Search Results | Clear Search | Previous (in doc) | Next (in doc) | Prev Doc | Next Doc
Qp Date
This Act has "Not in Force" sections. See the Table of Legislative Changes.

Pharmaceutical Services Act

[SBC 2012] CHAPTER 22

Assented to May 31, 2012

Contents
Part 1 — Definitions
1Definitions
Part 2 — Provincial Drug Program
Division 1 — Provincial Drug Program
2Provincial drug program established
3Establishing and maintaining formularies
4Establishing and maintaining related services lists
5Publishing formularies and related services lists
6Special payments
7Confidential information
Division 2 — Beneficiaries
8Enrolment of beneficiaries
9Entitlement to benefits
10Cancelling beneficiary enrolment
Division 3 — Providers, Suppliers and Manufacturers
11Enrolment of providers
12Duties
13Changing or cancelling provider enrolment
Division 4 — Providing and Receiving Benefits
14Limits or conditions on provision
15Identity numbers
16Claims for benefits
17Payments
18Reassessments
Division 5 — Emergency Circumstances
19Emergency circumstances
Part 3 — Price Regulation
20Price regulation
21Incentives
Part 4 — Administration
Division 1 — Information Management
22Collection, use and disclosure of personal information
23Disclosure of personal information
24Further use and disclosure of personal information
25No market research
26Disclosure for health research purposes
27Information management technology
28Attaching and removing protective words
29Effect of protective words
Division 2 — Administrative Matters
30Applications, notices, hearings, information or reports
31Advisory committees
32Whistle-blower protection
33Immunity from legal proceedings
Part 5 — Enforcement
Division 1 — Audits and Inspections
34Appointment of inspectors
35Audits and inspections
36Powers and duties of inspectors
37General records
38Practitioner records
39Duties during audit and inspection
40Warrants
41Results of audit
42Recovery of non-entitled amounts
43Sharing information for compliance purposes
Division 2 — Enforcement and Penalties
44Use of evidence and inferences
45Suspension of payments
46Enforcement orders
47Injunctions
48Imposing administrative penalties
49Recovery of administrative penalties
50Offence Act application
51Offences
52Fines and incarceration
Division 3 — General Provisions
53Person not to be charged with both administrative penalty and offence
54Actions by corporation or employee
55Continuing contraventions or offences
56No benefit from contravention or offence
57Limitation period
58Publication of orders and offences
Part 6 — Regulations
59Regulations respecting provincial drug program
60Regulations respecting beneficiaries
61Regulations respecting providers and others
62Regulations respecting price regulation
63Regulations respecting information
64Regulations respecting administration and enforcement
65General regulation-making powers
Part 7 — Transitional Provisions and Consequential Amendments
66Transition — definitions
67Transition — PharmaCare plans
68Transition — PharmaCare formularies and related services lists
69Transition — agreements
70Transition — special payments
71Transition — providers
72Transition — immunity
73Transition — incentives
74Transition — PharmaNet
75Transition — advisory committees
76Transition — new applicants to be beneficiaries
77Transition — new applicants to be providers
78Transition — regulations
79-105 Consequential and Related Amendments
106Commencement

Part 1 — Definitions

Definitions

1  (1) In this Act:

"alternate payee" means a person prescribed to receive payment under section 17 (2) [payments];

"beneficiary" means a person who is enrolled in a drug plan;

"benefit", subject to subsection (2), means a drug, device or substance listed on a formulary, or a related service listed on a related services list, for which full or partial payment may be made by the minister under this Act;

"claim" means a claim made under this Act for payment in respect of a benefit;

"college" has the same meaning as in the Health Professions Act;

"co-payment" means an amount a beneficiary must pay toward the cost of a benefit for which partial payment is being made by the minister under this Act;

"data stewardship committee" means the data stewardship committee established under the E-Health (Personal Health Information Access and Protection of Privacy) Act;

"deductible" means an amount a beneficiary must pay toward the cost of benefits before the minister may make a payment, under this Act, in respect of the beneficiary;

"device" means an article, instrument or apparatus used

(a) to prevent, diagnose, treat or mitigate a disease, a disorder or an abnormal physical or mental state or a symptom of any of them,

(b) to restore, correct or modify organic functions,

(c) to diagnose pregnancy, or

(d) to administer a drug;

"drug plan" means a prescribed plan that authorizes payment, by the minister under this Act, for benefits received by a class of beneficiaries;

"enforcement action" means any of the following:

(a) the making of an order made under section 46 [enforcement orders];

(b) the imposition of an administrative penalty under section 48 [imposing administrative penalties];

(c) the prosecution of an offence under section 51 [offences];

"formulary" means a list of drugs, devices and substances that are benefits for the purposes of a drug plan;

"franchisor" means a franchisor of a provider's pharmacy, facility or other place where drugs, devices, substances or related services are provided to persons;

"health authority" means

(a) a regional health board designated under the Health Authorities Act, and

(b) the Provincial Health Services Authority;

"incentive" includes money, gifts, discounts, rebates, refunds, customer loyalty schemes, coupons, goods, rewards and other prescribed things;

"inspector" means a person appointed or retained as an inspector under section 34 [appointment of inspectors];

"personal information" means recorded information about an identifiable individual;

"prescribed information management technology" means any of the following prescribed things:

(a) an information management system;

(b) a technological application;

(c) an integrated set of databases;

"protective word" means a word or phrase attached, under section 28 [attaching and removing protective words], to a person's personal information in prescribed information management technology;

"provider" means a person who is enrolled under section 11 [enrolment of providers] for the purpose of receiving payment for providing benefits;

"related service" means care, a service or an activity related to the provision, distribution, sale, purchase or use of a drug, device or substance;

"related services list" means a list of related services that are benefits for the purposes of a drug plan.

(2) The definition of "benefit" in subsection (1) does not apply

(a) for the purposes of section 32 [whistle-blower protection] or 56 [no benefit from offence or contravention], or

(b) in the context of benefits and services provided

(i) under an enactment other than this Act, or

(ii) through a program of Canada, a provincial or territorial government of Canada or a health authority for the purposes of section 60 (a) [regulations respecting beneficiaries].

(3) In this Act, the terms "child" and "spouse" have the same meaning as in the Medicare Protection Act.

(4) In this Act, the terms "dispense", "drug", "pharmacist", "pharmacy", "practitioner" and "prescription" have the same meaning as in the Pharmacy Operations and Drug Scheduling Act.

Part 2 — Provincial Drug Program

Division 1 — Provincial Drug Program

Provincial drug program established

2  (1) The provincial drug program known as BC PharmaCare is established, consisting of the benefits

(a) provided through the drug plans established under this Act, and

(b) provided, under this Act, outside of a drug plan.

(2) The minister is responsible for the administration of the provincial drug program.

Establishing and maintaining formularies

3  (1) Subject to the regulations, the minister must establish and maintain one formulary for each drug plan.

(2) The minister may do anything the minister considers necessary or appropriate for the purposes of establishing and maintaining formularies, including doing one or more of the following:

(a) considering all published and unpublished information respecting the clinical efficacy, effectiveness and safety of a drug, device or substance;

(b) considering the price and cost-effectiveness of a drug, device or substance;

(c) requesting information respecting a drug, device or substance from its manufacturer or a supplier;

(d) undertaking, or requiring a manufacturer or supplier to provide for, an independent review of the clinical efficacy, safety and cost-effectiveness of a drug, device or substance, and setting the terms and conditions of the review;

(e) considering the advice of a committee established under section 31 [advisory committees];

(f) if 2 or more drugs, devices or substances have different compositions or means of administration or use but have essentially the same therapeutic objectives, treating the drugs, devices or substances differently;

(g) determining, on any basis, including following a process involving the solicitation of competitive proposals, which drugs, devices or substances to list on a formulary;

(h) setting conditions that must be met for a drug, device or substance to be listed on a formulary;

(i) changing a formulary, including cancelling the listing of a drug, device or substance from the formulary.

(3) A change under subsection (2) (i) may be made at any time without notice to anyone or an opportunity to be heard.

(4) Subsection (3) does not relieve the minister of any notice requirement set out in an agreement made under this Act.

(5) The minister may designate a drug, device or substance listed on a formulary as a drug, device or substance that will be a benefit only

(a) for beneficiaries meeting criteria set by the minister, and

(b) if the drug, device or substance is the subject of an application made under section 6 [special payments].

Establishing and maintaining related services lists

4  (1) Subject to the regulations, the minister must establish and maintain one related services list for each drug plan.

(2) The minister may do anything the minister considers necessary or appropriate for the purposes of establishing and maintaining related services lists, including doing one or more of the following:

(a) considering all published and unpublished information respecting the clinical efficacy, effectiveness and safety of a related service;

(b) considering the price and cost-effectiveness of a related service;

(c) considering the advice of a committee established under section 31 [advisory committees];

(d) determining which related services to list on a related services list;

(e) setting conditions that must be met for a related service to be listed on a related services list;

(f) changing a related services list, including cancelling the listing of a related service from the related services list.

