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Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.
The UK's Medicines and Healthcare products Regulatory Agency has launched a public consultation regarding a scheme that could provide patients with access to unlicensed medicines in Phase II or III clinical trials.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation regarding a scheme that could provide patients with access to unlicensed medicines in Phase II or III clinical trials. The consultation will be open until Oct. 5, 2012.
The scheme is expected to apply to medicines for life-threatening, debilitating, or chronic conditions that are at the end of Phase III trials or, in certain cases, at the end of Phase II. Research conducted by MHRA has shown broad support for such a scheme, particularly for patients suffering from life-threatening illnesses.
If implemented, MHRA would review medicines that companies want to make available under the scheme and provide a scientific opinion on the risks and benefits. This information would help the country’s National Health Service in deciding whether the medicine should be available early.
“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 make appropriate treatment decisions,” explained Kent Woods, chief executive of MHRA, in a statement.
In its research, MHRA emphasises that patients will need to be fully aware of the risks of taking unlicensed medicines. There were also mixed views on whether early access to medicines should be given to patients with debilitating or chronic conditions, such as rheumatoid arthritis or diseases that may cause blindness.
After receiving all feedback, MHRA will aim to make a decision on implementing the scheme by the end of 2012.