1. 4th meeting of the EC International Dialogue on Bioethics: The governance of large research and medical databases in clinical and research multi-centres trials, 19 June 2012, Copenhagen, Denmark Problems with Russian law on protecting personal data Vasiliy Vlassov, MD, Society for Evidence based medicine, Russia

2. Data base is simple to create All office buildings has the simple security system based on registering the passport data of every entrée, usually by scanning the passport or writing down the name and passport number. Nobody worried about this activities by private security companites

3. Data base is simple to obtain One may purchase on the street the DVDs with e-databases of – Telephone company customers – Tax inspection – Central bank register of operations – State road inspection – Obligatory medical insurance – Any other They are not only regularly updated on the black market, what is good!

4. Russia, Legal frame work Federal Law 152 (2006,#261-2011) – On personal data ( since 2011 allows the transfer of personal data to EU countries - ECs Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data ) Federal Law 128 (2011) – Оn licensing of some kinds of activities Federal Law 61 (2010) – On the turnover of medicines Federal Law 323 (2011) – Basic law on health care in Russian Federation

5. Practicalities Operator obliged to prove that the written consent for information storage was obtained or the information is public. For purpose of health care the consent for information storage is not necessary. Legal requirements are bearable for the unidentifiable information. Therefore, for local clinical studies the requirements are reasonable, but for non- clinical studies the licensing is inescapable.

6. Insurance regulation progress After new Federal law on Drugs (#61,2009), trials subjects need to be insured Government had required that personal data of insured subjects be collected by insurance company, before inclusion in the trial After public demand, government changed the regulation of 2010 (dec. #383, 2011) and insurers may be supplied with subjects codes in the trial, not personal information

7. Dangers for international cooperation Five years ago there was a precedent of blocking the transfer of trials biosamples from Russia The xenophobia is increasing The law on drugs has a provision that all drugs need to be tested in Russia to be registered, and any trial is permitted only as a part of the process of registration of the drug

8. Dangers of misuse of the protection The Law is misused to hide the information about the criminals in the State: e.g. names of prosecutors who tortured victims of Stalins terror and who killed in Katyn Polish POWs are secret, because it is private information Further intervention of government agencies in the processes in multi-center trials is probable

9. Dangers of misuse of the databases The trust in the State is low (all State agents are trusted by <20% of population, based on: – Industrial/transport/registration data bases are mined by FSB/KGB for political oppression; – Content accessed by State agents surface on the black market; – All electronic connections incl. internet are secretly controlled without registration of access; – Only 7% believe that president is a honest person ( poll http://www.levada.ru/15-05-2012/rossiyane-o-politicheskikh- vzglyadakh-svoikh-i-vvputina )

10. Perspective Technically big databases are possible in Russia, and they already are the reality The low trust endangers the content of data basses Misuse by the State is the most important danger