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Human Tissue Gift Amendment Act (Trillium Gift of Life Network), 2000, S.O. 2000, c. 39 - Bill 142

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EXPLANATORY NOTE

The Bill changes the title of the Human Tissue Gift Act to the Trillium Gift of Life Network Act, establishes the Trillium Gift of Life Network and provides for the establishment of policies and procedures governing consent to the donation of human tissue for transplant and for education or research.  It also amends the definition of “tissue”.

The Network is established to plan, promote, co-ordinate and support activities relating to the donation of tissue for transplant and activities relating to education and research in connection with the donation of tissue.

Health facilities designated by the Minister are required to establish policies and procedures in accordance with requirements established by the Network for identifying and approaching potential donors and their families to provide information and inquire about consent.

 

 

chapter 39

An Act to amend the
Human Tissue Gift Act

Assented to December 21, 2000

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

1. The title of the Human Tissue Gift Act is repealed and the following substituted:

Trillium Gift of Life Network Act

2. (1) Section 1 of the Act, as amended by the Statutes of Ontario, 1998, chapter 18, Schedule G, section 58, is further amended by adding the following definitions:

“designated facility” means a hospital, health facility or other entity designated as a member of a prescribed class of facilities under section 8.2; (“établissement désigné”)

“General Manager” means the General Manager appointed under the Health Insurance Act; (“directeur général”)

“hospital” means a hospital approved as a public hospital under the Public Hospitals Act; (“hôpital”)

“Minister” means the Minister of Health and Long-Term Care or such other member of the Executive Council as may be designated under the Executive Council Act to administer this Act; (“ministre”)

“Ministry” means the ministry of the Minister;  (“ministère”)

“Network” means the Trillium Gift of Life Network established by subsection 8.7 (1); (“Réseau”)

“personal information” has the same meaning as in the Freedom of Information and Protection of Privacy Act; (“renseignements personnels”)

“prescribed” means prescribed by a regulation made under this Act; (“prescrit”)

“substitute” means, when used in relation to a patient, the person described in clause 5 (2) (a), (b), (c), (d), (e) or (f), as the case may be. (“remplaçant”)

(2) The definition of “tissue” in section 1 of the Act is repealed and the following substituted:

“tissue” means a part of a living or dead human body and includes an organ but, unless otherwise prescribed by the Lieutenant Governor in Council, does not include bone marrow, spermatozoa, an ovum, an embryo, a foetus, blood or blood constituents. (“tissu”)

3. The French version of subsection 7 (2) of the Act is amended by striking out “bénéficiaire” and substituting “receveur”.

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

PART II.1
Notice and Consent

Notice of death, imminent death

8.1 (1) A designated facility shall notify the Network as soon as possible when a patient at the facility has died or a physician is of the opinion that the death of a patient at the facility is imminent by reason of injury or disease.

Exception

(2) Despite subsection (1), a designated facility is not required to notify the Network if the Network has established requirements that set out circumstances in which notice is not required and those circumstances exist.

Information in notice

(3) The designated facility shall give a notice in accordance with such requirements as may be established by the Network and the notice must include the information required by the Network.

Determination

(4) When the designated facility gives notice to the Network, the Network shall determine whether the facility is required to contact the patient or the patient’s substitute concerning consent for tissue donation, and shall make the determination in consultation with the facility.

Query about consent

(5) If the Network advises the designated facility that it is required to contact the patient or the patient’s substitute, the facility shall make reasonable efforts to ensure that,

(a)  the patient or the patient’s substitute is contacted to determine whether he or she consents to the removal of tissue from the body of the patient for transplant; and

(b)  the contact is made in a manner that meets the requirements of the Network and by a person who meets such requirements as may be prescribed by the Minister.

Information exchange

(6) The person who contacts the patient or the patient’s substitute shall give to the patient or substitute the information required by the Network and shall make reasonable efforts to obtain from him or her the information required by the Network.

Commencement

(7) This section comes into force on a day to be named by proclamation of the Lieutenant Governor, and different subsections may be proclaimed into force at different times.

Classes of facilities

8.2 (1) The Minister may prescribe classes of facilities for the purposes of this Act.

Members of class

(2) The Minister may, by regulation, designate any of the following entities as a member of a prescribed class of facilities:

1.  A hospital.

2.  A health facility.

3.  Another entity engaged in activities related to tissue donations or transplants.

Confidentiality agreement

(3) Each designated facility, other than a hospital, is required to enter into an agreement with the Minister governing the confidentiality of personal information that is collected, used or disclosed by the facility for the purposes of this Act.

Committees, designated facilities

8.3 (1) A designated facility shall establish such committees as may be prescribed by the Minister, and the duties of the committees shall include such matters as the Minister may prescribe.

