BioWorld International Correspondent

BORNHEIM, Germany - The German Parliament, or Bundestag, last week decided to allow importation of human embryonic stem (ES) cells into Germany, with certain restrictions.

The parliament decided to create a law that “counteracts using further human embryos to generate new ES cells.” Importation of human ES cells is considered an exception.

The Bundestag proposed defining the following conditions to be fulfilled for importation of human ES cells:

There is no alternative to reach the goal of a project, except with human ES cells;

Importation is restricted to ES cell lines, which already exist at a certain qualifying date;

Parents’ written consent must be on hand for extraction of the ES cells from their embryo. The consent must have been given without any payment. And the ES cells under consideration must derive from a “surplus” embryo, one that was fertilized in vitro for pregnancy but cannot be implanted any more for reasons not caused by the embryo itself, such as illness or death of the mother-to-be before implantation of the embryo;

The project must be highly important to gain new knowledge in basic research or knowledge needed to develop new therapies and diagnostic procedures;

An ethics committee assesses the research project as ethically justifiable;

And legal authority to ensure all prerequisites are fulfilled.

As soon as a human egg cell is fertilized, German law protects it. Any research affecting human embryos is a prosecutable offense. This includes extraction of human ES cells from the embryo.

However, importation of existing human ES cells and research on these cells in Germany is not explicitly prohibited, because they are considered to be unable to grow into an embryo.

Even if importation of ES cells was not prohibited, it was considered taboo in Germany in terms of ethics.

A broad public and political discussion about research on human ES cells was triggered in the summer of 2000, when neuropathologist Oliver Brüstle of the University of Bonn applied for a public grant at Deutsche Forschungsgemein-schaft (the national research council, or DFG). He wanted to import human ES cells as part of the project.

Using murine ES cell grafts, Brüstle in mice had cured a disease similar to human multiple sclerosis. He aimed at developing therapies for human neurodegenerative diseases, and wanted to investigate human ES cells.

Instead of the grant, he received invitations to talk shows and public discussions. The DFG postponed the grant decision three times, seeking a political consensus before deciding. The discussion was highly controversial, with religious leaders voicing strong opposition.

The DFG at the beginning was in clear opposition to human ES cell research, but agreed to a compromise that would give priority to research on adult stem cells and allow research on ES cells under certain conditions.

In the parliament, support and opposition to ES cell research did not strictly correlate to political parties. Advocates supporting research on human ES included Chancellor Gerhard Schröder, Research Minister Edelgard Bulmahn and Health Minister Ulla Schmidt from the Social Democrats. There were also supporters among Christian Democrats, the Greens and the Socialists, and opponents in all parties except the Liberals. The Liberals completely supported importation.

The political discussion culminated in Bundestag’s debate last week.

The parliament’s vote for restricted importation of human ES cells was a compromise between a strict “No” on any human ES cell research in Germany and an unrestricted “Yes” on importation.

Schröder and the majority of representatives advocated the compromise. In Schröder’s words, the compromise opens new chances for cures and enables German scientists to influence international research policy.

The authors of the compromise stressed that they give clear priority to any research that can be performed with human adult stem cells.

The parliament now is expected to begin drafting legislation that clearly defines the details of importing human ES cells into Germany.

For the trans-Atlantic company Cardion AG, of Erkrath, which aims at development of stem cell-derived grafts, the vote of Bundestag was “responsible, right and good,” company spokesman Wolf-Henning Kriebel told BioWorld International. The vote opens the way for Cardion to start work on ES cells in Germany, he added.

After the Bundestag vote, Brüstle was granted the EUR200,000 by DFG, but he has to wait. “The grant will be paid [to Brüstle] if the project fulfills all the requirements defined by the legislation to come,” DFG President Ernst-Ludwig Winnacker said.