   6.  (1)  If it appears to the Minister that a person is not complying with this Act or the regulations or a compliance order, the Minister may apply to the Superior Court of Justice for an order directing the person to comply, and, upon the application, the court may make the order that the court thinks fit.

Same

   (2)  Subsection (1) applies in addition to the power to issue compliance orders, and may be exercised whether or not such an order has been issued.

Must comply

   (3)  A person to whom a restraining order is directed shall comply with it according to its terms.

Appeal

   (4)  An appeal lies to the Divisional Court from a restraining order.

Personal information

   7.  (1)  The Minister and an inspector may directly or indirectly collect personal information, subject to any requirements or conditions provided for in the regulations, for purposes related to the enforcement of this Act.

Use of personal information

   (2)  The Minister and an inspector may use personal information, subject to any requirements or conditions provided for in the regulations, for purposes related to the enforcement of this Act.

Disclosure of personal information

   (3)  The Minister and an inspector may disclose personal information, subject to any requirements or conditions provided for in the regulations, for purposes related to the enforcement of this Act.

Offences

   8.  (1)  Every person who contravenes a provision of this Act is guilty of an offence and on conviction is liable,

  (a)  in the case of an individual,

           (i)  for a first offence, to a fine not exceeding $10,000 for each day or part of a day on which the offence occurs or continues, and

          (ii)  for a second or subsequent offence, to a fine not exceeding $50,000 for each day or part of a day on which the offence occurs or continues; and

  (b)  in the case of a corporation,

           (i)  for a first offence, to a fine not exceeding $100,000 for each day or part of a day on which the offence occurs or continues, and

          (ii)  for a second or subsequent offence, to a fine not exceeding $500,000 for each day or part of a day on which the offence occurs or continues.

No limitation

   (2)  Section 76 of the Provincial Offences Act does not apply to a prosecution under this section.

Provincial Judge required

   (3)  The Attorney General or an agent of the Attorney General may, by notice to the clerk of the Ontario Court of Justice, require that a provincial judge preside over a proceeding in respect of an offence under this Act.

Publication re convictions

   (4)  If a person is convicted of an offence under this Act, the Minister may publish or otherwise make available to the general public the name of the person, a description of the offence, the date of the conviction and the person's sentence.

Compliance order not necessary

   (5)  A person may be prosecuted under this section whether or not a compliance order or a restraining order has been previously made with respect to the subject matter of the prosecution.

Certificates

   (6)  In any prosecution or other proceeding under this Act, a certificate of an analyst stating that the analyst has made an analysis of a sample and stating the result of that analysis is evidence of the facts alleged in the certificate without proof of the signature or the official character of the person appearing to have signed the certificate.

Protection from liability

   9.  No action or other proceeding shall be commenced against the Minister or anyone acting under the authority of the Minister for anything done in good faith in purported compliance with this Act.

Regulations, Minister

   10.  The Minister may make regulations exempting persons from this Act or any provisions of this Act, subject to any conditions that may be provided for in the regulations.

Regulations, Lieutenant Governor in Council

   11.  The Lieutenant Governor in Council may make regulations,

  (a)  defining any word or expression used in this Act but not defined in the Act;

  (b)  clarifying the definition of "payment" in section 2 and specifying what things do or do not constitute payment for the purpose of the Act;

   (c)  further clarifying the meaning of "solely for the purpose of research" as used in section 3;

  (d)  specifying requirements or conditions in respect of the collection, use or disclosure of personal information by the Minister or an inspector under this Act;

  (e)  for carrying out the purposes, provisions and intent of this Act.

Related Amendments

Laboratory and Specimen Collection Centre Licensing Act

   12.  (1)  The definition of "laboratory" in section 5 of the Laboratory and Specimen Collection Centre Licensing Act is repealed and the following substituted:

"laboratory" means, subject to any exclusions provided for in the regulations,

  (a)  an institution, building or place in which operations and procedures for the microbiological, serological, chemical, hematological, biophysical, immunohematological, cytological, pathological, cytogenetic, molecular genetic or genetic examination, or such other examinations as are prescribed by the regulations, of specimens taken from the human body are performed to obtain information for diagnosis, prophylaxis or treatment, and

  (b)  any other institution, building or place that may be provided for in the regulations; ("laboratoire")

   (2)  The definition of "specimen collection centre" in section 5 of the Act is repealed and the following substituted:

