BIA welcomes Early Access to Medicines Scheme

The BIA has welcomed the proposal to introduce an Early Access to Medicines Scheme in the UK, which was outlined in the Strategy for UK Life Sciences. In a detailed submission responding to the Medicines and Healthcare products Regulatory Agency (MHRA) consultation on the scheme, the BIA raises four key areas that require consideration to make the scheme attractive and workable:

Scope and candidate product qualification criteria:
The BIA asks that the determining factor for eligibility should be the treatment in an area of unmet medical need.

Stage of development:
The BIA wants a flexible approach which does not restrict the Early Access to Medicines Scheme to the end of phase III trials, which we believe may offer limited incentives for innovative drug developers in the UK.

The regulatory application process and fees:
The BIA wants this process to be as streamlined and cost effective as possible.

Reimbursement and wider economic considerations;
The BIA believes that central ring-fenced funding for the Early Access to Medicines Scheme is vital to make the scheme successful and attractive in a global market.

Steve Bates, BIA Chief Executive officer, said:
"A funded early access to medicines scheme that makes it quicker and easier for new medicines to reach patients can secure the UK's position as the country for innovative therapies to be launched. We are pleased that the UK government committed to this consultation in its Strategy for UK Life Sciences. Our submission provides the practical details needed to make early access a workable and useful scheme."