European Business Council (EBC) Medical Devices and IVD Committee

Meeting of Representatives
IVD Subcommittee Report
December 10, 2020
Vice Chairperson in Charge Shinichi Eda
Subcommittee Chairperson Miwa Nishida

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2020 IVD Subcommittee Action Plan⚫ In cooperation with JACRI (Japan Association of Clinical ReagentsIndustries) and the AMDD IVD Committee, strengthening ourapproach to the government as 3 IVD industry groups⚫ Active participation in the activities of 3 industry groups as
representatives of the EBC⚫ EBC-led proposal

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Results of Activities in 2020⚫

Page 3Related to Regulatory WG

Activities related to Regulatory WG

Summary of results of 2020 WG Activities⚫ Regulatory WG• Meetings of the Regulatory Affairs WG were held 7 times (6were web conferences).
⚫ Results of Regulatory WG Activities• Sharing of concerns/issues regarding electronic of packageinserts• Information sharing on clinical performance study guidelines• Planning of educational workshops (IVDR, VALID act, etc.)

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Activities related to Regulatory WG
Activities as 3 IVD industry groups⚫ Regular meetings to exchange opinions on approval reviews and safetymeasures for medical devices and in-vitro diagnostics (Aug. 28, 2020)⚫ Public-Private Dialogue (Nov. 16, 2020)⚫ Working-Level Council on Plan for Collaboration➢ FY 2020 1st Meeting of Working-Level Council on Plan for Collaboration⇒ Scheduled to be held in June but canceled➢ FY 2020 1st Meeting of Working-Level Council on Plan for Collaboration(Scheduled: Jan. 13, 2021)• Confirmation of progress on issues to be tackled by the new plan forcollaboration

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Regular Meeting for Exchange of Opinions(Aug. 28, 2020) @ Web
1.

Establishment of a system for handling emerging infectious diseases
a. Establishment of Emergency Use Authorization (EUA) System

2.

International harmonization
a. Expansion of the definition of in-vitro diagnostics (scope) in light of overseas
conditions
b. Review of classifications

3.

Review of regulations concerning in-vitro diagnostics
a. Development of clinical performance study guidelines
b. Promotion of digitization of PMDA procedures and operations
c. Procedure for changing operational rules/ over-the-counter (OTC) test drugs

4.

Requests regarding the PMD Act reforma. Electronic codes and UDI codes for information such as precautions: earlyclarification of operations
b. Qualification of total responsibility

Page 6Issues to be tackled by the Plan for Collaboration– Roadmap (1) –Item

19/Q3

19/Q4

Streamlining of the scopeof IVDs

1-1

Procedures for Exclusionfrom Designation as
Poisonous andDeleterious Substances

1-2

Assurance of reliability of
application documents

1-3

Preparation of clinicalperformance study
guidelines

1-4

Review of the CDx
framework

1-5

International
harmonization of review
requirements andstandards

1-6

Review of operation of
pre-approval tests

1-7

Modification of FD
application software1-8

Expanding the clinicalsignificance of IVDs

1-9I

Creation of new approvalconditions

1-10IPage 7

20/Q1
IIII

20/Q2

20/Q3

20/Q4

2021

2022

Policy decision

IIVIV

2019/12/10 Held briefing session: Completed

III
IIIII

Preparation of draft notifications

IIIIIIII2019/10/3 Issue/dissemination of notification - Completed

IV/V

Radical Review of Operations: I
Requests for modification are submitted
in December every year