(3) A change under subsection (2) (f) may be made at any time without notice to anyone or an opportunity to be heard.

(4) Subsection (3) does not relieve the minister of any notice requirement set out in an agreement made under this Act.

(5) The minister may designate a related service listed on a related services list that will be a benefit only

(a) for beneficiaries meeting criteria set by the minister, and

(b) if the related service is the subject of an application made under section 6 [special payments].

Publishing formularies and related services lists

5  (1) The minister must publish the formularies and related services lists that apply to each drug plan.

(2) The minister may publish information respecting one or more drugs, devices or substances listed on a formulary or one or more related services listed on a related services list, including information respecting one or more of the following:

(a) the clinical efficacy, effectiveness and safety of the drug, device, substance or related service;

(b) the price and cost-effectiveness of the drug, device, substance or related service;

(c) the process by which the decision was made to list the drug, device, substance or related service.

Special payments

6  (1) This section applies despite any provision of this Act or a regulation made under it, including a limit or condition imposed under another provision of this Act.

(2) On application made by one or more providers or practitioners, the minister may authorize payment under this Act for all or part of a drug, device, substance or related service provided to a person or class of persons, including a person who is not a beneficiary, or a class of persons who are not beneficiaries, even if

(a) the drug, device or substance is not listed on a formulary or the related service is not listed on a related services list,

(b) the person is not otherwise eligible to have the drug, device, substance or related service provided as a benefit, or

(c) the person would otherwise receive only partial payment.

(3) On application made by one or more providers or practitioners, the minister may authorize payment under this Act for all or part of a benefit designated under section 3 (5) [establishing and maintaining formularies] or 4 (5) [establishing and maintaining related services lists] provided to a person meeting the criteria set under section 3 (5) or 4 (5), as applicable.

(4) On application made by a beneficiary, the minister may authorize payment under this Act for all or part of

(a) a drug, device, substance or related service provided to the beneficiary and, for this purpose, subsection (2) (a) to (c) applies, or

(b) a benefit designated under section 3 (5) or 4 (5), if the beneficiary meets the criteria set under section 3 (5) or 4 (5), as applicable.

(5) The minister, as the minister considers appropriate, may do one or more of the following:

(a) establish classes of persons, including classes of providers or practitioners, for the purposes of this section;

(b) authorize payments based on the class of provider or practitioner to which the applicant belongs;

(c) set limits or conditions on the making of payments, including setting different limits or conditions on the making of payments based on the class of provider or practitioner to which the applicant belongs;

(d) without giving notice or an opportunity to be heard,

(i) change the limits or conditions set under this subsection, or

(ii) cancel an authorization made under subsection (2), (3) or (4).

(6) Subject to any limits or conditions set under subsection (5) of this section, if the minister authorizes a payment under subsection (2) or (4) (a) of this section,

(a) the drug, device, substance or related service is deemed to be a benefit in respect of the recipient for the purposes of sections 9, 16 to 18, 20, 37, 38, 42 and 51 and a regulation made in respect of one or more of those provisions,

(b) if the recipient is not a beneficiary, the recipient is deemed to be a beneficiary for the purposes of sections 17, 42 and 51 and a regulation made in respect of one or more of those provisions, and

(c) the minister may give binding directions respecting the application of a provision of this Act or a regulation made under it in respect of the deemed benefit, if applicable, the deemed beneficiary, and its provision by a provider to a person.

Confidential information

7  Despite the Freedom of Information and Protection of Privacy Act or any other enactment that would require the disclosure of information, the minister may refuse to make public information respecting the deliberations and recommendations, by an advisory committee or by employees of the ministry of the minister, respecting the following:

(a) the listing of a drug, device or substance on a formulary;

(b) the listing of a related service on a related services list;

(c) the authorization of payments under section 6 [special payments].

Division 2 — Beneficiaries

Enrolment of beneficiaries

8  (1) A person may enrol, in accordance with the regulations, in one or more drug plans for which he or she is eligible.

(2) For the purposes of determining a person's eligibility to enrol in a drug plan, the minister may require a person to provide information, including personal information, additional to that required under section 59 (c) [regulations respecting provincial drug program].

Entitlement to benefits

9  (1) Subject to this Act and the regulations made under it, a beneficiary is entitled to the benefits provided for by each drug plan in which the beneficiary is enrolled.

(2) Subject to the regulations, the minister may impose limits and conditions on a beneficiary's entitlement to benefits.

(3) Despite subsection (1) but subject to the regulations,

(a) the provincial drug program must be considered insurance of last resort, and

(b) a beneficiary is not entitled to payment under this Act for any part of a benefit for which the beneficiary is eligible for payment under a prescribed

(i) enactment, or

(ii) program, including a program of Canada, a provincial or territorial government of Canada or a health authority.

Cancelling beneficiary enrolment

10  (1) Subject to the regulations, the minister may cancel a beneficiary's enrolment in one or more drug plans.

(2) The minister may impose limits and conditions on the re-enrolment as a beneficiary of a person whose enrolment has been cancelled.

Division 3 — Providers, Suppliers and Manufacturers

Enrolment of providers

11  (1) An owner of a pharmacy, facility or other place where drugs, devices, substances or related services are provided to persons, other than on a wholesale basis, may apply to the minister to be enrolled as a provider.

(2) An owner of more than one pharmacy, facility or other place described in subsection (1) must apply for enrolment in respect of each pharmacy, facility or other place.

(3) Despite subsection (1), the minister may permit a person who is connected to a place referred to in subsection (1), but is not an owner of the place, to apply for enrolment.

(4) If satisfied that the applicant meets prescribed criteria, the minister

(a) may enrol the applicant as a provider, unless the minister is of the opinion that it would not be in the public interest to do so,

(b) may designate the provider as a member of a class of providers established by the minister, and

(c) may impose limits and conditions on the provider's enrolment.

Duties

12  (1) This section applies to

(a) a provider, a supplier, a manufacturer, a franchisor and an alternate payee,

(b) a former provider, supplier, manufacturer, franchisor and alternate payee,

(c) a person prescribed for the purposes of section 21 [incentives] or subsection (3) of this section, and

(d) a person who is an employee or agent of a person referred to in any of paragraphs (a) to (c).

(2) A person referred to in subsection (1) must comply with

(a) this Act and the regulations made under it,

(b) a limit or condition that is imposed under this Act, and

(c) a limit or condition that is identified in an agreement made under this Act as a limit or condition to which this section applies.

(3) A person referred to in subsection (1), and a prescribed person, must

(a) keep prescribed records in the manner required by the minister, and

(b) produce those records on request of the minister and within the time requested.

Changing or cancelling provider enrolment

13  (1) A provider may cancel his or her enrolment as a provider by giving 30 days' written notice to the minister.

(2) Subject to the regulations and after giving the provider 30 days' notice and an opportunity to be heard, the minister may

(a) change or cancel a designation made under section 11 (4) (b) [enrolment of providers], or

(b) cancel a provider's enrolment.

(3) The minister may change or add limits and conditions on a provider's enrolment

(a) on giving 30 days' notice but without giving an opportunity to be heard, or

(b) following a hearing in relation to the proposed cancellation of a provider's enrolment.

Division 4 — Providing and Receiving Benefits

Limits or conditions on provision

14  A provider must comply with all prescribed limits and conditions in respect of the prescription, dispensation, sale, purchase or use of a drug, device, substance or related service.

Identity numbers

15  (1) A person must not knowingly use, in order to obtain benefits, an identity number other than the one issued to the person by the Medical Services Commission under the Medicare Protection Act.

(2) A person prescribed for the purposes of this section must promptly report to the minister, in the form and manner required by the minister, if the prescribed person has reason to believe that another person has contravened subsection (1).

(3) No legal proceeding for damages lies or may be commenced or maintained against a person who makes a report, in good faith, under subsection (2).

Claims for benefits

16  (1) A person may claim payment for a benefit by making the claim in the form and manner required by the minister.

(2) For the purposes of assessing a claim, the minister may require a person to provide

(a) information to support the claim, including personal information, and

(b) written consent to the release, by another person, of personal information of the person.

Payments

17  (1) The minister may pay a claim in accordance with the beneficiary's entitlement to benefits under this Act.

(2) The minister may make all of a payment under subsection (1) directly to the beneficiary, the provider or a prescribed person, or part of the payment to each of them.

(3) A person is not entitled to payment under subsection (1) if, in providing the benefit or making the claim, the person acts contrary to

(a) this Act, the Health Professions Act, the Pharmacy Operations and Drug Scheduling Act or a prescribed enactment of British Columbia or Canada, or

(b) the regulations made, or a limit or condition imposed, under any of them.

(4) The minister may enter into agreements respecting the payment of claims with providers and persons prescribed for the purposes of subsection (2).

