The European and Japanese pharmaceutical industries are losing ground in the competitive race with the US and urgent measures are required to redress the balance, and the Japanese Government must take steps to improve the environment for its domestic drug industry.
This is the message that a delegation from pharmaceutical industry group the European Federation of Pharmaceutical Industries and Associations (EFPIA) delivered today to the authorities in Japan.
The delegation, led by EFPIA Director General Brian Ager and the chairman of the group's Japan Executive Committee, Martin Wright, pointed to the situation faced by the research-based pharmaceutical industry in Japan, and particularly its 'alarming' loss of competitiveness.
EFPIA maintains that there is an urgent need to provide an adequate environment for pharmaceutical innovation to help the industry develop new medicines.
It welcomed the progress made by the Japanese government on some areas, such as specific business and market-based measures to attract R&D investment, but he has said more needs to be done.
One urgent measure is the drawing up of new pricing rules for medicines that truly reward pharmaceutical innovation, said EFPIA.. Meanwhile, on the positive side, it welcomed the Japanese Intellectual Property Policy Headquarters' proposal to increase the incentives for new drug development and supports a 10-year regulatory data protection period.
"While Europe is moving to harmonise data protection to 10 years (plus one extra year for additional indications with significant therapeutic benefit), Japan - one of the world's leading knowledge-based economies - should ensure equal intellectual property standards," said Wright. Further progress should also be made to improve the performance of the country's regulatory authority, he added.
EFPIA feels it is in a position to press its case in Japan as its local branch represents 29 companies that play a significant role in global pharmaceutical development in this country. Between 2000 and 2003, European research-based pharmaceutical companies - which employ 26,500 people in Japan - accounted for nearly 40 per cent of the 129 new products launched on the Japanese market, it pointed out.
"Our companies are a key contributor to the improvement in national healthcare standards, but also to national economic growth," said Wright. "However, there is growing concern that the Japanese pharmaceutical market might not attract pharmaceutical business in the future," he warned.