New Pharmacy Ownership Requirements

New Pharmacy Ownership Requirements

In May 2016, the Provincial Government approved amendments to the Pharmacy Operations and Drug Scheduling Act.

These changes permit the College to know the identity of all pharmacy owners, determine their suitability for pharmacy ownership and hold them accountable for providing safe and effective care by ensuring their pharmacies are compliant with legislative requirements for pharmacies in BC.

The College has drafted amendments to the Pharmacy Operations and Drug Scheduling Act Bylaws and forms to incorporate the new pharmacy ownership requirements. The draft bylaws have been posted for public comment until September 20, 2017.

The new requirements are scheduled to come into effect on March 1, 2018.

Engagement on the Implementation of New Pharmacy Ownership Requirements

Feedback was important to help inform the College’s approach to operationalizing the new pharmacy ownership requirements.

The College reached out to pharmacy owners and managers through workshops, discussions, and an online survey, to seek feedback on the new draft pharmacy licensing bylaws.

Consultation focused solely on the application of the changes to the College’s pharmacy licensure process as the new pharmacy ownership requirements have already been set by the Provincial Government.  

The draft bylaws have been posted for public comment until September 20, 2017. To review the draft bylaws and forms and provide your feedback see Bylaws for Comment: PODSA Bylaws - New Pharmacy Ownership Requirements

Engagement Process

 

 

Results of Engagement

All the feedback received during the College’s consultation period is summarized in the New Pharmacy Ownership Engagement Report.

New Pharmacy Ownership Requirements Engagement Report

Engagement Report

Download Engagement Report

The feedback received was very helpful and informed the development of operational processes and IT enhancements needed to support the new requirements. For example, feedback from owners of multiple pharmacies suggested including the ability to submit eligibility information at one time, rather than waiting for each pharmacy renewal date.

The College also used feedback from the engagement to help inform the draft bylaws. A key example of this is regarding the roles and responsibilities of direct and indirect owners. These responsibilities were adjusted based on the feedback provided to be more proportionate to the level of control/involvement they have in the day to day operations of a pharmacy.

Feedback also included concerns about the new Criminal Record History process. Participants indicated they were not sure which type of charges or convictions are covered under Canada’s Criminal Code. While it is not possible to include an exact list of charges and convictions within the draft bylaws, the College is working to provide further clarification and education around which type of charges or convictions are covered under Canada’s Criminal Code through an informational guide and other resources. 

 

New Pharmacy Ownership Requirements Added to Pharmacy Operations and Drug Scheduling Act

The new pharmacy ownership requirements were developed and approved by the Provincial Government as amendments to the Pharmacy Operations and Drug Scheduling Act. These requirements cannot be changed by the College, instead our bylaws operationalize the requirements as part of the pharmacy licensing process.   

Review the approved amendments to the Pharmacy Operations and Drug Scheduling Act (Bill 6), or see the explanatory notes for Bill 6 which summarize the changes to the Act.

Key changes to the Pharmacy Operations and Drug Scheduling Act include:

  • Distinguishes between "direct owners" and "indirect owners"
  • Broadens the meaning of "pharmacy" and "pharmacy licence"
  • Harmonizes requirements and processes for issuing, renewing and reinstating a pharmacy licence
  • Sets eligibility requirements to hold a pharmacy licence
  • Establishes a new Application Committee to review licence applications that do not meet the requirements of the Act and bylaws
  • Clarifies that ownership of a pharmacy must be direct
  • Adds requirements for direct owners, indirect owners and managers to provide Criminal Record History
  • Requires direct owners, indirect owners and managers to comply with duties under the Pharmacy Operations and Drug Scheduling Act and Health Professions Act
  • Requires direct owners, indirect owners and managers to give notice to the Registrar if certain events occur
  • Applications received before the amendments come into force for pharmacy licences on or after March 1, 2018 will need to meet the new requirements
Explanatory Notes on the Pharmacy Operations and Drug Scheduling Act Amendments

BILL 6 – 2016

PHARMACY OPERATIONS AND DRUG SCHEDULING AMENDMENT ACT, 2016

EXPLANATORY NOTES

SECTION 1: [Pharmacy Operations and Drug Scheduling Act, section 1]

  • adds definitions consequential to the repeal and replacement of sections 2 to 4 of the Act and the enactment of sections 4.1 and 5.1 of the Act by this Bill;
  • distinguishes between "direct owners" and "indirect owners";
  • expands the meaning of "pharmacy" and "pharmacy licence".

