Commissioner for Information and Personal Data Protection Mr. Rodoljub Sabic addressed a letter today to the Minister of Health, Prof. Zoranu Stankovic, M.D,  advising him of the necessity and urgency of tackling outstanding issues in connection with personal data protection in transfusion activities and in the field of organ donation and adequate donor protection.

Emphasising that the issues involved pertain to a serious risk of mass violation of fundamental human rights and stating he was at a loss to understand why the Ministry had given no response to a similar letter of warning sent by the Commissioner as early as last year, Mr. Rodoljub Sabic said:

“As early as in October last year, after my associates inspected the operations of the Blood Transfusion Institute, I sent a communication to the previous Minister highlighting the identified issues and appealed to the Minister to pass relevant secondary legislation required under the Law on Transfusiology Activities.

Under the Law, the Minister must provide for the content of appropriate forms relevant for processing of blood donors’ personal data. However, although the twelve-month period for passing such secondary legislation expired on 10 September 2010, this has not been done, even after the Commissioner sent his letter of warning.

Hence, the manner of processing personal data in this field is contrary to the law. In theory, the Commissioner should, therefore, place a ban on such processing, all the more so because the data concerned are deemed to be particularly sensitive. Of course, given the enormous importance of transfusiology, I have no intention of doing that. I therefore once again strongly urge the Minister to pass the relevant secondary legislation without any further delay.

In June this year, the Commissioner’s authorised offices have inspected three institutions involved in promotion of voluntary organ donation and issuing of donor cards – the Military Medical Academy, the Nephrology Clinic of the Clinical Centre Nis and the Clinical Centre of Vojvodina.

During those inspections, my associates have had excellent cooperation from the staff of those institutions and I have no doubts they will comply with the measures imposed by the Commissioner for the purpose of rectifying all identified shortcomings. However, some of those shortcomings are not in the remit of those institutions, but fall within the sphere of competence of the Ministry of Health.

The Law on Organ Transplantation also imposes an obligation on the Minister to pass secondary legislation to regulate in detail the issues of record keeping, protection of donor information, donor card form and requirements with which institutions issuing donor cards must comply. Furthermore, the Minister also needs to lay down the manner of and procedure for keeping of and registration with the Single National Donor Register, the manner of and procedure for data storage and protection, the procedure for access to data, the manner of and procedure for issuing and keeping passwords etc.

Although the statutory limit for the passing of this secondary legislation has not yet fully expired, in view of past negative experiences with regard to observance of deadlines, I call on all persons in charge to pass those instruments without undue delay, in the light of the obvious threat to the rights of a large number of persons.

Under the existing arrangements, personal data of blood and organ donors are not processing as required by the law, there are no unified procedures across the entire country and there are no adequate safeguards for donor information. I therefore strongly believe it is incumbent on the Ministry to take appropriate steps without undue delay with a view to rectifying all of the shortcomings listed above.”