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Healthcare & Life Sciences

January 03 2018
Rainer Herzig Medical information and informed consent

Austria - Preslmayr Attorneys at Law

Providing patients with insufficient medical information may impede their ability to give informed consent to proposed medical treatments and thus may trigger the tort liability of physicians or healthcare institutions. However, a March 2017 Supreme Court decision has reduced the scope of the medical information that must be provided to patients.

Author: Rainer Herzig
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Katie Lee Health Canada publishes final guidance documents on quality requirements for regulatory filings

Canada - Smart & Biggar/Fetherstonhaugh

Health Canada recently published the final version of a number of guidance documents and templates which implement new requirements for new drug submissions and abbreviated new drug submissions. The changes will be implemented by way of a phased-in approach, with the general quality guidance requirements being implemented in January 2018 and the new stability requirements and requirements for commercial and pilot scale batches being implemented in October 2019.

Author: Katie Lee
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Recent updates

Urszula Wojtyra Recent developments in Alexion cases

Canada - Smart & Biggar/Fetherstonhaugh

Author: Urszula Wojtyra
William Sarraille California passes sweeping prescription drug price transparency law and co-pay coupon ban

USA - Sidley Austin LLP

Authors: William Sarraille, Meenakshi Datta, Trevor L Wear
Joanne van Harmelen Draft IP Policy Phase 1 – part two: access to medicines, state 'walk-in' rights and parallel import

South Africa - ENSafrica

Author: Joanne van Harmelen