CASE OF HRISTOZOV AND OTHERS v. BULGARIA

Remainder inadmissible;No violation of Article 2 - Right to life (Article 2 - Positive obligations) (Procedural aspect);No violation of Article 3 - Prohibition of torture (Article 3 - Degrading treatment;Inhuman treatment) (Substantive aspect);No violation of Article 8 - Right to respect for private and family life (Article 8-1 - Respect for private life)

David Thór Björgvinsson;George Nicolaou;Lech Garlicki;Nebojša Vučinić;Päivi Hirvelä;Vincent A. De Gaetano;Zdravka Kalaydjieva

The applicants were born in DATE , DATE , DATE , DATE , DATE , DATE and DATE respectively , and live(d ) in GPE , GPE , PERSON , PERSON , GPE , PERSON , PERSON and GPE respectively .

The first applicant in application no . CARDINAL and all CARDINAL applicants in application no . CARDINAL/CARDINAL have or had various types of terminal cancer . The second applicant in application no . CARDINAL is the first applicant ’s mother . CARDINAL of them succumbed to the illness shortly after lodging their applications ( see paragraph CARDINAL above ) .

Having either tried a host of conventional treatments ( including surgery , chemotherapy , radiotherapy and hormone therapy ) , or obtained a medical opinion that such forms of treatment would not work in their respective cases or were not available in GPE , all of them approached a private clinic in GPE , ORG ( Медицински център ORG ) , where they were told about an experimental anti - cancer product ( ORG ) which was being developed by a NORP company , ORG According to information from that company , their product has not been authorised in any country , but has been allowed for “ compassionate use ” ( for a definition of that term and comparable terms , see paragraphs DATE , CARDINAL and DATE below ) in a number of countries ( the GPE , GPE , GPE , GPE , GPE , GPE , GPE , GPE , GPE , GPE , and GPE ) . In a letter of CARDINAL DATE to ORG , the company said that as part of its preclinical development of the product it would be willing to provide the product free of charge to ORG , for use on cancer patients who could no longer benefit from conventional treatments , in return for data on the treatment ’s adverse and beneficial effects on each patient . It appears that ORG OOD has on a number of occasions in DATE applied for permission to import and use the product , but to no avail .

The parties were in dispute as to whether ORG had recently started undergoing clinical trials . The applicants said that , according to data extracted on DATE from the website of ORG and a website maintained by ORG , Mixed Bacteria Vaccine ( ORG ) was undergoing a phase CARDINAL clinical trial in GPE . On that basis , they argued that it complied with the requirements of LAW ( ORG ) no . CARDINAL/CARDINAL ( see paragraph CARDINAL below ) . The Government disputed that assertion , and submitted that it was not acceptable to establish the existence of clinical trials in GPE through information from websites in GPE .

The Government further submitted that ORG could not be described as a medicinal product within the meaning of the applicable ORG and domestic provisions . The applicants replied that the fact that it had not been authorised did not mean that it was not a medicinal product within the meaning of those provisions .

According to the applicants , MBVax PERSON has been used with some success on patients in clinics in GPE , GPE , GPE , and GPE . In support of that assertion the applicants submitted a number of letters and electronic mail messages from medical practitioners .

It appears that on DATE CARDINAL of the applicants , PERSON , travelled to GPE , where he obtained the product from ORG free of charge and it was administered to him CARDINAL times . However , shortly afterwards he returned to GPE because he could no longer afford to pay his living expenses in GPE or the fees of the health - care institution which administered the treatment .

Each of the applicants , including PERSON , who was acting on behalf of her sick son DATE applied to the authorities for permission to use ORG . In letters of DATE , DATE and CARDINAL and CARDINAL DATE the Director of ORG ( ORG агенция по лекарствата ) , the authority in charge of supervising the quality , safety and efficacy of medicinal products , pointed out that ORG was an experimental product not yet authorised or undergoing clinical trials in any country , which meant that it could not be authorised for use in GPE under Regulations no . DATE ( see paragraphs CARDINAL and CARDINAL below ) . He went on to say that NORP law made no provision for the use of unauthorised medicines outside clinical trials , and that , unlike the situation obtaining in other NORP countries , in GPE compassionate use of unauthorised products was not possible . Under the law of ORG there was no obligation to have a harmonised approach in this area . In some of the letters the Director added , without going into detail , that the information the applicants had about MBVax PERSON was incorrect .

Some of the applicants appealed to the Minister of Health , who in a letter of CARDINAL DATE fully agreed with the position expressed by ORG .

Three of the applicants in application no . PERSON applied to ORG . By letters of DATE and CARDINAL and DATE the ORG also informed them that ORG had not been authorised in any country , which meant that the only way in which they could obtain access to it in GPE was as part of a clinical trial .

The applicants did not seek judicial review .

On DATE ORG decided to strike ORG OOD out of the register of health institutions , on the ground that it was engaging in activities in breach of established medical standards . The clinic sought judicial review of the decision in ORG . A hearing was held on DATE . A second hearing was listed for DATE , but was adjourned to DATE , then to DATE , and then to CARDINAL October CARDINAL . The case is still pending before ORG .

Article CARDINAL of the LAW of DATE provides , in so far as relevant :

“ CARDINAL . Citizens shall be entitled to medical insurance guaranteeing them affordable health care , and to free health care under the conditions and in the manner provided for by law ...

The ORG shall protect the health of all citizens ...

No one may be subjected to forcible medical treatment or sanitary measures , except in cases provided for by law .

The ORG shall exercise control over all health care establishments and over the production of and trade in medicines , biologically active substances and medical equipment . ”

In a decision of CARDINAL DATE ( реш. № CARDINAL от CARDINAL февруари DATE г. по к. д. № CARDINAL от DATE г. , обн. , GPE , бр. CARDINAL от CARDINAL март DATE г. ) ORG said that unlike classic fundamental rights , such as the rights to life , freedom and security , private life , freedom of thought and of religion , the rights under LAW were social rights . They could not be directly enforced by the courts , and required ORG action to put them into effect . For that reason , the LAW specified that health care was to be carried out in a manner provided for by law .

