EHRM, 13-11-2012, nr. 47039/11, nr. 358/12

In November 2010 the European Clinical Research Infrastructures Network published a survey of ‘compassionate use’ programmes in ten European countries: Austria, Denmark, France, Germany, Ireland, Italy, Spain, Sweden, Switzerland and the United Kingdom (‘Whitfield et al: Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries. Trials 2010 11:104.’). It found that with one exception (Hungary) the laws of all the countries surveyed made provision for compassionate use/expanded access programmes. However, it also showed that those programmes had more differences than similarities. Some countries were without formal regulatory systems, and, for those who had adopted rules, they varied in content and comprehensiveness. For instance, some countries allowed ‘compassionate use’ solely on a ‘named/individual patient’ basis. The contents and requirements of the application for permission also varied. The survey called for European Union legislation to be more explicit with regard to regulatory requirements, restrictions and responsibilities in that area.

On the basis of more recent material available to the Court in respect of twenty-nine Contracting States, it appears that twenty-two States (Austria, the Czech Republic, Croatia, Estonia, France, Finland, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, the Netherlands, Poland, Romania, Serbia, Slovenia, Spain, Turkey and the United Kingdom) have in place rules, often adopted quite recently, allowing access to unauthorised medicinal products outside clinical trials for certain patients, notably for those who are terminally ill. The matter appears to be regulated in both primary and delegated legislation. In addition, in two States (Sweden and Russia) access to such products appears to be possible despite the absence of specific rules. Five States (Albania, Cyprus, Moldova, Montenegro and Ukraine) appear not to have in place rules allowing access to unauthorised medicinal products outside clinical trials. However, in two of those (Albania and Ukraine) domestic law appears to contain somewhat unclear provisions, which could be interpreted as allowing access. At the same time, there is a variety of practices among States as regards the type of access provided and the procedure to be followed. For instance, it appears that in four States (Croatia, Lithuania, Poland and Romania), access to unauthorised medicinal products is possible only if those products have been authorised in another jurisdiction. Seven States appear to allow access only for individual patients, and fifteen States allow access for both individual patients and groups (or cohorts). The procedures for individuals and groups tend to vary, with the conditions attaching to group access being more stringent.

In the United States of America, regulations were issued in May 1987 laying down conditions under which promising new drugs that had not yet been licensed could be made available to persons with serious and life-threatening illnesses for whom no comparable or satisfactory alternative drug or treatment was available. Those regulations were revised and expanded in 2009. They are currently contained in the Code of Federal Regulations, Title 21, Part 312, Subpart I (Expanded Access to Investigational Drugs for Treatment Use), §§ 312.300–320, and make provision for an ‘expanded access’ programme, under which the Food and Drug Administration (‘the FDA’) may, under certain conditions, authorise the use of an ‘investigational new drug’ in respect of patients suffering from ‘a serious or immediately life-threatening disease or condition, [when] there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition’ (21 CFR 312.305(a)(1)). The general criteria governing the FDA's decision are whether ‘[t]he potential patient benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease or condition to be treated’ and whether ‘[p]roviding the investigational drug for the requested use will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the expanded access use or otherwise compromise the potential development of the expanded access use’ (21 CFR 312.305(a)(2) and (3)). The regulations contain separate provisions for individual patients, including for emergency use (21 CFR 312.310), intermediate-size patient populations (21 CFR 312.315), and widespread treatment use (21 CFR 312.320).

In Canada, sections C.08.010 and C.08.011 of the Food and Drug Regulations make provision for a ‘special access programme’ allowing medical practitioners to request access to drugs that are unavailable for sale in Canada for the treatment of patients with serious or life-threatening conditions on a compassionate or emergency basis when conventional treatments have failed, are unsuitable, or are unavailable.

In Australia, the Therapeutic Goods Administration of the Department of Health and Ageing runs a ‘special access scheme’, which allows, under certain conditions, the importation or supply of an unlicensed medicine for a single patient, on a case by case basis (section 18 of the Therapeutic Goods Act 1989 and Regulation 12A of the Therapeutic Goods Regulations 1990).

In the case of United States v. Rutherford, 442 U.S. 544 (1979), the United States Supreme Court unanimously dismissed a request by terminally ill cancer patients to enjoin the authorities from interfering with the distribution of an unlicensed drug. The court held that the statutory scheme governing drug licensing did not contain an implicit exemption for drugs intended for use by the terminally ill. In its view, the safety and effectiveness standards laid down in the legislation applied equally to such drugs, because the legislature could be regarded as intending to protect terminal patients from ineffectual or unsafe drugs. For such patients, as for anyone else, a drug was unsafe if its potential to cause death or physical injury was not offset by the possibility of therapeutic benefit. In relation to terminally ill people, unlicensed drugs carried a further risk, namely that the individuals concerned might eschew conventional therapy in favour of a drug with no demonstrable curative properties, with potentially irreversible consequences. In that connection the court noted, on the basis of expert evidence presented to it, that with diseases such as cancer it was often impossible to identify a patient as terminally ill other than in retrospect. It went on to say that acceptance of the proposition that statutory safety and efficacy standards have no relevance for terminal patients would be tantamount to denying the authorities' power to regulate any drugs, however toxic or ineffective, for such individuals, which would allow abusive marketing of many purportedly simple and painless cures. Lastly, the court observed that its ruling did not exclude all resort to experimental cancer drugs by patients for whom conventional therapy was inefficacious, because the statutory scheme exempted from pre-marketing approval drugs intended solely for investigative use if they satisfied certain pre-clinical testing and other criteria.

In the more recent case of Raich v. Gonzales, in a decision of 14 March 2007 (500 F.3d 850) the United States Court of Appeals for the Ninth Circuit held, inter alia, that, as things stood, there was no right under the due process clause of the United States Constitution to use medical marijuana on a physician's advice, to preserve bodily integrity, avoid intolerable pain, and preserve life, even when all other prescribed medications and remedies had failed.

In the case of Abigail Alliance for Better Access to Developmental Drugs et al. v. von Eschenbach et al., in a decision of 2 May 2006 (445 F.3d 470) a three-member panel of the United States Court of Appeals for the District of Columbia Circuit held, by two votes to one, that under the due process clause of the United States Constitution terminally ill patients had the right to decide whether to take un unlicensed drug that was in Phase 2 or Phase 3 clinical trials and that the producer was willing to make available. The court found that that right was deeply rooted in the traditional doctrines of self-defence and interference with rescue, and that federal regulation of the effectiveness of drugs was too recent and haphazard ‘to establish that the government has acquired title to [that] right by adverse possession’. The panel went on to say that that right was ‘implicit in the concept of ordered liberty’.

On an application by the FDA, the same court reheard the case en banc, and in a decision of 7 August 2007 (495 F.3d 695) held, by eight votes to two, that federal regulation of drugs was ‘consistent with [the] historical tradition of prohibiting the sale of unsafe drugs’. The ‘arguably limited’ history of efficacy regulation prior to 1962, when such regulation in the United States took its current shape, did not establish a fundamental right, because the legislature and the executive had ‘continually responded to new risks presented by an evolving technology’ and because the legislature had a ‘well-established power to regulate in response to scientific, mathematical, and medical advances’. The court went on to say that self-defence, the tort of interference with rescue, and the United States Supreme Court's ‘life or health of the mother’ abortion cases provided no support for a right to seek investigational drugs, because those doctrines protected only ‘necessary’ life-saving measures, whereas the claimants sought ‘access to drugs that [were] experimental and [had] not been shown to be safe, let alone effective at (or ‘necessary’ for) prolonging life’.

On 14 January 2008 the United States Supreme Court denied a petition for a writ of certiorari (552 U.S. 1159).

In the case of Abney et al. v. Amgen, Inc., 443 F.3d 540, on 29 March 2006 the United States Court of Appeals for the Sixth Circuit upheld a lower court's decision not to issue an injunction sought by the claimants, who were individuals involved in a clinical drug trial sponsored by the defendant, a drug manufacturer, to require the defendant to continue providing them with the drug, even though the clinical trial had come to an end.

In the case of Delisle v. Canada (Attorney General), 2006 FC 933, the Federal Court of Canada had to deal with applications for judicial review of decisions taken by the Canadian federal health authorities under the above-mentioned special access programme (see paragraph 57 above). The court held that in deciding to restrict access to a drug previously available under the programme the authorities had failed to strike a proper balance, because they had not taken due account of humanitarian or compassionate concerns. It referred the matter back to the authorities with instructions to weigh the ‘valid objectives of public policy against the humanitarian factor’. The judgment was not appealed against, and in 2008 the case was settled, with the authorities agreeing to follow the court's recommendations.

In the case of B (a minor), R. (on the application of) v. Cambridge Health Authority [1995] EWCA Civ 43 (10 March 1995), the Court of Appeal held that the courts could not disturb a properly reasoned decision by the competent health authorities not to fund a round of experimental treatment for a terminally ill child. The Master of the Rolls, as he then was, Sir Thomas Bingham, made two general comments. He firstly pointed out that the case involved the life of a young patient, which was a fact which had to dominate all consideration of all aspects of the case, because British society was one in which a very high value was put on human life and no decision affecting human life could be regarded with other than the greatest seriousness. He secondly observed that the courts were not arbiters as to the merits of cases of that kind, because if they expressed opinions as to the likelihood of the effectiveness of medical treatment, or as to the merits of medical judgment, they would be straying far from their domain. He went on to say that difficult and agonising judgments had to be made as to how a limited budget was best allocated to the maximum advantage of the maximum number of patients. That was not a judgment which a court could make.

In the case of Simms v Simms and an NHS Trust [2002] EWHC 2734 (Fam) (11 December 2002), the parents of two teenagers suffering from variant Creutzfeldt-Jakob disease sought judicial declarations that their children could receive an experimental treatment which research on mice had shown could possibly inhibit the advance of their terminal condition. The High Court of Justice (Family Division) allowed the applications, holding, among other things, that the lack of an alternative treatment for the incurable disease meant that it was reasonable to use an experimental treatment that presented no significant risk to the patient. The President of the Family Division, Dame Elizabeth Butler-Sloss, observed that the treatment was an untried one, and that until then there had been no validation of experimental work done abroad. However, she went on to say that if one waited for full certainty in experimental treatments, no innovative work such as the use of penicillin or heart transplant surgery would ever have been attempted. Referring to, inter alia, Articles 2 and 8 of the Convention and ‘a very strong presumption in favour of a course of action which will prolong life’, and having regard to the patients' prospects with and without treatment and the fact that no alternative treatment was available, she concluded that it was in their best interest that the treatment should be carried out. In reaching that conclusion, she also considered the wishes and feelings of the families, finding that their advocacy of treatment ‘should carry considerable weight’.

The Government submitted that the applicants had failed to exhaust domestic remedies in respect of their complaints under Articles 2, 3 and 8 of the Convention, because they had not sought judicial review of the decisions denying them the opportunity to use MBVax Coley Fluid. They said that they were not aware of cases in which the Bulgarian courts had dealt with the ‘compassionate use’ of unauthorised medicinal products, and pointed out that those courts were not competent to declare what type of medical treatment should be applied in a particular case. It was nevertheless possible to refer the question raised by the case to a domestic court, and rely on arguments based on the Convention or on European Union law, inasmuch as the Convention had been incorporated in Bulgarian law and the relevant rules of European Union law were directly applicable. The Government went on to draw attention to the conditions under which patients could seek access to unauthorised medicinal products, and expressed the view that in the applicants' cases those conditions had not been met.

