Judicial review unhelpful, suggests biotech association

The ABPI confirmed that it has applied for a judicial review of the decision to introduce the ‘budget impact test’ – a new post-NICE approval price control mechanism. This will target any new medicines which could cost the health service £20 million or more in its first three years on the market.

The legal challenge is a rare step for the ABPI, and reflects anger in the pharmaceutical industry that another means of controlling cost has been introduced, adding to the existing PPRS pricing system and NICE’s own cost-conscious approach.

NHS England is the chief driver behind the budget impact test, as it is charged with controlling NHS finances but is struggling to do so.  Growing patient demand is not being matched by government funding, and a wave of high cost new drugs is among the most significant factors behind the problems.

The ABPI looks likely to have its judicial review granted by the UK courts, but there is no guarantee that its legal challenge will ultimately succeed.

Responding today to the news, Steve Bates, the chief executive of the UK’s biotech association the BIA stated plainly that it was neither party to the process nor had it been consulted.

Bates declined to comment on the details of the challenge, which will hinge on whether NHS England and NICE have followed proper procedures and observed existing laws and regulations.

Nevertheless, it was clear from his statement that the BIA thinks the move is an unhelpful distraction.

He said: "…there are several other complex issues the full life sciences sector is currently engaging with the government on. Namely, how we can make Brexit a success for the life sciences sector and how we can develop the most impactful industrial strategy to support the BIA’s ambition that the UK sustains itself a leading global cluster for life sciences."

Bates concluded: "This legal move must not impact or delay broader industry engagement with the UK government at a time of significant external change."

This difference of opinion is in contrast to recent collaborations between the ABPI and BIA, especially in regard to the Brexit question.

The BIA is clearly concerned that a legal battle might sour relations between the life sciences sector and the UK government.  The government had promised to produce a full Life Sciences Industrial Strategy, however the tumult around Brexit and the general election has meant only an outline document has so far emerged from Whitehall.

However breast cancer charity Breast Cancer Now put out a statement which was more supportive of the ABPI’s stance.

Baroness Delyth Morgan, chief executive at Breast Cancer Now, said: "We remain extremely concerned that the budget impact test could see NHS patients experience delays in accessing vital and cost-effective drugs."

Baroness Morgan said it was "incredibly disappointing" that NICE and NHS England went ahead with the budget impact test despite widespread opposition from those representing patients, as well as a willingness to discuss alternative solutions.

"Getting modern breast cancer drugs through to the NHS patients that desperately need them is already very difficult, and this test could represent a major additional hurdle. Thousands of women living with incurable breast cancer are relying on effective drugs to give them significant and precious extra time with their loved ones, and any further delays could sadly see patients lose their lives as they wait."

She concluded: "We will now be monitoring the progress of this possible legal action closely, and hope that it will provide clarity on the issue of timely access to drugs in England. We, alongside many other charities, remain ready and willing to work with all involved to look at how this critical issue can be resolved."

The judicial review process has two steps and was begun last month. The first step of the process is to apply to the court for permission and this usually takes around two months from the date that the permission application is submitted.

The decision to mount the legal challenge was made by the ABPI Board, which includes senior executives from across the pharma industry, and it collectively decided to apply for a judicial review.

NICE responded to pharmaphorum’s enquiries to say that it will not be commenting on the case.