The following Life Sciences practice note provides comprehensive and up to date legal information covering:
This Practice Note contains a jurisdiction-specific Q&A guide to pharmaceutical antitrust in Japan published as part of the Lexology Getting the Deal Through series by Law Business Research (published: April 2020).
Authors: Anderson Mori & Tomotsune—Yusuke Nakano
The primary piece of legislation setting out the regulatory framework for the authorisation and marketing of pharmaceutical products is the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (No. 145 of 1960) (the Act).
The Health Insurance Act (No. 70 of 1922) sets out the pricing of drugs covered by public health insurance (these drugs are roughly equivalent to drugs used in medical institutions and prescription drugs). Under the Japanese health insurance system, generally all residents of Japan are required to be covered by health insurance, and most of the drugs used in, or prescribed by, medical institutions are covered by this mandatory insurance. Under the health insurance system, the prices of drugs that medical institutions and dispensing pharmacies charge to insurers (national government or others) and insured persons are calculated according to a notification of the Ministry of Health, Labour and Welfare (MHLW). Prices of over-the-counter (OTC) drugs are not subject to the notification. This chapter
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AML and counter-terrorist financing—source of funds and source of wealthSource of funds and wealth was a key focus of the SRA’s Preventing Money Laundering and Financing of Terrorism thematic review, published in March 2018. Its findings included that:•most firms understood the distinction between
Indemnity costs orders—principlesThis Practice Note considers orders for costs determined on an indemnity basis (indemnity costs orders). A court may order that costs are assessed on an indemnity basis so that any doubt as to the costs claimed are resolved in favour of the receiving party. Compare
Nuisance—establishing a claim for private nuisancePrivate nuisance—what situations can give rise to a claim?Private nuisance normally involves interference with the claimant’s enjoyment of their land, usually by noise or smell or by the causing of actual physical damage to their property. In
Dawn raid—who can raid my organisation and why?IP COMPLETION DAY: 11pm (GMT) on 31 December 2020 marks the end of the Brexit transition/implementation period entered into following the UK’s withdrawal from the EU. At this point in time (referred to in UK law as ‘IP completion day’), key transitional
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