HRISTOZOV AND OTHERS v. BULGARIA - 47039/11 358/12 - HEJUD [2012] ECHR 1914 (13 November 2012)

PARTLY DISSENTING OPINION OF JUDGE KALAYDJIEVA

The present case raises important issues concerning the interpretation of the legitimate purposes pursued by State regulation of public health and pharmaceutical services and its limits under the Convention. I regret being unable to join the opposing conclusions of my learned colleagues as to the principles governing this important sphere.

I am not convinced that a comparison between the applicants’ situation and those obtaining in the cases of Pretty v. the United Kingdom (no. 2346/02, ECHR 2002-III), Evans v. the United Kingdom ([GC], no. 6339/05, ECHR 2007-I) and S.H. and Others v. Austria ([GC], no. 57813/00, ECHR 2011-...) is appropriate for the purposes of the analysis of the circumstances in the present case. The applicants in the above-mentioned three cases sought to secure increased positive involvement by the authorities - including the enactment of new legislation - to facilitate the pursuit of their private lives. In their cases this involvement inevitably risked conflicts with potentially competing or already protected individual rights or public interests. By contrast, the applicants in the present case cannot be said to have requested the establishment of any further positive obligations for the authorities beyond the ones already laid down in the context of the State’s regulatory functions. Furthermore, it is questionable whether the exercise of these functions in the present case risked any conflict with public welfare or with any other rights or interests - as was apparently assumed to be the case by the majority (see below).

It appears appropriate to mention that the situation of the applicants is not necessarily different from that of any other patient affected by a disease which is regrettably not curable with standard products available for market distribution. While for centuries human medicine has been concerned with the treatment of individual patients under the responsibility of medical doctors, State authorities undertook to share this responsibility through stricter regulations only fifty years ago. In this regard, the finding that “there is now a clear trend in the Contracting States towards allowing, under exceptional conditions, the use of unauthorised medicinal products” (see paragraph 123 of the judgment) does not seem accurately to reflect the historical development of medical and pharmaceutical services. Furthermore, the conclusion that “[i]t is not contrary to the requirements of [Article 8] to regulate [these] important aspects of private life without making provision for the weighing of competing interests in the circumstances of each individual case” (see paragraph 126 of the judgment) appears inappropriate for the future development of the recent undertaking to ensure safe progress in that it “tilts the balance between potential therapeutic benefit and medicine risk avoidance decisively in favour” of the status quo.

Indeed, a proper definition of the principles governing the State’s regulatory functions in human medicine may not be achieved by using the safety-valve of the “wide margin of appreciation” before analysing the scope and purposes of the positive obligations undertaken in ensuring safe progress in this field and the extent to which the operation of the established mechanisms met those obligations. These issues concern the compatibility of the impugned refusals with the legitimate aims pursued by State regulation of medical and pharmaceutical services and I regret the Court’s failure to deal with the issue of lawfulness before turning to the doctrine of the margin of appreciation - an instrument introduced by this very Court to facilitate the assessment of the necessity and proportionality of interferences with the free exercise of the rights and freedoms guaranteed by the Convention and not as a general waiver of the duty of States to respect them as required by Article 1 of the Convention.

The reasoning of the majority leaves the impression that for the first time the phrase “margin of appreciation” has been interpreted not in the sense of an estimation and evaluation of merit, but as an instrument to justify the national authorities’ complete failure to demonstrate any appreciation whatsoever of the applicants’ right to personal life, or to strike the requisite balance between this right and the presumed counterbalancing public interests. It is a separate issue whether the interests of individual patients and those of the community in ensuring safe progress in improved medical and pharmaceutical services may indeed be seen as competing (see paragraph 117 of the judgment), or as giving rise to any potential conflict (see paragraph 125 of the judgment). I fail to see any conflict between the public and the individual interest in ensuring the safe progress of medical treatment. In any event, the existence of such a conflict in the present case has neither been demonstrated nor alleged.

This dangerous use by the Court of its own motion of the instrument of “wide margin of appreciation” can easily be interpreted as granting the executive authorities unwarranted power to impose their own decisions as to the appropriate treatment of any patient, or the unjustified restriction of such treatment to the use of a limited pre-defined list of products - disregarding equally the opinion of medical professionals and the personal wishes of patients. I am far from convinced that any individual’s medical treatment may be seen to necessarily (not to mention exclusively) fall within the executive authorities’ margin of appreciation. In my understanding, such a result renders the exercise of the medical profession and the notion of informed consent (which should be one aspect of the State’s regulatory functions) redundant. This goes far beyond the legitimate aims pursued in the establishment of regulatory mechanisms.

