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German Society for Surgery again criticized Tissue Act of the Federal Government and offers solutions


? Berlin - The current federally-specified tissues law "will be difficult
tissue transplants significantly. During a hearing before
the Health Committee of the German Parliament in March, the DGCH
thus warns again of the consequences of the proposed "Law on Quality and
safety of human tissues and cells for medical
use. "In a recent opinion, the professional society
the surgeon should strongly consider their proposals for further legislation to
.

The draft law of the Federal Ministry of Health (BMG) to the
handling human cells and tissues in Germany in the future the
Drug Law (AMG) are subject. Before going around in a hospital taken
bone, blood vessels or heart valves on the way to the recipient,
need them like a drug to be approved. clinics, Keep removing the tissue
and will issue, is the proposed law so
pharmaceutical companies the same: it calls for mandatory registration and manufacturing license.
The BMG thus goes well above EU standards prescribed uniform
. Earlier on the part of DGCH amendments tabled
the ministry in a revised bill with little regard to
.

"The way to continue to pursue foreign control is excessively bureaucratic, and
generated additional costs for medical facilities, health insurance and
countries," says Professor Dr. Hartwig Bauer, general secretary of DGCH
in Berlin. Personnel and operating costs would be, for example, extremely high - among other things
by costly monitoring and reporting systems. "Most importantly, this approach involves
the risk of affecting patient care and reduce
by strict restrictions in the use of cells and tissues, the chances of the German
tissue medicine in the international research community to
," Professor Bauer.

The DGCH recommends, among other things, impute unworked tissues such as bone, blood vessels or heart valves
general the Transplantation Act (TPG) to
. Serve tissue-and cell harvesting the development of new therapies
had to handle this as well, possibly also separately regulate
. Only the further handling and processing of tissues or cells
to produce new drugs should come under the Medicines Act.

Because of the excessive requirements of the BMG, according DGCH
a meaningful implementation of the relevant EC directives had not yet occurred. In
an oral hearing before the Health Committee of the German Bundestag on 7
March 2007 in Berlin, the DGCH
with their member companies * represent their position. With her by Dr. Christoph
Gaissmaier of the BG Trauma Clinic Tübingen
prepared in advance and the BMG opinion received by the set
surgical societies a differentiated, legally and
practical approach before.

The complete statement of the German Society for Surgery
(DGCH) to bill the federal government about the quality and safety
of human tissues and cells (Tissue Act), interested
journalists www.dgch on request from the press office of the DGCH or online at
. de.

The German Society of Surgery and its member societies:

German Society for Vascular Surgery (DGG)

German Society for Pediatric Surgery (DGKCH)

German Society for Orthopaedics and Orthopaedic Surgery (DGOOC)

German Society of Plastic, Reconstructive and Aesthetic
Surgeons (DGPRÄC)

German Society for Thoracic Surgery (DGT)

German Society for Thoracic and Cardiovascular Surgery (DGTHG)
German Society for Accident Surgery (DGU)

German Society of Visceral Surgery (DGVC)