II

Preparation of draft guidelines

COVID-19

IVIssue of Q&A

Evaluation

Issues to be tackled by the Plan for Collaboration– Roadmap (2) –Item

19/Q3

19/Q4

Review ofclassifications

1-11

Approval system basedon IVD characteristics

1-12

Development of list of
infectious disease
epidemics overseas

1-13

Labeling of common
reagents

2-1

IIAchievement of targets
for standard overall
review period

3-1

Throughout the year

Improvement andeffective use of
consultation system

3-2

Throughout the year

Skill improvement forreviewers andapplicants

3-3

Streamlining andoptimization of PMDA
operations

3-4

20/Q1

20/Q2

20/Q3

20/Q4

2021

2022

2023

Indication of whether there areproducts that correspond to IVDs

IIIDecision on direction

IIDecision on response policy

COVID-19[Phase Image]I. Analysis ofcurrent
situation

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II. Formulation ofplan

III. Preparation
sof draftIV.
Completion

V. Dissemination andmeasurement ofeffectPublic-Private Dialogue (Nov. 16, 2020) @Web
Opinions and Requests from the In-vitro Diagnostics Industry:
Issues Made Visible by the COVID-19[JACRI, AMDD, EBC]

1. Formulation of contingency plans for emerging infectious diseases
In an emergency (outbreak of an emerging infectious disease), it is necessary to formulate, promote, andsupport a “strategy that is consistent from R&D through production and supply” in order to promote thesmooth and rapid development and supply of in vitro diagnostics without confusion. Please draw up anddisseminate concrete and feasible contingency plans involving ministries, related agencies, and industry

2. Proper provision of tests with confirmed quality and accuracy
For when there is an outbreak of an emerging infectious disease, we request that you design the following
type of system to ensure that the public is properly provided with tests for which a certain level of quality
and performance have been confirmed through a transparent process.
 Creation of the Emergency Use Authorization (EUA) system: review of the quality and accuracy oftests and authorization of their use
 Applicability to government testing and insurance-covered testing: Only for tests authorized for use

3. Development of environment for ensuring a stable supply system
When there is an outbreak of an emerging infectious disease, the following measures should be taken toensure smooth expansion of the testing system and a stable supply system.
 Emergency response: Preparing environment such as purchase guarantees and allocation ofmeasuring equipment
 Efforts to be made at all times, before an epidemic starts: “maintenance of measuring equipment at
medical institutions, etc.”, "securing and developing human resources"

Page 9Results of Activities in 2020⚫

Page 10Reimbursement WG related

Summary of results of 2020 WG Activities⚫ Reimbursement WG• Meetings of the WG were held 6 times (5 were webconferences)⚫ Results of Reimbursement WG’s activities• Review of 2020 Medical fee revisions• Strategy for the 2022 revision of medical fees➢ Value appeals for POCT testing, where home care andcommunity medical care are Key Words• Preparation for regular meetings with authorities

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Activities related to Reimbursement WG
Activities as 3 IVD industry groups⚫ 3-Group Joint Committee (JACRI, AMDD and EBC) on the Medical
Insurance System➢ Participated in the 6 committee meetings held
➢ 2020 Medical fees revision••

Consultations on comprehensive molecular testing for cancer
Review➢ Compilation of IVD Industry Groups' Requests for Revision ofMedical Fees in 2022
➢ 3 IVD industry groups’ response to administrative requirements⚫ Exchange of opinions with the MHLW (Economic Affairs Division andMedical Economics Division) on regular meetings➢ Meetings to exchange opinions were held 3 times (including alaboratory tour )➢ Exchanges of opinions on molecular testing for cancer were held 3times (including a visit to the NGS laboratory)
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Review of 2020 Medical fee revisions
1.

Clarification of evaluation of medical usefulness andinnovativeness of in-vitro diagnostics

2.

Implementation of an action plan for antimicrobial resistance(AMR) countermeasures – Enhancement of an implementation
system for microbial testing that contributes to AMR
countermeasures –Ongoing

Ongoing

3.

Handling of medical fees for tests using in-vitro diagnostics andtest items for which there is a coexisting LDT

Adddressed

4.

Contribution of POCT to "ensuring high-quality home medicalcare"

Ongoing5.

Introduce Response to market expansion after insurance listing

6.