In their additional observations on this point, the Government again argued that the applicants could have sought judicial review of the decisions denying them the opportunity to use MBVax Coley Fluid, or of the regulations on which those decisions had been based. In such proceedings the applicants could have relied on the Convention: the Bulgarian courts had on a number of occasions set aside administrative decisions or struck down regulations as inconsistent with the Convention or European Union law. The Government conceded that they could not speculate as to the outcome of such proceedings, but emphasised that in their view neither the decisions nor the regulations in issue were in breach of the Medicinal Products in Human Medicine Act 2007 or of European Union law. The Act itself was fully consistent with the relevant European Union law, and therefore not in breach of the Convention. Regulations no. 2 and Regulations no. 10 both required that the medicinal product in issue be authorised in another country, which was not the applicants' case. However, this was fully in line with Article 83 of Regulation (EC) no. 726/2004, which required that the product concerned either be the subject of an application for marketing authorisation or be undergoing clinical trials, which was again not the applicants' case.

The applicants replied that an application for judicial review of the decisions of the Director of the Medicines Executive Agency was not an effective remedy, for three reasons. First, in view of the wording of the applicable regulations, it would not have had any reasonable prospects of success. Secondly, its examination would have taken too long. Thirdly, the national courts would not have been in a position to obtain impartial expert opinions. An application for judicial review of the regulations themselves was not an effective remedy either, because such proceedings could have resulted only in the regulations being struck down, not their modification.

In their additional observations on this point, the applicants again argued that an application for judicial review of the decisions of the Medicines Executive Agency would not have had a reasonable prospect of success, for several reasons. First, the requirements laid down in the applicable regulations were vague. Secondly, because of the absence from Regulations no. 2 of provisions dealing with the possibility of judicial review, and of any case-law under that regulation or under the regulations that preceded it, it was unclear which would be the competent court, and even whether the courts would consider the Agency's pronouncements to be administrative decisions subject to judicial review. Thirdly, there was no guarantee that the applicants would be able to obtain unbiased expert opinions. The impossibility of securing objective opinions by medical experts was a systemic problem in Bulgaria, as illustrated by a number of cases concerning medical negligence and reports in the press. Fourthly, all those procedural uncertainties made it very likely that any legal challenges brought by the applicants would not have been determined before their deaths. In support of that assertion the applicants pointed to several cases in which proceedings brought by patients in connection with the State's failure to provide them with medicines had been marred by delays and had dragged on for years; in some of those cases the claimants had died long before the courts had dealt with their claims. As regards proceedings concerning challenges to statutory instruments, their average duration was two years. Fifthly, the regulations in issue were not contrary to Bulgarian law, and thus could be challenged only on Convention grounds. However, as was evident from their case-law, the Bulgarian courts were likely to take into account Convention-related arguments only if they were based on clear and consistent case-law of this Court in relation to Bulgaria, which was not the case. There was an abundance of Bulgarian judicial decisions which had given short shrift to Convention-based arguments. In sum, the prospect of a national court providing redress to the applicants before their deaths was illusory. Nor could they realistically hope to obtain from the authorities a different decision under newly issued Regulations no. 10, which likewise required that the medicinal product in issue be authorised in another country.

