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

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 securitycompanites

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!

Russia, Legal frame work

• Federal Law № 152 (2006,#261-2011) – On personal data (since 2011 allows the transfer of personal data to EU countries - EC’s “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

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.

Insurance regulation progress

• After new Federal law on Drugs (#61,2009), trial’s 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

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

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 Stalin’s 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

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)

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