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Introduce Comprehensive molecular testing for cancer

Requestreconsideration

Review of 2020 Medical fee revisions
1.

Clarification of evaluation of medical usefulness and innovativeness ofin-vitro diagnostics

Ongoing<<Issues>>• At present, applications are submitted in a cumulative manner, but in actual practice, they arereviewed by comparing them with existing items that are similar in principle of measurement,
seriousness of target disease, etc. Transparency is not ensured because the review is conductedwithout a clear evaluation mechanism.

• If this situation continues, both foreign and domestic companies will have to avoid launching productsin the Japanese market owing to lack of proper evaluation. This means that it will be difficult tointroduce cutting-edge diagnostics into Japan, and there is a risk that we will not be able to contributeto patients and medical practice.

• Japanese companies lead the world in the field of in-vitro diagnostics, and the unpredictability of thehandling of IVD in the insurance system is also an issue from the standpoint of their continuedcompetitiveness.

<<Proposal>> Clarification of design of system for evaluating usefulness and innovativeness;clarification of content of evaluation•

We would like you to establish a system to evaluate medical usefulness and innovativeness wheninsurance is applied.

• When an evaluation system is established, from the viewpoint of ensuring transparency, the details of
the evaluation should be presented in the proposed classification notified to MAHs at the time of
insurance listing and in the "insurance category for in-vitro diagnostics and number of insurance
points (draft)" at Chuikyo.
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Review of 2020 Medical fee revisions
2.

Implementation of an action plan for antimicrobial resistance (AMR)
countermeasures – Enhancement of an implementation system for
microbial testing that contributes to AMR countermeasures –Ongoing<<Issues>>• There is no requirement concerning the system for carrying out microbial testing in the facility criteria
for “infection prevention measure premium 1” Therefore, even if “infection prevention measurepremium 1” is included in the fee calculation, the system for microbial testing may vary from one
facility to another, and the medical treatment provided may also differ. For this reason, there also isconcern as to whether antimicrobial resistance (AMR) countermeasures are being promptlyimplemented.

• There are many companies that want to contribute to AMR countermeasures, and they are devoting
efforts to promoting the spread of microbial testing while developing and selling the products that arenecessary for conducting this testing. While we welcome requests and recommendations fromacademic societies to establish systems of microbial testing that contribute to AMR countermeasures,the memberships of academic societies include diverse stakeholders, so they have not presented aunified opinion on systems for conducting microbial testing.
<<Proposal>>Please add the following requirements to the facility criteria for “infection prevention measurepremium 1”.
⚫ Microbial testing should be performed in-house (At least the blood cultures should be
performed within the facility)⚫ Microbial testing should be performed on Saturdays, Sundays, and holidays as well (at leastfor blood cultures)
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Review of 2020 Medical fee revisions
3.

Handling of medical fees for tests using in-vitro diagnostics (IVD) and test
items for which there is a coexisting LDTAddres
sed<<Status>>• Laboratory Developed Tests (LDTs) developed by individual laboratories play an important rolein medical care, including tests for the diagnosis of rare diseases, etc.
• In some cases, an IVD is developed and insured for a test item that is reimbursed as an LDTtest• Since IVDs are subject to review and evaluation under the PMD Act, the quality and accuracy oftesting using the IVD is guaranteed to be of a certain level.
<<Issues>>
Even after the IVD is covered by insurance, the spread of the approved IVD does not makeprogress because the LDT coexists with the test using the IVD for the same test item, soequalization of testing does not occur. As a result, patients may miss opportunities to undergo acertain level of testing .

<<Proposal>>
From the viewpoint of ensuring the quality and accuracy of laboratory tests, we would like thefollowing to be reflected in insurance coverage of in vitro diagnostics for test items for which LDT
are used:⚫ Separation of LDTs from the tests using in-vitro diagnostics⚫ Subsequent establishment of a transitional period and arrangement of the corresponding
LDT test items
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Review of 2020 Medical fee revisions
4.

