Unit costs for reimbursement of clinical studies HORIZON 2020

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) T ravel and subsistence costs of patients are not included (reimbursed on the basis of eligible costs actually incurred under the cost category “other direct costs”)

* Use costs of third party making in-kind contribution. ** Capped at payment to third party, if any. [Insert name of clinical study] Tasks and unit cost componentsResources per patient 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 doctors other medical personnel Phlebotomy (nurse), 10 minutes 8,33 EUR10,55 EUR9,76 EUR technical personnel Sample Processing (lab technician), 15 minutes 9,51 EUR13,77 EUR12,35 EUR Costs of consumablesCategory 1Syringe, 1XX EUR Category 2Cannula, 1XX EUR … Costs of medical equipment Category 1Use of -80° deep freezer, 60 days XX EUR …. Costs of other specific services Category 1 … Indirect costs Task No. 2 … Total cost per unitXX EUR XX EUR** Estimated No of units (patients/subjects participating in the study) XX Total unit cost for beneficiary/linked third party (total cost per unit x estimated no of units) 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