Doc-tors are guilty of a long-standing tradition of not sufficiently explaining the treatments they choose to administer to their patients. They tend to consider that a patient’s general consent implicitly covers all aspects of the treatment, even though each aspect may not have been individually explained and discussed. In other words, doctors assume that, when a patient willingly consults them for a given medical problem, this patient auto-matically agree to whatever treatment they recommend.
2.2.1.4. Former intercantonal regulations
In November 1993, the Intercantonal Office for the Control of Medicaments (“IOCM”) – the executive body of the intercantonal convention that governed drug approval be-tween 1900 and 2001
158– enacted its first regulation specifically on clinical trials.
159This 32-page text entered into force on the 1
stof January 1995.
160tional touching. That theory, in turn, developed out of a basic judicial regard for the principle of individual autonomy, reflecting the belief that an individual has the right to be free from non-consensual interference with his or her person.” Id. at 74. See, e.g., Scott v. Bradford, 606 P.2d 554, at 557 (Okl. 1979); Canterbury v. Spence, 464 F.2d 772, at 783 (D.C.Cir. 1972).
See also GUILLOD,supra note 77, at 65-66; Dennis J. Mazur, Influence of the law on risk and informed con-sent, 327 BMJ 731 (Sept. 27, 2003), at http://bmj.bmjjournals.com/cgi/reprint/327/7417/731.pdf.
152 Given that the relationship between a doctor and a patient is deemed a contract of mandate, liability of the former toward the latter is governed, under Swiss law, by Article 398 (cum Article 97) of the Swiss Code of Obligations (“CO”). Under this provision, the doctor is liable if he breaches his duties of care and thus causes harm to his patient.
153 See also generally SPRUMONT,supra note 16, at 221-22; GUILLOD,supra note 77, at 37-38.
154 See, e.g., Article 125 of the Swiss Penal Code, available at http://www.admin.ch/ch/f/rs/3/311.0.fr.pdf. See also ATF 99 IV 208 = JdT 1974 IV 132; ATF 117 Ib 197, at 200-201 = JdT 1992 I 214, at 216-217; ATF 113 Ib 420 (at point 4) = JdT 1989 I 26 (at point 4). See also GUILLOD,supra note 77, at 40.
In the United States, see for instance Schloendorff v. The Society of the N.Y. Hospital, 211 N.Y. 125, at 130-13 (N.Y. Ct.App. 1914) (“a surgeon who performs an operation without his patient’s consent, commits an as-sault, for which he is liable in damages.”).
155 See, e.g., Dominique Manaï, Le devoir d’information du médecin en procès, 2000 SJ 341, at 344 [hereinafter Manaï (procès)].
156 See the Swiss Supreme Court decision at ATF 108 II 59, at 62, at point 3.
157 See SPRUMONT,supra note 16, at 207-208. See also Ummel (1990), supra note 74, at 2.
Nowadays, it is commonly accepted that the information given to the research subject must be more exten-sive than that offered to a patient, receiving standard care. Subjects also benefit from additional safeguards that “standard” patients do not enjoy (e.g., special insurance coverage in case of injuries). Id. at 208-209.
158 See generally PATRICIA LUTHY, ENREGISTREMENT ET CONTRÔLE DES MÉDICAMENTS SUR LES MARCHÉS DES PRODUITS PHARMACEUTIQUES SUISSE ET EUROPÉEN, 52-54 (Thèse Lausanne, Payot 1993).
159 See Règlement sur les médicaments au stade d’essais cliniques, [Regulation on Medicines in Clinical Studies (translation previously proposed by the IOCM on its website)]; November 18, 1993; N°230.1, at http://
www.pharmalaw.org/O_reglementessaiclinique.pdf [hereinafter IOCM 1995 Regulation].
The purpose of this regulation (hereinafter the 1995 IOCM Regulation) was to in-troduce, at the intercantonal level, key safeguards for research participants.
161For the first time a uniform system was implemented throughout Switzerland.
162Prior ap-proval by a research ethics committee (“REC”
163) became a necessary condition for con-ducting clinical trials. The IOCM also asked to be notified of trials before they started.
Clinical trials had to conform to Good Clinical Practices (“GCP”), which were stated in Annex I.
164.
2.2.1.5. Comprehensive federal regulations: the LPTh and the OClin
On January 1, 2002, seven years after the aforementioned IOCM regulation, the inter-cantonal
165system gave way to the Federal Law on therapeutic products (“LPTh”).
166The LPTh is accompanied by several Ordinances, including the Ordinance on clinical trials (“OClin”).
