CASE OF MAKHARADZE AND SIKHARULIDZE v. GEORGIA
Remainder inadmissible;Violation of Art. 2 (substantive aspect);Violation of Art. 34;Non-pecuniary damage - award
Alvina Gyulumyan;Egbert Myjer;Ján Šikuta;Josep Casadevall;Luis López Guerra;Mihai Poalelungi;Nona Tsotsoria
5. On 14 March 2006 the first applicant, born in 1967, was arrested on account of his purported connection with the criminal world and possession of drugs, offences prosecuted respectively by Articles 223(1) § 2 and 260 § 2 (a) of the Criminal Code. On 16 March the Tbilisi City Court ordered his detention pending trial. He was subsequently placed in Ksani no. 7 prison. 6. On 17 March 2006 the first applicant appealed against the detention order of 16 March 2006, complaining, inter alia, that the pre-trial detention was an unjustifiably severe and unnecessary measure, given the poor conditions in the prison and his critical state of health. In support, he submitted medical documents, dated 11 May 2005 and 16 March 2006, which diagnosed him with pulmonary fibro-cavernous tuberculosis and confirmed that he was a registered patient at a civil tuberculosis hospital, Abastumani Hospital, in Georgia. 7. On 24 March 2006 the Tbilisi Court of Appeal dismissed the first applicant’s appeal of 17 March 2006. In reply to the medical complaint, the appellate court stated that “the submitted medical documents show only the diagnosis; no other medical documents about [the first applicant’s] current state of health, or the type and stage of his disease have been made available...”. The appellate court did, however, inform the prison authorities that the first applicant should be provided with appropriate conditions of detention and medical care in prison. 8. The applicant’s state of health drastically deteriorated during the following eleven days of his detention in Ksani no. 7 prison. Notably, he started having acute respiratory difficulties and, with his joints painfully swollen, became unable to move around without assistance. Following the Public Defender’s intervention, the applicant was transferred on 25 March 2006 to the Medical Establishment of the Prison Department of the Ministry of Justice (“the old prison hospital”). 9. After only two days in the old prison hospital, the first applicant was transferred back to Ksani no. 7 prison on 27 March 2006, where his state of health deteriorated further. Consequently, on 30 March 2006 the authorities returned him to the old prison hospital, where he was initially placed in the intensive care unit. 10. On 24 July 2006 the Tbilisi City Court convicted the first applicant of the offences with which he had been charged. He was sentenced to 7 years in prison. 11. By letters of 22 and 24 August 2006, the Ministry of Justice acknowledged that, following a medical examination conducted by its National Forensic Office (“the NFO”) between 1 May and 20 June 2006, the first applicant had been diagnosed with an open form of multidrug-resistant fibro-cavernous (or disseminated) tuberculosis, in the phase of infiltration and decomposition; he was haemorrhaging from the lungs. In addition, the examination results showed that the first applicant had been infected with viral hepatitis C and suffered from a number of serious cardiac and neurosensory disorders. The above-mentioned letters further stated that, since 4 April 2006, the first applicant had been receiving conventional, firstline anti-tuberculosis medication under the DOTS programme (Directly Observed Treatment, Short-course – the treatment strategy for the detection and cure of TB recommended by the World Health Organisation, see paragraph 48 below). 12. On 12 December 2006 the Tbilisi Court of Appeal upheld the first applicant’s conviction of 24 July 2006. His cassation appeal was rejected as inadmissible by the Supreme Court on 10 April 2007. 13. Between 26 September and 26 November 2007, medical experts from the NFO conducted an additional examination of the first applicant. Their conclusions (“the medical conclusions of 26 September-26 November 2007”) confirmed the previous diagnosis as regards his cardiac problems and tuberculosis. Concerning the latter disease, the experts added that the first applicant should be considered as a gravely ill patient who needed special treatment in a tuberculosis hospital. 