Ms Helen Dixon:

In regard to consultation between the Department of Health and the Data Protection Commissioner, I think Mr. Muiris O'Connor referenced earlier that it had in fact taken place some years prior to the publication of the Bill. In fact, that was the case, the consultation took placer a number of years ago. It was prior to the general data protection regulation being enacted and I think it was also prior to some of the clarifications that have come out in the Court of Justice of the European Union in recent years that have underlined both the importance of and the independence of data protection authorities and precisely how that independence has to play out. That is the position in respect of consultation. It took place some years prior.

In regard to recent engagement, post the publication of the Bill, we immediately set about engaging with the Department of Health and pointing out the concerns we have had in regard to the role prescribed for the data protection authority which, as the Vice Chairman said, conflicts with our views on the requirements for independence of the authority under EU law. As the Department of Health outlined earlier, the Department is committed now to listening to those cancers. They have acknowledge why we have raised those concerns.

On the question of whether there can be a resolution, Mr. Muiris O'Connor referenced a resolution, I think there can be a resolution to what is required under the Bill, which is that health research can take place with an appropriate legal basis and with the appropriate safeguards. What he may have been referencing and what we referenced in our written statement to the committee is that the general data protection regulation is now opening up new legal bases for the conduct of health research as a subset of scientific research. In our written statement, we referenced Article 9 of the general Data Protection Regulation, which sets out the conditions under which member state law could prescribe health research to be conducted in the absence of consent of individuals. The resolution to the issue is the conduct of appropriate health research in the public interest with appropriate legal bases underpinning it.

In regard to the issue the Vice Chairman raised as to whether there was another agency that could substitute in place of the Data Protection Commissioner, that goes to the point of how this issue could be resolved. Either in certain instances, alternate legal bases could be used in respect of the conduct of health research that does not require consent or if consent remains the bases upon which the Department of Health views research as relying upon, in that case potentially the health research ethics committees, who are in any case examining all of the provisions in relation to any health research project could take on the role of examining whether the requirement for consent is met or not.