Last week (28 March 2024), the UK Health Research Authority (“HRA”) published a draft model investigator-initiated study agreement (“mIIS-CTA”) to govern investigator-initiated clinical studies (“IIS”) that involve NHS patients and receive support from commercial partners.  The HRA is calling for comments on the draft mIIS-CTA by 13 May 2024.

An IIS is a clinical study that is planned, designed, conducted and sponsored by a non-commercial sponsor (such as research institutions, universities or NHS hospitals) but also receives support from a commercial partner.  A commercial partner, such as a biopharmaceutical company, may wish to support the IIS (without assuming the role of regulatory sponsor) where the IIS relates to the commercial partner’s medicine, medical device or disease area of interest.  The commercial partner may support the study by providing funding, supplies of the company’s product for use in the study, personnel support etc.  An IIS clinical trial agreement, such as the mIIS-CTA, will set out the rights and obligations of the non-commercial sponsor and the commercial partner in relation to the conduct of the IIS.  Many commercial partners have developed their own IIS clinical trial agreement templates, although the negotiation of these agreements with non-commercial partners can often be lengthy in practice.

The HRA’s aim for the mIIS-CTA is to make it easier to set up an IIS in the UK and reduce the time required to negotiate IIS agreements.  The draft has been developed by the NHS R&D Forum in collaboration with the HRA and the devolved administrations of Northern Ireland, Scotland and Wales.  It does not appear that commercial companies have provided any input in the development of the mIIS-CTA at this stage.  If adopted, it is unclear whether the mIIS-CTA will be presented as “non-negotiable,” or whether non-commercial sponsors will be open to agreeing further changes with commercial partners.

We note that for commercially sponsored clinical trials involving NHS sites, sponsors must already contract with the trial sites and principal investigator using a model clinical trial agreement (“mCTA”).  The first version of the mCTA was published in 2003 and it has been updated various times since then.  Commercial sponsors are “strongly recommended to use the mCTA without modification, and it is essentially non-negotiable in practice.  This is the first time that a similar model IIS agreement template has been proposed.

Key Points in the mIIS-CTA

The draft IIS agreement can be found here.  Some interesting points in the draft include: 

  • Study Data.  The mIIS-CTA grants ownership of all study data to the non-commercial sponsor.  Commercial partners are not granted any data ownership rights under the mIIS-CTA.  A commercial partner may use the final study report for the purpose of research, development, marketing and future regulatory submissions.  However, the use of study data in marketing and regulatory submissions will require the non-commercial sponsor’s prior consent.
  • Study Inventions and Patent Rights.  All inventions created during the IIS, including those directly related to the study drug or device, will be owned exclusively by the non-commercial sponsor.  The commercial partner will benefit from irrevocable right to use such inventions for its “internal, research and development purposes only.”  With respect to any commercial use of such inventions, the commercial partner will receive an exclusive option to “first negotiate an exclusive, worldwide, royalty-bearing licence to use Invention(s) [directly related to the study drug or device],” which will expire after six months if the parties do not finalise the licence.  The non-commercial sponsor will use “reasonable endeavours” to promptly notify the commercial partner of any improvements or modifications made to the commercial partner’s background intellectual property during the IIS.
  • Background Intellectual Property Rights.  Under the mIIS-CTA, the commercial partner will grant the non-commercial sponsor an irrevocable, non-exclusive, worldwide licence to use its background intellectual property rights and know-how provided for use in the IIS for the purpose of “using and receiving the benefit associated with any Inventions or to derive the benefits and value from the Study.”
  • Publications.  The commercial partner will be provided with a copy of any draft publication relating to the IIS at least 30 days prior to publication for “scientific review” only.  The commercial partner does not benefit from any approval right for such publications.
  • Liability Cap.  The non-commercial sponsor’s liability under the mIIS-CTA will be subject to a liability cap, which may be a defined sum (not specified in the template) or “the value of the sums paid to [the non-commercial sponsor] by [the commercial partner] under [the mIIS-CTA].”  The commercial partner does not benefit from any cap on its liability.

Next Steps

Stakeholders wishing to provide comment on the draft IIS agreement must do so before 13 May 2024 by emailing research.agreements@hra.nhs.uk.

