A NEW scheme offering patients with life threatening or seriously debilitating illnesses access to medicines still awaiting marketing authorisation has been launched by the Government in England.
The Early Access to Medicines scheme will allow doctors to treat selected patients with innovative and promising drugs as soon the Medicines and Healthcare Products Regulatory Agency (MHRA) has signalled that the benefits outweigh the risks following an initial scientific assessment.
It is hoped the scheme will make the UK one of the best countries in the world to capitalise on breakthroughs in medical care.
The scheme is voluntary and the opinion from MHRA does not replace the normal licensing procedures for medicines. MHRA is responsible for the scientific aspects of the scheme and the scientific opinion will be provided after a two-step evaluation process.
The scheme will begin taking applications from companies from early April 2014 and MHRA will provide advice on the scheme when it is launched.
Dr Ian Hudson, Chief Executive of the Medicines and Healthcare Products Regulatory Agency said: "We are delighted that the Early Access to Medicines Scheme will be launched in April 2014. The scheme is intended to enable patient access to medicines for treatment of life threatening or seriously debilitating conditions where there is an unmet need. This is a major new development in medicines policy in the UK.
"The scheme offers a way by which unlicensed medicines can be available to patients before approval of a licence to benefit public health. It will also enable companies to gain additional knowledge and experience of these medicines in clinical use."