Medicinal products in human ( as opposed to veterinary ) medicine are regulated by ORG DATE ( ORG за лекарствените продукти в хуманната медицина ) . Section CARDINAL(CARDINAL ) of that LAW , which echoes LAW MONEY ( see paragraph CARDINAL below ) , defines a “ medicinal product in human medicine ” as ( a ) any substance or combination of substances presented as having properties for treating or preventing disease in human beings , or ( b ) any substance or combination of substances which may be used in or administered to human beings , with a view either to restoring , correcting or modifying physiological functions by exerting a pharmacological , immunological or metabolic action , or to making a medical diagnosis . Section CARDINAL(CARDINAL ) , which echoes LAW of the Directive , in turn defines “ substance ” as any matter whose origin may be human ( human blood , human blood products , and so on ) , animal ( microorganisms , animal organs , extracts , secretions , toxins , blood products , and so on ) , vegetable ( microorganisms , plants , parts of plants , vegetable extracts , secretions , and so on ) , chemical ( elements , naturally occurring chemical materials and chemical products obtained by chemical change or synthesis , and so on ) .

Section CARDINAL(CARDINAL ) of the Act lays down the general rule that only medicinal products which have been authorised , either in GPE or under ORG centralised authorisation procedure under LAW ( ORG ) no . CARDINAL/CARDINAL ( see paragraph CARDINAL below ) , may be produced , imported , traded in , advertised , or used for medical treatment , prophylaxis or diagnostics .

The following sections set out certain exceptions to that rule . Section CARDINAL provides that no authorisation is required in respect of , in particular , ( a ) medicinal products prepared in a pharmacy in accordance with a medical prescription for an individual patient ( the magistral formula ) ; ( b ) medicinal products prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia ( the officinal formula ) ; and ( c ) medicinal products for “ hightechnology therapy ” prepared for an individual patient in accordance with the individualised specifications of a medical doctor and for use in a health - care institution under the doctor ’s direct personal responsibility . Section CARDINAL(CARDINAL ) empowers the Minister of Health to allow , under certain conditions , treatment with an unauthorised medicinal product in the event of an epidemic or of a chemical or nuclear contamination , if there is no suitable authorised medicinal product . Section CARDINAL(CARDINAL ) empowers the Minister to allow , under certain conditions , the use of a product which has not been authorised in GPE but has been authorised in another Member State of ORG .

Section CARDINAL ) provides that a patient may be treated with a medicinal product which has not been authorised if a hospital makes a request to that effect . The method and criteria for doing so are to be laid down in regulations by the Minister of Health .

The regulations governing that issue at the time when the applicants made their requests to be allowed to use ORG were Regulations no . CARDINAL of DATE ( ORG CARDINAL от DATE г. за условията и реда за лечение с неразрешени за употреба в ORG лекарствени продукти ) . They superseded Regulations no . CARDINAL of DATE ( ORG № CARDINAL от CARDINAL юни DATE г. за условията и реда за лечение с нерегистрирани лекарствени средства ) . Both of those regulations had been issued under LAW ) of ORG за лекарствата и аптеките в хуманната медицина ) , superseded by the DATE Act , which provided that medicinal products needed for the treatment of diseases having specific symptoms , when treatment with authorised medicinal products had proved fruitless , were to be exempted from authorisation under criteria and by methods laid down by ORG .

Regulation CARDINAL of Regulations no . CARDINAL provided that medicinal products which had not been authorised in the country could be prescribed if they had been authorised in other countries and were intended for the treatment of rare diseases or diseases having specific symptoms , when treatment with authorised medicinal products had proved fruitless .

Similar requirements had been laid down in LAW no . CARDINAL . Under that provision , medicinal products not registered in GPE could be used only if registered in other countries and if the disease that they were intended to treat could either not be treated with products registered in GPE or such treatment had proved fruitless .

The procedure under Regulations no . CARDINAL was as follows . A panel of CARDINAL medical doctors appointed by the head of a hospital ( CARDINAL of the doctors being a specialist in the treatment of the disease in issue ) was to prescribe the unauthorised product ( Regulation CARDINAL(CARDINAL ) and CARDINAL(CARDINAL ) ) . The prescription could not cover a period of DATE ( Regulation CARDINAL(CARDINAL ) ) . After that the prescription was to be approved by the head of the hospital ( Regulation CARDINAL(CARDINAL ) ) and sent to ORG , along with a declaration by the patient ( or his or her parent or guardian , as the case might be ) that he or she agreed to be treated with the unauthorised product ( Regulation CARDINAL(CARDINAL ) ) . ORG had DATE to decide whether to grant permission . If the relevant requirements had not been met , the ORG would issue a negative decision , which could be appealed against within DATE to the Minister of Health , who had DATE to decide the appeal ( regulation CARDINAL ) ) .

If the need for an unauthorised lifesaving product arose in a health - care institution other than a hospital , the head of that institution could draw up a document specifying the product and the required quantity and , having obtained the assent of ORG , apply for permission to ORG . The Minister could then make a decision specifying the product , the quantity and its recipients ( Regulation CARDINAL(CARDINAL ) ) .

On DATE no . CARDINAL were superseded by Regulations no . CARDINAL of CARDINAL DATE ( ORG CARDINAL от CARDINAL ноември DATE г. за условията и реда за лечение с неразрешени за употреба в ORG лекарствени продукти , както и за условията и реда за включване , промени , изключване и доставка на лекарствени продукти от списъка по чл. CARDINALа , ал. CARDINAL от Закона за лекарствените продукти в хуманната медицина ) .

