CEDH · CASELAW;CLIN;ENG — 13 novembre 2012

.s3ABFC313 { font-size:10pt } .sEB86A30B { margin-top:0pt; margin-bottom:14pt; page-break-after:avoid } .sBB9EE52A { font-family:Arial } .sA241FE93 { margin-top:0pt; margin-bottom:18pt; text-align:justify; page-break-after:avoid; border-bottom:0.75pt solid #000000; padding-bottom:1pt } .s2EF62ED2 { margin-top:0pt; margin-bottom:0pt; font-size:12pt } .s4DDA3AA3 { font-family:Arial; font-weight:bold; font-style:italic } .s29100277 { font-family:Arial; font-weight:bold } .s32563E28 { margin-top:0pt; margin-bottom:0pt } .s8F2B0B1B { margin-top:12pt; margin-bottom:12pt; page-break-after:avoid; font-size:12pt } .s9FF10068 { margin-top:0pt; margin-bottom:12pt } .sA36B60A1 { font-family:Arial; font-style:italic } .s5F48796F { margin-top:12pt; margin-bottom:0pt; text-align:justify } .s5CB9E8AB { margin-top:12pt; margin-bottom:0pt; text-align:justify; border-bottom:1pt solid #000000; padding-bottom:1pt } .sDF790F1E { margin-top:12pt; margin-bottom:0pt; text-align:center } .s7ED160F0 { text-decoration:none } .s3DC36BA9 { font-family:Arial; text-decoration:underline; color:#0069d6 } Information Note on the Court’s case-law No. 157 November 2012 Hristozov and Others v. Bulgaria - 47039/11 and 358/12 Judgment 13.11.2012 [Section IV] Article 8 Positive obligations Article 8-1 Respect for private life Refusal to allow the use of an unauthorised experimental drug for medical treatment: no violation   Article 2 Positive obligations Article 2-1 Life Refusal to allow the use of an unauthorised experimental drug for medical treatment: no violation   Article 3 Positive obligations Refusal to allow the use of an unauthorised experimental drug for medical treatment: no violation   Facts – The ten applicants were cancer sufferers who complained that they had been denied access to an unauthorised experimental drug. Having exhausted a number of conventional treatments for cancer, the applicants were advised by a private clinic about an experimental drug in development in Canada, the provision of which was offered free of charge. Permission was sought from the Government to use the drug. Domestic law stated that such permission could only be given where the drug in question had been authorised in another country. While the drug was permitted for “compassionate use” in a number of countries, nowhere had it been officially authorised. Accordingly, permission was refused. Law – Article 8: It is under Article 8 that the extent to which States may use their power to protect people from the consequences of their own conduct is examined, as it concerns issues of personal autonomy and quality of life, even when that conduct poses a danger to health or is of a life-threatening nature. The salient issue was to determine whether a fair balance had been struck between the competing interests of the individual and of the community as a whole, with due regard to the State’s margin of appreciation. The applicants’ interest was described as “the freedom to opt, as a measure of last resort, for an untested treatment which may carry risks but which the applicants and their medical doctors consider appropriate to their circumstances, in an attempt to save their life”. The countervailing public interest was threefold: first, to protect patients from the risks of unauthorised treatment; second, to ensure the statutory framework governing the provision of unauthorised medicine was not circumvented; third, to ensure that the development of medicinal products would not be compromised by, for instance, diminished patient participation in clinical trials. The Court noted that generally matters of health-care policy fall within the Contracting States’ margin of appreciation. In addition, while the clear trend among the Contracting States is towards allowing the use of unauthorised medicinal products, there is no consensus on the precise manner in which this is regulated, nor is there a settled principle of law on the matter. With regard to the above, the Court concluded that the balance struck by the domestic law, irrespective of whether there might have been a fairer balance, did not exceed the wide margin of appreciation afforded to the State. Conclusion : no violation (four votes to three). Article 2 § 1: The Court took note of the fact that Bulgaria has regulations governing access to unauthorised medicinal products in cases where conventional forms of medical treatment appear insufficient. It was held that there is no positive obligation under Article   2 to frame those regulations in a particular way. Conclusion : no violation (five votes to two). Article 3: Suffering which flows from an illness may be covered by Article   3 where it is exacerbated by treatment for which the authorities can be held responsible. However the threshold in such situations is high because the alleged harm emanates not from the authorities but the illness. In this case, the complaint arose not from inadequate treatment, but from the denial of potentially life-saving treatment the safety and efficacy of which were still in doubt. The Court could not accept that such denial could be characterised as inhuman or degrading treatment. While the refusal may have caused the applicants mental suffering, it was not of a sufficient level of severity to fall within the scope of Article   3. Conclusion : no violation (five votes to two).   © Council of Europe/European Court of Human Rights This summary by the Registry does not bind the Court. Click here for the Case-Law Information Notes