New roadmap to help speed up patient access to ATMP products
The Association of the British Pharmaceutical Industry and the Accelerated Access Collaborative have launched a new roadmap to help companies get their new, innovative products onto the market in the UK.
Our roadmap helps to demystify the often-complex processes that innovators face and is an essential tool for those launching products in the UK. Dr Paul Catchpole, Value and Access Policy Director at the Association of the British Pharmaceutical Industry
Advanced therapy medicinal products (ATMPs) have the potential to save and transform the lives of some of the sickest patients and potentially help to cure them.
But the process of getting these products to patients can often be complex, difficult to navigate, and hard for companies to understand.
The UK Government has recognised the potential of ATMPs and put in place initiatives to help develop Britain as a world leader in the sector, but more can still be done to help attract innovators to research, develop, manufacture, and launch their products in the UK.
The new roadmap aims to clarify the processes companies have to go through and how to engage with the system. It sets out four things that companies have to consider when launching a product:
1. Engage early with all parts of the healthcare system including the MHRA, NICE and NHS England – from early product development and regulatory stages right through to service planning and commissioning to make sure the system is ready.
2. Keep the patient in mind throughout and talk to patient groups to keep them at the heart of development. Also, consider patient population diversity.
3. Take advantage of all available guidance and support including what’s on offer from the NHS and other parts of the system partners who can help you understand the landscape and how to meet the specific requirements of regulators, commissioners, and providers.
4. Aim for simplicity wherever possible and look for where things can be standardised. The health service already delivers ATMPs to patients, and companies should consider what they can do to make them fit existing systems and processes to speed up time to market and to patients.
Dr Paul Catchpole, Value and Access Policy Director at the Association of the British Pharmaceutical Industry, said:
"We want to make Britain the most attractive place in the world to research, develop, manufacture and launch new ATMP products and for NHS patients to be amongst the first to benefit.
"Our roadmap helps to demystify the often-complex processes that innovators face and is an essential tool for those launching products in the UK."
Matt Newman, Deputy Director, Accelerated Access Collaborative (AAC) said:
"The ABPI led the development of the ATMP roadmap as part of the Accelerated Access Collaborative, coordinating with a range of AAC partners throughout. This is one aspect of a broader programme of work to ensure that the NHS is ready to adopt the latest ATMPs, building on the successful introduction of treatments like CAR-T.
"Thanks to the new roadmap, ATMP developers have access to a rich source of information, in one place, set out in an accessible format. This first of kind resource will make the end-to-end pathway for ATMPs easier for developers to navigate, increase NHS adoption and make the UK an attractive place to launch ATMPs. Ultimately, the new ATMP Roadmap will support innovators in getting ATMPs to NHS patients faster."
Last modified: 20 September 2023
Last reviewed: 20 September 2023