Draft EBC for Public-Private Sector Dialogue in 2022

November 28, 2022
European Business Council (EBC)
Medical Device and IVD Committee
Medical Fee Subcommittee / Pharmaceutical Affairs
Subcommittee
Page 1

Table of contents

1. Regarding stable supply- Responses in normal times and emergencies

2. Integration into medical DX-PHR- Expansion to support system of telemedicine and medical monitoring◆ Reference ; Connection of information on implanted medical devices to My Number Cards

3. Evaluation of innovative medical devices- Consideration of a provisional license (provisional approval / provisional insurance) system for SaMD / SiMD
◆ Reference : Possibility of selective treatment (non-insurance combined treatment)- Promotion of preventive medical care

1. Stable supply - Response in normal times and emergencies
Current situation ; Securing the emergency medical supply system in response to thepandemic (COVID-19)

Proposal for Public-Private Sector
Dialogue in 2022

• Stable supply of medical device continued to be required in the situation of the spread of corona••••infection and in a situation where medical institutions were under pressure.
The company faced a reduction in air cargo flights, and production was unstable due to unstable material
shortages.
In addition, it was difficult to secure airmail, and transportation costs increased significantly. Sales ofnormal business continued to be difficult
Stable supply was required, but efforts to maintain a large inventory led to a sharp rise in maintenanceand management costs.
As a result, there were concerns about the company's continued existence.

Issue ;As a countermeasure, following the financial support for securing beds in medical institutions during normal times,➢Explore the possibility of financial support for inventory management➢In the event of an emergency, consider a system in which the national government sets air cargo quotas for medical
use on regular flights.

2. Medical DX - Expansion to support system of telemedicine and medical monitoring
1. Current Status - Telemedicine Support System• Online medical consultations, which were delayed compared to overseas, have been expanded as an emergency response to COVID-19, improving convenience for patients.
Further expansion is expected. In particular, the diagnosis and treatment of Doctor to Doctor by remote control overseas is globalizing and spreading. On the other hand, inJapan, diagnosis is only a tool for instruction of operation by remote communication. Ex.: Only ordering from the doctor at the outside facility to the operating technician at
the facility where the device is installed• Utilization of these technologies is consistent with improving the quality of medical care, ensuring its accessibility, and maximizing therapeutic effects through active
involvement with patients who need treatment. In the social issues such as population decline and a decrease in the number of surgeons, telesurgery will contribute to thestandardization of high-quality medical care, and in addition, it will contribute to public welfare by improving medical standards. It is also expected to have the effect ofpromoting technological development in related fields in Japan.
• Therefore, it will greatly contribute to the shortage of doctors in Japan and the standardization of medical care.
2. Current Status - eHealth and Related• Although digital health (eHealth) is not progressing as compared to Europe, its development is expected, and in Japan, the expansion of PHR to medical care has been
stipulated as a basic policy (HONEBUTO) medical DX. Related to this is the utilization and sharing of patient information. In particular, sharing information for patients withimplanted medical devices can be a challenge.

Request ; Further promotion of telemedicine and digital health• Although deregulation is progressing toward the realization of telemedicine, we ask that you continue to discuss deregulation, etc., toward concrete realization in clinicalsettings.
(Ex.: D-D operation/manipulation support system of remote treatment, D-D imaging support system of remote diagnostics etc.)• In order to realize eHealth, we would like to set up a forum for joint consultations between the public and private sectors so that concrete actions can be taken.
• Integration of implantable medical device information into systems: It is expected that information such as the patient notebook will be incorporated into my number card.
MRI examinations of patients with implanted devices such as cochlear
implants, cerebral aneurysm clips, and coronary artery stent are sometimes
performed without specifying the material or manufacturer, as the patient'sdeclaration of examination is ambiguous.
Page 4

[Reference materials]

