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Healthcare & Life Sciences

06 November 2019
Katie Lee Health Canada updates Guidance Document: The Management of Drug Submissions and Applications

Canada - Smart & Biggar

Health Canada recently released an updated version of Guidance Document: The Management of Drug Submissions and Applications. The updates follow on from an earlier consultation and reflect the updated processes and procedures relating to filing a submission or application with Health Canada.

Author: Katie Lee
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Chen Li Court dismisses judicial review application of minister of health's interchangeability designation

Canada - Smart & Biggar

The Court of Queen's Bench of Alberta recently dismissed Allergan's application for judicial review of the Alberta minister of health's decision to designate Allergan's glaucoma treatment product Lumigan RC 0.01% and Sandoz's generic bimatoprost ophthalmic solution Vistitan 0.03% as interchangeable. While the criteria for interchangeability decisions and resubmissions may differ, the questions as framed by Allergan were "opposite sides of the same coin".

Author: Chen Li
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Altair Richards It all hinges on 2026 – will we be prepared for national health insurance?

South Africa - ENSafrica

The National Health Insurance (NHI) scheme, which is set to come into force on 1 January 2026, will centralise the purchasing of healthcare services in a single body established by the government: the National Health Insurance Fund. The proposed link between the NHI scheme's full implementation and the arbitrary date of 1 January 2026 may be irrational considering the risk of the requisite infrastructure not being sufficiently in place by such date.

Authors: Altair Richards, Alexandra Wood
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Recent updates

Andreas Wildi Federal Supreme Court upholds breast implant decision

Switzerland - Walder Wyss

Author: Andreas Wildi
Jonas Löfgren Heavily discounted starter pack considered unethical grant to healthcare

Sweden - Westerberg & Partners Advokatbyrå Ab

Authors: Jonas Löfgren, Siri Alvsing
Fabian Huber Granting of gifts by pharmacies

Germany - Simmons & Simmons LLP

Authors: Fabian Huber, Caroline von Nussbaum
Brandon Heard Certificate of supplementary protection regime: second anniversary update

Canada - Smart & Biggar

Authors: Brandon Heard, Nancy Pei, Eric Saragosa, Daphne Lainson
Eduardo Buitrón de Vega Patuel SPC regulation amendment and export manufacturing waiver: in-depth analysis

European Union - Eversheds Sutherland (Germany) LLP

Author: Eduardo Buitrón de Vega Patuel
Julien Gaul Incentives and public procurement in the healthcare sector: be careful what you wish for

Belgium - ALTIUS

Authors: Julien Gaul, Kirian Claeyé
Riccardo Fruscalzo Milan court sets precedent on second medical use invention plausibility

Italy - Hogan Lovells

Author: Riccardo Fruscalzo
Jaime L M Jones DOJ defends Medicare Advantage upcoding claims against Sutter

USA - Sidley Austin LLP

Authors: Jaime L M Jones, Scott D Stein, Jennifer M Haney

Upcoming event

4th Annual IBA European Start-Up Conference

20 November 2019 – London, England

This year's European Start-Up Conference will feature discussions on health and wellness, European ecosystems, technology transfers, London trends and digital health.

For more details go to: