Recommendationsof theEU-Japan Business Round Table
to the Leaders of the European Union and JapanTokyo, 15 November 2022

Working Party 2
Life Sciences and Biotechnologies,
Healthcare and Well-being

Working Party Leaders:Mr. Julio Triana
President, Representative
Director & Senior Bayer
Representative for Japan
Bayer Holding Ltd.

Mr. Osamu Nagayama
Honorary Chairman
Chugai PharmaceuticalCo., Ltd.

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List of Abbreviations
Abbreviation
BRT
CAS
CEA
CGP
EIR
EPA
EU
EUA
GCP
GMO
GMP
GOJ
HTA
ICER
IP
ISHL
ISO
J-PMD Act
MDD
MDR
MDSAP
METI
MHLW
MRA
NHI
PBT/vPvB
PDSCL
PHR
PMDA
PMP
PRTR
QALY
QMS
R&D
REACH
RMP
SME
UK
WP

Meaning
Business Round Table
Chemical Abstracts Service
Cost Effectiveness Analysis
Comprehensive Genomic Profiling
Environment Impact Reduction
Economic Partnership Agreement
European Union
Emergency Use Authorisation
Good Clinical Practice
Genetically Modified Organism
Good Manufacturing Practice
Government of Japan
Health Technology Assessment
Incremental Cost Effectiveness Ratio
Intellectual Property
Industrial Safety and Health Law
International Organization for Standardization
Japanese Pharmaceutical and Medical Device Act
Medical Device Directive
Medical Device Regulation
Medical Device Single Audit Program Pilot
Ministry of Economy, Trade and Industry
Ministry of Health Labor and Welfare
Mutual Recognition Agreement
National Health Insurance
Persistent, Bioaccumulative and Toxic / very Persistent and very
Bioaccumulative
Poisonous and Deleterious Substance Control Law
Personal Health Records
Pharmaceutical and Medical Device Agency
Price Maintenance Premium
Pollutant Release and Transfer Register
Quality-adjusted life years
Quality Management System
Research & Development
Registration, Evaluation, Authorization, Restriction and Chemicals
Risk Management Plan
Small-to-mid-sized enterprise
United Kingdom
Working Party

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Introduction
Japan and the EU face many similar challenges, such as aging populations,shifting demands for products and services, food security and environmental
protection. In addition, the crisis caused by COVID-19 profoundly affected every
part of society and has underlined the importance of science and technology. Life
sciences and biotechnologies offer the possibility of technologies that will help
address these challenges and achieve both economic growth and sustainable
recycling-oriented society or bioeconomy society.
Working Party 2 focuses on the following sectors:• Life Science & Healthcare (pharmaceuticals and medical devices)• Biotechnology (agriculture and industry)• Animal Health• Industrial Chemicals
The recommendations of WP-2 have the clear aim to improve the innovation
capabilities of both the EU and Japan through concrete action plans in healthcare
and biotechnology. The focus is on measures that will enhance efficient
healthcare practices, sustainable agriculture, food production and supply, andhigh performance materials and that will eventually contribute to theestablishment of a bioeconomy society.
In addition to the publication of the Pharmaceutical Industry Vision 2021 by the
Ministry of Health, Labour and Welfare (MHLW) in Japan, which emphasizes theimportance of continuous innovation to protect people’s health and lives andthereby the need to promote pharmaceutical industry policy, the BRT welcomes“Basic Policy on Economic and Fiscal Management and Reform 2022” approvedby the Cabinet of Japan in June 2022. The Basic Policy stipulates investment toensure the quality and stable supply of pharmaceuticals, strengthen drug
discovery capabilities, improve science and technology capabilities, and realize
innovation. The BRT expects that public-private collaboration will be further
enhanced to realize the MHLW Vision and improve the drug discovery, researchand development systems as well as the international harmonization ofregulations to achieve an innovation-conducive environment.
The conclusion of the Economic Partnership Agreement (EPA) was a majorachievement for both sides and will bring mutual economic benefit.
Instead of an ending, the EPA should be seen as a beginning. It should be alaunch pad: a chance to renew our commitment to removing barriers to business;a chance to find new energy for strengthening our economic relationship; achance to deliver on the recommendations in this report. Let us take thosechances.
An asterisk (*) identifies “priority” recommendations.
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Recommendations from both
European and Japanese industries
LIFE SCIENCE & HEALTHCARE
WP-2 / # 01 / EJ to EJ
Regulatory environment should be improved for COVID-19 and infectious
disease control
The BRT calls on the EU and Japanese Authorities to:
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•
•
•

