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Healthcare & Life Sciences

18 September 2019
Abigail Smith Countdown begins: getting ready for new patented medicines pricing regime

Canada - Smart & Biggar

The long-awaited amendments to the Patented Medicines Regulations were recently published in Part II of the Canada Gazette. Major changes include the introduction of three new price regulatory factors and a revised schedule of reference countries. Although the new law will not be in force until 1 July 2020, there are immediate implications.

Authors: Abigail Smith, Daphne Lainson
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Urszula Wojtyra Market access: biosimilars no longer reviewed by CADTH

Canada - Smart & Biggar

The Canadian Agency for Drugs and Technologies in Health (CADTH) recently released Issue 8 of its Pharmaceutical Reviews Update announcing revisions to its Procedure and Submission Guidelines for the CADTH Common Drug Review, among other things. The update also announced that the CADTH will no longer review biosimilars through the Common Drug Review or the pan-Canadian Oncology Drug Review.

Author: Urszula Wojtyra
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Andreas Wildi Consultation on direct medical prescriptions for cannabis-based treatments

Switzerland - Walder Wyss

The Federal Council recently submitted a draft amendment to the Narcotics Act for consultation that aims to facilitate patients' access to cannabis-based treatments. The revised act would allow patients to obtain direct medical prescriptions for cannabis-based treatments with a tetrahydrocannabinol content of more than 1% without having to obtain an exceptional licence from the Federal Office of Public Health.

Author: Andreas Wildi
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Meenakshi Datta Government will allow broader use of co-pay accumulator programmes for 2020

USA - Sidley Austin LLP

The Department of Health and Human Services (HHS), the Department of Labour and the Treasury have jointly announced that they will not enforce the HHS's recently finalised policy that limits private health plans' use of accumulator programmes to prescription brand drugs for which a medically appropriate generic equivalent is available. Stakeholders should remain alert to any changes in state enforcement policies and consider opportunities to engage with the administration on future revisions.

Authors: Meenakshi Datta, Donielle McCutcheon, Kat Makielski, Corbin T Santo
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Recent updates

Abigail Smith Canada releases final amendments to patented medicines pricing regulations

Canada - Smart & Biggar

Authors: Abigail Smith, Nancy Pei, Daphne Lainson
Andreas Wildi Fertility preservation and dementia prevention covered by compulsory healthcare insurance

Switzerland - Walder Wyss

Author: Andreas Wildi
Jaime L M Jones Medicare Advantage providers pay $5 million to settle False Claims Act allegations

USA - Sidley Austin LLP

Authors: Jaime L M Jones, Jennifer M Haney
Fabian Huber MDR and medical software: insurance under German law

Germany - Simmons & Simmons LLP

Authors: Fabian Huber, Caroline von Nussbaum

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