SECTION 2: [Pharmacy Operations and Drug Scheduling Act, sections 2 to 4.1]

  • harmonizes the requirements and processes for issuing, renewing and reinstating a pharmacy licence;
  • sets out eligibility requirements to hold a pharmacy licence;
  • removes from the registrar the discretion to refuse a pharmacy licence or to issue a pharmacy licence with conditions and grants that discretion to an application committee;
  • removes from the registrar's or application committee's consideration matters that will be addressed in the bylaws.

SECTION 3: [Pharmacy Operations and Drug Scheduling Act, section 5]

  • adds an exception to the prohibition against the ownership of pharmacies by persons authorized to prescribe drugs;
  • clarifies that ownership of a pharmacy must be direct;
  • is consequential to the enactment of section 7.1 of the Act by this Bill.

SECTION 4: [Pharmacy Operations and Drug Scheduling Act, section 5.1]

  • adds requirements for direct owners, indirect owners and managers to provide criminal record histories.

SECTION 5: [Pharmacy Operations and Drug Scheduling Act, section 6]

  • is consequential to the amendments made to section 1 of the Act by this Bill.

SECTION 6: [Pharmacy Operations and Drug Scheduling Act, sections 7 and 7.1]

  • adds a prohibition against operating unlicensed pharmacies;
  • is consequential to the enactment of section 3 of the Act by this Bill;
  • requires direct owners, indirect owners and managers to comply with duties imposed under the Act and under the Health Professions Act;
  • requires direct owners, indirect owners and managers to give notice to the registrar if certain events occur.

SECTION 7: [Pharmacy Operations and Drug Scheduling Act, section 20]

  • clarifies how the Health Professions Act applies to the Act;
  • is consequential to the amendments made to section 1 and the enactment of section 3 of the Act by this Bill.

SECTION 8: [Pharmacy Operations and Drug Scheduling Act, section 21]

  • adds bylaw-making powers with respect to forms and authorizes the board to delegate to the registrar the power to establish forms;
  • is consequential to the repeal and replacement of sections 2 to 4 and the enactment of sections 4.1, 5.1 and 7.1 of the Act by this Bill.

SECTION 9: [Pharmacy Operations and Drug Scheduling Act, section 34.1]

  • adds regulation-making powers consequential to the repeal and replacement of section 5 (1) and the enactment of section 7.1 of the Act by this Bill.

SECTION 10: [Pharmacy Operations and Drug Scheduling Act transition]

  • applies new application requirements to applications for pharmacy licences received before the amendments to the Pharmacy Operations and Drug Scheduling Act made by this Bill come into force.

SECTION 11: [Health Professions Act, section 25.94]

  • removes a reference to a repealed provision.

(From 2016 Legislative Session: 5th Session, 40th Parliament, First Reading)

 

Types of Pharmacy Ownership

The amendments to the Pharmacy Operations and Drug Scheduling Act define the types of pharmacy ownership allowed in BC. In particular, the amendments distinguish between direct owners and indirect owners.

The type of ownership of your pharmacy determines what information is required as part of the pharmacy licensing process. While there are different types of ownership, the majority of pharmacies will fall under the “corporation” type of ownership.

It is important for owners to be able to identify their ownership type to ensure they meet the requirements for renewing their pharmacy licence or opening a new pharmacy.

In accordance with the amended Pharmacy Operations and Drug Scheduling Act, asses your pharmacy’s ownership model using the Types of Pharmacy Ownership flow chart.