It is true that the national regulations governing the applicants’ situation “do not appear to run counter to a higher-ranking statutory or constitutional rule, or to a rule of European Union law” (see paragraph 88 of the judgment) in allowing for exceptions to the general rule that only authorised medicinal products may be “produced, imported, traded ... or used for medical treatment” (see paragraphs 22-23 of the judgment). However, in this regard the State authorities have a margin of appreciation in deciding whether or not to undertake regulatory functions in relation to individual patients’ treatment (see paragraphs 45, 49, 50, 51 and 54-55). The extent to which the implementation of the national secondary legislation fulfilled the intended purposes of such functions is highly questionable. The fact remains that these regulations did not require any analysis or consultation for the purposes of quality control of the product requested and the risk/benefit test normally involved in the process of authorisation. In this regard, these regulations served to restrict the meeting of individual needs concerning the “exceptional use of unauthorised products” only to “already authorised” ones (see paragraph 125 of the judgment), thus rendering meaningless the “exceptional” nature of such permission. On the other hand, the same regulations relieved the national authority “in charge of supervising the quality, safety and efficacy of medicinal products” (see paragraph 14 of the judgment) of any duty to carry out such supervision, by redirecting this duty to other countries’ regulatory bodies, thus rendering its own functions redundant.

The facts of the present case illustrate that a failure to discharge the functions of “supervising the quality, safety and efficacy of medicinal products” leads automatically to unjustified restrictions of medical treatment, seeing that “unlike the situation obtaining in other European countries, in Bulgaria the compassionate use of unauthorised products was not possible” (see paragraph 14 of the judgment). The Court has failed to analyse whether the limited access of Bulgarian patients to allegedly useful products available elsewhere may be justified and, if so, on what grounds.

Far from wishing to see my country become an arena for dangerous or degrading medical experiments with human beings, I am prepared to agree that there is no established positive obligation on the State authorities to ensure the access of individual patients to products for medicinal purposes which have not been tested for their quality, efficacy and safety - as concluded by the majority. If any positive obligations exist with regard to individual patients, they concern the duty to respect their rights and to ensure their properly informed consent to proposed medical treatment.

However, where the authorities have undertaken the obligation to put in place regulatory mechanisms to control the practice of medical and pharmaceutical professions so as to meet the public and individual interests regarding safety, this undertaking requires them to assume relevant and appropriate functions capable of meeting this obligation, rather than substituting the undertaking with a discretion to refuse treatment in the absence of any justification. I am not prepared to accept that fifty years after the thalidomide tragedy, which triggered the necessity of stricter State regulation, this responsibility may be interpreted as involving some “wide margin of appreciation” as to how to avoid discharging it. Unlike the dissenting minority, I consider that this is a question of the lawfulness of the purpose of the restrictions, which appear to have been imposed instead of the promised proactive functions in the interests of safe medical services, and not a question of the authorities’ “margin of appreciation” in striking the requisite balance between the allegedly competing public and individual interests in obtaining such services. I also fail to agree with the opinion of the minority that “the public interest identified by the majority in paragraph 122 of the judgment may be usefully served by more narrowly tailored requirements” (see paragraph 8 of the dissenting opinion of Judge De Gaetano joined by Judge Vučinić) rather than by the effective exercise of the responsibility undertaken, while in fact “there are no major factors of public interest to weigh against the interest of the applicants” (see paragraph 9). No specific considerations in this regard were submitted before the Court.

Turning to the specific substantive issue of the presumed risk involved in “unauthorised”, “untested” or “experimental” products, it is impossible not to share the view that no particular dangers calling for the applicants’ protection were ever indicated or alleged, nor were they informed of such dangers in the course of the brief examination of their requests. In this regard, it cannot be overlooked that the applicants’ condition rendered them eligible for the compassionate use of morphine - a substance whose distribution is not only unauthorised, but also criminalised. It was not argued that the new product to which the applicants sought access was more dangerous or less effective than morphine. I mention this fact as it cannot be overlooked that the State’s functions relating to the authorisation of medicinal products involve a distinction of different levels of authorisation for the use of medicinal products for different purposes. I will not make any contribution to pharmaceutical or medical science in noting that some products, including poisons, are never authorised for market distribution, whereas their use is legitimate and authorised for specific medical purposes. Thus, even the thalidomide tragedy, which triggered the introduction of stricter controls on the distribution of medicinal products on the market, did not result in the “prohibition” of that product, but in its limited use, which is currently authorised for specific patients. Regrettably, the distinction of authorised use for different purposes, such as market distribution, prescribed use, off-label individual treatment or compassionate individual use, was neither reflected in the applicable secondary legislation nor taken into consideration by the majority in their analysis of the proportionality or necessity of the automatic refusal with which the applicants were confronted, despite the already approved use of the experimental product for specific purposes in other countries. Finally, it appears that the impugned refusals served neither to inform the applicants of any risk to life or of any degrading experiments which the treatment requested might entail, nor to prevent such treatment. In fact, some of the applicants availed themselves of the product in question outside the territory over which the national authorities exercised jurisdiction. Is State regulation of patients’ and public safety in medical treatment only a question of money?

