Why can’t I get that drug? It’s already approved overseas

Every country has its own medicines authority that has to check if a drug is safe and effective before doctors can prescribe it. Just because it’s been approved overseas doesn’t mean Australia has approved it. That review takes time, sometimes years, and the order in which drug companies apply to different countries depends on where they think the biggest market is, how much the application costs, and how complicated the local rules are. 

Even after a drug is approved in a country, that’s not the end of it. If it’s not added to the government’s subsidy list, most people still can’t afford it – approval and access are two different things. 

Before any drug can be approved anywhere, it has to be tested in people first – this is where clinical trials come in. If trials run slowly, get delayed, or don’t find enough participants, the whole timeline pushes back for everyone who needs the new medicine. 

The gap between “approved somewhere” and “available here” frustrates patients and doctors alike. Understanding why it exists is the first step toward understanding how it gets closed. 

By Katie Spillane.