Decision of the 22nd Meeting of the Committee for
Drawing Up and Promoting the Action Program
The Government of Japan has voluntarily decided upon the "Operational Guidelines with respect to Measures related to Japanese Public Sector Procurement of Medical Technology Products and Services," as outlined herein.
The Guidelines will be implemented as of November 1, 1994, except for procurements in which a Notice of Procurement or a Request for Comments was published before November 1, 1994.
OPERATIONAL GUIDELINES WITH RESPECT TO MEASURES RELATED TO JAPANESE PUBLIC SECTOR PROCUREMENT OF MEDICAL TECHNOLOGY PRODUCTS AND SERVICES
The Government of Japan has decided to issue and implement these Operational Guidelines to supplement and clarify the Measures Related to Japanese Public Sector Procurement of Medical Technology Products and Services (hereinafter referred to as "the Measures") which were decided by the Committee for Drawing Up and Promoting the Action Program on 28 March, 1994, as follows. In carrying out the Measures, the Guidelines will be fully implemented and respected.
In carrying out the Measures, entities recognize that they should meet their needs with the most appropriate competitive medical technology products or services without regard to national origin. To this end, the head of each entity specified in Annexes 1 and 2 of the Measures will send a notice to all procurement officials within his or her authority, including those in hospitals, encouraging them to give fair, non-discriminatory and positive consideration in all procurements without regard to the threshold to the procurement of competitive foreign medical technology products and services, with the understanding that such procurements constitute positive and beneficial steps in implementing the Measures. The notice will, in this regard, also ask the hospitals and other subordinate organizations within his or her entity to assist foreign suppliers, on request, in appointments and contacts with procurement officials in those organizations.
When an entity publishes in the Kanpo procurement information on medical technology products and services covered by the Measures as set forth in Section III.1, the entity will invite suppliers to submit materials, comments and other necessary information on the procurement. Entities will give full consideration to any information submitted by suppliers.
(1) In the case of Request for Submission of Materials set forth in Section III.5.1, suppliers can submit materials and comments on the entity's actual needs with regard to the procurement for which a Request for Submission of Materials has been issued.
(2) With respect to Section III.5.1, all procurements in which the contract award is expected to be greater than 800,000 SDRs are deemed to be those in which entities face difficulties in developing appropriate specifications without requesting the submission of materials from suppliers.
(3) For procurements in which the contract award is expected to be 800,000 SDRs or below, entitles may use the Request for Submission of Materials procedures when they determine that they face difficulties in developing appropriate specifications without requesting the submission of materials from suppliers.
(4) The phrase in Section III. 5.2 of the Measures, which states "entities will take the following measures in order to ensure that interested suppliers submit their comments on draft specifications prepared by the entities" is not intended to limit comments submitted to those on draft specifications. Suppliers can submit materials and comments on, in addition to draft specifications, other technical information or any other aspect of the procurement, including the supplier's view on the estimated cost of the procurement.
(1) With respect to the threshold that applies to overall greatest value evaluation and Request for Comments, as set out in Sections III.5.1, III.5.2 and III.10.4 of the Measures and paragraphs 3(2) and 3(3) of these Guidelines, the Government will lower the threshold from 800,000 SDRs to 600,000 SDRs on April 1, 1996, to 400,000 SDRs on April 1, 1997, and to 385,000 SDRs on April 1, 1998.
(2) Off-the-shelf products or services with a unit value of 500 SDRs or below which are being procured in high volume may be exempted from the areas to which overall greatest value evaluation and Request for Comments procedures apply.
Entities which procured in the previous fiscal year a total of two million SDRs or more of medical technology products and services covered by the Measures will hold their own meetings.
"Medical technology products" includes, in addition to those described in Section XII of the Measures, in-vitro diagnostic reagents stipulated in Article 56-2 of the Enforcement Regulations of the Pharmaceutical Affairs Law.