The Pharmaceutical Journal
Vol 279 No 7478 p557
17 November 2007

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Why the UK must continue to nurture skills required for drug development

As Asia gains ground as an attractive research location for companies developing new medicines, and regulations threaten trials based in Europe, Tom Moberly (on the staff of The Journal) looks at work the Government and others are doing to nurture UK drug development skills

The UK is a leader in the development of new medicines. One in five of the top 100 medicines in use today originated from research in the UK — a record that only the US can beat.

The pharmaceutical industry carries out more research than any other sector in the UK and in 2006 invested £3.3bn in UK R&D, employing more than 65,000 people and generating another 250,000 jobs in related industries. But everyone involved will have to work hard to maintain this position.

Threats

Uncertainty and new rules introduced in the wake of the TGN1412 clinical trial disaster (PJ, 18 March 2006, p307) have led to concerns that companies may decide to undertake UK-based clinical research elsewhere. As yet, this does not seem to have happened to any great extent.

But a number of measures proposed after the TGN1412 trial have still not been put in place and concerns over delays may yet dent companies’ confidence in the UK as a base for research.

In addition, many drug developers fear that the EU clinical trials directive, designed to standardise reporting and protect patients, could reduce the number of clinical trials based in Europe by increasing the regulatory burden on clinical researchers. These fears appear, initially at least, to be borne out by evidence.

The number of new cancer trials in Europe fell by 63 per cent in the space of a year (from 19 in 2004 to seven in 2005) while the costs of these trials increased by 85 per cent and delays in trial initiation rose by about five months.

This summer, the European Commission launched a consultation on the future of pharmaceutical development in Europe. “Today’s globalisation means that, due to structural factors which go beyond the pharmaceutical sector (eg, labour costs), the centre of gravity for worldwide R&D investment in the field is gradually moving to the US and Asia,” it warned.

In addition, Lord Hunt of King’s Heath pointed out earlier this year that the UK cannot be complacent about continued pharmaceutical and biotechnology investment as competition increases from the US and emerging economies, such as China and India. And last month the Association of the British Pharmaceutical Industry stressed that the UK’s position as a global leader in biomedical sciences, both in the academic and private sector, is under threat.

The ABPI has identified weaknesses in the “skills pipeline” of the UK pharmaceutical and biopharmaceutical industry, especially in areas critical to sustaining biomedical research, such as in vivo skills.

“If the UK is going to sustain its competitiveness in attracting global biomedical research we must address the in vivo skills supply,” the ABPI said. “China, India and Singapore are all striving to create the pools of skills required in modern day drug discovery and biomedical research. Several major employers have set up animal facilities in these countries. We cannot let a shortage of in vivo skills be a reason for disinvestment from the UK.”

The Government has acknowledged the need to respond to this global challenge. In February this year the Ministerial Industry Strategy Group produced its long-term leadership strategy, which set out a range of recommendations designed to facilitate UK-based health research.

As part of this drive, the Department of Health announced last month that it had negotiated a model clinical trial agreement (CTA) for contract research organisations and hospital trusts. The agreement replaces the many different contracts companies previously had to negotiate with individual hospital trusts.

Sally Davies, director general of R&D at the DoH, believes the use of this agreement by research managers in the NHS will help to implement what she calls the Government’s “bureaucracy busting” agenda for health research. It will also, she suggests, increase opportunities for NHS patients to participate in clinical trials, speed up the process of setting up approved clinical trials, and make it easier for patients to access innovative treatments, as well as reducing legal costs for trusts, clinical research organisations and research funders.

Funding

In addition to regulatory change, the UK is also to benefit from an extra £1bn of Government funding for scientific research over the coming three years. The funding will be used to improve knowledge transfer from research to business, to support business-facing universities, early stage technology and the teaching of science, technology, engineering and mathematics.

To improve teaching and skills, the Government recommended that an advisory group should report on undergraduate and graduate job trends and subjects where the employers and the Government believe there is likely to be a shortage of graduates with key skills.

The development of skills required to support clinical trials will be at least as important as providing the money to fund them if the UK is to remain a leader in drug development. Last week, details of a new certificate in human pharmacology were revealed (see Panel below) and in October 2007 the ABPI launched an action plan to boost UK students’ in vivo skills. Employer demand for these skills has been stable over the past 10 years, but supply has declined, the ABPI says.

Three-quarters of employers who require these skills are finding it “difficult” or “very difficult” to find suitably qualified staff, the ABPI found. The report recommends that sub-disciplines that include in vivo techniques — pharmacology, physiology, toxicology and pathology — should be formally recognised by the Government as important to the economy and society and vulnerable to low student demand.