Medicines and Medical Devices Bill - a briefing
On 16 January 2020, Doris-Ann attended a briefing at the Department of Health & Social Care on the Medicines and Medical Devices Bill which will be needed to enable healthcare product regulation in the UK after we leave the European Union.
The briefing was focussed on explanation of the mechanics of the Bill, and it was noted that this is proceeding more rapidly than other legislation without going through the development via green and white papers. There will still be pauses for consultation as the Bill progresses through stages of the legislative process. The timetable for the Bill and its commencement will be announced imminently and BIVDA has an email address for the Bill team which will act as an initial route for any queries.
There are elements of the Bill which will focus on the introduction, access and delivery of medicines alongside a mechanism to prevent falsified medicines from entering the supply chain, as well as elements focussed on medical devices and IVDs. At the same time, there is opportunity to ensure that the NHS and UK patients have faster access to innovative medicines and maintain a leading role in the development of diagnostics, advance therapies and devices in order to provide transformational patient care, with the UK at the forefront of the global life sciences industry.
In the meanwhile, BIVDA will be focussed on ensuring that for the medium term, the IVD sector can continue to place product on the market through the use of the CE Mark and the EU regulation, allowing focus on getting compliance to the IVD Regulation before any UK specific changes need be considered.