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 terminal stage of their disease want, as a measure of last resort, to be allowed to try an experimental, and possibly controversial, anti-cancer 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 specific 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 (see 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, and 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, 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 in having the opportunity to try treatment which, although involving acceptance of additional uncertainty as to risk, may prove to be the only remaining opportunity for them to attempt to save their lives.

7. I am, of course, fully aware 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 does overlook – the fact that such exceptions already exist and do not appear to have imperilled the operation of that system, both at the national and the 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 obstruct 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 exercise 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 Medicines Executive 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.