support the research, development, and manufacturing of diagnosis,
treatments and vaccines for COVID-19 and coordinately promotecollaborative actions of companies and/or academia to accelerate theirdevelopments, in alignment with the100 Days Mission proposed by G7, theambition to make safe and effective vaccines, therapeutics and diagnostics
available within 100 days of an epidemic or pandemic threat being identified,address the inequity in access to COVID-19 vaccines in collaboration withindustry and non-governmental organizations by removing barriers hindering
the equity,
protect and respect intellectual property rights of COVID-19 vaccines andtherapeutics, andcontinuously promote the research and development for other infectious
diseases especially for AMR (Antimicrobial Resistance).

The BRT believes that:•••

although collaborations among government, industry and academia havemade COVID-19 vaccines available at an unprecedented speed, COVID-19
vaccines are not equally reaching all populations worldwide. Traderestrictions and regulatory barriers should be removed to facilitate the crossborder supply of COVID-19 vaccines and support should be given to enhance
the infrastructure to deliver vaccination programs around the world,
respect of intellectual property rights is fundamental to stimulating R&D andensuring the scale up of supply. Waiving intellectual property rights on
COVID-19 vaccines and therapeutics would not assist in improving vaccine
equity but only undermine the ability to innovate and respond to ongoing andfuture global health threats, andovercoming the pandemic is the most important issue, but there are alsosignificant challenges in the medium to long term. The number of drugresistant bacteria is increasing, and if this situation continues, it is predictedthat the annual number of deaths worldwide by 2050 due to drug-resistantbacterial infections will rise to approximately 10 million. At the same time, it isnecessary to secure resources for solving such problems. Support for thedevelopment of new anti-infectives, including support for small-to-mid-sizedenterprises (SMEs) which play a critical role in developing innovative new
medicines, is vital. The BRT welcomes the governments’ recognition of theWorking Party 2 : Life Science and Biotechnology, Healthcare and Well-being
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need to foster SMEs. Building on some measures taken in response to the
COVID-19 pandemic, further enhancing public support is a way forward to
help hedge the risk of the research and development for emerging AMR andother infectious diseases.

WP-2 / # 02 / EJ to EJ
Mutual recognition should be improved for Medical Devices
Mutual recognition of quality management audit results for Medical
Devices should be established between EU and Japan.
The BRT calls on the EU and Japanese Authorities to:
•

•
•
•
•
•

introduce a mutual recognition scheme for Quality Management System(QMS) audit results, preferably through EU accession to the Medical Device
Single Audit Program Pilot, or through regulatory harmonization between the
EU and Japan,
harmonize submission-related formats and standards,
ensure post-approval QMS inspection dates coincide with the renewal ofmarketing authorization rather than every 5 years in order to simplify andassure proper renewal operation,
introduce mutual recognition of Medical Devices products for lower risk
classes as soon as possible,
harmonize the introduction schedule for new ISO standards, including a grace
period, thereby ensuring they apply the same revision of a particular ISO
standard, andaddress the issues above through the next revision of the J-PMD Act.

The BRT believes that:•

the QMS inspection process remains complicated and burdensome despite
Japan now accepting the ISO13485 audit report under the 2014 J-PMD Act.

There should be mutual recognition of Medical Devices product licenses.
The BRT calls on the EU and Japanese Authorities to:•mutually recognize Medical Devices product licenses. Existing similarities
between EU and Japanese regulations on low risk class II devices makemutual recognition on product licenses for this category of products possible.

