A new model clinical trial agreement – the good, the bad and (in its current form) the ugly

Introduction

The NHS’ Health Research Authority (HRA) recently published its draft template Investigator Initiated Study Agreement (IIS Agreement)¹ and called for comments on the draft.   

According to the HRA, and in a similar way to the other model agreements used for other types of clinical trials conducted in the UK, the IIS Agreement is intended to act as a “standard contract agreement template” for use between non-commercial sponsors and commercial organisations providing support for investigator-initiated studies. 

In principle, this is good news for the UK life sciences community.  Investigator-initiated studies are commonly seen in the industry. However, to date, there is no model agreement for these type of studies conducted in the UK.  Model agreements for other types of clinical trials in the UK have been around for a while and are generally seen as having a positive effect on short circuiting negotiations and assisting those navigating the complex world of clinical trials. Indeed, we regularly advise clients seeking to put in place bespoke agreements to cover investigator-initiated studies – and, in our opinion, a balanced, and well-drafted, model agreement would be broadly welcomed by both biotech/pharma companies and non-commercial sponsors. 

Investigator-initiated studies have many benefits for a pharma/biotech company and not just in terms of cost savings. These non-biased studies can help enhance the general understanding of medicinal products and their appropriate uses (including, crucially, in terms of product safety) and often result in novel ideas for further research and application² - all ultimately resulting in improvements to patient care.

For the non-commercial sponsor, in addition to providing the general scientific and patient care benefits described above, investigator-initiated studies enable Principal Investigators (PIs) to enhance their profile in the industry and access clinical products which may otherwise be difficult (or impossible) to access on the open-market. This ultimately provides PIs with the unique opportunity to generate data and results based on their own clinical experience and expertise. 

Therefore, there is no doubt in our mind that a model agreement of this nature is beneficial.  However, unfortunately, the draft IIS Agreement contains a number of significant issues (most notably in terms of IP and data) which, as currently drafted, drastically reduces this benefit.  More concerningly, given that the similar model agreements are intended to be (almost) non-negotiable terms for clinical trials conducted in the UK, without amendment, the draft IIS Agreement is likely to actually deter life sciences companies from entering into such arrangements – which could result in a decline in commercially supported investigator-initiated trials and a loss of the benefits to companies, researchers and, crucially, patients described above.  

Intellectual Property

As currently drafted, the IIS Agreement states that all foreground IP generated under the agreement will be owned by the non-commercial sponsor (irrespective of inventorship and the ownership of the relevant background IP).  Given the critical nature of IP in drug development and commercialisation, this off-market approach is, almost certainly, going to be impossible for the biotech/pharma company to accept.  Rather confusingly, the IIS Agreement also contains an obligation on the commercial party to transfer its rights in all such foreground IP to the non-commercial sponsor (although, we query how this would work as such foreground IP is IP that is generated by the non-commercial sponsor, not the commercial party). 

The draft IIS Agreement also states that the pharma/biotech company must grant a non-exclusive royalty-free irrevocable licence to its relevant background IP for “the purpose of using and receiving the benefit associated with any Inventions (i.e. all foreground IP generated) or to derive the benefits and value from the Study.”  While we appreciate this may not be the intended meaning of the language, the scope of this licence is unacceptably broad for any pharma/biotech company – with unreasonable and far-reaching consequences.  As an example, if the non-commercial sponsor discovered a secondary medical use, the non-commercial sponsor would have the right, without any form of payment to the originating company, to exploit that company’s rights to the drug for that use (including potentially licensing this IP to a competitor). Clearly, this is not going to be acceptable to any well-advised pharma/biotech company. 

The draft IIS Agreement does give the commercial organisation a first right to negotiate an exclusive licence to any such foreground IP.  However, this right of negotiation only lasts for 6 months and the non-commercial sponsor is only obliged to use its “commercially reasonable endeavours” to actually disclose the inventions to the company.  Again, this could put the biotech/pharma company in a very difficult negotiating position (with limited negotiation time) whereby they must accept onerous terms to obtain access to IP, which may itself constitute an improvement to its own background IP. 

Data Rights 

Similarly, the draft IIS Agreement contains some onerous, and indeed illogical, provisions regarding data access and ownership.  After publication of the study results, the pharma/biotech company may only use the final study report for research and development purposes – and may only use such report for “marketing or future regulatory submissions” with the non-commercial sponsor’s consent.  Again, we struggle to see how the commercial counterpart could ever agree to this proposal given that a key driver for the company is to obtain this data for commercialisation purposes, including regulatory submissions.  It is also unclear whether the commercial company gets any rights to use the underlying study data, as opposed to the final study report itself which has much more limited value.  Worse still, and this is perhaps the most objectionable part of the entire agreement from the commercial entity’s perspective, this restriction on their use of the study data in the final report puts the company in a worse position for actually having assisted with the trial.  Once published, this information is in the public domain for anyone to use and would therefore result in the perverse position of the company’s competitors (or anyone else) being in a better position to exploit such information than the company supplying its product and otherwise supporting the trial.

Publication Regime 

The draft IIS agreement also contains some unusual publication provisions.  Most notably, there is no right for the commercial organisation to comment on any publications (or for the non-commercial sponsor to consider such comments) and no right for publications to be delayed to preserve patent rights or to remove commercially sensitive information of the biotech/pharma company – all of which are customary for arrangements of this nature.  Similarly, there are no rights for the commercial organisation to have any say over patent filings and prosecution strategy which, bearing in mind the IP ownership position described above, has the potential to significantly devalue the company’s IP portfolio. 

Conclusion

This article purposely focuses on the concerns that a commercial partner would have in terms of IP and data, given the central importance of these topics to an arrangement of this nature.  However, we note more generally that the draft IIS Agreement also contains a number of other issues and drafting inconsistencies – such as, to give just one example, inconsistent and ambiguous language regarding the liability and indemnity regime. 

We would hope that these issues in the draft IIS Agreement, particularly around IP and data, are resolved in the next iteration following feedback from relevant stakeholders.  If not, the worthy ambition of providing a resource to help expedite and increase the number of investigator-initiated studies in the UK could have the polar-opposite effect - to the detriment of all. 

We will be keeping a keen eye out for the next draft of the IIS Agreement and will keep you updated with its progress.  

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[1] https://hra.nhs.uk/about-us/news-updates/call-for-comments-on-new-study-agreement-template/

[2] This is particularly the case where the PI wishes to explore a novel combination of therapies.  See our article on combination therapies more generally for a greater understanding of the key negotiation points between parties for agreements of this nature.