Reassessments

18  (1) The minister may reassess a claim if the minister is of the opinion that any of the following has occurred:

(a) an error or an accidental or inadvertent omission has been made in respect of making or paying the claim;

(b) within the calendar year in which the benefit to which the claim relates was provided, the beneficiary's

(i) eligibility for enrolment in a drug plan changed, or

(ii) entitlement to benefits changed.

(2) On reassessment of a claim, the minister may adjust the determination of the amount to which a person is entitled as payment of the claim and, after adjustment,

(a) make a further payment under section 17 [payments], or

(b) require a person to repay amounts to which the person was not entitled under this Act or an agreement made under this Act.

(3) An amount that a person is liable to repay under subsection (2) (b), and any interest payable on the amount, is a debt due to the government and may be

(a) deducted from any subsequent payment that may be made to the person under this Act, including under an agreement made under this Act, or

(b) recovered in a court of competent jurisdiction.

Division 5 — Emergency Circumstances

Emergency circumstances

19  (1) If there is an emergency within the meaning of section 51 of the Public Health Act and the minister is of the opinion that it is necessary for the purposes of preventing, controlling or eradicating a health hazard, the minister may order that a person, whether or not the person is a beneficiary, is entitled to receive

(a) a designated drug, device or substance, whether or not the drug, device or substance is listed on a formulary, or

(b) a designated related service, whether or not the related service is listed on a related services list.

(2) For the purposes of this Act,

(a) a drug, device, substance or related service designated under subsection (1) is deemed to be a benefit in respect of the recipient for the purposes of sections 9, 16 to 18, 20, 37, 38, 42 and 51 and a regulation made in respect of one or more of those provisions, and

(b) if the recipient is not a beneficiary, the recipient is deemed to be a beneficiary for the purposes of sections 17, 42 and 51 and a regulation made in respect of one or more of those provisions.

Part 3 — Price Regulation

Price regulation

20  (1) Without limiting section 3 (2) (h) [establishing and maintaining formularies] but subject to any limit or condition prescribed under section 62 (1) (a) [regulations respecting price regulation], the minister may set limits or conditions on the amount that will be paid, by the minister under this Act, for a particular drug, device, substance or related service that is a benefit.

(2) Subject to any limit or condition prescribed under section 62 (1) (b), the minister may enter into agreements with any person respecting prices of, or amounts that may be charged for, drugs, devices, substances or related services, including setting conditions that must be met for

(a) a drug, device or substance to be listed, or to continue to be listed, on a formulary, or

(b) a related service to be listed, or to continue to be listed, on a related services list.

(3) The conditions that may be set under subsection (2) include, without limitation, conditions respecting the amounts charged and the use, or prohibition of the use, of incentives.

Incentives

21  (1) A provider, a franchisor and a prescribed person, and a person who is an employee or agent of any of these, must not accept any incentive prohibited by the regulations.

(2) A supplier, a manufacturer and a prescribed person, and a person who is an employee or agent of any of these, must not provide an incentive that is prohibited by the regulations to

(a) a person described in subsection (1), or

(b) a person within a prescribed class of persons.

(3) On request of the minister, a provider, franchisor, supplier, manufacturer and prescribed person must report to the minister information respecting all of the following:

(a) amounts received or provided for

(i) drugs, devices and substances listed on a formulary,

(ii) related services listed on a related services list, and

(iii) drugs, devices, substances and related services for which payment is authorized under section 6 [special payments];

(b) the nature and value of any incentive received or provided in relation to

(i) drugs, devices and substances listed on a formulary,

(ii) related services listed on a related services list, and

(iii) drugs, devices, substances and related services for which payment is authorized under section 6.

Part 4 — Administration

Division 1 — Information Management

Collection, use and disclosure of personal information

22  (1) The minister may collect personal information under this Act for one or more of the following purposes:

(a) to provide health services, or facilitate care, in relation to drugs, devices, substances and related services;

(b) to administer this Act;

(c) for a prescribed purpose.

(2) The minister may use and disclose, inside Canada, personal information collected under subsection (1) for one or more of the following purposes:

(a) to administer this Act or another enactment for which the minister is responsible;

(b) to identify an individual who needs or is receiving health services;

(c) to provide health services to, or facilitate the care of, an individual;

(d) to identify a person who is providing health services;

(e) to prevent or manage chronic conditions, at the individual or population level;

(f) to facilitate health insurance and health service billing, including for the purposes of

(i) a payment in respect of health services or drugs, devices, substances or related services to be made to or by the government of British Columbia or a public body,

(ii) authorizing, administering, processing, verifying or cancelling such a payment,

(iii) resolving an issue regarding such a payment, or

(iv) an audit by a federal or provincial government payment agency that makes reimbursement for the cost of health services, drugs, devices, substances or related services;

(g) to assess and address public health needs;

(h) to engage in health system planning, management, evaluation or improvement, including

(i) health service development, management, delivery, monitoring and evaluation,

(ii) the compilation of statistical information,

(iii) public health surveillance, and

(iv) the assessment of the safety and effectiveness of drugs, devices, substances and related services;

(i) to conduct or facilitate research into health issues;

(j) to assess and address threats to public health;

(k) for a prescribed purpose.

(3) The minister may disclose, outside Canada, personal information collected under subsection (1) for one or both of the following purposes:

(a) to conduct or facilitate research into health issues;

(b) to assess and address threats to public health.

Disclosure of personal information

23  (1) The minister may disclose, inside Canada, personal information under this Act for one or more of the following purposes:

(a) for a purpose described in section 33.2 (f) or (i) of the Freedom of Information and Protection of Privacy Act only;

(b) to investigate or discipline a person regulated by a governing body of a health profession that has authority, under an enactment of any jurisdiction, to investigate or discipline the person;

(c) to monitor, by a governing body of a health profession, the practice of a health profession that is, under an enactment of any jurisdiction, regulated by that body;

(d) for a purpose to which the person who is the subject of the personal information has consented.

(2) The minister may disclose personal information under this Act inside or outside Canada for one or more of the following purposes:

(a) for a purpose described in section 33.1 (1) (a), (c), (e), (e.1), (g), (i), (i.1), (m), (m.1), (n), (p) or (t), (6) or (7) of the Freedom of Information and Protection of Privacy Act only;

(b) for a purpose to which the person who is the subject of the personal information has consented in writing.

Further use and disclosure of personal information

24  (1) A person to whom the minister discloses personal information under this Act must not use or disclose the personal information for any purpose other than the purpose for which it was disclosed to the person, except

(a) in respect of his or her own personal information,

(b) in accordance with this Act or a regulation made under it,

(c) for the purposes of court proceedings, or

(d) for the purposes of enabling the college, a committee of the college or a person acting for the college to exercise powers or perform duties under

(i) an enactment that applies to the college, or

(ii) the college bylaws.

(2) A person to whom the minister discloses personal information under this Act must comply with any limits or conditions set, in writing, by the minister.

No market research

25  (1) This section applies despite Part 2 of the Freedom of Information and Protection of Privacy Act and any provision of this Act or a regulation made under it.

(2) The minister must not disclose, for the purpose of market research, any of the following information collected under this Act:

(a) the personal information of any person;

(b) information related to a practitioner.

(3) A person to whom the minister discloses, under this Act, information described in subsection (2) must not use or disclose the information for the purpose of market research.

Disclosure for health research purposes

26  (1) A person may request that personal information collected under this Act be disclosed to the person for the purpose of conducting or facilitating research into health issues only by submitting the request, in the form and manner required by the data stewardship committee, to the data stewardship committee.

(2) Despite subsection (1), that subsection does not apply to a person who is

(a) an officer or employee of the ministry of the minister, or

(b) a service provider to the ministry of the minister.

(3) Section 14 [disclosure for planning or research purposes] of the E-Health (Personal Health Information Access and Protection of Privacy) Act applies to a request made under subsection (1) of this section in the same manner as if the personal information were contained in a ministry database under that Act.

Information management technology

27  (1) Subject to subsections (2) to (4), a person other than the minister must not access or record information in prescribed information management technology.

(2) Subject to the regulations, a pharmacist and a prescribed person may access information contained in prescribed information management technology.

(3) A pharmacist working in a community pharmacy who dispenses a drug, device or substance or provides a related service, and a prescribed person, must record in prescribed information management technology all personal information and other information relevant to the drug, device, substance or related service, including its prescription and dispensation.

(4) Subject to the regulations and without limiting subsection (3), a prescribed person may record information described in subsection (3) in prescribed information management technology.

(5) A person may access and record information in prescribed information management technology only in the form and manner required by the minister.

(6) A practitioner may issue electronically a prescription for a drug, device, substance or related service, but only through prescribed information management technology.

Attaching and removing protective words

28  (1) Subject to the regulations, a person may attach a protective word to the person's personal information recorded in prescribed information management technology, or remove an attached protective word,

(a) in the manner set out in the regulations, or

(b) by requesting, in the form and manner required by the minister, that a pharmacist attach or remove a protective word.

