PAREXEL - Shogo Nakamori Discusses Trends in Drug Development in Japan
When I look at recent trends in drug development in Japan, the following seven points are very important. First, Japan Pharmaceutical and Medical Device Act (JPMD-Act) was renewed in November 2014. This is due to Governmental strong policy to accelerate drug and therapy development in Japan. Second, drug development for rare-diseases and orphan drugs are accelerated through the change of the governmental pricing policy. In the past, due to national health insurance (NHI) price setting rule, pharmaceutical industry did not have good motivation to develop rare-diseases and orphan drugs due to low price. However, recently the government accepted high price for innovative drugs, such as Hepatitis C treatment. When such high price is adopted for the treatment, the total payment by patients per treatment will be beyond $35,000 even adopting 30% payment rule by the patients. However the government decided to designate limited HCV diseases as a special category disease and patient’s payment will be less than $200 monthly under the government’s support. This is big motivation for pharmaceutical and medical device companies. Third, regenerative therapy development will be accelerated due to the renewal of JPMD-Act. PMDA is very open to consult development strategy in Japan and support to such a consultation will be our business scope of PAREXEL consultation. Fourth, generic drugs penetration is roughly 50% right now and governmental target penetration in 2020 was 80%. However due to the budget constraint government decided to accelerate the target year from 2020 to 2018. This will negatively impact to local pharmaceutical companies who are enjoying long listed drugs. That means only pharmaceutical companies with innovative drugs and with successful business outside Japan, for example the US and EU, will survive. Also, biosimilar development will be accelerated. The current situation is that Japan is behind non-Japanese companies including Korean companies. The Japanese Government announced to support bio-similar development recently. Fifth, post marketing activities will be more important in Japan. Trend of drug development outside Japan is that minimize NDA package to get approval as early as possible and collect evidence after the launch through observational studies and risk management plan (RMP). Sixth, post Marketing Surveillance (PMS) is Japan specialized activity and date collection was done by Medical Reps. However, due to some violations of date collection by Medical Reps recently reported, they no longer can take care of PMS data collection. Data management and pharmacovigilance were our main business for PMS in the past, and now supplying monitoring force for data collection is a new opportunity for our post marketing business. Seventh, and finally, adoption to Global Standard will be realized in 2016. CDISC (Clinical Data Interchange Standards Consortium) data set will be mandatory in mid of 2016. Also IDMP (Identification of Medicinal Products) will be mandatory in mid-2016 in Europe and will come to Japan without long delay. In summary, the environment of drug development in Japan is changing in order to give more benefit to the patients suffering from diseases as early as possible. PAREXEL is surely ready to support all the services I mentioned last few minutes. I believe we are one of very few CROs in Japan to do so.