"specimen collection centre" means a place where specimens are taken or collected from the human body for examination to obtain information for diagnosis, prophylaxis or treatment, and any other place that may be provided for in the regulations, but does not include,

  (a)  a place where a legally qualified medical practitioner is engaged in the practice of medicine or surgery,

  (b)  a place where a registered nurse who holds an extended certificate of registration under the Nursing Act, 1991 is engaged in the practice of nursing,

   (c)  a place where a member of the College of Dietitians of Ontario is engaged in the practice of dietetics,

  (d)  a place where a member of the College of Midwives of Ontario is engaged in the practice of midwifery,

  (e)  a laboratory that is established, operated or maintained under a licence under this Act, or

   (f)  a place that is excluded from this definition by the regulations; ("centre de prélèvement")

   (3)  Section 8 of the Act is amended by striking out "instituted against the Director" and substituting "instituted against the Minister or the Director".

   (4)  Section 9 of the Act is amended by adding the following subsections:

Blood collection facilities

   (7.1)  Despite subsections (2) and (4), where an application is made for a licence to establish, operate or maintain a laboratory or a specimen collection centre which will operate as a blood collection facility within the meaning of the Voluntary Blood Donations Act, 2014 and the Minister states in writing to the Director that it is not in the public interest to issue such a licence, section 11 shall not apply and the Director shall not issue the licence to the applicant and shall give written notice to the applicant of the refusal and of the Minister's statement.

Same

   (7.2)  In making a decision in the public interest in subsection (7.1), the Minister may consider any matter the Minister regards as relevant including, without being limited to, the principles set out in the Voluntary Blood Donations Act, 2014.

   (5)  Subsection 9 (8) of the Act is amended by adding the following clause:

  (e)  any other ground for refusal that is prescribed in the regulations exists.

   (6)  Clause 9 (17) (e) of the Act is amended by adding "or any other Act or law relevant to the operation or maintenance of a laboratory or specimen collection centre" at the end.

   (7)  Subsection 9 (17) of the Act is amended by striking out "or" at the end of clause (f), by adding "or" at the end of clause (g) and by adding the following clause:

  (h)  any other ground for revoking or refusing renewal that is prescribed in the regulations exists.

   (8)  Subsection 16 (1) of the Act is amended by striking out "5 to 18" and substituting "5 to 17".

   (9)  Subsection 16 (3) of the Act is amended by striking out "5 to 18" and substituting "5 to 17".

   (10)  Subsection 16 (4) of the Act is amended by striking out "and probable".

   (11)  The Act is amended by adding the following section:

Restraining orders

   17.  (1)  If it appears to the Director that a person is not complying with this Act or the regulations, the Director may apply to the Superior Court of Justice for an order directing the person to comply, and, upon the application, the court may make the order that the court thinks fit.

Same

   (2)  Subsection (1) applies in addition to any other procedures that may be available to the Director, whether or not the Director has exercised his or her rights under such procedures.

Compliance

   (3)  A person to whom an order under subsection (1) is directed shall comply with it according to its terms.

Appeal

   (4)  An appeal lies to the Divisional Court from an order made under subsection (1).

   (12)  Section 18 of the Act is amended by adding the following clauses:

(a.1) excluding institutions, buildings or places from the definition of "laboratory" in section 5, and providing for additional institutions, buildings or places that are laboratories for the purposes of that definition;

(a.2) providing for additional places that are specimen collection centres for the purposes of the definition of "specimen collection centre" in section 5, and excluding places from that definition;

(a.3) prescribing grounds for the purposes of subsections 9 (8) and 9 (17);

   (13)  Subsections 22 (1) and (2) of the Act are repealed and the following substituted:

Offences

   (1)  Subject to subsection (2), a person who contravenes any provision of this Act or of the regulations is guilty of an offence and on conviction is liable,

  (a)  for a first offence, to a fine of not more than $25,000 for each day or part of a day on which the offence occurs or continues or to imprisonment for a term of not more than 12 months, or to both;

  (b)  for a subsequent offence, to a fine of not more than $50,000 for each day or part of a day on which the offence occurs or continues or to imprisonment for a term of not more than 12 months, or to both.

Same, corporation

   (2)  A corporation that is convicted of an offence under subsection (1) is liable to a fine of not more than $50,000 for each day or part of a day on which the offence occurs or continues for a first offence and to a fine of not more than $200,000 for each day or part of a day on which the offence occurs or continues for a subsequent offence.

