Prescription Drugs

(asked on 17th November 2014) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what steps his Department is taking to encourage flexibility in the licensing process for potential new treatments for rare conditions.


Answered by
George Freeman Portrait
George Freeman
This question was answered on 24th November 2014

Most new medicines for rare conditions are licensed by the European Commission.

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.

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.

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.

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.

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