im-ported drug must be for personal consumption and the quantity imim-ported must remain small (often limited to a 3-month use).
Second, as we saw before (
subsection 3.4.4.), physicians have the right to prescribe and administer drugs “off-label,” that is for therapeutic indications which have not been approved in their country.
466Third, physicians also have the right to import drugs which have not been author-ized in their country.
467In Switzerland, they must request an authorization from Swissmedic.
468Since September 2004, this system has been made more flexible by authorizing pharmacists (acting upon requests made by physicians) to freely import small quantities of unapproved drugs.
469This change relieved the pressure on
Swiss-465 See M.D. Greenberg, supra note 129, at 316.
In Switzerland, these imported drugs must not contain genetically modified organisms; Article 36.1 of the Federal Council’s Ordinance on authorizations in the sector of pharmaceuticals of October 17, 2001; RS 812.212.1; in French: “Ordonnance sur les autorisations dans le domaine des médicaments”; abbreviated (from the French): OAMéd, text in French at http://www.admin.ch/ch/f/rs/8/812.212.1.fr.pdf. See also Swissmedic, Autorisations spéciales pour les médicaments non autorisés, Swissmedic Journal 1/2002, at 6, at http://www.swissmedic.ch/files/pdf/01_2002.pdf.
In the United States, see FDA, Coverage of Personal Importations, Guidance (Personal Importation Policy), Regulation Procedures Manual, chapter 9, at
http://www.fda.gov/ora/compliance_ref/rpm_new2/ch9pers.html.
466 “Off-label” prescribing is not limited to unapproved therapeutic indications; it may also refer to prescription of a drug at a dosage or in a manner not advised by the approved notice of use. Such conduct does not give rise to a clinical trial if the central motivation is to treat a patient therapeutically, as opposed to research purposes. The FDA has issued a guidance for cancer treatment, since the distinction is particularly unclear in this area. See Lester M. Crawford, IND Submission Exemptions, 287 JAMA 2936 (June 12, 2002), at http://jama.ama-assn.org/cgi/reprint/287/22/2936-a.pdf (“The proposal emphasizes that exemption from the IND requirement depends primarily on whether the investigation significantly increases risk associated with use of the product. … because in oncology modifications of labeled dosing recommendations are com-mon, oncology studies deviating from the approved labeling can be exempted, provided such changes are supported by the literature and generally known clinical experience…. [These studies should not be] in-tended to support FDA approval of a new indication, significant change in labeling, or advertising of the product ….”).
467 Physicians who exercise their profession on both sides of the border between Switzerland and a neighboring country have a right to import small quantities of medicines for their patients; Article 11 OAMéd.
468 Article 36.2 OAMéd.
See also decision of the Swiss federal appeal commission for therapeutic products, JAAC 67.93, at point 5.2.
(Jan. 28, 2003), at http://www.vpb.admin.ch/franz/doc/67/67.93.html.
469 See the new Article 36.3 OAMéd, which entered into force on September 1, 2004. See also the FOPH expli-cative report of June 5, 2003, at page 38, http://www.bag.admin.ch/heilmitt/gesetz/f/erl_hmvp_f.pdf.
medic, which had been overwhelmed by the number of physicians’ requests under this system.
470Article 9.4 LPTh is a general clause granting Swissmedic the authority to allow distribution of non-authorized treatment to patients. Three conditions must be met.
First, patients must suffer from a life-threatening disease. Second, the drug must show notable efficacy as determined by Swissmedic. Third, there must not be other equiva-lent pharmaceutical for these patients.
471Swissmedic retains the mandate to appreciate if, at this early stage, the anticipated benefits exceed the risks, both known and un-known. It can enjoin the sponsor, the physician or the patients to take additional pre-cautions or to consent to special obligations. The provision does not specify who is sup-posed to apply for this authorization. In theory at least, it could be anyone. In practice, the request is more likely to come from the sponsor or the patient’s physician. How-ever, the latter would presumably prefer to use the simplified procedure set forth by Article 36 OAMéd. New ordinances – submitted for consulation in June 2005 – would clarify the requirements of Article 9.4. LPTh.
In addition, according to Article 5 of the Ordinance on pharmaceuticals,
472prom-ising drugs against serious diseases can receive their marketing authorization following an accelerated procedure. Swissmedic has not yet passed guidelines to explain how it plans to apply both provisions. By contrast, in the United States, the various circum-stances that warrant accelerated access are the subject of detailed provisions.
