Mark down June 26th, 2019 in your calendars.
It is now widely expected the patented medicines price regulations will be in Canada Gazette Part II (CGII), volume 151 No.13, which will be released on June 26th. Draft PMPRB Guidelines for consultation will likely be published immediately following CGII publication. Comments earlier this week from Federal Health Minister Petitpas-Taylor, appeared to confirm these expectations. When asked in an interview surrounding when changes to the PMPRB Guidelines are expected, the Minister replied, “In the very near future”.
PDCI Strategic Pricing Analyses
PDCI Market Access has actively engaged in the consultation process on proposed changes to the pricing regulations. Our team prepared detailed submissions to government on behalf of the industry; we engaged in discussions with senior officials conveying the gaps and concerns with approaches being proposed; and, we analyzed the expected impact of regulatory changes for products, individual companies, and the pharmaceutical industry as a whole. With all this previous strategic work and experience, the PDCI team has an action plan to respond to draft guidelines immediately.
PDCI Continuing to Promote Policy Transparency
PDCI will remain committed to post and host all submissions, responses, and analyses from any groups and organizations onto our website. Our team of clinical, economic and pricing experts will analyse the implications of the proposed changes for both new and existing medicines and will publish a response to the guidelines consultation. We encourage all clients to respond to the draft guidelines.
PDCI is available to support you in developing or refining your response to Draft Guidelines. And, we will be inviting all stakeholders to share final Submissions with PDCI. We will post all submissions to our e-portal, promoting transparency for all stakeholders to share and read responses.
PDCI Client Services in the Wake of New Price Regulations
For clients, PDCI will develop “living” training materials to clarify the impact of proposed changes. These materials will be continually updated with information and insights as the proposed guidelines evolve from initial publication to implementation.
The PDCI team is available to provide tailored client-specific estimates of the expected impact on the prices of current portfolios and pipeline products.
For more information on how we can help your organization prepare for the change to the guidelines, please contact Kimberly Robinson at Kimberly.robinson@pdci.ca, and visit our website at www.pdci.ca to read the biographies of our diverse team.