Health System Improvements Act, 2007

   13.  Section 18 of Schedule P to the Health System Improvements Act, 2007 is repealed.

Regulated Health Professions Statute Law Amendment Act, 2009

   14.  Subsection 12 (2) of the Regulated Health Professions Statute Law Amendment Act, 2009 is repealed.

Trillium Gift of Life Network Act

   15.  (1)  Section 10 of the Trillium Gift of Life Network Act is amended by striking out "other than blood or a blood constituent".

   (2)  Section 10 of the Act is amended by adding the following subsections:

Blood

   (2)  Despite anything else in this Act or the regulations, blood and blood constituents shall not be considered to be tissue or part of a body for the purposes of subsection (1).

Voluntary Blood Donations Act, 2014

   (3)  Subsection (2) shall not be construed as authorizing anything that is prohibited by the Voluntary Blood Donations Act, 2014.

Commencement and Short Title

Commencement

   16.  (1)  Subject to subsection (2), the Act set out in this Schedule comes into force on a day to be named by proclamation of the Lieutenant Governor.

Same

   (2)  Sections 13 and 14 come into force on the day the Safeguarding Health Care Integrity Act, 2014 receives Royal Assent.

Short title

   17.  The short title of this Act set out in this Schedule is the Voluntary Blood Donations Act, 2014.

 

Schedule 2
Amendments respecting the regulation of pharmacies and other matters concerning regulated health professions

Drug and Pharmacies Regulation Act

   1.  Subsection 1 (1) of the Drug and Pharmacies Regulation Act is amended by adding the following definitions:

"hospital" means a hospital within the meaning of the Public Hospitals Act or a private hospital within the meaning of the Private Hospitals Act; ("hôpital")

"hospital patient" means a patient within the meaning of the Public Hospitals Act or the Private Hospitals Act; ("malade d'un hôpital")

"hospital pharmacy" means a location that is deemed to be a pharmacy by virtue of section 119; ("pharmacie en milieu hospitalier")

"institutional pharmacy" means a premises that is deemed to be a pharmacy by virtue of section 120; ("pharmacie en milieu institutionnel")

   2.  Subsection 118 (1) of the Act is amended by striking out the portion before clause (a) and substituting the following:

Application of the Act

   (1)  Subject to sections 119 and 120, this Act does not apply to,

.     .     .     .     .

   3.  The Act is amended by adding the following sections:

Hospital pharmacies

   119.  (1)  Despite anything else in this Act, where drugs are compounded, dispensed or supplied for hospital patients by a hospital in premises located in a hospital, the primary location or locations in the hospital where drugs are compounded, dispensed or supplied from, together with any other location in the hospital where drugs are stored or supplied from and any other location prescribed in regulations made under subsection (2), is deemed to be a pharmacy for the purposes of the following provisions of this Act, subject to the regulations and to any necessary modifications:

    1.  Section 139.

    2.  Section 140.

    3.  Section 140.1.

    4.  Section 143.

    5.  Section 148.

    6.  Section 148.1.

    7.  Section 148.2.

    8.  Section 148.3.

    9.  Section 148.4.

  10.  Section 160.1.

  11.  Section 161.

  12.  Section 162.

  13.  Section 162.1.

  14.  Section 164.

  15.  Section 165.

  16.  Section 166.

  17.  Section 167.

Regulations

   (2)  The Lieutenant Governor in Council may make regulations prescribing locations for the purposes of subsection (1).

Institutional pharmacies

   120.  (1)  The Lieutenant Governor in Council may make regulations,

  (a)  designating premises in or associated with one or more health or custodial institutions as institutional pharmacies;

  (b)  providing that any or all provisions of this Act apply with respect to institutions designated under clause (a), subject to the modifications, if any, provided for in the designating regulation.

Same

   (2)  Where a premises has been designated in regulations described in subsection (1), the premises is deemed to be a pharmacy for the purposes of the provisions of this Act provided for in those regulations, subject to the regulations and to any necessary modifications.

Not pharmacies for other purposes

   121.  (1)  Hospital pharmacies and institutional pharmacies are not pharmacies, and the operators of hospital pharmacies and institutional pharmacies are not operators of pharmacies, for the purposes of any other Act or regulation, except,

  (a)  as may be explicitly provided for in the other Act or regulation, with reference to this section; or

  (b)  as may be provided for in regulations made under subsection (2).

