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Healthcare & Life Sciences

20 March 2019
Rainer Herzig Social security system to undergo restructure – but will it achieve cost savings?

Austria - Preslmayr Attorneys at Law

The Austrian social security system has been characterised by regional and occupational fragmentation and the domination of employee representatives. However, a recent amendment to the Social Security Act proposes merging the provincial social security institutions with the company insurers into one Austrian Health Insurer, which will be the only provider of employee health insurance.

Author: Rainer Herzig
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Urszula Wojtyra Health Canada announces decision on naming of biologic drugs

Canada - Smart & Biggar/Fetherstonhaugh

Following its stakeholder consultations and analysis of issues relating to the name of biologic drugs, including biosimilars, Health Canada recently announced its Policy Statement on the Naming of Biologic Drugs. To implement the naming convention, Health Canada will, among other things, communicate with stakeholders on the importance of recording both brand and non-proprietary names throughout the medication use process.

Author: Urszula Wojtyra
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Brandon Heard Orders of prohibition relating to polymorphic form patent for Pristiq upheld on appeal

Canada - Smart & Biggar/Fetherstonhaugh

In a pair of decisions, the Federal Court granted orders prohibiting Apotex and Teva from marketing their generic o-desmethyl-venlafaxine succinate products. The Federal Court of Appeal recently dismissed both Apotex's and Teva's appeals. Among other things, Apotex and Teva argued that the application judge had misapplied the test for obviousness and that the application judge had erred in considering several aspects of the inventors' course of conduct.

Author: Brandon Heard
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José Alberto Campos Vargas Traditional indigenous medicine: historic asset or mere political move?

Mexico - Sanchez DeVanny Eseverri SC

Traditional medicine is still a primary health resource for millions of people who do not have access to so-called 'modern medicine'. However, traditional medicine and knowledge are not covered by the general legal provisions which govern human health or specifically recognised by the Mexican health authorities. In some cases, traditional medicine has even been deemed illegal and attempts have been made to outlaw its practice and promotion.

Author: José Alberto Campos Vargas
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Kristin Graham Koehler Eighth Circuit tightens False Claims Act pleading requirements

USA - Sidley Austin LLP

A recent US Court of Appeals for the Eighth Circuit decision follows a growing trend among courts in tightening False Claims Act pleading requirements. The court affirmed the dismissal of a qui tam action brought against a non-profit hospital because the relators had failed to meet the particularity standard set out under Rule 9(b) of the Federal Rules of Civil Procedure.

Authors: Kristin Graham Koehler, Brendan C Smith, Cameron James Gibbs
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Recent updates

Brandon Heard Apotex seeks leave to appeal ramipril pleadings amendment decision

Canada - Smart & Biggar/Fetherstonhaugh

Author: Brandon Heard
Jonas Löfgren Trilogue negotiations: originator company compensation for parallel imported products

Sweden - Westerberg & Partners Advokatbyrå Ab

Authors: Jonas Löfgren, Måns Ullman
Scott D Stein DOJ announces more than $2.5 billion in FY 2018 False Claims Act recoveries from healthcare industry

USA - Sidley Austin LLP

Authors: Scott D Stein, Neil G Nandi
Christian di Mauro New medical device regulations: what liability do notified bodies face?

Italy - Hogan Lovells

Authors: Christian di Mauro, Riccardo Fruscalzo
Kirian Claeyé Anti-tampering devices – fading boundaries of parallel trade?

Belgium - ALTIUS

Authors: Kirian Claeyé, Laura Traest