Biotechnology policies

Regulatory Developments in Xenotransplantation in Germany

 

German Bundesärztekammer (BÄK) Committee on Xenotransplantation

In Germany, following a mini-symposium organised by the Paul Ehrlich Institute on 20 February 1998, the German Medical Council, Bundesärtztekammer, formed a committee to prepare guidelines on xenotransplantation for the medical community. In Germany, clinical trials on xenotransplantation would currently fall under the responsibility of local ethical committees.

Source: Denner, NY'98.


Additional Relevant Laws/ Regulations/ Rules

Genetic Engineering Act (1 July 1990, amended 1993):

For the contained use of GMOs
The Federal Länder (regional governments) are competent for decisions both for the Genetic engineering installations and Genetic operations. The Federal Länder inform the Robert Koch-Institut (the Ministry of Health) of their decisions.

For deliberate release of GMOs
The responsible agency is the Robert Koch-Institute.

For the placing on the market without reproductive medicine and the use of somatic-genetic therapeutic procedures in humans.
The responsible agency is the Paul Ehrlich Institut.

The relevant regulations are:

Regulations on Containment Levels and Safety Measures for Genetic Operations in Genetic Engineering Installations
Regulations on the Advisory Committee for Biological Safety
Regulations on the Keeping og Records for Genetic Operations
Regulations on Hearing Procedures and Regulations on Application and Notification Documents
(The simplified procedure defined by the Commission Decisions 93/584/EEC and 94/730/EEC, is directly applied in Germany).
The Central Advisory Committee for Biological Safety gives its opinion. The Committee consists of 30 experts from diversified fields (microbiology, cell biology, virology, genetics, hygiene, ecology, trade unions, occupational safety, economy, research-promoting organisation and environmental protection).
The Department of Genetics/Genetic Engineering of the RKI supports the Committee as the Secretariat.
The Federal Länder also give their opinions and take responsibility for the supervision of experiments.

For the placing on the market
The Robert Koch-Institute is the competent German authority for decisions concerning marketing, defined by EC Directive 90/220/EEC. The RKI has to ask the following institutions to consider applications.
Federal Environmental Agency
Federal Biological Research Centre for Agriculture and Forestry
Federal Research Centre for Virus Diseases of Animals (in cases of animal application)
The Central Advisory Committee for Biological Safety gives its opinion. The Federal Länder are responsible for the monitoring of products placed on the market.

 

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