Drafting clinical trial agreements

management forumLast week, IP Draughts participated in Management Forum’s 30th anniversary conference, Promoting Synergies Across Life Sciences by giving his all-day course on Drafting and Negotiating Clinical Trial Agreements.  His colleagues Paul and Mario were there too, giving a presentation on confidentiality agreements, which seemed to be going well when IP Draughts briefly attended.

IP Draughts enjoys speaking at Management Forum events, mainly because their representatives are a pleasure to work with.

bendallIP Draughts runs this course as a double act with the excellent Christine Bendall, who is now a regulatory consultant in the pharmaceutical sector, but earlier in her career was an IP lawyer and a partner at CMS Cameron McKenna.  Christine is also a speaker on the UCL IP transactions course and she has advised some of IP Draughts’ clients on regulatory matters.

Drafting and negotiation points from the course include:

  • Clinical trial agreements are essentially technical services agreements.  Industry practice affects their terms, but what makes them unique is the regulatory framework for products that will be administered to humans.
  • The regulations vary, depending on the product, its applications, where the trials are taking place and where the eventual product will be marketed.  Careful thought needs to be given to whether the agreement has the right terms to reflect the particular mix of regulations that apply in the individual case.  It will generally not be sufficient to pull a generic template agreement from the computer and expect it to “work” in an individual case.  The drafter should work with regulatory colleagues to ensure that the agreement is suitable tailored.
  • As well as life sciences regulation, these agreements often include terms dealing with other aspects of regulatory compliance, eg data protection, freedom of information, and bribery.  Agreements with international sponsors often ask the trial site to comply with overseas laws with which they are unlikely to be familiar, and which may not be strictly relevant, eg the US Foreign Corrupt Practices Act and the US Sunshine Act.
  • In the UK, most trials in NHS hospitals are conducted under one of the NHS standard clinical trial agreements.  Unfortunately, those agreements are not well drafted and they include some bizarre terms, eg a limit of liability for wilful default of twice the contract price.  Some other countries have “standard” agreements but the extent to which they are used in practice varies.
  • Clinical trial agreements raise basic contract issues such as who will the parties be (eg the investigator or their employer) as well more sophisticated points such as indemnities, publication rights, and intellectual property ownership and use.
Before the days of pharmaceutical regulation...

Before the days of pharmaceutical regulation…

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Filed under Commercial negotiation, courses and training, Intellectual Property

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