ABPI's judicial review could be pointless - lawyer

The UK pharma industry wants to challenge new spending limits on medicines in England – but one legal expert says the bid could fail

The Association of the British Pharmaceutical Industry (ABPI) revealed two weeks ago that it is seeking a judicial review to challenge the new Budget Impact Test, which was introduced in April.

The rule allows NHS England to open price negotiations with companies who have just received NICE approval, and whose product is likely to exceed sales of £20 million during any of the first three years on the market.

The industry says this is unfair, as it adds to an already tough NICE process, where manufacturers routinely cut their prices to meet NICE’s cost-effectiveness requirements.

NICE and NHS England introduced the new rule earlier this year because of situations where expensive medicines such as hepatitis C cures were considered cost-effective by NICE, but caused budgeting problems for the health service.

Critics have said that by reaching this arrangement with NHS England, NICE has compromised its status as an independent cost-effectiveness body.

Catherine Drew, partner at legal firm Pinsent Masons, noted that the judicial review is a request for a judge to review the lawfulness of a decision.

The ABPI’s request may be denied, although there is the possibility of an appeal. Drew said that if permission is granted the matter could go before a judge in an administrative court who will consider the legality of the decision-making process.

But even if the decision goes against NICE, the cost-effectiveness body could decide to take the decision to introduce the same policy again.

Drew said in an interview with pharmaphorum: “It could be that the NICE decision is quashed and NICE is ordered to take the decision again where the outcome could of course be the same.”

She did not want to be drawn on the likelihood of a successful judicial review and said that the review would be unlikely to have implications for other healthcare policies.

She added: “If the judge makes comments as to the decision making of NICE more generally then, other policies may in due course be challenged.  But at the moment the simple fact is that the ABPI has challenged NICE’s decision."

"In this circumstance, I do not consider this makes it likely that other NICE or NHS policies will be subject to challenge.”