Concerning the possibility of seeking judicial review of the decisions of the Director of the Medicines Executive Agency, the Court observes that at the relevant time the impossibility for the applicants to obtain access to the unauthorised medicinal product that they wished to have administered flowed directly from the wording of Regulation 2 of Regulations no. 2 of 10 January 2001, preceded and superseded by similar texts (see paragraphs 25 and 30 above). Under the express terms of that Regulation, and of the Regulations that preceded and superseded it, medicinal products which had not been authorised in another country — which was the case here — could not exceptionally be permitted for use in Bulgaria (see paragraphs 26, 27 and 31 above). It has not been disputed that in his decisions in respect of each of the applicants the Agency's Director applied that provision correctly; this is confirmed by the opinion expressed by the Ombudsman of the Republic (see paragraph 16 above) and by the Government's submissions (see, mutatis mutandis, Immobiliare Saffi v. Italy [GC], no. 22774/93, § 42 in limine, ECHR 1999-V; Urbárska Obec Trenčianske Biskupice v. Slovakia, no. 74258/01, § 86, 27 November 2007; Ognyan Asenov v. Bulgaria, no. 38157/04, § 32, 17 February 2011; and Valkov and Others v. Bulgaria, nos. 2033/04, 19125/04, 19475/04, 19490/04, 19495/04, 19497/04, 24729/04, 171/05 and 2041/05, § 72, 25 October 2011). As regards the possibility of relying on the direct application of European Union law, the Court takes note of the examples cited by the Government in which the Bulgarian courts relied on that law to set aside administrative decisions (see paragraphs 38 and 39 above). However, the Court observes that, as evident from the terms of its relevant provisions, European Union law enables, but does not require, the Union's member States to allow ‘compassionate use’ of unauthorised medicinal products (see paragraphs 45–51 above). There is therefore no basis on which to argue that the Director's decisions were in breach of that law. Lastly, the Court is not persuaded that the applicants could have successfully challenged those decisions on the strength of Convention-based arguments. It takes note of the examples cited by the Government in which the Bulgarian courts relied on the Convention and the Court's case-law to set aside administrative decisions, or to hold that they had jurisdiction to review such decisions (see paragraphs 39 and 40 above). However, it cannot be overlooked that in all those examples the Bulgarian courts based their decisions on established case-law of this Court, whereas there is to date no firm basis in the Court's case-law on which to hold that impossibility of access to unauthorised medicinal products on a ‘compassionate use’ basis is in breach of the Convention. The issue is novel and not free from doubt. The Court is mindful that its role is intended to be subsidiary to that of national systems safeguarding human rights, and that the national courts should normally have the initial opportunity to determine whether domestic law is compatible with the Convention (see Burden v. the United Kingdom [GC], no. 13378/05, § 42, ECHR 2008-…). However, it considers that the examples cited by the Government cannot lead to the conclusion that in the specific circumstances of this case a domestic legal challenge based on Convention-related arguments would have had a reasonable prospect of success (see, mutatis mutandis, Slavgorodski v. Estonia (dec.), no. 37043/97, 9 March 1999, and Odièvre v. France [GC], no. 42326/98, §§ 21 and 23, ECHR 2003-III). The Court also notes that, by the Government's own admission, the Bulgarian courts have never dealt with the use of unauthorised medicinal products; it appears that since 1995, when the Minister of Health laid down regulations on this matter for the first time, no cases have been reported under those regulations (see paragraph 34 above).

The burden of proof is on the Government claiming non-exhaustion to satisfy the Court that the remedy to which they refer offered a reasonable prospect of success (see, as a recent authority, Nada v. Switzerland [GC], no. 10593/08, § 141, 12 September 2012). In view of the above reasons, the Court is not satisfied that an application for judicial review of the decisions of the Director of the Medicines Executive Agency can be regarded as offering such a prospect.

Nor is the Court persuaded that the applicants would have been able successfully to seek judicial review of the regulations on which those decisions were based. Those regulations do not appear to run counter to a higher-ranking statutory or constitutional rule, or to a rule of European Union law. There is thus no basis in domestic law or European Union law for a challenge to them. The Court is not persuaded that the applicants could have successfully challenged the regulations on the strength of Convention-based arguments either. It is true that the Supreme Administrative Court has previously struck down statutory instruments on the ground that they were contrary to the Convention, when the discrepancy between the two was clear (see the decisions cited in paragraph 37 above, and in Bochev v. Bulgaria, no. 73481/01, § 45, 13 November 2008). However, in cases where the incompatibility was not immediately apparent, it has refused to do so (see the decisions cited in Ponomaryovi v. Bulgaria, no. 5335/05, §§ 23–24, ECHR 2011-…). As already noted, in the present case it is far from clear that the impossibility of access to unauthorised medicinal products on a ‘compassionate use’ basis is in breach of the Convention.

