Cross-border collaboration between U.S. and Japan in the biopharma sector has intensified in recent years, in part because of important progress and reform within Japan’s drug regulatory system. However, new proposals for the pricing and reimbursement of new drugs now threaten to hinder innovation in Japan, and with it, opportunities that global innovative biopharma companies have to develop and launch new drugs in the Japan market. Some of these developments could make it particularly difficult for small, emerging biotechs to consider developing and launching in Japan.

Most recently, the Japanese government approved a drug pricing reform package that contains a number of new pricing efforts that significantly undermine Japan’s pro-innovation environment. Panelists will discuss the newly established criteria of Japan’s PMP (Price Maintenance Premium) system, which may discriminate against life sciences start-ups and emerging biotech companies, as well as ongoing efforts in Japan to develop a rigid CEA (Cost-Effective Assessment) system. These policies could have the unintended consequence of disincentivizing innovation in Japan and can potentially delay patient access to new medicines.

Session ID: 546637