Regulations

   (2)  The Lieutenant Governor in Council may make regulations,

  (a)  providing that hospital pharmacies are pharmacies for the purposes of one or more other Acts or regulations, and providing for those Acts or regulations;

  (b)  providing that institutional pharmacies are pharmacies for the purposes of one or more other Acts or regulations, and providing for those Acts or regulations;

   (c)  providing that operators of hospital pharmacies are operators of pharmacies for the purposes of one or more other Acts or regulations, and providing for those Acts or regulations;

  (d)  providing that operators of institutional pharmacies are operators of pharmacies for the purposes of one or more other Acts or regulations, and providing for those Acts or regulations;

  (e)  governing who is the operator of a hospital pharmacy or institutional pharmacy for the purposes of this section.

   4.  The Act is amended by adding the following section:

Contact person, hospital/institutional pharmacies

   146.1  (1)  Every hospital or institution in which a hospital pharmacy or an institutional pharmacy is operated shall designate a contact person for the hospital pharmacy or institutional pharmacy, and file notice of the designation with the College in accordance with the regulations.

One contact person or several

   (2)  For greater certainty, a hospital or institution may designate a different person as the contact person for every hospital pharmacy or institutional pharmacy for which it must designate a contact person, but is not obliged to do so.

   5.  (1)  Subsection 161 (1) of the Act is amended by adding the following clauses:

(l.1)  establishing one or more separate classes of certificates of accreditation with respect to pharmacies, hospital pharmacies or institutional pharmacies, setting terms, conditions and limitations with respect to such classes, and requiring compliance with those terms, conditions and limitations;

(l.2)  respecting the operation of hospital pharmacies and clarifying the application to hospital pharmacies of the provisions set out in section 119;

(l.3)  respecting the operation of institutional pharmacies and clarifying the application to institutional pharmacies of the provisions of this Act that apply to them by virtue of their designating regulations;

   (2)  Section 161 of the Act is amended by adding the following subsections:

Circulation

   (5)  A regulation shall not be made under subsection (1) unless the proposed regulation is circulated to every person who holds a valid certificate of accreditation at least 60 days before it is approved by the Council.

Same

   (6)  Subsection (5) does not apply to a regulation if the Minister required that the Council make the regulation under clause 5 (1) (c) of the Regulated Health Professions Act, 1991.

Exception

   (7)  Despite subsection (5), the Council may, with the approval of the Minister, exempt a regulation from the requirement that it be circulated or abridge the 60-day period referred to in subsection (5) to such lesser period as the Minister may determine.

   6.  Section 166 of the Act is amended by adding the following subsection:

Exception, hospital pharmacies

   (3)  A director of a corporation operating a hospital pharmacy is not liable for an offence by virtue of subsection (1), and may not be proceeded against under subsection (2).

   7.  The Act is amended by adding the following section:

Notice to Minister

   166.1  Where the College or a committee of the College proposes to take action under section 140 or any other provision of this Act and the action will involve a hospital pharmacy or an institutional pharmacy, the College or committee shall,

  (a)  give notice of the proposed action to the Minister in writing before taking the action; and

  (b)  provide the Minister with any information the Minister requests with respect to the action.

Public Hospitals Act

   8.  Clause 33 (c) of the Public Hospitals Act is repealed and the following substituted:

   (c)  a physician resigns from a medical staff of a hospital or restricts his or her practice within a hospital and the administrator of the hospital has reasonable grounds to believe that the resignation or restriction, as the case may be, is related to the competence, negligence or conduct of the physician,

.     .     .     .     .

Regulated Health Professions Act, 1991

   9.  Subsection 5.0.1 (1) of the Regulated Health Professions Act, 1991 is repealed and the following substituted:

College supervisor

   (1)  The Lieutenant Governor in Council may appoint a person as a College supervisor, on the recommendation of the Minister, where the Minister considers it appropriate or necessary.