In view of these conclusions, the Court does not find it necessary to enquire whether the effectiveness of the remedy proposed by the Government would have been hindered by uncertainties as to whether a legal challenge to the Director's decisions or the underlying regulations would have been heard on the merits, or by the alleged impossibility of obtaining impartial expert opinions, or by the allegedly limited powers of the Supreme Administrative Court in proceedings for review of statutory instruments. Nor is it necessary to speculate as to whether such judicial review proceedings would have lasted so long as to render a ruling in the applicants' favour devoid of practical purpose.

The Government's objection must therefore be rejected.

The Government pointed out that Bulgarian law made provision for ‘compassionate use’ of unauthorised medicinal products. However, they emphasised that such products carried serious risks, which required them to be carefully regulated. The State was entitled to refuse permission for the use of an unauthorised medicinal product, and this did not breach the right to life, but safeguarded it. The positive obligations under Article 2 of the Convention had limits, and could not exceed what was reasonable. The applicants had been given conventional medical treatment. There was no further duty to allow them to use a product which was not authorised in any member State of the European Union or had not been subjected to a clinical trial. A State could not be obliged to make available all possible drugs, let alone products whose contents and origins were not clearly known, and which had not been authorised in developed countries with strong health care systems. The product at issue did not comply with the requirements for ‘compassionate use’ under Article 83 of Regulation (EC) no. 726/2004. If its producer met the applicable requirements, the authorities could envisage allowing its use in the future. In that sense, the applicants were not left with no hope at all.

The applicants submitted that the refusal to allow them to use the product had been in breach of their right to life. They highlighted the similarities and differences between their case and previous cases in which the Court had dealt with complaints under Article 2 of the Convention in relation to health care. They argued that, properly framed, the issue in their case was whether the State had taken appropriate steps to safeguard the lives of those under its jurisdiction. In their view it had not, because the rules governing ‘compassionate use’ were not adequate, in that they did not allow the authorities to have regard to specific circumstances. All individuals in Bulgaria who, like the applicants, had cancer which was terminal and which was no longer responding to conventional treatment, were being denied access to experimental medicinal products. In the applicants' case, this was not justified by lack of budgetary resources, because the company which had developed the product was willing to provide it free of charge. There were indications that the condition of some cancer patients had improved as a result of its use. This had given the applicants hope that it might help them as well.

The Government drew attention to the minimum threshold bringing Article 3 of the Convention into play, which in their view had not been reached, and to the limited extent of the State's positive obligations under that Article. They pointed out that there had been no intention to deny the applicants access to safe medicinal products. The experimental product that they wished to use had not been authorised in any country, and had not undergone clinical trials. Its safety and efficacy had not been established. Not being given the opportunity to use it could not therefore be regarded as inhuman treatment. On the contrary, its use, which would have amounted to a medical experiment, might have resulted in a breach of Article 3.

The applicants submitted that they had been forced to await their deaths in spite of being aware of the existence of an experimental product which might improve their health and prolong their lives. Those of them who had died had had to endure pain and suffering before their death, in the knowledge that the use of the product in other countries had in some cases even led to complete remission from the disease.

The Government submitted that any interference with the applicants' rights under Article 8 of the Convention had been lawful and necessary. The refusals to allow them to use the experimental product had been reasoned, made by an independent authority, and based on legal provisions which were fully in line with European Union law. It could therefore be presumed that they were compliant with the Convention. Those provisions, which took into account the need to strike a balance between the public interest and personal autonomy, sought to protect the health and life of those concerned by preventing abuses and the risks accompanying the use of untested products. For that purpose they had laid down certain conditions, which in the applicants' cases had not been met. That regulatory arrangement could not be described as a blanket prohibition on the ‘compassionate use’ of unauthorised medicinal products.