Regulation CARDINAL(CARDINAL ) provides that only medicinal products which can be prescribed by a doctor in another country can be authorised for use under LAW Regulation CARDINAL(CARDINAL ) provides that medicinal products intended for use by an individual patient may be prescribed if they are authorised in other countries and treatment with medicinal products authorised in GPE is impossible or has failed . Regulation CARDINAL(CARDINAL ) provides that hospitals may also obtain unauthorised medicinal products if those have been made available under “ international and national programmes ” or by an international organisation which is the only entity in a position to procure those products .

The procedure under Regulations no . CARDINAL is as follows . A panel of CARDINAL medical doctors appointed by the head of the hospital ( CARDINAL of the doctors being a specialist in the treatment of the disease in issue ) must prescribe the unauthorised product ( regulations CARDINAL , CARDINAL ) and DATE ) ) . The prescription must be accompanied by the written informed consent of the patient ( or his or her parent or guardian , as the case may be ) ( Regulations CARDINAL(CARDINAL ) and CARDINAL ) ) , and can not cover a period of DATE ( Regulations CARDINAL(CARDINAL ) and CARDINAL ) ) . The prescription must then be approved by the head of the hospital ( Regulation CARDINAL(CARDINAL ) ) . After that ORG must either grant permission or issue a reasoned refusal ( Regulation CARDINAL(CARDINAL ) ) . It must issue a refusal if the form of the prescription or the medicinal products at issue do not meet the requirements of LAW ) ) . Refusal by the ORG is subject to appeal and judicial review ( Regulation CARDINAL(CARDINAL ) ) .

On DATE ORG added a new section , ORG , to the DATE Act . It came into force on DATE and provides , in subsection CARDINAL , that where it is not possible to treat a disease with medicinal products available in the country , an individual patient may be treated with a product which has been authorised in another member ORG of ORG and under LAW , but is not on the market in GPE . The Minister of Health must keep a list of such products and update it annually ( subsection CARDINAL ) . The explanatory notes to the amending PERSON referred to the need to allow NORP patients access to authorised medicines which are not available on the NORP market but which are available in other member GPE of ORG .

There is no reported caselaw under any of the three successive regulations ( Regulations no . CARDINAL , Regulations no . CARDINAL and Regulations no . CARDINAL ) .

Under LAW DATE , individual administrative decisions may be challenged before a court by those affected by them , on grounds of unlawfulness ( Articles CARDINAL § CARDINAL and CARDINAL § CARDINAL ) . There is no general requirement to first exhaust administrative remedies ( Article CARDINAL ) .

Statutory instruments , such as regulations , may also be challenged before ORG ( Articles CARDINAL § CARDINAL and CARDINAL § CARDINAL ) . Any individual or organisation whose rights , freedoms or legal interests have been or could be affected by such an instrument may do so ( LAW ) . The court ’s decision has erga omnes effect ( LAW ) . If a court strikes down a statutory instrument , it is deemed repealed from the date on which the court ’s decision becomes final ( LAW ) .

In a decision of DATE ( реш. № DATE от CARDINAL декември DATE г. по адм. д. № DATE г. , PERSON , петчл. с. ) ORG struck down regulations which required telephony and internet service providers to give ORG “ passive ” technical access to the communications data they were storing . The court held that , in not laying down any conditions or procedures for the grant of such access , the regulations enabled disproportionate interference with the rights protected under LAW ( private life ) and LAW ( correspondence and communications ) of the DATE LAW and under LAW , whereas it was obligatory for any such interference to be made subject to appropriate safeguards against abuse . The court went on to say that the regulations ran counter to various provisions of Directive CARDINAL/CARDINAL/EC on the retention of data generated or processed in connection with the provision of publicly available electronic communications services or of public communications networks , and amending Directive PERSON .

In decisions of DATE and DATE ( реш. № CARDINAL от CARDINAL март DATE г. по адм. д. № DATE г. , БАС ; реш. № CARDINAL от CARDINAL април DATE г. по адм. д. № CARDINAL г. , ORG ) the GPE and GPE administrative courts set aside international travel bans imposed on account of unpaid judicially established debts . In doing so the courts held that the provisions of NORP law under which those bans had been ordered ran counter to LAW CARDINAL/CARDINAL/EC on the right of citizens of ORG and their family members to move and reside freely within the territories of the member GPE . Just before that , on DATE , ORG had held , in a binding interpretive decision ( тълк. р. № CARDINAL от CARDINAL март DATE г. по т. д. № CARDINAL/CARDINAL г. , ORG , ORG ) , that such bans should be set aside if in breach of the Directive .

In a decision of CARDINAL DATE ( реш. от CARDINAL май DATE г. по адм. д. № ORG г. , ORG , ORG с. ) ORG set aside an order for the removal of an alien who had come to GPE at a very young age and had lived in the country with his family for a number of years . The court held that the order , which had not taken into account the alien ’s family situation and level of integration in the country , and corresponding lack of ties with the country to which he was to be removed , had been disproportionate . To reach that conclusion the court had relied not only on the relevant provisions of NORP law , but also on LAW CARDINAL § CARDINAL of the LAW on the Functioning of ORG and Articles CARDINAL , DATE and DATE of Directive CARDINAL/CARDINAL/EC , concerning the status of thirdcountry nationals who are longterm residents .

NORP In decisions of DATE and CARDINAL DATE ( опр. № CARDINAL от CARDINAL юни DATE г. по ч. к. а н. д. № CARDINAL г. , ORG , ORG к. с. ; опр. № CARDINAL от CARDINAL март DATE г. по к. DATE а. х. д. № CARDINAL г. , КАС ) the GPE and PERSON administrative courts quashed the lower courts’ decisions to discontinue proceedings for judicial review of fines imposed by the authorities in respect of administrative offences ( which had been excluded from judicial review by statute ) . The courts relied on LAW and the ORG ’s judgments in the cases of GPE v. GPE ( DATE , Series A no . CARDINAL ) , and PERSON v. GPE ( DATE , Reports of Judgments and Decisions CARDINALVI ) .

