Away from public scrutiny, MPs in France have decided - under cover of the streamlining of administrative procedures - to "simplify" the administrative framework for cell therapies. We shouldn't kid ourselves: this simplification is not intended to achieve the stated objective but is in fact a way of finally preventing the creation of private tissue banks in France!

After openly attacking, in the context of the revision of the bioethics law, private banks of umbilical cord blood, our legislators have decided to broaden their fight by attacking any private bank which may dare to propose the autologous or family conservation of tissues or cells with a view to a possible therapeutic use in the future.

Thus, the bill on the simplification of the law and the streamlining of administrative procedures adopted on 18 October 2011 by the National Assembly, proposes bringing together two separate authorisation systems under one article.

The first relates to activities which can be carried out by the tissue bank (Art. L. 1243-2 of the CSP) which could be described as the authorisation for the establishment itself, and the second relates to the procedures for the preparation and conservation of the cell therapy product (L. 1243-5 du CSP) which could be compared to the commercialisation authorisation for a drug.

In the future, article L. 1243-5 should disappear but the authorisation issued by Afssaps, now the National Agency for the Safety of Drugs and Health Products (the unstoppable march of progress!), will detail "tissue category and the derivatives and cell therapy preparations and mention the agreements reached between an establishment and third parties for the carrying-out of these activities, the preparation and conservation procedures used and the recognised therapeutic indications".

What a fine example of administrative streamlining, real progress!

Bringing together under one article two separate administrative authorisation systems which will finally allow our administrative health authorities to be able to refuse, completely legally, the opening of private tissue banks.

Merging these two authorisations under one article will not achieve this result, but the conditions attaching to this will do so.

The only tissue banks which can be authorised are those which apply preparation and conservation procedures with recognised therapeutic indications.

Decoded, this means allowing the competent authority (whatever it may be called) to reject all plans for tissue banks proposing to store tissues for a possible future therapeutic use without the benefit of currently recognised therapeutic indications, in particular by clinical trials.

What, in concrete terms, are the consequences if a text such as this should be published?

By preventing such establishments in France, the legislators prevent the conservation of therapeutic resources (tissues or cells) which could be used in the context of clinical trials enabling the existence of therapeutic indications to be demonstrated in autologous or family allogeneic applications.

Indeed, by forbidding the personalised and ethical conservation of tissues and cells other than where there is a recognised therapeutic indication, how can researchers discover new related autologous or allogeneic indications, for which the chances of compatibility are infinitely greater than in the context of a non-family allogeneic use?

They will not be able to, as they don't have the biological resource required, and will have to content themselves with working on non-family allogeneic applications, leaving to their foreign counterparts the benefit of research into autologous and family allogeneic applications! Thank goodness - the dogma of collectivist solidarity is safe!

At the current time when we are being promised the advent of a customised medicine - a pledge of better efficacy - when public finances are channelling phenomenal sums in support of therapeutic innovation, in particular cell therapy, it would set the right tone if there were greater coherence and if a clear message were sent to our citizens, our researchers and our innovative businesses!

Thomas Roche, lawyer