The Association of Clinical Research Organizations (ACRO) offered a number of recommendations to the US House Energy and Commerce Committee’s “21st Century Cures” initiative last week as part of an effort to keep the US research industry competitive globally.
ACRO executive director Doug Peddicord wrote in a letter to the committee suggesting ways Congress can help to push the CRO industry to achieve more in the US, including a re-jiggering of the US tax credit, more work with the NIH’s National Center for Advancing Translational Sciences, and new functionalities for EHRs (electronic health records).
As more and more large pharmaceutical companies, such as Pfizer and AbbVie, look to domicile in countries like the UK and Ireland to lower their tax rates, the contract research industry is seeing similar incentives to move their work abroad.
While there are many reasons to conduct clinical trials on a global basis, including access to populations and markets, US tax policy currently encourages clinical trials to be placed outside the country, the association contends.
“Current U.S. tax law prohibits the R&D credit for ‘contract research’ and further limits to 65 percent the amount of the credit the research sponsor may take when using contract research providers,” ACRO notes. CROs also increasingly make decisions about where clinical trials are located, and with that, employment has shifted along with the research, but US tax law “has not kept pace. The result is CROs have an incentive to conduct clinical trials in other countries because they cannot avail themselves of the R&D tax credit within the US,” ACRO says.
“Our solution is to simply make the 35 percent of the tax credit that currently evaporates when research is contracted out available to companies performing contract research,” the association recommends.
In terms of a public-private partnership to accelerate the drug development process, ACRO says it commends the Committee’s consideration of the Innovative Medicines Initiative (IMI), which includes a €1bn contribution from the European Commission and matching contributions from EFPIA (European Federation of Pharmaceutical Industries and Association). But the association stopped short of calling for a similar public-private research network as “high-quality, functioning clinical research networks are maintained by leading global CROs.”
But the association believes there is an opportunity to engage private-sector expertise within the NIH’s National Center for Advancing Translational Sciences (NCATS).
“The CRO industry possesses project management, data management, patient recruitment and feasibility expertise that simply does not exist within the NIH or among academic researchers. Congressional direction for NCATS to work more closely with industry would, we believe, accelerate this translational research,” Peddicord writes.
And as EHR (electronic health record) adoption grows globally, ACRO calls on Congress to encourage inclusion of new EHR functionalities that will facilitate clinical and data-driven research as part of ONC/CMS (Office of the National Coordinator/Centers for Medicare and Medicaid Services) Meaningful Use Phase 3 requirements.
“We envision a scenario where EHRs are integrated with clinical trial data from clinicaltrials.gov and can match eligible patients to appropriate research protocols. The EHR would incorporate a ‘pop up’ box to inform the physician of the availability of a potential clinical trial for their patient,” ACRO says. “This would greatly speed the recruitment process, reduce development time and cost, and bring treatments to patients more quickly.”
In order to achieve this, ACRO says there may need to be a “small additional appropriation for the National Library of Medicine, which administers clinicaltrials.gov, but we believe this is a small price to pay for the potential billions of dollars in savings in R&D costs, not to mention the added patient benefits.”