Direct Owners
Indirect Owners

Publicly Traded

  • officers and directors of the corporation

Note: Shareholders of a corporation that is traded publicly, that are not officers or directors, are not considered indirect owners. 

Not Publicly Traded

  • officers, directors and shareholders of the corporation
  • officers, directors and shareholders of a parent corporation for a subsidiary corporation

(See Section 1 of the amendments to Pharmacy Operations and Drug Scheduling Act and Section 5(2) of the Pharmacy Operations and Drug Scheduling Act)

Types of Pharmacy Ownership

 

Roles and Responsibilities of Direct Owners, Indirect Owners and Managers

The new pharmacy ownership requirements specifically state that direct owners, indirect owners and managers must comply with duties imposed under the Pharmacy Operations and Drug Scheduling Act and Health Professions Act.

Managers will continue to be required to actively participate in the day-to-day management of the pharmacy.

Shareholders must meet the eligibility criteria for pharmacy ownership. Responsibilities will also include cooperating with College inspectors acting under the Pharmacy Operations and Drug Scheduling Act or Health Professions Act, and notifying the College of  a change of name, address, telephone number, electronic mail address or any other information previously provided.

Draft Bylaws: Responsibilities of Direct Owner, Indirect Owner(s) and Manager

(See Section 16 of the draft bylaws]

 

Eligibility Criteria

The new pharmacy ownership requirements establish clear eligibility criteria for direct owners to be eligible to hold a pharmacy licence. The eligibility requirements set in the Pharmacy Operations and Drug Scheduling Act amendments allow the College to better protect the public by determining the suitability of a manager or owner.

Managers and owners need to meet the eligibility criteria in the Act, in addition to requirements under the College’s bylaws for a pharmacy to be licenced by the College.

The following would make an ownership application ineligible, or may require that conditions be imposed:

  • owner/manager is subject to a limitation imposed by the discipline committee that precludes them from being an owner or manager
  • owner/manager has, within the previous 6 years, been convicted of an offence under the Criminal Code
  • owners/managers have, within the previous 6 years, been convicted of an offence under the Pharmaceutical Services Act
  • owner/manager has been subject to an information or billing contravention,
  • owner/manager has, within the previous 6 years, had their registration as a pharmacist suspended or canceled
  • owner/manager has, within the previous 6 years, had a judgment entered against him or her in a court proceeding related to commercial or business activities that occurred in relation to the provision of drugs or devices, or substances or related services within the meaning of the Pharmaceutical Services Act (See Section 4(3) and 4(4) of the amendments to Pharmacy Operations and Drug Scheduling Act)

(See Section 4(3) and 4(4) of the amendments to Pharmacy Operations and Drug Scheduling Act)

Eligibility for Pharmacy Licence

A direct owner is eligible to hold a pharmacy licence if all of the following apply:

  1. the ownership of the pharmacy complies with section 5 and the bylaws;
  2. no direct owner, indirect owner or manager is subject to a limitation imposed by the discipline committee that precludes him or her from being a direct owner, an indirect owner or a manager;
  3. the manager is a pharmacist, and that pharmacist will have responsibility for the actual management and operation of the pharmacy;
  4. no direct owner, indirect owner or manager is or has been the subject of an order or a conviction for an information or billing contravention;
  5. no direct owner, indirect owner or manager has, within the previous 6 years, been convicted of an offence prescribed under the Pharmaceutical Services Act for the purposes of section 45 (1) (a) (ii) of that Act;
  6. no direct owner, indirect owner or manager has, within the previous 6 years, been convicted of an offence under the Criminal Code (Canada), other than an offence to which paragraph (e) applies;
  7. no direct owner, indirect owner or manager has, within the previous 6 years, had a judgment entered against him or her in a court proceeding related to commercial or business activities that occurred in relation to the provision of
    1. drugs or devices, or
    2. substances or related services within the meaning of the Pharmaceutical Services Act;
  8. no direct owner, indirect owner or manager has, within the previous 6 years, had his or her registration with one of the following bodies suspended or cancelled:
    1. the College of Pharmacists of British Columbia
    2. a body, in another province or in a foreign jurisdiction, that regulates the practice of pharmacy in that other province or foreign jurisdiction;
  9. no direct owner, indirect owner or manager has, within the previous 6 years, had limits or conditions imposed on his or her practice of pharmacy as a result of disciplinary action taken by a body referred to in paragraph (h).

