Eucomed and the European Diagnostic Manufacturers Association (EDMA) have expressed their support of the European Commission’s intention to seek a mandate from EU member states to negotiate a free trade agreement (FTA) with Japan. By clearing a path towards convergence, the FTA can help reduce Japan’s device lag and device gap, whereby medical technologies that are widely used in Europe are either not available or are delayed by several years before they are approved for the Japanese market. Eucomed and EDMA published a press release today on their respective websites welcoming the commission announcement made on 24 July 2012.
For many years, Eucomed and EDMA, along with the European Business Council in Japan (EBC), and industry associations from Japan, have worked with the European Commission and the government of Japan to find constructive ways to promote timely access to safe, high-quality medical technologies available in Europe. Closer integration of the two economies would promote regulatory convergence, facilitate international clinical investigations, encourage wider use of international standards, and reduce compliance burdens whilst maintaining public confidence in medical devices marketed under the two systems, notes the press release.
Regulatory convergence will help remove technical barriers to trade. Japan’s patient population also would benefit from increased and accelerated access to life-saving and life-enhancing treatments. “The device lag eliminates opportunities for Japanese people to benefit from the most recent advances in medical technology,” Kazuo Ogino, chairman of the Japan Federation of Medical Device Associations (JFMDA), told Miki Anzai, Associate Editor of Japan Medical Design & Manufacturing Technology, in an interview published in EMDT.
Eucomed and EDMA remain committed to providing technical support to both parties as the negotiations progress.