Last Updated February 20, 2019

Law and Practice

Contributed By Jones Day

Authors



Jones Day assists with all facets of clients' marketing, promotion, and advertising efforts by devising marketing strategies, developing packaging and labelling, obtaining internal and governmental approvals and implementing compliant advertising campaigns, including print, radio and television advertising, website development and social media platforms. The firm's Life Sciences team helps clients to preserve their advertising position and challenge infringing competitors. Its lawyers provide assistance with pharmaceutical, medical device and biological regulations, including counselling and representation on diverse issues such as product development, product clearance and approval, clinical trials, biosafety, licensing agreements, facility and establishment registration, product listing, government inspections, product and ingredient notifications, recalls, corrective actions, regulatory and due diligence projects, and audits and compliance with good manufacturing practices and the quality systems regulation. The team has successfully defended clients against FDA enforcement actions including warning letters, seizures, product recalls, inspections, civil monetary penalties, adverse agency determinations, consent decrees and corporate integrity agreements. The views and opinions set forth herein are the personal views or opinions of the author; they do not necessarily reflect views or opinions of the law firm with which [he or she] is associated.

The Clinical Research Act

The Clinical Research Act (Act No 16 of 14 April 2017), which took effect on 1 April 2018, requires that pharmaceutical companies and their subsidiaries disclose certain transfers of value to healthcare professionals and institutions in connection with specified clinical research. Clinical research includes human trials examining the efficacy or safety of pharmaceuticals but would not include a clinical trial for new drug conducted under the PMD Act.

Specified clinical research is defined as clinical research funded by pharmaceutical companies, clinical research on unapproved drugs or clinical research concerning off-label use of a drug.

Transfers of value which must be disclosed under the Clinical Research Act include research funds for specified clinical research, donations provided during the term of or within two years after specified clinical research, and fees for writing, lectures or other services provided during the term of and within two years after specified clinical research. The recipients of payments covered by the regulation include healthcare providers involved in specified clinical research, healthcare institutions or other organisations to which a principal investigator belongs, and organisations managing the specified clinical research. The transfers of value for specified clinical research made in each fiscal year shall be disclosed the following fiscal year on the company’s website.

The JPMA Transparency Guideline

The JPMA 'Transparency Guideline for the Relation between Corporate Activities and Medical Institutions' (the 'Transparency Guideline') requires that JPMA member companies disclose certain information regarding transfers of value made to healthcare professionals or healthcare institutions.

The Transparency Guideline further requires that each member company create its own internal 'transparency policy' based on the Transparency Guideline. Therefore, each JPMA member company has established its own internal transparency policy and has been disclosing information on transfers of value it has made to healthcare institutions based on this internal policy.

The Transparency Guideline creates five different categories of transfers of value (fees or expenses). For each category the relevant fees or expenses must be disclosed in detail. The five categories are:

  • research and development expenses (such as those for clinical trials for new drugs);
  • academic support expenses (such as donations to academic societies);
  • manuscript/writing fees (such as fees for writing manuscripts containing scientific information regarding the pharmaceutical companies’ own drugs);
  • expenses related to the provision of information (such as expenses for lectures and seminars); and
  • other expenses (such as for hospitality as a social courtesy).

The types of transfers of value to be disclosed include not only cash but also medicines, medical devices and other goods. Value transferred through a third party, such as a subcontractor or foundation, must be disclosed as well.

The recipients of payments covered by the Transparency Guideline are healthcare institutions (such as hospitals and pharmacies), research institutes (such as medical and pharmaceutical departments of universities), healthcare associations (such as medical associations and pharmacists’ associations) and persons engaged in medical care and nursing care (such as doctors and nurses) and medical personnel (such as life-science researchers). The transfers of value made in each fiscal year shall be disclosed in the following fiscal year through the company’s website.

As the transparency requirements under the Clinical Trial Act would apply only to the marketing authorisation holder and its subsidiaries, the requirements would not apply to foreign companies or companies that do not sell products on the market in Japan.

The transparency requirements under trade association rules such as the above-mentioned Transparency Guideline only bind members of such trade associations. Accordingly, the transparency requirements under the self-regulatory rules will not apply to foreign companies and/or companies that do not yet have products on the market, unless such companies are members of trade associations with transparency requirements.

Jones Day

Kamiyacho Prime Place
1-17, Toranomon 4-chome
Minato-ku
Tokyo 105-0001
Japan

+81 334333939

+81 354012725

www.jonesday.com/tokyo/

Authors



Jones Day assists with all facets of clients' marketing, promotion, and advertising efforts by devising marketing strategies, developing packaging and labelling, obtaining internal and governmental approvals and implementing compliant advertising campaigns, including print, radio and television advertising, website development and social media platforms. The firm's Life Sciences team helps clients to preserve their advertising position and challenge infringing competitors. Its lawyers provide assistance with pharmaceutical, medical device and biological regulations, including counselling and representation on diverse issues such as product development, product clearance and approval, clinical trials, biosafety, licensing agreements, facility and establishment registration, product listing, government inspections, product and ingredient notifications, recalls, corrective actions, regulatory and due diligence projects, and audits and compliance with good manufacturing practices and the quality systems regulation. The team has successfully defended clients against FDA enforcement actions including warning letters, seizures, product recalls, inspections, civil monetary penalties, adverse agency determinations, consent decrees and corporate integrity agreements. The views and opinions set forth herein are the personal views or opinions of the author; they do not necessarily reflect views or opinions of the law firm with which [he or she] is associated.

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