   10.  Clause 36 (1) (d) of the Act is repealed and the following substituted:

  (d)  as may be required for the administration of the Drug Interchangeability and Dispensing Fee Act, the Healing Arts Radiation Protection Act, the Health Insurance Act, the Health Protection and Promotion Act, the Independent Health Facilities Act, the Laboratory and Specimen Collection Centre Licensing Act, the Ontario Drug Benefit Act, the Coroners Act, the Controlled Drugs and Substances Act (Canada) and the Food and Drugs Act (Canada);

(d.1) for a prescribed purpose, to a public hospital that employs or provides privileges to a member of a College, where the College is investigating a complaint about that member or where the information was obtained by an investigator appointed pursuant to subsection 75 (1) or (2) of the Code, subject to the limitations, if any, provided for in regulations made under section 43;

(d.2) for a prescribed purpose, to a person other than a public hospital who belongs to a class provided for in regulations made under section 43, where a College is investigating a complaint about a member of the College or where the information was obtained by an investigator appointed pursuant to subsection 75 (1) or (2) of the Code, subject to the limitations, if any, provided for in the regulations;

   11.  Subsection 43 (1) of the Act is amended by adding the following clauses:

(g.1) prescribing purposes and providing for limitations for the purposes of clauses 36 (1) (d.1) and (d.2);

(g.2) providing for classes of persons for the purposes of clause 36 (1) (d.2);

   12.  Subsections 25 (5) and (6) of Schedule 2 to the Act are repealed and the following substituted:

Complainant to be informed

   (5)  The Registrar shall give a complainant notice of receipt of his or her complaint and a general explanation of the processes of the College, including the jurisdiction and role of the Inquiries, Complaints and Reports Committee and the power of the Registrar to make a determination that it is not reasonable to believe that the allegations contained in the complaint, if established, could constitute professional misconduct, incompetence or incapacity on the part of the member, together with a copy of the provisions of sections 28 to 29.

Notice to member

   (6)  Except where the Registrar makes a determination referred to in subsection (7), the Registrar shall give the member, within 30 days of receipt of the complaint or the report,

  (a)  notice of the complaint, together with a copy of the provisions of sections 28 to 29, or notice of the receipt of the report;

  (b)  a copy of the provisions of section 25.2; and

   (c)  a copy of all available prior decisions involving the member unless the decision was a determination under subsection (7) or a decision to take no further action under subsection (11) or under subsection 26 (5).

No selection of a panel

   (7)  Despite subsection (1), the chair of the Inquiries, Complaints and Reports Committee shall not select a panel of the Committee to investigate a complaint where the Registrar has determined that it is not reasonable to believe that the allegations contained in the complaint, if established, could constitute professional misconduct, incompetence or incapacity on the part of the member.

Notice

   (8)  Where the Registrar has made a determination referred to in subsection (7), the Registrar shall, within 30 days of having received the complaint, give the complainant and the member who is the subject of the complaint notice of the Registrar's determination.

Request for review by Inquiries, Complaints and Reports Committee

   (9)  Where, within 30 days of receiving notice under subsection (8), the complainant makes a request in writing to the Registrar seeking a review of the Registrar's determination, the chair of the Inquiries, Complaints and Reports Committee shall select a panel of the Committee to review the Registrar's determination.

Notice

   (10)  Where a panel of the Inquiries, Complaints and Reports Committee has been selected under subsection (9), the panel shall give the complainant and the member notice that a review has been requested.

What a panel may do

   (11)  A panel selected under subsection (9) may do one of the following:

    1.  Confirm the Registrar's determination under subsection (7), in which case no further action shall be taken by the Inquiries, Complaints and Reports Committee with respect to the complaint.

    2.  Refer the complaint to the chair to select another panel of the Inquiries, Complaints and Reports Committee, with different members, to investigate the complaint in accordance with subsections (1) to (4).

Notice to complainant and member

   (12)  A panel that has made a decision under subsection (11) shall give notice of the decision to the complainant and member within 14 days of making the decision.

Notice to member where reference to another panel

   (13)  Where a panel of the Inquiries, Complaints and Reports Committee has referred a complaint to the chair under paragraph 2 of subsection (11), the Registrar shall give the member, within 14 days of the complaint having been referred to the chair,

  (a)  notice of the complaint, together with a copy of the provisions of sections 28 to 29, or notice of the receipt of the report;

  (b)  a copy of the provisions of section 25.2; and

   (c)  a copy of all available prior decisions involving the member unless the decision was a determination under subsection (7) or a decision to take no further action under subsection  (11) or under subsection 26 (5).

   13.  Subsection 25.2 (1) of Schedule 2 to the Act is amended by striking out "subsection 25 (6)" at the end and substituting "subsection 25 (6) or (13)".

