CEDH · CASELAW;JUDGMENTS;CHAMBER;ENG — 14 décembre 2021

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text-align:center; page-break-inside:avoid; page-break-after:avoid; font-size:14pt } .s5BA5B7C7 { margin-top:12pt; margin-bottom:12pt; text-align:center; font-size:14pt } .sEC2CB098 { margin-top:6pt; margin-bottom:6pt; text-indent:14.2pt; text-align:justify }     SECOND SECTION CASE OF GRAŽULEVIČIŪTĖ v. LITHUANIA (Application no. 53176/17)       JUDGMENT   Art 6 § 1 (civil) • Fair hearing • Failure of Supreme Administrative Court to respect res judicata effect of a final court decision annulling the applicant’s suspension as a clinical researcher • Reassessment of same factual circumstances without reopening the first set of court proceedings, and rendering the first set largely devoid of any legal effect   STRASBOURG 14 December 2021   FINAL   14/03/2022   This judgment has become final under Article 44 § 2 of the Convention. It may be subject to editorial revision. In the case of Gražulevičiūtė v. Lithuania, The European Court of Human Rights (Second Section), sitting as a Chamber composed of:   Jon Fridrik Kjølbro, President,   Marko Bošnjak,   Aleš Pejchal,   Egidijus Kūris,   Branko Lubarda,   Pauliine Koskelo,   Saadet Yüksel, judges, and Stanley Naismith, Section Registrar, Having regard to: the application (no.   53176/17) against the Republic of Lithuania lodged with the Court under Article   34 of the Convention for the Protection of Human Rights and Fundamental Freedoms (“the Convention”) by a Lithuanian national, Ms Edita Gražulevičiūtė (“the applicant”), on 21   July 2017; the decision to give notice to the Lithuanian Government (“the Government”) of the complaints concerning the right to a fair hearing, the right to respect for private life, and the right to an effective domestic remedy, and to declare inadmissible the remainder of the application; the parties’ observations; Having deliberated in private on 9 November 2021, Delivers the following judgment, which was adopted on that date: INTRODUCTION 1.     The applicant is a doctor and a clinical researcher. After one of her patient’s died, she was suspended. The applicant complains that the final court decision, by which she was exculpated, was overturned, in breach of the principle of res judicata and Article   6 §   1 of the Convention. She also complains that she was not compensated for the damage sustained due to her suspension, in breach of Article   8. THE FACTS 2.     The applicant was born in 1971 and lives in Vilnius. She was represented by Ms   L.   Meškauskienė , a lawyer practising in Vilnius. 3.     The Government were represented by their Acting Agent, Ms   L.   Urbaitė. 4.     The facts of the case, as submitted by the parties, may be summarised as follows. 5 .     The applicant is a rheumatologist and has been working in that capacity since 2004. According to what appears to be an extract from a tax declaration provided by the applicant, she was working as a clinical researcher ( tyrėja ) from 12   November 2004. According to another document issued by a private company, the Centre for Clinical and Basic Research, the applicant worked for that company from May 2007 to July 2011 as a “consulting doctor”. The applicant’s work as a clinical researcher and her suspension 6 .     In 2011, the applicant was carrying out several clinical trials as a clinical researcher in a team with other researchers. At a certain point, she was on maternity leave. One of the trials concerned a drug, tocilizumab, and in the course that trial, on 14   April 2011 a patient, V.S., died. On 27   September 2011, V.S.’s daughters asked the State Medicines Control Agency ( Valstybinė vaistų kontrolės tarnyba – hereinafter “the SMCA”) to investigate whether the applicant had carried out her duties properly during the clinical trial. 7.     On 11   October 2011 the head of the SMCA ordered an unscheduled good clinical practice inspection (hereinafter – “the inspection”). 8 .     The inspection was carried out on 16   December 2011, and certain shortcomings, two of which were considered to be critical (dangerous) ( kritiniai ( pavojingi )) violations of the Good Clinical Practice Rules were identified (see paragraphs   53 and 54 below): firstly, failure to accept the patient for an unscheduled appointment, and, secondly, failure to report serious side-effects of the medicine which was being tested. Besides that, the inspectors also found ten significant ( reikšmingi ) and six minor ( nereikšmingi ) violations of those rules. The inspectors further concluded that the researchers’ actions had possibly caused damage to the patient V.S.’s health, leading to her death. According to the inspectors, during the trial the welfare of V.S. had not been guaranteed, thus breaching her rights. The inspectors recommended that the measures set out in point   78 of the Description of Control Procedure (see paragraph   54 below) should be imposed on the principal researcher, A.V., and on the applicant. 9 .     By order ( įsakymas ) no.   1A-29 of 10   January 2012 of the head of the SMCA, the applicant and A.V. were suspended ( nušalinti ) from the clinical trial of tocilizumab being carried out at the Santariškės Clinics of Vilnius University Hospital (hereinafter – the first clinical trial). They were prohibited from taking up new clinical trials. That order was to be made public on the SMCA website. 