Recommendationsof theEU-Japan Business Round Table
to the Leaders of the European Union and Japan
Brussels, 7 November 2023

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 Pharmaceutical Co., 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 forStandardization
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 Labour and Welfare
Mutual Recognition Agreement
National Health Insurance
Persistent, Bioaccumulative and Toxic /very Persistent and very
Bioaccumulative
Poisonous and Deleterious SubstanceControl Law
Personal Health Records
Pharmaceutical and Medical Device
AgencyPrice Maintenance Premium
Pollutant Release and Transfer Register
Quality-adjusted life years
Quality Management System
Research & Development
Registration, Evaluation, Authorisation,
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 ageing populations, shifting
demands for products and services, food security, and environmental protection. In
addition, geopolitical issues have profoundly been affecting many parts of society. Life
sciences and biotechnologies offer the possibility of technologies that will help addressthese challenges and achieve both economic growth and a sustainable recyclingoriented society or bioeconomy society.
Working Party 2 focuses on the following sectors:• Life Science & Healthcare (pharmaceuticals and medical devices)• Biotechnology (agriculture, food, 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 andbiotechnology. The focus is on measures that will enhance efficient healthcare
practices, sustainable agriculture, food production and supply, and high-performancematerials, eventually contributing to the establishment of a bioeconomy society.
The BRT welcomes the aims of both the EU and Japan to support competitiveness andinnovation, improve access to medicines, and secure a stable medicine supply as
provided in the EU Pharmaceutical Strategy for Europe and the “Basic Policy on
Economic and Fiscal Management and Reform 2023”, respectively. While the EU andJapan share common challenges to regain the attractiveness for investment ininnovation, the BRT expects that comprehensive and sustainable measures will be takenin the EU and Japan to retain their roles to lead innovation. The BRT hopes that therecommendations in this report would help develop solutions to remove barriers toinnovation and enhance their innovation ecosystems and drive economic growth whilestrengthening our economic relationship.
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
infectious disease control

The BRT calls on the EU and Japanese Authorities to:•Protect and respect intellectual property rights of vaccines, diagnostics, andtherapeutics, and•Continuously promote the research and development for infectious diseases,
especially for antimicrobial resistance (AMR) by reinforcing incentives.

The BRT believes that:•

Respect of intellectual property rights is fundamental to stimulating research anddevelopment and ensuring supply. Waiving intellectual property rights on any
vaccines and therapeutics would undermine the ability to innovate and respond toongoing and future global health threats.

•

The number of drug-resistant bacteria is increasing, and if this situation continues,
it is predicted that the annual number of deaths worldwide by 2050 due to drugresistant bacterial infections will rise to approximately 10 million.

•

The European Commission’s adoption of stepping up EU actions to combat AMR
is expected to lead to effective measures, which should incentivise antimicrobial
development and provide predictability in access, and•

It is necessary to secure resources for solving AMR 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. Further enhancing public support is a way forward to help hedge
the risk of the research and development for emerging AMR and other 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 harmonisation between the EU and Japan.

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•Harmonise submission-related formats and standards.

•

Ensure post-approval QMS inspection dates coincide with the renewal of marketing
authorisation rather than every 5 years in order to simplify and assure proper
renewal operation.

•

Introduce mutual recognition of Medical Devices products for lower risk classes assoon as possible.

•

Harmonise the introduction schedule for new ISO standards, including a grace
period, thereby ensuring they apply the same revision of a particular ISO standard,and•Address 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 recognise Medical Devices product licenses. Existing similarities between
EU and Japanese regulations on low-risk class II devices make mutual recognitionof 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 account thedifference in the classification of medical devices between Japan and the EU.

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, and•Monitor 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:•

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

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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 theconformity is currently insufficient due to the existing strict conditions applied when
accepting clinical evaluation reports originating outside of Japan.

•

Provide early disclosure of clear guidance for judgment on the need for clinicalstudies, conditions for acceptance, etc. in order to make the actual operation of GCP
smoother, and•Develop guidelines for the effective utilisation of clinical evaluation reports soon.
The EU industry side requests that the GOJ responds with specific timelines for thisaction as this has been a previously listed request with no practical progress.

The BRT believes that:•

Although foreign clinical trial data can be accepted in Japan as part of theapplication dossier under specific circumstances, additional data requirements
were sometimes imposed on manufacturers without providing the rationale
regarding such requests.

•

The acceleration of mutual recognition of clinical trial results for the development of
new Medical Devices would ensure access to new products for patients in Japanand the EU, both within the same timeframe and through one process. This would
allow for further reducing the device lag, ensuring a high level of quality whilst
minimising the administrative burden on manufacturers, and•Early disclosure of clinical trial-related guidance would promote the entry ofoverseas companies into the Japanese market.

