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

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• respect of human dignity• non-instrumentalization• beneficence• autonomy• justice• proportionality• freedom of research

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• 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

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JS Rome May 2007

the conflict: competing ethical principlescompeting 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 obligation to alleviate the suffering of

human beingshuman beings

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...”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”

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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

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research on (supranumerary) embryos

• for therapeutic purposes• no alternative method of research as

effective • carried under supervision• entails informed consent from donors

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• need for hES cell lines derivationneed for hES cell lines derivation• restraints on the use of restraints on the use of

cryopreserved supranumerary cryopreserved supranumerary embryos for researchembryos for research

somatic cells nuclear transfer somatic cells nuclear transfer solutionsolution

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SCNT – SCNT – ethical constraintsethical constraints

• is it a true embryo?is it a true embryo?

• oocytes donnorsoocytes donnors

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• “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 8 2005

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L’homme n’est pas un mammifère comme les autres.L’homme n’est pas un mammifère comme les autres.On peut reproduire un animal en le clonant. Mais ce sont On peut reproduire un animal en le clonant. Mais ce sont l’education, la science et la culture qui font l’humain. Pas le l’education, la science et la culture qui font l’humain. Pas le clonage.clonage.

Koichiro MatsuuraKoichiro Matsuura

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• official USA policy on embryos research official USA policy on embryos research ethical constraintsethical constraintspublic funding restraintspublic funding restraints

• dolly died (2006)dolly died (2006)science expectancies on cloningscience expectancies on cloning

• fraud of Hwang-Woo-suk (2005)fraud of Hwang-Woo-suk (2005)scientific misconductscientific misconduct

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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

3 National Center for Biological Sciences, Bangalore, India

6Monash University, Melbourne, Australia

5 Karolinska 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.

20062006President Bush justifies the vetoPresident Bush justifies the veto

by saying the bill by saying the bill “crosses a moral “crosses a moral boundary that our decent society boundary that our decent society needs to respect”needs to respect”

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• official USA policy on embryos research official USA policy on embryos research ethical constraintsethical constraintspublic funding restraintspublic funding restraints

• dolly died (2006)dolly died (2006)science expectancies on cloningscience expectancies on cloning

• fraud of Hwang-Woo-suk (2005)fraud of Hwang-Woo-suk (2005)scientific misconductscientific misconduct

JS Rome May 2007

Last Updated: Friday, 13 January 2006, 05:30 GMT

E-mail this to a friend Printable version

Journal 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.

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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 embryo research: risk of a slippery

slope of abuseslope of abuse• stem cell bank: preventing proprietary stem cell bank: preventing proprietary

interests and allowing acess to SC linesinterests and allowing acess to SC lines• scientific integrity promotionscientific integrity promotion

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hES cells research

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Where we are

Non EU countries - hES cell research without

legal restrains

• ISRAEL *

• SINGAPORE*

• SOUTH KOREA*

• AUSTRALIA

• CANADA

• JAPAN

• SWITZERLAND

• CHINA

• COLUMBIA

*therapeutic cloning

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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

• AUSTRIAAUSTRIA

• BULGARIABULGARIA

• CYPRUSCYPRUS

• IRELANDIRELAND

• LITHUANIALITHUANIA

• LUXEMBOURGLUXEMBOURG

• MALTAMALTA

• POLANDPOLAND

• ROMANIAROMANIA

• SLOVAKIASLOVAKIA

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Prohibiting creation of human embryo for research purpose and for Prohibiting creation of human embryo for research purpose and for

procurement of hES cells by law or by ratification of the Convention of procurement of hES cells by law or by ratification of the Convention of

the Council of Europe on Human Rights and Biomedicine signed in the Council of Europe on Human Rights and Biomedicine signed in

Oviedo on 4 April 1997Oviedo on 4 April 1997

• AUSTRIAAUSTRIA

• CYPRUSCYPRUS

• CZECH REP.CZECH REP.

• DENMARKDENMARK

• ESTONIAESTONIA

• GREECEGREECE

• SPAINSPAIN

• FINLANDFINLAND

• FRANCEFRANCE

• HUNGARYHUNGARY

• IRELANDIRELAND

• ITALYITALY

• LITHUANIALITHUANIA

• NEDERLANDSNEDERLANDS

• PORTUGALPORTUGAL

• SLOVENIASLOVENIA

• 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

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PROHIBITING PROCUREMENT OF hES CELLS PROHIBITING PROCUREMENT OF hES CELLS

FROM EXCESS IFV EMBRYOS BUT ALLOWING FROM EXCESS IFV EMBRYOS BUT ALLOWING

IMPORTATION OF hES CELL LINESIMPORTATION OF hES CELL LINES

• DENMARKDENMARK• HUNGARYHUNGARY• LATVIALATVIA• ITALYITALY

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Allowing creation of human Allowing creation of human embryos for procurement of hESembryos for procurement of hES

• BELGIUMBELGIUM• SWEDENSWEDEN• UNITED KINGDOMUNITED KINGDOM

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• 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

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hES cells research

• continuing evaluation and ethical discussion

• protected from unethical commercialization

• legal regulation by committees for research ethics

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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

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Europe

the future

• ethical challenges of rapid technological progress

• concernes and hopes of patients• responsability of policy makers

hES cells research

• 20022002: no agreement for EU research on : no agreement for EU research on human embryos and hES cellshuman embryos and hES cells

• 20042004: “the Comission has the legal : “the Comission has the legal obligation to implement the 6th obligation to implement the 6th framework programme for research”framework programme for research”(hES cells not excluded)(hES cells not excluded)

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• 2006 - EU will continue to fund research from 2007-2013 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

• Europe’s historic cultural pluralism• contrasting approaches on certain

issues (eg. abortion)fostering harmonised regulations in

stem cell research

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