Mr Andrew Mandlsohn

Andrew Mandlsohn

Updates

Healthcare & Life Sciences

PMPRB releases Annual Report 2016
Canada | December 20 2017

The federal minister of health recently submitted the Patented Medicine Prices Review Board Annual Report 2016 to the House of Commons and the Senate. The report indicates that in 2016 Canadian patented drug prices were the fourth-highest among the seven comparator countries against which the board reviewed prices and that sales of patented drug products totalled C$15.5 billion. Research and development spending remained unchanged from 2015.

Patented Medicine Prices Review Board update
Canada | November 22 2017

The Patented Medicine Prices Review Board recently announced the release of a hearing panel's decision regarding the pricing of a breakthrough drug and the publication of a report which compares lists of drugs covered by the public drug plans to determine the extent of overlap in drug coverage. Further, in response to an unopposed request filed by the board to do so, a hearing panel discontinued an excessive pricing proceeding relating to Apotex's Apo-Salvent CFC Free.

Health Canada update
Canada | November 15 2017

Health Canada recently issued a notice of intent soliciting comments on possible changes to the Food and Drug Regulations relating to pharmaceutical equivalence and an updated notice on its interim policy regarding the interpretation of a medicinal ingredient. In addition, it recently solicited online comments regarding proposed pre-market transparency initiatives for human prescription drugs.

Life sciences update
Canada | September 13 2017

Recent life sciences developments include the release of the Patented Medicine Prices Review Board's July 2017 newsletter, the issuance of a Common Drug Review Update by the Canadian Agency for Drugs and Technologies in Health and the release of the Therapeutic Products Directorate Statistical Report 2016/2017 by Health Canada.

CADTH releases fourth edition of Guidelines for Economic Evaluation of Health Technologies
Canada | August 02 2017

The Canadian Agency for Drugs and Technologies in Health recently published the fourth edition of the Guidelines for Economic Evaluation of Health Technologies: Canada, which set out the best practices for determining the economic value of health technologies. The updated guidelines account for methodological advancements which have occurred in the economic evaluation of health technologies since the publication of the last edition of the guidelines in 2006.

CADTH proposes process for assessment of companion diagnostics
Canada | January 11 2017

The Canadian Agency for Drugs and Technologies in Health recently invited stakeholders to provide feedback on its proposed process for the assessment of companion diagnostics, which is integrated through the Common Drug Review and Pan-Canadian Oncology Drug Review programmes.

Intellectual Property

PMPRB releases Annual Report 2016
Canada | January 08 2018

The federal minister of health recently submitted the Patented Medicine Prices Review Board Annual Report 2016 to the House of Commons and the Senate. The report indicates that in 2016 Canadian patented drug prices were the fourth-highest among the seven comparator countries against which the board reviewed prices and that sales of patented drug products totalled C$15.5 billion. Research and development spending remained unchanged from 2015.

Patented Medicine Prices Review Board update
Canada | November 27 2017

The Patented Medicine Prices Review Board recently announced the release of a hearing panel's decision regarding the pricing of a breakthrough drug and the publication of a report which compares lists of drugs covered by the public drug plans to determine the extent of overlap in drug coverage. Further, in response to an unopposed request filed by the board to do so, a hearing panel discontinued an excessive pricing proceeding relating to Apotex's Apo-Salvent CFC Free.

Damages under Patented Medicines (Notice of Compliance) Regulations
Canada | July 02 2012

Nearly 20 years after the Patented Medicines (Notice of Compliance) Regulations were passed, the Federal Court has released its first decisions assessing the quantification of damages under Section 8 of the regulations. In its simplest terms, Section 8 provides for liability by an innovator to a generic manufacturer for the generic manufacturer's damages if an application for a prohibition order is unsuccessful.