Biotechnology (Agriculture)
WP-2 / # 03* / EJ to EJ

New technologies, including biopesticides, should befurther promoted to achieve a paradoxical agenda offeeding population without starving the planet

There is an urgent need to achieve sustainable development of agriculture as well as
environmental protection. Climate change has led to increases in the frequency andintensity of natural disasters and loss of biodiversity, which affects agricultural
production and jeopardises food security. To reduce the environmental impact throughagricultural production, both the EU and Japan have developed sustainable foodproduction policies a reduction in the use and risk of chemical pesticides and an
expansion of the land use for organic farming.
Innovation that enables the replacement of hazardous chemical pesticides with safer
pesticides is a key driver to achieving such goals. It is critical to promote newtechnologies, including biopesticides, biostimulants, and RNA interferences, to reduce
the use and risk of chemical pesticides and improve agricultural efficiency.

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While many measures are being developed to achieve a sustainable agriculture systemand environmental protection, BRT places a greater focus on the development ofeffective and safe technologies, including biopesticides, biostimulants and RNAinterferences, and methods to improve agricultural productivity.
The BRT calls on the EU and Japanese Authorities to:•

Mutually accept biostimulants and biopesticides that are authorised in therespective markets without requiring local risk assessments.

•

Further establish and enhance definitions, rules, and guidelines for biopesticides topromote the development and use of biopesticides. Make the registration processes
simple and efficient, similar to the comprehensive system provided by the US
Environmental Protection Agency with clear definitions and guidelines, whichenables 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, and•Work with stakeholders to promote emerging technologies for sustainable andprecision food production to lower the environmental load associated with
agricultural production.

The BRT believes that:•As there is no single solution that fits all, integrated solutions are needed to achievesustainable food production and environment impact reduction with limited
resources.

•

Promotion of biopesticides, biostimulants, and RNA interferences is key toachieving environmental goals without impeding agricultural productivity.

•

Enhancement and harmonisation of registration systems for biopesticides in the EU
and Japan should support the achievement of their sustainable food production
policies and reduction of the use and risk of chemical pesticides, and•Incentives to growers are necessary to promote new technologies forenvironmental impact reduction (EIR) to enable growers to benefit from EIR
initiatives.

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WP-2 / # 04 / EJ to EJ

Legal clarity for and appropriate regulation for
agricultural innovation, including genetically modified
crops and genome-edited crops, should be established

The BRT calls on the EU and Japanese Authorities to:•Regulate agricultural technologies, including crop protection, genetically modified(GM) and genome-edited (GE) crops in a science-based and proportionate manner.

•

Advance and adhere to global harmonisation 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 scienceand 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 weed out
misinformation, and•Ongoing regulations regarding data requirements for emerging technologies are
not fully updated resulting in duplication of studies.

Biotechnology (Food Tech)
WP-2 / # 05*/ EJ to EJ

Emerging food technologies should be promoted toensure food security while minimising theenvironmental impact

The BRT calls on the EU and Japanese Authorities to:•

Promote emerging food technologies to secure food supply while reducing theenvironmental burden, and•Establish and harmonise regulations that are necessary to advance food techs.

The BRT believes that:•

Reducing the environmental burden and achieving a sustainable food supply is anurgent issue and requires the development of new technologies and investment in
new fields as the global food demand is estimated to increase to 1.7 times the 2010
level by 2050 while the environmental burden by agriculture, forestry, and fisheries
is on the increase.

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•Food techs, such as plant- or insect-based foods, genome-edited foods, cultured
meat or cellular foods, and foods utilising microorganisms, are expected to provide
alternative ways to meet the increasing demand for proteins, lipids, carbohydrates,
etc.,

•

Approvals for new food products are currently granted earlier in countries outside
Europe and Japan, such as Singapore and the US, resulting in delays inrulemaking, market development, and investment for food techs. It is necessary togain the trust and interest of investors and entrepreneurs by clarifying the process
to launch such products, establishing rules and regulations and improving thebusiness environment.

•International harmonisation and standardisation of regulations in the food tech field
are necessary to activate imports and exports and promote technology transfer.

•

Open innovation should be promoted through collaboration between establishedbusinesses and startups to apply innovative technologies from various fields to foodtechs, and•

It is vital to foster an understanding of new food products and acceptance among
consumers, existing industry and agricultural producers, to promote use ofalternatives through incentives, credits, etc., and to strengthen research on newtechnologies (food techs) and human resource development at universities.