(2) A pharmacist who receives a request under subsection (1) must comply with the request in the manner set out in the regulations.

(3) Until the contrary is demonstrated, a person is presumed to be capable of understanding

(a) the nature of a protective word, and

(b) the consequences of attaching or removing a protective word.

(4) A protective word takes effect when activated in the prescribed information management technology.

(5) A reference to a person in this section, section 29 [effect of protective words] or section 63 (4) [regulations respecting information] in relation to the attachment or removal of a protective word includes the person's personal representative when acting in the course of his or her duties.

Effect of protective words

29  (1) A person within a prescribed class of persons who is otherwise permitted under this Act to collect, use or disclose personal information from prescribed information management technology must not do so if a protective word is attached to the personal information, except as follows:

(a) to notify a person that a protective word applies to personal information that would otherwise be available to the person;

(b) for a purpose described in section 33.1 (1) (c) of the Freedom of Information and Protection of Privacy Act;

(c) with the express consent of the person to whose personal information the protective word applies;

(d) if section 12 of the Health Care (Consent) and Care Facility (Admission) Act applies and a health care provider acting under that section reasonably believes that the personal information may be required to provide health care in accordance with that section.

(2) For the purposes of subsection (1) (d) of this section, a reference in section 12 of the Health Care (Consent) and Care Facility (Admission) Act to an adult is to be read as a reference to a person to whose personal information a protective word applies.

(3) A person must not disclose to a person within a prescribed class of persons personal information to which a protective word is attached, except in a circumstance described in subsection (1).

Division 2 — Administrative Matters

Applications, notices, hearings, information or reports

30  (1) The minister may make forms for the purposes of this Act and the regulations made under it, other than a form for the purposes of section 49 (3) [recovery of administrative penalties].

(2) Unless the minister provides otherwise, use of a form made under subsection (1) is compulsory.

(3) The minister may specify the manner in which applications or reports may be made, or notices or information must be given, under this Act.

(4) An application or a report made under this Act must provide all information requested by the minister.

(5) If the minister is required under this Act to give a person notice and an opportunity to be heard, the giving of notice and of the opportunity to be heard must be done in accordance with the regulations.

Advisory committees

31  (1) The minister may establish committees for the purpose of advising the minister respecting any matter under this Act, including in relation to the listing of

(a) drugs, devices or substances on a formulary, and

(b) related services on a related services list.

(2) The minister may designate the chair and vice chair of a committee established under subsection (1).

(3) Members of a committee established under subsection (1) may be paid

(a) remuneration set by the minister, and

(b) reasonable and necessary travel and out-of-pocket expenses incurred in carrying out the work of the committee.

Whistle-blower protection

32  A person must not dismiss, suspend, demote, discipline, harass or otherwise disadvantage another person, or deny another person a benefit, because

(a) the other person, acting in good faith and on the basis of reasonable belief, has notified the minister, a provider, the chief data steward under the E-Health (Personal Health Information Access and Protection of Privacy) Act, a college, or the commissioner under the Freedom of Information and Protection of Privacy Act, that a person has contravened or is about to contravene this Act,

(b) the other person, acting in good faith and on the basis of reasonable belief, has done or stated an intention of doing anything that is required to be done in order to avoid having any person contravene this Act,

(c) the other person, acting in good faith and on the basis of reasonable belief, has refused to do or stated an intention of refusing to do anything that is in contravention of this Act, or

(d) the person believes that the other person will do anything described in any of paragraphs (a) to (c).

Immunity from legal proceedings

33  (1) This section applies to the following persons:

(a) a member of a committee under section 31 [advisory committees], other than a member who

(i) is employed in the ministry of the minister, or

(ii) sits on the board of a health authority;

(b) an inspector retained under section 34 (2) [appointment of inspectors];

(c) a person acting under the order or direction of any person referred to in paragraph (a) or (b) of this subsection.

(2) Subject to subsection (3), no legal proceeding for damages lies or may be commenced or maintained against a person referred to in subsection (1) because of anything done or omitted

(a) in the exercise or intended exercise of a power under this Act, or

(b) in the performance or intended performance of a duty under this Act.

(3) Subsection (2) does not apply to a person referred to in that subsection in relation to anything done or omitted in bad faith.

(4) Subsection (2) does not absolve the government from vicarious liability arising out of anything done or omitted by a person referred to in that subsection for which the government would be vicariously liable if this section were not in force.

Part 5 — Enforcement

Division 1 — Audits and Inspections

Appointment of inspectors

34  (1) The minister may appoint one or more persons, employed under the Public Service Act, to exercise the powers and perform the duties of an inspector under this Act.

(2) Despite subsection (1), the minister may retain persons as necessary to be inspectors, and, for this purpose, delegate to those persons any power or duty of an inspector.

(3) A person retained under subsection (2) may be paid

(a) remuneration set by the minister, and

(b) reasonable and necessary travel and out-of-pocket expenses incurred in carrying out the work of an inspector.

(4) The Public Service Act does not apply to a person retained under subsection (2).

Audits and inspections

35  (1) The minister may appoint inspectors to conduct audits and inspections for the following purposes:

(a) to determine compliance with this Act;

(b) to fulfill a prescribed purpose.

(2) An inspector may audit or inspect the matters set out in subsection (3) in respect of

(a) a provider, a manufacturer, a supplier, a franchisor or an alternate payee,

(b) a former provider, manufacturer, supplier, franchisor or alternate payee,

(c) a person prescribed for the purposes of section 21 [incentives], or

(d) a person who was formerly a person prescribed for the purposes of section 21.

(3) The following matters may be the subject of an audit or inspection:

(a) a claim;

(b) the billing and business practices of a person referred to in subsection (2);

(c) prescribed matters.

Powers and duties of inspectors

36  (1) An inspector must conduct an audit or inspection in conformity with the practices and procedures set by the minister.

(2) An inspector, at any reasonable time and for the purposes of an audit or inspection, may

(a) enter any premises, and

(b) inspect the premises and the records found in the premises.

(3) An inspector must not enter a private dwelling under subsection (2) of this section without either the consent of the occupier or a warrant under section 40 [warrants].

General records

37  Without limiting section 36 (2) [powers and duties of inspectors], the records that may be inspected under that section include the following:

(a) records that an inspector considers relevant to

(i) the provision of benefits,

(ii) the making of claims and the payment of appropriate amounts for benefits, or

(iii) billing and business practices;

(b) records that would aid the minister in determining whether to take action under section 13 (2) or (3) [changing or cancelling provider enrolment];

(c) records relevant to a matter prescribed for the purposes of section 35 (3) (c) [audits and inspections];

(d) records that would indicate whether a person is in compliance with this Act.

Practitioner records

38  (1) An inspector may require the production of or electronic access to any record that is

(a) in the possession or control of a practitioner, and

(b) relevant to the provision of a benefit by a provider or former provider who is the subject of an audit or inspection.

(2) A practitioner must comply with a requirement made under subsection (1).

Duties during audit and inspection

39  (1) A person who is the subject of an audit or inspection must do all of the following on the request of an inspector:

(a) produce or provide electronic access to, and permit inspection of, the records referred to in section 36 (2) (b) [powers and duties of inspectors];

(b) supply copies of or extracts from the records;

(c) answer all questions of the inspector respecting any matter relating to the records or to the audit or inspection generally.

(2) If required by an inspector, a person must produce, or provide electronic access to, all books of account and other records that the inspector considers necessary for the purposes of an audit or inspection.

(3) If records that may be required under this section are not located on the premises of a person referred to in subsection (1), a person who has possession of those records, on the request of an inspector, must produce and permit inspection of those records by the inspector.

Warrants

40  (1) Without notice to any person, the minister may apply to a justice of the peace for an order under this section.

(2) A justice of the peace may issue a warrant authorizing a person to enter and search a place, including a private dwelling, and take any necessary action if satisfied by evidence on oath or affirmation that it is necessary for the purposes of

(a) taking an action authorized under this Act, or

(b) determining whether an action authorized under this Act should be taken.

Results of audit

41  (1) The minister must report the results of an audit to the person who is the subject of the audit.

(2) On receiving a report under subsection (1), the recipient may request the minister to reconsider the results by submitting to the minister, within 30 days after receiving the report, a request in the form and manner required by the minister.

(3) After considering a request for reconsideration, the minister may

(a) affirm or vary the results of the audit, or

(b) send notice to the person who is the subject of the audit that no action will be taken under this Act.

(4) Nothing in this section prevents the minister from taking any action available to the minister under this Act.

Recovery of non-entitled amounts

42  (1) An amount is a non-entitled amount if the amount is paid by the minister to a provider or an alternate payee, or a former provider or alternate payee, who, under this Act, is not entitled to the amount, including any amount paid

(a) for a drug, device, substance or related service provided to a person who was not a beneficiary,

(b) for a drug, device, substance or related service that was not a benefit,

(c) in respect of a claim for payment

(i) for a benefit that was not provided, or

(ii) that is not supported by the records kept or produced under this Act,

(d) after relying on a representation of fact that was untrue, or

(e) by mistake.