Regrettably, in adopting the secondary regulations in question and issuing the resulting refusals, the national authorities failed to indicate any convincing reason pertinent to the regulatory functions of State authorities in relation to individual patients’ medical treatment.

Looking at the cited case-law of other courts (see paragraphs 59-67 of the judgment), I find it embarrassing that the Court, when called upon to examine the extent to which the authorities complied with their duty to respect the individual right to medical services, as well as their positive obligations to ensure the effective and safe exercise of that right, seems to be the first to fail to examine the complex ethical and moral issues arising in similar cases.

DISSENTING OPINION OF JUDGE DE GAETANO JOINED BY JUDGE VUČINIĆ

1. I regret that I cannot share the majority’s conclusions in this case, other than on the question of the admissibility of the complaints concerning the authorities’ refusal to allow the applicants to use the experimental product that they wished to have administered and on the question of the inadmissibility of the complaint in respect of the alleged violation of Article 13. In my view there was in this case a violation of Article 8, and such a finding would have rendered it unnecessary to examine the issue under Articles 2 and 3 (see Guerra and Others v. Italy, 19 February 1998, Reports of Judgments and Decisions 1998-I).

2. The facts of the case may be summed up as follows: a number of cancer patients in the late stage of their disease want, as a measure of last resort, to be allowed to try an experimental, and possibly controversial, anticancer product which is being developed by a Canadian company. They are fully aware of the risks which go with this treatment. The treatment is not available in Bulgaria, and, although it has been offered for free by the Canadian company, the participation of Bulgarian medical institutions and Bulgarian doctors is nevertheless required for it to be administered in Bulgaria. Hence the need for the applicants to apply to the domestic authorities for the necessary permission (see paragraphs 14 and 26 of the judgment).

3. In my view the possibility to “treat oneself” - whether it be by the use of non-medical products, the use of ordinary medication, or the use of available extraordinary medication, as in this case - and to make an informed and free choice in this connection (and provided such a choice does not negatively impinge upon another’s life or health) falls within the ambit of one’s private life. Indeed, as correctly pointed out in paragraph 116 of the judgment, the very notion of “private life” implies a degree of personal autonomy coupled with an assessment of the quality of life in a concrete situation. I also agree that matters of health-care policy are, in principle, within the margin of appreciation of the domestic authorities, who are best placed to assess priorities, use of resources and social needs (paragraph 119 of the judgment). However, the issue in the present case is a considerably narrower one, and does not involve the allocation of resources. No financial considerations or imperatives were involved. The applicants were not calling upon the State to pay for this treatment (contrast, among others, Wiater v. Poland (dec.), no. 42290/08, § 33, 15 May 2010). They were simply asking for the State to “get out of the way” and allow them access to an experimental product which would be provided to them free of charge. In the instant case, therefore, the Court should have determined the applicable margin of appreciation by reference to factors that are more specific to the situation at hand (see Hatton and Others v. the United Kingdom [GC], no. 36022/97, § 103, ECHR 2003-VIII, where the court said that a conflict of views on the margin of appreciation can be resolved only by reference to the context of a particular case), and in particular to the applicants’ critical medical condition and the available prognosis.

4. Moreover, a State’s margin of appreciation is not unlimited and, broad as it may be, must always be viewed in the light of the values underpinning the Convention, chief among them the value of life. The Court has often stated that the Convention must be read as a whole and interpreted (and I would say also applied) in such a way as to promote internal consistency and harmony between its various provisions and the various values enshrined therein (see, albeit in different contexts, Stec and Others v. the United Kingdom (dec.) [GC], nos. 65731/01 and 65900/01, § 48, ECHR 2005-X; Austin and Others v. the United Kingdom [GC], nos. 39692/09, 40713/09 and 41008/09, § 54, ECHR 2012-...). The Court, therefore, in assessing this margin of appreciation in the circumstances of the instant case, and the method chosen by the Bulgarian authorities to “balance” the interests mentioned in paragraphs 120 and 122 of the judgment, should have given more weight to the value of life.

5. As is stated in paragraph 125 of the judgment, the Bulgarian authorities chose “to balance the competing interests” - I very much doubt whether those interests were really “in competition” with each other given the facts of the case - by adopting the general formula that if a medicinal product is not authorised in another country, it cannot be exceptionally used to treat patients in Bulgaria. In my view, in the case of the applicants - terminally ill patients - this generalised solution is unnecessarily restrictive and exceeds the State’s margin of appreciation in this domain, and this for two reasons. The first reason concerns the manner in which the solution was arrived at (see, mutatis mutandis, Hatton and Others, cited above, § 99). There is no evidence that when adopting the regulations at issue, or those that succeeded them, the Minister of Health sought to weigh the competing interests or to assess the proportionality of the restriction (see, mutatis mutandis, Dickson v. the United Kingdom [GC], no. 44362/04, § 83 in limine, ECHR 2007-V) by, for instance, carrying out a public consultation process (contrast, mutatis mutandis, Hatton and Others, cited above, § 128). Moreover, since the bar on access to unauthorised medicinal products which have not been authorised in another country was not embodied in primary legislation, the various competing interests were never weighed, nor were issues of proportionality ever assessed, by the legislature (see, mutatis mutandis, Dickson, § 83, cited above, and contrast Evans v. the United Kingdom [GC], no. 6339/05, § 86, ECHR 2007-I). It is important to observe in this connection that the issue has obvious life-or-death implications, and that its importance cannot be emphasised enough.

6. The second reason has to do with the solution’s substantive content. It is an unfortunate fact of life in the modern world that the development of new medicinal products is a complex endeavour facing scientific, financial and regulatory hurdles, and as a rule taking many years to complete. As a result, terminally ill patients often do not have the time to await the full testing and authorisation of new medicines which may help them mitigate or defeat their disease. A number of Contracting States, as well as other States and the European Union, are apparently alive to this problem and have for this reason made provision for early access to experimental products which have not yet obtained regulatory approval (see paragraphs 45, 49-51 and 54-58 of the judgment). It is true that the specific way in which such access is being provided varies among countries. However, it appears that in many of them it embraces products which have not obtained regulatory approval anywhere and are in this sense truly new and experimental. The development of new medicinal products is a field which is constantly impacted by scientific developments and advances in technology. By denying the applicants - terminally ill patients - any access to those developments, the Bulgarian authorities effectively disregarded completely their very strong interest to be able to try treatment which, although involving acceptance of additional uncertainty as to risk, may prove to be the only remaining possibility to attempt to save their lives.

7. I am, of course, fully aware that that allowing too many exceptions to the system of authorising medicinal products may undermine its function to ensure that only products whose quality, safety and efficacy have been convincingly demonstrated should be allowed for use by patients. However, I cannot overlook - and unfortunately the majority decision overlooks - the fact that such exceptions already exist and do not appear to have imperilled the operation of that system, both at the national and higher level. The fact that a number of other States operate such mechanisms in respect of products which have not been authorised anywhere in the world shows that any difficulties that are likely to arise are manageable.

8. The public interest identified in paragraph 122 of the judgment may be usefully served by more narrowly tailored requirements. For instance, the applicable regulations could require the authorities to assure themselves that the possible benefit of using an unauthorised product justifies the possible risks of using it, and that the risks posed by the product are not unreasonable in the circumstances and do not outweigh the risks posed by the disease which it is purported to treat. They could additionally insist that medical practitioners who propose to treat terminally ill patients with an unauthorised product explain in detail the known and unknown risks, so as to allow those patients to make truly informed decisions. They could also require that the use of unauthorised products does not get in the way of clinical trials of those products, and remains an option of last resort. The majority decision washes its hands of all these considerations by using the safety-valve of the “wide margin of appreciation” (see paragraph 125 of the judgment).

9. In sum, I am of the view that there are no major factors of public interest to weigh against the very significant - indeed vital, in a very literal sense - interest of the applicants in obtaining access to experimental medicinal products which have not been authorised for use in another country. Naturally, the State cannot be required to grant access to such medicines without a regulatory framework. But this framework must allow for a proper balancing exercise of the interests involved. In the present case, however, there is no indication that such an examination was undertaken, and in fact nowhere does the judgment conclude that the State struck a fair balance. The near uniformity of the reasons given by the Director of the Executive Medicines Agency for rejecting each of the applicants’ requests indicates that those refusals did not flow from relevant considerations but were entirely based on the blanket prohibition on the compassionate use of products not authorised in other countries. More specifically, no attention was given to the special and vulnerable situation of the applicants and the consequent need for respect for, and protection of, their physical and psychological integrity.

10. For these reasons, as has already been stated in paragraph 1, above, I am of the view that there has been a violation of Article 8 of the Convention in this case, and that as a consequence it was unnecessary to examine the applicants’ complaints under Articles 2 and 3.

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