14. On 4 July 2008 the first applicant, referring to all the available medical documents about the critical phase of his tuberculosis, including the medical conclusions of 26 September-26 November 2007, requested the suspension of the outstanding part of his prison sentence on the basis of the Order of 27 March 2003 of the Minister of Health (“the Order of 27 March 2003”). He complained, under Articles 2 and 3 of the Convention, that he was not provided with effective anti-tuberculosis drugs in prison, and that, consequently, there was a real risk to his life. 15. On 30 July 2008 the Tbilisi City Court examined the first applicant’s request of 4 July 2008 at an oral hearing. Amongst others, the court heard one of the medical experts who had issued the conclusions of 26 September-26 November 2007. The expert confirmed the accuracy of those conclusions, namely that the first applicant required treatment in a specialised hospital with particular drugs of second-line family (“SLDs”) to which his tuberculosis had not yet developed a resistance and which were not available in the prison system. The expert suggested that the first applicant’s condition would only deteriorate in prison, given the lack of the necessary drugs there. The expert confirmed that, according to the Order of 27 March 2003 (see paragraph 41 below), the applicant’s type of tuberculosis could serve as a basis for release from serving a sentence. 16. The Tbilisi City Court also heard a representative of the prison authorities, who stated that a more comprehensive system of multidrug resistant forms of tuberculosis treatment, DOTS+, would soon be introduced in Georgian prisons, and that the first applicant would be entitled to benefit from it. He was unable to specify the approximate dates of the introduction of that programme. The representative further stated that the first applicant had already been provided with permanent medical supervision in prison, and that the authorities would transfer him to a specialised hospital if his condition deteriorated. 17. During the hearing of 30 July 2008, the first applicant’s representative submitted a handwritten letter of his client dated 29 July 2008 informing the Tbilisi City Court of his inability to attend the hearing in person owing to his state of health. His counsel also submitted a medical opinion of Dr T.J., the doctor who was treating the applicant in prison, dated 30 July 2008, which confirmed the first applicant’s diagnosis at that time and stated that all the previous attempts to treat him in prison with the medication available through the already introduced DOTS programme had proved unsuccessful. The doctor confirmed that the comprehensive DOTS+ programme was planned to be introduced in the near future. 18. On the same day, 30 July 2008, the Tbilisi City Court delivered a decision dismissing the first applicant’s request for the suspension of his sentence as manifestly ill-founded. The court reasoned that no recent medical document about his current state of health had been made available. 19. On 15 August 2008 the first applicant lodged an appeal against the decision of 30 July 2008, denouncing the City Court’s failure to endorse the medical opinion of 30 July 2008 as proof of his current medical condition. He reiterated his fears that, without proper medical treatment in prison, the violation of his right under Article 3 of the Convention would persist and, in the worst scenario, could lead to his death, in violation of Article 2. 20. In the course of the appellate proceedings the first applicant made a request for an additional medical examination, so that all possible doubts about his state of health at that time could be dissipated. The Tbilisi Court of Appeal granted that request on 25 September 2008, ordering the prison authorities, and in particular the NFO, to examine the first applicant with the aim of establishing the nature and gravity of his diseases and obtaining recommendations on appropriate treatment for him. 21. In a reply dated 20 October 2008, the NFO implicitly refused to enforce the court order of 25 September 2008, stating that the first applicant’s state of health had already been assessed between 26 September and 26 November 2007, and that, prior to assessing the need for an additional examination, the Tbilisi Court of Appeal should first hear the relevant medical experts. 22. On 21 October 2008 the first applicant began a hunger strike to protest against the non-enforcement of the court order of 25 September 2008. In particular, and in line with that order, he requested a transfer to a specialised medical setting for diagnostic examinations, and denounced the fact that, despite his very critical condition, he was detained in a closed, “cellar-type” establishment. On the same day, the head of the old prison hospital issued an order putting the medical staff on alert for the duration of the applicant’s hunger strike. As disclosed by his medical file, the applicant was advised by doctors on a daily basis throughout the entire duration of his hunger strike (see paragraph 26 below) about the damage his self-harming conduct could cause to his health. 