(2) Without limiting any action the minister could take under section 46 [enforcement orders], if the minister determines that the minister has paid a non-entitled amount to a provider or an alternate payee, or a former provider or alternate payee, the minister may require the provider or alternate payee, or former provider or alternate payee, to

(a) repay the non-entitled amount,

(b) pay a prescribed surcharge, and

(c) pay interest on the amounts owing under paragraphs (a) and (b).

(3) The total amount that a person is liable to pay under subsection (2) is a debt due to the government and may be

(a) deducted from any subsequent payment that may be made to the person under this Act, including under an agreement made under this Act, or

(b) recovered in a court of competent jurisdiction.

Sharing information for compliance purposes

43  (1) In this section:

"health care body" means

(a) the ministry of the minister,

(b) a health care body as defined in the Freedom of Information and Protection of Privacy Act,

(c) the Provincial Health Services Authority, and

(d) a society that reports to the Provincial Health Services Authority;

"private insurer" means a private body operating in any jurisdiction in Canada that provides funding in the nature of a health insurance scheme in respect of a health service;

"public insurer" means a public body of any jurisdiction in Canada that provides funding in the nature of a public health insurance scheme in respect of a health service.

(2) Without limiting section 22 [collection, use and disclosure of personal information] or 23 [disclosure of personal information],

(a) a college, health care body, public insurer and private insurer may disclose personal information to the minister for the purposes of determining any person's compliance with this Act, and

(b) a college, health care body and public insurer may collect and use personal information from the minister for the purposes of determining any person's compliance with an enactment that governs the college, health care body or public insurer, as applicable.

(3) Without limiting section 22 or 23, the minister may

(a) collect and use personal information from a college, health care body, public insurer and private insurer for the purposes of determining any person's compliance with this Act, and

(b) disclose personal information to a college, health care body and public insurer for the purposes of determining any person's compliance with an enactment that governs the college, health care body or public insurer, as applicable.

Division 2 — Enforcement and Penalties

Use of evidence and inferences

44  (1) This section applies to

(a) an inspector, for the purpose of conducting an audit or inspection, including determining whether to conduct an audit or inspection and determining the results of the audit or inspection, and

(b) the minister, for the purpose of making an order or a determination under this Act.

(2) For a purpose set out in subsection (1), an inspector or the minister, as applicable, may do any of the following:

(a) subject to subsection (4), consider, and base a determination or an order on, any relevant source of information, including a source created

(i) on a statistical basis, including information derived from sampling, or

(ii) by a comparison between benefits provided by a provider and corresponding benefits provided by other providers;

(b) draw an adverse inference from any failure to produce sufficient information in relation to the matter that is the subject of a determination or an order by

(i) a person in respect of whom an audit or inspection is conducted or the determination is to be made, or

(ii) a person against whom the order is proposed to be made.

(3) It is not necessary for an inspector or the minister to consider, under subsection (2) (a), any particular benefit that was provided by a provider.

(4) The minister may make orders respecting the use or application of, or reliance on, statistical methodologies for the purposes of subsection (2) (a).

(5) The minister must publish an order made under subsection (4).

Suspension of payments

45  (1) The minister, without giving notice or an opportunity to be heard, may suspend payments owing under this Act by the government to a provider or an alternate payee, or a former provider or alternate payee, if the minister has reason to believe that

(a) the provider or alternate payee, or former provider or alternate payee,

(i) has engaged in conduct that could be the subject of enforcement action, or

(ii) has been convicted of a prescribed offence under an enactment of British Columbia or Canada,

(b) prescribed circumstances exist, or

(c) it would be in the public interest to suspend payment.

(2) As soon as reasonably practicable after suspending payments under subsection (1), the minister must give notice of the suspension and an opportunity to be heard.

(3) The minister must resume payments and pay any amounts owing during the suspension period if the minister suspends payments on the grounds set out in

(a) subsection (1) (a) (i) and enforcement action is not commenced within 3 months of the suspension, or

(b) subsection (1) (a), (b) or (c) and, following a hearing, the minister determines that

(i) the grounds for suspending the payments no longer exist, or

(ii) suspension of payments is unnecessary for any reason, or is not required to protect the public interest.

(4) If a provider or an alternate payee, or a former provider or alternate payee, does not respond within 21 days after notice is given under subsection (2) or if the minister does not resume payments after giving an opportunity to be heard under that subsection,

(a) the minister, if applicable, may cancel the enrolment of the provider without giving further notice or an opportunity to be heard under section 13 (2) (b) [changing or cancelling provider enrolment], and

(b) despite any provision of this Act or a regulation or an agreement made under it,

(i) no further amounts are owing to the provider or alternate payee, or former provider or alternate payee, and

(ii) any agreement with the provider or alternate payee, or former provider or alternate payee, is terminated without notice or compensation of any kind.

(5) The minister may designate a person to exercise the powers and perform the duties of the minister under this section.

Enforcement orders

46  (1) This section applies if the minister is satisfied that a person has

(a) contravened this Act, or

(b) committed an offence under section 51 [offences].

(2) In the circumstances set out in subsection (1), the minister may

(a) order a person to do anything that, in the opinion of the minister, is necessary to bring the person into compliance, and

(b) attach limits and conditions to the order, including requiring proof, at the cost of the person against whom the order is made, that the order has been complied with.

(3) A person against whom an order is made must comply with the order.

Injunctions

47  (1) Without notice to any person, the minister may apply to a judge of the Supreme Court for an order under this section.

(2) If satisfied by evidence on oath or affirmation that there has been or will be a contravention of this Act or an order made under section 46 [enforcement orders], a judge of the Supreme Court may grant an injunction restraining a person from contravening, or requiring a person to comply with, this Act or the order.

(3) If satisfied by evidence on oath or affirmation that a person is interfering with or obstructing, or will likely interfere with or obstruct, a person who is exercising powers or performing duties under this Act, a judge of the Supreme Court may order the first person to do or refrain from doing those things the judge considers necessary.

(4) A judge of the Supreme Court may grant an interim injunction or order until the outcome of an application commenced under this section.

Imposing administrative penalties

48  (1) Subject to subsection (3) of this section, the minister, after giving 30 days' notice and an opportunity to be heard, may impose an administrative penalty if satisfied on a balance of probabilities that a person has

(a) contravened this Act,

(b) without limiting paragraph (a) of this subsection, contravened an order made under section 46 [enforcement orders], or

(c) committed an offence under section 51 [offences].

(2) If a person is subject to an administrative penalty, the person must pay the administrative penalty within 30 days following the imposition of that administrative penalty.

(3) An administrative penalty imposed under subsection (1) must not be greater than

(a) $5 000, in respect of an administrative penalty imposed on an individual, or

(b) $50 000, in respect of an administrative penalty imposed on a person other than an individual.

(4) The minister may designate a person to exercise the powers and perform the duties of the minister under this section.

Recovery of administrative penalties

49  (1) If a person is liable to pay an administrative penalty under this Act, the administrative penalty may be recovered

(a) as a debt due to the government, or

(b) by deducting the amount of the administrative penalty from any subsequent payment that may be made to the person under this Act, including under an agreement made under this Act.

(2) If a person fails to pay an administrative penalty as required, the minister may file a certificate in a court of competent jurisdiction and, on filing, the certificate has the same force and effect, and all proceedings may be taken on it, as if it were a judgment of the court with which it is filed.

(3) A certificate under subsection (2) must be in the prescribed form, be signed by the minister and contain

(a) the name of the person who is liable for the administrative penalty,

(b) the contravention or failure in relation to which the administrative penalty is imposed, and

(c) the amount of the administrative penalty.

Offence Act application

50  Sections 4 and 5 of the Offence Act do not apply in respect of this Act or the regulations made under it.

Offences

51  (1) A person who does any of the following commits an offence:

(a) contravenes section 12 (3) [duties], 15 (1) [identity numbers], 21 [incentives], 25 [no market research], 32 [whistle-blower protection] or 39 [duties during audit and inspection];

(b) knowingly provides false or misleading information

(i) to a person who is exercising a power or performing a duty under this Act, or a person acting under the order or direction of that person, or

(ii) for the purposes of receiving a benefit;

(c) wilfully interferes with or obstructs a person who is exercising a power or performing a duty under this Act, or a person acting under the order or direction of that person;

(d) collects, uses or discloses personal information other than as permitted under this Act.

(2) A person commits an offence if the person offers an incentive

(a) to a beneficiary, as an inducement for the beneficiary to receive a benefit from a particular provider, or

(b) to any person, as an inducement to refer a beneficiary for the purposes of the beneficiary receiving a benefit from a particular provider.

