National transpositions differ significantly – the transposition of the conditions of consent differ considerably from country to country.
In the legislative discussions leading to the drafting of the Regulation, there was a focus on consent, and on the conditions of consent (European Commission 2012b).
Accordingly, it is legitimate to consider European level interpretation on conditions of consent in the Directive as having continued relevance in understanding similar conditions in the Regulation.
Formally, there is no reference in the Articles referring to the conditions of consent, nor in Article 14, to a reduced standard of obligation based on risk reduction mechanisms being in place.ii In turn, the authors know of no relevant jurisprudence defining how, or how far, such risk reduction approaches can function to change the relevant conditions of consent.
Finally, given that open consent cannot succeed under the Regulation de lege lata, the authors considered whether there was any justification for a legislative reconsideration of the problematic conditions of consent in relation to biobanking.
In relation to Kosta's first category, the Articles in the Regulation directly elaborating the conditions of consent do not clarify which kinds of information must be provided to the data subject.
Equally, it has been suggested that – as will be argued in the following sections of this article – if open consent cannot be regarded as legitimate under the conditions of consent in the Regulation, this means that biobanks are in fact not able to obtain consent as understood in 9(2)(a).
It is one of the general principles of data processing laid down in Article 5 of the Regulation and is applicable to all processing situations.bb Although it does not directly clarify the conditions of consent, the concept of 'purpose limitation' in Article 5 and the concept of 'purpose specificity' in relation to 9(2)(a) are tightly linked (Article 29 Data Protection Working Party 2013, pp 13 14).
The article begins this section with an introduction to the concepts behind this form of argument – including pointing out that the conditions of consent are not rights, but are ties to assumptions as to the substance of regulation, the function of consent, and the actors involved (section 12).