3.4.6.2.4. Do compassionate access programs come under the OClin?
Under the previous intercantonal system, the IOCM had detailed its position on the compassionate access programs.
473It distinguished four situations where non-approved drugs were administered to patients outside clinical trials: parallel trial programs,
474compassionate use,
475extended access,
476isolated use.
477There was, however, some irritating overlap between the IOCM’s four categories, particularly between the first two. While parallel trial programs were governed by requirements analogous to those
470 In 2002, Swissmedic had to issue some 4500 authorizations for the importation of unapproved drugs, about three times as much as was previously issued by all cantons. See Press Release, Swissmedic, Swissmedic:
premier bilan après 15 mois [Swissmedic: first assessment after 15 months], (Apr. 14, 2003), at http://www.swissmedic.ch/Archiv/Fazit-f.pdf.
471 See Decision of the Swiss Federal Tribunal of September 6, 2004 (2A.469/2003), at
http://wwwsrv.bger.ch/cgi-bin/AZA/JumpCGI?id=06.09.2004_2A.469/2003 (“Die Erteilung einer Bewilligung ist danach nicht nur dann ausgeschlossen, wenn bereits identische Präparate zugelassen sind, sondern auch dann, wenn der gleiche therapeutische Erfolg mit anderen Arzneimitteln erreicht werden kann. Ob diese Präparate umständlicher oder teurer sind, müsse ausser Betracht fallen.”).
472 Federal Council’s Ordinance on pharmaceuticals of October 17, 2001; RS 812.212.21; in French: “Ordon-nance sur les médicaments”; abbreviated (from the French): OMéd; text in French at
http://www.admin.ch/ch/f/rs/8/812.212.21.fr.pdf.
473 See IOCM former Compassionate Explanations, supra note 414, at 170-74.
474 Id. at B.2.1, at 171.
475 Id. at B.2.2, at 172.
476 Id. at B.2.3, at 172.
477 Id. at B.2.4, at 172.
applicable to “normal” clinical trials (in particular, approval by an ethics committee), compassionate use only required compliance with cantonal procedures.
478In April 2004, Swissmedic subscribed to these four categories of compassionate ac-cess. It laid down in four “commentary” the conditions that govern them
479Although this is not explicitly confirmed in Swissmedic’s commentaries, it appears that the OClin is not applicable to either of these categories.
480The following table summarizes the re-quirements set down by Swissmedic.
Conditions Compassionate
Use
Parallel trial Extended access Beyond compassionate use
Conditions pertaining to the drug Drug to be used not (yet)
regis-tered
; ; ;
(request forMajor therapeutic benefit expected
; ; ; _
No satisfactory alternative
479 Swissmedic’s commentaries are available at
http://www.swissmedic.ch/files/pdf/Commentary_special_authorization_compassionate_use.pdf;
http://www.swissmedic.ch/files/pdf/Commentary_special_authorization_parallel_trial.pdf;
http://www.swissmedic.ch/files/pdf/Commentary_special_authorization_extended_access.pdf;
http://www.swissmedic.ch/files/pdf/Commentary_special_authorization_exceptional_cases.pdf.
480 Id. Article 3 OClin (defining human research subjects) has sometimes been interpreted to mean that this Ordinance applies to patients taking part in some of these programs. However, Article 3 OClin (whose text is to be moved to Article 5.d OClin in September 2004) is not specific enough to encompass all compassionate programs. See also supra note 331.
This classification problem does not only arise under Swiss law. See also CIOMS 2002 Guidelines, supra note 105, at Guideline 2 (commentary) and Guideline 13 (commentary) (answering that compassionate access programs are not “properly regarded as research”).
In the United States, compassionate programs are not regulated as clinical trials.
Approval procedure
Approval of the ethics committee
_ ;
(with help of sponsor);
(with help of sponsor)_
Request made by Physician Investigator Investigator or physician
Physician
Authorization granted to
physi-cian
; ; ; ;
Physician has insurance coverage
; ; ; ;
Duty to report adverse events
; ; ; ;
Reporting obligation by physician
at the end
; ; ; ;
In September 2004, changes in the Ordinance on the authorizations in the area of drugs (“OAMéd”
481) transferred Swissmedic’s authority to authorize physicians’ im-ports of small quantites of unapproved drugs back to the cantons
(see subsection 3.4.6.2.3.above)