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Getting The Deal Through

Life Sciences

Published: January 2019

Japan


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  • 1.

    How is healthcare in your jurisdiction organised?

  • 2.

    How is the healthcare system financed in the outpatient and inpatient sectors?

  • 3.

    Which legislation governs advertising of medicinal products to the general public and healthcare professionals?

  • 4.

    What are the main rules and principles applying to advertising aimed at healthcare professionals?

  • 5.

    What are the main rules and principles applying to advertising aimed at the general public?

  • 6.

    What are the most common infringements committed by manufacturers with regard to the advertising rules?

  • 7.

    Under what circumstances is the provision of information regarding off-label use to healthcare professionals allowed?

  • 8.

    Which legislation governs the collaboration of the pharmaceutical industry with healthcare professionals? Do different rules apply regarding physicians in the outpatient and inpatient sector?

  • 9.

    What are the main rules and principles applying to the collaboration of the pharmaceutical industry with healthcare professionals?

  • 10.

    What are the most common infringements committed by manufacturers with regard to collaboration with healthcare professionals?

  • 11.

    What are the main rules and principles applying to the collaboration of the pharmaceutical industry with patient organisations?

  • 12.

    Are manufacturers’ infringements of competition law pursued by national authorities?

  • 13.

    Is follow-on private antitrust litigation against manufacturers possible?

  • 14.

    What are the main mandatory anti-corruption and transparency rules applicable to pharmaceutical manufacturers?

  • 15.

    Is the advertising of medical devices and the collaboration of manufacturers of medical devices with healthcare professionals and patient organisations regulated as rigorously as advertising and collaboration in the pharmaceuticals sector?

  • 16.

    Which legislation sets out the regulatory framework for granting marketing authorisations and placing medicines on the market?

  • 17.

    Which authorities may grant marketing authorisation in your jurisdiction?

  • 18.

    What are the relevant procedures?

  • 19.

    Will licences become invalid if medicinal products are not marketed within a certain time? Are there any exceptions?

  • 20.

    Which medicines may be marketed without authorisation?

  • 21.

    Are any kinds of named patient programmes in place? If so, what are the requirements for pre-launch access?

  • 22.

    To what extent is the market price of a medicinal product governed by law or regulation?

  • 23.

    Must pharmaceutical manufacturers negotiate the prices of their products with the public healthcare providers?

  • 24.

    In which circumstances will the national health insurance system reimburse the cost of medicines?

  • 25.

    If applicable, what is the competent body for decisions regarding the pricing and reimbursability of medicinal products?

  • 26.

    Are manufacturers or distributors of medicinal products statutorily obliged to give a discount?

  • 27.

    What rules are in place to counter the counterfeiting and illegal distribution of medicines?

  • 28.

    What recent measures have been taken to facilitate the general public’s access to information about prescription-only medicines?

  • 29.

    Outline major developments to the regime relating to safety monitoring of medicines.

  • 30.

    Outline your jurisdiction’s vaccination regime for humans.

  • Updates and trends

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As one of the largest and most diversified law firms in Japan, Anderson Mōri & Tomotsune boasts a staff of more than 480 attorneys, including attorneys-at-law (bengoshi), patent attorneys (benrishi), and lawyers qualified in foreign jurisdictions.

View more information about Anderson Mōri & Tomotsune


Tokyo
Otemachi Park Building, 1-1
Otemachi 1-chome
Chiyoda-ku
100-8136
Tokyo
Japan
T: +81 3 6775 1221
F: +81 3 6775 2221


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