Japan reaping the benefits from faster approval process

Print 02 December 2015
Matthew Driskill / FiercePharmaAsia

European drugmakers say that at least as far as they are concerned, Japan is beginning to reap the benefits from its drug regulator's faster process of reviewing and approving drug applications.

The head of the European Federation of Pharmaceutical Industries and Associations also applauded the changes in the "innovation premium" of Japan's Pharmaceutical and Medical Devices Agency (PMDA) pricing system that makes it more attractive to sell in Japan.

EFPIA Japan Chairman Carsten Brunn said in an interview with EURObiz Japanthat together the changes are also a boon to Japan, where 10% of the world's top 100 drugs that have not been available to patients are now entering the local market.

EFPIA Japan Chairman Carsten Brunn

The innovation premium system the PMDA adopted changed the system of setting price caps on drugs to ease its restrictions on innovative products. Although the Japanese patient would pay a higher price for those medicines, the issue was moot to a large extent because drugmakers did not bother marketing them at prices they considered too low.

As a result of the premium adjustment, Brunn said, drugmakers now are conducting more clinical trials in Japan that in turn will result in more drug approvals. But, that would not have been enough incentive for his drugmakers, he said, had the PMDA not speeded its approval process.

Now, he said, European drugmakers consider Japan "a very pro-innovation country," but the government could stand to make even more improvements in its market.

One, he said, is the two-week restriction that remains in drug regulations from the days before Japan participated in global trials. It stipulates that physicians may write prescriptions covering only two weeks during the first year after drug approval. That discourages patients from getting their prescription refilled during that year and thus has an adverse effect on sales during that important initial year. Brunn said the current approval system makes that provision obsolete and it should be eliminated.

Although Japan is now an attractive market, Brunn said drugmaker investments in the country still have to compete with a trend to focus more on investing in emerging markets that offer greater growth prospects. That means Japan also will have to continue to reward innovation, the chairman said.

Source

Return