23. On 24 October 2008 representatives from the Public Defender’s Office visited the first applicant in the old prison hospital. As disclosed by the minutes of their visit, they found him in a critical condition – with his swollen joints, he remained bedridden, was vomiting purulent blood, and so on. The representatives also noted that only his family had been providing the applicant with such SLDs as cycloserin, p-aminosalicylic acid (“PAS”). 24. On 28 October 2008 the Public Defender’s Office expressed its concern about the first applicant’s aggravated state of health and invited the prison authorities to ensure his appropriate treatment. 25. On 31 October 2008, pursuant to the court order of 25 September 2008, the NFO started the first applicant’s medical examination, which ended on 7 November 2008. Its results (“the medical recommendations of 31 October-7 November 2008”) fully confirmed the previously diagnosed grave form of tuberculosis, showed that the disease had deteriorated since the previous examination and recommended that the applicant be treated with SLDs in a hospital specialised in tuberculosis treatment. 26. In the meantime, on 4 November 2008, the first applicant terminated his hunger-strike as the court order of 25 September 2008 had been enforced. On the same day his advocate enquired of the head of the old prison hospital whether or not the prison was able to provide the applicant with SLDs (such as cycloserin and PAS). The reply was negative. 27. On 27 November 2008 the first applicant was transferred to the newly opened medical wing of Tbilisi no. 8 prison (“the new prison hospital”). He was visited there on 2 December 2008 by representatives of the Public Defender’s Office, who witnessed that, although he was in a newly refurbished room, he was not being provided with the necessary SLDs and diet, or allowed to receive food parcels from his family, and the hospital staff would not change his bed-linen regularly even though he was sweating profusely. 28. On 5 December 2008 the first applicant started another hunger strike in protest against the failure to follow the medical recommendations of 31 October-7 November 2008. In particular, he requested that the prison authorities either provide him with the SLDs or transfer him to a specialised hospital. The new prison hospital was put on alert. As disclosed by the applicant’s medical file, he was reminded by the doctors on a daily basis, throughout the entire duration of his strike (see paragraph 31 below), how deleterious his refusal to take meals was for his state of health. The applicant also refused blood transfusions during that period. 29. On 8 December 2008 the Tbilisi Court of Appeal examined the first applicant’s appeal against the decision of 30 July 2008 at an oral hearing. The court heard one of the medical experts who had issued the medical recommendations of 31 October-7 November 2008. The expert confirmed the gravity of the applicant’s condition and stated that his anti-tuberculosis treatment had been unsuccessful owing to the lack of the necessary drugs in prison. The expert added that the applicant required a special diet and the exposure to fresh air, suggesting that there were some chances of successful treatment of his type of tuberculosis outside of prison. The appellate court also heard a representative of the prison authorities, who submitted an opinion of Dr T.J, the doctor who was treating the applicant in prison, dated 1 December 2008. According to that opinion, the applicant had been provided with a combination of unspecified SLDs since 22 June 2008 against which his tuberculosis maintained sensitivity. The examination of various parties during the hearing further disclosed the fact that it was the applicant’s family who had procured those SLDs from Germany. 30. In a decision of 8 December 2008, relying on the medical opinion of 1 December 2008 the Tbilisi Court of Appeal dismissed the first applicant’s appeal against the decision of 30 July 2008 as being unfounded. 31. On 9 December 2008 the first applicant terminated his hunger strike. 32. As disclosed by his medical file, from early January 2009 the applicant refused to take PAS and cycloserin, the SLDs procured by his family, in protest against the prison administration’s failure to provide him with a diet necessary for his condition. On 20 January 2009 the Public Defender’s Office complained about that problem to the prison authorities. 33. On the same day, 20 January 2009, following a drastic deterioration in his condition, the first applicant was placed in the intensive therapy unit of the new prison hospital. Nevertheless, his condition continued to deteriorate and he died at midnight on 29 January 2009. 34. On 24 October 2008 the first applicant requested, under Rule 39 of the Rules of Court, that the Government be indicated to transfer him to a specialised tuberculosis hospital, to arrange for his medical examination and treatment and to suspend his sentence pending treatment. 