Patented Medicine Prices Review Board’s multi-stakeholder Steering Committee holds first meeting
As previously reported (here and here), the Patented Medicine Prices Review Board (PMPRB) has been consulting on its proposed reform of the federal price review process and associated guidelines. As part of this reform, the Steering Committee (Committee) held its first meeting on June 25, 2018, “to discuss aspects of the new regime and assist the PMPRB in synthesizing stakeholder views on key technical and operational modalities of new draft Guidelines that would give effect to these changes.” According to the Presentation to Steering Committee, the Committee had “until July 13 to identify further issues it believes would benefit from expert review and analysis.” Additional reference materials from the Committee’s meeting can be found here (with meeting minutes still to come).
PMPRB releases annual report on drug market entry
On June 26, 2018, the PMPRB announced the publication of the second annual edition of Meds Entry Watch, 2016. The report provides a review of long-term trends in new active substances approved by the U.S. Food and Drug Administration, the European Medicines Agency and/or Health Canada during the period 2009-2015, describes, among other things, their availability, pricing and sales in 2015-2016, and provides a preliminary analysis of their effect on the market as of Q4-2016.
New guidelines released by CADTH
On June 27, 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) published new guidelines, Procedure and Submission Guidelines for the CADTH Common Drug Review, which consolidate two previously separate guidelines and include a number of revisions to the submission requirements. These changes are summarized in CDR Update – Issue 138, and will be enforced for all submissions and resubmissions received on or after July 27, 2018.
Supreme Court of Canada News
Supreme Court of Canada denies Alexion leave to appeal in case challenging constitutionality of PMPRB remedial powers
On June 28, 2018, the Supreme Court of Canada dismissed Alexion Pharmaceuticals’ application for leave to appeal a decision of the Federal Court of Appeal (FCA) that dismissed its challenge to the constitutionality of certain provisions in the Patent Actrelating to the Patented Medicine Prices Review Board (PMPRB)’s remedial powers: SCC Case No. 37949. The FCA decision, Alexion Pharmaceuticals Inc v Canada (Attorney General), 2017 FCA 241, was previously reported here.
Tobacco companies cannot compel production of health records in British Columbia’s lawsuits to recover health care costs related to tobacco exposure
The province of British Columbia (BC) brought an action against Philip Morris International and other tobacco manufacturers to recover health care costs related to treatment of diseases caused or contributed to by exposure to a tobacco product, pursuant to the Tobacco Damages and Health Care Costs Recovery Act (Act). The constitutionality of the Act had previously been upheld: British Columbia v Imperial Tobacco Canada Ltd, 2005 SCC 49. On July 13, 2018, the Supreme Court of Canada (SCC) held that BC could not be compelled to produce a collection of anonymized health care databases that the province intended to use to prove causation and damages: British Columbia v Philip Morris International, Inc, 2018 SCC 36. The SCC held that the anonymized databases fell within the scope of a subsection of the Act that excluded from production “health care records and documents of particular individual insured persons or the documents relating to the provision of health care benefits for particular individual insured persons”.
Health Canada News
Recent Health Canada developments include:
Advisory Council on the Implementation of National Pharmacare – On June 20, 2018, the Advisory Council on the Implementation of National Pharmacare was launched, together with the release of a Discussion Paper and the opening of a public consultation.
Health Canada and health technology assessment organizations (HTAs) to align reviews – On June 22, 2018, the Notice to industry: Aligned reviews between Health Canada and health technology assessment organizations was released, which provides an option to biological and pharmaceutical new drug submission sponsors to seek an aligned review between Health Canada and the Canadian Agency for Drugs and Technologies in Health (CADTH) and l’Institut national d’excellence en santé et en services sociaux (INESSS) (collectively, the HTAs). According to the notice, these aligned reviews are expected to reduce duplication and time lags between Health Canada market authorization and HTA recommendations.
TPD, BGTD and NNHPN Annual Performance Reports released – The Therapeutic Products Directorate (TPD), the Biologics and Genetic Therapies Directorate (BGTD), and the Natural and Non-Prescription Health Products Directorate (NNHPD) have released their Drug Submission Performance Annual Reports for Fiscal Year 2017-2018. The reports contain information regarding pharmaceutical, biologic and radiopharmaceutical drug submission review activity in 2017-2018, including approval times.
Drug and Medical Device Highlights 2017 – This Health Canada report includes numbers of new drugs and medical devices approved, brief details of approvals, the number of various post-market surveillance report and 2017 accomplishments.
Revised Guidance Documents on Post-Notice of Compliance (NOC) Changes – On June 26, 2018, Health Canada published notice of the revised Guidance Document: Post-Notice of Compliance (NOC) Changes – Framework and notice of the revised Guidance Document: Post-Notice of Compliance (NOC) Changes – Safety and Efficacy. These Guidance Documents clarify when Level III changes should be filed, and reflect changes implemented over the past several years, including safety changes under Vanessa’s Law and changes to Plain Language Labelling requirements.
Revised Summary - Cancellation of a Drug Identification Number (DIN) and Notification of Discontinuation of Sales – As previously reported, Health Canada released a Guidance Document to facilitate compliance with provisions requiring notification upon discontinuance of the sale of a drug. On June 13, 2018, the Guidance was updated (Guidance Document: Cancellation of a Drug Identification Number (DIN) and Notification of Discontinuation of Sales), including to address the recent Regulations Amending the Food and Drug Regulations and the Regulations Amending the Food and Drug Regulations (DIN Requirements for Drugs Listed in Schedule C to the Food and Drugs Act that are in Dosage Form) relating to the Minister’s powers to require assessments, tests and studies, as reported here. We have updated our previously published chart (An Update on Vanessa’s Law) to include this Guidance.
Guidance Document on Notifying Health Canada of Foreign Actions – As previously reported, Health Canada had released a draft Guidance Document to provide clarity on when to report foreign incidents in accordance with Vanessa’s Law. On July 12, 2018, Health Canada released a further revised Guidance, Notifying Health Canada of Foreign Actions – Guidance Document for Industry. We have updated our previously published chartto include this Guidance.
Pharmaceutical solid forms – Patent Office proposes examination practice
The Canadian Intellectual Property Office has released a proposed new section of Chapter 17 (Biotechnology and Medicinal Inventions) of its Manual of Patent Office Practice (MOPOP), on the examination of pharmaceutical solid forms such as polymorphs, salts, hydrates, solvates, desolvates and co-crystals.
Consultation on the new MOPOP section is open until August 10, 2018.