Officials

(2) A designated facility shall designate such persons to perform such duties as may be required by the Network.

Eligibility

(3) A person is not eligible to be designated under subsection (2) unless he or she meets such requirements as may be established by the Network.

Policies and procedures

8.4 (1) Every designated facility shall establish such policies and procedures as may be required by the Network, and they must meet the requirements established by the Network.

Public inspection

(2) Every designated facility shall make the policies and procedures it establishes under this Act available for public inspection.

Compliance

(3) Every designated facility shall make reasonable efforts to ensure that it follows the policies and procedures it establishes under this Act.

Compliance, requirements

8.5 Every designated facility shall make reasonable efforts to ensure that it follows such requirements that apply to it as may be established by the Network.

Minister’s directions

8.6 (1) The Minister may issue directions to a designated facility on matters relating to the exercise of the facility’s rights and powers and the performance of its duties under this Act.

Compliance, directions

(2) A designated facility that receives a direction under subsection (1) shall comply with the direction.

5. The Act is amended by adding the following Part:

PART II.2
Trillium Gift of Life Network

Network established

8.7 (1) A corporation without share capital known in English as the Trillium Gift of Life Network and in French as Réseau Trillium pour le don de vie is hereby established.

Composition

(2) The Network is composed of the members of its board of directors.

Status

(3) The Network is not an agent of Her Majesty for any purpose despite the Crown Agency Act.

Other Acts

(4) The Corporations Act and the Corporations Information Act do not apply to the Network.

Conflict of interest and indemnification

(5) Sections 132 and 136 of the Business Corporations Act apply to the Network and to the members of its board of directors.

Objects of the Network

8.8 The following are the objects of the Network:

1.  To plan, promote, co-ordinate and support activities relating to the donation of tissue for transplant and activities relating to education or research in connection with the donation of tissue.

2.  To co-ordinate and support the work of designated facilities in connection with the donation and transplant of tissue.

3.  To manage the procurement, distribution and delivery of tissue.

4.  To establish and manage waiting lists for the transplant of tissue and to establish and manage a system to fairly allocate tissue that is available.

5.  To make reasonable efforts to ensure that patients and their substitutes have appropriate information and opportunities to consider whether to consent to the donation of tissue and to facilitate the provision of that information.

6.  To provide education to the public and to the health care community about matters relating to the donation and use of tissue and to facilitate the provision of such education by others.

7.  To collect, analyse and publish information relating to the donation and use of tissue.

8.  To advise the Minister on matters relating to the donation of tissue.

9.  To do such other things as the Minister may direct.

Powers of the Network

8.9 (1) Except as limited by this Act or by a regulation made by the Minister, the Network has the capacity, rights, powers and privileges of a natural person for carrying out its objects.

Same

(2) The Network may establish requirements that one or more designated facilities are required to comply with for the purposes of this Act.

Restriction, real property

(3) The Network shall neither acquire nor dispose of real property without the approval of the Lieutenant Governor in Council.

Restriction, borrowing

(4) The Network shall not borrow money on its credit or give security against its property without the approval of the Lieutenant Governor in Council.

Board of directors

8.10 (1) The Network shall have a board of directors composed of a minimum of 10 and a maximum of 15 members, appointed by the Lieutenant Governor in Council.

Members

(2) When making appointments to the board, the Lieutenant Governor in Council shall endeavour to ensure that the board includes health professionals, persons representative of the interests of donors and recipients of tissue and of their families and persons with appropriate financial and governance skills.

Chair and vice-chair

(3) The Lieutenant Governor in Council may designate a chair and a vice-chair of the board from among the members of the board.

Remuneration

(4) The members of the board shall be paid such remuneration and expenses as the Lieutenant Governor in Council determines.

Powers of the board

8.11 (1) The board of directors of the Network shall oversee the management of financial and other affairs of the Network.

By-laws

(2) The board may make by-laws regulating its proceedings and generally for the conduct and management of the affairs of the Network.

Delegation

(3) The board may delegate any of its powers or duties under this Act to such person or persons as the board considers appropriate and may impose conditions and restrictions with respect to the delegation.

Minister’s directions

8.12 (1) If the Minister considers the action necessary, he or she may issue policy directions on matters relating to the exercise of the Network’s rights and powers and the performance of its duties under this Act.

Compliance, directions

(2) The Network shall comply with all policy directions given by the Minister.

Regulations Act

(3) The Regulations Act does not apply with respect to the policy directions.

Public inspection

8.13 The Network shall make details of its requirements established under this Act available for public inspection.

Auditor

8.14 (1) The Network shall appoint one or more auditors licensed under the Public Accountancy Act to audit annually the accounts and financial transactions of the Network.

