NEW YORK – A new white paper commissioned by the British In Vitro Diagnostics Association has found several problematic flaws with how the UK government procured test kits during the COVID-19 pandemic and issued suggestions for potential future emergencies.
Helen Dent, chief operating officer at BIVDA, said the association commissioned the report, released on Tuesday, because it "felt strongly that a comprehensive examination of the government's COVID-19 test procurement strategy was needed to accurately catalog the events of this particular aspect of the pandemic."
Additionally, the report, she said, could be used as a "springboard" to better understand the challenges that were faced and to support cooperation between government and industry going forward.
The paper is entitled, "In Vitro Diagnostic Test Procurement During the COVID-19 Pandemic: Lessons Learned and Recommendations." Luke Butler, an associate professor of law at the University of Nottingham and director of the executive program in public procurement law and policy there, was the main author of the paper.
The paper provided a timeline of the COVID-19 pandemic in the UK and discussed how the government reacted and formulated its strategy and began to procure tests in early 2020 at the start of the pandemic. According to the paper, there was a "degree of uncertainty" at first regarding who was responsible for validation versus procurement decisions, and some tests were procured before they received standard approval. Guidances concerning target product profiles, test validation, and the approval process were released months later.
The paper noted that in the future, target product profiles should be published as early as possible, and that the "clarity and quality of validation process guidance" should be improved. It also recommended the government provide more updates on tests undergoing validation, so that test makers can be made aware of potential issues that might face their tests.
Another issue outlined in the paper was a "high incidence of direct awards made without any formal competition." According to the paper, of the £14.1 billion ($17.7 billion) in test contracts awarded from April 2020 through March 2021, more than half were awarded via a legal mechanism that allowed direct awards without competition because of "extreme urgency." BIVDA, the paper noted, expressed its concerns about these awards in a Freedom of Information Request to the Department of Health and Social Care already in August 2020, arguing that DHSC's procurement activity had not been "competitive, transparent, or fair."
"Discoveries from the research reflected the frustration that many of our members experienced during the pandemic," said Dent. She noted that while a few companies profited from such direct awards, the government imposed a "higher regulatory burden upon remaining companies" that limited market access even though some suppliers had been providing diagnostics to the UK National Health Service for years.
While the paper conceded that the awards were arguably justified on the grounds of extreme emergency, it recommended that the procurement process be streamlined in the future, and that the government be made more aware of its diagnostic supply chain. The paper also urged policymakers to develop clearer target product profiles for manufacturers, to encourage competition in the procurement process, and to apply "more principled controls" on the use of direct awards. The paper also called for the government to publish a guidance covering the procurement process from end to end.
According to the paper, public procurement can play a role as a strategic tool for achieving UK diagnostics policy aims. While there has been an emphasis on investing in the diagnostics supply chain, the government should also pay attention to how it defines what kinds of tests it needs, and how it procures them, the paper said. One suggestion made in the paper is for a cross-government department expert procurement group be set up to look into how procurement aligns with diagnostics policy strategy.
Also, the paper urged industry associations, such as BIVDA and the Association of British HealthTech Industries to establish "more formal lines of communication" to improve dialogue between industry and government. Such a more regular forum would allow the government to better inform industry of its priorities and potential market opportunities.
"We hope that this white paper will help the government to evaluate the impact their decisions have upon business," said Dent.