ABPI drug assessment judicial review turned down

A judicial review could have resulted in the High Court declaring that NICE and NHS England did not follow proper procedure in forming the new process.

Royal Courts of Justice

An application by the Association of the British Pharmaceutical Industry (ABPI) for a judicial review of new rules on the assessment of drugs to be used by the NHS has been rejected.

The application was lodged after the National Institute for Health and Care Excellence (NICE) and NHS England introduced an additional negotiation process for medicines that were likely to cost the NHS more than £20m in any of the first three years of use. The decision was made by the two bodies in an attempt to cut costs across the health service.

A judicial review could have resulted in the High Court declaring that NICE and NHS England did not follow proper procedure in forming the new process.

It introduced a new negotiating procedure for drugs and technologies that trigger the £20 million threshold and also introduced changes for the assessment of medicines for very rare diseases.

The ABPI, which filed its application for judicial review in June, claimed the new rules were likely to most severely impact patients with rare conditions, and would delay patients’ access to new treatments that had been deemed clinically and cost-effective.

However, after the ruling, the ABPI said it would not challenge the High Court’s decision.

“Following the decision by the Honourable Justice Mrs Elisabeth Laing not to grant the ABPI a judicial review against NICE, the Board of the ABPI has unanimously agreed to accept the decision and will not appeal,” the ABPI said in a statement.

It added it wanted to now focus on working constructively with the government and the NHS.

“Throughout this action, the ABPI has maintained positive and constructive dialogue with NICE, the NHS and government and we are encouraged that the issues are now better understood,” the statement said.

“Working in partnership with industry, government and the NHS we must now focus on finding real, workable solutions to help NHS patients get fast access to the medicines they need.”

Following the ruling, NHS England said in a statement: “In this ruling the High Court has rejected ABPI’s flawed legal manoeuvres which the judge said would ‘produce an absurd result’. Rather than attempting to further frustrate NICE and the NHS’ work to ensure patients and taxpayers get maximum value out of the £15 billion being spent on drugs, it now makes sense to work together towards that shared goal.”

Last updated
Citation
The Pharmaceutical Journal, October 2017;Online:DOI:10.1211/PJ.2017.20203698