The draft OClin even had a provision that implicitly aimed at retaining the good- good-will of pharmaceutical companies: the State Secretariat for Economic Affairs

(“SECO”)

would have been consulted whenever a change in Good Clinical Practices could amount to a technical barrier to trade.

This clause was not retained in the final text of the OClin, presumably because of consumer groups’ resistance.

Switzerland is prepared to consent many sacrifices to retain the pharmaceutical companies located on its territory as well as those launching trials there.

High drug prices are currently the major cost of this policy

.

4.4.2. Assets and drawbacks of Swiss clinical trials

In Switzerland, estimates place the annual number of drug clinical trials at about 500.

Swissmedic tracks some 400 clinical trials, of which about 100 are phase I trials, less than 100 phase II trials, some 150 phase III trials, the rest being phase IV studies (for an explanation of clinical trial phases, see subsection 6.1.

.

Half of all drug trials taking place in Switzerland are multicentric.

788 See, e.g., Amstad (Suche), supra note 425, at 2218.

789 See, e.g., id. at 2217; Amanda Burls & Josie Sandercock, How to make a compelling submission to NICE:

tips for sponsoring organisations, 327 BMJ 1446, at 1148 (Dec. 20-27, 2003), at http://bmj.bmjjournals.com/cgi/reprint/327/7429/1446.pdf.

See also interview with Vito Grimaudo, Swissmedic, Clinical Trial Division (May 8, 2002).

790 See website at http://www.seco-admin.ch.

791 See Article 35.2 of the 2000 draft OClin, supra note 8. See more generally Article 1.3.b & c LPTh.

792 See Comments by the Swiss Fédération Romande des Consommateurs during the consultation procedure [hereinafter FRC (OClin comments)].

793 See, e.g., Fabio Lo Verso, Après l’« affaire Lipobay »: haro sur la surveillance des médicaments, Le Courrier (Feb. 26, 2002), at http://www.lecourrier.ch/Selection/sel2002_139.htm.

794 See D. Sprumont et al., Essais cliniques, responsabilité civile et contrats d’assurance, 83 BULLETIN DES MEDECINS SUISSES 2092-2096, at 2096 (2002), at http://www.saez.ch/pdf/2002/2002-40/2002-40-881.PDF.

There are many other clinical trials aside from those focusing on drugs. Thus, Swiss ethics committees have reviewed over 1500 protocols in 2002. See H. Amstad et al., Die Schweizer Ethikkommissionen reden mitein-ander, 84(34) BULLETIN DES MÉDECNS SUISSES 1733-36, at 1733 (2003), at

http://www.bullmed.ch/pdf/2003/2003-34/2003-34-722.PDF [hereinafter Amstad (Reden)].

Compare these numbers with the figures given for the United States in subsection 4.2.1.1. above.

795 Interview with Vital-Durand, supra note 484. See also Swissmedic, Annual Report 2002, at 47, at http://www.swissmedic.ch/files/pdf/Swissmedic_GB_2002.pdf.

The number for 1996, 1997, 1998, and 1999 are respectively, for phase I trials: 107 (1996), 125 (1997), 142 (1998) and 85 (1999); for phase II trials: 75, 77, 91, 66; for phase III trials: 190, 199, 183, 140. There were

Some have voiced reservations that Switzerland is not – or no longer – an attractive place to conduct clinical trials.

First, Switzerland is a small country.

Recruiting enough patients with an uncommon medical condition can be a tall order. Second, Swiss patients get excellent health care (through normal channels) and thus have no rea-son to turn to clinical trials to get access to medical care.

Third, the partition along three different languages imposes an additional burden: each subject must receive infor-mation in his own language; written inforinfor-mation has to be translated; collaboration between research centers in different regions may be hampered. Four, general costs of living are high in Switzerland, which translate into high payments to investigators, hos-pitals, clinics and subjects (for their health care).

Five, Swiss medical schools have not placed the emphasis on clinical research.

There may not be enough qualified investi-gators eager to get involved in clinical trials. Rates of publication of Swiss clinical re-search papers are low.

Hospitals are only gradually introducing Standard Operating Procedures (SOP) to facilitate clinical research.

Public funding of clinical research is lacking.

Social insurance funds cannot be used to fund health research nor clinical

respectively 39 (1996), 34 (1997), 35(1998) and 32 (1999) for phase IV trials reported to the IOCM. See OICM, Annual Report 1998, at 69, at

http://www.pharmalaw.org/O_rapport%20annuel%201998.pdf and Annual Report 1999, at 71, at http://www.pharmalaw.org/O_rapport%20annuel%201999%20(2).pdf.

796 See, e.g., Peter Kleist, Patienten dringendst gesucht !, 81(43) BULLETIN DES MÉDECINS SUISSES, at 2449 (2000), at http://www.saez.ch/pdf/2000/2000-43/2000-43-1065.PDF [hereinafter Kleist (dringendst)]; Paul Dietschy, Werner Stauffacher and Hermann Amstad, Les essais cliniques souffrent encore de nombreuses lacunes en Suisse, [Swiss clinical trials are still plagued with many faults], LETEMPS, Oct. 18, 2002.

797 Interview with Vital-Durand, supra note 484. See also Conseil suisse de la science et de la technologie [Swiss Science and Technology Council] (SWTR), Recherches cliniques en Suisse [Clinical research in Swit-zerland], at 10, Recommandations (2002) at

http://www.swtr.ch/swtr_fr/pdf/KliFo/Recherche_clinique.pdf [hereinafter SWTR (Recommendations)]. See also Kleist (dringendst), supra note 796, at 2450; Indermühle, supra note 162, at 243.

