Legal Issues for the Third Level Sector

Sculpture outside Arthur Cox building, via Arthur Cox websiteI spent the morning at a seminar on Legal Issues for the Third Level Sector hosted by the Arthur Cox Technology & Intellectual Property Group. The morning was chaired by Rob Corbet.

First up were Claire McGrade and Karen Killoran discussing “The Arbitration Act 2010 and Other Forms of Alternative Dispute Resolution”. Claire discussed Alternative Dispute Resolution (ADR) in general, and Karen discussed the (also here). The second full paper was presented by Lisa Kinsella, on “Clinical Research at Third Level: Recent Developments in the Regulatory Framework”. And third was Tara MacMahon, who gave an update on the work implementing the recommendations of the Innovation Taskforce.

The first speakers were on Karen Killoran on arbitration, and Claire McGrade on other forms of alternative dispute resolution. Arbitration is a process whereby parties agree to refer their disputes to an arbitrator instead of the courts. The arbitrator acts like a judge and his decision is binding upon the parties. It is confidential, but can be very formal. Karen explained the details of the new regime established by the 2010 Act. Her message was that arbitration has been given a very strong and detailed statutory foundation underpinning the integrity of the arbitration process, but this means that the process has now become very formal indeed.

That formality makes other ADR mechanisms attractive, and they take many forms (see, generally, the Law Reform Commission Consultation Paper on Alternative Dispute Resolution ). Claire pointed out that ADR is initially a matter of including a relevant ADR clause at the time of drafting of the relevant contract and she ran through the options. Mediation is an informal, voluntary process, and Claire argued that it can work very well: it can be more flexible and cost effective, and the courts are very supportive; but, unlike arbitration, it is non-binding. Conciliation is a variant of mediation which is particularly suited to consumer disputes, but is an option in any commercial dispute. Expert determination is appropriate for technical or niche disputes, such as IT matters; and the courts are very supportive of this too. For example, in HSE v Keogh [2009] IEHC 419 (15 July 2009) Laffoy J enforced an expert determination clause. Finally, Claire pointed out that independent Adjudication is a judgmental process where the dispute is considered by an independent party. It is very popular in the UK, and is now prescribed in statute for construction contracts (section 108 of the Housing Grants, Construction and Regeneration Act 1996 gives a statutory right for either party to a construction contract, at any time, to refer disputes to adjudication). Claire’s message was that everything turns on the relevant clause in the contract or on agreement to go for an ADR mechanism once a dispute has arisen, and making the choice between these various options is a matter of choice for the parties, having regard to the issue in dispute and the value of the claim.

The second full paper was presented by Lisa Kinsella, on “Clinical Research at Third Level: Recent Developments in the Regulatory Framework”. Current Government policy means that health research very important to the Irish economy, especially via the Health Research Board and Science Foundation Ireland. According to the Irish Medicines Board (IMB) Annual Report for 2008, there were in that year 117 authorised clinical trials (for drugs) and 4 authorised clinical investigations (for medical devices), so there lots of scope for these numbers to grow.

She began by looking at the regulatory framework for clinical trials for drugs in Ireland, including the Control of Clinical Trials Acts, 1987 (also here) and the Control of Clinical Trials and Drugs Act 1990 (also here), increasingly supplemented by EU Directives implemented into Irish law. The regulations require the approval of an appropriate Ethics Committee, followed by IMB Clinical Trial Authorisation; and the sponsor of the trial – such as the third level institution – must be established in the EU. The sponsor is responsible for everything: approvals and authorizations; insurance; vigilance; safety, and breach of the regulations a criminal offence and associated civil liability.

Although there has been stringent regulation of clinical trials and medicinal products since the 1960s, there has far less until recently for medical devices. However, this is now all changing, with the implementation into Irish law of EU medical devices rules. This requires a considerable amount of data to be submitted to the IMB. Lisa’s view was that, although this brings welcome clarity to the area, the framework is not as detailed as for clinical trials for drugs

She made a series of recommendations for the Higher Education sector: there ought to be clear governance structures and standard operating procedures; training for the Investigator community ought to be provided; and standard form contracts need to be developed (this is particularly important, given that there is potentially a large of web of relationships between the many parties involved). Finally, she looked to the future: more legislation is coming down the line (eg, the Health Information Bill and the Human Tissues Bill, and new Directives on Clinical Trials and Medical Devices).

Third was Tara MacMahon; she was seconded from NovaUCD to the Innovation Taskforce and now to the IP Implementation Group; and she gave an update on the work implementing the recommendations of the Taskforce. I have learned a great deal about the Taskforce from the regular updates provided by Chris Horn on his blog and via twitter. Tara pointed out that the background to the Taskforce was the Government policy on Building Ireland’s Smart Economy (Taoiseach’s Office, December 2008). On foot of this, the Taskforce was appointed in July 2009, and its Report was published in March 2010. At about the same time, Forfas published a parallel Review of Supports for Exploitation of IP from Higher Education Research (Forfas, April 2010). The Taskforce looked at the issue of technology transfer from the outside (industry) in (to Higher Education), whereas the Forfas looked from the inside out; and though they had different starting points and perspectives, they reached very similar recommendations on the issue of technology transfer.

Tara pointed out that, of the various principles on which the Taskforce Report was founded, two were particularly important for technology transfer in higher education: the entrepreneur and enterprise must be at the centre of efforts (principle 1) and education must foster independent thinking, creativity and innovation (principle 4). The Report is now in the implementation phase, and this is being undertaken by various groups, including the IP Implementation Group, of which she is a member. The remit of that group is to review (i) transfer technology structures and supports, (ii) model contracts, and (iii) intellectual property integrity.

From her perspective, the process of technology development and transfer in higher education flows from funding, through the research, to the identification and protection of relevant IP, followed by commercialization of the IP. At the other end, industry needs to know what IP is available, and who to deal with. Hence, an issue currently being considered by the IP Implementation Group is whether there should be a single national technology office. Reflecting principle 1, this would make it easier for the entrepreneur. Similarly, the Report recommended that there should be a national framework agreement between all the various higher education institutions in the state to deal with IP bundling, so taht industry only has to deal with one lead HEI rather than many. The IP Implementation Group is in the course of developing this framework agreement. Finally, she argued that a national IP licensing policy for the sector is very important: the Report recommended a national IP protocol, to focus on the research outputs from state funding, and the various implementation groups are now working on this.

It was a fascinating morning and it presages many changes to university-based research in Ireland.