Communicated on 22 January 2014

FIRST SECTION

Application no. 75971/12 Irina NIKOLOVA against the former Yugoslav Republic of Macedonia lodged on 20 November 2012

STATEMENT OF FACTS

The applicant, Ms Irina Nikolova , is a Macedonian national, who was born in 1955 and lives in Prilep . She is represented before the Court by Mr N. Sredovski , a lawyer practising in Bitola .

A. The circumstances of the case

The facts of the case, as submitted by the applicant, may be summarised as follows.

1. Background to the case

On 12 January 2001 the applicant was examined in the Prilep Hospital and diagnosed as suffering from fibrocystic mastopathy . Soon after she was examined at the Radiology Institute of Skopje Hospital. On 9 March 2001 Dr Lj.I. from the Radiotherapy and Oncology Institute of Skopje Hospital carried out a biopsy and established a benign lesion on the applicant ’ s right breast. According to the medical report of that date, no malignant tissues were discovered.

On 28 and 29 March 2001 the applicant underwent, at her own expense, a series of medical examinations at Odessa Regional Medical Centre, Ukraine, where she was diagnosed as suffering from fibroadenoma .

On 22 May 2001 Dr M.K. operated on the applicant and removed the affected tissue.

On 30 May 2001 Dr S.B. from the Pathology Institute of Skopje Hospital examined the extracted tissue and established, in a report drawn up that day that the applicant was suffering from a progressive malignant cancer. The diagnosis was based on four samples of the extracted tissue. On the basis of that diagnosis, on the same day Dr M.K. carried out a radical mastectomy, which included a complete amputation of the applicant ’ s right breast and a removal of all underarm lymph nodes.

In a medical report of 4 June 2011 regarding the material obtained after the mastectomy, Dr S.B. noted the presence of benign lesions around the affected tissue. Furthermore, he found no metastatic deposits in any lymph nodes. However, the findings – taken in conjunction with the report of 30 May 2001 (see above) – suggested the presence of malignant cancer.

On 6 June 2001 the applicant was discharged from the hospital. Between 19 June and 1 July 2001 she was admitted to the Radiotherapy and Oncology institute, where she received post-surgery treatment. Between 21 June and 27 August 2001 she apparently underwent four sessions of chemotherapy.

At the request of the applicant, Dr Lj.I. reviewed the earlier results of his analysis and reached the same conclusion, namely that the applicant was not suffering from breast cancer.

In the meantime, the applicant obtained possession of all four samples of the isolated tissue that Dr S.B. had used in his analysis of 30 May 2001. She handed over three samples of the tissue to Dr Lj.I. and Dr G.Z. who, after a detailed analysis, confirmed that there were no malignant elements in the analysed material.

The applicant also sent one sample of the tissue to Odessa Regional Medical Centre, which, in a report of 15 October 2001, ruled out the presence of malign ant elements.

Dr Lj.I. also sent a sample of the tissue to the Netherlands Cancer Institute in Amsterdam for further analysis. According to a medical report of 21 November 2001, the Netherlands Cancer Institute confirmed that there were no malignant elements in the tissue submitted for analysis. In the course of the compensation proceedings (see below), Dr Lj.I. stated that he had been told by experts at the Netherlands Cancer Institute that the applicant ’ s case had been very interesting and difficult to diagnose.

2. Compensation proceedings against the Skopje Hospital

On 7 March 2002 the applicant brought a civil action in the Skopje Court of First Instance against Skopje Hospital, seeking compensation for the non-pecuniary damage resulting from the alleged medical error as a result of which her right breast had been amputated. She claimed non-pecuniary damage in respect of fear, physical pain and emotional suffering for the disfigurement and reduced life activity. In this connection she argued that due to the error an important part of her body had been cut off as a result of which she became permanently handicapped.

In a judgment delivered on 27 April 2010 the Skopje Court of First Instance dismissed the applicant ’ s claim. In so doing, it relied on an expert opinion drawn up on November 2008 by a forensic panel ( Одбор за судско-медицински вештачења ) , the validity of which was not contested by the applicant. According to the forensic panel, there was no doubt as to the reliability of the expert opinions given by Drs Lj.I . and G.Z., the Odessa Regional Medical Centre and the Netherlands Cancer Institute. However, it noted that they had been provided with only a part of the medical material extracted from the applicant ’ s breast. In such circumstances, the forensic panel found that no inferences could be drawn as to whether the diagnosis – according to which the applicant was suffering from breast cancer – had been wrong. Any conclusion regarding the accuracy of that diagnosis would have to be based on an analysis of the entire material, which the applicant had refused to provide. In this latter context the court noted that, notwithstanding the court ’ s repeated requests to this effect, the applicant had refused to make the entire material available for examination. The court observed, in particular, the applicant ’ s refusal to provide the entire material after the forensic panel had submitted its opinion.