The BRT calls on the Japanese Authorities to:•ensure PMDA and MHLW introduce mutual recognition, taking into accountthe difference in the classification of medical devices between Japan and theEU.
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The BRT calls on the EU Authorities to:••

improve their communication with the Government of Japan (GOJ) in relation
to the new Medical Device Regulation (MDR) implementation, andmonitor whether the switch from the Medical Device Directive to MDR does
indeed accelerate the mutual recognition of clinical trial results in Japan.

The BRT believes that:••

harmonizing QMS and classification should allow new products to be
introduced in both the EU and Japan within the same time frame and in one
process, andthe EU Authorities are communicating insufficient information to Japan about
the MDR.

There should be mutual recognition of clinical trial results for Medical
Devices.
The BRT calls on the Japanese Authorities to:•••accelerate mutual recognition of clinical trial results in actual operation, where
the conformity is currently insufficient due to the existing strict conditions
applied when accepting clinical evaluation reports originating outside ofJapan,
provide early disclosure of clear guidance for judgment on the need for clinicalstudies, conditions for acceptance, etc. in order to make the actual operationof GCP smoother, anddevelop guidelines for the effective utilization of clinical evaluation reports
soon. The EU industry side requests that the GOJ responds with specifictimelines for this action as this has been a previously listed request with nopractical progress.

The BRT believes that:•••

although foreign clinical trial data can be accepted in Japan as part of theapplication dossier under specific circumstances, additional datarequirements were sometimes imposed on manufacturers without providing
the rationale regarding such requests,
the acceleration of mutual recognition of clinical trial results for thedevelopment of new Medical Devices would ensure access to new products
for patients in Japan and the EU, both within the same timeframe and throughone process. This would allow for further reducing the device lag, ensuring ahigh level of quality whilst minimizing the administrative burden on
manufacturers, andearly disclosure of clinical trial-related guidance would promote the entry ofoverseas companies to the Japanese market.

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BIOTECHNOLOGY (AGRICULTURE)
WP-2 / # 03* / EJ to EJ
New technologies, including biopesticides, should be further promoted toachieve a paradoxical agenda of feeding population without starving theplanetThere is an urgent need to achieve sustainable development of agriculture aswell as environment protection. Climate change has led to increases in thefrequency and intensity of natural disasters and loss of biodiversity, which
affects agricultural production and jeopardizes food security. To reduce theenvironmental impact through agriculture production, both the EU and Japan
have developed sustainable food production policies, including a reduction in
the use and risk of chemical pesticides and an expansion of the land use fororganic farming. Innovation that enables the replacement of hazardous
chemical pesticides with safer pesticides is a key driver to achieving suchgoals. It is critical to promote new technologies, including biopesticides,
biostimulants and RNA interferences, to reduce the use and risk of chemical
pesticides and improve agricultural efficiency.
While many measures being developed to achieve a sustainable agriculture
system and environmental protection, BRT places a greater focus on thedevelopment of effective and safe technologies, including biopesticides,
biostimulants and RNA interferences, and methods to improve agricultural
productivity.
The BRT calls on the EU and Japanese Authorities to:
•
•

•
•
•

mutually accept biostimulants and biopesticides that are authorized in therespective markets without requiring local risk assessments,
further establish and enhance definitions, rules and guidelines forbiopesticides to promote the development and use of biopesticides. Make theregistration processes simple and efficient, similar to the comprehensive
system provided by the US Environmental Protection Agency with clear
definitions and guidelines, which enables the assessment and registration
with a minimum data package,develop scientifically sound data requirements and risk assessment
processes for products based on new technologies, like RNA interferences,develop a policy to encourage growers to adopt safer and more sustainable
solutions in their farming practices, andwork with stakeholders to promote emerging technologies for sustainable andprecision food production to lower the environmental load associated with
agricultural production.

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The BRT believes that:
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•
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as there is no single solution that fits all, integrated solutions are needed toachieve sustainable food production and environment impact reduction withlimited resources,
promotion of biopesticides, biostimulants and RNA interferences is a key toachieving environmental goals without impeding agricultural productivity,
enhancement and harmonization of registration systems for biopesticides inthe EU and Japan should support the achievement of their sustainable foodproduction policies and reduction of the use and risk of chemical pesticides,
andincentives to growers are necessary to promote new technologies forenvironmental impact reduction (EIR) to enable growers to benefit from EIR
initiatives.

