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Legal and Tax Aspects of Contracts for Conducting Clinical Trials

A training workshop entitled “Legal and Tax Aspects of Contracts for Conducting Clinical Trials: Practical Issues” will be held in Warsaw on 4 April 2013. The event is organized by Centrum Promocji Informatyki.

During the event, presentations will be led by Karolina Stawowska, the partner in charge of the tax advisory team at Wierzbowski Eversheds, and Marta Gadomska-Gołąb, an attorney at law on the life sciences team.

In a presentation on key legal and tax issues for parties negotiating and concluding contracts for clinical trials, the speakers will discuss such issues as:

  • Types of contracts and negotiation of provisions
  • Legal and tax differences between a contract of mandate and a contract for a specific work with the clinical investigator or co-investigators
  • The nature of illusory contracts and the approach to such contracts by the tax authorities
  • VAT exemption for clinical trials
  • The nature and role of individual tax interpretations—whom are they binding on, what issues may be raised, and does confirmation of a VAT exemption eliminate the risk entirely?
  • Personal income tax withholding on contracts of mandate with a Polish or foreign entity and cooperation agreements with “business activity.”

In the second part of the event, the speakers will analyze standard contract provisions and the comments most frequently raised by research institutions and investigators, such as:

  • The scope of duties of the research institution and the investigator
  • Settlement of fees between the parties and models for payment of fees:
    • Types of fees
    • Invoicing and payment—watch out for the new “deregulation act”
  • Financing of healthcare benefits in clinical trials
  • Inspections, audits and monitoring of clinical trials in the context of the confidentiality of research documentation
  • Provisions concerning personal data protection
  • Contractual liability and contractual provisions limiting liability
  • Provisions concerning termination of contracts and completion of the trial
  • Reimbursement of costs for patients:
    • Cost reimbursement models used
    • Are benefits obtained by patients taxable? Who must withhold tax?

More detailed information and the registration form are available at the Centrum Promocji Informatyki website >>