The IMI (Innovative Medicines Initiative) drive large public private partnerships (PPPs) to work collaboratively towards the development of new and effective medicines. IMI PPPs such as U-BIOPRED, ABIRISK and OncoTrack produce vast amounts of data that with the right management will enable development of new therapeutic approaches for diseases such as cancer and asthma. However to do this, PPP data has to be shared.
Intellectual Property matters
Data in its various forms need to be formatted, shipped and stored to enable analysts to get the best they can out of it. This requires specialist help that compel owners to share their data between IMI projects. To facilitate data sharing comprehensive sharing agreements are essential, but the development of such agreements can be very time consuming.
When sharing data the two main challenges relate to intellectual property (IP) rights and defining who is accountable for what. Addressing these concerns can require the finite alignment of as many as sixty project partner’s views. Ensuring the rights of individuals and partners and agreeing what belongs to who is not a clear-cut process. To complicate the issue, national and international legislation concerning data transfer also has to feature in the process.
How to align 60 partners
Chris Marshall is the practical entity in eTRIKS that has been overseeing this work. He is familiar with many of the legal challenges that data sharing pose. eTRIKS has a dedicated cross consortia legal team that meet via Tele Conference once a week. They specifically focus on contract agreements between projects, to enable the sharing, access to, and movement of data, whilst observing state and company legislation.
The legal agreements used to enable data sharing include:
- CDA – Confidential Disclosure Agreement
- DPA – Data Processing Agreement
- MTA – Material Transfer Agreement
- Collaboration agreement (that includes a MTA material transfer agreement element)
- Mandate – Document on which the project coordinators are able to sign on behalf of their respective consortia.
These documents are tailored to suit the needs of each supported IMI project involved. As part of the collaboration agreement that sets out how two projects work together, the transfer of datasets and images between projects and project partners are laid out. A lot of effort goes into defining how datasets can be shared and managed by each project.
What has eTRIKS done to date?
eTRIKS, with considerable help from the ABIRISK and OncoTrack projects, have developed generic agreements and an agreement development process that can be used to facilitate specific project legal requirements, related to data transfer.
This piece of work is more than just data management, as the eTRIKS project actively works with the data, subsequently adding intellectual input as the data is curated and loaded for analysis. Under normal law that means eTRIKS would have a claim to the IP on the restructured data sets. However, projects need to ensure the transfer agreements aligns with the IMI stance that the supplying project owns the data, even though eTRIKS has added to it. However, eTRIKS does own the process by which the changes were made.
Can data cross national borders?
Data transfer between countries in Europe is covered by many restrictions, but anonymised data is much less restricted than identifiable data. A lot of the issues go away with data from which you can`t identify individual patients. People like Anne Bahr of the eTRIKS ethics work package, were engaged early on in the agreement development process, to make sure what we do is acceptable internationally and by the companies involved. Drafted agreements are circulated throughout eTRIKS and the supported PPPs for review. After review the agreements are updated according to any feedback received from the partners and circulated again for signatures.
Sign this please!
Getting these documents signed by every partner is a big challenge the eTRIKS legal team face. The more partners an IMI project has, the more complicated forming an agreement is. Organisations often request specific clauses to be included within the agreements. These clauses have to be agreed by both consortia. eTRIKS partners have signed up to the principles laid out in the eTRIKS project agreement to work together, however, if the internal research interests of an eTRIKS partner competes with a supported project’s objectives, they have to stay clear of the supported work itself, as this is a conflict of interest and threatens the prospect of research contamination.
Agreements are complex legal documents, and so partners really need to make sure their legal teams see the documents. This takes time. If an entity is less engaged for any reason, it can be difficult to get time with their lawyers. As every partner needs to sign the project-to-project agreements to enable the projects to work together, it only takes one partner not to sign or to delay signing to bring the process to a halt.
Signing for someone else
To try and overcome this issue, eTRIKS developed a project mandate to cover nondisclosure agreements between eTRIKS and other projects or individuals. The eTRIKS Mandate enables AstraZeneca (eTRIKS’ Coordinating EFPIA partner) to sign certain pre-agreed documents on behalf of the whole eTRIKS consortium. This helps with the signing process itself, but does not completely remove the evaluation and review step of the agreements. Often companies will not allow alternate entities to sign more complex legal agreements (such as an MTA) on their behalf, due to the specific and individual nature of the activities covered by the document. The Mandate does however make CDAs easier to address because partners need only to agree in writing and do not need to sign the CDA.
Agreeing everything from the middle
You might ask why we don’t have IMI funded consortia sign such agreements at the beginning of a projects lifetime. Currently this is not possible, as the activities involved in data transfer are too variable. What may have been relevant at proposal acceptance phase of a project may be very different a year down the line. The project needs to settle and fully earth its course before it commits to such legal agreements.
The MTA developed is generic, which means it should be reusable. The document was developed with the help of the IMI ABIRISK project, and the generality of the content and the process has since been tested with the IMI project OncoTrack.
Data created in a project fall under the foreground rules for Intellectual Property management and need to be treated as material assets of the project, nevertheless, eTRIKS has established that it is possible for projects to work together to provide cross-project data support but it is not a simple process. In the MTA constructed with ABISRISK we do have what would form over 90% of a general MTA between projects. Both document and process seem to be working, as only a few comments from the OncoTrack partners have been returned so far.
This work lowers the barriers of legal issues surrounding information management, but it doesn’t solve all the problems. The project data need to be ethically compliant, for example data should be anonymised, or at least pseudononymised with the keys held securely outside the system. Data must be suitable for sharing on the provider’s side, and eTRIKS must ensure that the level of sharing necessary will be made possible and no more. This means the supported project members need to understand how to manage their data ethically, for example, by preventing recruits that supplied the data becoming identifiable. eTRIKS offers an anonymisation safety check service, if a supported project requires it.
In terms of the future of such agreements, it would be great to see MTAs as a standard document that partners will sign unchanged, rather than having to reword it ever time. We realize that this is impractical due to the specific needs of every organization to review exactly what it is agreeing to but we believe we have created a template that provides a framework from which an agreement can be quickly constructed, at least for information management, and we are sharing our work with the IMI to help them better understand what is needed in this area.