(See Section 3 of the amendments to Pharmacy Operations and Drug Scheduling Act)

 

Application Committee

Where an application for a pharmacy licence does not meet the eligibility criteria in the Pharmacy Operations and Drug Scheduling Act and the requirements in the College's bylaws, the Registrar must refer the application to the Application Committee.

The Application Committee can:

  • request additional information or evidence from the direct owner, indirect owner and proposed manager
  • issue, renew or reinstate the pharmacy licence
  • issue, renew or reinstate the pharmacy licence with conditions
  • refuse to issue, renew, or reinstate the pharmacy licence

​(See Section 4(2)(3)(4) of the amendments to Pharmacy Operations and Drug Scheduling Act)

 

Criminal Record History

The new pharmacy ownership requirements require the Criminal Record History for direct owners, indirect owners and managers as part of the pharmacy licensing process.

To meet the new requirements under the Act, all direct and indirect owners (see Types of Pharmacy Ownership) and the manager of a pharmacy must provide a Criminal Record History to the College every five years as part of the pharmacy licence renewal process. This is also required as part of a new pharmacy application process.

In the case of a Hospital Pharmacy Licence and Pharmacy Education Site Licence, only the manager will be required to provide a Criminal Record History.

All registered pharmacists and pharmacy technicians currently undergo a Criminal Record Check by the Criminal Records Review Program as required under Section 20(2) of the Health Professions Act. However, this check does not provide same level of comprehensive Criminal Record History that is required to be provided under the Pharmacy Operations and Drug Scheduling Act. It also does not allow for Criminal Record History of non-registrants to be provided to the College.

As a result, the College cannot use the same criminal record check under the Criminal Records Review Program for the pharmacy licensing process since it does not meet the Criminal Record History requirements included in the amendments to the Act. The College will be using a vendor that will meet the new requirements while supporting a timely and efficient process for obtaining a Criminal Record History.

Registrants will continue to undergo a Criminal Record Check by the Criminal Records Review Program as part of registering or renewing their registration as required under Section 20(2) of the Health Professions Act.

Direct owners, indirect owners, and managers of a pharmacy who are registered as pharmacists with the College will continue to have a Criminal Record Check completed every 5 years as part of their pharmacist registration renewal process (required under HPA). They will need also need to provide a separate Criminal Record History every 5 years as part of the pharmacy licensing process (required under PODSA).

Criminal Record History Required

5.1  A direct owner, an indirect owner and a manager must provide to the registrar the information specified in the bylaws respecting the direct owner's, indirect owner's and manager's history of charges and convictions as follows:

  1. on the making of an application for a new pharmacy licence;
  2. if requested by the application committee, the discipline committee or the inquiry committee, within the time requested;
  3. if the direct owner ceases to be eligible, under section 3 (e) or (f), to hold a pharmacy licence, within 20 days of ceasing to be eligible;
  4. 5 years from the date that the information was last provided under this section.

(See Section 5.1 of the amendments to Pharmacy Operations and Drug Scheduling Act)

 

Pharmacy Licensing Process

Direct and indirect pharmacy owners and managers will be required to meet the new eligibility requirements once the amendments to the Act and amendments to College bylaws come into effect. The changes also mean that the direct owner of the pharmacy must apply for a new pharmacy licence or pharmacy licence renewal.

A transition process will be established to bring all pharmacies into compliance with the new requirements through the annual pharmacy licence renewal.