10 .     By order ( įsakymas ) no.   1A-45 of 12   January 2012 of the head of the SMCA, the applicant, as the principal researcher (she had been granted such status by the SMCA on 25   July 2011), was suspended from the clinical trial of tocilizumab carried out in the Vilnius Region Central Polyclinic ( Vilniaus rajono centrinė poliklinika , hereinafter – the second clinical trial). The head of the SMCA himself annulled the latter order on 29   May 2012. 11 .     On 27   August 2011 the authorities started a pre-trial investigation into the circumstances of V.S.’s death. A forensic examination was ordered. On 11   October 2012 the experts produced report no.   DM   6   (76)/13   (01), which stated that V.S. had died of “sepsis which [had] developed as fast as lighting” ( žaibiškai išsivystęs sepsis ), and not because of the applicant’s actions. The report also stated that sepsis could develop whether taking tocilizumab or not. It was also noted that, once she had been informed of the deterioration of V.S.’s state of health, the applicant, suspecting that such deterioration did not have rheumatologic causes, but instead was a result of other medical issues (complications) such as torn tendons or an infection, had advised V.S. to contact a traumatology specialist. Administrative court proceedings regarding the applicant’s suspension as a researcher 12 .     On an unknown date, the applicant challenged the suspension decisions (see paragraphs 9 and 10 above). She argued, among other things, that when reaching their conclusion the SMCA inspectors had not properly evaluated all the information and that therefore the suspension decisions had been unlawful and unfounded. Regarding the facts surrounding V.S.’s death, the applicant argued that legal regulation did not provide for an obligation to organise an unscheduled appointment for diagnosis [at the patient’s house] if the patient refused to come in to a medical institution. The applicant stated that, having learned by telephone of the deterioration of V.S.’s state of health on 11   April 2011, she had suspected complications. Having consulted several other doctors, the applicant had recommended that V.S. come immediately to the hospital, which she had failed to do. As a result, examining V.S. in a timely manner had become impossible, which had eventually resulted in her death. 13 .     In its reply to the applicant’s action, the SMCA argued that the information established in the inspection report had been objective. The SMCA also pointed out that the orders to suspend the applicant had been issued “only because” two critical (dangerous) violations of the Good Clinical Practice Rules (see paragraph   53 below) had been established, and that therefore only those two violations of the rules were pertinent to the court proceedings. Any other – significant or minor – violations had not been the basis for the orders to suspend the applicant. 14 .     On 6   December 2013 the Vilnius Regional Administrative Court fully allowed the applicant’s claim. At the outset, the court clarified that, since the administrative courts examine disputes regarding the actions or decisions which have an impact on the claimant’s rights or obligations, the inspection report, and the circumstances established in that report (see paragraph   8 above), as such, had no consequences for the applicant, which meant that that report could not be challenged in court. In other words, only the orders to suspend her had affected her rights or obligations, and not the inspection report. That being so, the court would only issue a verdict regarding the circumstances mentioned in the inspection report that had led to the orders to suspend the applicant. Given that the applicant’s suspension and removal from clinical trials had been based on the two critical (dangerous) violations of the Good Clinical Practice Rules (see paragraph   8 above), the court decided to limit its assessment to those aspects. 15 .     As to the circumstances leading to V.S.’s death, the court established that before the clinical trial V.S. had signed an agreement to participate in the clinical trial and had been informed whom to contact in the event of complications. That agreement had not indicated the applicant’s contact details, only the details of doctor J.R. and those of the principal researcher, A.V. Although V.S.’s daughters had complained of the actions of the applicant, they had not been able to explain why V.S. had failed to contact the other researchers (J.R. or A.V.). The court also noted that even though V.S. had been obliged to inform the researchers of any possible deterioration of her health, once her state of health had started worsening on 9   April 2011, V.S. had instead contacted an outside doctor she had “personally known” ( asmeniškai pažįstamo gydytojo ), had taken medication prescribed by the latter doctor and had also taken methadone. She had contacted the applicant only several days later. 16.     