May 23, 2016

the regulation of medicines and devices and the EU referendum

The debate about the pros and cons of remaining – or leaving – the EU continues unabated. One important area that has not been publicly explored – or explained – are the benefits of membership of the EU when it comes to the regulation of drugs and devices.

These benefits:

• The European Medicines Agency (an Agency of the European Commission) is based in London, which gives the UK a number of advantages;
• EU regulations mean that Clinical Trials can be done in all EU countries under the same rules: this speeds up research on new medicines and medical devices;
• Marketing Authorisations of almost all new medicines is done under a Centralised Procedure which means that they are immediately available across the EU
• The way that medical devices are approved – by CE marketing – gives UK manufactures immediate access to the whole European market, as well as a recognized standard in the rest of the world.
• Co-ordinated vigilance by all EU countries for medicines and devices allows serious side effects and other problems to be recognised and dealt with quickly.

Speakers:

Professor Simon Wessely, FMedSci, President of the Royal College of Psychiatrists & Chair of Psychological Medicine and Vice Dean, Institute of Psychiatry Psychology & Neuroscience, King’s College London

Professor Bruce Campbell, FRCS, Surgeon and Non-executive Director, Medicines and Healthcare Products Regulatory Agency

Professor Patrick Vallance, FMedSci, President of Pharmaceutical R&D, GlaxoSmithKline

Professor Sir Michael Rawlins, FMedSci, Chair, Medicines and Healthcare Products Regulatory Agency

Dr Melanie Lee CBE, FMedSci, Chief Scientific Officer, BTG plc