Hristozov and Others v. Bulgaria

Application Nos. 47039/11 and 358/12
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The applicants had terminal cancer, and all had either tried forms of conventional medicine (e.g. surgery, chemotherapy, radiotherapy and hormone therapy) or obtained a medical opinion that these treatments would not work for their illness.

They then approached a private client in Sofia where they were told about an experimental anti-cancer product in development by a Canadian company. It had not been authorized in any country but had been allowed for compassionate use in several countries. The company which developed the drug said that, as part of its pre-clinical development of the product, it would be willing to provide the product for free in return for patient data. The Government decided that it would not allow the provision of this medicine because Bulgarian law did not make provision for use of unauthorized medicines outside of clinical trials, and compassionate use in Bulgaria was not possible. The Government also stated that under the Law of the European Union, there was no obligation to have a harmonized approach in this area. The Ministry of Health agreed with the Government’s decision.

The parties were in dispute as to whether the drug had recently started undergoing clinical trials –the applicants argued that it had done so in Germany but the Government claimed that it was not acceptable to establish the existence of clinical trials in Germany through websites in the USA. The applicants also asserted that the drug had been used with some success on patients in clinics in Germany, Ireland, the UK and the USA.

The applicants alleged that the Government’s refusal to provide them with the experimental anti-cancer product breached the following provisions of the European Convention of Human Rights (“Convention”): Article 2 (right to life) Article 3 (prohibition on torture), and Article 8 (right to respect for private and family life).

The Court held that  there had been no violation of the Convention, and thus the Bulgarian authorities could refuse the applicants the ability to use the experimental cancer treatment.

Regarding Article 2, the Court reasoned that Bulgarian law allowed the use of unauthorized medicinal products for “compassionate use.” The court stated that the particular medicinal product in this case did not meet the requirements to be considered for “compassionate use” under Article 83 of Regulation (EC) no. 726/2004.

Regarding Article 3, according to the court, a sufficient level of severity to be classed as “inhuman treatment” was not reached by the authorities’ refusal. In addition, the court emphasized that Article 3 involves no obligation of the Contracting States to emulate the levels of health care available in various other countries. It is very much a domestic decision. The Court did not accept that the refusal of treatment was humiliating or debasing to the applicants.

Regarding Article 8, the main issue was whether a fair balance between competing interests of individuals and the community as a whole was struck. The Court stated that, while the applicants had a right to medical treatment for their illnesses, including experimental treatment, the denial of the experimental drugs protected the interests of the community because the drugs’ safety, efficacy, and quality were still in question.

The dissent argued that there had been a violation of Article 8 because the use of available extraordinary medication, as in this case – and to make an informed and free choice in this connection- falls within the ambit of one’s private life. In this case, no financial considerations or imperatives were involved and the applicants were not calling upon the State to pay for this treatment.

“It is true that the positive obligations under Article 2 may include the duty to put in place an appropriate legal framework, for instance regulations compelling hospitals to adopt appropriate measures for the protection of their patients’ lives (see Calvelli and Ciglio, cited above, § 49), or regulations governing dangerous industrial activities (see Öneryıldız v. Turkey [GC], no. 48939/99, § 90, ECHR 2004-XII). Nevertheless, it cannot be said that Bulgaria does not have in place regulations governing access to unauthorised medicinal products in cases where conventional forms of medical treatment appear insufficient. Such regulations exist and have recently been updated (see paragraphs 23-32 above). The applicants rather take issue with the terms of those regulations, arguing that they are overly restrictive. However, in the Court’s view Article 2 of the Convention cannot be interpreted as requiring access to unauthorised medicinal products for the terminally ill to be regulated in a particular way. It should be noted in this connection that in the European Union this matter remains within the competence of the member States (see paragraphs 45-51 above), and that the Contracting States deal differently with the conditions and manner in which access to unauthorised medicinal products is provided (see paragraphs 54-55 above).” Para. 108.

“The applicants rather claim that the refusal by the authorities to allow them access to an experimental product which, according to them, was potentially life-saving, amounted to inhuman and degrading treatment for which the State was responsible, as it thereby failed to protect them from the suffering resulting from the final stages of their illness. However, as in Pretty (cited above, § 54), the Court considers that this claim puts an extended construction on the concept of inhuman or degrading treatment that it cannot accept. It cannot be said that by refusing the applicants access to a product – even if potentially life-saving – whose safety and efficacy are still in doubt, the authorities directly added to the applicants’ physical suffering. It is true that the refusals, inasmuch as they prevented the applicants from resorting to a product which they believed might improve their chances of healing and survival, caused them mental suffering, especially in view of the fact that the product appears to be available on an exceptional basis in other countries. However, the Court does not consider that the authorities’ refusal reached a sufficient level of severity to be characterised as inhuman treatment (see, mutatis mutandis, A, B and C v. Ireland, cited above, §§ 163-64). It notes in this connection that Article 3 does not place an obligation on the Contracting States to alleviate the disparities between the levels of health care available in various countries (see, mutatis mutandis, N. v. the United Kingdom, cited above, § 44). Lastly, the Court does not consider that the refusals can be regarded as humiliating or debasing the applicants.” Para. 113.

“The countervailing public interest in regulating the access of terminally ill patients such as the applicants to experimental products appears to be based on three premises. Firstly, to protect them, in view of their vulnerable state and the lack of clear data on the potential risks and benefits of experimental treatments, against a course of action which may prove harmful to their own health and life, their terminal condition notwithstanding (see, mutatis mutandis, Haas, cited above, § 54). The Court notes in this connection that it has emphasised, albeit in a different context, the importance of informed consent to medical procedures (see V.C. v. Slovakia, no. 18968/07, §§ 107-17 and 152, ECHR 2011-... (extracts), and N.B. v. Slovakia, no. 29518/10, §§ 76-78 and 96, 12 June 2012). Secondly, to ensure that the prohibition laid down in section 7(1) of the Medicinal Products in Human Medicine Act 2007 (see paragraph 22 above) against the production, importation, trade in, advertisement, or use for medical treatment, prophylaxis or diagnostics of products which have not been granted authorisation under the appropriate regulatory channels is not diluted or circumvented. Thirdly, to ensure that the development of new medicinal products is not compromised by, for instance, diminished patient participation in clinical trials. All those interests are related to the rights guaranteed under Articles 2, 3 and 8 the Convention, the first very specifically and the second and third more generally. Moreover, balancing them against the applicants’ interest touches upon complex ethical and risk-assessment issues, against a background of fast-moving medical and scientific developments.” Para. 122.

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