Pharmaceutical Business review

ABPI applies for Judicial Review against new procedures for cost-effective medicines

Following a story published today in the Financial Times, the Association of the British Pharmaceutical Industry (ABPI) can confirm that it has applied for a Judicial Review.

The Judicial Review has been applied for over the introduction – by the National Institute for Health and Care Excellence (NICE) – of an additional negotiation process for medicines that have already been assessed as cost-effective if they are likely to cost the NHS more than £20million in any of the first three years of use. NICE’s own analysis shows that around one in five new medicines will be impacted.   ?

The ABPI is also seeking to reverse changes to the assessment of medicines for very rare diseases, which we believe to be inappropriate and unworkable.

The new procedures have the potential to cause significant delays for patients waiting for treatment for a range of conditions, including for cancer, heart disease and diabetes. ABPI believes it is important to challenge these new procedures before the first medicines get caught in the system, creating uncertainty for patients about whether they will be able to receive them.

After raising concerns about the plans and offering to work constructively on alternative proposals, the ABPI is now reluctantly seeking to challenge the NICE decisions in the courts. 

ABPI Chief Executive, Mike Thompson, said: "These new arrangements will delay access to cost-effective medicines and deny treatments to patients suffering from rare diseases. After many months of raising concerns with NICE, NHS England and the Department of Health and offering to work constructively on alternative proposals, we have applied to formally challenge these proposals in court. 

"?We believe this to be the right course of action due to the potential damage these changes will cause to NHS care and on our ability to research, develop and use new medicines here in the UK. We hope that the Government will reverse the changes and work with us to find a solution that works for everyone."