Biotechnology (Industry)
WP-2 / # 06 / EJ to EJ

Utilisation of DSI (Digital Sequence Information on
Genetic Resources) should be carefully discussed

The BRT calls on the EU and Japanese Authorities to:•

Discuss carefully, the establishment of a benefit-sharing multilateral mechanism forthe use of DSI, which will be considered for the next COP16, to ensure that the
impact on industry and open innovation is kept within appropriate limits and thatscientific progress is not negatively impacted, as adopted in the second part of the
15th Conference of the Parties (COP15) to the Convention on Biological Diversity
in Montreal, Canada, in December 2022.

The BRT believes that:•

The definition and scope of DSI, the multilateral system for DSI benefit sharing, theobjective and manner of benefit sharing, the point in time when benefit sharing
becomes effective, etc., should be discussed and determined in a fair and equitablemanner in a public forum to find solutions that meet the following criteria:••

Efficient, feasible, and practical; generate more benefits; provide certainty andlegal clarity; not hinder research and innovation; and be consistent with open
access to data,

It is also essential that an appropriate, fair, and equitable collection and distribution
system be established so that there is no bias toward either developed ordeveloping countries, andWorking Party 2: Life Science and Biotechnology, Healthcare and Well-being
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•

It is critical that the EU and Japan show leadership in this area in order to address
many of the biodiversity issues and to defend the line that industry must uphold.
Life Science & Healthcare

WP-2 / # 07* / EJ to J

Reform of the pharmaceutical pricing system should
provide a stable, predictable environment thatrewards innovation

The BRT calls on Japanese Authorities to:•

Support the pharmaceutical industry to innovate in and accelerate new drug
development and bring new drugs rapidly to meet the needs of patients in Japan
without any delay from other countries and to eliminate “drug lag” and “drug loss”.

•

Vitalise the drug discovery and development capabilities in Japan in line with the
MHLW’s Pharmaceutical Industry Vision by improving the current pricing system tostrengthen the reward for innovation and maintain an incentive for companies.

•

Optimise the reimbursement and payment systems for emerging technologies,
including cell and gene therapies, so that patients and society can reap thetransformative benefits of innovations.

•

Determine a drug price that properly reflects evaluation which includes a wide rangeof elements such as clinical efficacy to patients and doctors and patient-reported
outcomes, and is carried out under a transparent and highly predictable process.

•

Limit the scope of off-cycle price revisions. Since drug expenditure has been wellcontrolled by the current pricing system, the scope of off-cycle price revisions mustbe 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 secure sufficientlead time before the enforcement of any pricing rule changes to ensure long-termbusiness predictability and facilitate investment decisions.

•

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 and ensuretransparency of policy decisions.

The BRT believes that:•

The repeated revisions to the pharmaceutical pricing system introduced in 2018 withas short as three-month notice, created significant issues with businesspredictability for the Japanese market resulting in delayed access to the latest
treatments for patients in Japan. Market predictability is essential as thedevelopment of innovative drugs requires long-term, substantial investment, unlessinnovation is properly evaluated, it becomes increasingly challenging for theindustry to continuously create innovative drugs to fulfil unmet medical needs. This
will not be beneficial for the patients nor for society.

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•A paradigm shift in the reimbursement and payment systems is needed fortransformative cell and gene therapies with the potential to cure diseases, which is
not contemplated in the current systems.

•

Among key developed markets in the world, Japan is the only country with pricing
rules that provide mandatory annual price reductions for new drugs during thepatent period, and•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 be limited to
managing drug prices only. Thus, to ensure long-term healthcare system
sustainability while securing rewards 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.

WP-2 / #08* / EJ to J

Regulatory environment should be improved toensure fast access to ground-breaking innovations

The BRT calls on the Japanese Authorities to:•

Promote regulatory reform to enable flexible regulatory decision-making andaccelerate international regulatory harmonisation to ensure fast access toinnovations for the people in Japan without any delay from EU and other countries.

•

Utilise regulatory processes, including priority review system, pioneering drug
designation system, exceptional approval system, and emergency approvalsystem, more appropriately and effectively to promote evaluation and authorisationof pharmaceuticals with high needs, as the criteria for designation are excessively
stringent and the number of designations is much smaller in Japan than in other key
countries, and•Apply more flexible evaluation processes for breakthrough innovations rather thanthe conventional one-size-fits-all processes in order to adapt to rapidly evolving
healthcare innovations and to ensure that patients in need have fast access to them.