The applicants highlighted the similarities and differences between their case and previous cases in which the Court had dealt with similar issues under Article 8 of the Convention. They pointed out that they were not trying to derive from that provision a right to die, but on the contrary a right to try to prolong life and avert death. The refusals to allow them access to an experimental medicinal product which might help them do so amounted to interference with their rights under that Article. The manner in which a person chose to live, even if that choice could entail harmful consequences, was part of that person's private life. The refusals had been of a blanket nature, not taking into account the specifics of each case. They had been based on inadequate legal provisions which did not permit an individualised assessment, and did not correspond to a pressing social need. They had not been intended to protect the applicants' lives, because all of them were terminally ill and, without recourse to some new medicinal product, had only a short span of life left. In that connection, it had to be borne in mind that the exception sought would simply have given the applicants a chance to prolong their lives, and would not have shielded anyone else from criminal liability. It might have helped them avert suffering and death, as had happened with some patients in other countries.

The Court's task in cases arising from individual applications is not to review domestic law in the abstract, but to examine the manner in which that law has been applied to the applicants (see, among other authorities, McCann and Others v. the United Kingdom, 27 September 1995, § 153, Series A no. 324; Pham Hoang v. France, 25 September 1992, § 33, Series A no. 243; Sommerfeld v. Germany [GC], no. 31871/96, § 86, ECHR 2003-VIII; and S.H. and Others v. Austria [GC], no. 57813/00, § 92, ECHR 2011-…). The Court must also confine its attention, as far as possible, to the particular circumstances of the case before it (see, among other authorities, Wettstein v. Switzerland, no. 33958/96, § 41, ECHR 2000-XII, and Sommerfeld, cited above, § 86). It is therefore not called upon in the present case to pass judgment on the system of rules governing access to unauthorised medicinal products in Bulgaria, or to decide whether refusal of access to medicinal products is in principle compatible with the Convention. Moreover, the Court is not competent to express an opinion as to the suitability of a particular medical treatment. Lastly, the Court does not have to establish whether the product that the applicants wished to use met the requirements of European Union law, and in particular the requirement of Article 83 § 2 of Regulation (EC) no. 726/2004 to be undergoing clinical trials (see paragraphs 10, 45 and 50 above); the Court is competent only to apply the Convention, and it is not its task to review compliance with other international instruments (see Di Giovine v. Portugal (dec.), no. 39912/98, 31 August 1999; Hermida Paz v. Spain (dec.), no. 4160/02, 28 January 2003; Somogyi v. Italy, no. 67972/01, § 62, ECHR 2004-IV; Calheiros Lopes and Others v. Portugal (dec.), no. 69338/01, 3 June 2004; and Böheim v. Italy (dec.), no. 35666/05, 22 May 2007). In the present case, the Court must determine only whether the refusals to allow the applicants access to the product at issue were compatible with their Convention rights.

The first sentence of Article 2 enjoins the State not only to refrain from the intentional and unlawful taking of life, but also to take appropriate steps to safeguard the lives of those within its jurisdiction (see, among other authorities, Calvelli and Ciglio v. Italy [GC], no. 32967/96, § 48, ECHR 2002-I, and Wiater v. Poland (dec.), no. 42290/08, § 33, 15 May 2012). The Court has previously held that it cannot be excluded that acts and omissions of the authorities in the field of health care policy may in some circumstances engage the State's responsibility under Article 2 (see Powell v. the United Kingdom (dec.), no. 45305/99, ECHR 2000-V; Nitecki v. Poland (dec.), no. 65653/01, 21 March 2002; Trzepałko v. Poland (dec.), no. 25124/09, § 23, 13 September 2011; and Wiater, cited above, § 34). It has also held that, with respect to the scope of the State's positive obligations in the provision of health care, an issue may arise under Article 2 where it is shown that the authorities have put an individual's life at risk through the refusal of health care which they have undertaken to make available to the general population (see Cyprus v. Turkey [GC], no. 25781/94, § 219, ECHR 2001-IV; Nitecki, cited above; Pentiacova and Others v. Moldova (dec.), no. 14462/03, ECHR 2005-I; Gheorghe v. Romania (dec.), no. 19215/04, 22 September 2005; and Wiater, cited above, § 35).

