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<p>Most new medicines for rare conditions are licensed by the European Commission.</p><p>
</p><p>The European Union offers a range of incentives to encourage the development
of these medicines in order to address unmet clinical need. These incentives include
a period of 10 years market exclusivity, the provision of Protocol Assistance (scientific
advice specifically tailored for orphan medicinal products) and fee reductions and
waivers for regulatory procedures.</p><p> </p><p> </p><p> </p><p>Through the Medicines
and Healthcare products Regulatory Agency (MHRA), the United Kingdom takes an active
role in the decision making process at the European Medicines Agency’s Committee on
Orphan Medicinal Products, ensuring applications for Orphan Drug designation of potential
drug candidates for rare diseases are appropriately recognised, encouraging companies
to develop their products further and recommending use of existing flexibilities such
as conditional authorisation, authorisation under exceptional circumstances and accelerated
assessment. The UK is actively involved in the European Medicines Agency’s adaptive
licensing pilot that is exploring further use of these flexibilities. The MHRA has
an Innovation Office that can offer advice and assistance to developers of drugs for
rare diseases, including on the use of flexibilities.</p><p> </p><p><strong> </strong></p><p>
</p><p>In addition, in the UK, the Early Access to Medicines Scheme aims to give patients
with life threatening or seriously debilitating conditions access to medicines that
do not yet have a marketing authorisation when there is a clear unmet medical need.</p><p>
</p><p> </p><p> </p><p>We are also commissioning an external review of the pathways
for the development, assessment, and adoption of innovative medicines and medical
technology. This review will consider how to speed up access for NHS patients to cost-effective
new diagnostics, medicines and devices.</p><p> </p><p><strong> </strong></p><p> </p><p><strong>
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