Pharmaceutical antitrust—Japan—Q&A guide

The following Life Sciences practice note provides comprehensive and up to date legal information covering:

  • Pharmaceutical antitrust—Japan—Q&A guide
  • 1. What is the applicable regulatory framework for the authorisation, pricing and marketing of pharmaceutical products, including generic drugs?
  • 2. Which authorities are entrusted with enforcing these rules?
  • 3. Are drug prices subject to regulatory control?
  • 4. Is the distribution of pharmaceutical products subject to a specific framework or legislation? Do the rules differ depending on the distribution channel?
  • 5. Which aspects of the regulatory framework are most directly relevant to the application of competition law to the pharmaceutical sector?
  • 6. What are the main competition law provisions and which authorities are responsible for enforcing them?
  • 7. What actions can competition authorities take to tackle anticompetitive conduct or agreements in the pharmaceutical sector and what remedies can they impose?
  • 8. Can remedies be sought through private enforcement by a party that claims to have suffered harm from anticompetitive conduct or agreements implemented by pharmaceutical companies? What form would such remedies typically take and how can they be obtained?
  • 9. Can the antitrust authority conduct sector-wide inquiries? If so, have such inquiries ever been conducted into the pharmaceutical sector and, if so, what was the main outcome?
  • More...

Pharmaceutical antitrust—Japan—Q&A guide

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

1. What is the applicable regulatory framework for the authorisation, pricing and marketing of pharmaceutical products, including generic drugs?

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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