Japan Bioindustry Association

Domestic Implementation of the Nagoya Protocol in Japan:
General Observations and Opinions of Japan’s Bioindustry
Submitted to the Japanese Government for “the Amendment to the National Biodiversity
Strategy of Japan (Draft)”
In July –August 2012, the government of Japan was seeking public comments on “theAmendment to the National Biodiversity Strategy of Japan (Draft)” which stated that Japanplans to advance the formulation of Japan’s domestic measures and aims at the ratification ofthe Nagoya Protocol (NP) and its implementation in Japan as soon as possible. The ABS
Committee of JBA member companies submitted its opinion to the government in August 2012.
The following is excerpted from the Committee’s opinion.

I. General observations
A diverse range of industry sectors utilize genetic resources (GRs). They create value
from GRs in various forms. Industry plays an essential role in generating social as well as
economic benefits from GRs.
To access GRs in compliance with the Convention on Biological Diversity (CBD), we
have invested the necessary financial, human, and time resources in our activities. We also
have been conscientiously complying with the “Japan’s Guidelines on Access to GRs forUsers” which the Ministry of Economy, Trade and Industry put in place in 2005, in cooperation
with Japan Bioindustry Association.
We hope that the government will acknowledge the activities that Japanese companies
have been carrying out to comply with the CBD. We will welcome rules that are transparent,
consistent, pragmatic, science-based and able to provide sound justification for investment inbusiness. However, the domestic compliance measures under the NP should not impose
unrealistic obstacles on research, development and business.
We propose that the government will provide opportunities for dialogue with thebioindustry sector with a view to sharing opinion and experiences, from early stages of thegovernment’s policy making process. Such dialogue will be useful in achieving practicable andcost-effective compliance measures under the NP. We look forward to having suchopportunities.
Our opinions are given in the following section. We hope that the government will takethem into consideration.

1Japan Bioindustry Association
Grande bldg. 8F, 2-26-9 Hatchobori Chuo-ku, Tokyo, JAPAN
Telephone +81 3 5541 2731 Fax +81 3 5541 2737
Website www.jba.or.jp

Japan Bioindustry AssociationII. Opinions
1. Certainty of measures
1) Certainty is essential to domestic compliance measures under the NP. However, there are
a number of ambiguous points in major provisions of the NP with regard to theirinterpretation. This seems to be a major issue not only domestically, but also in othercountries. This is an international issue. Under these circumstances, the government
should not act too hastily. The government needs to keep track of international trends on
this matter carefully, and to bear them in mind when formulating the domestic compliancemeasures.
2) Domestic compliance measures under the NP should be simple and pragmatic so that all
the companies utilizing GRs can, regardless of their size and nature of business, complywith the measures without difficulty. Therefore, it is desirable for the domestic compliancemeasures under the NP to take a form of voluntary system.
3) The scope of domestic compliance measures should be clearly defined.
For example:a) Domestic compliance measures under the NP should be applicable only to those GRs
accessed after the NP has entered into force in the country that provides the GRs.
b) Human GRs should be exempt.
c) Commodities generally traded in commercial distribution should in principle be exempt.
For example, GRs, such as industrial raw materials and agricultural produce that are ingeneral distribution, should be outside the scope of the domestic compliance measures.
d) It is important for user countries to verify to what extent the domestic access andbenefit-sharing (ABS) legislation or regulatory requirements of providing countries
comply with the NP. Depending on the extent of compliance, there may be a need toconsider differential treatments for different providing countries. Domestic compliancemeasures under the NP of user countries should be applicable only to those providing
countries whose domestic ABS legislation or regulatory requirements not only comply
with the NP (e.g., Article 6.3), but also are made available to the ABS Clearing-house(ABS-CH) (e.g., Article 14.2).
e) Domestic compliance measures under the NP should not interfere with domestic
intellectual property systems and product licensing systems.
4) The government should not force companies to disclose their confidential information in
the course of implementing domestic compliance measures under the NP. No disclosureof information besides what is disclosed on ABS-CH should be mandated.

2Japan Bioindustry Association
Grande bldg. 8F, 2-26-9 Hatchobori Chuo-ku, Tokyo, JAPANTelephone +81 3 5541 2731 Fax +81 3 5541 2737
Website www.jba.or.jp

Japan Bioindustry Association
2. Important points to consider when setting up checkpoint(s)1) The objective of checkpoint(s) is to support compliance by taking measures to monitor andto enhance transparency about utilization of GRs (NP Article 17.1). If a checkpoint(s)imposes a heavy bureaucratic burden, the vast majority of honest and compliant GRsusers would be victimized because of ill-willed users who are an extremely small fraction of
the society. The function of checkpoint(s) should never be a “policing mechanism.”
2) The establishment of checkpoint(s) means an additional burden for the companies andresearchers. Therefore, checkpoint(s) should be a pragmatic mechanism that functions
effectively, but should not hinder research, development and business operation.
Checkpoint(s) should meet all the points given above (Section 1: Certainty of Measures).
3) Checkpoint(s) should constantly study the domestic ABS legislation or regulatory
requirements of the providing countries made available to the ABS-CH, and have thecapability to make balanced and objective judgments to allegations from providingcountries.
3. Simultaneous implementation of “domestic compliance measures” and “measures
to facilitate access to genetic resources”“Domestic compliance measures under the NP” and “measures to facilitate access toGRs” are like the two wheels of a bicycle. Only when the two work together, the bicycle canfunction properly. By promoting this approach, both providers and users of GRs will benefit,and the ABS system function. The Ministry of Economy, Trade and Industry (METI) has beenpromoting this approach in cooperation with JBA, since 2005, by implementing, e.g., “Japan’sGuidelines on Access to Genetic Resources for Users”, “nationwide awareness-raisingseminars”, “specialized website”, and “help desk”.

Bilateral approach through microbial

resource centers has also been beneficial to both providers and users (e.g. researchcooperation between the National Institute of Technology and Evaluation of Japan and Asiancounterparts). We hope that the government will further reinforce this sort of measures under
the NP.

Developed by the ABS Committee of JBA member Companies
Prepared by the secretariat of Japan Bioindustry Association（JBA）
September 7, 2012

3Japan Bioindustry Association
Grande bldg. 8F, 2-26-9 Hatchobori Chuo-ku, Tokyo, JAPAN
Telephone +81 3 5541 2731 Fax +81 3 5541 2737
Website www.jba.or.jp