Proposal for early access to medicines under trial

PATIENTS with life threatening, chronic or debilitating conditions could be offered medicines still undergoing development trials in a scheme being considered by the Medicines and Healthcare products Regulatory Agency (MHRA).

A 12-week public consultation on the proposals has been launched by the MHRA as a "key part of the Government’s commitment to growing the UK’s life sciences sector and economy".

Under the scheme, the MHRA would provide a scientific opinion on the benefits and risks of making medicines available at the end of Phase 3 trials and in exceptional cases at an earlier stage of development such as the end of Phase 2.

Professor Sir Kent Woods, Chief Executive of the MHRA, said: "We have launched this consultation because we are committed to ensuring that where pharmaceutical companies want to make their new medicines available under this scheme, clinicians treating patients have access to robust scientific information to help them to make appropriate treatment decisions.

"We welcome all comments on the proposed Early Access to Medicines Scheme and we will carefully consider these and ministers will make a decision on implementing the scheme by the end of the year."

Comments on the Early Access to Medicines Scheme can be posted or emailed to the MHRA at earlyaccess@mhra.gsi.gov.uk by 5 October.