35. On 10 November 2008 the President of the Chamber partly granted the above-mentioned request, indicating to the Government that the first applicant should be placed in a specialised medical establishment capable of dispensing appropriate anti-tuberculosis treatment. That measure was imposed until further notice. In so far as the case file, as it stood at the material time, did not disclose that the Tbilisi Court of Appeal’s decision of 25 September 2008 ordering the applicant’s medical examination had already been enforced (see paragraph 25 above), the President indicated to the Government to ensure that it was enforced. The Government were further invited to report on the implementation of the indicated medical measures by 1 December 2008. 36. By a letter of 1 December 2008, the Government submitted to the Court the medical recommendations of 31 October-7 November 2008 in support of the fact that the court decision of 25 September 2008 had duly been enforced. 37. As to the first applicant’s transfer to a specialised tuberculosis hospital, the Government stated that such a measure was not necessary for the following reasons. First, the applicant had already been transferred, on 27 November 2008, to the new prison hospital, the medical services of which were comparable if not superior to those of a civil tuberculosis hospital. Secondly, even if the applicant were allowed to be treated at an outside tuberculosis hospital, such treatment would in any event be limited to DOTS, to which programme he had already had access in prison. 38. The Government further stated that the shortage of SLDs was a general pharmaceutical problem on a nationwide scale, which could in no way be imputed to the prison only. They promised that as soon as ofloxacin, PAS and cycloserin, the drugs capable of fighting the first applicant’s tuberculosis, appeared in the country’s pharmaceutical network, they would immediately be dispensed to him. In the meantime, the authorities allowed the applicant’s family to provide him with those drugs in prison. 39. In a letter of 27 January 2009, addressed to the Minister of Justice, the Public Defender expressed his deep concern about the failure to transfer the first applicant to a specialised tuberculosis hospital, contrary to the interim measure indicated by the Court on 10 November 2008; the Minister was urged to ensure the immediate enforcement of that measure. 40. Pursuant to section 65 §§ 1 (b) and 2 of the Imprisonment Act, a convict could be released from detention on account of his or her grave and/or incurable illness. The list of such grave/incurable illnesses was to be prepared by the Ministry of Healthcare. 41. On 27 March 2003 the Minister of Health issued an Order (Order no. 72) on the basis of section 65 of the Imprisonment Act, which established that destructive forms of pulmonary tuberculosis (fibrocavernous, milliary or cirrhotic) as well as poly or multidrug resistant tuberculosis are grounds for requesting early release. 42. Pursuant to Article 607 § 1 (a) of the CCP, a court could suspend a prison sentence in view of the convict’s grave state of health, if his or her illness impeded the proper execution of the sentence, pending the convict’s full or partial recovery. 43. Article 608 of the CCP provided for a possibility of early release by a court on account of the convict’s grave or incurable illness, which fact was to be established by a qualified medical opinion. 44. The relevant excerpts from the above-mentioned Report, bearing on the problem of tuberculosis in Georgian prisons, read: “Health-care services 76. Despite the goodwill and commitment of health-care staff at the penitentiary establishments visited, the provision of health care to prisoners remained problematic, due to the shortage of staff, facilities and resources. The delegation heard a number of complaints from prisoners at all the establishments visited concerning delays in access to a doctor, the inadequate quality of care ... and difficulties with access to outside specialists and hospital facilities. 77. The delegation noted that the supply and range of medication available at the establishments visited had considerably improved in recent years. Nevertheless, a number of prisoners complained that they depended on their families for the acquisition of most of the necessary medication. As to the equipment available at the establishments visited, it was generally limited to a stethoscope and an apparatus for measuring blood pressure; there were no facilities for taking X-rays or basic blood tests. This made the screening for transmissible diseases, including the detection of cases of tuberculosis unfeasible... 