A patient DATE defined as any person who has asked for or who is being given medical treatment ( section GPE ) of LAW ) DATE has the right to , inter alia , ( a ) respect for his or her civil , political , economic , social , cultural and religious rights ; ( b ) clear and accessible information on his or her state of health and methods of treatment , if any ; ( c ) security and safety of the diagnostic and treatment procedures used for his or her treatment ; and ( d ) access to modern methods of treatment ( section CARDINAL(CARDINAL)(CARDINAL ) , ( CARDINAL)(CARDINAL ) , ( CARDINAL ) and ( CARDINAL)(CARDINAL ) of the same Act ) . Section CARDINAL(CARDINAL ) of the Act lays down the general rule that medical procedures may be carried out only with the patient ’s informed consent . In order to obtain such consent , the medical doctor responsible for the patient ’s treatment has to inform the patient of ( a ) the diagnosis and character of the disease ; ( b ) the aims and the nature of the proposed treatment , reasonable alternatives which may be available , the expected results and the prognosis ; ( c ) the potential risks of the diagnostic and proposed treatment methods , including side effects and adverse reactions , pain or other difficulties ; and ( d ) the likelihood of positive effects , as well as the risks to health of other methods of treatment or a refusal to submit to treatment ( section CARDINAL(CARDINAL ) ) . All this information must be given in an appropriate volume and form , so as to ensure freedom of choice of treatment ( section CARDINAL ) ) . In the event of surgical intervention , general anaesthesia or other diagnostic or treatment methods which entail a heightened level of risk to life or health , this information , as well as the patient ’s informed consent , must be in writing ( section CARDINAL ) ) .

The Medical Institutions Act DATE governs , inter alia , the registration and licensing of medical institutions . Under section CARDINAL(CARDINAL ) , institutions for nonhospital care and hospices are subject to registration , which has to be carried out by the health inspectorate with territorial jurisdiction ( section CARDINAL(CARDINAL ) ) . Under section CARDINAL ) , hospitals , complex oncological centres , and some other institutions which are not relevant to the present case , are subject to licensing . These licences are issued by ORG ( section CARDINAL(CARDINAL ) ) . Medical institutions can carry out their activities only if they have been registered or licensed , as the case may be ( section CARDINAL(CARDINAL ) ) . Their medical activities are subject to monitoring by the authorities ( section CARDINAL(CARDINAL ) ) .

Practising medical professionals must have an appropriate degree ( section CARDINAL ) and ( CARDINAL ) of LAW ) , and must be registered members of a professional association ( section CARDINAL(CARDINAL ) ) .

In ORG , a medicinal product may as a rule be placed on the market only when authorised , either via the “ centralised authorisation procedure ” or under national procedures ( there are detailed rules as to which products must or may go through the centralised procedure ) . The relevant provision , Article CARDINAL ) of Directive CARDINAL of ORG and of ORG on the ORG code relating to medicinal products for human use , as amended , provides as follows :

“ No medicinal product may be placed on the market of a Member ORG unless a marketing authorisation has been issued by the competent authorities of that Member ORG in accordance with this Directive or an authorisation has been granted in accordance with Regulation ( ORG ) No CARDINAL/CARDINAL , read in conjunction with Regulation ( ORG ) No DATE of ORG and of ORG on medicinal products for paediatric use and Regulation ( ORG ) No DATE . ”

There are , however , exceptions to this rule , such as the possibility of obtaining an unauthorised medicinal product via “ individual patient use ” , “ compassionate use ” or “ offlabel use ” . Article CARDINAL ) of the abovementioned Directive , which reproduced wording first introduced in DATE by the now - repealed Directive CARDINAL/CARDINAL/EEC , governs “ individual patient use ” . It reads as follows :

“ A Member ORG may , in accordance with legislation in force and to fulfil special needs , exclude from the provisions of this Directive medicinal products supplied in response to a bona fide unsolicited order , formulated in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under his direct personal responsibility . ”

The case of ORG v. GPE ( Court of Justice of ORG , ORG ) concerned the interpretation of those provisions . GPE argued that its domestic law complied with the derogation envisaged by Article CARDINAL ) of Directive CARDINAL . In a judgment of CARDINAL DATE , ORG held that by allowing the importation and placing on the market of unauthorised medicinal products which were cheaper than , and similar to , products already authorised in GPE , the ORG had failed to fulfil its obligations under LAW . In relation to the construction to be put on the derogation provided for under LAW , it held as follows :

“ CARDINAL As is apparent from the wording of that provision , implementation of the derogation for which it provides is conditional on fulfilment of a set of cumulative conditions .

CARDINAL NORP In order to interpret that provision , it must be taken into account that , generally , provisions which are in the nature of exceptions to a principle must , according to settled caselaw , be interpreted strictly ( see in particular , to this effect , Case CCARDINAL/CARDINAL Erotic Center [ DATE ] ECR ICARDINAL , paragraph CARDINAL and the caselaw cited ) .

CARDINAL More specifically , as regards the derogation referred to in Article CARDINAL ) of Directive CARDINAL , the ORG has already pointed out that the possibility of importing nonapproved medicinal products , provided for under national legislation implementing the power laid down in that provision , must remain exceptional in order to preserve the practical effect of the marketing authorisation procedure ( see , to this effect , Case CCARDINAL/CARDINAL LudwigsApotheke [ DATE ] ORG , paragraphs CARDINAL and DATE ) .

CARDINAL As the Advocate General stated in point CARDINAL of his ORG , the power , which arises from LAW , to exclude the application of the directive ’s provisions can be exercised only if that is necessary , taking account of the specific needs of patients . A contrary interpretation would conflict with the aim of protecting public health , which is achieved through the harmonisation of provisions relating to medicinal products , particularly those relating to the marketing authorisation .

The concept of ‘ special ORG , referred to in LAW of that directive , applies only to individual situations justified by medical considerations and presupposes that the medicinal product is necessary to meet the needs of the patient .