The court had regard to the expert medical report obtained in the criminal proceedings, where it had been found that V.S. had died because of acute sepsis and not because of the applicant’s actions (see paragraph   11 above). The court also questioned as a witness doctor J.R., who had taken part in the same clinical trial and who had been named therein as one of the contact persons in the event of complications. J.R. confirmed that she had heard the telephone conversation between V.S. and the applicant on 12   April 2011, during which the applicant “had insisted” ( primygtinai liepė ) that V.S. go to hospital to see a traumatology specialist. J.R. stated that when V.S. had ultimately been taken to hospital by ambulance on 13   April 2011, J.R. had examined V.S. together with the applicant and they had seen that V.S.’s leg was dark grey and the complication was at least four days old. The court established that both the applicant and J.R. had examined V.S., and thus one of the conclusions of the inspection held against the applicant – that she had not participated in that examination – was unfounded. 17 .     The court also found that the inspectors had based their findings on the explanations given by V.S.’s daughters, by presuming that the applicant could have intentionally filled in the medical and other records incorrectly in order to avoid trouble. However, such a conclusion lacked a factual basis and was based only on the subjective view of the daughters, in their testimony given after V.S.’s death, possibly in order to substantiate their claims against the applicant. 18 .     Contrary to what had been suggested by V.S.’s daughters, the fact that the applicant had been on maternity leave ( vaiko priežiūros atostogos ) (see paragraph   6 above) was not important because the applicant had not been the only researcher taking part in that clinical trial. Another doctor, J.R., had also taken part with the same responsibilities as the applicant. The court also specifically held that the applicant had not been an “irreplaceable person” during that clinical trial, and that her being on maternity leave, as such, had not complicated the situation and had not directly influenced the carrying out of the clinical trial. 19 .     In the light of the above, the Vilnius Regional Administrative Court held that the inspectors’ conclusions as regards the breach of the Good Clinical Practice Rules, which had been qualified as inappropriate organisation of unscheduled appointments, had been incorrect and had contradicted the factual circumstances. 20 .     The court then turned to the second critical (dangerous) violation of the Good Clinical Practice Rules which had been attributed to the applicant’s actions, namely her alleged failure to inform, within twenty-four hours, the sponsor of the clinical trial ( užsakovas ) of any “serious side ‑ effects” ( sunkus nepageidaujamas reiškinys ) which had resulted in death or disability or had had other serious consequences. Having examined the medical records and also having questioned an expert in clinical trials, the court established that the applicant had not breached this requirement to report side-effects, since at first V.S. had experienced pain in her ankle, which was not a serious side-effect of the medication being trialled. The applicant had also immediately informed the sponsor when it had been suspected that V.S. had septic arthritis. 21 .     The court thus held that the conclusions reached by the inspectors had been based on their subjective assessment of circumstances, without giving reasons as to why they had rejected the applicant’s arguments. For the court, there was no evidence to help to reach a categorical conclusion that the arguments of the applicant had been unfounded. Accordingly, the court concluded that the applicant’s actions – reporting negative side ‑ effects – had been unjustifiably qualified as a critical (dangerous) violation. 22 .     Given its finding that the inspectors had incorrectly concluded that the applicant had committed two critical (dangerous) violations, the Vilnius Regional Administrative Court held that restrictions on the applicant’s working as a researcher had been imposed “unjustly” ( neteisingai ). Thus, the court annulled the orders to suspend the applicant from the clinical trials and not to take part in new ones (see paragraphs   9 and 10 above). 23 .     This decision was not appealed against and became final on 21   December 2013. Administrative court proceedings in respect of damage sustained owing to suspension 24 .     The applicant afterwards lodged a claim against the State, represented by the SMCA, claiming pecuniary and non-pecuniary damage which she argued she had sustained owing to her suspension from the clinical trials. The applicant submitted, among other things, that she had been working as a clinical researcher as of 12   November 2004. She argued that damage had been caused to her by the unlawful actions of the SMCA in ordering her suspension, a suspension which had been annulled by the court in the earlier set of proceedings (see paragraphs   12-23 above). The applicant argued that, had she not been suspended, she would have received income from the first and the second trials. The applicant underscored the “particularly high requirements of care and professionalism” ( ypač aukšti atidumo ir rūpestingumo reikalavimai ) applicable to the medical profession and submitted that any doubts about her competence had tarnished her reputation, causing her great stress. The applicant specified that the first clinical trial had taken place from 11   October 2010 to 19   August 2013. Responding to the applicant’s claim, the SMCA referred to the two critical violations, as established by the inspectors: obligatory medical assistance had not been provided to V.S., in breach of clinical trial protocol and relevant regulations, and systemic failures of reporting serious side-effects had damaged the integrity of the data of the critical trial. Those two critical violations had been the basis for the applicant’s suspension by the SMCA, and there was nothing unlawful in the SMCA taking such a measure. 