Medical DX Integrating Information on Implanted Medical Devices to My Number Cards
System to confirm the information of implanted devices at medical institutions nationwide
A system to confirm the information of implantable medical devices at medical institutions nationwide in order to avoid accidents at the timeof emergency or MRI imaging, or when changing hospitals Please expand the scope of information subject to My Number card registration toinclude information on implantable devices Implantable device
Patient record bookPatientinformation

notebook

MRI card

System to allow viewing of own implantable device informationAccess by citizens and patients to their own information on implanted devices via PCs,
smartphones, etc. ・ A system that enables use

Digital Tracking of Designated Medical Devices
When medical devices are collected, the medical institution inquires about the implantable device information from the lot number (information included in UDI) published by thecompany to the operator, and the operator responds to the patient information online. From the viewpoint of privacy protection, it is possible to limit the database of patient informationin companies.
Registration of implantable device information

MedicalInstitution Acontact
Individual unit insured number and specifichealth checkup data, Drug information, etc.
1:1

Providing collection
information to medicalinstitutions

Patient
Identity confirmation
Displaying
Information

Surgery / transplantation, dialysis, names of medical institutions, etc.

Browsing implanted medical device information at the time of hospital transfer/emergency
Page 5Company

Browsing patient information and implanted
device information

Online Qualification Confirmation System

MedicalInstitution B

3. Evaluation of medical device (medical technology) innovation- Consideration of a provisional license system (provisional approval and provisionalinsurance system) for SaMD / SiMD
[Current status]• In the case of Programmed Medical Devices SaMD or SiMD (Software) in Medical Device etc., the development rotation is fast and it takes time to obtain
Evidence for insurance coverage, and there are cases where the value of the product is lost. Alternatively, there are cases where the development or putting
on the market is abandoned due to lack of predictability by caused many major changes. In order to revitalize development, it is necessary to recoverdevelopment costs as soon as possible.
• In the revision of the act in Heisei 25, a chapter on regenerative medicine products was established and approval system with conditions and deadline forregenerative medicine products was introduced.
In Heisei 27, regenerative products were approved under this conditional and time-limited approval system, and real example pf approval system wasimplemented to confirm effectiveness and further safety after putting on market.
• In the Heisei 29, a notice of rebalancing was issued, and early approval has begun to take place.
• In addition, in recent years, a system of having a provisional license system with insurance for programmed medical device has started oversea, and a certain
degree of predictability is secured in the development and sales of start-up companies. (Germany ; DiGA System)

Issue ;In order to ensure early access to patients, the public and private sectors will consider a system in which products whose safety is ensured by QMS standard, etc.
are first put on market, and then re-evaluated and covered by health insurance.
Apply for approval again within thedeadline

New system for early approval and insurance system
SamD/SiMD
Diagnostic andTherapeuticDevices

Ensuring safety＆Estimation ofeffectivenessApprovalwithCondition& Deadline

Early access to patients
Putting on market](Evaluative medicaltreatment)••

Page 6

Evaluate effectiveness and further safety after putting on market
Approve using RWD

Issue: it takes time to obtain evidence for reimbursement until treatment

Approvalof PMD actand HealthinsuranceContinue to sell
(Covered by insurance)

Combined treatment not coveredby insurance(Selective medical treatment)[Reference materials]

Proper evaluation of medical technology and reform of the health insurance system⇒ Possibility of selective treatment (combined treatment not covered by insurance)
Non-insurance combined treatment system

Created by amendment of the act in 2006
(Scope expanded from Specified Medical CareExpenses)

Current status•

There is a big gap between the evaluation of new technology using
diagnostic and therapeutic equipment in Japan and the evaluation
overseas. As a result, some companies gave up insurance coverage.
(Examples: Diagnostic equipment testing, malignant tumor genetesting, PET testing, etc.)•Innovative products are approved under PMD act and are being
used in medical settings. However, it rarely leads to addition ofmedical fees, etc. In order to revitalize development, it is necessary
to recover development costs.

