Scientific Research: the Italian Data Protection Commissioner Soro to support a very dangerous position about Biobanks

In an interview published by the Italian newspaper “La Stampa” on Oct. 31, 2017 the Italian Data Protection Commissioner Soro stated that:

“If it is true that a profit can be gained from the research on human biological material, is it true – too – that there is no such thing as biobank ownership, but only the right to research the available samples. [1. “Se è vero che si possono ottenere profìtti dalle ricerche sul materiale biologico degli esseri umani, è altrettanto vero non esiste la proprietà di una biobanca, ma solo il diritto a fare studi sui campioni disponibili” – English translation by Andrea Monti. ]”

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Upcoming Data Protection Regulation to Hampers Genetic and Pharmaceutical Research

The privacy hysteria that since twenty or so years affects policy makers and data protection authorities, reached a new peak with the upcoming data protection regulation whose text has been published last Dec, 18, 2015.

While, thanks God, the text clearly states that “biosample” as such aren’t “personal data”

genetic data should be defined as personal data relating to the genetic characteristics of an individual which have been inherited or acquired as they result from an analysis of a biological sample from the individual in question, in particular by chromosomal, deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) analysis or analysis of any other element enabling equivalent information to be obtained

Nevertheless there is no clear reference to the fact that genetic (and, in general, health-related) researches can’t be pre-emptively limited to specific processing since scientists work with microscopes and not with crystal balls.

The result is that every research project that deals with patient (and patient’s relatives) records might face enormous bureaucratic burdens every time a new path of study emerges from the current one.

Furthermore, the regulation says that:

Member States may maintain or introduce further conditions, including limitations, with regard to the processing of genetic data, biometric data or health data

In other words, then, we will likely face a flood of local regulation that will make harder to perform researches that save human life.

Sure, there will always be the possibility to challenge in court the letter of the law, claiming that no provision can be interpreted in such a way to endanger human life and that data protection, in constitutional terms, is a “lesser right” when compared to the right to health. But this takes time, money and an open-minded court.

In the meantime, scientists will either slow down their activities or risk to be taken in court.

Does it make sense?

Wrongful Conviction and Protection of the Innocent

Tomorrow, at the University of Milan, I shall participate to a round-table organized by the Italy Innocence Project. The topic is: The Italian Legal System and the Judiciary Mistake.

Here is the full program:

ERRORE GIUDIZIARIO E TUTELA DELL’INNOCENTE

WRONGFUL CONVICTION AND PROTECTION OF THE INNOCENT

EVENTO SPONSORIZZATO DAL CENTER FOR THE GLOBAL STUDY OF WRONGFUL CONVICTIONS DELLA FACOLTÀ DI LEGGE DELLUNIVERSITÀ DI CINCINNATI, OHIO, STATI UNITI (DIRETTO DAL PROF. M. GODSEY)

VENERDÌ 6 GIUGNO 2014 9.30 – 18.30

UNIVERSITÀ DEGLI STUDI DI MILANO – SALA NAPOLEONICA – VIA SANT’ANTONIO 10

SALUTI INTRODUTTIVI: LUCA LUPÁRIA (Professor of Criminal Procedure at the University of Milan, Director of the Italy Innocence Project); VINICIO NARDO (Segretario dell’Unione delle Camere Penali )

PRIMA SESSIONE (ORE 09.50) COORDINA: PROF. LUCA LUPARIA

L’ESPERIENZA DEGLI STATI UNITI D’AMERICA
M
ARK GODSEY (Professor at the University of Cincinnati, Director of the Ohio Innocence Project)
JUSTIN BROOKS (Professor at the California Western School of Law, Director of the California Innocence Project)

LA TUTELA DEL CONDANNATO INNOCENTE IN EUROPA
M
ICHAEL NAUGHTON (Director of the University of Bristol Innocence Project, Director of the Innocence Network UK)
DAVID LANGWALLNER (Professor at the Griffith College of Dublin, Director of the Irish Innocence Project)
SYLVAIN CORMIER (Attorney, Director of the Innocence Project of France)
EVELYN BELL (Chief Scientist of the Knoops’ Innocence Project)
MARIA EJCHART-DUBOIS (Member of the Helsinki Foundation for Human Rights and of the Innocence Legal Clinic in Warsaw)

SECONDA SESSIONE (ORE 14.45)

CAUSE E RIMEDI DELL’ERRORE GIUDIZIARIO IN UNA PROSPETTIVA COMPARATA
M
ARTIN KILLIAS (Expert in Criminology, Professor at the Universities of St. Gallen, Lausanne and Zurich) DANIEL VANEK (Expert in forensic DNA identifications, Professor at the Charles University in Prague) ERIC VOLZ (International Innocence Expert, Director of The David House Agency)
ULF STRIDBECK (Professor in Criminal Law at the Faculty of Law, University of Oslo)

ERRORE GIUDIZIARIO E SISTEMA ITALIANO
T
AVOLA ROTONDA
LUCA LUPÁRIA (Professor of Criminal Procedure at the University of Milan, Director of the Italy Innocence Project) GIUSEPPE GENNARI (Judge at the Court of Milan)
ANDREA MONTI (Attorney, Expert in forensic DNA)
MARTINA CAGOSSI (Junior researcher at the University of Milan)

EVENTO GRATUITO (PREVIA ISCRIZIONE)

TRADUZIONE SIMULTANEA INGLESE-ITALIANO

Evento accreditato dall’Ordine degli Avvocati di Milano (n. 6 crediti formativi)

Data Protetcion, MTA, Human Samples and Identity Backtracing

To comply with privacy and data-protection regulations, Material Transfer Agreements for human samples often state that the samples are either anonymous (meaning: the donor institution doesn’t know at all the ID of the patient) or anonymized (the donor institution only knows and keeps secret the patient ID.) But this compliance approach won’t work anymore, since the probability of backtracing the ID of patient accessing third parties provided information is not only a proof-of-concept but an “actual reality.”

Amending the MTA to handle this issue is far more complicated than ask the lawyers to just re-phrase their lingo, because what is actually needed is a thorough analysis of the human sample collection process back to the first ring of the donor chain.

The sooner the biobank community will address this issue, the better for the research, the pharma industry and – first of all – the patient himself.