CARDINAL Also , the requirement that medicinal products are supplied in response to a ‘ bona fide unsolicited ORG means that the medicinal product must have been prescribed by the doctor as a result of an actual examination of his patients and on the basis of purely therapeutic considerations .

It is apparent from the conditions as a whole set out in Article CARDINAL ) of Directive CARDINAL/CARDINAL , read in the light of the fundamental objectives of that directive , and in particular the objective seeking to safeguard public health , that the derogation provided for in that provision can only concern situations in which the doctor considers that the state of health of his individual patients requires that a medicinal product be administered for which there is no authorised equivalent on the national market or which is unavailable on that market . ”

Separately , Article PERSON of the Directive permits a member ORG to allow a medicinal product authorised in another member ORG to be placed on its market , under certain conditions . Paragraph CARDINAL of that Article reads :

“ In the absence of a marketing authorisation or of a pending application for a medicinal product authorised in another Member ORG in accordance with this Directive , a Member ORG may for justified public health reasons authorise the placing on the market of the said medicinal product . ”

Further conditions are laid down in DATE and CARDINAL .

A further exception to the general prohibition laid down in DATE ) of Directive PERSON is contained in LAW ( ORG ) no . CARDINAL of ORG and of ORG , laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a ORG .

Recital CARDINAL of the Regulation says , in so far as relevant :

“ In order to meet , in particular , the legitimate expectations of patients and to take account of the increasingly rapid progress of science and therapies ... [ i]n the field of medicinal products for human use , a common approach should also be followed , whenever possible , regarding the criteria and conditions for the compassionate use of new medicinal products under Member PERSON legislation . ”

Article CARDINAL of the ORG provides :

“ CARDINAL . By way of exemption from LAW CARDINAL/CARDINAL/EC Member GPE may make a medicinal product for human use belonging to the categories referred to in LAW ) and ( CARDINAL ) of this Regulation [ medicinal products to be authorised either mandatorily or optionally via the centralised authorisation procedure , listed in an annex to the Regulation ] available for compassionate use .

For the purposes of this Article , ‘ compassionate use’ shall mean making a medicinal product belonging to the categories referred to in Article CARDINAL ) and ( CARDINAL ) available for compassionate reasons to a group of patients with a chronically or seriously debilitating disease or whose disease is considered to be lifethreatening , and who can not be treated satisfactorily by an authorised medicinal product . The medicinal product concerned must either be the subject of an application for a marketing authorisation in accordance with LAW or must be undergoing clinical trials .

When a Member ORG makes use of the possibility provided for in paragraph CARDINAL it shall notify the ORG .

When compassionate use is envisaged , ORG , after consulting the manufacturer or the applicant , may adopt opinions on the conditions for use , the conditions for distribution and the patients targeted . The opinions shall be updated on a regular basis .

Member GPE shall take account of any available opinions .

The Agency shall keep an uptodate list of the opinions adopted in accordance with paragraph CARDINAL , which shall be published on its website . Article CARDINAL ) and LAW shall apply mutatis mutandis .

The opinions referred to in paragraph CARDINAL shall not affect the civil or criminal liability of the manufacturer or of the applicant for marketing authorisation .

Where a compassionate use programme has been set up , the applicant shall ensure that patients taking part also have access to the new medicinal product during the period between authorisation and placing on the market .

This Article shall be without prejudice to Directive CARDINAL [ the Clinical Trials Directive ] and to LAW CARDINAL . ”

In DATE ORG adopted a Guideline on compassionate use of medicinal products pursuant to the said LAW . It states that the implementation of compassionate use programmes remains within the competence of a member ORG , that LAW is complementary to national legislations , and that the existence of Community authorisation for a medicinal product is without prejudice to any national legislation relating to compassionate use . The guideline goes on to specify that the objectives of LAW are threefold : ( a ) to facilitate and improve access for patients in ORG to compassionate - use programmes ; ( b ) to favour a common approach regarding the conditions of use , the conditions for distribution and the patients at whom the compassionate use of unauthorised new medicinal products is directed ; and ( c ) to increase transparency between member GPE in terms of availability of treatments . It also makes it clear that LAW is not applicable to products which are not eligible for the centralised authorisation procedure , nor to compassionate use on a namedpatient basis , as envisaged in LAW PERSON ( see paragraph CARDINAL above ) .

ORG has so far given CARDINAL opinions under LAW paragraph CARDINAL of the Regulation . The first , given on DATE in respect of GPE , concerned the product PERSON . The second , given on DATE in respect of GPE , concerned the product IV LOC .

A guideline drawn up by ORG pursuant to LAW CARDINAL/CARDINAL/EC and LAW ( ORG ) no . CARDINAL/CARDINAL , and entitled ‘ Volume CARDINALA – Guidelines on Pharmacovigilance for ORG Use’ , states the following :

“ CARDINAL . Reporting from Compassionate / Namedpatient use

Compassionate or namedpatient use of a medicine should be strictly controlled by the company responsible for providing the medicine and should ideally be the subject of a protocol .

Such a protocol should ensure that the ORG is registered and adequately informed about the nature of the medicine and that both the prescriber and the ORG are provided with the available information on the properties of the medicine with the aim of maximising the likelihood of safe use . The protocol should encourage the prescriber to report any adverse reactions to the company , and to ORG , where required nationally .

Companies should continuously monitor the riskbenefit balance of medicines used on compassionate or namedpatient basis ( subject to protocol or not ) and follow the requirements for reporting to the appropriate ORG . As a minimum , the requirements laid down in LAW , LAW [ Requirements for Expedited Reporting of ORG ] apply .

