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. Read more on the written evidence submitted to the Parliamentary Science and Technology Committee in September 2013.
Clinical trials have always been a vital part of the medicine development process in establishing safety and efficacy in humans, as they provide data on the best ways of treating diseases and are required by regulators.
The UK has made a significant contribution 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 global locations for running the complex, innovative and often multinational studies needed to develop new medicines.
The Ministerial Industry Strategy Group Clinical Research Working Group has produced a report looking at the UK performance against a number of criteria. The report demonstrates an encouraging position for UK clinical trials broadly across all trial phases. It brings together many data sources to give insights on the current status of clinical research in the UK, and to set a baseline for future activities.
The implementation of the EU Clinical Trial 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 Trial 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. The UK government have committed to be aligned to the Clinical Trial Regulation as far as possible, irrespective of the outcome of Brexit. There is further information on the Medicines and Healthcare Products Regulatory Agency (MHRA) guidance published in August 2018. In January 2019 the MHRA issued a further updated guidance for the regulation of medicines, medical devices and clinical trials in the event that there is no Brexit deal.
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. 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 the 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) Framework 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 and with the UK Government through the Life Sciences Council and subgroups. We organise expert networks with special interest in specific disease areas (e.g. cancer) or innovation (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 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.
We also work with the European Federation of Pharmaceutical Industries and Associations (EFPIA) in line with the principles in the codes of practice at the European level.
ABPI is currently focussing on the following areas, in conjunction with other stakeholders: