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The BAG files criminal charges against

Bern, 13.9.2019 - The Swiss Federal Office of Public Health (FOPH) filed a lawsuit this
week with the Geneva Public Prosecutor's Office against Cryo-Save AG Plan-les-
Quates (Geneva) or the responsible persons. There are grounds for suspicion that
the company might have violated the Transplantation Act (violation of reporting and
co-operation obligations).

Cryo-Save AG operated a private umbilical cord blood bank in Plan-les-Ouates (canton of

Geneva). Since 2016, it has had the necessary approval from the BAG for the import,
export and storage of stem cells from umbilical cord blood. At the end of August, the BAG
canceled Cryo-Save AG from the list of license holders. This was after the branch Plan-les-
Ouates was deleted in the commercial register of the canton of Geneva, the company
according to own data had brought the stored stem cells to Poland and for the authorities no
contact persons were attainable.

The examinations are carried out in close cooperation with Swissmedic. The Swiss Agency
for Therapeutic Products has withdrawn Cryo-Save AG's authorization to handle umbilical
cord tissue and, at the end of August, opened criminal proceedings in its own competence
for possible violations of the Therapeutic Products Act and the Transplantation Act. In this
context, Swissmedic, in coordination with the BAG - with the support of the cantonal law
enforcement agencies and fedpol - carried out several house searches in Switzerland on 10
and 11 September 2019.

General information
The company Cryo Save AG is located in Pfäffikon (Canton Schwyz). Since 2014, she has
been operating a private umbilical cord blood bank in her office Plan-les-Ouates (Geneva).

In the spring of 2019, the BAG and Swissmedic received a notification from Cryo-Save AG,
in which the company announced the move of the blood cells and tissues stored in Plan-les-
Ouates abroad (Warsaw, Poland) and corresponding customer information. The FOPH and
Swissmedic have pointed out to those persons who have stored umbilical cord blood or
tissue at Cryo-Save AG and wanted to inform themselves, the corresponding contact

In Switzerland, the handling of stem cells from umbilical cord blood and umbilical cord
tissue is governed by the Transplantation Act and the Therapeutic Products Act. Cord blood
banks are subject to specific reporting and licensing requirements as well as to the quality
of storage and safety of the stored stem cells. The supervision lies with the BAG and
Swissmedic. The storage of umbilical cord blood in a umbilical cord tank is on the other
hand on a private law basis.

On the homepage of the FOPH on the subject of storage, import and export of stem cells in
cord blood banks further legal and professional information as well as a link to the
recommendation of the Council of Europe for parents (Parent's guide to umbilical cord
blood banking - A guide for parents).