25 .     On 4   November 2015 the Vilnius Regional Administrative Court allowed the applicant’s claim in part. The court firstly noted that in her claim the applicant had claimed as pecuniary damage the income which she would have received if the SMCA had not adopted the orders of 10 and 12   January 2012 by which she had been suspended from conducting the first and the second clinical trials. The court also referred to Article   6.249 § 1 of the Civil Code, regarding the notion of damage, and Articles 6.246 and   6.271 thereof (see paragraph   56 below), which provided that one of the necessary conditions for civil liability was unlawful actions. 26 .     The court also pointed out that, under Article 58 § 2 of the Law on Administrative Proceedings (see paragraph   55 below), facts which had been established in one administrative case by a court decision which had come into effect did not need to be proven again in other administrative cases where the same parties were taking part. The court then referred to the Vilnius Regional Administrative Court’s decision of 6   December 2013 regarding the dispute between the applicant and the SMCA, which had not been appealed against and which had entered into force (see paragraphs   14 ‑ 23 above). The court pointed out that in the instant (second) set of proceedings “essentially the same parties [had been] taking part”, and accordingly there was no need to prove again the conditions for the public liability ( viešosios atsakomybės sąlygos ) in respect of the applicant. 27 .     Regarding the first clinical trial, the court established that on 17   August 2010 an agreement had been concluded whereby concrete amounts to be paid for one person for a complete trial had been fixed. The court noted that the applicant had de facto carried out that clinical trial until she had been suspended from it by the SMCA order of 10   January 2012, which had later had been annulled by the administrative court. Given that one of the patients had died, the applicant had continued the clinical trial with the remaining five patients. On the basis of the case-file material the court also established that the first clinical trial had been completed and documented as planned. There was no information in the file which could raise doubts as to whether the clinical trial would not have taken place because of the applicant’s actions. Moreover, contrary to what had been suggested by the defendant in those court proceedings, medical records showed that it had been precisely the applicant who had carried out the clinical trials with those five patients and that the clinical trials had been completed in respect of them. 28.     For the court, it had to be underscored that, as had been mentioned in the court decision of 6   December 2013, the inspectors’ conclusions regarding the violations of the Good Clinical Practice Rules had been erroneous, and that therefore the SMCA order of 10   January 2012 to suspend the applicant from the first trial had been annulled. In the Vilnius Regional Administrative Court’s view, this meant that the order of the SMCA removing the applicant from the first clinical trial had caused the applicant pecuniary damage. 29 .     Lastly, the administrative court referred to the Supreme Court’s ruling of 13   November 2006 in civil case no.   3K-3-585/2006, where it had held that the amount of income not received had to be proven by the plaintiff, and that amount had to be real. When deciding on whether the unreceived income could be seen as pecuniary damage it was necessary to have regard to whether that income had been planned, whether the plaintiff could reasonably have expected to receive it, and whether he or she had not received it because of unlawful actions on the part of the defendant. In the instant case, had the applicant not been suspended from conducting the first clinical trial for the remaining five patients, she would have received   6,128   euros (EUR), a sum which had been calculated in advance in the contract with the pharmaceutical company and which the applicant had not received because of the “unlawful actions” ( neteisėti veiksmai ) of the SMCA. The court thus awarded the applicant the sum of EUR   6,128 for pecuniary damage. 30 .     