The BRT believes that:•

While new scientific and medical capabilities are bringing more precision andpersonalised medicine, with the potential to overcome diseases where there are
currently no treatments available or where treatments have limitations, it isnecessary to promote pro-innovation policies as well as regulatory harmonisationand convergence in Japan with more flexibility and adaptability in regulatory andhealth insurance systems to ensure that patients in Japan can benefit from thelatest innovations in the world.

•

Minimising Japan-specific standards and accepting more international data will
accelerate the authorisation and availability of healthcare innovations in Japan, andmore flexibility in accepting international data is vital to ensure that patients in Japan
have fast access to innovations.

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•While MHLW intends to expedite the regulatory processes for emergency cases
and the BRT welcomes the recent improvement in the number of the designationof pioneering products, further regulatory harmonisation and flexibility are needed
not only for emergency cases, and•A paradigm shift is required in the evaluation and reimbursement systems to bringbreakthrough innovations, such as cell and gene therapies, to patients.

WP-2 / # 09 / 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
classifications, and•

Set the reimbursement price for old products separately from the reimbursement
price for new products.

forinnovationbysub-dividing

currentfunctional

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) testing shouldbe improved to ensure early access for patients to indicated testing
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 health insurance andreimbursed as a medical device since June 2019 and August 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 the standard of care when patients alreadyget drug resistance or are in worse general status. An environment is sociallydemanded 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, and treatment approaches developed based on genetic information
will lead to further improvement in the quality of healthcare.

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WP-2 / # 10 / EJ to J

Health Technology Assessment (HTA) should be
carefully applied

Health Technology Assessment (HTA) for Pharmaceuticals should not becomea barrier to patient access
The BRT calls on the Japanese Authorities to:•

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

The BRT believes that:•

Use of CEA for reimbursement decisions would possibly lead to a recurrence ofdrug lag and fully agrees with the government’s decision not to use CEA to decidereimbursement. CEA/HTA should be positioned as being supplemental to thecurrent drug pricing system and a scientific approach should be ensured in theprocess,•

significant additional values that new medicines bring about need to be assessed
comprehensively and transparently, involving multiple stakeholders including
patients. Disease severity, unmet need, and ethical, and societal considerations
should be considered as additional factors in evaluating the true value of drugs.
Through this approach, Japan should establish a more balanced HTA system.

•

Careful use and interpretation of the estimated ICER values are required as ICERs
calculated from models based on various data and assumptions inevitably contain
uncertainties, and•All stakeholders, including clinical experts from both the public analysis team andindustry, should fully participate in the discussion of refining the newly introduced
system to ensure that the experiences and failures of other countries are duly
evaluated and considered.

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 device,•

Users’ skills and techniques of each medical device can affect theevaluation,•

Medical devices have a shorter improvement cycle than pharmaceuticals.

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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 or adding humanresources). 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 / # 11 / EJ to J

A harmonised approach for integration of healthrelated data and construction of data healthinfrastructures should be established

The BRT calls on the Japanese Authorities to:•

Foster a harmonised approach for the integration of health-related data in order toaccelerate digital transformation and strongly promote the construction of data
health infrastructures in the medical field of Japan, and•

Accelerate the integration according to the grand design under cross- ministerial
guidance.

The BRT believes that:•

Personal health records (PHR) will directly contribute to individual patients’ choiceof personalised treatments.

•

The integrated health data will be fundamental to accelerate digital transformationin the medical field of Japan and promote evidence-based policymaking in healthareas to improve the efficiency of healthcare, medical services, and nursing care.

•

Utilisation of big data by academia and industries will lead to new products andservices, and•

Acceleration of the digital transformation is therefore much expected while the BRT
welcomes the initiatives led by the Cabinet Office on the healthcare digitaltransformation.

WP-2 / # 12 / EJ to J

Infectious disease control and vaccine policies should
be reinforced

The BRT calls on the Japanese Authorities to:•

Accelerate international harmonisation of vaccine regulations and minimise Japanspecific standards to offer access to vaccines to people in Japan without delay.

•

Promote regulatory reform to enable flexible regulatory decision-making dependingon the evidence level and urgency, including improvement of the Emergency Use
Authorization (EUA) system and expansion of the use of the conditional approvalsystem, andWorking Party 2: Life Science and Biotechnology, Healthcare and Well-being
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•

Reinforce infectious disease control, preventive medicine, and vaccine policies,
including the national immunisation program, using learnings from the COVID19 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 harmonisation andlimited agility in regulatory systems to respond to the public health emergency. The
BRT welcomes MHLW’s plan to expedite the regulatory processes for emergency
cases. Japan-specific standards should be minimised and fast access to vaccines
and therapeutics should be ensured for the people in Japan, and•Investing 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 to promote vaccine
development and infectious disease control

Biotechnology (Industry)
WP-2 / # 13 / EJ to J

Fostering bioeconomy by encouraging small-to-midsized enterprises, such as start-up companies should
be promoted

The BRT calls on the Japanese Authorities to:•

Accelerate the project to promote the drug discovery venture ecosystem by theJapan Agency for Medical Research and Development, enhance support for thedevelopment of the business environment, and promote innovations driven bysmall-to-mid-sized enterprises, such as start-up companies under the
Pharmaceutical Industry Vision and the action plans in Bio Strategy 2020,
authorised by the GOJ.