WP-2 / # 04 / EJ to EJ
Legal clarity for and appropriate regulation for agricultural innovation,
including genetically modified crops and gene-edited crops, should beestablished.
The BRT calls on the EU and Japanese Authorities to:• regulate agricultural technologies, including crop protection, geneticallymodified (GM) and gene-edited (GE) crops in a science-based andproportionate manner,• advance and adhere to global harmonization of genetically modified
organisms’ risk assessments, and support the Global Low Level Presence
Initiative,• provide legal clarity on the status of techniques such as genome editing andcorresponding labelling requirements (e.g., for genome edited derived food),and• work with industry and other stakeholders to increase trust in the regulatory
science and gain greater societal acceptance.
The BRT believes that:• a fact-based platform for dialogue and sharing of information as well as a riskproportionate, predictable, science-based treatment of new technologies isrequired,• taking a science-based and proportionate regulatory approach to agricultural
technologies will aid in gaining societal acceptance and help to weed out
misinformation, and• ongoing regulations regarding data requirements for emerging technologies
are not fully updated resulting in duplication of studies.

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LIFE SCIENCE & HEALTHCARE
WP-2 / # 05* / EJ to J
Reform of the pharmaceutical pricing system should provide a stable,
predictable environment that rewards innovation
The BRT calls on Japanese Authorities to:• support the pharmaceutical industry in line with the Cabinet’s Basic Policy on
Economic and Fiscal Management and Reform 2022, in order for it to innovatein and accelerate new drug development and bring new drugs rapidly to meetthe needs of patients in Japan without any delay from other countries,• vitalize the drug discovery and development capabilities in Japan in line with
the MHLW’s Pharmaceutical Industry Vision 2021 by improving the current
pricing system to strengthen the reward for innovation and maintain an incentive
for companies,• determine a drug price that properly reflects evaluation which includes a wide
range of elements such as clinical efficacy to patients and doctors, and is
carried out under a transparent and highly predictable process,• limit the scope of off-cycle price revisions. Since drug expenditure has been
well controlled by the current pricing system, the scope of off-cycle pricerevisions must be limited to exceptional cases with huge discounts. Drug prices
of innovative patented products should be protected and should not be subject
to off-cycle price cuts,• avoid frequent revisions of the pharmaceutical pricing system and securesufficient lead time before the enforcement of any pricing rule changes toensure long-term business predictability,• expand the scope of pricing policy reforms beyond annual drug costs, as drug
costs are only one part of the overall and long-term healthcare costs, and• increase opportunities and time for constructive and meaningful dialogues
between the authorities and industry to allow the industry to provide input andensure transparency of policy decisions
The BRT believes that:••the administrative labour and costs involved in drug price surveys and drug
price revisions, which are required to implement annual revisions are aconsiderable cost driver and in consequence hinder a sustainable reduction
in medical costs. Therefore, in order to improve the return on investment andpolicy implications of the off-cycle price revision, it is necessary to limit therevision’s scope,
the repeated revisions to the pharmaceutical pricing system introduced since
2018 with as short as three-month notice, created significant issues withbusiness predictability for the Japanese market and could result in delayedaccess to the latest treatments for Japanese patients. Market predictability isessential as the development of innovative drugs requires long-term,
substantial investment,
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•

•

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the MHLW’s Pharmaceutical Industry Vision 2021 should be leveraged toencourage the industry to generate innovations in Japan. Unless innovation
is properly evaluated, it becomes increasingly challenging for the industry tocontinuously create innovative drugs to fulfil unmet medical needs. This will
not be beneficial for the patients nor for society,annual drug costs are only one part of the overall and long-term healthcare
costs: a holistic view is needed, and a fundamental reform should not belimited to managing drug prices only. Thus, to ensure long term healthcare
system sustainability while securing reward for innovation, future reforms
should include a review of all healthcare costs and revenue sources, including
medical fees, medical procedures, hospital stays, patient co-payments etc.,
andopportunities for the industry to provide input on healthcare and pricing reformare currently limited, with which meaningful discussions cannot be made.
Opportunities should be enhanced for more constructive dialogues andworking level discussions.

