Details of the government's proposal to replace the Medicines Act were released in late April.  The proposal comes after a series of attempts to reform and update the Act since the 1990s that has resulted in various minor fixes to the regime but not a complete overhaul.  The current Act is considered to be dated and inflexible with significant gaps in coverage.  The Act is also structured in a way that does not allow separation of responsibilities for accountability purposes and makes the Minister responsible for technical decisions. Key aspects of the new regime include devolving product and licencing decisions to an independent regulator with a clear and principled legislative mandate, bringing all therapeutic products and related activities within scope of regulation and clearly distinguishing medicines and therapeutic products.  The new regime will also take an approach to regulation that is comprehensive (whole of lifecycle) and risk appropriate (regulatory scrutiny will be proportionate to risk).  A draft of the Therapeutic Products Bill that will replace the Medicines Act will be released for consultation in 2016 and it is proposed to be passed in 2017.