FOURTH SECTION

Applications nos. 47039/11 and 358/12 , Hristozov a nd Staykova ‑ Petermann against Bulgaria and Misheva a nd Others against Bulgaria lodged on 15 July 2011 and 5 December 2011 respectively

ADDITIONAL QUESTIONS TO THE PARTIES

1. Did the applicant s do everything that could reasonably be expected of them to exhaust domestic remedies ?

1.1. Was it open to the applicants to claim before the administrative courts that the refusal s to grant them authorisation to use the product that they wished to have administered , or the regulations by reference to which those refusals were issued, were in breach of the Medicinal Products in Human Medicine Act 2007 or another statute? Would such claims have stood a reasonable prospect of success or have been destined to fail ?

1.2. Were the applicants required to raise arguments relating to the alleged breaches of Articles 2, 3 and 8 of the Convention in such judicial review proceedings? Would claims based on such arguments have stood a reasonable prospect of success or have been destined to fail ? The Government are requested to provide examples, if any, of cases in which the administrative courts have struck down administrative decisions ( индивидуални административни актове ) or statutory instruments ( подзаконови нормативни актове ) on the basis that their provisions, while not directly inconsistent with higher ‑ ranking rules, ran counter to general constitutional or international law rules.

2. Was it open to the applicants (those who were still alive at the relevant time) to seek authorisation to use the above ‑ mentioned product under Regulations no. 10 of 17 November 2011 ( Наредба â„– 10 от 17 ноември 2011 г. за условията и реда за лечение с неразрешени за употреба в Република България лекарствени продукти, както и за условията и реда за включване, промени, изключване и доставка на лекарствени продукти от списъка по чл. 266а, ал. 2 от Закона за лекарствените продукти в хуманната медицина ), which superseded Regulations no. 2 of 10 January 20 0 1 ( Наредба â„– 2 от 10 януари 2001 г. за условията и реда за лечение с неразрешени за употреба в Република България лекарствени продукти ) on 6 December 2011 ? Would have the different wording of those new Regulations led to a different outcome?