HORIZON 2020
Unit costs for reimbursement
of clinical studies
Use of unit costs for
reimbursement of clinical studies
•
EC decision on 7 March 2014
•
Scope: projects under ‘Societal Challenge 1: Health,
Demographic Change and Wellbeing’ of H2020
•
Communicated via the Participants Portal
Why using unit costs for
reimbursement of clinical studies?
•
Costs for clinical studies: Multitude of small elements,
complex, extremely difficult to track as actual costs
•
Hospitals = not typical beneficiaries of EU FPs: often not
equipped to track the actual costs.
•
Greater attractiveness for participation
•
Simplification
• When checking at the payment stage,
• When reporting (no CFS to be provided for those costs).
•
Less risk of error.
Unit costs per patient
conditions I
• Alternative to the use of actual costs, on voluntary basis.
• Resources and costs will be evaluated with the proposal.
• Unit costs per patient fixed for the entire duration of the project.
• Costs of clinical studies = amount per unit set out in Annex 2
multiplied by the number of actual units (patients or subjects).
• For costs not included in the unit cost, reimbursement based on
actual cost.
• Verification and audit ex-post only:
•
•
number of patients declared = number of patients actually
participating in the study
beneficiary has used the accounting data of year N-1.
Unit costs per patient
conditions II
• Per clinical study: Estimation of the resources
• per task on the basis of the protocol,
• the same for all beneficiaries involved.
• Per beneficiary: Calculation of costs based on its historical
costs:
• recorded in its certified or auditable profit and loss
accounts,
• for last closed financial year at the time of
submission of the proposal.
Categories of eligible costs covered
by the unit cost
1) Direct costs of clinical studies:
• Personnel (doctors and other medical and technical personnel)
• Consumables
• Medical equipment (depreciation and costs of service contracts
necessary for their functioning)
• Other specific service contracts necessary for the clinical study
2) Indirect costs of the clinical study (25% of direct costs)
Travel and subsistence costs of patients are not included
(reimbursed on the basis of eligible costs actually incurred
under the cost category “other direct costs”)
[Insert name of clinical study]
Tasks and unit cost components
Resources
patient
per Cost per unit
for
beneficiary/linked
third party 1
[insert short name]
…
Cost per unit
for beneficiary/linked third party 3
[insert short name]
in-kind
contributions
by
third party*
Task No. 1 Blood sample
Personnel costs
Costs of consumables
Costs
of
equipment
doctors
---0
other medical Phlebotomy
8,33 EUR
personnel
(nurse),
10
minutes
technical
Sample Processing 9,51 EUR
personnel
(lab technician),
15 minutes
0
10,55 EUR
0
9,76 EUR
13,77 EUR
12,35 EUR
Category 1
Syringe, 1
XX EUR
XX EUR
XX EUR
Category 2
Cannula, 1
XX EUR
XX EUR
XX EUR
Use of -80° deep XX EUR
freezer, 60 days
XX EUR
XX EUR
XX EUR
XX EUR
XX EUR**
XX
XX
…
medical Category 1
….
Costs of other specific Category 1
services
…
Indirect costs
Task No. 2
…
Total cost per unit
Estimated No of units (patients/subjects participating in the XX
study)
Total unit cost for beneficiary/linked third party (total cost per XX EUR
* Use costs of third party making in-kind contribution.
unit
x estimated
of party,
units)
** Capped
at paymentno
to third
if any.
XX EUR
Unit cost component ‘personnel costs’
Average hourly cost for Doctors/ Other medical personnel/
Technical personnel X Estimated number of hours worked for
each task described in the protocol and for each patient
Where
• Average hourly cost = Certified or auditable total personnel
costs for the specific personnel category for year N-1
________________________________________________
{1720 X number of full-time equivalent for the personnel
category for year N-1}
• Total personnel costs = Actual salaries + actual social
security contributions + actual taxes and other costs included in
the remuneration, provided they arise from national law or the
employment contract or equivalent appointing act
Unit cost component ‘consumables’
{Average price per item for the a category of consumables
X Estimated number of items used for each task described in
the protocol and for each patient or subject
Where
•
average price per item for a category of consumables =
Certified or auditable total costs of purchase of the consumables in
year N-1 for the category of consumables concerned
______________________________________________
Total number of items purchased in year N-1 for the
category of consumables concerned
• total costs of purchase of the consumables = Total
value of the supply contracts (including related duties, taxes
and charges such as non-deductible VAT) concluded by the
beneficiary for consumables delivered in year N-1 provided
the contracts were awarded according to H2020 rules