The treatments discovered and developed in the UK help to save lives, reduce suffering and improve the quality of life for millions of people all over the world. We have traditionally been at the forefront of international medicines research – only the USA has discovered and developed more medicines.
Clinical trials have always been a vital part of the medicine development process, as they provide data on the best ways of treating diseases.
The UK has made a significant contribution to this, and continues to do so. With a high concentration of research-based pharmaceutical and biotechnology companies, leading centres of academic medicine, and a long history of pioneering research, we are one of the leading venues in Europe for running the complex and often multinational studies needed to develop new medicines.
Once adopted, the new legislation, due to come into force in 2016, will take the form of a regulation to ensure a greater level of harmonisation of the rules of conducting clinical trials throughout the EU and it replaces the current EU Clinical Trial Directive.
The implementation of the EU Clinical Trials Directive in 2004 improved the overall quality of clinical research performed in Europe, but some elements of its content and its uneven implementation across EU Member States resulted in a large amount of unnecessary administrative burden. Since its implementation, there has been a steady decline in Europe’s share of clinical research, which has, in part, been attributed to the implementation of the Directive. This decline has also impacted the UK.
In July 2012, the European Commission published a proposed revision to the EU Clinical Trials Directive, converting it into a Regulation and updating some key content, to address the issue of unnecessary complexity. Revising the Directive as a Regulation will create a simpler, more efficient and uniform legal and regulatory framework for the authorisation and conduct of clinical trials in Europe.
ABPI has engaged at a UK and European level to ensure the Commission’s proposals remained as intended for this legislation, which was approved by the European Parliament and the Council of Europe in early 2014. It is expected to be implemented from mid-2016. The focus of work has now shifted from the legislative revision to implementation process.
A Government-sponsored strategy for research in the NHS continues to work towards improving the research processes in the UK and the advent of the UK Clinical Research Collaboration (UKCRC). The formation of the National Institute for Health Research (NIHR) in England, NHS Research Scotland (NRS) and National Institute for Social Care and Health Research (NISCHR) in Wales has brought innovation to the way clinical research is conducted in the UK.
The NIHR has implemented the Research Support Services (RSS) across England to professionalise the local management of health research through national standards for governance, incorporating a risk-proportionate approach to assessment at NHS sites and collecting and publishing outcome indicators. Key objectives are to eliminate duplication in the review process, speed up approval decisions and improve reliability and the quality of clinical research delivery.
We work with our member companies, encouraging participation in Government initiatives which enhance the clinical research environment in the UK. We host groups with special interest in specific disease areas (e.g. cancer) or innovations (e.g. electronic health research and database use) in order to coordinate industry participation in specific collaborations. We provide a neutral forum to share best practice and work with our team of experts in clinical research and medical affairs (the ABPI Clinical Research Expert Network and Medical Expert Network) to represent the UK pharmaceutical industry on research matters by instilling good practice and innovative approaches. We keep ABPI members informed of regulatory, policy and legislative developments which affect the clinical research environment.