IVD (In Vitro Diagnostics)

In the fight against this emerging infectious disease, In Vitro Diagnostics (IVD) plays an extremely important role in determining the presence of infection and in understanding disease status and predicting prognosis, and the importance of stable supply and environment for accurate testing have been widely recognized.

Taking a helicopter view of the healthcare system in Japan, it is under increasing pressure to overhaul it due to the effects of the ageing society, declining birth rate, and rising national healthcare costs. Serious　discussions on the value and role of diagnostics & IVDs 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 field of medical practices, but also on the governance of the medical systems.

For example, based on the experience with COVID-19, an emergency approval system was introduced under the Pharmaceutical and Medical Device Act in response to outbreaks of emerging infectious diseases, but issues remain regarding the reimbursement system for emerging infectious diseases for which the timing and scale of outbreaks are difficult to predict. It is hoped that a system will be established in the future that will enable necessary tests to be made available to the medical community as quickly and appropriately as possible.

From the perspective of international harmonization, intended use of IVDs have been under discussion. In addition to its intended use for diagnosis of diseases, EBC has been promoting the idea to have prevention and risk assessment as additional intended use of IVD, as done in IVDR This discussion is being held in conjunction with the revision of the Pharmaceutical and Medical Device Act, including a review of the classification of IVDs classified as pharmaceutical products under the current Act.

The medical reimbursement system for IVDs 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). EBC acknowledges that these activities influenced the Government’s policy and they led to rise in IVD fees. Special focus should be given to “Reference to quality and accuracy of IVDs” in the partial revision of Medical Law in 2018. In 2022, ‘Challenge Application’, a mechanism to allow post approval revision based on real world data, was put on the table also for IVDs, following acceptance for Medical Devices.  It was agreed to follow up this item for IVDs in the coming years. EBC-IVD sub-committee will work on this as a key issue to achieve this in the FY2024 revision.

The clinical application of innovative technologies, such as next-generation sequencing, is rapidly advancing. 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 IVD 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.