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Healthcare & Life Sciences

17 July 2019
Urszula Wojtyra National pharmacare update: publication of advisory council's final report

Canada - Smart & Biggar

The minister of health recently published the final report from the Advisory Council on the Implementation of National Pharmacare. The council has recommended that Canada implement universal, single-payer, public pharmacare by enacting new legislation and proceeding in a stepwise approach to implementation.

Author: Urszula Wojtyra
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Katie Lee Federal Court upholds PMPRB's pricing decision regarding Alexion's Soliris

Canada - Smart & Biggar

The Federal Court recently dismissed Alexion's application for judicial review of a Patented Medicines Price Review Board (PMPRB) panel's decision that Soliris (eculizumab) had been sold at an excessive price and its order fixing the amount of the payment to offset excess revenues (C$4.2 million). The application was dismissed on the grounds that, among other things, the PMPRB had not been unreasonable in ordering payment of excess revenues based on the highest international price comparison.

Author: Katie Lee
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Magdalena Kotyrba EU Medical Devices Regulation to apply from May 2020 – preparations underway

European Union - Eversheds Sutherland (International) LLP

The existing EU legislation regulating medical devices will be replaced by the Medical Devices Regulation. The new regulation changes the European legal framework for medical devices, broadens the scope of the products and operators covered under this legislation and provides for increased responsibilities and obligations for manufacturers and notified bodies. It entered into force in May 2017 and will fully apply from 26 May 2020.

Author: Magdalena Kotyrba
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Recent updates

Brandon Heard Supreme Court of Canada denies Apotex leave to appeal in two cases

Canada - Smart & Biggar

Author: Brandon Heard
Sean Griffin Lethal injection opinion from DOJ OLC threatens FDA's claims-based interpretation of 'intended use'

USA - Sidley Austin LLP

Authors: Sean Griffin, Joseph R Guerra, Coleen Klasmeier
José Alberto Campos Vargas Software – the unregulated medical device

Mexico - Sanchez DeVanny Eseverri SC

Author: José Alberto Campos Vargas