For inclusion of experience from compassionate or namedpatient use in ORG , see LAW [ ORG ] . ”

In DATE ORG published a survey of “ compassionate use ” programmes in CARDINAL NORP countries : GPE , GPE , GPE , GPE , GPE , GPE , GPE , GPE , GPE and GPE ( ‘ PERSON : Compassionate use of interventions : results of a European Clinical Research Infrastructures Network ( ECRIN ) survey of CARDINAL NORP countries . Trials DATE ) . It found that with CARDINAL exception ( GPE ) the laws of all the countries surveyed made provision for compassionate use / expanded access programmes . However , it also showed that those programmes had more differences than similarities . Some countries were without formal regulatory systems , and , for those who had adopted rules , they varied in content and comprehensiveness . For instance , some countries allowed “ compassionate use ” solely on a “ named / individual patient ” basis . The contents and requirements of the application for permission also varied . The survey called for ORG legislation to be more explicit with regard to regulatory requirements , restrictions and responsibilities in that area .

On the basis of more recent material available to the ORG in respect of GPE , it appears that GPE ( GPE , GPE , GPE , GPE , GPE , GPE , GPE , GPE , GPE , GPE , GPE , GPE , GPE , GPE , the GPE , GPE , GPE , GPE , GPE , GPE , GPE and GPE ) have in place rules , often adopted quite recently , allowing access to unauthorised medicinal products outside clinical trials for certain patients , notably for those who are terminally ill . The matter appears to be regulated in both primary and delegated legislation . In addition , in GPE ( GPE and GPE ) access to such products appears to be possible despite the absence of specific rules . GPE ( GPE , GPE , GPE , GPE and GPE ) appear not to have in place rules allowing access to unauthorised medicinal products outside clinical trials . However , in CARDINAL of those ( GPE and GPE ) domestic law appears to contain somewhat unclear provisions , which could be interpreted as allowing access . At the same time , there is a variety of practices among GPE as regards the type of access provided and the procedure to be followed . For instance , it appears that in GPE ( GPE , GPE , GPE and GPE ) , access to unauthorised medicinal products is possible only if those products have been authorised in another jurisdiction . GPE appear to allow access only for individual patients , and GPE allow access for both individual patients and groups ( or cohorts ) . The procedures for individuals and groups tend to vary , with the conditions attaching to group access being more stringent .

In GPE , regulations were issued in DATE laying down conditions under which promising new drugs that had not yet been licensed could be made available to persons with serious and life - threatening illnesses for whom no comparable or satisfactory alternative drug or treatment was available . Those regulations were revised and expanded in DATE . They are currently contained in LAW , LAW , Part CARDINAL , Subpart I ( Expanded Access to Investigational Drugs for Treatment Use ) , § § CARDINAL.CARDINAL , and make provision for an “ expanded access ” programme , under which ORG ( “ the ORG ” ) may , under certain conditions , authorise the use of an “ investigational new drug ” in respect of patients suffering from “ a serious or immediately lifethreatening disease or condition , [ when ] there is no comparable or satisfactory alternative therapy to diagnose , monitor , or treat the disease or condition ” ( CARDINAL CFR CARDINAL.CARDINAL(a)(CARDINAL ) ) . The general criteria governing the ORG ’s decision are whether “ [ t]he potential patient benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease or condition to be treated ” and whether “ [ p]roviding the investigational drug for the requested use will not interfere with the initiation , conduct , or completion of clinical investigations that could support marketing approval of the expanded access use or otherwise compromise the potential development of the expanded access use ” ( CARDINAL CFR CARDINAL ) and ( CARDINAL ) ) . The regulations contain separate provisions for individual patients , including for emergency use ( CARDINAL ORG ) , intermediatesize patient populations ( CARDINAL CFR CARDINAL ) , and widespread treatment use ( CARDINAL CFR CARDINAL ) .

In GPE , sections C.CARDINAL.CARDINAL and NORP of ORG make provision for a “ special access programme ” allowing medical practitioners to request access to drugs that are unavailable for sale in GPE for the treatment of patients with serious or lifethreatening conditions on a compassionate or emergency basis when conventional treatments have failed , are unsuitable , or are unavailable .

NORP In GPE , ORG of ORG runs a “ special access scheme ” , which allows , under certain conditions , the importation or supply of an unlicensed medicine for a single patient , on a case by case basis ( section CARDINAL of LAW DATE and LAW of LAW DATE ) .

In the case of GPE v. PERSON , CARDINAL GPE CARDINAL ( DATE ) , ORG unanimously dismissed a request by terminally ill cancer patients to enjoin the authorities from interfering with the distribution of an unlicensed drug . The court held that the statutory scheme governing drug licensing did not contain an implicit exemption for drugs intended for use by the terminally ill . In its view , the safety and effectiveness standards laid down in the legislation applied equally to such drugs , because the legislature could be regarded as intending to protect terminal patients from ineffectual or unsafe drugs . For such patients , as for anyone else , a drug was unsafe if its potential to cause death or physical injury was not offset by the possibility of therapeutic benefit . In relation to terminally ill people , unlicensed drugs carried a further risk , namely that the individuals concerned might eschew conventional therapy in favour of a drug with no demonstrable curative properties , with potentially irreversible consequences . In that connection the court noted , on the basis of expert evidence presented to it , that with diseases such as cancer it was often impossible to identify a patient as terminally ill other than in retrospect . It went on to say that acceptance of the proposition that statutory safety and efficacy standards have no relevance for terminal patients would be tantamount to denying the authorities’ power to regulate any drugs , however toxic or ineffective , for such individuals , which would allow abusive marketing of many purportedly simple and painless cures . Lastly , the court observed that its ruling did not exclude all resort to experimental cancer drugs by patients for whom conventional therapy was inefficacious , because the statutory scheme exempted from pre - marketing approval drugs intended solely for investigative use if they satisfied certain pre - clinical testing and other criteria .

In the more recent case of PERSON v. PERSON , in a decision of DATE ( CARDINAL F.CARDINALd CARDINAL ) ORG for ORG held , inter alia , that , as things stood , there was no right under the due process clause of GPE to use medical marijuana on a physician ’s advice , to preserve bodily integrity , avoid intolerable pain , and preserve life , even when all other prescribed medications and remedies had failed .

