Notice and Comment – On the change to the definition of Gap medicines, the references to the comparator countries and the international price tests for Grandfathered medicines and their line extensions
The Patented Medicine Prices Review Board (PMPRB) invites stakeholders to comment on three proposed amendments to the new PMPRB Guidelines.
All feedback must be submitted in writing to email@example.com by August 31, 2021. See: Notice and Comment – On the change to the definition of Gap medicines, the references to the comparator countries and the international price tests for Grandfathered medicines and their line extensions – Canada.ca
To get a better understanding and gain perspective, consider attending the Refocus PMPRB “Back to the Future”: Part One which will be hosted by CORD on August 19, 2021 from 1-2 pm EST for CORD’s LAST SUMMER webinar, Part 1 of our series on “How to Get Back to the PMPRB Original Mandate to prevent excessive drug pricing and support pharma R&D investment.” Learn why responding to the most recent (July 15th) proposed guideline changes is very important for all stakeholders, even while trying to escape for summer holidays.
See below for a list of perspectives and background:
PMPRB FAQs – https://www.canada.ca/en/patented-medicine-prices-review/services/consultations/notice-comment-references-comparator-countries/frequently-asked-questions.html
Fraser Institute view on impact on drug access – https://www.fraserinstitute.org/blogs/new-review-rules-the-impact-on-drug-access-in-canada
Despite our busy schedules, everyone patient organization and stakeholder is encouraged to submit feedback to PMPRB so your comments, concerns and feedback is heard. Many groups feel these most recent changes are rather significant and are complex, making it particularly difficult to anticipate the impact to access to drugs with their implementation. We are in the process of trying to accumulate details and data, and preliminary findings suggest that these changes could cause a significant price decrease for some drugs. There is possibility that drugs that were approved many years ago could be facing high price reductions such as an 80% price reduction resulting from these new guideline changes. Although we all would like to see lower prices for medicines to improve the access for patients, such dramatic drops in price are likely to result in these drugs being discontinued and may therefore not be available in Canada because manufacturers do not see it feasible to continue to market these drugs at such low costs or at a loss in Canada. This turbulence and loss or predictability of drug prices with these changing guidelines need to be evaluated and you input to PMPRB is very important.