Covington will continue to follow developments and provide further updates.  If you would like to discuss the mIIS-CTA or any issues relating to IIS arrangements more broadly, please contact members of our Food, Drug and Device practice.

Photo of Robin Blaney Robin Blaney

Robin Blaney is a partner in the firm’s Life Sciences practice. He advises pharmaceutical, biotechnology, medical device and cosmetic manufacturers and trade associations on a wide range of regulatory, compliance, transactional and legislative matters, as well as the full range of commercial agreements…

Robin Blaney is a partner in the firm’s Life Sciences practice. He advises pharmaceutical, biotechnology, medical device and cosmetic manufacturers and trade associations on a wide range of regulatory, compliance, transactional and legislative matters, as well as the full range of commercial agreements that span the product life-cycle in the life sciences sector. His expertise includes clinical trial agreements, manufacturing and supply agreements, distribution and other marketing agreements, regulatory services agreements, and tenders. He has particular experience structuring and documenting EU pharmaceutical distribution arrangements and transitional arrangements relating to product acquisitions. Robin writes and speaks regularly on subjects such as medical device regulation, pharmacovigilance and clinical trials.

Photo of Sarah Cowlishaw Sarah Cowlishaw

Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and software technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah has particular expertise in advising on legal issues presented by digital health…

Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and software technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah has particular expertise in advising on legal issues presented by digital health technologies, helping companies navigate regulatory frameworks while balancing challenges presented by the pace of technological change over legislative developments.

Sarah is a co-chair of Covington’s multidisciplinary Digital Health Initiative, and is the Graduate Recruitment Partner for Covington’s London office.

Sarah regularly advises on:

  • classification determinations for software medical devices, including on developments resulting from the implementation of the EU Medical Devices Regulation;
  • legal issues presented by digital health technologies including artificial intelligence;
  • general regulatory matters for the pharma and device industry, including borderline determinations, adverse event and other reporting obligations, manufacturing controls, and labeling and promotion;
  • the full range of agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, and manufacturing and supply agreements; and
  • regulatory and commercial due diligence for life sciences transactions.

Sarah’s pro bono work includes advising the Restoration of Appearance and Function Trust (RAFT) on the classification of a wound healing product containing human blood derivatives, and assisting in a project aimed at improving regulatory systems for clinical trials of drugs and vaccines for neglected diseases in developing countries.

Sarah has been recognized as one of the UK’s Rising Stars by Law.com (2021), which lists 25 up and coming female lawyers in the UK. She was named among the Hot 100 by The Lawyer (2020) and was included in the 50 Movers & Shakers in BioBusiness 2019 for advancing legal thinking for digital health.

Sarah has undertaken several client secondments, including to the in-house legal department of a multinational pharmaceutical company.

Photo of Roderick Dirkzwager Roderick Dirkzwager

Roderick Dirkzwager advises clients in the life sciences sector on a broad range of regulatory, transactional and intellectual property matters relating to the discovery, development and commercialization of their products.

Roderick is a member of Covington’s Diversity and Inclusion Committee and is a…

Roderick Dirkzwager advises clients in the life sciences sector on a broad range of regulatory, transactional and intellectual property matters relating to the discovery, development and commercialization of their products.

Roderick is a member of Covington’s Diversity and Inclusion Committee and is a co-lead of the LGBT+ Affinity Group in London.

With a broad life sciences practice, Roderick regularly advises on:

  • EU, Irish, and UK regulatory issues relating to pharmaceutical products, medical devices and consumer products;
  • commercial agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, distribution arrangements and manufacturing and supply contracts;
  • regulatory and commercial due diligence for life sciences transactions; and
  • intellectual property issues arising in corporate transactions and IP-related contracts.

Prior to joining the firm, Roderick completed his Ph.D. in Biochemistry, focusing on the development of novel, low-cost malaria diagnostic technologies using DNA aptamers.

Tamzin Bond

Tamzin Bond is a Trainee Solicitor who attended BPP School of Law. Prior to joining the firm, Tamzin completed her Ph.D in Chemistry from Imperial College London.