(3) Subsection (2) does not apply to a drug, device, substance or related service for which the minister does not make a payment, in respect of the recipient of the drug, device, substance or related service, under the Act.

Fines and incarceration

52  A person who commits an offence listed in section 51 (1) or (2) [offences], or established under the regulations and identified as an offence to which this section applies, is liable on conviction to a fine not exceeding $200 000 or to imprisonment for a term not exceeding 6 months, or to both.

Division 3 — General Provisions

Person not to be charged with both administrative penalty and offence

53  (1) A person subject to an administrative penalty must not be prosecuted for an offence in respect of the same incident that gave rise to the administrative penalty.

(2) A person charged with an offence must not be subject to an administrative penalty in respect of the same incident that gave rise to the charge.

Actions by corporation or employee

54  (1) If a corporation contravenes

(a) this Act, or

(b) without limiting paragraph (a) of this subsection, an order made under section 46 [enforcement orders],

an officer, a director, an employee or an agent of the corporation who authorized, permitted or acquiesced in the contravention is also liable to an administrative penalty under section 48 [imposing administrative penalties] even though the corporation is liable for or pays the administrative penalty.

(2) If a corporation commits an offence under section 51 [offences], an officer, a director, an employee or an agent of the corporation who authorized, permitted or acquiesced in the offence commits the offence whether or not the corporation is convicted.

(3) If an employee commits an offence under section 51, an employer who authorized, permitted or acquiesced in the offence commits the offence whether or not the employee is identified or convicted.

Continuing contraventions or offences

55  If a person

(a) contravenes

(i) this Act, or

(ii) without limiting subparagraph (i) of this paragraph, an order made under section 46 [enforcement orders], or

(b) commits an offence under section 51 [offences],

and continues to contravene the Act or order, or to commit the offence, separate penalties may be imposed in respect of the contravention or offence for each day the original contravention or offence continues.

No benefit from contravention or offence

56  (1) This section applies if a person gains a benefit in

(a) contravening

(i) this Act, or

(ii) without limiting subparagraph (i) of this paragraph, an order made under section 46 [enforcement orders], or

(b) committing an offence under section 51 [offences].

(2) In any of the circumstances set out in subsection (1) of this section but subject to subsection (3) of this section,

(a) the minister may impose, in addition to any administrative penalty imposed under section 48 [imposing administrative penalties], an administrative penalty in an amount not exceeding the amount of the benefit, or

(b) the person is liable on conviction, in addition to any fine imposed under this Act, to a fine in an amount not exceeding the amount of the benefit.

(3) Subsection (2) of this section does not apply in respect of any amount recovered under section 42 [recovery of non-entitled amounts].

Limitation period

57  A proceeding for

(a) an administrative penalty under section 48 [imposing administrative penalties] may not be commenced under this Act, and

(b) an offence under section 51 [offences] may not be commenced in any court

more than 3 years after the facts on which the proceeding is based first come to the knowledge of the minister.

Publication of orders and offences

58  The minister may publish information, including personal information, respecting the following:

(a) a change to a designation made under section 13 (2) (a) [changing or cancelling provider enrolment];

(b) a cancellation of a provider's enrolment under section 13 (2) (b) or 45 (4) [suspension of payments];

(c) enforcement action taken under this Act.

Part 6 — Regulations

Regulations respecting provincial drug program

59  The Lieutenant Governor in Council may make regulations respecting the provincial drug program as follows:

(a) establishing one or more drug plans and providing that a drug plan need not have either a formulary or a related services list established for the drug plan;

(b) respecting eligibility for enrolment as a beneficiary in one or more drug plans, including respecting assessments for eligibility;

(c) respecting requirements for enrolment as a beneficiary in a drug plan, including respecting proof of eligibility for enrolment;

(d) if a beneficiary is enrolled in more than one drug plan, establishing rules for the purpose of determining which drug plan applies to the beneficiary in relation to a particular benefit;

(e) respecting deductibles and co-payments, including requiring a beneficiary or authorizing the minister to make full payment for the cost of receiving benefits;

(f) respecting limits and conditions for the purposes of paragraph (e).

Regulations respecting beneficiaries

60  The Lieutenant Governor in Council may make regulations respecting beneficiaries as follows:

(a) for the purposes of section 9 [entitlement to benefits],

(i) respecting co-ordination of the assessment of claims and payment of benefits with insurers and other reimbursement programs,

(ii) respecting reciprocal arrangements for the provision of benefits with Canada or with a provincial or territorial government of Canada,

(iii) prohibiting beneficiaries from receiving payment for benefits under this Act that are provided for through insurers and other reimbursement programs, and

(iv) prescribing enactments and programs for the purposes of subsection (3) of that section;

(b) respecting limits and conditions on a beneficiary's entitlement to benefits;

(c) respecting verification of the identity and enrolment, under the Medicare Protection Act, of a person requesting benefits under this Act;

(d) respecting the cancellation of a beneficiary's enrolment in one or more drug plans, including requiring the minister to give notice of the cancellation.

Regulations respecting providers and others

61  (1) The Lieutenant Governor in Council may make regulations respecting persons described in section 12 [duties] as follows:

(a) respecting the information that must be supplied by a person applying to be enrolled as a provider;

(b) respecting the criteria a person must meet to be enrolled as a provider, or to continue enrolment;

(c) respecting records that must be kept and the period of time for which they must be kept;

(d) respecting changes to a provider's designation and the cancellation of a provider's designation or enrolment;

(e) prohibiting providers from charging beneficiaries for drugs, devices, substances or related services for which the provider receives payment from the minister under this Act;

(f) requiring providers to make certain information available to the public.

(2) A regulation made under subsection (1) (c) may adopt by reference, in whole or in part and with any changes the Lieutenant Governor in Council considers appropriate, a bylaw of the College of Pharmacists of British Columbia.

(3) Unless otherwise stated, a bylaw referred to in subsection (2) is adopted as amended from time to time.

(4) The Lieutenant Governor in Council, for the purposes of section 14 [limits or conditions on provision], may make regulations setting limits and conditions in respect of the prescription, dispensation, sale, purchase or use of drugs, devices, substances or related services.

(5) The Lieutenant Governor in Council may make regulations prescribing persons, by class, for the purposes of sections 12, 15 [identity numbers] and 17 [payments].

(6) The Lieutenant Governor in Council may make regulations prescribing enactments for the purposes of section 17.

Regulations respecting price regulation

62  (1) The Lieutenant Governor in Council may make regulations for the purposes of regulating the price of drugs, devices, substances and related services as follows:

(a) setting limits and conditions on the amount that will be paid under this Act in respect of a class of drugs, devices, substances or related services;

(b) setting limits and conditions on the price of, or amount charged for, a class of drugs, devices, substances or related services, and for this purpose, the Lieutenant Governor in Council may specify that a limit or condition applies in respect of one or more classes of beneficiaries and persons who are not beneficiaries;

(c) requiring the minister not to list, or to discontinue listing, a drug, device or substance on a formulary, or a related service on a related services list,

(i) if prescribed limits or conditions are not met, or

(ii) in prescribed circumstances.

(2) An amount for the purposes of subsection (1) may be expressed in any form, including

(a) as a formula, or

(b) in relation to other classes of drugs, devices, substances or related services,

(i) a percentage of the price of them, or

(ii) amounts that may be paid or charged for them.

(3) The Lieutenant Governor in Council may make regulations respecting incentives as follows:

(a) prescribing persons, by class, for the purposes of section 21 [incentives];

(b) respecting the means of determining the value of incentives;

(c) prohibiting the receipt or offer of an incentive;

(d) providing that the prohibition set out in section 21 does not apply to specified matters that are the subject of ordinary commercial terms.

Regulations respecting information

63  (1) In making a regulation under this Part, the Lieutenant Governor in Council may make regulations requiring a person to provide either or both of the following:

(a) personal information;

(b) written consent to the release, by another person, of personal information.

(2) The Lieutenant Governor in Council may make regulations respecting the management of information as follows:

(a) prescribing additional purposes for which personal information may be collected, used and disclosed, or further used or disclosed, under this Act;

(b) if the disclosure of personal information is authorized under this Act,

(i) clarifying or limiting the purposes for which further use or disclosure is authorized, and

(ii) setting limits and conditions, in addition to any limits or conditions already provided for under this Act, on that further use or disclosure;

(c) defining "health services" and "health system" for the purposes of Division 1 [Information Management] of Part 4;

(d) prescribing information management technology for the purposes of the definition of "prescribed information management technology" in section 1;

(d.1) prescribing activities or circumstances that do or do not comprise market research for the purpose of section 25 [no market research];

(e) prescribing persons, by class, for the purposes of section 27 (2), (3) and (4) [information management technology];

(f) respecting access to and recording in prescribed information management technology, including prohibiting access to and setting limits or conditions on access or recording;

(g) respecting the recording of personal information in prescribed information management technology by a person authorized, under the terms of a designation order, to collect or have disclosed to him or her information from a health information bank;

(h) respecting the disclosure of personal information from prescribed information management technology to a person authorized, under the terms of a designation order, to collect information into a health information bank;

(i) respecting fees that may be charged for access to information in the custody of the minister, but not including fees for access, by a person, to personal information of the person.