Regarding the second clinical trial, the court noted that on 26   August 2011 the applicant had concluded a clinical trial contract, with her as the principal researcher, with a pharmaceutical company. Later on, she had been suspended from conducting that trial by the decision of 12   January 2012 (see paragraph   10 above). That being so, the court also noted that, as the applicant herself had confirmed in the courtroom, she had refused to take part in that second clinical trial, and therefore that trial had not taken place in the Vilnius Region Central Polyclinic. Although at the court hearing the applicant had argued that she had withdrawn from the second clinical trial due to the psychological stress she had experienced due to the inspection of the first clinical trial, there was no evidence to substantiate that. It was also worth noting that the pharmaceutical company had informed the SMCA that no patients had taken part in or had even been chosen for the second clinical trial. It followed that the applicant’s claim regarding the pecuniary damage sustained in connection with the second clinical trial had to be dismissed. 31 .     Lastly, as regards non-pecuniary damage, the court noted the applicant’s complaint that she had been suspended from conducting the first clinical trial and could not take up researcher’s activity for nearly two years, between 10   January 2012 and 6   December 2013 (see paragraphs   9 and 23 above), and that any doubts as to her competence as a medical professional had been damaging to her reputation, also given the fact that information about her suspension and about critical (dangerous) violations of the Good Clinical Practice Rules had been made public on the SMCA’s website. The court reiterated that the decision of 10   January 2012 for the applicant’s suspension had been annulled as unlawful. The court considered that the nearly two years of suspension from clinical trials objectively could have caused the applicant a “negative experience” ( neigiami išgyvenimai ), and decided to award her EUR   200 in compensation. 32 .     The applicant appealed, asking to be awarded pecuniary damage in connection with the second clinical trial. She also contested that the claim for non-pecuniary damage had not been fully granted. The SMCA also appealed, arguing that the applicant had failed to substantiate her claim for pecuniary damage as regards the first clinical trial and was not entitled to have that claim granted. The SMCA further submitted that the applicant should not be granted a monetary award as compensation for non-pecuniary damage. The SMCA also argued that, within the second set of court proceedings, the first instance court had not assessed the factual and legal aspects of the SMCA’s actions, which were relevant for the question of the State’s tortious liability. In the view of the SMCA, the first instance court had failed to take into account that the head of the SMCA had issued the orders to suspend the applicant on the basis of the inspection conclusions showing the presence of two critical violations – damage to a patient’s health and damage to the integrity of the trial data. The SMCA also argued that when taking action against the applicant – adopting the decisions to suspend her – it had sought to protect the health of those taking part in the clinical trials. 33 .     By a ruling of 30   January 2017, in written proceedings, the Supreme Administrative Court allowed the SMCA’s appeal, rejected the civil claim for damages on the part of the applicant and dismissed her appeal. 34.     At the outset, the Supreme Administrative Court referred to its consistent case-law in cases concerning liability for damage caused by State institutions’ unlawful actions (Article   15   §   1   (3) of the Law on Administrative Proceedings, see paragraph   55 below) to the effect that the annulment of an administrative decision was, as such, not a basis to hold that the actions of a State institution had been unlawful and that therefore civil liability under Article 6.271 of the Civil Code arose. The court also pointed out that, when deciding the question of a State institution’s civil liability, Article   6.271 §   4 of the Civil Code had to be applied as this was the “special norm” ( specialioji norma ), as opposed to the general norm set out in the first paragraph of that Article (see paragraph 56 below). 35 .     The Supreme Administrative Court held that, in accordance with the principle of res judicata , factual and legal elements established in another court decision had to be accepted, and parties to the proceedings or another interested party could rely on them. That notwithstanding, this did not mean that in cases concerning the issue of damages the court had no right to verify supposedly unlawful actions in the context of tortious liability on the part of the State. For the Supreme Administrative Court, legal assessment ( teisinis vertinimas ) of the circumstances established by a court decision was not to be treated as denial of the binding and res judicata value of that decision. Moreover, disputes in administrative cases regarding the annulment of administrative decisions differed from disputes regarding compensation for damage caused by unlawful actions on the part of the State (the Supreme Administrative Court referred to its earlier ruling of 14   July 2011 in case no.   