On 20 November 2013, the Japanese Diet passed the Act regarding Ensuring of Safety of Regenerative Medicine (the "Regenerative Medicine Law") and the revisions to the Pharmaceutical Affairs Law (new PAL) as it applies to drugs, medical devices and regenerative medicine. Both laws will come into effect some time within one year from the date of promulgation. Also, on 5 December 2013, a bill to partially revise the Pharmaceutical Affairs Law and the Pharmacists Act, which regulate online sales of drugs (Online Sales Bill) was approved by the Diet. It will come into effect some time within six months from the date of promulgation.
This Legal Insight analyzes the main points of these three new rules.
Regenerative Medicine Law
Summary
For the first time, the Regenerative Medicine Law sets out the definitions of regenerative medicine and criteria for:
(i) organizations that provide regenerative medicine
(ii) manufacturers of specific cell products, and
(iii) cell culture processing facilities.
With these new rules, Japan intends to expedite the use of regenerative medicine as to ensure the safety of such use.
New Rules Under the Regenerative Medicine Law
The regenerative Medicine Law categorizes and regulates three types of 'Regenerative Medical Techniques'.
First, before a medical institution provides regenerative medicine to patients for the purpose of treatment, it is required to:
(i) submit a plan for the provision of such regenerative medicine, and
(ii) to meet the criteria regarding the provision of regenerative medicine set out in the Ordinance of the Ministry of Health, Labour and Welfare (MHLW).
The types of regenerative medicine covered by the Regenerative Medicine Law are as follows:
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Type
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Definitions
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Examples
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Type I
Regenerative Medical Techniques
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Regenerative Medical Techniques the effect of which is not clear or which may significantly affect the life or health of human beings even with reasonable care and which is specified in the Ordinance of the MHLW.
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Regenerative medicine with induced pluripotent stem cells (iPS cells) or embryonic stem cells (ES cells) products.
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Type II
Regenerative Medical Techniques
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Regenerative Medical Techniques which may affect the life or health of human beings even with reasonable care and which is specified in the Ordinance of MHLW.
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Regenerative medicine with own-fat stem cells.
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Type III
Regenerative Medical Techniques
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Regenerative Medical Techniques other than Type I and II Regenerative Medicinal Techniques.
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Traditional cancer therapy with activated lymphocyte.
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Second, the Regenerative Medicine Law enables medical institutes to outsource processing cell cultures to companies that are not medical institutes. Pursuant to the law, the companies processing cell cultures are subject to the regulation described below.
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Types of manufacturers
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Cell culture processing manufacturer
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Foreign cell culture processing manufacturer
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Cell culture processing manufacturer with specific cell culture processing facilities (eg medical institutes)
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Required process
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Permission
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Authorization
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Filing
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Regulations
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Buildings and equipment used in the cell culture processing facilities must meet the criteria set out in the Ordinance of MHLW.
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Cell culture processing facilities must have a staff member who has certain biological knowledge related to the specific cell products.
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Manufacturers must comply with the criteria set out in the Ordinance of MHLW related to manufacturing, quality management, testing and inspection, storage, transportation, preparation and maintenance of records and periodical reports.
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New PAL
Background
On 20 November 2013, a new law titled "Act on Assurance of Quality, Effectiveness and Safety of Drugs and Medical Devices, etc." (the "Pharmaceuticals and Medical Devices Act") was approved. In addition to the important changes described in our Global Food, Drug and Medical Device Newsletter, issued in Fall 2013, the following changes are now applicable.
New Rules under the New PAL
1. Package Insert
The new PAL requires companies marketing and selling drugs, medical devices and regenerative medical products (“products”) to provide cautions related to the use or handling of the products based on knowledge obtained by latest articles or other information. The part of language in the package insert is required to be filed to MHLW. An online announcement is also required.
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Who
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Companies marketing and selling drugs, medical devices and regenerative medical products.
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When
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When preparing a package insert for the products.
Before marketing and selling the products.
Before revising the package insert.
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Rules
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Must provide cautions related to the use or handling of the products based on knowledge obtained by latest articles or other information.
A part of the language in the package insert is required to be filed to MHLW.
Online announcement is also required.
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2. License Requirements for Charge-Free Lease
Companies that lease "specially controlled medical devices" (higher risk medical devices) or certain "maintained and controlled medical devices" (which require professional knowledge and techniques for maintenance, inspection and repairs) for free in the course of trade must be licensed for such leasing. Currently, only a fee charging lease is subject to license requirement but this amendment expands the license requirement to the charge-free lease of medical devices.
Online Sales Bill
Background
On 5 December 2013, the Online Sales Bill, which would allow online sales of over-the-counter (OTC) drugs directly to consumers, was approved to the Diet.
New Regulations
The following new rules for online sales are set out in the Online Sales Bill:
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Type of Drugs
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Regulations
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Non prescription drugs
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Online sales are permitted.
Companies need to comply with new rules including providing necessary information to customers.
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Drugs required to be guided
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Switched Drugs (Drugs which have been categorized as non prescription drugs from prescription drugs
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Online sales are prohibited for a specific period (maximum three years). Online sales will be allowed after safety of the drugs is evaluated through post marketing surveillance.
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Poisons
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Online sales are prohibited.
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Prescription drugs
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Online sales are prohibited.
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On 12 November 2013, a company conducting online drug sales took legal action against the Japanese Government, claiming that it is unconstitutional to prohibit online sales of Prescription Drug by ordinances. We will continue to monitor new developments and any potential revisions to regulations on online sales of these drugs.
Impact on Companies
The Regenerative Medicine Law, New PAL and Online Sales Bill will impact medical institutes, pharmaceutical companies, medical device companies and other companies in the medical field and we recommend that those entities review their internal rules for compliance and educate their employees on new regulations as they come into effect.