(3) In subsection (2) (g) and (h), "designation order" and "health information bank" have the same meaning as in the E-Health (Personal Health Information Access and Protection of Privacy) Act.

(4) The Lieutenant Governor in Council may make regulations respecting protective words as follows:

(a) limiting or prohibiting classes of persons from attaching protective words;

(b) respecting conditions that apply to the attachment or removal of a protective word, including requiring the submission of records to a person;

(c) respecting the manner in which a protective word may be attached or removed;

(d) prescribing classes of persons for the purposes of section 29 [effect of protective words] applies.

Regulations respecting administration and enforcement

64  The Lieutenant Governor in Council may make regulations as follows:

(a) respecting the service of a notice or an order under this Act, including providing for the waiver of notice if service is not reasonably practicable;

(b) respecting hearings under this Act and providing for the manner and form of the hearing, including by written submissions;

(c) prescribing purposes for which an audit may be conducted;

(d) prescribing matters that may be the subject of an audit;

(e) prescribing surcharges that must be paid on non-entitled amounts;

(f) prescribing, for the purposes of section 45 [suspension of payments],

(i) offences, and

(ii) circumstances that may be grounds for suspending payments;

(g) respecting administrative penalties that may be imposed, including providing factors to be considered in the determination of the appropriate penalty;

(h) respecting the form of a certificate under section 49 [recovery of administrative penalties];

(i) respecting any other matter for which regulations are contemplated by this Act.

General regulation-making powers

65  (1) The Lieutenant Governor in Council may make regulations referred to in section 41 of the Interpretation Act.

(2) A person must not read any section of this Part as limiting the general powers to make regulations described in subsection (1) of this section.

(3) The Lieutenant Governor in Council may

(a) make regulations establishing classes of persons, drug plans, drugs, devices, substances or related services, and

(b) make different regulations for different classes, including limiting the application of a regulation made under this Part to one or more classes.

(4) The Lieutenant Governor in Council may make regulations

(a) exempting a person, drug, device, substance or related service, or a class of any of them, from one or more provisions of this Act or a regulation made under it, or

(b) authorizing the minister to waive or modify one or more requirements, limits or conditions of a regulation made under this Part in respect of a person, drug, device, substance or related service, or a class of any of them, including a class established by the minister.

(5) Without limiting subsection (4) (b) of this section, a regulation made under this Part may confer a discretion on the minister.

Part 7 — Transitional Provisions and Consequential Amendments

Transitional Provisions

Transition — definitions

66  In this Part:

"corresponding drug plan" means a drug plan, deemed to be established under this Act by section 67 (2) (a) [transition — PharmaCare plans], that

(a) corresponds to a PharmaCare plan, and

(b) has the same name as the PharmaCare plan to which the drug plan corresponds;

"PharmaCare formulary" means a list of drugs, devices and substances that, under the terms of a PharmaCare plan, are benefits for the purposes of that plan;

"PharmaCare manual" means the policy manual of the ministry of the minister entitled "PharmaCare Policy Manual Version 1.0", dated March 2012, as amended from time to time;

"PharmaCare plan" means a plan within the PharmaCare program;

"PharmaCare program" means the collection of Plans B, C, D, F, G, I, M, P, S and X established under section 2 of the Schedule to the Continuing Care Programs Regulation, B.C. Reg. 146/95, as it read on the date this section comes into force;

"PharmaCare related services list" means a list of related services that, under the terms of a PharmaCare plan, are benefits for the purposes of that plan.

Transition — PharmaCare plans

67  (1) In this section, "PharmaCare benefit" means

(a) a drug, device or substance that is listed on a PharmaCare formulary, and

(b) a related service that is listed on a PharmaCare related services list.

(2) On the date this section comes into force,

(a) each PharmaCare plan, for the purposes of this Act, is deemed to be a drug plan established under this Act, having the same name,

(b) PharmaCare benefits for a PharmaCare plan are deemed to be benefits for the purposes of the corresponding drug plan, subject to

(i) any changes to benefits made under section 3 [establishing and maintaining formularies] or 4 [establishing and maintaining related services lists], or

(ii) a regulation made under section 59 [regulations respecting provincial drug program],

(c) a person who is registered in a PharmaCare plan is deemed to be enrolled as a beneficiary under this Act in the corresponding drug plan, and

(d) the requirements, prohibitions, limits and conditions in respect of entitlement to PharmaCare benefits under a PharmaCare plan, as described in the PharmaCare manual, apply for the purposes of paragraphs (a), (b) and (c) of this subsection.

(3) This section ceases to have effect in respect of a PharmaCare plan that is deemed to be a drug plan on the earliest of

(a) the making of a regulation under this Act that establishes the PharmaCare plan's corresponding drug plan, and

(b) 3 years after the date this section comes into force.

(4) Despite subsection (3) (a), the Lieutenant Governor in Council may provide, in a regulation made under this Act that establishes a corresponding drug plan, that a requirement, prohibition, limit or condition in respect of entitlement to PharmaCare benefits described in the PharmaCare manual continues to apply to the corresponding drug plan for up to 3 years after the date this section comes into force.

(5) If there is a conflict or an inconsistency between a regulation made under this Act and the PharmaCare manual, subsection (4) does not apply and the regulation prevails.

Transition — PharmaCare formularies and related services lists

68  (1) A PharmaCare formulary that applies to a PharmaCare plan continues in effect and is deemed to be the formulary that applies to the corresponding drug plan.

(2) A PharmaCare related services list that applies to a PharmaCare plan continues in effect and is deemed to be the related services list that applies to the corresponding drug plan.

Transition — agreements

69  (1) This section applies to an agreement made

(a) before the date this section comes into force between a manufacturer or a supplier and Her Majesty the Queen in Right of British Columbia, as represented by the Minister of Health, and

(b) in respect of

(i) the listing of a drug, device or substance on a PharmaCare formulary, or

(ii) a drug, device or substance for which the minister is making a payment.

(2) An agreement described in subsection (1) continues for the purposes of this Act as if the agreement were made under this Act.

(3) Despite any provision of an agreement to the contrary, if an agreement does not provide for termination of the agreement by the government, on notice and without cause, the minister may terminate the agreement without cause on giving 60 days' notice to the other party or parties to the agreement.

(4) Despite any other enactment or law to the contrary,

(a) no damages or compensation of any kind is payable by the government, and

(b) no proceedings in which damages or compensation is claimed may be commenced or maintained against the government,

arising from the exercise of a power or the performance of a duty under this Act in relation to an agreement described in subsection (1), the termination of an agreement described in subsection (1) or the operation of this section.

Transition — special payments

70  (1) If, on the date this section comes into force,

(a) there is a subsisting authorization, by the minister, for payment for a drug, device, substance or related service, or a benefit, and

(b) the authorization is in the nature of an authorization that may be granted under section 6 [special payments],

the authorization is deemed to be an authorization granted under that section.

(2) An authorization under subsection (1) of this section continues, subject to any limits and conditions applicable as of the date this section comes into force, until changed or cancelled under section 6 (5) (d).

Transition — providers

71  (1) This section applies to a person who, on the date this section comes into force, is a party to any of the following agreements with Her Majesty the Queen in Right of British Columbia, as represented by the Minister of Health:

(a) a PharmaCare Enrolment Agreement;

(b) a Pharmacy Participation Agreement;

(c) a British Columbia PharmaCare Non-Pharmaceutical Supplier Participation Agreement;

(d) a British Columbia PharmaCare Pharmacy Participation Agreement for the Provision of PharmaCare Services to Long Term Care Facilities;

(e) a Methadone Maintenance Payment Program Addendum to a Pharmacy Participation Agreement.

(2) On the date this section comes into force, a person described in subsection (1) is deemed to be a provider subject to

(a) any designation made and any limits or conditions imposed under subsection (3) of this section,

(b) the requirements, prohibitions, limits or conditions in respect of the provision of PharmaCare benefits described in the PharmaCare manual,

(c) the terms of an agreement described in subsection (1) to which the provider is subject, and

(d) a change to or the cancellation of the person's enrolment under section 13 [changing or cancelling provider enrolment].

(3) The minister may

(a) designate a deemed provider as a member of a class of providers established by the minister, and

(b) impose limits and conditions on the deemed provider's enrolment.

(4) An agreement described in subsection (1) of this section in respect of a deemed provider, along with that provider's deemed enrolment under subsection (2) of this section, is terminated on the earlier of

(a) the agreement's termination in accordance with the terms of the agreement, and

(b) 180 days after the making of a regulation under section 61 (1) (a) and (b) [regulations respecting providers and others].