In the present case, it is not being argued that the applicants have been refused health care which is otherwise generally available in Bulgaria. Nor are the applicants suggesting that the State should pay for a particular form of conventional treatment because they are unable to meet its costs (contrast Nitecki; Pentiacova and Others; Gheorghe; and Wiater, all cited above). The applicants' claim is rather that, because conventional treatments did not work in their cases, domestic law should be framed in such a way as to entitle them, exceptionally, to have access to an experimental and yet untested product that would be provided free of charge by the company which is developing it.

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).

There has therefore been no violation of Article 2 of the Convention.

Article 3 of the Convention enshrines one of the most fundamental values of a democratic society. It prohibits in absolute terms torture and inhuman or degrading treatment or punishment. However, to fall under that provision a given form of treatment must attain a minimum level of severity. The assessment of this minimum level is relative. It depends on all the circumstances of the case, such as the duration of the treatment, its physical and mental effects and, in some cases, the sex, age and state of health of the victim (see, as a recent authority, A, B and C v. Ireland [GC], no. 25579/05, § 164, ECHR 2010-…). In considering whether a treatment is ‘degrading’, the Court will have regard to whether its object was to humiliate and debase the person concerned and whether, as far as the consequences are concerned, it adversely affected his or her personality in a manner incompatible with Article 3 (see, among other auhtorities, Wainwright v. the United Kingdom, no. 12350/04, § 41, ECHR 2006-X).

An examination of the Court's case-law shows that Article 3 has been most commonly applied in contexts in which the risk of being subjected to a proscribed form of treatment has emanated from intentionally inflicted acts of State agents or public authorities. It may be described in general terms as imposing a primarily negative obligation on States to refrain from inflicting serious harm on persons within their jurisdiction. However, in view of the fundamental importance of Article 3, the Court has reserved to itself sufficient flexibility to address its application in other situations (see Pretty v. the United Kingdom, no. 2346/02, § 50, ECHR 2002-III). For instance, suffering which flows from a naturally occurring illness may be covered by Article 3 where it is, or risks being, exacerbated by treatment stemming from measures for which the authorities can be held responsible (see N. v. the United Kingdom [GC], no. 26565/05, § 29, ECHR 2008-…). However, the threshold in such situations is high, because the alleged harm emanates not from acts or omissions of the authorities but from the illness itself (ibid., § 43).

In the present case, there is no complaint that the applicants have not received adequate medical treatment. It appears that all of them have benefited from such treatment, which has sadly proved insufficient to treat their medical conditions. Their situation is therefore not comparable to those of persons in custody who complain of a lack of medical treatment (see, for example, Keenan v. the United Kingdom, no. 27229/95, §§ 109-16, ECHR 2001-III; McGlinchey and Others v. the United Kingdom, no. 50390/99, §§ 47–58, ECHR 2003-V; and Sławomir Musiał v. Poland, no. 28300/06, §§ 85–98, 20 January 2009), seriously ill persons who would be unable to obtain treatment if removed to a country which lacks adequate medical facilities (see N. v. the United Kingdom, cited above, §§ 32–51, and the cases cited therein), or persons in a vulnerable situation who have, as a result of rank indifference on the part of health care professionals, been denied access to otherwise available diagnostic services to which they were entitled as a matter of law (see R.R. v. Poland, no. 27617/04, §§ 148-62, 26 May 2011).

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.

Whether the refusals unduly interfered with the applicants' right to respect for their physical integrity is a point which the Court will examine below by reference to Article 8 of the Convention (see, mutatis mutandis, Tysiąc v. Poland, no. 5410/03, § 66, ECHR 2007-I, and L. v. Lithuania, no. 27527/03, § 47, ECHR 2007-IV).

There has therefore been no violation of Article 3 of the Convention.