Eighteen new clinical trial hubs, so-called Commercial Research Delivery Centers (CRDCs), to speed up the pace of research and a total public-private investment program of up to £400 million launched at the end of August by the UK government: these are the figures put in place to support faster patient access to new treatments, the strengthening of the UK clinical trials sector and local pharmaceutical manufacturing.
What the voluntary program involves
The program is based on the agreement reached between the UK government’s Department of Health and Social Care (DHSC), NHS England, and the Association of the British Pharmaceutical Industry (ABPI) and is known as the Voluntary Scheme for Branded Medicine Pricing, Access, and Growth (VPAG). At the heart of it is the expectation that the total expected amount of investment will be spread over the five years of the Voluntary Scheme of 2024, in addition to the payments already planned. Most of the funds (about 75 percent) will be allocated to clinical trials, in addition to drug manufacturing (20 percent) and health technology assessment (about 5 percent).
In addition, within the first three years of the new scheme, the UK PharmaScan platform is also expected to be created, aimed at supporting UK regulatory authorities, HTA bodies, and the local health system in horizon scanning activities. The platform will receive data on medicines in development from scheme participants. A cross-government working group with industry participation as well, aimed at ensuring that HTA and payer processes remain aligned with emerging regulatory pathways, should also be established within the first year of operation. Finally, the increased focus on the end-to-end pathway should help better delineate how to reach the market, how to align commercial development pathways with HTA, and what are the mechanisms for industry involvement.
Industry comments
According to ABPI, the program should allow patients better opportunities to participate in commercial trials. Researchers, on the other hand, will have access to the most innovative equipment and technologies and thus be able to design clinical trials that see an increasing interconnection between hospitals, the primary care network, and community and residential care settings.
Funds for manufacturing will be aimed at developing sustainable manufacturing initiatives, with promotion of efficiency and reduction of waste and emissions from the pharmaceutical sector.
In the field of HTA, the goal is to modernize processes and support the HTA Innovation Laboratory of the National Institute for Health and Care Excellence (NICE).