- On December 15, 2021, the IVD Sub-Committee of the EBC Medical Equipment & Diagnostics Committee, JACRI and AMDD submitted a position paper as the IVD industry which is a proposal on the appropriate implementation system for clinical testing to the relevant departments, including the Minister of Health, Labour and Welfare. (go to News section)
In December, 2019, the first case of COVID-19 was identified in Wuhan, China. It has now spread worldwide, causing 1.7 trillion infections as of June 1, 2021 and 3.55 million lost lives. In Japan, the corresponding numbers are 750,000 infected and 13,000 deaths. Vaccination programmes have started. Hope is therefore that the cases will decrease; however, we do not see the clear endpoint of the pandemic yet.
In the fight against this emerging infectious disease, In Vitro Diagnostics (IVDs) have played crucial roles to detect the infection, to grasp the disease state and to predict the prognosis. Demand for PCR-based genetic testing was so high that the tests were nearly out of stock in the early phase of pandemic. We also experienced an issue of false positives with rapid Point Of Care Testing (POCT) at the beginning of pandemic and it was widely acknowledged that accuracy of the assays is crucial. Public institutes then made investigations and identified POCTs with acceptable quality and now we see many reliable rapid POCTs in the field.
As outlined above, the COVID-19 pandemic has made the roles and contributions of laboratory diagnostics and IVDs widely visible to the general public. Under these circumstances, EBC Medical Equipment & IVD Committee had an opportunity to hold a public webinar entitled “EBC BRIEFING ON COVID-19 – 9 MARCH” on March 9, 2021
Taking a helicopter view of the healthcare system in Japan, it is under increasing pressure to overhaul due to the effects of the ageing society, declining birth rate, and rising national healthcare costs. The EBC considers serious discussions on the value and role of diagnostics & IVDs, which already play a significant part in medical practice, are crucial to achieve the Government’s objectives of “improvement of the quality of medical care” and “optimisation of medical costs”. The current COVID-19 pandemic has greatly accelerated the discussion on these elements, not only in the medical practices, but also on the governance of the medical systems.
For example, experience during the COVID-19 pandemic has raised the discussion on Emergency Use Authorization (EUA) which is already implemented in the USA and other countries. This process will enable speedy adoption of required assays, e.g., for emerging infectious disease, and realise effective diagnosis and treatment.
In addition, not only the tests used for medical practices (covered by health insurance), but also the tests used for quarantine, epidemiological studies, and social testing for resuming economic activities are essential for understanding the infection status and for determining policies. COVID-19 antibody-tests in this category are not applicable to IVDs under current regulation, and they are distributed as research-use-only reagents. A mechanism of EUA is desired to provide assays with certified quality/precision for such applications. This is also an important issue in the viewpoint of global harmonisation of regulations.
The medical reimbursement system for diagnostics has been under discussion since 2007 between the Japanese Promotion Council for Laboratory Testing (JPCLT), IVD industry associations, incl. EBC, and the Ministry of Health, Labour and Welfare (MHLW). Since then, the results of investigations into current problems and issues as well as possible future directions have been announced, opinions have been exchanged and proposals and recommendations have been made both at “study sessions on medical diagnostics” and at “regular meetings on the medical reimbursement system”. The EBC acknowledges that these activities influenced the Government’s policy and they led to a continuous rise in IVD fees. Special focus should be given to “Addition to ISO 15389-based Examination Management” in 2016 and reference to quality and accuracy of IVDs in the partial revision of Medical Law in 2018.
Cooperation between the diagnostics industry and the pharmaceutical industry, and consultations with the authorities are progressing on the increasingly important topics of companion diagnostics. The clinical application of innovative technologies, such as next-generation sequencing, is rapidly advancing. It is necessary for all the stakeholders to establish a system to assure the accuracy and quality of these innovative assays. It would also be essential that the current medical system is streamlined and reformed so that personalised treatment can be expanded and quality of diagnostics and medical care are improved, In the current COVID-19 pandemic, it is re-acknowledged that “Speedy access to novel IVDs” and ‘proper reimbursement for diagnostic tests reflecting the clinical value” are critical elements for improving the quality of medical care and for promptly providing patients with advanced medical care.
Finally, digital health has become an important topic in IVDs. Diagnostic test results are more and more utilised as digital data in variety fields, e.g., diagnosis based on digital images, prediction of prognosis, among others. Under these circumstances, the IVD industry will put more focus on this new field.
The EBC Committee on Medical Devices & IVD and IVD Group will make recommendations for international coordination based on foreign trends. We will, moreover, continue to work with the JPCLT and other in vitro diagnostics industry organisations to contribute to healthcare by promptly introducing and appropriately using laboratory tests of high social and clinical significance, as well as to educate the general public about the value of testing.
Key issues and recommendations
Implementation of Emergency Use Authorization (EUA) Process and Speedy Access of required tests by EUA
Vice-Chair, Medical Equipment & Diagnostics Committee
(Scientific Advisor, Roche Diagnostics K.K.)
c/o Roche Diagnostics K.K.
Shinagawa Season Terrace, 1-2-70, Konan, Minato-ku,
EBC Medical Equipment and Diagnostics Committee Secretariat contact:
bioMérieux Japan Co., Ltd.
Biotronik Japan, Inc.
Dornier MedTech Japan Co., Ltd.
Draeger Medical Japan Ltd.
Edaptechnomed Co., Ltd.
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On December 15, 2021, the IVD Sub-Committee of the EBC Medical Equipment & Diagnostics Committee, JACRI and AMDD submitted a position paper as the IVD industry which is a proposal on the appropriate implementation system for clinical testing to the relevant departments, including the Minister of Health, Labour and Welfare. (臨床検査の適正な実施体制に関する提言書 [pdf]).
The history of clinical testing is also clear.
Recommendation 1: Development of comprehensive monitoring and regulatory laws and regulations for clinical tests to be used in medical care and clinics
We propose the following two points regarding the development of a regulatory and monitoring system specialising in pharmaceuticals and medical devices, as well as in clinical testing aimed at ensuring the analytical validity and clinical validity of clinical testing.
- Institutionalisation of risk-based review and approval processes and safety measures
- Institutionalisation of Emergency Use Permits for Clinical Tests Require for Emerging Infectious Diseases
Recommendation 2: Optimisation of Medical Fee Evaluation for Inspection Innovation and Renovation of Evaluation Methods for Existing Inspection Technologies
- Definition of examination innovation and the introduction of transparency and reasonable evaluation standards based on it
- Rationalisation of fees for conducting diagnostics for existing testing technologies and items and appropriate distribution of medical resources