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Healthcare & Life Sciences

11 September 2019
Abigail Smith Canada releases final amendments to patented medicines pricing regulations

Canada - Smart & Biggar

Health Canada recently announced the final amendments to the Patented Medicines Regulations. The amendments – which represent the first substantive revision to the regulations since their introduction in 1987 – are a significant departure from the existing framework and include new price regulatory factors, updated reference countries and changes in reporting requirements.

Authors: Abigail Smith, Nancy Pei, Daphne Lainson
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Lynn Ing Updates to guidance documents: what you need to know

Canada - Smart & Biggar

Health Canada recently released a revised Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs, which is effective immediately. The revisions include clarifying additions on the requirements for cross-licensed products for an administrative certification form and letter of authorisation, a drug notification form and labelling. Health Canada also recently released an updated Good Label and Package Practices Guide for Prescription Drugs.

Author: Lynn Ing
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Andreas Wildi Fertility preservation and dementia prevention covered by compulsory healthcare insurance

Switzerland - Walder Wyss

​The Federal Department of Home Affairs recently decided that measures to preserve the fertility of people suffering from cancer will now be covered by compulsory health insurance. Under the new measures, if cancer patients run the risk that a planned treatment will lead to impaired ovarian or testicular function, sperm, egg cells or ovarian tissue can be frozen (so-called 'cryopreservation') and reused after therapy. Cerebrospinal fluid analyses for diagnosing dementia will also be covered.

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

USA - Sidley Austin LLP

Beaver Medical Group LP and an affiliated physician recently agreed to pay a combined total of $5 million to resolve allegations that providers had knowingly submitted diagnosis codes that were not supported by medical records in order to inflate reimbursements from Medicare. The settlement reflects the Department of Justice's continuing efforts to use its enforcement power to pursue fraud in the Medicare Advantage space despite recent setbacks.

Authors: Jaime L M Jones, Jennifer M Haney
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Recent updates

Fabian Huber MDR and medical software: insurance under German law

Germany - Simmons & Simmons LLP

Authors: Fabian Huber, Caroline von Nussbaum
Abigail Smith Health Canada consults on promotional and non-promotional activities for health products

Canada - Smart & Biggar

Author: Abigail Smith
Andreas Wildi Federal Council intends to improve access to psychotherapy

Switzerland - Walder Wyss

Author: Andreas Wildi
Joanne van Harmelen Bolar provisions for generic and biosimilar medicines

South Africa - ENSafrica

Author: Joanne van Harmelen
Jonas Löfgren Cannabis causes confusion in Sweden

Sweden - Westerberg & Partners Advokatbyrå Ab

Authors: Jonas Löfgren, Måns Ullman
Magdalena Kotyrba EU Medical Devices Regulation to apply from May 2020 – preparations underway

European Union - Eversheds Sutherland (Germany) LLP

Author: Magdalena Kotyrba

Upcoming event

IBA Annual Conference 2019

22 – 27 September 2019 – Seoul, South Korea

The IBA Annual Conference 2019 will be held in Seoul, South Korea, a thriving metropolis that mixes the traditional with the modern – from skyscrapers, high-tech subways, K-pop culture and K-beauty to Buddhist temples, palaces and street markets and a history going back 5,000 years. This technologically forward, but deeply traditional city, located between the North Asian powerhouses of Japan and China, is an ideal location for the largest and most prestigious event for international lawyers.

For more details go to: