Health
Tony O’Brien: Our medicines system would be better off without the HSE, and the HSE without it
Under-resourced and overly complicated bureaucratic, the drugs approval and reimbursement process is both a hidden waiting list and the likely subject of a future commission of inquiry
There is a complex process that separates any medicine that has been developed, manufactured or imported from the patients in Ireland who may need it.
It is an additional layer of decision-making that comes into play after years of clinical trials, and following a licence being granted by a safety regulator such as the European Medicines Agency.
This licence is called “market authorisation”, and it permits a pharma company to begin the process of selling ...