WP-2 / #06* / EJ to J
Regulatory environment should be improved to ensure fast access toground-breaking innovations
The BRT calls on the Japanese Authorities to:•••promote regulatory reform to enable flexible regulatory decision-making andaccelerate international regulatory harmonization, including removal ofJapan-specific regulatory standards and requirements, especially forregenerative medicine, to ensure fast access to innovations for the people inJapan without any delay from EU and other countries,
utilize regulatory processes, including priority review system, pioneering drug
designation system, exceptional approval system and emergency approvalsystem, more appropriately and effectively to promote evaluation andauthorisation of pharmaceuticals with high needs, as the criteria fordesignation are excessively stringent and the number of designations is muchsmaller in Japan than in other key countries, andapply more flexible evaluation processes for breakthrough innovations rather
than the conventional one-size-fits-all processes in order to adapt to rapidly
evolving healthcare innovations and to ensure that patients in need have fastaccess to them.

The BRT believes that:•while new scientific and medical capabilities are bringing more precision andpersonalized medicine, with the potential to overcome diseases where there
are currently no treatments available or where treatments have limitations, itis necessary to promote pro-innovation policies as well as regulatory
harmonization and convergence in Japan with more flexibility and adaptability

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•

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in regulatory and health insurance systems to ensure that patients in Japan
can benefit from latest innovations in the world,
minimizing Japan-specific standards and accepting more international data
will accelerate the authorization and availability of healthcare innovations inJapan, and more flexibility in accepting international data is vital to ensurethat patients in Japan have fast access to innovations,while MHLW intends to expedite the regulatory processes for emergency
cases, further regulatory harmonization and flexibility is needed not only for
emergency cases, anda paradigm shift is required in the evaluation and reimbursement systems tobring breakthrough innovations, such as cell and gene therapies, to patients.

WP-2 / # 07 / EJ to J
The environment for innovative Medical Devices should be improved in
Japan
Japan should further sub-divide the current functional classification for
Medical Devices
The BRT calls on the Japanese Authorities to:•••revise the reimbursement pricing scheme bringing it closer to a productoriented system,
improve the reward for innovation by sub-dividing current functionalclassifications, andset the reimbursement price for old products separately from thereimbursement price for new products.

The BRT believes that:•

it would be sensible to allow a certain period of time prior to conclusive
assessment, because it often takes time for the effectiveness of new products
to become apparent and for safety and efficacy to be adequately addressed.

The health insurance system for cancer genome profiling (CGP) testingshould be improved to ensure early access for patients to indicatedtesting
The BRT calls on the Japanese Authorities to:•enable patients to conduct CGP testing and receive their results at optimal
timings and types of samples using the public insurance system.

The BRT believes that:•

Tissue-based CGP testing and blood-based CGP testing which
comprehensively detect cancer-related genes have been covered by national
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health insurance and reimbursed as a medical device since June 2019 andAugust 2021 respectively, but there is a restriction that they are reimbursed
only if CGP testing is performed either by tissue or blood at the end of thestandard of care when patients already get drug resistance or are in worse
general status. An environment is socially demanded where each patient can
get access to CGP testing at early and optimal timings and types of samples.
Enhanced accessibility to CGP testing is expected to improve access to safer
and more effective treatments tailored to individual patient needs, andtreatment approaches developed based on genetic information will lead tofurther improvement in the quality of healthcare.
WP-2 / # 08 / EJ to J
Health Technology Assessment (HTA) should be carefully applied
Health Technology Assessment (HTA) for Pharmaceuticals should not
become a barrier for patient access
The BRT calls on the Japanese Authorities to:••

keep refining the system of using HTA and Cost Effectiveness Analysis (CEA)
for Pharmaceuticals, andrefrain from using CEA in making reimbursement decisions.