167The regulation project was prepared by a group of experts led by Professor Pierre Dayer. See Theodore We-ber, La recherche clinique en Suisse: le point de vue de l’Office intercantonal de contrôle des médicaments, 39(2) CMS 231 (1995). On the development of the IOCM 1995 Regulation, see also Dominique Sprumont, De l’éthique au droit: la réglementation des recherches sur l’être humain dans l’ordre juridique suisse, 39(2) CMS 133, at 148-49 (1995) [hereinafter Sprumont (De l’éthique)]; Jean-Christophe Méroz & Dominique Sprumont, Le Règlement de l’OICM sur les médicaments au stade d’essai clinique, Points de repère pour les investigateurs, 75 BULLETIN DES MÉDECINS SUISSES 674-75 (Apr. 27, 1994) [hereinafter Méroz & Sprumont]. See also SPRUMONT,supra note 16, at 278-79 (broadly admitting the jurisdiction of the authorities under the In-tercantonal Convention)
See also Article 8ter.2 of the IOCM Regulation on the Execution of the Convention, at
http://www.pharmalaw.org/Reglement%20de%20la%20Convention_OICM.pdf. This provision entered into force in October 1994. See also Instructions de l’OICM pour la présentation des demandes d’enregistrement de specialités pharmaceutiques contenant de nouveaux principes actifs et destinées à l’usage human, [IOCM Guidance for the Submission of Registration Applications of Pharmaceutical Specialties for Humans with New Active Substances], part IV, (Feb. 14, 1989), at
http://www.pharmalaw.org/O_InstructionsOICM.pdf.
160 Article 17 of the (former) IOCM 1995 Regulation.
161 See Méroz & Sprumont, supra note 159, at 676.
162 See, e.g., Ummel & Mandofia, supra note 39, at 57.
This uniformity was supported by the Swiss pharmaceutical industry. See Bernard Indermühle, Point de vue de l’industrie pharmaceutique sur la recherche clinique en Suisse, 39(2) CMS 241, at 241-42 and 245 (1995).
163 This abbreviation REC is used for example in the United Kingdom. See EFGCP, The EFGCP News, at 15 (Winter 2001), at http://www.efgcp.org/webitems/doc/newsletters/2001_Winter.pdf. Another abbreviation in use is “IECs” which stands for “Independent Ethics Committees.” See, e.g., EFGCP, European Guidelines for Auditing Independent Ethics Committees, at 3, (2001), at
http://www.efgcp.org/webitems/EFGCP_IEC_Audit.pdf [hereinafter EFGCP (Auditing IECs)].
164 These IOCM’s GCP were organized in five main chapters, the first one dealing with the protection of re-search subjects and with the consultation of ethics committee. These GCP were inspired by the European GCP. They also resemble the ICH E6 Guideline on Good Clinical Practice (which was adopted later in May 1996). See Weber, supra note 159, at 232.
On the reasons underlying the distribution of rules among the 1995 Regulation and its Annex, see Sprumont (De l’éthique), supra note 159, at 149.
165 The 2002 Federal Regulation also abrogated the ordinance on clinical trials of immunobiologic products of June 26, 1996 (FO 1996 2342). See Article 35 OClin.
166 More specifically, its chapter 4, section 2 (articles 53 to 57) applies to clinical trials.
167 Since 2003, the administration and Swissmedic have been preparing a second and third set of ordinances.
The second set of ordinance entered into force on September 1st, 2004. It had limited impact on the conduct of clinical trials and does not directly concern clinical trials. See also supra note 48. The third set of ordi-nance has been submitted for comments. See FOPH, Droit d’application des produits thérapeutiques, train
The LPTh and OClin provisions regarding clinical trials are modeled after the for-mer IOCM regulation.
168The OClin also closely resembles the European Union’s 2001/20/EC Directive,
169which entered into force on May 1, 2001, just a few months before the OClin.
170The OClin and the E.U. Directive also share a common source of inspiration: the ICH (International Conference on Harmonization) guideline on Good Clinical Practice (hereinafter “ICH E6”).
171The ICH finalized this detailed guideline in May 1996 with the purpose of unifying clinical research in the three main ICH regions (i.e., the United States, the European Union and Japan)
(see subsection 4.3.1. below).
172Good Clinical Practices (“GCP”) are defined as “a set of internationally recognized ethical and scien-tific quality requirements that must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.”
173GCP are inherently international standards, even though each country or region may well have its own, slightly different, internal version of GCP. Because of this shared origin, national regulations of clinical trials tend to resemble each other. Comparisons between Swiss, European and U.S. regulations are not only facilitated, but also apposite
(see sub-section 1.3. above).
d’ordonnances II [Executive provisions on therapeutic products: set of ordinance II] (Aug. 18, 2004), at http://www.bag.admin.ch/heilmitt/aktuell/f/index.htm et
http://www.bag.admin.ch/heilmitt/gesetz/f/index.htm; Swissmedic, Letter to interested groups (June 16, 2005), at http://www.swissmedic.ch/files/pdf/Begleitbrief_AH_fr_Scan.pdf and the relevant documents from http://www.swissmedic.ch/fr/industrie/overall.asp?lang=3&theme=
0.00105.00002&theme_id=518&news_id=4568&page=1.
168 See the FOPH’s explicative report regarding the draft Ordinance on clinical trials, at 3, (Dec. 2000), at http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vklinver_erl.pdf.