81. The CPT is concerned that the progress observed during the second periodic visit in the area of combating tuberculosis is jeopardised by the steep increase in the prison population and the ensuing problem of prison overcrowding. Despite the efforts of the ICRC, it was no longer possible to screen all new arrivals at Prison No. 5 in Tbilisi. Further, in the absence of routine medical examination upon arrival and the necessary laboratory equipment, no systematic screening for tuberculosis was performed at Prison No. 4 in Zugdidi, Prison No. 6 in Rustavi, Prison No. 7 in Tbilisi or Penitentiary establishment No. 2 in Rustavi. ... [R]ecommendations - the Georgian authorities to take steps to ensure that all newly arrived prisoners are seen by a health-care staff member within 24 hours of their arrival. The medical examination on admission should be comprehensive, including appropriate screening for transmissible diseases (paragraph 79);... - the Georgian authorities to persevere in their efforts to combat tuberculosis in the prison system, through systematic screening and treatment of prisoners in accordance with the DOTS method for tuberculosis control (paragraph 81).” 45. The relevant excerpts from the above-mentioned Report, bearing on the problem of tuberculosis in Georgian prisons, read: “46. Georgia’s imprisonment rate is very high by international standards and, as noted in the report on the visit in 2007, cannot be convincingly explained away by a high crime rate. If no steps are taken to limit the number of persons sent to prison, all attempts to improve conditions of detention will inevitably founder. ... Health care 94. The spread of tuberculosis in the prison system remains a major challenge for the Georgian authorities. The progress made over the years, with the important assistance of the International Committee of the Red Cross (ICRC), has been jeopardised by the increase in the inmate population and the ensuing problem of prison overcrowding. The delegation was concerned to note that, in the absence of routine medical examination upon arrival, no systematic screening for tuberculosis was performed ... TB case finding was based on a passive method (which essentially means waiting for prisoners with symptoms of TB to present themselves to clinical staff for diagnosis).... 99. The Medical establishment for prisoners in Tbilisi (Gldani), located within the perimeter of the Gldani penitentiary complex, represents a great improvement on the Central Prison Hospital visited by the CPT in 2001 and 2004. The delegation gained a globally positive impression of this new facility, inaugurated at the end of 2008 but in fact functioning fully only for a few months. With an official capacity of 258 beds, the establishment was accommodating 231 sick prisoners at the time of the visit. All the patients were men. There were five wards: surgery, psychiatry, infectious diseases, internal medicine and intensive care/reanimation. Further, there was an admissions unit, an X-ray unit, a dental office, a laboratory, rooms for endoscopy and physiotherapy, and a pharmacy. 100. The diagnostic equipment was modern and functional, and the establishment offered an adequate range of hospital treatments for prisoners. It was also possible to transfer sick prisoners to other hospital facilities for diagnostic treatments which were not available at the Medical establishment (an average of 5 transfers per week).... [R]ecommendations - ensure that prisoners in need of diagnostic examination and/or hospital treatment are promptly transferred to appropriate medical facilities...; - further steps to be taken to ensure the supply of appropriate medication in sufficient quantities to all establishments ...; - urgent measures to be taken to ensure that all newly arrived prisoners ... are seen by a health-care staff member within 24 hours of their arrival. The medical examination on admission should be comprehensive, including appropriate screening for transmissible diseases and injuries (paragraph 91); - the Georgian authorities to persevere in their efforts to combat tuberculosis in the prison system, through systematic screening and treatment of prisoners in accordance with the DOTS method for tuberculosis control. In this context, steps to be taken to ensure that prisoners diagnosed as BK-positive are promptly transferred to a hospital facility for treatment and that inmates with whom such prisoners have been in contact are screened for TB (paragraph 95).” 