BioWorld International Correspondent

LONDON - UK biotech has set out battle plans to hang onto its position as European leader and No. 2 after the U.S., following the biggest policy review of the sector to date.

More than 70 leaders of the industry contributed to the review by the Bioscience Innovation and Growth Team (BIGT), which Monday published its report, "Bioscience 2015: Improving National Health, Increasing National Wealth."

Among its proposals is a £150 million (US$253.4 million) plan to create a National Clinical Trials Agency to make the UK the most efficient and effective setting for clinical trials in the world; regulatory changes to speed drug development and approval times; measures to make it easier for companies to raise money in the capital markets; increased investment in biomanufacturing; and a call for a single piece of legislation to deal with animal rights extremists.

A new body, the Bioscience Leadership Council, lead by Richard Sykes, former CEO of GlaxoWellcome plc and now rector of Imperial College in London, has been set up to oversee the implementation of the proposals.

Writing in the report's forward, Prime Minister Tony Blair acknowledged the scientific, regulatory and financial challenges facing the industry and promised to respond to the report's proposals.

"The increasing cost of new drug approvals and the length of time it takes to bring new ideas to market together create the need for innovative financial backing and a flexible regulatory environment," he said.

The chairman of BIGT, David Cooksey, said that if the recommendations are carried out they would "make a tangible difference to the environment for developing bioscience business in the UK, yet without distorting markets or creating false expectations."

Cooksey, who is chairman of the venture capital group Advent Venture Partners, added that the report is addressed not only to government but also to the industry and the financial and academic communities.

"Many of the recommendations will need industry input as well as government support to succeed," he said.

Sustaining the UK's position as the second-largest biotech sector after the U.S. is by no means certain. Countries including Singapore, Ireland, India and China are offering extremely generous financial incentives to build a bioscience sector. "All have sights set on becoming the world's second-largest player," the report said.

The key recommendation to improve access to capital markets is a relaxation of the preemptive guidelines that require consent from existing shareholders for issues of more than 5 percent of capital. It takes time to comply with that requirement, during which a funding window might close, and as it is public, often has a depressing effect on the share price.

The BIGT proposes increasing the 5 percent limit to 20 percent. Paul Haycock, a former partner at the venture capital group Apax Partners, who chaired the BIGT working group on finance, told BioWorld International the biotechnology sector should be singled out as a special case. "Fund managers have to be amenable to change. This won't dilute people out of existence. There will still be a limit, and existing investors can participate."

The BIGT's vision for the National Clinical Trials Agency is to provide a single gateway to the largest pool of patients in the world, in the UK's National Health Service. The agency would not act as a contract research organization but provide access to high-quality, rapid and economic clinical trials. The report said that would give UK companies a significant competitive advantage and be an incentive for overseas companies to set up in the UK.

Aisling Burnand, CEO of the UK BioIndustry Association, told BioWorld International that there was already a momentum behind the proposal.

"Clearly, it needs government money to get it up and running in the right way, but it can be self-sustaining because companies will pay to get trials done more effectively," Burnand said.

Speaking as the BIGT report was published Monday, Blair announced the government would put in £10 million to get the clinical trials agency off the ground. A detailed implementation plan will be worked out over the next six months.