(5) If the minister enrols a deemed provider who, within 180 days after the making of a regulation under section 61 (1) (a) and (b), applied for enrolment, the minister may specify that the person is enrolled as of a particular date, including the date on which the person's deemed enrolment is terminated under subsection (4) (b) of this section.

(6) Subsection (2) (b) ceases to have effect 3 years after the date this section comes into force, unless the Lieutenant Governor in Council, on making a regulation under section 61, provides that subsection (2) (b) of this section ceases to have effect on an earlier date.

(7) Despite any other enactment or law to the contrary,

(a) no damages or compensation of any kind is payable by the government, and

(b) no proceedings in which damages or compensation is claimed may be commenced or maintained against the government,

arising from the exercise of a power or the performance of a duty under this Act in relation to an agreement described in subsection (1), the termination of an agreement described in subsection (1) or the operation of this section.

Transition — immunity

72  No legal proceeding for damages lies or may be commenced or maintained against the minister or an employee of the government because of anything done or omitted

(a) in the exercise or intended exercise of a power under section 69 [transition — agreements] or 71 [transition — providers], or

(b) in the performance or intended performance of a duty under section 69 or 71.

Transition — incentives

73  (1) This section applies to a person who is a party to an agreement that provides for incentives to be received or provided in relation to drugs, devices and substances listed on a formulary or in relation to related services listed on a related services list.

(2) Despite any other enactment or law to the contrary,

(a) no damages or compensation of any kind is payable by the government, and

(b) no proceedings in which damages or compensation is claimed may be commenced or maintained against the government,

arising from the contravention or termination, by a party, of an agreement referred to in subsection (1) of this section or the operation of section 21 [incentives].

Transition — PharmaNet

74  (1) In this section and in section 78 (1) [transition — regulations], "PharmaNet" and "PharmaNet stewardship committee" have the same meaning as they had in section 1 of the Pharmacy Operations and Drug Scheduling Act before those definitions were repealed by this Act.

(2) The provincial computerized networks and associated databases, collectively known as PharmaNet, are continued under this Act and are deemed to be prescribed information management technology for the purposes of this Act until a regulation is made under section 63 (2) (d) [regulations respecting information].

(3) The rules, policies and procedures of the PharmaNet stewardship committee as they existed immediately before the repeal of section 14 of the Pharmacy Operations and Drug Scheduling Act by this Act

(a) in respect of data that relate to drugs, devices, substances or related services continue to apply, and

(b) in respect of any other matter are the rules, policies and procedures of the data stewardship committee under the E-Health (Personal Health Information Access and Protection of Privacy) Act,

except to the extent the rules, policies and procedures are repealed or amended by the data stewardship committee.

(4) If personal health information was being disclosed under section 16 of the Pharmacy Operations and Drug Scheduling Act immediately before the repeal of that section by this Act, the disclosure may continue in accordance with the terms under which the disclosure was authorized under that section.

(5) A reference, in a bylaw made under the authority of section 21 of the Pharmacy Operations and Drug Scheduling Act and in force immediately before the amendment of that section by this Act,

(a) to PharmaNet is to be read as a reference to prescribed information management technology under section 27 [information management technology] of this Act, and

(b) to the PharmaNet stewardship committee is to be read as a reference to the data stewardship committee under the E-Health (Personal Health Information Access and Protection of Privacy) Act.

(6) The Access to PharmaNet Regulation, B.C. Reg. 117/2009, whether or not consistent with or authorized to be made under this Act, is deemed to be validly made under this Act and is given effect until the earliest of

(a) the regulation's repeal by regulation of the Lieutenant Governor in Council,

(b) the regulation's amendment in accordance with this Act, and

(c) 3 years from the date this section comes into force.

Transition — advisory committees

75  (1) This section applies to the committees, established by the minister, that advise the minister respecting one or more of the following:

(a) drugs, devices, substances and related services;

(b) clinical matters in relation to drugs, devices, substances and related services;

(c) adjudication in relation to matters under the PharmaCare program.

(2) The committees referred to in subsection (1) are continued as advisory committees for the purposes of section 31 [advisory committees].

(3) A person who, on the date this section comes into force, is a member of a committee referred to in subsection (1)

(a) continues to be a member of the committee, and

(b) is subject to the limits and conditions of the person's appointment to the committee, until the minister changes or rescinds that person's appointment.

Transition — new applicants to be beneficiaries

76  (1) If a person applies to be a beneficiary after the date this section comes into force but before a regulation is made under section 59 (b), (c) or (d) [regulations respecting provincial drug program], the requirements, prohibitions, limits and conditions described in the PharmaCare manual in respect of entitlement to PharmaCare benefits apply for the purposes of

(a) making the application, and

(b) determining the person's eligibility, and continued eligibility, to receive benefits.

(2) If an applicant under subsection (1) is eligible to receive benefits under a corresponding drug plan, the applicant is deemed to be a beneficiary enrolled in that corresponding drug plan, subject to

(a) any limits or conditions imposed under section 9 (2) [entitlement to benefits],

(b) the requirements, prohibitions, limits or conditions in respect of entitlement to PharmaCare benefits described in the PharmaCare manual, and

(c) the cancellation of the person's enrolment under section 11 [cancelling beneficiary enrolment].

(3) Subsections (1) and (2) (b) of this section cease to have effect on the earliest of

(a) the making of a regulation under section 59 (b), (c) or (d), and

(b) 3 years after the date this section comes into force.

(4) Despite subsection (3) (a) of this section, the Lieutenant Governor in Council may provide, in a regulation made under section 59 (b), (c) or (d), that a requirement, prohibition, limit or condition in respect of entitlement to PharmaCare benefits described in the PharmaCare manual continues to apply for up to 3 years after the date this section comes into force.

(5) If there is a conflict or an inconsistency between a regulation made under this Act and the PharmaCare manual, subsection (4) does not apply and the regulation prevails.

Transition — new applicants to be providers

77  (1) If a person applies to be a provider after the date this section comes into force but before a regulation is made under section 61 (1) (a) or (b) [regulations respecting providers and others], the requirements, prohibitions, limits and conditions in respect of the provision of PharmaCare benefits described in the PharmaCare manual apply for the purposes of

(a) making the application, and

(b) determining the person's eligibility, and continued eligibility, to provide benefits.

(2) If an applicant under subsection (1) is eligible to provide benefits, the person is deemed to be enrolled as a provider subject to

(a) any designation made and any limits or conditions imposed under subsection (3) of this section,

(b) the requirements, prohibitions, limits or conditions in respect of the provision of PharmaCare benefits described in the PharmaCare manual, and

(c) a change to or the cancellation of the person's enrolment under section 13 [changing or cancelling provider enrolment].

(3) The minister may

(a) designate a deemed provider as a member of a class of providers established by the minister, and

(b) impose limits and conditions on the deemed provider's enrolment.

(4) A provider's deemed enrolment under subsection (2) of this section is terminated 180 days after the making of a regulation under section 61 (1) (a) or (b).

(5) Subsections (1) and (3) of this section cease to have effect on the earliest of

(a) the making of a regulation under section 61 (1) (a) or (b), and

(b) 3 years after the date this section comes into force.

(6) Despite subsection (5) (a) of this section, the Lieutenant Governor in Council may provide, in a regulation made under section 61 (1) (a) or (b), that a requirement, prohibition, limit or condition in respect of the provision of PharmaCare benefits described in the PharmaCare manual continues to apply for up to 3 years after the date this section comes into force.

(7) If there is a conflict or an inconsistency between a regulation made under this Act and the PharmaCare manual, subsection (6) does not apply and the regulation prevails.

(8) Subsection (2) (b) of this section ceases to have effect 3 years after the date this section comes into force, unless the Lieutenant Governor in Council, on making a regulation under section 61, provides that subsection (2) (b) of this section ceases to have effect on an earlier date.

Transition — regulations

78  (1) The Lieutenant Governor in Council may make regulations the Lieutenant Governor in Council considers necessary or advisable for the orderly transition

(a) from the Pharmacy Operations and Drug Scheduling Act to this Act in respect of PharmaNet and the PharmaNet stewardship committee under that Act, and

(b) from the PharmaCare program to the provincial drug program under this Act.

(2) The authority to make or amend a regulation made under subsection (1), but not the authority to repeal a regulation made under subsection (1), ends 3 years after the date subsection (1) comes into force.

Consequential and Related Amendments

[Note: See Table of Legislative Changes for the status of sections 79 to 105.]

Section(s)   Affected Act
79-92   E-Health (Personal Health Information Access and Protection of Privacy) Act
93   Freedom of Information and Protection of Privacy Act
94   Health Care Costs Recovery Act
95-96   Health Statutes Amendment Act, 2007
97-98   Medicare Protection Act
99-100   Ministry of Health Act
101-104   Pharmacy Operations and Drug Scheduling Act
105   Public Health Act
 

Commencement

106  This Act comes into force on the date of Royal Assent.