 
New Pharmacy Applications

Starting March 1, 2018, all new pharmacy licence applications must must meet the new pharmacy ownership requirements in Pharmacy Operations and Drug Scheduling Act and College bylaws.

The Type of Pharmacy Ownership,will determine what information is required for a New Pharmacy Application. All pharmacy owners (direct and indirect) will need to be identified and will need to provide a Criminal Record History to determine their suitability for pharmacy ownership based on the eligibility criteria. All managers will also need to provide their Criminal Record History.

To learn how to apply for New Pharmacy Licence under the Act, determine your pharmacy’s ownership type then review the draft bylaws and use the New Pharmacy Applications flow chart to determine what information is required.

Draft Bylaws: New Community Pharmacy Licence

(See Section 3 of the draft bylaws)

Draft Bylaws: New Hospital Pharmacy Licence

(See Section 6 of the draft bylaws)

 

New Pharmacy Applications

 

 

Information flow chart for New Pharmacy Applications (Hospital) coming soon.

 

Pharmacy Licence Renewal Process

The new pharmacy ownership requirements move the responsibility of renewing a pharmacy licence from the manager to the direct owner.

A transition process has been established from March 1, 2018 to February 28, 2019 to bring all pharmacies into compliance with the new requirements through the annual pharmacy licence renewal.

Managers together with direct and indirect pharmacy owners will be required to meet the new eligibility requirements once the amendments to the Pharmacy Operations and Drug Scheduling Act and amendments to College bylaws come into effect.

The College recognizes that additional work will be needed during this transition period renewal, and we thank you for your patience and understanding in implementing in these new pharmacy ownership requirements.

To learn what’s needed as part of a pharmacy licence renewal under the new pharmacy ownership requirements, see the Pharmacy Licence Renewal flow chart below and review the draft bylaws.

Transition Period Renewal (March 1, 2018 to February 28, 2019)

To bring all pharmacies into compliance with the new requirements, pharmacies will initially need to submit the information necessary to demonstrate that they meet the new eligibility requirements as part of the pharmacy licence renewal process.

For this reason, pharmacy renewals between March 1, 2018 and February 28, 2019 are part of a transition process designed to bring all pharmacies into compliance with the new requirements. The transition renewal, which is only required once, resembles the more detailed process for new pharmacy applications.

To learn what’s required for a Pharmacy Licence Renewal during the transition period, determine your pharmacy’s ownership type then review the draft bylaws and use the Pharmacy Licence Renewals flow chart to determine what information is required.

Draft Bylaws: Community Pharmacy Licence Renewal (Transition Period)

(See Section 4.1 of the draft bylaws)

Draft Bylaws: Hospital Pharmacy Licence Renewal (Transition Period)

(See Section 7.1 of the draft bylaws)

 
 
Renewal (starting March 1, 2019)

Following the transition period, the process for pharmacy licence renewals will be streamlined. Starting in March 1, 2019 direct owners, indirect owners and managers will only be required to review and update pharmacy ownership information and attest to meeting the eligibility requirements.

To learn what’s required for a Pharmacy Licence Renewal after the transition period, determine your pharmacy’s ownership type then review the draft bylaws and use the Pharmacy Licence Renewals flow chart to determine what information is required.

Draft Bylaws: Community Pharmacy Licence Renewal

(See Section 4 of the draft bylaws)

Draft Bylaws: Hospital Pharmacy Licence Renewal

(See Section 7 of the draft bylaws)

 
Pharmacy Licence Renewals

 

Information flow chart for Pharmacy Renewal Process (Hospital and Education Sites) coming soon.

 

Review the Draft Bylaws

The draft amendments to the Pharmacy Operations and Drug Scheduling Act bylaws which incorporate the new pharmacy ownership requirements have been posted for public comment until September 20, 2017. To review the draft bylaws and forms and provide your feedback see Bylaws for Comment: PODSA Bylaws - New Pharmacy Ownership Requirements

Questions  

Questions about the new pharmacy ownership requirements? Contact ownership@bcpharmacists.org.