China is changing its attitude to Orphan Drugs – what used to be a barren waste land could become the next major Orphan Drug opportunity.
China has long been a difficult market for orphan drug companies - no conducive legislative frameworks, the need for local clinical trials and then, even with registration, more issues have been encountered with sampling of imported products on arrival at customs. For this reason few Orphan Drugs have successfully managed to enter a market where the WHO estimates there are more than 10 million sufferers of rare diseases.
Culturally the “needs of the many” have always outweighed the “needs of the few” but over the last decade the lack of access to modern Western drugs has unsettled this assertion and brought forward the real possibility of not only access but also reimbursement for Orphan Drugs. China is reforming the national healthcare system and health insurance plans with a “Bill of Rare Diseases” under review by the national People’s Congress (NPC) of China.
Proposals include:
- Establishment or reimbursement mechanisms and succour networks for the diagnosis and treatment of rare diseases.
- Active importation of Orphan Drugs by governmental agencies rather than taking a passive stance.
- Support and encouragement of local companies conducting R&D into rare diseases.
These changes mean that a number of the barriers to Orphan Drug success in China are coming down opening the prospect that meaningful gains will be possible in China in the future. If you have a commercialized Orphan Drug and would like access to expert advice on market entry please contact giles@aftpharm.com.
This blog posting is part of a series of articles that focus on the opportunity to bring Orphan Drugs to patients in Asia Pacific.