Auditor’s report

(2) The Network shall give a copy of every auditor’s report to the Minister.

Minister’s audit

(3) The Minister may require that any aspect of the affairs of the Network be audited by an auditor appointed by the Minister.

Annual report

8.15 (1) The Network shall give the Minister an annual report on the affairs of the Network for the preceding fiscal year and shall include in the report such information as the Minister may specify.

Table report

(2) The Minister shall lay the annual report before the Assembly if it is in session or, if not, at the next session.

Administrator

8.16 (1) The Minister may appoint a person as administrator of the Network if the Minister considers it in the public interest.

Powers of administrator

(2) Unless the appointment provides otherwise, the administrator has the exclusive right to exercise all of the rights and powers and perform all of the duties of the Network until the appointment is terminated by the Minister.

Report to the Minister

(3) The administrator shall carry out such directions as the Minister may give and shall report to the Minister as required by the Minister.

Right of access

(4) An administrator has the same rights as the Network in respect of the documents, records and information of the Network.

Additional powers

(5) If the board continues to have any rights or powers or may continue to perform any duties during the term of the administrator’s appointment, any act of the board during that time is valid only if approved by the administrator in writing.

Personal information

(6) Any personal information acquired by the administrator in the course of his or her activities under this section is the property of the Ministry and shall be deemed to be under the control of the Ministry for the purposes of the Freedom of Information and Protection of Privacy Act.

6. The Act is amended by adding the following Part:

PART II.3
aDMINISTRATION

Reports

8.17 (1) The Minister may request the Network, a designated facility or another person to submit such reports and information that relate to tissue donations and transplants as the Minister may require for purposes relating to tissue donations and transplants.

Compliance

(2) A person who receives a request from the Minister for information shall comply with the request within the time specified by the Minister and shall submit the report or information to the Ministry or to such other person as may be requested by the Minister.

Inspectors

8.18 (1) The Minister may appoint inspectors for the purposes of determining compliance with this Act.

Inspection

(2) For the purpose of determining compliance with this Act, an inspector may, without a warrant, enter and inspect the premises of designated facilities and the Network.

Restrictions

(3) In an appointment, the Minister may restrict the inspector’s powers of entry and inspection to specified premises.

Time of entry

(4) The power to enter and inspect a place without a warrant may be exercised only during the regular business hours of the premises or, during daylight hours if there are no regular business hours.

Identification

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

Powers of inspector

(6) An inspector conducting an inspection may,

(a)  examine a record or other thing that is relevant to the inspection;

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

(c)  remove for review and copying a record or other thing that is relevant to the inspection;

(d)  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 on the premises; and

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

Written demand

(7) A demand that a record or other thing be produced for inspection must be in writing and must include a statement of the nature of the record or thing required.

Obligation to produce and assist

(8) If an inspector demands that a record or other thing be produced for inspection, 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

(9) A record or other thing that has been removed for review and copying,

(a)  shall be made available to the person from whom it was removed, for review and copying, 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.

Copy admissible in evidence

(10) A copy of a record 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

(11) No person shall 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 information, on matters relevant to the inspection, that the person knows to be false or misleading.

Report to the Minister

(12) An inspector shall report to the Minister on the results of each inspection.

Personal information

(13) Any personal information acquired by any person in the course of an inspection is the property of the Ministry and shall be deemed to be under the control of the Ministry for the purposes of the Freedom of Information and Protection of Privacy Act.

Personal information

8.19 (1) Subject to such conditions as may be prescribed by the Minister, the Minister, the General Manager and the Network may directly or indirectly collect personal information about individuals for a purpose related to tissue donations or transplants.

Use of information

(2) Subject to such conditions as may be prescribed by the Minister, the Minister, the General Manager and the Network may use personal information that is in his, her or its custody or under his, her or its control for a purpose related to tissue donations or transplants.

Purpose for which information obtained

(3) For the purposes of the Freedom of Information and Protection of Privacy Act, personal information used by the Minister, the General Manager or the Network for a purpose related to tissue donations or transplants shall be deemed to have been obtained or compiled for that purpose or for a consistent purpose.

Disclosure by designated facility

(4) A designated facility shall disclose personal information about an individual to the Network, the Minister or the General Manager, as the case may be, if the designated facility is of the opinion that the disclosure is necessary for a purpose related to tissue donations or transplants and shall not disclose the information if the facility is of the opinion that the disclosure is not necessary for that purpose.

Same

(5) Despite subsection (4), a designated facility shall disclose personal information about an individual to the Network, the Minister or the General Manager, as the case may be, if,

(a)  the disclosure is required by the Network, the Minister or the General Manager, as the case may be, for a purpose the Network, the Minister or the General Manager, as the case may be, considers related to tissue donations or transplants; or

(b)  the disclosure is required by the Network as part of the information included in a notice under subsection 8.1 (3).