   14.  Subsection 26 (2) of Schedule 2 to the Act is repealed and the following substituted:

Prior decisions

   (2)  A panel of the Inquiries, Complaints and Reports Committee shall, when investigating a complaint or considering a report currently before it, consider all of its available prior decisions involving the member, including decisions made when that committee was known as the Complaints Committee, and all available prior decisions involving the member of the Discipline Committee, the Fitness to Practise Committee and the Executive Committee, unless the decision was a determination by the Registrar under subsection 25 (7) or was a decision to take no further action under subsection (5) of this section or under subsection 25 (11).

   15.  Section 28 of Schedule 2 to the Act is amended by adding the following subsection:

Not affected by referral

   (2.1)  A referral to the chair under paragraph 2 of subsection 25 (11) does not affect the time requirements under this section.

   16.  Subsection 29 (2) of Schedule 2 to the Act is repealed and the following substituted:

Request for review

   (2)  The complainant or the member who is the subject of the complaint may request the Board to review a decision of a panel of the Inquiries, Complaints and Reports Committee unless,

  (a)  the decision was made under subsection 25 (11);

  (b) the decision was to refer an allegation of professional misconduct or incompetence to the Discipline Committee; or

   (c)  the decision was to refer the member to a panel of the Inquiries, Complaints and Reports Committee under section 58 for incapacity proceedings.

   17.  Subsection 85.5 (2) of Schedule 2 to the Act is repealed and the following substituted:

Same

   (2)  Where a member resigns, or voluntarily relinquishes or restricts his or her privileges or practice, a person referred to in subsection (3) who has reasonable grounds to believe that the resignation, relinquishment or restriction, as the case may be, is related to the member's professional misconduct, incompetence or incapacity, shall file with the Registrar within 30 days after the resignation, relinquishment or restriction a written report setting out the grounds upon which the person's belief is based.

Commencement

Commencement

   18.  This Schedule comes into force on a day to be named by proclamation of the Lieutenant Governor.

 

EXPLANATORY NOTE

Schedule 1
Voluntary Blood Donations Act, 2014

It is made an offence to pay or offer to pay blood donors for blood, and for blood donors to accept such payments.

Inspection and enforcement provisions are provided for, including compliance orders.

Related amendments are made to other legislation.

Schedule 2
amendments respecting the regulation of pharmacies and other matters concerning regulated health professions

The Drug and Pharmacies Regulation Act is amended to allow premises associated with hospitals and health and custodial institutions to be considered "pharmacies" for the purposes of certain provisions of the Act.  Related amendments are also made.

The Public Hospitals Act is amended to require a hospital administrator to prepare and forward a detailed report to the College of Physicians and Surgeons where a physician resigns or restricts his or her practice and there is reason to believe the resignation or restriction is related to his or her competence, negligence or conduct.

The Regulated Health Professions Act, 1991 and the Health Professions Procedural Code are amended. Among the amendments:

    1.   The Lieutenant Governor in Council, upon the recommendation of the Minister of Health and Long-Term Care, may appoint a person as a supervisor of a health profession college where the Minister considers it to be appropriate or necessary to do so. The Bill removes the existing requirement that the Minister must additionally be of the opinion that the college's Council has failed to comply with a requirement previously issued to the college's Council by the Minister. 

    2.   Additional exceptions are created to the existing duty of confidentiality under the Act, including,

            i.  for the purposes of administering the Health Protection and Promotion Act,

           ii.  where the disclosure is to a public hospital that employs or that provides privileges to a member of a college, where the college is investigating the member, subject to any limitations in the regulations,

          iii.  disclosure to additional classes of persons provided for in regulations, subject to any limitations to be prescribed in those regulations.

    3.   Procedures are put in place to deal with instances where the Registrar of a College determines that it is not reasonable to believe that the allegations contained in a complaint against a member could, if established, constitute professional misconduct, incompetence or incapacity on the part of the member.

    4.   The Health Professions Procedural Code is amended to provide that where a college member resigns, or voluntarily relinquishes or restricts his or her privileges or practice, a person such as an employer who has reasonable grounds to believe that the resignation, relinquishment or restriction, as the case may be, is related to the member's professional misconduct, incompetence or incapacity, shall file with the Registrar within 30 days after the resignation, relinquishment or restriction a written report setting out the grounds upon which the person's belief is based.