The BRT believes that:
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•

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use of CEA for reimbursement decisions would possibly lead to a recurrenceof drug lag and fully agrees with the government’s decision not to use CEA todecide reimbursement. CEA/HTA should be positioned as being
supplemental to the current drug pricing system and a scientific approachshould be ensured in the process,significant additional values that new medicines bring about need to beassessed comprehensively and transparently, involving multiple stakeholders
including patients. Disease severity, unmet need, ethical, and societal
considerations should be considered as additional factors in evaluating thetrue value of drugs. Through this approach, Japan should establish a morebalanced HTA system,
careful use and interpretation of the estimated ICER values is required as
ICERs calculated from models based on various data and assumptions
inevitably contain uncertainties, andall stakeholders, including clinical experts from both the public analysis teamand industry, should fully participate in the discussion of refining the newly
introduced system to ensure that the experiences and failures of othercountries are duly evaluated and considered.

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HTA for Medical Devices should be introduced with caution
The BRT calls on the Japanese Authorities to:•be prudent in the introduction of HTA (Health Technology Assessment)
systems for Medical Devices taking into account the following factors:- QALY, an indicator often used in HTA evaluation for pharmaceuticalproducts is difficult to be applied for the evaluation of medical devices;- users’ skills and techniques of each medical device can affect theevaluation;- medical devices have a shorter improvement cycle than pharmaceuticals.

The BRT believes that:•

it is important that HTA systems do not hinder the creation of innovative
products, delay the listing for medical insurance reimbursement, or impose
an excessive burden on the industry (e.g., development of databases oradding human resources). Such outcomes would delay patient access to
cutting-edge medical technologies. To avoid this, there should be a clear
distinction and balance between assessment and appraisal. There should be
no inappropriate use of the ICER measure.

WP-2 / # 09 / EJ to J
A harmonized approach for integration of health-related data andconstruction of data health infrastructures should be established
The BRT calls on the Japanese Authorities to:••foster a harmonized approach for the integration of health-related data inorder to accelerate digital transformation and strongly promote theconstruction of data health infrastructures in the medical field of Japan, andaccelerate the integration according to the grand design under crossministerial guidance.

The BRT believes that:•••

personal health records (PHR) will directly contribute to individual patients’choice of personalised treatments,
the integrated health data will be fundamental to accelerate digitaltransformation in the medical field of Japan and promote evidence-based
policymaking in health areas to improve the efficiency of healthcare, medical
services and nursing care, andutilization of big data by academia and industries will lead to new products
and services.

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WP-2 / # 10 / EJ to J
Infectious disease control and vaccine policies should be reinforced
The BRT calls on the Japanese Authorities to:
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accelerate international harmonization of vaccine regulations and minimize
Japan-specific standards to offer access to vaccines to people in Japan
without delay,
promote regulatory reform to enable flexible regulatory decision-making
depending on the evidence level and urgency, including improvement of theEmergency Use Authorization (EUA) system and expansion of the use of theconditional approval system,
oppose a waiver on intellectual property rights on COVID-19 vaccines andtherapeutics by the WTO Agreement on Trade-Related Aspects of Intellectual
Property Rights (TRIPs), andreinforce infectious disease control, preventive medicine and vaccine policies,
including the national immunization program, using learnings from the
COVID-19 pandemic.

The BRT believes that:•••the people in Japan suffer a disadvantage from delayed access to COVID-19
vaccines, largely resulting from a lack of international regulatory
harmonization and limited agility in regulatory systems to respond to the
public health emergency. The BRT welcomes MHLW’s plan to expedite theregulatory processes for emergency cases. Japan-specific standards should
be minimized and fast access to vaccines and therapeutics should beensured for the people in Japan,
waiving patents on COVID-19 vaccines would not assist the capacity
expansion of COVID-19 vaccines but only induce the risk of counterfeit
vaccines and negate any innovation-based response to future pandemics,
andinvesting in preventive medicine and infectious disease control is one of theimportant pillars for our healthcare system to ensure a healthy and safe
society. It requires a robust national strategy and upfront investment topromote vaccine development and infectious disease control.

