Is human embryonic stem cell research creating a cultural revolution? JS Rome May 2007

stem cells type and derivations (embryonic, blood cord, fetuses, somatic) different legal uses and restraints social and economical impact of the new technologies intellectual properties rights ethical implications and policy considerations JS Rome May 2007

respect of human dignity non-instrumentalization beneficence autonomy justice proportionality freedom of research JS Rome May 2007

uphold the principle of respect for the human being from the very beginning of life (and even before birth) the principle of human dignity is stronger than the principle of unrestrained freedom of research the border between life and death is defined according to societal conventions diversity in legislation dealing with embryo research JS Rome May 2007

competing ethical principles the conflict: competing ethical principles respect for general principlesrespect for general principles moral status of the embryomoral status of the embryo satisfaction of human needssatisfaction of human needs obligation to alleviate the suffering of human beingsobligation to alleviate the suffering of human beings JS Rome May 2007

...the research should have the potential to lead to major therapeutic advances and only be undertaken if there is no alternative method of comparable effectiveness available JS Rome May 2007 hES cells research

embryos left-over from IFV treatments maintained in a frozen state indefinitely destroyed donation to other infertile couples made available for research purposes JS Rome May 2007

research on (supranumerary) embryos for therapeutic purposes no alternative method of research as effective carried under supervision entails informed consent from donors JS Rome May 2007

need for hES cell lines derivationneed for hES cell lines derivation restraints on the use of cryopreserved supranumerary embryos for researchrestraints on the use of cryopreserved supranumerary embryos for research somatic cells nuclear transfer solution somatic cells nuclear transfer solution JS Rome May 2007

SCNT – ethical constraints is it a true embryo?is it a true embryo? oocytes donnorsoocytes donnors JS Rome May 2007

to prohibit all forms of human cloning in as much as they are incompatible with human dignity and the protection of human life United Nations General Assembly, March JS Rome May 2007

Lhomme nest pas un mammifère comme les autres. On peut reproduire un animal en le clonant. Mais ce sont leducation, la science et la culture qui font lhumain. Pas le clonage. Koichiro Matsuura Koichiro Matsuura JS Rome May 2007

official USA policy on embryos research ethical constraints public funding restraintsofficial USA policy on embryos research ethical constraints public funding restraints dolly died (2006) science expectancies on cloningdolly died (2006) science expectancies on cloning fraud of Hwang-Woo-suk (2005)fraud of Hwang-Woo-suk (2005) scientific misconduct JS Rome May 2007

5Wisconsin Alumni Research Foundation, Madison, Wisconsin 19Göteborg University, Göteborg, Sweden 2University of California, San Francisco, California 4Technion-Israel Institute of Technology, Haifa, Israel 7Reliance Life Sciences, Mumbai, India 3National Center for Biological Sciences, Bangalore, India 6Monash University, Melbourne, Australia 5Karolinska Institute, Stockholm, Sweden 9CyThera, Inc., San Diego, California 4BresaGen, Inc., Athens, Georgia Number of cell lines Name NIH statement: 64 cell lines in existence as of August 9, 2001, at the following ten laboratories: Scientists raised concerns about these cells centering on five questions: whether the cell lines were indeed robust stem cell colonies; whether the procedures used to create the cells were consistent with high ethical standards; whether the different cell lines had sufficient genetic diversity; whether cells produced from the cell lines would be safe for implantation in humans; and whether the owners of the cell lines would make them available to researchers in a timely fashion and at a reasonable cost.

2006 President Bush justifies the veto 2006 President Bush justifies the veto by saying the bill crosses a moral boundary that our decent society needs to respect by saying the bill crosses a moral boundary that our decent society needs to respect JS Rome May 2007

official USA policy on embryos research ethical constraints public funding restraints official USA policy on embryos research ethical constraints public funding restraints dolly died (2006) science expectancies on cloning dolly died (2006) science expectancies on cloning fraud of Hwang-Woo-suk (2005) fraud of Hwang-Woo-suk (2005) scientific misconduct JS Rome May 2007

L ast Updated: Friday, 13 January 2006, 05:30 GMT this to a friend Printable version J ournal retracts Hwang research A panel found two of Dr Hwang's landmark papers were flawed The respected US journal Science, which printed two now-discredited papers by disgraced South orean scientist Hwang Woo-suk, has retracted both articles. An investigation panel concluded on Tuesday that evidence supporting both papers had been faked. The journal therefore decided that an "immediate and unconditional retraction of both papers" was needed, it said. Dr Hwang made a public apology for the fabrications on Thursday, asking South Koreans for their forgiveness. He said he would take responsibility for the errors, but claimed he had been deceived by junior researchers. The case of Dr Hwang - once seen as a celebrated cloning pioneer and a national hero in South Korea - is now being investigated by prosecutors. More scientists in his research team were prevented from leaving the country on Friday, local media reported. A total of 28 team members have now been ordered to stay in South Korea pending further investigations, according to Yonhap news agency. Retraction A final report from experts at Seoul National University, published on Tuesday, said that Dr Hwang had faked his most famous work, the production of a stem cell line taken from a cloned human scientific misconduct