In the case of ORG et al . v. PERSON . , in a decision of CARDINAL DATE ( CARDINAL F.CARDINALd CARDINAL ) a threemember panel of ORG for GPE held , by CARDINAL votes to CARDINAL , that under the due process clause of GPE terminally ill patients had the right to decide whether to take un unlicensed drug that was in LAW clinical trials and that the producer was willing to make available . The court found that that right was deeply rooted in the traditional doctrines of selfdefence and interference with rescue , and that federal regulation of the effectiveness of drugs was too recent and haphazard “ to establish that the government has acquired title to [ that ] right by adverse possession ” . The panel went on to say that that right was “ implicit in the concept of ordered liberty ” .

On an application by the ORG , the same court reheard the case en banc , and in a decision of CARDINAL DATE ( CARDINAL F.CARDINALd CARDINAL ) held , by CARDINAL votes to CARDINAL , that federal regulation of drugs was “ consistent with [ the ] historical tradition of prohibiting the sale of unsafe drugs ” . The “ arguably limited ” history of efficacy regulation prior to DATE , when such regulation in GPE took its current shape , did not establish a fundamental right , because the legislature and the executive had “ continually responded to new risks presented by an evolving technology ” and because the legislature had a “ wellestablished power to regulate in response to scientific , mathematical , and medical advances ” . The court went on to say that selfdefence , the tort of interference with rescue , and ORG “ life or health of the mother ” abortion cases provided no support for a right to seek investigational drugs , because those doctrines protected only “ necessary ” lifesaving measures , whereas the claimants sought “ access to drugs that [ were ] experimental and [ had ] not been shown to be safe , let alone effective at ( or ‘ ORG for ) prolonging life ” .

On DATE ORG denied a petition for a writ of certiorari ( CARDINAL GPE CARDINAL ) .

In the case of PERSON v. ORG , CARDINAL F.CARDINALd CARDINAL , on DATE ORG for ORG upheld a lower court ’s decision not to issue an injunction sought by the claimants , who were individuals involved in a clinical drug trial sponsored by the defendant , a drug manufacturer , to require the defendant to continue providing them with the drug , even though the clinical trial had come to an end .

In the case of PERSON v. GPE ( Attorney General ) , DATE FC CARDINAL , ORG had to deal with applications for judicial review of decisions taken by the NORP federal health authorities under the abovementioned special access programme ( see paragraph CARDINAL above ) . The court held that in deciding to restrict access to a drug previously available under the programme the authorities had failed to strike a proper balance , because they had not taken due account of humanitarian or compassionate concerns . It referred the matter back to the authorities with instructions to weigh the “ valid objectives of public policy against the humanitarian factor ” . The judgment was not appealed against , and in DATE the case was settled , with the authorities agreeing to follow the court ’s recommendations .

In the case of B ( a minor ) , NORP ( on the application of ) v. ORG [ DATE ] EWCA Civ CARDINAL ( DATE ) , ORG held that the courts could not disturb a properly reasoned decision by the competent health authorities not to fund a round of experimental treatment for a terminally ill child . The Master of the Rolls , as he then was , Sir PERSON , made CARDINAL general comments . He firstly pointed out that the case involved the life of a young patient , which was a fact which had to dominate all consideration of all aspects of the case , because NORP society was CARDINAL in which a very high value was put on human life and no decision affecting human life could be regarded with other than the greatest seriousness . He secondly observed that the courts were not arbiters as to the merits of cases of that kind , because if they expressed opinions as to the likelihood of the effectiveness of medical treatment , or as to the merits of medical judgment , they would be straying far from their domain . He went on to say that difficult and agonising judgments had to be made as to how a limited budget was best allocated to the maximum advantage of the maximum number of patients . That was not a judgment which a court could make .

In the case of PERSON v PERSON and an ORG [ DATE ] EWHC CARDINAL ( Fam ) ( DATE ) , the parents of CARDINAL teenagers suffering from variant CreutzfeldtJakob disease sought judicial declarations that their children could receive an experimental treatment which research on mice had shown could possibly inhibit the advance of their terminal condition . ORG ( ORG ) allowed the applications , holding , among other things , that the lack of an alternative treatment for the incurable disease meant that it was reasonable to use an experimental treatment that presented no significant risk to the patient . The President of ORG , Dame PERSON , observed that the treatment was an untried one , and that until then there had been no validation of experimental work done abroad . However , she went on to say that if one waited for full certainty in experimental treatments , no innovative work such as the use of penicillin or heart transplant surgery would ever have been attempted . Referring to , inter alia , ORG and CARDINAL of the LAW and “ a very strong presumption in favour of a course of action which will prolong life ” , and having regard to the ORG prospects with and without treatment and the fact that no alternative treatment was available , she concluded that it was in their best interest that the treatment should be carried out . In reaching that conclusion , she also considered the wishes and feelings of the families , finding that their advocacy of treatment “ should carry considerable weight ” .


CASE OF PUOLITAIVAL AND PIRTTIAHO v. FINLAND

The applicants , PERSON and ORG , are NORP nationals who were born in DATE and DATE and live in GPE and GPE respectively .

The applicants were owners of a former company called PERSON ( hereinafter “ the applicants ' company ” ) , which was a claimant in civil proceedings initiated on DATE against another company called ORG ( hereinafter “ the GPE company ” ) . The proceedings concerned a dispute about the sale of movable property : the ORG company had refused to pay the applicants ' company the purchase price of an engine as they claimed , inter alia , that it did not contain all the components ordered .

The lawyer of the ORG company in the proceedings before ORG and in the lodging of an appeal with ORG on DATE was ORG , who was also at that time a judicial secretary ( hovioikeudenviskaali , hovrättsfiskal ) at ORG . Together with her husband , she owned a law firm until DATE . At the material time , PERSON worked part - time for the law firm as a partner , having been given permission to do so by ORG .

