Question to the Department of Health and Social Care:

To ask Her Majesty's Government what assessment they have made of reports that, following its acquisition by a Swiss private equity firm, Essential Pharma has increased the price of one of its branded lithium carbonate tablets from £3.22 to £87.00 a packet, and withdrawn its other brand of lithium carbonate tablet; what estimate they have made of the time it would take to obtain a marketing authorisation for a replacement; and what plans they have to speed up that process.

Camcolit 250 tablets - branded lithium 250 milligram (mg) tablets - were discontinued in 2015. The generic list price of lithium carbonate 250 mg tablets manufactured by Essential Pharma has been £87 since 2016. While there are no controls on prices of generic medicines, we rely on competition to drive prices down which has led to some of the lowest prices in Europe. Where we have seen some very large price increases, the Department has brought the issue to the attention of the Competition and Markets Authority (CMA). The CMA is considering the case of lithium pricing.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for licensing of medicines. Its evaluation of a submitted application which meets the necessary standards of quality, safety and efficacy through to determination, would normally be within the statutory time frame of 210 days following receipt of a valid application. This excludes clock-stop periods when time is taken by the applicant to provide further information or generate the necessary data and update their dossier in response to questions raised during the assessment of the application. The MHRA has expedited processes to ensure that marketing authorisation applications are evaluated as rapidly as possible if necessary, to meet a public health need.