The Bulgarian Commission for Personal Data Protection published an opinion on the determination of the figures of “controller” and “processor” in the conduct of clinical trials
09 July 2019
Crucial for the pharmaceutical sector opinion of the Bulgarian Commission for Personal Data Protection (CPDP/Commission) on the determination of the figures of “controller” and “processor” in the conduct of clinical trials was published on 10.06.2019 on the website of the Commission.
According to the opinion, when conducting clinical trials, the medical institutions and the sponsor of the clinical trial act in the capacity of joint controllers under the meaning of Art. 26 of the Regulation (EU) 2016/679 (GDPR).
The opinion has been published after CPDP examined a request by a company having the capacity of a “sponsor” under the meaning of § 1, item 8 of the Additional Provision of the Medical Products in the Human Medicine Act (MPHMA), i.e. a company which is responsible for initiating, management and/or financing a clinical trial and is participating in the clinical trials initiated by it. The requesting company states that while conducting clinical trials, the sponsor also has relations with other persons participating in the clinical trials, namely with the principal investigator and the investigators, as well with the members of the investigator’s team – collaborators, monitors and auditors of the trial.
To clearly determine the roles of the parties, CPDP examines the figures of “Controller” and “Processor” in the light of the national and EU legislation regulating clinical trials. Furthermore, CPDP explains that the Regulation (EU) No 536/2014 of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use and the MPHMA exhaustively determines the functions and tasks of all persons participating in a clinical trial. According to the Commission, the data processing activities related to the conduct of clinical trials, could not be carried out “on behalf” of the sponsor of the trial, since such activities cannot be carried out by it, but only by organizations authorized in accordance with the applicable procedures and having the status of a “medical institution”. This is yet another confirmation of the thesis long ago adopted both in theory and practice (including that of CPDP), that not each assignment contract automatically leads to arising of relationship of the type of controller-processor and that in order to adequately determine the roles and responsibilities of the parties with regard to the processing of personal data, the nature of the rights and obligations of the parties in the contractual relationship need to be taken into account.
An additional argument for classification of the parties‘ roles according to CPDP is the Opinion 1/2010 of the Article 29 Data Protection Working Party(now European Data Protection Board) on the concepts of “controller” and “processor” which explicitly states that when conducting clinical trials, the participants are processing personal data in the capacity of joint controllers (p. 30 from the Opinion).
The main consequence of this opinion for the pharmaceutical companies and the medical institutions that conduct clinical trials is that they will need to conclude an agreement between themselves that shall in a transparent manner determine their respective responsibilities for compliance with the obligations in the field of data protection. In particular, they will have to regulate matters related to exercising the rights of the data subject and their respective obligations to provide the information referred to in Art. 13 and 14 of GDPR. Furthermore, the data subjects-participants in the clinical trial may exercise their rights in respect of and against each any of the controllers. (Art. 26, Para. 3 of GDPR).
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