A502-3034/2011, decided by an enlarged chamber composition). Likewise, the “verification” ( patikra ) by the court of purportedly unlawful actions in the context of tortious liability was an assessment of the respective factual and legal elements within the meaning of Article   6.271 of the Civil Code, and such verification in the case for the compensation of damage could be performed without questioning the established facts and their assessment in another (previous) case (the Supreme Administrative Court referred to the same ruling, and to its ruling of 8   October 2015 in case no.   A3155-624/2015, also decided by an enlarged chamber composition). The Supreme Administrative Court considered that the first-instance court had failed to take all this case-law into account when examining the applicant’s claim for damages (see paragraphs   25-31 above), and thus had adopted an unreasoned and unlawful decision. 36 .     Next, the Supreme Administrative Court pointed out that when examining whether there had been civil liability on the part of the State in the instant case, not only did domestic legal regulations have to be taken into account, but also international and European Union law. Firstly, it cited the principle that a person’s interests and well-being are more important than society’s and science’s interests. It also referred in this connection to the general rule that scientific research was performed freely, taking into account legal rules protecting human rights, set out, respectively, in Articles   2 and 15 of the Oviedo Convention on Human Rights and Biomedicine (see paragraph   48 below). The court pointed out that the principle enunciated in Article   2 of that Convention had been reflected in Article   5 §   1 of the Law on Ethics of Biomedical Research (see paragraph   51 below) and point   2.3 of the Good Clinical Practice Rules (see paragraph 53 below). 37 .     Secondly, at the material time, provisions of Directive   2001/20/EC of the European Parliament and of the Council of 4   April 2001 (hereinafter “the Directive”, see paragraph   49 below) had applied and had been relevant. In Lithuania, the Directive was implemented by the Law on Ethics of Biomedical Research (see paragraph   51 below), the Law on Pharmacy (see paragraph   52 below) and other relevant legal acts. The Directive established the principle of protection of individuals participating in clinical trials (point   2 of its preamble). Likewise, the Directive set out “core provisions” ( esminės nuostatos ), including that a clinical trial once commenced should be verified and supervised, and its compliance with the Good Clinical Practice standards should be monitored, and that, should objective evidence be detected, the Member States had a right to suspend it or to discontinue it (point   18 of the preamble and Article   12 of the Directive, see paragraph   49 below). Lastly, a clinical trial could not be opened until the committee on ethics agreed. In Lithuania, the relevant authorities for the approval of clinical trials were the SMCA and the Bioethics Committee (Article   18 §   4 of the Law on Pharmacy, see paragraph 52 below). 38.     In the present case, the Vilnius Regional Administrative Court had annulled the relevant part of the order concerning the applicant because it had assessed the conclusions of the investigation against her as insufficient to substantiate the two critical (dangerous) violations of the Good Clinical Practice Rules and held that too much weight had been given to the subjective explanations given by V.S.’s daughters (see paragraph   17 above). For the Supreme Administrative Court, it was important to establish whether agreements by the authorities to carry out two clinical trials had been in accordance with the law. 39 .     The Supreme Administrative Court held that the findings which the first-instance court had reached within the first set of administrative court proceedings, which had led to the annulment of the decision of 10   January 2012, “in themselves [had] not constitute[d] a basis” ( savaime nėra pagrindas ) to rule that the SMCA’s actions had been unlawful within the meaning of Article 6.271 of the Civil Code. For the purpose of Article   6.271 §   4 of that Code, to assess possible tortious liability on the part of the State, it was necessary to have a “broader legal assessment of the circumstances pertinent to the case and in a broader legal viewpoint” ( turi būti atliktas platesnis bylai aktualių aplinkybių teisinis vertinimas platesniu teisiniu aspektu ). When examining the claim for damages, it had to be verified whether the actions of the SMCA when ordering the inspection as well as how that inspection had been carried out had complied with the letter of the law: whether the SMCA and its employers had acted in a manner compliant with the law, since if essential violations of the rules applicable to such an inspection were found, this could be the basis to hold that the individual administrative decision adopted on the basis of such a conclusion had resulted in an unlawful action within the meaning of Article   6.271 of the Civil Code. For the Supreme Administrative Court, when examining whether there was tortious liability on the part of the State, the relevant court also had to examine whether when adopting the decision to suspend the applicant the SMCA had acted as the law required it to act as regards firstly the protection of individuals taking part in the clinical trial, and secondly checks on the reliability of the data received during the clinical trial. 40.     Over several pages of its decision the Supreme Administrative Court then extensively analysed the SMCA’s actions against the background of existing legal regulations, in particular the Good Clinical Practice Rules. Eventually, it reached the conclusion that, within the meaning of Article   6.271 §   4 of the Civil Code, the SMCA had acted within its competence, and as it was required to act under the law. 41 .     In the light of the aforementioned legal regulations and the factual circumstances of the case, the Supreme Administrative Court shared the SMCA’s view that that agency, when applying the measure prescribed in point   78.1 of the Description of Control Procedure to the applicant, and also on the basis of the inspectors’ conclusion, had acted within the bounds of its competence with aims prescribed by law – to prevent violations of individuals’ rights, and to guarantee their safety and well-being, as well as to guarantee that the clinical trial would be performed in accordance with the Good Clinical Practice Rules and other legal acts, and also so that the data received during clinical trials would be reliable and of quality. For the Supreme Administrative Court, there was no reason to disagree with such arguments of the SMCA. 42.     The Supreme Administrative Court also noted that the relevant legal acts did not grant the head of the SMCA discretion to “revise” ( revizuoti ) the inspectors’ conclusions and to “correct them” ( atitinkamai jas koreguoti ). Likewise, when performing his function, the head of the SMCA had no right to disregard those conclusions. The inspectors’ conclusions, set out in the relevant report (see paragraph   8 above), thus amounted to a factual basis by which measures would be applied to the clinical researcher. The lawfulness and reasonableness of the inspectors’ conclusions could be verified only “in court” ( tik teismine tvarka ) by challenging a decision imposing measures on a researcher. 43.     The Supreme Administrative Court also agreed with the defendant’s position that, after the inspectors’ conclusions unfavourable to the applicant had been received and specified – that she had committed two critical (dangerous) violations – the head of the SMCA could only adopt the decision to suspend her. The mere fact that the order for the applicant’s suspension had later been annulled by the Vilnius Regional Administrative Court did not mean that the SMCA’s actions, when adopting that order, had been unlawful within the meaning of Article   6.271 of the Civil Code. It had to be emphasised that during the first set of court proceedings the order of 10   January 2012 in respect of the applicant had been annulled not because the court had established any of the absolute grounds for annulment of that order, as set out in Article   89 of the Code of Administrative Procedure (see paragraph   55 below), but because that court had disagreed with the inspectors’ reasoning that the applicant had committed two critical (dangerous) violations of the Good Clinical Practice Rules. This meant that the order of 10   January 2012 regarding the applicant’s suspension had not been unlawful ab initio . 44 .     The Supreme Administrative Court also re-examined the factual circumstances regarding the two critical (dangerous) violations of the Good Clinical Practice Rules that the inspection had attributed to the applicant. Regarding the first critical violation, the Supreme Administrative Court retraced the sequence of events leading to S.V.’s death, and how those events had been reflected in the inspection report. The court found that data established by the inspection had not been refuted by any other information in the case file, and that that data showed that the applicant had not guaranteed that when side-effects had occurred on 11   April 2011 V.S. would receive proper medical care. The applicant had also not taken effective measures to ensure that unscheduled medical appointments would take place, as she had been required to do by the Good Clinical Practice Rules. 45 .     In its reasoning the Supreme Administrative Court also referred to the addendum to the agreement to take part in the clinical trial, signed by both V.S. and the applicant on 6   April 2011, which partly amended the initial agreement to take part in the clinical trial, concluded on 9   November 2010. The addendum warned of a higher possible risk of serious, and sometimes deadly, infection from the medication tested during that clinical trial. For the Supreme Administrative Court, that addendum had imposed on the applicant, as a researcher, an “increased duty of care” ( reikalavo iš tyrėjo padidinto budrumo ) to ensure that the rights and well-being of the patients taking part in the clinical trial, including V.S., remained protected. The Supreme Administrative Court thus considered that the SMCA had acted within its competence when imposing measures on the applicant. 46 .     