BIOTECHNOLOGY (INDUSTRY)
WP-2 / # 11/ EJ to J
Fostering bioeconomy by encouraging small-to-mid-sized enterprises,
such as start-up companies should be promoted
The BRT calls on the Japanese Authorities to:•enhance support for the development of business environment and promote
innovations driven by small-to-mid-sized enterprises, such as start-up

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companies under the Pharmaceutical Industry Vision 2021 and the actionplans in Bio Strategy 2020, authorized by the GOJ.
The BRT believes that:••

supporting start-up companies, from every aspect of their business activities,
such as research, development, human resources, funding etc., is importantfor innovation in the Healthcare sector, andplanning and implementation of specific measures for this bio-strategy allows
for an early opportunity to cooperate and collaborate with European
stakeholders engaged in the bioeconomy promotion in the EU and Japan, toaim at sustainable development of the economy in both EU and Japan.

BIOTECHNOLOGY (AGRICULTURE)
WP-2 / # 12 / EJ to J
New technologies, including biopesticides and biostimulants, should befurther promoted to achieve both environment protection and sustainableagriculture
The BRT calls on the Japanese Authorities to:••encourage a reduction in the use of antibiotics in agriculture production to
reduce the risk of the well-being of humans, andpromote the development of new technologies to reduce the use of soil
fumigants which would represent about 50% of chemical inputs.

The BRT believes that:•

key technologies include newer and safer chemicals with higher selectivity
or farming practice, such as crop rotation or improved soil health withimproved soil diagnosis.

WP-2 / # 13 / EJ to J
Reviewing period for genetically modified crops should be shortened
The BRT calls on the Japanese Authorities to:•••further shorten reviewing period through harmonization in data requirement
for genetically modified crops as well as dossier on human & environment
safety, and through acceptance of summaries in English, as well as
take advantage of the evaluation results from foreign countries in order toreduce the resource burden on the Japanese authorities, andexpand the scope of the genetically modified crops for which local confined
field testing may be excluded to genetically modified soybean and other crops
based on accumulated evidence and scientific justification by leveraging
confined field testing data from foreign countries.
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The BRT believes that:
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along with the unstable international situation and rising food prices, concerns
are growing over stable food supply in Japan. Delivering novel and safe seeds
is vital for addressing such concerns by increasing food production, saving
labour and energy in agriculture and reducing environmental impact,
while R&D-intensive companies are continuously and heavily investing in newtechnologies, the innovation will not contribute to food production without theirgovernmental approval. Hence, early market access to novel geneticallymodified crops is crucially important,delayed market access to novel genetically modified crops will cause
technology gaps, resulting in unnecessary disadvantages for farmers due tolimited access to innovative products,
further progress in shortening the reviewing period would bring Japan muchcloser to international best practice standards, while the BRT acknowledges
the shortened time to market for new active substance of crop protection
products, andharmonizing international data requirements will enable the industry to avoid
duplicated investment for market access in the respective area. Currently only
China and Japan request local confined field testing for GMO crops for importuse, while other import countries like the EU, Korea and Taiwan etc. leverage
the field data collected in cultivation countries for safety assessment.

WP-2 / # 14 / EJ to E
Measures should be established to secure a stable supply of agriculturalchemicals to importing countries
The BRT calls on the EU Authorities to:•

Not to immediately stop production and exportation of the pesticidal active
substances banned in the EU as they are critically important for stable foodproduction in the countries that import them from the EU.

The BRT believes that:•••

Pesticides are essential materials for the stable and sustainable production ofaffordable foods,
The EU policy not to produce and export the pesticidal active substancesbanned in the EU under the Chemicals Strategy for Sustainability in the EU
New Green Deal will affect the stable and sustainable production of affordable
foods globally, while the BRT respects the EU decision,
Because of their intrinsic hazardous properties of pesticidal active substances,the quality and use of pesticides are highly regulated, and they are only used
after intensive risk assessments in respective countries. Any addition orchange in the sourcing of pesticidal active substances is strictly controlled andrequires demonstration of the equivalence, and thereby stable production andWorking Party 2 : Life Science and Biotechnology, Healthcare and Well-being
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•

supply of high-quality active substances is critically important, andPesticides are highly regulated in the destination countries and the use ofsuch pesticides in the destination countries is different from that in the EU and
thereby the outcomes of the pesticide use are different.

Recommendations from European industries
LIFE SCIENCE & HEALTHCARE
WP-2 / # 15 / E to J
Requirements for Japanese versions of the clinical trial protocol andinvestigator’s brochure should be relaxed
The BRT calls on the Japanese Authorities to:•accept clinical trial protocols and investigator’s brochures as well as
applications, which are written only in English.

The BRT believes that:••

acceptance of English-only protocols and investigator’s brochures would
reduce costs and make innovative drugs available to patients in Japan more
quickly, andthe requirement for translation of the original English version of a clinical trial
notification is delaying the start of patients’ enrolment in Japan.

INDUSTRIAL CHEMICALSWP-2 / # 16 / E to J
English translations for issued regulations should be provided
The BRT calls on the Japanese Authorities to:•provide English translations of all issued regulations from METI (Ministry of
Economy, Trade, and Industry) and MHLW at the same time as, or shortly
after, the announcement in Japanese.

The BRT believes that:•Japan’s regulating authorities should provide English translations of issued
regulations, adapting to global practice and thereby enhancing Japan’s
presence in the world market.

Working Party 2 : Life Science and Biotechnology, Healthcare and Well-being
EU-Japan BRT 2022 Recommendation Report
Page 17 of 19

WP-2 / # 17/ E to J
Reference to CAS numbers in regulations for Chemical substances should
be provided
The BRT calls on the Japanese Authorities to:•indicate CAS (Chemical Abstract Services) numbers in addition to chemicalcompound names in regulations issued by authorities, as has become a
global practice.

The BRT believes that:•

if METI and MHLW regulations would refer to Chemical Abstracts Service(CAS) numbers in addition to chemical compound names, risks of differinginterpretations and varying degrees of regulatory compliance can be avoided.
In addition, swift and accurate internal alignment of concerned companies
could be ensured.

WP-2 / # 18 / E to J
Naming requirements for product labels of chemicals with the names usedin Japanese law should be aligned
The BRT calls on the Japanese Authorities to:•revise the labelling requirement of the Poisonous and Deleterious SubstanceControl Law (PDSCL) to indicate chemicals in accordance with the namingused in Japanese law instead of stating the specific names of the included
substance.

The BRT believes that:••a harmonization of the labelling requirement regulations (PDSCL, ISHL andPRTR) to list the contained chemical “as regulated by the Japanese law” on
the label would allow users to quickly assess the toxicity and regulatory
relevance of the materials they handle, andthe discrepancies between naming in Japanese regulations and productlabelling requirements pose a risk that substances are used without a clear
understanding of the regulations they relate to. This should be avoided.

Working Party 2 : Life Science and Biotechnology, Healthcare and Well-being
EU-Japan BRT 2022 Recommendation Report
Page 18 of 19

Recommendations from Japanese industries
ANIMAL HEALTH
WP-2 / # 19 / J to EJ
Mutual recognition of GMP for Animal Health products should be ensured
The BRT calls on the EU and Japanese Authorities to:••agree on the mutual recognition of European and Japanese marketing
authorizations for veterinary products, starting with mutual recognition of
GMP certification of veterinary medicines, andinclude veterinary products within the scope of the MRA (Mutual Recognition
Agreement).

The BRT believes that:•mutual recognition of GMP certification for veterinary products between the
EU and Japan will provide for faster access to new useful products.

INDUSTRIAL CHEMICALSWP-2 / # 20 / J to E
The draft regulations on microplastics for cosmetics in EU under REACH(regulation for chemicals) should be reconsidered
The BRT calls on the EU Authorities to:•derogate all wiped-off cosmetic products (make-up, lip and nail products) fromthe restriction of microplastics.

The BRT believes that:•microplastic emission from make-up, lip and nail cosmetic products to theaquatic environment is insignificant, because they are wiped-off after theiruse and, in addition, they are trapped in sewage treatment systems.
Restriction of make-up, lip and nail cosmetic products does not contribute to
reducing the environmental impact.

(Document ends)

Working Party 2 : Life Science and Biotechnology, Healthcare and Well-being
EU-Japan BRT 2022 Recommendation Report
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