Market access is a fluid term but can broadly be described as the set of considerations around getting a therapy to patients on a commercial basis. It might therefore range from measures necessary for meeting local manufacturing requirements, to challenges around policy and regulations, to having an appropriate sales and distribution network in place.
These issues are often particularly pertinent in emerging markets, which may have less developed or ambiguous regulatory frameworks, or unique sets of challenges related to infrastructure or medical care systems. They can also pose proportionately greater hurdles to mid- or small-sized companies, which commonly have a narrower and less well-developed global presence and cannot always rely on direct local resources to elucidate and address problems. But even in some larger markets, major multinationals with an on-the-ground presence can still face challenges.
One high-profile example is China, where despite multiple rounds of positive regulatory reforms over the past few years, new drug legislation still leaves some concerns around intellectual property protection and the use of the marketing authorization holder system. Other outstanding access issues in this huge and growing market include reimbursement and pricing strategy and marketing initiatives in lower-tier cities.
The good news is that there continue to be numerous positive steps taken by regulators in Asia to streamline and simplify requirements to get needed drugs to patients faster. Expedited and conditional review programs and the improved availability of English-language information are just two examples.
In Asia’s dynamic and diversified environment, working with appropriate partners to better understand and benefit from these changes remains an important way for companies to ensure their market access efforts are appropriately tailored and optimized, to the ultimate benefit of patients and their business.
We hope the content in this e-book provides some useful insights to this end.
Ian Haydock
Editor-in-Chief, Pharma, APAC
Informa Pharma Intelligence
