The five main barriers for Orphan Drugs in Asia Pacific are (1) Market complexity (2) Regulatory strategy (3) Pharmaco-vigilance concerns (4) Ethical marketing and (5) Access to skilled regional management. This article focuses on the first
Market complexity (part one)
The Asia Pacific region offers not only vast populations but also great diversity in how healthcare is delivered. There are for instance 4 reimbursed markets (Australia, New Zealand, South Korea and Taiwan) which have systems and processes in place that are recognizable from a western perspective. In addition there are 3 primary dispensing markets (Malaysia, Singapore and Hong Kong) where diagnosis and dispensing are handled by the physicians and the patient largely funds their own treatment. Then there are a number of large population prescription markets such as the Philippines, Indonesia, Thailand and Vietnam where a physician writes a script which is then dispensed in a hospital or retail pharmacy. Drug reimbursement in these markets can range from extensive, for instance in Thai civil servants to the virtually nonexistent elsewhere.
Each market within these broad categories requires different infrastructures, commercial tactics and at times specific local partners to ensure the best structure is in place for successful commercialization – market complexity and resource management are therefore a challenge for the most experienced of Asia Pacific specialists. Given the fact that many Orphan Drugs are commercialised by small biotech companies (with limited commercial experience of Asia Pacific) the result is that the challenges appear too daunting to tackle - quite understandable when you consider that the primary focus for these companies is success in the US and Europe (needed to keep their investors happy).
It is often argued that the reason Asia Pacific stands out badly is due to lack of funding. The vast majority of patients have to contribute, or indeed find all of the money, to pay towards Orphans Drugs from out of their own pockets. Ten or fifteen years ago families could not afford to help - but with the explosion of wealth at the top end of society and the creation of large populations of middle class citizens (with cash to spend) it is now clear that self funding or part funding of Orphan Drugs is feasible and does take place.
It is a little known fact that each country Health Ministry has well established special access schemes which allow importation of unlicensed medicines. Many in fact also provide unofficial funding for patients being treated in selected specialist clinics in university or top government hospitals. These Ministries are also aware that a full registration process is either unlikely from a commercial perspective or is not possible due to lack of specific orphan legislation and the differences in clinical proof available for orphans.
Innovative access opportunities for Orphan Drugs therefore exist across Asia Pacific – if you have an Orphan Drug and want to explore Asia Pacific please contact AFT Orphan via giles@aftpharm.com.
