Mirocals Consortium and the MND Association: legal position

As an Association we signed up as a member of the MIROCALS Consortium in 2015. Since then, changes at leadership and board level, have meant we needed to seek absolute clarity on our role as the MND Association and as one of the 11 members of the Consortium.

To do that, we have taken legal advice, including a review of the Consortium documentation available to us. The outcome of that is as follows: 

Our role in the Consortium

We made a relatively small financial contribution to the trial, to help cover the costs of the UK trial centres and pharmacies. We also awarded research grants to two of the UK universities tasked with analysing samples.

A research trial is split into work packages – this trial has seven work packages. We had a clearly defined role in just one of those. Our role was to spread awareness and promote the trial, promote recruitment, provide information to trial participants and share results from the pilot study; organisation of two international conferences; facilitate the communication of the trial results, once published by the sponsor, which is the University of Nimes.

Decision-making

Our role in decision-making is minimal. There are committees within the Consortium which manage the project on a day-to-day basis. The MND Association doesn’t have a representative on any of those committees. We have a seat at the General Assembly which meets in person once a year and makes decisions, taking into account scientific, health, ethical and socio-economic aspects.

Ownership

We didn’t provide any of the background intellectual property required for the trial and we don’t own any rights in any of the intellectual property, results or data from the trial. Nor do we have any rights to use or disclose any results or data from the trial.

Our role in disseminating results starts once they have been published by the members of the Consortium (not the MND Association), led by the University of Nimes.

Agreement with ILTOO Pharma

The decision to choose ILTOO Pharma as the commercial partner was based on a vote by Consortium members in the General Assembly. Along with other members of the Consortium, our representative assisted in reviewing the bids received from potential commercial partners. The assessments took into account a wide variety of criteria, including commercial, scientific and legal considerations, and went through a full legal tender process.

The choice of ILTOO Pharma as the commercial partner was made by the Consortium as a whole.

As the Association owns no rights to the results or intellectual property (IP), our role in appointing ILTOO as a commercial partner was limited to the initial stage of the assessment in the General Assembly. We weren’t involved in the confidential discussions or negotiations which followed and haven’t been privy to the details of the agreement and arrangements put in place.

Because we aren’t part of that agreement, the Association isn’t entitled to any royalties or milestone payments from ILTOO Pharma.

Publication of data

The publication of data in any form, including a pre-print, is completely out of the MND Association’s control. The lead investigator has told us that the data is still being analysed and processed. The MND Association hasn’t had access to any of the clinical trial data, other than the headline results which were published in December 2022 at the International Symposium on ALS / MND.

Next steps

I realise there is a lot of information here but I was keen to provide a full update to help you understand the MND Association’s position both now and going forward. What has become clear during this process is that, in the spirit of being as helpful to the MND community as we can, we have been trying to answer questions that clearly sit outside of our remit. Now we have the clarity on our position and our responsibilities within the Consortium we are going to focus on those – and, of course, on all the other work in the access to emerging treatments space where we know we can influence, provide information and support people with and affected by MND to have access to the best evidenced-based treatment possible, in agreement with their neurologist.

Where we can signpost you to information that will be useful, we will. Where we can answer questions because we have the information, knowledge and responsibility, we will. Where we can work with our partners and colleagues to update them, provide information or signpost, we will.

For queries, questions and requests for information relating to the MIROCALS trial, which sit outside of our limited responsibility as a Consortium member we will forward them onto the most relevant organisation or trial sponsor.

We hope this has given clarity on our position.

Tanya Curry, Chief Executive