Mr Andrew Mandlsohn

Andrew Mandlsohn

Updates

Healthcare & Life Sciences

Health Canada reports on consultation on proposed approach to cannabis regulation
Canada | June 06 2018

Bill C-45 – An Act respecting Cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and Other Acts – is currently before the Senate. Rather than pre-publishing draft regulations, the government released regulatory proposals by way of a consultation paper. Health Canada recently announced the release of a report which provides a summary of the comments received on the consultation paper.

CADTH releases 2018-2021 strategic plan
Canada | May 30 2018

The Canadian Agency for Drugs and Technologies in Health (CADTH) recently announced the release and published a brief overview of its strategic plan for 2018 to 2021. According to the plan, the CADTH – a health technology assessment agency – plans to transition to a health technology management agency.

CADTH Common Drug Review accepting submissions up to six months before market approval
Canada | May 16 2018

The Canadian Agency for Drugs and Technologies in Health has announced that the Common Drug Review Programme will now accept drug submissions up to six months before a drug manufacturer's anticipated receipt of a notice of compliance (NOC) or NOC with conditions from Health Canada.

Patented Medicine Prices Review Board releases March 2018 newsletter
Canada | May 09 2018

The Patented Medicine Prices Review Board (PMPRB) recently released its March 2018 newsletter (the first since July 2017). Highlights include an update on the PMPRB guidelines, the release of the PMPRB's 2016 annual report and notice that several publications will be released in 2018.

Court dismisses Section 8 damages appeal and grants cross-appeal
Canada | April 18 2018

The Federal Court of Appeal recently issued public reasons for its dismissal of Eli Lilly Canada Inc's appeal of a Federal Court decision that had awarded Teva Canada Limited more than C$70 million under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. The court granted Teva's cross-appeal – which sought to add to its recovery of lost pipefill sales – and an adjustment to account for an underreporting of sales in the data relied on by both parties' experts.

Health Canada publishes updated guidance on classification of products at device-drug interface
Canada | March 28 2018

Health Canada recently published an update to the guidance document Classification of Products at the (Medical) Device-Drug Interface. The update is intended to reflect the changes to the definition of a 'medical device' made to the Food and Drugs Act following the enactment of the Protecting Canadians from Unsafe Drugs Act and bring greater clarity to the description of how Health Canada classifies health products at the device-drug interface.

PMPRB releases report analysing generic drug pricing
Canada | March 28 2018

The Patented Medicine Prices Review Board (PMPRB) recently announced the publication of the most recent edition of its series of reports on generic drug pricing. Generics360 compares generic drug prices in Canada with those in other countries, with a particular focus on the PMPRB comparator countries. Although not factored into the published results, the report also describes a joint initiative to introduce price discounts of 25% to 40% on some of the most commonly prescribed drugs.

Consultation on use of foreign-sourced reference product as Canadian reference product
Canada | March 07 2018

Health Canada recently published a notice soliciting comments and recommendations from stakeholders regarding potential changes to its guidance document on the use of a foreign-sourced reference product as a Canadian reference product. Stakeholder feedback should be submitted to Health Canada by March 18 2018, preferably in electronic form.

Health Canada issues guidance on use of foreign-sourced reference products as CRPs
Canada | January 24 2018

Health Canada recently issued a guidance document on the use of foreign-sourced reference products as Canadian reference products. The guidance is directed at sponsors of all abbreviated new drug submissions and abbreviated extraordinary use new drug submissions that seek to obtain approval based on a demonstration of pharmaceutical equivalence and bioequivalence to a reference drug product marketed outside Canada.

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

Patented Medicine Prices Review Board releases March 2018 newsletter
Canada | May 14 2018

The Patented Medicine Prices Review Board (PMPRB) recently released its March 2018 newsletter (the first since July 2017). Highlights include an update on the PMPRB guidelines, the release of the PMPRB's 2016 annual report and notice that several publications will be released in 2018.

Court dismisses Section 8 damages appeal and grants cross-appeal
Canada | April 23 2018

The Federal Court of Appeal recently issued public reasons for its dismissal of Eli Lilly Canada Inc's appeal of a Federal Court decision that had awarded Teva Canada Limited more than C$70 million under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. Further, the court granted Teva's cross-appeal – which sought to add to its recovery of lost pipefill sales – and an adjustment to account for an underreporting of sales in the data relied on by both parties' experts.

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.