Contribution of POCT to "ensuring high-quality home medical care"

Ongoing<<Status>>• In recent years, POCT-compatible testing equipment and reagents that can be used at home havebeen sold, and medical care based on clinical tests has become possible. Spreading POCT tests
in the field of home medical care has enabled us to provide "high-quality medical care".
• Performing POCT testing in the home care setting may reduce the severity of the patient's
prognosis owing to early assessment of the disease state and intervention in the acute caresetting, and it is currently attracting attention in the field of cardiovascular diseases and infectious
diseases.
<<Issues>>• Since rapid testing at home is not widespread and the patient's condition cannot be judged
objectively, coordination with medical specialists, etc. is delayed, and the opportunity for earlyintervention is missed, or unnecessary emergency transport is performed.
• There is concern as to whether accuracy control for home care testing is being properlyperformed<<Proposal>>
We would like you to consider a system for POCT tests that differs from that for existing tests in the
cardiovascular and infectious disease areas, where demand is particularly high, in order to deliver
POCT tests that have ensured quality and accuracy and can enable early assessment of diseasestate in home care patients.
 e.g., additional medical fee for POCT performed at home, etc.
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Activities for regular meetings on 2022 revision
Requests for regular meetings with the authority (draft)
1. Evaluation of in-vitro diagnostics(1) Evaluation and clarification of medical usefulness and innovativeness(1) Regarding consistent handling of medical fees for tests using in-vitro
diagnostics and test items for which there is a coexisting LDT(2) Fair Evaluation (E3 Challenge Application)

2. Enhancement of an system for performing microbial testing to contribute tocountermeasures against emerging and re-emerging infectious diseases andcountermeasures against AMR

3. Contributing to medical outcomes through rapid testing and emergency
assessment

4. Contribution of POCT to "ensuring high-quality community medical care"
5. Review of establishment of test items in molecular testing for cancer
6. Handling of testing in the discussion of insurance coverage for infertility
treatment
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EBC is incharge

Results of Activities in 2020⚫

Page 19

Position Paper

Outline of IVD Position PaperI.

Development of relevant laws and regulations to optimize
the safety and efficacy of in-vitro clinical testing (IVD, LDT)
1. Development of new legislation to realize the review andapproval process and safety measures according to the risk
level of in-vitro clinical testing
2. Systematization of EUA for clinical tests required for
emerging infectious diseases, etc.

II.

Appropriate evaluation of technological innovation intesting fees and reform of testing technology evaluation
methods
1. Transparency in evaluation of technological innovation
2. Optimization of technical fees for existing tests and review ofthe allocation of testing fees, assessment fees, additionalfee, etc.

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2021 Basic Action Plan

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Basic Action Plan of IVD Subcommittee⚫ In cooperation with JACRI (Japan Association of Clinical
Reagents Industries) and the AMDD IVD Committee,
strengthening our approach to the government as 3 IVD
industry groups⚫ Active participation in the activities of 3 industry groups
as representatives of the EBC⚫ EBC-led proposal

Page 22

Action Plan of Regulatory WG⚫ Promotion of appropriate response to revision of the PMD Act➢ Response to electronic of package inserts➢ Response to use of UDI system⚫ Promotion of 2nd Collaboration Plan
➢ International harmonization of applications (consideration foracceptance of foreign regulations)➢ Making approval system more rational by reviewing definition ofIVD (scope)⚫ Deepening understanding of overseas regulations andpromoting international harmonization➢ Understanding of IVDR and VALID act, etc.

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Action Plan of Reimbursement WG⚫ Strategic Activities toward 2022 Revision of Medical Fees
➢ Proper evaluation and value appeal of POCT tests➢ Collaboration with JACRI /AMDD/EBC Joint Committee on the
Medical Insurance System⚫ Consideration of expansion of market to preventive medicine
and medical examinations➢ Identifying issues➢ Formulation of Action Plan

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