169 The full name of the Directive is Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal product for human use, published in the Official Journal (“OJ”) L 121, 1.5.2001, p.34, at http://europa.eu.int/eur-lex/pri/en/oj/dat/2001/l_121/l_12120010501en00340044.pdf [hereinafter Directive 2001/20/EC]. The Direc-tive was initially proposed in 1997; it was then modified in 1999. It was adopted in March 2001 and entered into force on May 5, 2001. Member States had until May 1, 2004 to fully comply with the Directive (Article 22.1 of the aforementioned Directive).
Several commentators have expressed doubts about E.U. readiness for this deadline. See, e.g., Peter O’Donnell, Squeezing the European Union Into Shape, APPLIED CLINICAL TRIALS (Nov. 2003), at http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=77553 [hereinafter O’Donnell (Squeezing)].
170 Article 23 of Directive 2001/20/EC.
The adoption of the European Directive could explain why the December 2000 draft of the OClin is so dis-similar to the actual ordinance. Visibly, the Federal Council and the Federal Administration decided midway that it was more appropriate to follow the European Directive. Some of the OClin’s provisions are almost verbatim replica of the European Directive. Compare for example Article 22 OClin with Article 16 of the European Directive 2001/20/EC. Long live euro-compatibility!
Nonetheless, for the time beeing, Swissmedic has decided not to endorse directly this E.U. Directive, believ-ing that it should wait to see exactly how it will be implemented in Member States. See Telephone Interview with Yves Chautems, Swissmedic’s clinical trial division, (Mar. 25, 2004) [hereinafter Chautems (Mar. 2004)].
171 The ICH E6 Guideline is applicable in Switzerland pursuant to Article 53.1 LPTh and Article 4.1 OClin.
172 On the importance of the ICH GCP, see Sprumont (RSDS), supra note 100, at 42.
173 Article 1.2. of the Directive 2001/20/EC. See also the definition of the ICH E6 Guideline, at 1 and 4.
2.2.2. Scandals in Switzerland: the VanTx affair
Scandals have always been a powerful driving force for change. This is also true for Swiss clinical trials. What is commonly known as the “VanTx affair” is a perfect illus-tration.
In spring 1999, the Swiss authorities realized that the most important Swiss con-tract research organization (“CRO”) had been conducting its clinical trials in gross vio-lation of legal, ethical and scientific rules.
174The CRO (called successively Clin-Pharma and VanTx)
175was carrying out 40% of all Swiss phase I* clinical trials
176submitted to the IOCM.
177The sponsors which had hired out VanTx were reputable multinational pharmaceutical firms.
178Yet, the policy of VanTx since 1998 had been to “import” into Switzerland research subjects coming from less developed countries.
179In exchange for their participation in early phase clinical trials, these subjects were offered money and the promise of a trip through the Alps.
180As can be expected, the subjects did not fully understand what they were committing to; moreover, the information they received was incomplete and not provided in their own language.
181The investigator and the research site lacked the necessary authorizations. Clinical trials were not properly con-ducted;
182medical follow-up of the subjects was entirely lacking.
183The ethics commit-tee which had approved the research did not operate properly: It was organized as a private company. Worse, it was chaired by the principal investigator – a gross violation of a basic principle of ethical review.
184When the OICM (the Swiss drug agency before Swissmedic) finally caught up with VanTx – after an Estonian newspaper had made the story public –, it appointed a Work-ing Group to assess the situation. In September 2000, this Group, headed by Pierre Dayer and Dominique Sprumont,
185delivered an illuminating report detailing the fail-ings of the Swiss regulatory system.
186The report sets forth several recommendations to improve the regulations of clinical trials.
187174 See VanTx Report, supra note 148, at 4 and 11.
175 On the relationship between the two contract research organizations, Clin-Pharma and VanTx, see id. at 10.
176 Phase I clinical trials correspond to the earliest phase of clinical research. It is during a phase I clinical trial that an investigational drug is first administered to human research subjects. On the various phases of clini-cal trials, see subsection 6.1. below.
177 Out of 450 clinical trials notified to the IOCM, VanTx/Clin-Pharma was performing 40% of the 150 phase I clinical trials. See VanTx Report, supra note 148, at 11. VanTx was also conducting many bioequivalence studies in connection with marketing application for generic drugs. See, e.g., Press Release, Swissmedic, Fo-cus: Clinical trials, (Jan. 10, 2003), at http://www.swissmedic.ch/Archiv/Klinische_Studien-F.pdf.
178 See VanTx Report, supra note 148, at 16.
179 Id. at 12. Out of 61 studies that Van-Tx notified to the Swiss authority, at least nine had enrolled foreign subjects. Over 150 foreign subjects were brought to Switzerland. Id.
180 Id. at 11 and 20.
181 Id. at 13.
182 Id. at 9.
183 Id. at 13-14.
184 Id. at 4 and 16-17.
185 See Professor Sprumont’s webpage at http://www.unine.ch/droit/profs/profbiog.asp?prof=dsprumont.
186 See VanTx Report, supra note 148, at 4.
187 At that time, Swiss clinical trials were still governed by the Intercantonal regulation, in particular the (former) 1995 IOCM Regulation.