313 See, e.g., SNSF, Position du FNS sur l’utilisation des cellules souches embryonnaires humaines dans la re-cherche en biomédecine [SNSF’s position on the use of human embryonic stem cells in biomedical research], at 1, (Sept. 28, 2001), at http://www.snf.ch/downloads/snf_position_stammzellen_f.pdf.
314 See Federal Council’s Message on the LTransplant, FF 2002 19, at 34-35; Federal Council’s Message on the LRCS, FF 2003 1065, at 1087.
315 The cells are taken from the patient’s own bone marrow or from peripheral blood. This is therefore an autologous (cell) transplant. For a list of diseases for which stem cell transplants are used, see National Mar-row Donor Program, Diseases Treatable by Stem Cell Transplant (2003), at
http://www.marrow.org/MEDICAL/diseases_treatable_by_stem_cell_transplants.html.
316 See for example the detailed explanations provided by ECRI (formerly the Emergency Care Research Insti-tute), High-dose chemotherapy with bone marrow transplant for metastatic breast cancer, at 11-15, (Mar.
1996), at http://www.ecri.org/Patient_Information/Patient_Reference_Guide/bc.pdf [hereinafter ECRI (che-motherapy)].
317 See Janice Hopkins Tanne, Stem cell transplants are not helpful in breast cancer, studies say, 327 BMJ 68 (July 12, 2003), at http://bmj.bmjjournals.com/cgi/reprint/327/7406/68-b.pdf.
318 See in relation with diabetes, Palle Serup et al., Islet and stem cell transplantation for treating diabetes, 322 BMJ 29-32 (Jan. 6, 2001), at http://bmj.bmjjournals.com/cgi/reprint/322/7277/29.pdf. See also A. L. Len-nard & G. H. Jackson, Stem cell transplantation, 321 BMJ 433-37 (Aug. 12, 2000), at
http://bmj.bmjjournals.com/cgi/reprint/321/7258/433.pdf.
319 See, e.g., Doris A. Taylor, Cellular cardiomyoplasty with autologous skeletal myoblasts for ischemic heart disease and heart failure, 2 CURR. CONTROLTRIALSCARDIOVASC. MED. (Sept. 10, 2001), at
http://www.bioheartinc.com/cvm-2-5-Taylor.pdf.
320 See, e.g., FDA, FDA Expands Access to Experimental Treatment for Advanced Renal Cell Cancer, (Sept. 26, 1995), at http://www.fda.gov/bbs/topics/ANSWERS/ANS00684.html.
321 See Federal Council’s Message on the LTransplant, FF 2002 19, at 37.
322 Embryonic stem cells (ESC) are extracted from surplus embryos initially produced for the purpose of in-vitro fertilization but then no longer needed. ESC can also be obtained from aborted embryos. However, the LRCS applies only to ESC obtained from surplus embryos (Article 1.1 LRCS).
See TA-Swiss (Centre for Technology Assessment), Ethical and legal questions on stem cell research in Swit-zerland, (Apr. 15, 2002), at
http://www.ta-swiss.ch/www-remain/reports_archive/press_releases/pressemitteilungen2002/PM020415_
Menschliche_Stammzellen_en.pdf. See also Federal Council’s Message accompanying the law on research on embryos, FF 2003 1065, at 1080-81.
cells derived from clones (“therapeutic cloning”)
323has generated passionate controver-sies. Most countries are reticent to allow research that inevitably leads to the destruction of early-stage embryos, including cloned embryos.
324Similarly, the creation and ex-ploitation of embryos or clones specifically for research purpose is a divisive issue.
325The debate often centers on the social-religious issue of the point in time when Life is thought to begin (at the time of fecundation, when the fetus is viable, either with or without medical assistance, or at birth?).
326The concept of “Dignity” is also put for-ward, the argument being that submitting unconsenting embryos to research is per se degrading.
327Switzerland has adopted a strict position to constrain ESC research.
328A draft law on research on embryos and embryonic stem cells (hereinafter: “LRE”) was circulated among interested parties between May and August 2002.
