The British In Vitro Diagnostics Association (BIVDA) commissioned the University of Nottingham to produce an independent White Paper examining the UK Government’s procurement of COVID-19 tests during the pandemic, which has now been published.
This paper is a comprehensive examination of the Government’s COVID-19 test procurement strategy. The research has revealed a high number of direct awards to select companies, limiting market access of established suppliers who have provided diagnostics to the NHS over many years, leading to questions concerning transparency and best use of taxpayer money.
The paper, produced by Dr Luke Butler, Associate Professor in Law at the University of Nottingham, investigated how test kit contracts were awarded, technically validated for use, and approved for placement on the market as part of the Government’s Test and Trace strategy.
There are several lessons and recommendations which emerge from the paper, which BIVDA says it hopes will improve pandemic preparedness and closer engagement with UK diagnostics operators in future.
Direct awards and higher regulatory burden for the sector is something BIVDA strongly opposed on behalf of its members throughout the UK’s response to the pandemic and this evaluation provides a roadmap for closer collaboration between the IVD industry and Government to ensure failings are not repeated.
The paper recommends that the Government should understand the challenges resulting from procurement decisions which affect competition, market access and industry resilience in emergency circumstances.
Commenting on the paper’s release, Helen Dent, Chief Operating Officer at BIVDA, said: “This paper highlights the necessity for the system overall to be more aware of the impact of decisions across a sector, and how critical it is for Government and Industry to be transparent and fair. It is clear that scientific validation and approval has a significant impact on procurement decisions and competition and that the two are not always mutually exclusive. The recommendations should be taken up and implemented to build trust for industry and the public. We look forward to working with Government and agencies with industry to do so.”
Dr Luke Butler, who produced the report for BIVDA, said: “The recently published MedTech Strategy has identified the significant role of diagnostics in the health and social care system. The instrumental role of public procurement is also acknowledged. However, the Government should focus more attention on the role of public procurement as a strategic tool for achieving UK diagnostics policy aims and the processes needed in support.”
Doris-Ann Williams, BIVDA Chief Executive, added: “The COVID pandemic really brought the role of the IVD sector to the public’s attention and our member companies were all very keen to play their part in helping to provide information to help manage and treat the UK population. However, it was felt that their role was not as well recognised as the vaccines and drugs sectors, and BIVDA wanted to provide a clear timeline on the procurement and lessons that could be learnt by both sides in the event of a future national health-related emergency. We wanted this to be independently led and considered, not a paper rushed out amid all the other reports at the beginning of 2022. We are delighted that Dr Butler from the University of Nottingham agreed to undertake this for us and that BIVDA is now in a position to put this information into the public domain.”
The full paper can be downloaded here.
