Evaluation of the Pharmaceutical Drugs Program: Results at a Glance

Program context

The Pharmaceutical Drugs Program (PDP) is responsible for helping to ensure human and veterinary pharmaceutical drugs sold in Canada are safe, effective, and of high quality. It verifies that regulatory requirements are met through pre-market submission reviews, risk-benefit assessments, monitoring, surveillance, compliance, and enforcement activities, including laboratory analysis. It also provides information to enable informed decision making on pharmaceutical products.

The PDP is led by the Health Products and Food Branch in partnership with the Regulatory Operations and Enforcement Branch at Health Canada.

Evaluation approach

The evaluation focused on the impact of the PDP activities from 2017-18 to 2022-23 and its agility in addressing current and emerging needs regarding human and veterinary drugs. The evaluation also considered how the Program adjusted to the pandemic crisis, including regulatory and operational adjustments, and the extent to which these are being considered moving forward to fulfill its regulatory role.

Methodology:

• Document review
• Interviews
• Performance data analysis
• Financial data review
• International scan
• Survey

What the evaluation found

The PDP has put several changes in place since 2017 to modernize its regulatory processes (focusing on multiple priorities at both the corporate and branch levels). There is now an opportunity for a thorough priority review as the Program moves forward in a post-pandemic landscape where expectations have increased and faces additional important issues, such as climate change, global supply chain issues and nitrosamines.

Over the past five years, the PDP has ensured that Canadians have access to safe, effective, and quality pharmaceutical drugs. This includes maintaining service standards to approve drugs and drug establishment licenses and an expedited approval process under specific circumstances during the pandemic, as well as implementing the provisions under the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) to strengthen safety oversight.

Nonetheless, due to the number and complexity of submissions, pre-market reviews required more time than they previously have. Decisions have been made increasingly closer to the deadlines for generic drug reviews, putting the Program at risk of not meeting its performance standards. Moreover, approval rates for new generic drugs in the first cycle of review decreased due to a decrease in the quality of evidence provided in submissions, which often led to a second or third cycle of review.

Challenges also remain in raising awareness among practitioners of their role in supporting healthcare institutions reporting requirements under Vanessa's Law, problems for stakeholders in navigating the website and outdated and siloed Information Technology systems. Enhancements in these areas could lead to greater integration and timelier sharing of surveillance and compliance data, better collaboration with international regulators, and ultimately, support of access to drugs and sharing drug-related risks with Canadians.

Recommendations

1. Review and update Program priorities to align with its objectives and pressures moving forward.
2. Review and update the Program's communications approach to ensure stakeholders can access relevant information.
3. Enhance information technology systems to support program activities, including integration across the regulatory life cycle.
4. Examine the potential causes for the higher rate of negative decisions of applications for new generic drugs and communicate them with industry to improve their application submissions moving forward.
5. Explore the factors leading to the downward trend in available veterinary drugs in Canada.