798 See, e.g., Peter Kleist et al., Seite 23, oben rechts: « Leiden Sie under allergischem Asthma ? », 83(14) BULLETIN DES MÉDECINS SUISSES 656 (2002), at http://www.saez.ch/pdf/2002/2002-14/2002-14-310.PDF [hereinafter Kleist (23)].

799 Interview with Vital-Durand, supra note 484.

800 See Hermann Amstad et al., Essais cliniques en Suisse: état des lieux [Clinical trials in Switzerland: overview of the situation], 83 BULLETIN DES MEDECINS SUISSES 2451 (2002), at

http://www.saez.ch/pdf/2002/2002-45/2002-45-1106.PDF [hereinafter Amstad et al. (Lieux)]; SWTR (Rec-ommendations), supra note 797, at 7 and 10-14. See however P. Kleist et al., Die (Un-) Abhängigkeit der klinischen Forschung, 82 BULLETIN DES MÉDECINS SUISSES 2346, at 2348 (2001), at http://www.saez.ch/pdf/2001/2001-44/2001-44-1137.PDF [hereinafter Kleist (Abhängigkeit)] (mentioning a recent advanced training opportunity for doctors wishing to specialize in clinical research).

801 See, e.g., Press Release, Federal Office for Statistics, Les activités de recherche en Suisse sont intenses [Swiss research activities are intensive], at 2, (Feb. 1999), from

http://www.bfs.admin.ch/bfs/portal/fr/index/themen/bildung_und_wissenschaft/wissenschaft_und_

technologie/blank/medienmitteilungen.Document.

802 See Swiss Society of Chemical Industries (“SSCI”), Clinical research in Switzerland: opportunities and chal-lenges, (Feb. 2000), at http://www.sgci.ch/plugin/template/sgci/164/3668/---/Klinische+Forschung+in+

der+Schweiz+%28EN%29+%28Internet+Artikel+%28SGCI+Exporter%29%29.

803 See SWTR (Recommendations), supra note 797, at 7. See generally Conseil suisse de la science et de la technologie [Swiss Science and Technology Council] (SWTR), Evaluation du Fonds national Suisse de la re-cherche scientifique (FNS) et de la Commission pour la technologie et l’innovation (CTI) [Evaluation of the Swiss National Science Foundation and the Commission for technology and innovation], (May 30, 2002), at 14, at http://www.swtr.ch/swtr_en/pdf/SNF_KTI_Evaluationen/SNF_KTI_Abschlussbericht_F.pdf.

See however Federal Council, Message relatif à l’encouragement de la formation, de la recherche et de la technologie pendant les années 2004 à 2007, [Message regarding the encouragement of education, re-search and technology during the years 2004 to 2007] (Nov. 29, 2002), FF 2003 2067, at 2088, 2102, 2105, 2123 and 2217, at http://www.admin.ch/ch/f/ff/2003/2067.pdf.

training of physicians.

Six, because research ethics committees (“RECs”) are organ-ized along cantonal, not national, lines, a sponsor often has to satisfy the requirements of several RECs.

Each REC can uphold its own views as to the proper conduct of the trial. Not uncommonly, written information provided to subjects has to be adapted for each cantonal study site to satisfy each REC. Clearly, the industry would prefer a more centralized procedure.

Seven, the pharmaceutical industry

as well as non-profit research centers

sometimes complain that Swissmedic is particularly exacting, com-pared to other drug agencies. Whether this is true or not remains to be seen.

On the other hand, many clinical trials still take place in Switzerland. Swiss hospi-tals and academic centers have a good reputation.

Swiss patients are said to make good subjects. Another reason has to do with the good social reimbursement prices offered in Switzerland as compared with other European countries. To stay in the good graces of the FOPH,

pharmaceutical companies voluntarily choose to conduct at least part of their clinical trials in Switzerland. Apparently, during later price negotiations, they find an advantage in claiming that part of the development effort took place in Switzerland.

Certain groups are working to maintain, or even enhance, the attractiveness of Switzerland. The Swiss Society of Chemical Industry has organized various training courses to coach physicians about GCP.

804 See, e.g., Dayer (Limites), supra note 74, at 66-67.

805 See Interview with Vital-Durand, supra note 484. See also Kleist (dringendst), supra note 796, at 2449.

806 See, e.g., SSCI, supra note 802.

807 See Interview with Vital-Durand, supra note 484.

808 See Swiss Institute for Applied Cancer Research (SIAK), Annual Report 2002-2003, at 9 and 13, (criticizing what it describes as a paralyzing increase in clinical trials administrative burden with no corresponding im-provement in the quality of studies or in the safety of patients).

809 See generally Michael Batty, Citation Geography: It's About Location, 17:16 THENEWSCIENTIST (Aug. 25, 2003), at http://www.the-scientist.com/yr2003/aug/opinion_030825.html; Kleist (dringendst), supra note 796, at 2450.

810 Reimbursement prices were previously set by the Federal Office for Social Insurance. In 2002, jurisdiction was transferred to the Federal Office for Public Health (FOPH).

811 See Kleist (Abhängigkeit), supra note 800, at 2346. See SSCI, supra note 802.

4.5. Clinical trials in developing countries

High R&D costs are a reason often put forward to justify doing clinical trials abroad. In the early 1990s, the trend was to move clinical trials from the U.S. to Eastern Europe.

Nowadays, more and more clinical trials take place in low to middle-income countries (e.g., South America, Eastern Europe).

Although drug agencies in Western countries do not keep tab of foreign clinical