Disclosure by Network, etc.

(6) Subject to subsection (7), the Network or a person prescribed by the Minister shall disclose personal information about an individual to any of the following persons for a purpose related to tissue donations or transplants:

1.  A designated facility.

2.  An employee of the Ministry.

3.  A physician.

4.  A person or class of persons prescribed by the Minister.

Conditions

(7) A disclosure under subsection (6) shall be made only if,

(a)  such conditions as may be prescribed by the Minister have been met; and

(b)  the person making the disclosure is of the opinion that the disclosure is necessary for a purpose related to tissue donations or transplants.

Exception

(8) No disclosure shall be made under subsection (6) if the person who would otherwise make the disclosure is of the opinion that the disclosure is not necessary for a purpose related to tissue donations or transplants.

Disclosure to Minister, etc.

(9) Despite subsections (7) and (8), the Network or a person prescribed by the Minister shall disclose personal information about an individual to the Minister or to the General Manager if the Minister or the General Manager, as the case may be, requires the personal information for a purpose he or she considers to be related to tissue donations or transplants.

Disclosure by Minister, General Manager

(10) The Minister or the General Manager, as the case may be, shall disclose personal information to a person described in paragraph 1, 2, 3 or 4 of subsection (6) or to the Network if, in the opinion of the Minister or the General Manager, as the case may be, the disclosure is necessary for a purpose related to tissue donations or transplants and if all of the conditions prescribed by the Minister have been met.

Restriction

(11) Despite subsection (10), the Minister or the General Manager shall not disclose the information referred to in that subsection if, in the opinion of the Minister or the General Manager, as the case may be, the disclosure is not necessary for such a purpose.

Agreements

8.20 (1) The Network, the Minister or the General Manager may enter into agreements with other persons to collect, use or disclose personal information for any purpose related to tissue donations or transplants.

Confidentiality

(2) An agreement under subsection (1) shall provide that personal information collected, used or disclosed under it is confidential and shall establish mechanisms for maintaining the confidentiality of the information.

Deletion of names, etc.

8.21 Before disclosing personal information about an individual that is obtained under this Act or under an agreement, the person who obtained it shall delete from it all names and identifying numbers, symbols or other particulars assigned to individuals unless disclosure of the names or other identifying information,

(a)  is necessary for a purpose related to tissue donations or transplants;

(b)  is authorized under the Freedom of Information and Protection of Privacy Act; or

(c)  is otherwise authorized at law.

7. Section 9 of the Act is repealed and the following substituted:

Immunity

9. (1) No action or other proceeding for damages or otherwise shall be instituted against a member of the medical or other staff of a designated facility or any other person employed in a designated facility for any act done or performed in good faith in the performance or intended performance of any duty or function or in the exercise or intended exercise of any power or authority under this Act or for any neglect, default or omission in the performance or execution in good faith of any duty, function, power or authority under this Act.

Immunity, Crown

(2) Despite sections 5 and 23 of the Proceedings Against the Crown Act, no action or other proceeding for damages or otherwise shall be instituted against the Crown, the Minister or an officer, employee or agent of the Crown for any act done or performed in good faith in the performance or intended performance of any duty or function or in the exercise or intended exercise of any power or authority under this Act or for any neglect, default or omission in the performance or execution in good faith of any duty, function, power or authority under this Act.

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

Regulations, Lieutenant Governor in Council

14. The Lieutenant Governor in Council may, by regulation, provide that the definition of “tissue” in section 1 includes one or more of the following:  bone marrow, spermatozoa, an ovum, an embryo, a foetus, blood or blood constituents.

Regulations, Minister

15. (1) The Minister may make regulations,

(a)  prescribing those things that are required or permitted to be prescribed by the Minister or to be done by the Minister by regulation;

(b)  prescribing limitations or restrictions on the rights, powers and privileges of the Network.

Classes

(2) A regulation may establish different entitlements, requirements or conditions relating to each prescribed class of facilities.

Exemptions

(3) A regulation may exempt a designated facility or a class of facilities from the application of a specified provision of this Act or a specified provision of a regulation.

Restriction, person who contacts a patient or substitute

(4) The Minister shall consult with the Network before prescribing requirements for the purposes of clause 8.1 (5) (b).

Commencement

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

Same

(2) Sections 1 and 3 to 8 come into force on a day to be named by proclamation of the Lieutenant Governor.

Short title

10. The short title of this Act is the Human Tissue Gift Amendment Act (Trillium Gift of Life Network), 2000.