The five main barriers for Orphan Drugs in Asia Pacific are (1) Market complexity (2) Regulatory strategy (3) Pharmaco-vigilance (4) Ethical marketing and (5) Access to skilled regional management. This article focuses on the area of regulatory strategy.
2. Regulatory strategy
Unlike the US and EU only a limited number of countries in Asia Pacific have formal orphan legislation. This means that in the majority of countries local knowledge relating to what is possible and conversely, what is likely to be impossible is vital for strategy formation.
Registration is necessary and advisable in some countries whilst for others taking on the administrative burden of registration is going to be counterproductive. Special access schemes (for patient access to unregistered drugs) are generally available across the region with most countries providing some form of administrative mechanism. There are however a few sad exceptions - for example in Thailand in 2011 Orphan Drug access proved extremely difficult without full registration – in fact even free humanitarian donations were blocked at times as the authorities couldn’t decide how to handle import duty on these free goods!
Formulating regulatory strategy can therefore be challenging and a number of factors need to be taken into account:
- Government registration agency attitudes to Orphan Drugs.
- The need in some countries to undertake local clinical trials to support the registration process.
- Expected timelines for registration and pricing approval.
- Existence of robust special access schemes.
- Necessity to supply through local agents and/or semi government local organizations.
- Waiver of importation restrictions.
The next blog will look at some of the standard issues that also need to be taken into account e.g. file formats and stability data.
There are numerous options available for any Orphan Drug company – if you would like to learn more and make a conscious decision which benefits all parties please contact AFT Orphan via giles@aftpharm.com.
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