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Greece: Offsets of clawbacks, pharmaceutical R&D and investment expenses

Greece: Offsets of clawbacks

Guidance (a Joint Ministerial Decision) addresses the offsets of “clawback amounts” against expenses related to research and development (R&D) and investment projects.

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R&D projects

The guidance establishes the terms and conditions as well as the procedure for offsetting of clawback amounts payable to the Greek National Health Service Organization (GNHSO) and hospitals, against R&D and investment projects for the development of products, services or production lines incurred by pharmaceutical companies. 

  • For 2019, the total amount of expenses that can be offset against clawback amounts to be paid to GNHSO and hospitals cannot exceed €50 million.
  • This amount will be allocated on a percentage basis between R&D projects and investment projects; amounts to be allocated to each category cannot exceed €25 million (50% of the total amount) for each category. If the amount allocated to one category has been fully absorbed, any excessive amount of expenses related to this category can be transferred to be covered by the other category.
  • The total amount of expenses that can be offset is expected to increase to €100 million for the year 2020.

Activities that qualify as R&D projects relate to the marketing of a pharmaceutical product, and can include:

  • Laboratory R&D of pharmaceutical nature
  • R&D on the raw materials for the medicine production
  • The first through third testing of stages necessary for the preparation of the product’s approval file
  • The production of trial products and evaluation of the process on a pilot scale with sufficient size and number of trial products
  • R&D in the field of new technologies (digital technology, artificial intelligence, etc.) aimed towards the improvement of human health

Eligible expenses related to R&D projects therefore may include:

  • Expenses for the purchase, construction, expansion, repairing, maintenance, renovation of buildings, and purchase or leasing of machinery
  • Expenses for the acquisition of intangible assets, licences for the use of specialized scientific software programs
  • Payroll cost of employees of any level engaged in the implementation of the R&D project
  • Costs for outsourcing/subcontracting to third parties or other bodies (private laboratories, public research centers and laboratories, universities) regarding implementation of a specific and explicitly defined part of the research project

Investment projects

An investment project related to the development of products, services or production is considered any activity aiming for the establishment of new facilities or the modernization of the existing ones, aiming to improve the quality of the products and of the existing production methods, and/or aiming to increase the dynamics of the production procedures.

Eligible expenses related to investment projects may include:

  • Expenses for the purchase, construction of buildings, auxiliary facilities, as well as expenses for the purchase or leasing of modern new or used machinery
  •  Expenses for the acquisition of intangible assets to be used for the transfer of technology, purchase of intellectual property rights, exploitation licenses, patents, know-how and not patented technical knowledge

Especially for 2019, eligible expenses are considered those effected as of 1 July 2019 assuming the relevant contracts were signed as of 1 January 2019. 

Procedure for clawback offsetting

  • R&D projects and investment projects must be self-funded, and the eligible expenses must be recorded in a special account. Records of relevant decisions and documentation files submitted to the competent authorities must be retained.
  • Expenses eligible for offsetting must be documented. In particular such expenses need to be certified by a certified public accountant or entity, and there must be documentation submitted to the General Secretariat for Research and Technology (GSRT). The required supporting documents are defined in the Ministerial Decision. 
  • Claims for clawback offsetting and certification of R&D projects and investment projects are assessed by special certification committees of the GSRT.
  • Following completion of the assessment procedure and drafting of the relevant reports by the certification committees (for the approval or rejection of the claim), the GSRT General Secretary will issue certificates (that must be filed with the competent authorities within 10 days of the date of issuance).
  • At this point, the clawback amount that was initially imposed can be adjusted (offset).

The documentation file and relevant supporting documentation must be submitted to the GSRT within four months after the end of the applicable tax year.


Read a February 2020 report prepared by the KPMG member firm in Greece

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