•In the supplementary opinion for the 2022 revision, it was clarified
that the government will continue to consider appropriate
evaluations of pharmaceuticals, medical devices, and medicaltechnology, while understanding the status of discussions on thescope of insurance benefits.

Medical treatment that can be used in combination with health insurance
123

Evaluative medical treatment ⇒ Assess for insurance introduction
Medical treatment by patient ‘s request ⇒ Assess for insurance introduction
Selective medical treatment ⇒ Not premised on the insurance introduction
Structure of Medical Expenses Combined withTreatment Outside Insurance Coverage[Cases of Evaluative Treatment]

Basic portion(portion covered byinsurance such as basichospitalization charge)

Benefit covered by healthinsurance as combined
medical expenses notcovered by insurance

Add-on portion(portion not coveredby insurance)

Fees can be collectedfrom patients (Free fee)

* For medical expenses combined with treatmentoutside insurance coverage, the requirements forcollecting fees from patients (such as posting offees) are clearly specified.

⚫ Evaluative medical treatment
Advanced medical
Medical treatment related to clinical trials ofpharmaceuticals, medical devices, regenerative medicine
products, etc.
Use of pharmaceuticals, medical devices, andregenerative medicine products that have not yet been
covered by health insurance after being approved by the
Pharmaceutical Affairs Law
Off-label use of drugs listed in the National Health
Insurance drug price list
Non-applicable use of insurance-covered medical
devices and regenerative medicine products⚫ Patient request medical treatment⚫ Selective medical treatment
Special recuperation environment (different price bed)
After-hours medical care
Appointment treatment
First visit/return visit at a large hospital
Hospitalization for 180 days or more, etc[Issues]•Appropriate innovation technology evaluation is essential for stable supply to patients. There are products that are marketed but have a negative
spread, and products such as SiMD that are difficult to reimburse with the cost of the technology applied mutatis mutandis in Japan.
How about considering the products such as these products that contribute to the convenience of patients (for example, the patient's burden of theequipment cost in online medical treatment) as a framework for medical treatment combined with non-insurance?

3. Evaluation of medical device (medical technology) innovation- Promotion of preventive medicine
Promotion of preventive medical care is expected to contribute to patients.
Low-dose lung cancer CT screening•

Promotion of incentives for preventive medicine similar level to overseas is expected tocontribute greatly to reducing medical expenses and improving health (QOL) toward theera of 100-year life in Japan.
• It is possible to extend healthy life expectancy by preventing aggravation and preventing illness (predisease) before it occurs.
• Low-dose lung cancer CT screening is used as a preventive measure in the insurance system, etc. inEurope and the United States.
• In the United States, health insurance-funded screening is available for smokers over the age of 50.
• In some local governments, lung cancer screening is performed by CT, but in many local governments,lung cancer screening by X-ray photography has been carried out for a long time.

•Status Apr. 2019
EUPosition
paper, whitepaper

UK
Rollout

Germany
Guideline, BfS decision process
Croatia
Screening in implementation
RussiaPoland Russia
6 pilot regions
Pilot (Moscow)

CanadaOntario, BC started 2018
USA
Screening since 2016

China
New guideline

Age standardize
mortality

Is it possible for the Ministry of Health, Labor and Welfare to appeal to local governments
nationwide to make low-dose lung cancer CT screening an essential item for lung cancer
screening under specific medical examinations and specific health guidance in Japan?

SaMD equivalent to Class I (health claim)• SaMD has a program equivalent to Class I aimed at public prevention, recurrence
prevention, and prognostic use, but it cannot claim that the public's healthy life expectancy
can be expected.
• Class I-equivalent programs are treated as non-medical devices, but may scientifically
proven to "maintain health conditions or healthy activities" or "healthy lifestyles reduce
certain chronic”.
• Can doctors, dentists, and pharmacists encourage the use of programmed medical
devices in medical examinations, etc.?
Page 8Electric RFID toothbrushes

Smart sleeve[cannot declare]• Prevention of gingivitis andperiodontitis[not recommended]• People with sleep
disorder