In the complex process of introducing new drugs to the Canadian market, patient advocacy groups serve as influential catalysts. This article explores the collaborative efforts between patient advocacy groups and key regulatory bodies such as Health Canada, the Patented Medicine Prices Review Board (PMPRB), the Canadian Agency for Drugs and Technologies in Health (CADTH), and the pan-Canadian Pharmaceutical Alliance (pCPA).
Health Canada
Health Canada, the country’s regulatory authority for drugs, reviews the data from clinical trials to assess the drug’s safety and efficacy. This process is stringent and ensures that only drugs meeting high standards are authorized to be given to persons in Canada. Many patient advocacy groups participate in this process, providing valuable insights about the real-world impact of potential therapies. Their contributions during the regulatory review help ensure that the patient perspective is considered in decision-making, ultimately influencing whether a drug receives approval for distribution.
The Patented Medicines Review Board (PMPRB)
PMPRB is a quasi-judicial body that assesses a medication’s therapeutic benefit relative to existing therapies and suggests a ceiling price based on:
- Median international price;
- Highest price in the domestic therapeutic classes, or;
- Some combination of the two.
Patient advocacy groups can engage with the PMPRB to advocate for fair and reasonable pricing, taking into account the economic burden on patients and the healthcare system.
Canadian Agency for Drugs and Technologies in Health (CADTH)
CADTH conducts health technology assessments (HTAs) to determine a drug’s clinical and cost-effectiveness and its impact on the healthcare system. Based on these HTAs, CADTH provides a recommendation to public drug plans on whether a drug should be reimbursed for public funding. In Quebec, the equivalent of CADTH is Institut national d’excellence en santé et en services sociaux (INESSS).
Advocacy groups contribute to this process by representing the patient perspective regarding the impact and value of a drug, emphasizing factors such as quality of life.
To see an example of a completed health technology review by CADTH, here is one that evaluates the clinical effectiveness and cost-effectiveness of a higher dose type II diabetes medication compared to a currently-approved lower dose.
Pan-Canadian Pharmaceutical Aliance (pCPA)
pCPA uses the recommendations from CADTH and INESSS and other factors to determine whether they will enter into a negotiation for a drug. Following a successful negotiation, pCPA will issue a letter of intent which sets the terms of the agreement between the pCPA and the drug manufacturer. Patient advocacy groups actively engage with the pCPA to advocate for equitable access to new drugs across Canada. Their involvement contributes to discussions on accessibility, ensuring that patients from all regions can benefit from breakthrough treatments.
Post-Approval Collaboration:
The work doesn’t stop there. After regulatory approvals, patient advocacy groups continue to collaborate with regulatory bodies and stakeholders to monitor the post-market landscape. They provide ongoing feedback on the real-world experiences of patients using the newly approved drugs, helping to shape post-approval decisions and strategies related to safety, efficacy, and accessibility.
In conclusion, the collaborative efforts between patient advocacy groups and regulatory bodies in Canada highlight the importance of a patient-centric approach to drug approval and distribution. By actively participating in regulatory reviews and engaging with organizations like Health Canada, PMPRB, CADTH, INESSS, and pCPA, patient advocacy groups help shape a more accessible pharmaceutical landscape that is receptive to unique patient needs. As the healthcare landscape evolves, the voices of patient advocates will continue to be instrumental in ensuring that new drugs truly meet the needs of those they aim to help.
