Gender-based Analysis Plus, 2022-23

Section 1: institutional GBA Plus governance and capacity

Governance

No changes were made to governance related to GBA Plus at the PMPRB in 2022-23.

Capacity

Work began in 2022-23 to scope the potential expansion of GBA Plus capacity, particularly through the PMPRB’s reporting function under the Pharmaceutical Trends Program. This work included an assessment of potential areas of analysis within the pharmaceutical market that disproportionally affect equity-deserving groups, such as a gender-based analysis of the cost of healthcare related to heart failures, as well as a demographic analysis of health plan beneficiaries. This work is expected to be expanded upon in 2023-24.

Section 2: gender and diversity impacts, by program

Core responsibility: Regulate Patented Medicine Prices

Program name: Patented Medicine Price Regulation Program

Program goals: The Patented Medicine Price Regulation Program aims to protect consumers by ensuring that the prices of patented medicines in Canada are not excessive. The PMPRB reviews the prices of the first sale of a patented medicine at arm’s length by the rights holder, directly to a class of customer, namely a wholesaler, hospital, pharmacy or other. The PMPRB has no authority over prices charged by wholesalers or retailers or over pharmacists’ professional fees.

Since the price of a medicine does not vary by user, the PMPRB’s price review process does not take explicit account of the diversity of user groups or their economic situation. However, lower medicine prices and associated savings for all payers will benefit all populations directly through lower out-of-pocket costs and indirectly through health system reinvestments and improved access to better care.

Target population: All Canadians

Specific demographic group outcomes

Although the regulation of patented medicine prices has broad-reaching impacts across the segment of the population that uses pharmaceutical medicines, this program is likely to carry the most benefits for lower-income Canadians, particularly those who are not insured by a public or private drug plan, as well as those who are dependent on patented medicines to maintain their quality of life. This may include seniors, Canadians with disabilities and/or severe illnesses, and groups who are disproportionately affected by environmental health impacts.

Key program impacts on gender and diversity

Not available.

GBA Plus data collection plan

The information provided to the PMPRB by rights holders as set out in the Patent Act (the Act) and the Patented Medicines Regulations (Regulations) does not take explicit account of the diversity of user groups or their economic situation, consequently the price review process cannot consider these factors. By law, rights holders must file information about the sale of their patented medicines in Canada. The Act and the Regulations set out the following five factors to be used for determining whether a patented medicine is excessively priced, as outlined in section 85 of the Act:

• the prices at which the medicine has been sold in the relevant market;
• the prices at which other medicines in the same therapeutic class have been sold in the relevant market;
• the prices at which the medicine and other medicines in the same therapeutic class have been sold in countries other than Canada;
• changes in the Consumer Price Index; and,
• any other factors that may be set out in regulations.

The PMPRB reviews the average price of each strength of an individual dosage form of each patented medicine. In most cases, this unit is consistent with the Drug Identification Number (DIN) assigned by Health Canada at the time the drug is approved for sale in Canada.

Program name: Pharmaceutical Trends Program

Program goals: Under the Pharmaceutical Trends Program, the PMPRB reports on trends in pharmaceutical sales and pricing for all medicines and for reporting research and development spending by rights holders. As prices and sales reported by rights holders and in available databases have little demographic information, analysis from a GBA Plus lens is limited. However, the PMPRB has undertaken research to identify opportunities for the GBA Plus lens to inform its analytic reporting.

Target population: All Canadians and public and private drug plan administrators

Specific demographic group outcomes

As PMPRB reporting is targeted to support decision making at all levels of the healthcare system, including patients, prescribers, pharmacists, public and private drug plan administrators, federal/provincial/territorial policy-makers, and academics, among others, benefits are relatively widely distributed across demographic groups. Those who have greater need for pharmaceuticals or who are lower income may be more likely to benefit indirectly from the public availability of information on trends in pharmaceuticals sales and pricing, as well as research and development spending by rights holders. Those who do not see themselves represented in the available data may experience a disproportionately lower indirect benefit from this reporting work, due to the lack of disaggregated demographic data in this field. This might include members of the 2SLGBTQI+ community, Black and Indigenous Canadians, and Canadians with disabilities.

Key program impacts on gender and diversity

Not available.

GBA Plus data collection plan

Under the Pharmaceutical Trends Program, the PMPRB reports on trends in pharmaceutical sales and pricing for all medicines and for reporting research and development spending by rights holders. Rights holders are required to submit detailed information on their sales of patented medicines, including quantities sold, gross and net prices, and net revenues, but not indirect discounts provided to third party payers, such as product listing agreements. Given that this information does not take explicit account of the diversity of user groups or their economic situation, relevant reporting cannot consider these factors.

However, the PMPRB also provides information on key pharmaceutical trends, including analyses of Canadian national, public, and private payer markets for all medicines as part of the reporting program using supplementary data suppliers including the Canadian Institutes for Health Information’s NDPUIS Database, IQVIA’s MIDAS and Private Payers databases, as well as GlobalData Health databases.

Innovative use of this supplementary data has allowed the PMPRB to start to explore options for the application of GBA Plus in its analytic reporting. Data under NPDUIS includes age and sex but does not include other indicators such as race, ethnicity, or other socio-economic indicators. Also, analysis can be limited by the absence of diagnosis information which would provide more information on the health concern for which a drug is dispensed. Current exploratory work includes factors such as gender-based analysis of the cost of heart failure on healthcare systems, pharmaceutical spending for seniors, and demographic-driven analyses of drug plan beneficiaries.

Scales

Gender scale

• First group: predominantly men (80% or more men)
• Second group: 60% to 79% men
• Third group: broadly gender-balanced
• Fourth group: 60% to 79% women
• Fifth group: predominantly women (80% or more women)

Income level scale

• First group: strongly benefits low income individuals (strongly progressive)
• Second group: somewhat benefits low income individuals (somewhat progressive)
• Third group: no significant distributional impacts
• Fourth group: somewhat benefits high income individuals (somewhat regressive)
• Fifth group: strongly benefits high income individuals (strongly regressive)

Age group scale

• First group: primarily benefits youth, children or future generations
• Second group: no significant intergenerational impacts or impacts on generations between youths and seniors
• Third group: primarily benefits seniors or the baby boom generation

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