In response to Andrew Lansley’s announcement on better access to medicines for rare diseases, Stephen Whitehead, Chief Executive of the ABPI, said:
"We welcome all initiatives which seek to improve appropriate access to medicines and improve the health of UK patients.
"There can be very important clinical reasons why people should be prescribed an unlicensed or off-label medicine, such as when an appropriately licensed alternative is not available. We recognise this can be a particular issue in rare conditions where the fact that there are very small numbers of patients for whom the medicine could be beneficial can make clinical studies examining safety and effectiveness particularly challenging. Whilst we are supportive of the initiative in principle, it will always be preferable for a medicine to be licensed for the purposes for which it is used and has been subject to the rigorous scrutiny of the regulatory authorities.
"The regulatory and licensing system in the UK exists to protect the public, so the circumstances when an unlicensed or off-label medicine is prescribed should continue to be strictly limited to occasions where there is no suitable licensed alternative available and use is in the best interests of the patient concerned.
"We look forward to engaging with all government and healthcare stakeholders in the months to come to help shape the implementation of these proposals, and ultimately, improve patient access to new, innovative medicines."
Andrew Horne, Media Officer Tel: 020 7747 1410Mobile: 07850 312064
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