ABPI Turned Down for Judicial Review of Budget Impact Test

The UK’s Association of the British Pharmaceutical Industry (ABPI) had hoped to stop a new policy that amounts to price negotiation and potentially delaying access to some new medicines but its request for a Judicial Review (JR) has been denied by the High Court.

The ABPI had sought to challenge a new policy introduced in April 2017 by the National Institute for Health and Care Excellence (NICE). A key architect was also NHS England (NHSE), the agency that pays for many high cost specialist drugs.

The policy was not popular, but it is unusual for the ABPI to take the legal route signally just how strongly (some at least) felt about the policy. It’s also been divisive amongst some of the big players in the industry.

The policy includes the potential for price negotiation with NHSE on new drugs that cost more than £20million a year in any of the first three years after launch, even if they are approved by NICE and seen as cost-effective. The policy also includes a new threshold for ultra-orphan drugs, up to £300,000 cost per Quality Adjusted Life Year (QALY), but only if certain criteria are met.

The ABPI is reported to have sought the JR on the basis that the policy conflicted with legislation that patients have access to NICE approved drugs within 90 days and a patient right in the NHS Constitution to NICE approved drugs. NICE had already questioned the independence of witnesses.

The ABPI said in its statement on 4 October 2017 that it was disappointed. It added on October 5 that the Board has decided not to appeal the decision made by Honourable Justice Mrs Elisabeth Laing. The tone has shifted; the ABPI is focusing more on working in partnership.

NHSE and NICE are reported to have welcomed the Courts decision. NHSE have suggested that industry work with NICE and the NHS to ensure that patients and taxpayers get the maximum value out of drug spend.

That the ABPI has taken the decision not to appeal may be a relief to some. The pharmaceutical industry is just one of many trying to ensure that it makes the best of Brexit and that means treading a fine line between challenging the Government to do more, but also recognising that the pharmaceutical industry’s issues are just some of the wider industrial policy issues that the Government has to deal with. Add to that the impending negotiations on a successor to the main pricing regulation, the Pharmaceutical Price Regulation Scheme (PPRS).

No drug has yet gone through the budget impact test, so in practice it remains to be seen whether it will be quite as bad as some fear, or perhaps the warm words of partnership will lead to negotiations that are acceptable to both sides?