329In November 2002, the Swiss Home Affair Department issued a report compiling the comments received.
330It was immediately followed by the Federal Council’s Message published in February 2003.
331The Federal Law on embryonic stem cell research ("LRCS") was adopted by
In the United States, see the chapter on ethical issues of the NBAC, ETHICAL ISSUES IN HUMANSTEM CELL RESEARCH, VOLUME I, at 45-62, at http://www.georgetown.edu/research/nrcbl/nbac/stemcell.pdf [hereinafter NBAC (Stem cell report)]
323 See generally Federal Council’s Message on the LTransplant, FF 2002 19, at 37.
324 Of course, the embryos would be destroyed anyway, since this type of research uses surplus (i.e., unneces-sary) embryos from in vitro fecondation or cloned embryos that either could develop into a fetus or would not be allowed to do so.
See in Switzerland, TA-Swiss (Centre for Technology Assessment), Recherche sur les cellules souches em-bryonnaires [Research on embryonic stem cells], PubliFocus, Rapport d’une méthode participative, at http://www.ta-swiss.ch/www-remain/reports_archive/publications/2002/UN_Rapport_entier.pdf. On issues related to the extraction and use of stem cells, see for instance in Switzerland: Central Ethic Commission of the SAMS, Position sur le prélèvement et l’usage des cellules souches pour la recherche scientifique, (Aug.
28, 2001).
For an overview of policies in other countries, see TA Swiss (stir), supra note 312, at 29-30 and at 38-39.
In the United States, President Bush linton has excluded federal funding for the creation of new embryonic stem cell lines. Only research using existing lines is to receive federal funding. See Remarks by the President on Stem Cell Research (Aug.9,2001), at
http://www.whitehouse.gov/news/releases/2001/08/print/20010809-2.html.
325 See more generally Article 19.2.c. of the Swiss Constitution forbidding that “more human ova than are capa-ble of being immediately implanted into the woman” be produced. See also Article 36.2.a and 37 of the law on transplantation.
326 See for instance in Switzerland, Groupe de travail “Bioéthique” de la Conférence des évêques suisses, Le statut de l’embryon, Prise de position, (Feb. 27, 2003), at http://www.kath.ch/sbk-ces-cvs/pdf/Der_
Status_von_Embryonen_f.pdf. For more in-depth analysis regarding the status of embryos, see two inter-esting collections of essays: ANTHONY DYSON & JOHNHARRIS(editors), EXPERIMENTS ON EMBRYOS, (Routledge, 1990); JOHNHARRIS & SORENHOLM, THEFUTURE OF HUMANREPRODUCTION, (Oxford Univ. Press, 1998).
327 See ATF 119 Ia 460, at cons.12, at p.499 = JdT 1995 p.586, at cons.12, at 598.
328 See Article 42.2 LPMA, which temporarily authorizes the use for research purposes of research on surplus embryos. These embryos were initially made and stored for procreation purposes. Once the couple has achieved or abandoned this objective, it can authorize research on its now superfluous embryos. Article 42.3 LPMA was voted in October 2003, and entered into force on December 31, 2003. Without this provision, all previously stored surplus embryos would have had to be destroyed.
See also Articles 5-10 of the LRCS as well as the accompanying Federal Council’s Message, at FF 2003 1065, at 1067-68.
329 See Federal Council’s Message on the LRCS, FF 2003 1065, at 1127.
330 See Department of Home Affairs, Rapport sur les résultats de la procédure de consultation portant sur le projet de loi relative à la recherche sur les embryons [Report on the results of the comment procedure re-garding the draft law concerning research on embryos] (Nov. 2002), at
http://www.bag.admin.ch/embryonen/bundesgesetz/f/vern_ber.pdf [hereinafter DHA Embryo Report].
331 Federal Council’s on the LRCS, FF 2003 p.1065-1181.
Parliament on December 19, 2003, but was attacked by a popular referendum.