If there is such a thing as the Korean Dream, then Hwang Woo-suk was surely its embodiment. At the height of his popularity he was regarded as a national hero. Colleagues feted him as a pioneer in his field; politicians rewarded his achievements with cash and citations; thousands signed up to an online group devoted to his genius; some even said he was performing the work of God. JS Rome May 2007

In March 2006 it was revealed that the scientists involved were in major disagreement over who deserves credit for Dolly. In 2006, while testifying at an Edinburgh court following accusations of racial harassment of his fellow Prim Singh, Ian Wilmut denied the accusations, but acknowledged that he was not the 'father' or 'creator' of Dolly, that he has minimised the role of some of his fellows, and he gave most of the credit (66 percent) to Keith Campbell, while playing a 'supervisory' or managerial role.

consensus: ban on reproductive cloningconsensus: ban on reproductive cloning embryo research: risk of a slippery slope of abuseembryo research: risk of a slippery slope of abuse stem cell bank: preventing proprietary interests and allowing acess to SC linesstem cell bank: preventing proprietary interests and allowing acess to SC lines scientific integrity promotionscientific integrity promotion JS Rome May 2007 hES cells research

JS Rome May 2007 Where we are

Non EU countries - hES cell research without legal restrains ISRAEL * SINGAPORE* SOUTH KOREA* AUSTRALIA CANADA JAPAN SWITZERLAND CHINA COLUMBIA *therapeutic cloning JS Rome May 2007

about Europe

Europe – divergent positions research activities on excess IVF embryos procurement of hES cells from excess IFV embryos creation of human embryos for research purposes the import and use of hES cell lines

No specific legislation regarding human embryo research AUSTRIA AUSTRIA BULGARIA BULGARIA CYPRUS CYPRUS IRELAND IRELAND LITHUANIA LITHUANIA LUXEMBOURG LUXEMBOURG MALTA MALTA POLAND POLAND ROMANIA ROMANIA SLOVAKIA SLOVAKIA JS Rome May 2007

Prohibiting creation of human embryo for research purpose and for procurement of hES cells by law or by ratification of the Convention of the Council of Europe on Human Rights and Biomedicine signed in Oviedo on 4 April 1997 AUSTRIA AUSTRIA CYPRUS CYPRUS CZECH REP. CZECH REP. DENMARK DENMARK ESTONIA ESTONIA GREECE GREECE SPAIN SPAIN FINLAND FINLAND FRANCE FRANCE HUNGARY HUNGARY IRELAND IRELAND ITALY ITALY LITHUANIA LITHUANIA NEDERLANDS NEDERLANDS PORTUGAL PORTUGAL SLOVENIA SLOVENIA SLOVAK REP. SLOVAK REP. JS Rome May 2007

Allowing procurement of hES cells from excess IFV embryos by law under certain conditions BELGIUM CZECH REP DENMARK FINLAND FRANCE GREECE NEDERLAND SPAIN SWEDEN PORTUGAL UNITED KINGDOM JS Rome May 2007

PROHIBITING PROCUREMENT OF hES CELLS FROM EXCESS IFV EMBRYOS BUT ALLOWING IMPORTATION OF hES CELL LINES DENMARK DENMARK HUNGARY HUNGARY LATVIA LATVIA ITALY ITALY JS Rome May 2007

Allowing creation of human embryos for procurement of hES BELGIUM BELGIUM SWEDEN SWEDEN UNITED KINGDOM UNITED KINGDOM JS Rome May 2007

investigation of all potential sources of SC should be pursued the interests of SC donors and recipients of therapy should be respect the repercussions that SC therapies may have for society as a whole should be carefully considered freedom for research should be fostered coherent regulation should replace prohibition of research HUGO Ethics Committee, Nov 2004 JS Rome May 2007

hES cells research continuing evaluation and ethical discussion protected from unethical commercialization legal regulation by committees for research ethics JS Rome May 2007

Patenting (cell lines and technologies) this problematic raises a number of ethical and legal issues. patenting policy should not hamper the development of new technologies and acquisition of new relevant information patenting should not limit the principle of freedom of research social value of the scientific information (potential benefits for a large number of patients) should take priority over commercial goals JS Rome May 2007

Europe the future

ethical challenges of rapid technological progress concernes and hopes of patients responsability of policy makers hES cells research

2002: no agreement for EU research on human embryos and hES cells2002: no agreement for EU research on human embryos and hES cells 2004: the Comission has the legal obligation to implement the 6th framework programme for research (hES cells not excluded)2004: the Comission has the legal obligation to implement the 6th framework programme for research (hES cells not excluded) JS Rome May 2007

EU will continue to fund research from via the 7th research framework programme (FP7) - the funding for the SC programs amounts to 500,000 euros (less than 0.1% of the total EU health research funds and less than 0.002% of the FP6 budget)

Need for european regulations Europes historic cultural pluralism contrasting approaches on certain issues (eg. abortion) fostering harmonised regulations in stem cell research JS Rome May 2007