Every company with a commercialized Orphan Drug has gone through the blood, sweat and tears required to register their product in either the US or EU. If that first registration was gained in the EU then every effort will be made to ensure introduction in the US as soon as possible - these two markets are the key global commercial opportunities. They also offer secure supply chains and predictable pharmaco-vigilance (PV) reporting in a way that ensures the minimum amount of risk is created through commercial activities.
Unfortunately it isn’t that simple in Asia Pacific and there are real fears concerning non secure supply chains and inferior pharmaco-vigilance reporting that might jeopardise marketing back home in the West.
The problem is that quality standards tend to break down when multiple partners are involved due to their varied (and at times insufficient) training on supply chain integrity and PV reporting. This is exacerbated when trying to market an orphan across wide geographies with partners using different reporting systems.
Whilst supply chain and reporting standards in some of the Asia Pacific countries such as Australia and New Zealand are just as high as anyway in the world there can be considerable variation across the Asia Pacific region. World class, multi-country, secure, temperature controlled specialist pharmaceutical distribution companies do exist but at present few companies can offer coverage of all territories – as a result careful partner choice becomes an immediate priority.
Taking into account all of the considerable complexities associated with commercialization and secure supply it is important for new entrants to be guided by partners that can advise across the whole region – taking a piece meal approach to supply chain integrity by allowing multiple partners to use their own distribution and partner networks can lead to confusion, poor PV, unnecessarily expired stock and disgruntled local partners.
Innovative solutions are possible and if you would like to learn more and make a conscious decision which benefits all parties please contact AFT Orphan via giles@aftpharm.com.