46. The relevant excerpts from the above-mentioned Report read: “Tuberculosis nevertheless remains a serious problem in the Georgian prison system. The spread of multi-drug resistant forms of tuberculosis remains a real threat, particularly in prisons, where lack of proper hygiene, lack of adequate medical facilities, insufficient medical staff, and, in particular, overcrowding, leave detainees more vulnerable to becoming infected with this highly contagious disease. Tuberculosis isolation facilities also become overcrowded and overburdened as the prison population increases; as a result, existing facilities may not be sufficient to isolate all tuberculosis patients from the general prison population. The growth of a tuberculosis epidemic in the prison system also places society at a real risk of an epidemic, as the disease can be readily transmitted from detainees to prison employees and to family members and others once detainees are released. Some experts also believe that there is a serious risk of an increase in coinciding HIV and tuberculosis epidemics in the region.... Recommendations ... Convicted persons who are seriously ill, in the final stages of terminal illness, or have diseases that require consistent and high-level treatment must be adequately monitored in detention. As conditions of detention risk exposing such vulnerable persons to inhuman and degrading situations, imprisonment should be used strictly as a last resort; efforts should be made to release such persons who are currently detained and alternative sanctions should be imposed whenever possible.... Conduct, without fail, systematic screening for tuberculosis of prisoners entering all facilities... Ensure that the internationally-recommended tuberculosis control strategy, directly observed therapy, short course (DOTS), is undertaken effectively by providing a regular supply of anti-tuberculosis drugs in sufficient quantities to all facilities and by training medical personnel in issuing DOTS. Provide nutrition and material conditions that are conducive to the improvement of tuberculosis patients’ health.” 47. The relevant excerpts from the above-mentioned report read: “Tuberculosis The high prevalence of tuberculosis in prisons is not something new, and constitutes one of the serious problems [facing] the penitentiary system worldwide. In spite of a series of projects implemented within the Georgian penitentiary system in coordination with the International Committee of the Red Cross, the problem of tuberculosis has ... worsened, far less been resolved. This is shown by the especially high number of persons who deceased with tuberculosis in 2009. In our view, one reason for this worsened situation is ineffective implementation of standard antituberculosis measures within the Georgian reality, with no regard to local specificities and without having assessed and analyzed the risk of a spread in TB. Medical personnel require in-depth preparation. Individual short-term training is not sufficient to resolve the problem, since the medical personnel are either unaware of or unable to use basic skills and knowledge of TB-infection management, given their very low medical autonomy and independence in taking decisions... Tuberculosis is currently the most widespread disease within the penitentiary system’s establishments in Georgia. In addition, as in previous years, in 2009 tuberculosis remained the number-one cause of death ... in prisons. Monitoring has revealed a high frequency of multi-resistant forms of tuberculosis. Extra-pulmonary forms of TB are not a rarity either, and their spectrum has significantly expanded so as to include [other] diseases, starting with TB pleurisy and ending with neuro-tuberculosis, which damages almost all internal organs. In our view, such a trend is a direct result of inadequate management of TB infection within the penitentiary system. Although a great number of penitentiary establishments do carry out screening for TB, and identify and include infected prisoners in relevant programmes, such measures are not effective enough, especially against the background that systemic and specific reasons for the spread of the disease have remained unresolved for years. Newly-built penitentiary establishments are not planned with a view to due consideration of lighting and aeration systems, which are crucial components in preventing the spread of tuberculosis. The infection is spread by inhaling air containing airborne parcels of mycobacterium tuberculosis, coughed out by a person infected with tuberculosis. Mycobacterium survives a few hours in the air and depends on the actual environment. Infection occurs, as a rule, in a closed space (room) that is not properly aerated. It should also be mentioned that direct sunbeams can quickly kill the mycobacterium tuberculosis, which is not possible in a closed space... We have discovered through monitoring that a total of 1,579 persons suffering from tuberculosis were identified by screening and further tests conducted in the establishments of the Georgian penitentiary system. Of these, 1,172 persons were involved in the DOTS program. 