332The vote took place in November 2004, resulting in a clear majority (over 60%) in favour of the law. The LRCS and its ordinance (the ORCS) entered into force on March 1, 2005.
Under Swiss law, all stem cells are regulated as transplants.
333This includes hemato-poietic stem cells, even though blood and blood products are regulated by the LPTh as pharmaceuticals.
334Embryonic stem cells used for transplantation purposes (on human beings) fall within the scope of the 1996 Decree/LTransplant.
335Research involving ESC originating from clones is not possible, since Switzerland bans all forms of cloning, in-cluding (unwisely, in my view) therapeutic cloning.
336The production (or extraction) of ESC is governed by the Federal Law on embry-onic stem cell research (“LRCS”), which entered into force on March 1, 2005.
337While the LPTh and its ordinances are not applicable to preclinical and clinical research using ESC, the LRCS refers such research projects to the ethics committees instituted by Arti-cle 57 LPTh.
338The Swiss FOPH is endowed with the authority to oversee ESC research;
in particular, it receives advance notification of each project.
339Prior to this stage, the FOPH must have authorized the production of ESC.
340Swissmedic has no jurisdiction over stem cell research, even if stem cells are ad-ministered on research subjects in the context of a clinical trial.
341This is surprising con-sidering that Swissmedic oversees clinical trials involving the use of gene therapy or genetically modified microorganisms. There is a close link between stem cell therapy and gene therapy. Indeed, in many other countries, stem cell therapies follow the same rules as gene therapy
(on gene therapy, see subsection3.2.3.
below).
342Provided that the
332 See supra note 287.
333 See Article 2.2.b. of the future LTransplant.
334 See Federal Council’s Message on the LTransplant, FF 2002 19, at 131.
335 See Article 1.3 LRCS. See also Federal Council’s Message accompanying the LRCS, at FF 2003 1065, at 1070 and 1146 (indicating that clinical trial (on human beings) of embryonic stem cell therapies are governed by the LTransplant, and not the LRCS).
336 “All forms of cloning and interference with genetic material of human reproductive cells and embryos is prohibited.” Article 119.2.a of the Constitution (English translation proposed by the Swiss administration on its website). See also Articles 35.1 and 36.1 LPMA and Article 3.1 LRCS; Federal Council’s Message regarding the LRCS, FF 2003 1065, at 1091-92.
337 Article 1.1 LRCS. See also supra note 287. Under the LRCS, ESC lines can only be producted if needed for a specific research project. Moreover this project must have received the favorable opinion of an ethics com-mittee. Article 7 LRCS. Compare with Federal Council’s Message on the LRCS, FF 2003 1065, at 1151-52 (which did not require a specific research project.
338 See Article 11 LRCS. See Federal Council’s Message on the LRCS, FF 2003 1065, at 1138-39 and at 1155-56.
See also with respect to research on embryos: id. at 1150.
339 See Article 13.1 LRCS.
340 Both the production of ESC and research on embryos necessitate an authorization delivered by the FOPH.
See Articles 7, 8, and 10 LRCS. Research on ESC only requires notification. See Article 13 LRCS. See also the accompanying Federal Council’s Message, FF 2003 1065, at 1143-45, 1149, 1151, 1156.
341 Article 2.1 OClin. See also Telephone Interview with Chautems (Mar. 2004), supra note 170.
342 In the United States, “[t]he FDA defines somatic-cell therapy as the administration to humans of autologous, allogeneic, or xenogeneic living somatic cells that have been manipulated or processed to change their bio-logic characteristics. … Gene therapy encompasses interventions that involve deliberate alteration of the ge-netic material of living cells to diagnose, prevent, or treat disease. The administration of cells that have un-dergone ex vivo genetic manipulation is considered a combination of somatic-cell therapy and gene therapy.”
David A. Kessler et al., Regulation of Somatic-Cell Therapy and Gene Therapy by the Food and Drug Admini-stration, 329 NEW. ENG. J. MED. 1169 (Oct. 14, 1993). See also FDA, Application of Current Statutory