The court also took into consideration the statements of Drs M.K. and S.B., according to which the results of a histopathological examination were more reliable than those obtained on the basis of a biopsy. Furthermore, in his oral statement at the trial Dr S.B. confirmed the validity of his expert opinions. Dr Lj.I . also gave evidence endorsing the necessity of the surgery and the post-surgery chemotherapy carried out in the applicant ’ s case.

On the basis of the available evidence and the initial diagnosis, the court ruled that the mastectomy of the applicant ’ s right breast and the subsequent chemotherapy had been necessary in the circumstances. Analysis of the entire material ( four samples) would not compromise that conclusion. Accordingly, the court concluded that there had been no medical error or inadequate medical treatment in the applicant ’ s case.

The applicant appealed against the first-instance court ’ s judgment, complaining that it had wrongly established the facts, specifically that it had not given weight to the expert opinions militating against the presence of a cancer, and that it had relied on the expert opinion of the forensic panel. She submitted that she had not challenged the validity of that opinion since it had not stated whether or not she was suffering from cancer and whether it required urgent surgery, but instead had merely summarised the results of the previous expert opinions.

On 21 April 2011 the Skopje Court of Appeal dismissed the applicant ’ s appeal and upheld the lower court ’ s judgment, finding no grounds to depart from its findings of fact and the reasons given.

The applicant lodged an appeal on points of law in which she complained that the courts had not established whether or not the radical mastectomy of her breast had been necessary. In this connection she submitted that no explanation had been given as to whether the expert examinations carried out in Odessa and Amsterdam Hospitals would have led to different results had the entire material been made available. The courts established that the results would have remained the same had the entire material been submitted for examination. The fact that she had consented to the operation – a decision which she had taken on the basis of the information provided by Dr M.K. – had not released the Skopje Hospital from responsibility for the erroneous diagnosis that had led to amputation of her breast. Given her age, the surgery in question had considerably affected her immune system (because of the removal of lymph nodes) and her private life.

On 28 June 2012 the Supreme Court dismissed the applicant ’ s appeal on points of law and confirmed the lower courts ’ judgments on the basis of the admitted evidence (verbal and documentary). In this connection the court noted that the forensic panel had confirmed that it had proved possible to find malign ant elements in all of the four samples secured for examination. The applicant ’ s refusal to submit the samples which had been in her possession had been correctly interpreted by the lower courts as a factor militating against her claim.

B. Relevant international law and materials

1. 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 , Council of Europe, Oviedo, 4.IV.1997

“ Article 10 – Private life and right to information

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2. Everyone is entitled to know any information collected about his or her health. However, the wishes of individuals not to be so informed shall be observed. ”

2. A Declaration on the promotion of patients ’ rights in Europe, ICP/HLE 121 , 28 June 1994, World Health Organization

“ 2.2 Patients have the right to be fully informed about their health status, including the medical facts about their condition; about the proposed medical procedures, together with the potential risks and benefits of each procedure; about alternatives to the proposed procedures, including the effect of non-treatment; and about the diagnosis, prognosis and progress of treatment

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2.6 Patients have the right to choose who, if any one, should be informed on their behalf .”

3. European Charter of P atients ’ R ights, Rome, November 2002

“ Article 11 (right to avoid unnecessary suffering and pain)

Each individual has the right to avoid as much suffering and pain as possible, in each phase of his or her illness.

Article 14 (right to compensation)

Each individual has the right to receive sufficient compensation within a reasonably short time whenever he or she has suffered physical or moral and psychological harm caused by a health service treatment. ”

COMPLAINT

The applicant complains that due to the alleged medical error her immune system sustained considerable damage. Her compensation claim lodged against the Skopje Hospital in this respect was dismissed in proceedings that allegedly did not meet “the reasonable time” requirement under Article 6 of the Convention . She also relied on the international legal materials specified above (see “Relevant international legal materials” above).

QUESTIONS TO THE PARTIES

Do the facts of the case fall to be examined under Article 3 or 8 of the Convention ? If so, can it be said that the requirement of promptness and expedition was respected in the applicant ’ s case ( see I.G. and Others v. Slovakia , no. 15966/04, §§ 1 3 2 and 13 3 , 13 November 2012 ; and Bajić v. Croatia , no. 41108/10, § 103, 13 November 2012 , in the context of Article 2 of the Convention ) ?