60 persons were diagnosed with the multi-resistant form of tuberculosis, of whom 59 persons were involved in the DOTS+ programme... Death rate in the penitentiary system of Georgia The Office of the Public Defender has been studying the death rate in Georgian penitentiary establishments for the last few years. 371 prisoners died in 2006-2009. 90 prisoners die every year on average... Based on various sources, including the results of the monitoring, the Office of the Public Defender has found that 91 prisoners (1 woman and 90 men) died in Georgia in 2009... As for the spread of tuberculosis and its effect on the [prisoners’] death rate, it should be noted that tuberculosis was found in 46 of the 91 deceased patients. As in previous years, tuberculosis remains a major cause of death within Georgian penitentiaries. Half of the prisoners (50.54%) who died in 2009 had lung tuberculosis. The increase in the proportion of prisoners infected with tuberculosis in the total number of deceased prisoners has become a recurrent trend. An increase in the number of extra-pulmonary forms of tuberculosis in recent years should be regarded as being directly caused by inadequate management of the tuberculosis infection. 13.18% of the deceased prisoners were infected with the multiresistant form of tuberculosis. Also, 19% of the deceased prisoners had pneumonia (39% of those who died from tuberculosis). Among the causes death in patients infected with tuberculosis, hemorrhagic shock and acute anemia were the direct cause of death in a number of cases. These, in their turn, were caused by bleeding from TBinfected lungs. Instances of pulmonary bleeding of varying intensities are described in 9 forensic medical reports. It should be mentioned that even the Medical Establishment for Tubercular Convicts does not offer TB-surgery services. Hence, such patients are, in fact, destined to die. TB infection is often contracted at the same time as virus hepatitis and human immunodeficiency virus... The index of prisoners who died from the multi-resistant form of tuberculosis was higher in the second half of 2009 than in the first half. For this reason, we think it is necessary to enquire into details of how the DOTS+ programme is progressing and to include the country’s leading specialists and institutions in future planning. Organisational errors are also frequent in the management of tuberculosis.” 48. In 1992 the World Health Organisation (“the WHO”) developed a global strategy for treatment of ordinary tuberculosis, which was called DOTS (Directly Observed Treatment, Short-course). In 1997 the WHO extended the initial DOTS programme to include the treatment of multidrug resistant forms of tuberculosis. To facilitate the implementation of this new, extended programme, which was subsequently called DOTS+, the WHO published in the same year Guidelines for the Management of Drug-Resistant Tuberculosis. The relevant excerpts from these Guidelines read as follows: “FOREWORD 1. About one third of the world’s population is infected by M. tuberculosis. Worldwide in 1995 there were about nine million new cases of tuberculosis with three million deaths. M. tuberculosis kills more people than any other single infectious agent. Deaths from tuberculosis comprise 25% of all avoidable deaths in developing countries. 95% of tuberculosis cases and 98% of tuberculosis deaths are in developing countries; 75% of these cases are in the economically productive age group (15 - 50 years). 2. As a consequence, the world is facing a much more serious situation as we approach the twenty-first century than in the mid-1950s. Due to demographic factors, socio-economic trends, neglected tuberculosis control in many countries, and in addition, the HIV epidemic, there are many more smear-positive pulmonary tuberculosis cases, often undiagnosed and/or untreated. When tuberculosis cases are treated, poor drug prescription and poor case management are creating more tuberculosis patients excreting resistant tubercle bacilli. 3. In 1991, the World Health Assembly adopted Resolution WHO 44.8, recognizing “effective case management as the central intervention for tuberculosis control”, and recommending the strengthening of national tuberculosis programmes by introducing short course chemotherapy and improving the treatment management system. Since 1992, the WHO Global Tuberculosis Programme has developed a new strategy, to meet the needs of global tuberculosis control. “DOTS” is the brand name of the WHO recommended tuberculosis control strategy. ... 