[In-vitro diagnostics in Japan: its value and recognition--from the industry/providers' perspective]

Since the 1960's in-vitro diagnostic tests (IVD) have been contributing greatly to the progress of medical care, which has lead to significant improvements in patients' quality of life. Today, it is apparent that IVD tests are an inevitable component of healthcare for individual treatment as well as national healthcare programs. Despite its significant contributions, the recognition for the value of IVD has been declining. This lack of recognition can be observed among healthcare professionals, governing bodies, as well as among patients, who are the immediate beneficiaries of innovative, and high quality IVD. As a result reimbursement levels for IVD testing have been reduced significantly by the National Health Institute (NHI) over the past 15 years. Recent activities to create a better understanding of the value of IVD have created less unfavorable NHI rate revisions in 2008 and 2010, but further strategic improvement plans will still need to be addressed with perseverance: 1) Enhancement of clinical value based NHI rate assignment processes, 2) Improvement of the accessibility to new/advanced IVD products, and 3) Public awareness programs to promote the value of IVD. There have been many efforts started to discuss critical issues of IVD within the Japanese healthcare system involving academics, IVD industry representation, and government officials (MHLW) since 2005. This article is describing and summarizing the identified and required priorities in order to create an environment that will allow to enhance Japanese healthcare through sustainable, reliable, and innovative IVD.