UK: the gateway to Europe – regulatory and clinical affairs

Distinctive location

• The UK is at the forefront of innovative medicines that are revolutionising healthcare. With a world-leading research base and a long established pharmaceutical industry, the UK’s prolific drug discovery and development sector is highly productive.

• All of the world’s leading pharmaceutical companies have R&D and/or manufacturing facilities in the UK.

• The UK is the leader in biotech in Europe, with 40 per cent of the EU’s public biotech companies (Ernst & Young 2007).

Established track record

• Twenty-five of the world’s 100 top-selling medicines were discovered and developed in the UK.

Drug Manufacturer

Viagra - Pfizer

Augmentin - GSK

Nolvadex - AstraZeneca

Zyprexa - Eli Lilly

Maxalt - Merck Sharp & Dohme

The UK accounts for over 40 per cent of the medicinal products currently in late-stage clinical trials in Europe.

Well respected pool of talent and expertise

World opinion leaders are based at the numerous centres of excellence in medicine across the UK.

New training and career structures have been put in place for clinical academics to develop and support the clinical research leaders of the future.

The UK is the home to postgraduate degree granting institutions specialising in regulatory and clinical affairs.

World class expertise in experimental medicine

The UK’s capacity and capability for experimental medicine research and early phase clinical studies has been boosted by major investment (>£200 million) over recent years.

UK experimental medicine resources, expertise and technologies are detailed in a new information portal – www.ukcrcexpmed.org.uk

Leading edge infrastructure for clinical trials

The UK Clinical Research Network (UKCRN) has been operational since 2005 providing a performance managed infrastructure within the National Health Service (NHS) for both investigator-initiated and industry sponsored clinical trials and other well designed studies.

UKCRN is made up of a series of topic-specific and comprehensive research networks across the UK covering the full range of medical conditions, including rare diseases.

UKCRN is working with pharmaceutical, biotech and devices companies to facilitate commercial research and streamline the process of conducting industry sponsored trials in the UK.

• Over 250 potential industry trials are being discussed with UKCRN, with more than 80 formally adopted.

UKCRN has a number of key targets for industry sponsored research including:

• prompt and reliable assessment of study feasibility

• acilitation of study site activation through the use of standardised agreements and costing processes

• rapid patient recruitment and delivery of high quality data for clinical studies across all areas of disease and clinical need.

In oncology, the National Cancer Research Network has dramatically increased the number of UK patients in clinical trials since its establishment in 2001 and has an accrual rate to cancer studies of over 12 per cent –one of the highest in the world.

Robust regulatory environment

The UK has a stable and efficient regulatory environment providing a good balance between protecting human and environmental safety, and promoting innovation and entrepreneurial endeavour.

Major initiatives are underway to streamline the UK regulatory and governance environment and speed trial start up times, including the use of standardised model agreements, the development of streamlined systems for research permissions and approvals, and a simplified approach to investigator honorary research contracts.

Since 2005, all new applications for market authorisation for biotech, orphan drugs, new drugs for HIV/AIDS, cancer, neurodegenerative disease and diabetes must be submitted to the London-based European Medicines Evaluation Agency (EMEA). Clinical trial applications proceed via the relevant Member State.

The Medicines and Healthcare Regulatory Agency (MHRA) was created by a merger of the MCA and the MDA in 2003, providing regulatory review for both medical devices and drugs. It has also recently reviewed and put in place new regulatory processes for certain first in man studies with novel products, allowing timely but enhanced review.

The MHRA holds a large number of scientific advice meetings nationally each year and is amongst the leading Member States in acting as coordinator for European Scientific Advice. MHRA also acts as Rapporteur more often than other Member States at the time of applications for Market Authorisation.

The UK has fully implemented the EU Clinical Trials Directive, which simplifies and harmonises the administrative provisions governing clinical trials.

World’s largest centralised healthcare system

The NHS is the world’s biggest health service and is the fourth largest employer in the world.

There is high-level commitment by Government to make the UK the best place in the world for health research, development and innovation. The UK Health Departments have strategies in place, such as Best Research for Best Health in England, to support these goals.

“The NHS contribution to health research is a centrepiece of the Government’s ambition to raise the level of R&D to 2.5 per cent of GDP by 2014.”

Patricia Hewitt, former Secretary for Health, January 2006

The NHS has well-kept and extensive medical records which can help to optimise patient selection (and exclusion) for clinical studies.

The Research Capability Programme has been established under NHS Connecting for Health to deliver the Government’s commitment to provide ethical access to electronic patient data to support clinical trials and observational research, including pharmacovigilance.

New landscape for public funding for research

Government funding for health research rising to £1.7 billion per annum by 2010-11, bringing together the research budgets of the Medical Research Council and the National Institute for Health Research into a Single Health Research Fund.

Single integrated Government health research strategy designed to facilitate and accelerate the movement of ideas from academia to industry.

Pan-Government approach to partnership with industry, with unprecedented involvement of industry in helping to shape the UK research agenda.

Proven culture of innovation

The NHS has been at the centre of pioneering medical and technological breakthroughs, ranging from cataract surgery to vaccine development. Advances are now being made in areas of gene therapy in stem cells.

The NHS National Technology Adoption Hub is committed to ensuring the adoption of innovative technologies in the NHS.

Comprehensive approach to the development of new medicines and devices

The UK has established end-to-end capability in bringing products to market – the UK accounts for 35 per cent of the total number of European drugs in the clinical trials pipeline.

There are over 200 companies engaged in the management of clinical trials in the UK.

Many of the full-service, international clinical trial research organisations have European headquarters located in the UK.