The BRT believes that:•

Supporting start-up companies, from every aspect of their business activities, suchas research, development, human resources, funding, etc., is important for
innovation in the healthcare sector,•

Enhancing the project to promote the drug discovery venture ecosystem should
help to secure investment in drug development and commercialisation in Japan andensure the availability of breakthrough innovations, including gene and celltherapies, without delay from other countries, and•Planning and implementation of specific measures for this bio-strategy allow for an
early opportunity to cooperate and collaborate with European stakeholders
engaged in the bioeconomy promotion in the EU and Japan, to aim at sustainable
development of the economy in both EU and Japan.

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Biotechnology (Agriculture)
WP-2 / # 14 / EJ to J

New technologies, including biopesticides andbiostimulants, should be further promoted to achieveboth 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 to the well-being of humans, and•Promote 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 with improved soil
diagnosis.

WP-2 / # 15/ 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 harmonisation in data requirement for
genetically modified crops as well as dossier on human & environment safety, andthrough acceptance of summaries in English, as well as•

Take advantage of the evaluation results from foreign countries in order to reduce
the resource burden on the Japanese authorities, and•Expand the scope of the genetically modified crops for which local confined fieldtesting may be excluded to other crops and traits based on accumulated evidence
and scientific justification by leveraging confined field-testing data from foreigncountries.

The BRT believes that:•

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 genetically modified
crops is crucially important.

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•

Delayed market access to novel genetically modified crops will cause technology
gaps, resulting in unnecessary disadvantages for farmers due to limited access toinnovative products.

•

Further progress in shortening the reviewing period would bring Japan much closer
to international best practice standards, while the BRT acknowledges the shortened
time to market for the new active substance of crop protection products, and•Harmonising 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 import use, whileother import countries like the EU, Korea, Taiwan, etc. leverage the field datacollected in cultivation countries for safety assessment.

WP-2 / # 16 / EJ to E

Measures should be established to secure a stablesupply of agricultural chemicals 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 substances bannedin 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, thequality and use of pesticides are highly regulated, and they are only used after
intensive risk assessments in respective countries. Any addition or change in thesourcing of pesticidal active substances is strictly controlled and requires
demonstration of the equivalence, and thereby stable production and supply ofhigh-quality active substances is critically important, and•Pesticides are highly regulated in the destination countries and the use of suchpesticides in the destination countries is different from that in the EU and thereby theoutcomes of the pesticide use are different.

Working Party 2: Life Science and Biotechnology, Healthcare and Well-being
EU-Japan BRT 2023 Recommendation Report
Page 17 of 20

Recommendations from European industries
Industrial Chemicals
WP-2 / # 17 / 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, theannouncement 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 presencein the world market.

WP-2 / # 18/ 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 differing interpretationsand varying degrees of regulatory compliance can be avoided. In addition, swift andaccurate internal alignment of concerned companies could be ensured.

WP-2 / # 19 / E to J

Naming requirements for product labels of chemicals
with the names used in 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 naming used inJapanese law instead of stating the specific names of the included substance.

Working Party 2: Life Science and Biotechnology, Healthcare and Well-being
EU-Japan BRT 2023 Recommendation Report
Page 18 of 20

The BRT believes that:•

A harmonisation of the labelling requirement regulations (PDSCL, ISHL, and PRTR)
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, and•The discrepancies between naming in Japanese regulations and product labelling
requirements pose a risk that substances are used without a clear understandingof the regulations they relate to. This should be avoided.

Working Party 2: Life Science and Biotechnology, Healthcare and Well-being
EU-Japan BRT 2023 Recommendation Report
Page 19 of 20

Recommendations from Japanese industries
Animal HealthWP-2 / # 20 / 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
authorisations for veterinary products, starting with mutual recognition of GMP
certification of veterinary medicines, and•Include 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 andJapan will provide for faster access to new useful products.

Working Party 2: Life Science and Biotechnology, Healthcare and Well-being
EU-Japan BRT 2023 Recommendation Report
Page 20 of 20