6. The issue of the treatment of those pulmonary tuberculosis patients who remain sputum smear-positive following fully supervised WHO retreatment regimen should be considered. Although these cases represent a small minority of tuberculosis patients, they constitute an ongoing problem for programme managers. Due to the lack of financial resources, many countries cannot provide the range of the expensive second-line drugs which might give some hope of cure to these patients. However, more economically prosperous countries might wish to do so, especially if they have inherited a significant number of patients with multi drug resistant (MDR) tuberculosis from a period when treatment was unorganized and chaotic. Many countries also lack information about the correct use of second-line drugs. The WHO Tuberculosis Control Workshop held in Geneva, October 1995, discussed this issue and recommended that a country prepared to go to this expense should only provide these second-line drugs for a specialised unit (or units in large countries), in close connection with a laboratory able to carry out cultures and reliable susceptibility tests of M. tuberculosis to the drugs. The WHO Global Tuberculosis Programme has prepared these “Guidelines for the Management of Drug-Resistant Tuberculosis”, to meet the need for clear advice on this issue. ... 1.2 HOW IS MDR TUBERCULOSIS PRODUCED? As with other forms of drug resistance, the phenomenon of MDR tuberculosis is entirely man-made. Drug resistant bacilli are the consequence of human error in any of the following: prescription of chemotherapy; management of drug supply; case management; process of drug delivery to the patient. The most common medical errors leading to the selection of resistant bacilli are the following: (a) the prescription of inadequate chemotherapy to the multibacillary pulmonary tuberculosis cases (e.g. only 2 or 3 drugs during the initial phase of treatment in a new smear-positive patient with bacilli initially resistant to isoniazid); (b) the addition of one extra drug in the case of failure, and repeating the addition of a further drug when the patient relapses after what amounts to monotherapy. The most common errors observed in the management of drug supply are the following: (a) the difficulty experienced by poor patients in obtaining all the drugs that they need (due to lack of financial resources or social insurance); (b) frequent or prolonged shortages of antituberculosis drugs (due to poor management and/or financial constraints in developing countries); (c) use of drugs (or drug combinations) of unproven bioavailability. The following also have the effect of multiplying the risk of successive monotherapies and selection of resistant bacilli: (a) the patient’s lack of knowledge (due to a lack of information or due to inadequate explanation before starting treatment); (b) poor case-management (when the treatment is not directly observed, especially during the initial phase). ... 2.1 SPECIALISED UNIT Treatment of patients with MDR tuberculosis (especially those with resistance to rifampicin and isoniazid) may have to involve “second line” reserve drugs. These are drugs other than the “standard” essential antituberculosis drugs, i.e. rifampicin (R), isoniazid (H), streptomycin (S), ethambutol (E), pyrazinamide (Z), thioacetazone (T). These reserve drugs are much more expensive, less effective and have many more side effects than standard drugs. They should only be made available to a specialised unit and not in the free market. It is the responsibility of national health authorities to establish strong pharmaceutical regulations to limit the use of second-line reserve drugs in order to prevent the emergence of incurable tuberculosis. 2.2 DESIGNING AN APPROPRIATE REGIMEN Designing an appropriate regimen for the individual patient needs experience and skill. It includes allocating the time and patience to define precisely the following: (a) which regimen(s) the patient had previously received; (b) whether the patient took all the drugs in each regimen prescribed and for how long; (c) to find out what happened bacteriologically, in terms of sputum positivity (at least by direct smear, if possible also by culture and susceptibility tests) during and after the administration of each regimen. Clinical and radiological progress or deterioration is much less reliable but may be used as a check on the bacteriological results. 2.3 RELIABLE SUSCEPTIBILITY TESTING The specialised unit must have the services of a laboratory able to carry out culture and reliable tests for drug resistance (to the essential drugs and also to second-line drugs). The quality of the susceptibility tests carried out in this laboratory should be regularly checked by another reference laboratory at national or supranational level. 2.4 RELIABLE DRUG SUPPLIES The unit must also be guaranteed reliable supplies of the expensive “second line” reserve drugs, so as to ensure that any treatment undertaken for an individual patient can be successfully completed.