Regarding the second critical (dangerous) violation of the Good Clinical Practice Rules, concerning reporting of serious side-effects (see paragraph   8 above), the Supreme Administrative Court also held that “there were data in the case file” to the effect that during the inspection it had been established that the applicant had not taken measures to guarantee the “quality, completeness and reliability” of the clinical trial documents ( dokumentų kokybę, pilnumą ir patikimumą ). The Supreme Administrative Court also considered that, under point   78.1 of the Description of Control Procedure, the first critical (dangerous) violation of Good Clinical Practice Rules alone had been sufficient to suspend the applicant, and that the second critical violation established by the inspection had essentially been related to that first violation, and had had no impact on the adoption of the decision to suspend the applicant. 47 .     In the light of the foregoing, the Supreme Administrative Court concluded that the SMCA, when adopting order no.   1A-29 within the meaning of Article   6.271 §   4 of the Civil Code, had acted in accordance with Article   18 §   1 of the Law on Pharmacy, and points   78, 79 and 79 1 of the Description of Control Procedure (see paragraph   54 below), as it had been seeking to protect the rights and well-being of individuals taking part in clinical trials, as well as seeking that the data gathered during clinical trials would be reliable and of quality. Contrary to what had been found by the first-instance court (see paragraphs   25-31 above), there was no basis on which to find that the SMCA had acted improperly, which also meant that the State could not be held civilly liable under Article   6.271 of the Civil Code, since there had been no unlawful actions on the part of the SMCA – an element indispensable for such a finding. RELEVANT LEGAL FRAMEWORK AND PRACTICE Council of Europe instruments and European Union Law 48 .     The Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (known as the Oviedo Convention on Human Rights and Biomedicine), which entered into force in respect of Lithuania on 1   February 2003, in so far as relevant, reads as follows: Article 2 – Primacy of the human being “The interests and welfare of the human being shall prevail over the sole interest of society or science.” Article 15 – General rule “Scientific research in the field of biology and medicine shall be carried out freely, subject to the provisions of this Convention and the other legal provisions ensuring the protection of the human being.” 49 .     Directive 2001/20/EC of the European Parliament and of the Council of 4   April 2001, on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, in so far as relevant, reads as follows: “Whereas: ... (2) The accepted basis for the conduct of clinical trials in humans is founded in the protection of human rights and the dignity of the human being with regard to the application of biology and medicine ... ... (18) It is also necessary to make provision for the monitoring of adverse reactions occurring in clinical trials ... in order to ensure the immediate cessation of any clinical trial in which there is an unacceptable level of risk ...” Article 3 Protection of clinical trial subjects “1. This Directive shall apply without prejudice to the national provisions on the protection of clinical trial subjects if they are more comprehensive than the provisions of this Directive ... 2. A clinical trial may be undertaken only if, in particular: (a) the foreseeable risks and inconveniences have been weighed against the anticipated benefit for the individual trial subject and other present and future patients. A clinical trial may be initiated only if the Ethics Committee and/or the competent authority comes to the conclusion that the anticipated therapeutic and public health benefits justify the risks and may be continued only if compliance with this requirement is permanently monitored;   (b) the trial subject ... has had the opportunity, in a prior interview with the investigator or a member of the investigating team, to understand the objectives, risks and inconveniences of the trial, and the conditions under which it is to be conducted and has also been informed of his right to withdraw from the trial at any time; (c) the rights of the subject to physical ... integrity ... are safeguarded; (d) the trial subject ... has given his written consent after being informed of the nature, significance, implications and risks of the clinical trial ...; ... 3. The medical care given to, and medical decisions made on behalf of, subjects shall be the responsibility of an appropriately qualified doctor ... 4. The subject shall be provided with a contact point where he may obtain further information.” Article 12 Suspension of the trial or infringements “1. Where a Member State has objective grounds for considering that the conditions in the request for authorisation ... are no longer met or has information raising doubts about the safety or scientific validity of the clinical trial, it may suspend or prohibit the clinical trial and shall notify the sponsor thereof. ... 2. Where a competent authority has objective grounds for considering that the sponsor or the investigator or any other person involved in the conduct of the trial no longer meets the obligations laid down, it shall forthwith inform him thereof, indicating the course of action which he must take to remedy this state of affairs. The com