Novartis appeals the High Court judicial review judgment to defend the UK’s regulatory framework
Oct 12, 2018
The purpose of the UK’s world-renowned regulatory system for medicines is to safeguard and protect patients. This regulatory system must not be compromised. Doing so puts the health and wellbeing of patients at risk. It has taken years to build the safeguarding regulations to address previous threats to patient safety. Yet, the judicial review judgment on a Clinical Commissioning Group policy to offer patients unlicensed bevacizumab for the treatment of wet age-related macular degeneration (wet AMD) challenges the leading, indeed statutory, role of the MHRA and EMA (Medicines and Healthcare products Regulatory Agency and European Medicines Agency) in protecting public health and assuring the quality of medicines.This sets a dangerous precedent, which we should all be concerned about.
Today, people living with wet AMD are now being asked to compromise on the assured quality and safety of their treatment, purely on the basis of cost. This is inappropriate and unnecessary when there are two NICE approved - and therefore cost effective - licensed treatments available. In the future, on the basis of this judgment, it may be people living with cancer, diabetes, or any other long-term condition being asked to compromise on the quality and safety of their treatments. This must not be allowed to happen.
It is for this reason that Novartis will appeal the judgement. The judgement puts the financial burden faced by the NHS above patients’ right to medicines which have met the MHRA and EMA regulatory requirements, and the UK public are now being asked to accept this. It also potentially pressurises clinicians to make clinical choices based on cost, and not clinical need.
There is a real need for collaboration between the NHS, Government and Life Sciences companies to ensure the NHS is successful for years to come, particularly at a time when medical innovation is at its strongest. Novartis is fully committed to this. The UK’s ageing and growing population needs a health service that is efficient and adopts new technologies and medicines quicker than it has done in the past. Currently, UK patients already wait longer than their European counterparts to access vital medicines, and policies like this will only see that worsen whilst discouraging future investment in innovation.
This judgement is a step backwards - for our regulatory system, for innovation, for decision-making based on clinical need, and most importantly for patients who are being put at risk - and therefore must be challenged.
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 125,000 full-time-equivalent
associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.
In the UK, we employ approximately 1,500 people to serve healthcare needs across the whole of the UK, as well as supporting the global operations of Novartis. In 2017 Novartis invested almost £30million in R&D and is a leading sponsor of clinical trials in the UK. For more information, please visit www.novartis.co.uk.