GDPR vs CRISPR: the Bureaucracy Against the Science that Saves Human Life

Man Receives First In Vivo Gene-Editing Therapy. This is how The Scientist titles about the news of a man (whose personal data have been made public) affected by Hunter Syndrome that has been treated with a gene-editing technique.

It is much too early to know whether the genetic therapy will work (thus withdrawing the need to pay huge money just to control, and not eliminate, this rare disease). But fact is that scientists did a giant step ahead by treating humans with this method.

Thus it is reasonable to expect that in the very next years many genetic diseases will be finally cured and not just taken under control until the patient dies.

This will happens notwithstanding the GDPR – or, better – notwithstanding the blind madness of the bureaucratic and pedantic interpretation that, in the name of the “protection of fundamental rights” endangers the scientific research and deprive us of the basic right we all deserve to protect: the right to life.

A CRISPR-Cas9 Research and the GDPR. A case-study

Personal genetic data processing is routinely believed to be subjected to Data Protection Regulations and in particular to the EU General Data Protection Regulation. While this is – in general – true, it is important to know exactly when and until where those regulation can affect the genetic research and – therefore – the possibility to find a cure for genetic diseases. Clearly, an actual life-or-death problem. Continue reading “A CRISPR-Cas9 Research and the GDPR. A case-study”

Playing God. CRISPR and the re-shaping of fundamental rights

I just came back from Japan where I gave a few lectures on data protection, computer forensics and genetics. I addressed this last topic at Tokyo’s Keio University with a talk titled “Playing God. CRISPR and the re-shaping of fundamental rights“.

This is the agenda (the transcript is coming…):

Agenda 議題

Molecular Biology and Bioinformatics Basics

分子生物学とBioinformaticsの基本

CRISPR – A Step Ahead

CRISPR 一歩先

Law, Science, Religion

法則, 科学, 宗教

Can Life be Owned?

人生を所有することは可能ですか

Copyright: a New Cage

Copyright: 新しい檻

Who Owns (Bio) information

誰が(bio)情報を所有しているか

Genetics, Privacy and Data Protection

遺伝学, 内証, 情報の保護

Freedom of Research

研究の自由

Criminal Investigations and Trials

犯罪捜査と刑事裁判

National DNA Database and Public Policing

警察庁DNA型データベース・システムと政治戦略

Conclusions

終局

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?