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Breakthrough Therapies in U.S. Spur U.K. in Similar Plan

The U.K. may follow the U.S. in adopting a program designed to make novel medicines available to patients more quickly.

The Department of Health is at an advanced stage of talks for a “promising innovation medicine” plan, according to the BioIndustry Association, a trade group, which cited comments made by Under Secretary of State Frederick Curzon at a meeting yesterday. Under the proposal, some treatments would be fast-tracked through the licensing process and made available to National Health Service patients more quickly, the BIA said.

The U.K. proposal would have goals similar to those of the U.S. Food and Drug Administration’s “breakthrough therapy” designation to speed product development and approval, the BIA said. In addition, the U.K. program may be linked with reimbursement from the state-run NHS through a plan to give patients with serious conditions access to experimental medicines, the BIA said.

“We’ve seen the importance of ‘breakthrough therapy’ designation at the FDA on investor sentiment and the speed of drug approval in the U.S.A., so it would be great for companies in our sector to see this real policy innovation from the U.K. government,” BIA Chief Executive Officer Steve Bates said in a statement posted on the organization’s website.

92 Requests

The FDA began designating certain medicines as breakthrough therapies under a U.S. law signed on July 9, 2012. The designation means that preliminary evidence shows a medicine might offer substantial improvement over current treatment for serious or life-threatening conditions.

The agency’s Center for Drug Evaluation and Research received 92 such requests from Oct. 1, 2012, to Sept. 30, 2013, granted 31 and denied 52 in that period, according to the FDA’s website.

While European Union regulators make drug approval decisions for the bloc, which includes the U.K., the country’s Medicines and Healthcare Products Regulatory Agency oversees the design and execution of clinical trials within its borders, as well as licensing medicines and monitoring their safety and marketing.

Faster adoption of new medicines would probably have a “positive effect” on companies developing the therapies and investors’ views of them, Bates said.

Curzon, the Department of Health under secretary, sits in the House of Lords as Earl Howe.

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