In her notice of appeal of CARDINAL DATE on behalf of the GPE company ORG submitted to ORG , inter alia , that the applicants ' company “ seems to use concepts quite carelessly in its agreements in general ” ; that “ what is essential about the case is that the seller must not act fraudulently and must not , even in good faith , draw up agreements the contents of which are unclear ” ; and , further , that “ if we follow the logic of ORG , overcharging is not a crime if you manage to overcharge CARDINAL victim ” .

The final decision in the above case was given by ORG on DATE in favour of the applicants .

The applicants ' company was also the claimant in another set of civil proceedings initiated on CARDINAL DATE in ORG ( kihlakunnanoikeus , häradsrätten ) , in which the respondent was an investment bank . That case concerned the bank 's refusal to grant the applicants ' company a bank guarantee for acquiring financing from abroad , and compensation for the ensuing loss of business profits . The applicants maintained , inter alia , that their company had been dissolved in DATE because of the bank 's failure to fulfil its contractual obligations . The applicants claimed , inter alia , MONEY ( ORG , equivalent to MONEY ( ORG ) ) in compensation for the business they had lost .

On DATE the ORG refused to examine the applicants ' claims as it found them to be too unspecific to provide a basis for any court proceedings .

On DATE ORG ( hovioikeus , hovrätten ) remitted the case to ORG ( from DATE käräjäoikeus , tingsrätten ) , finding that ORG should have examined the applicants ' claims . ORG did not take part in those proceedings .

On DATE the case was opened for re - examination by ORG . It found that although the bank had breached its obligations towards the applicants ' company , it had not caused the company 's liquidation , and dismissed its claims on DATE .

The applicants ' company appealed against that decision to ORG , which upheld ORG decision and dismissed the appeal on DATE . The bench of ORG which examined the case was composed of CARDINAL judges , including PERSON , who was now a judge .

The applicants ' company requested leave to appeal to ORG , stating , inter alia , that PERSON was biased as she had taken part in other proceedings in DATE ( the first set of proceedings ) , in which the opposing party had been represented by the law firm in which ORG had been a partner at that time . She had , for example , signed her client 's submissions to ORG and to ORG .

NORP Before making its decision concerning the request for leave to appeal , ORG requested a statement from ORG The statement , dated DATE ( the date was apparently erroneous in that DATE should have been DATE ) , read as follows :

“ In addition to full - time judge 's duties , I practised law as a partner in a law firm on a part - time basis , with the permission of the President of ORG , until DATE , when the firm was closed down . Thereafter I have had no part - time duties .

It is true that our law firm represented a client in a civil case between [ the GPE company ] and [ the applicants ' company ] before ORG . At that time the pleadings before ORG were handled by GPE ... and , after an appeal was lodged with ORG , the pleadings before ORG were handled by the advocate PERSON , as I found that it was not appropriate for me to continue with the case in ORG .

At the time of participating in the consideration of the present civil case between [ the applicants ' company ] and the investment bank , I did not even remember that our law firm , which had been closed down , had DATE represented a client in a different case in which [ the applicants ' company ] was the opposing party . Thus , no question of possible disqualification arose to be considered .

My personal view is that , when assessed on objective grounds , [ the applicants ' company ] had no real reason to doubt my impartiality , considering in particular that the period of time between my earlier representation and the decision - making stage in the present case was long , and that there was no factual link between the CARDINAL cases . ”

On CARDINAL DATE ORG refused the applicants ' company leave to appeal . According to the decision , Judge PERSON 's statement had been communicated to the applicants for information .

On DATE the applicants applied to ORG for annulment of the decision , again drawing attention , inter alia , to the alleged bias on the part of ORG The application was refused by ORG on DATE .

The provisions concerning the disqualification of judges were at the relevant time contained in LAW , section CARDINAL , of LAW ( oikeudenkäymiskaari , rättegångsbalken ) . It contained a list of grounds on which a judge might be disqualified . The relevant provisions concerning the impartiality of judges were subsequently amended ( Act no . CARDINAL/CARDINAL ) .

According to the domestic courts ' case - law , the question of possible bias on the part of a judge was addressed , inter alia , by assessing whether his or her earlier activities as legal counsel constituted a justified reason to doubt his or her impartiality .

ORG found in a decision of DATE ( no . CARDINAL:CARDINAL ) that a judge was not disqualified on the ground that he had earlier assisted CARDINAL of the parties to the case in separate proceedings , as his duties as a legal representative and counsel did not pertain to the case at hand and his conduct and standpoint in his capacity as counsel or legal representative did not give rise to any objective reason to doubt his impartiality in respect of matters concerning the other party .

LAW , section CARDINAL ( Act no . PERSON ) , of the Code of Judicial Procedure provides that the deadline for lodging an appeal is DATE from the date when the decision of ORG was delivered or made available to the parties . LAW , section CARDINAL , of the Code of Judicial Procedure , as in force at the relevant time , corresponded in essence to the current provision in the above - mentioned respects .


The applicants , Mr PERSON and PERSON , are NORP nationals who were born in DATE and DATE respectively and live in PERSON .

They were represented before the ORG by PERSON , a lawyer practising in Overath . ORG ( “ the Government ” ) were represented by their Agent , PERSON , PERSON , of ORG .

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

The applicants are the owners of a house and a flat in ORG , which is situated QUANTITY northeast of FAC .

As of DATE , on account of complaints from people living in another community close to the airport , the ORG responsible for consulting ORG with regard to noise pollution ( Fluglärmkommission des Luftverkehrsbundesamts ) , hereinafter referred to as “ the Commission ” ) identified other possible flight paths .

From DATE to CARDINAL DATE , still in order to obtain further data , a number of the new flight routes were used . This resulted in numerous protests on the part of the then affected communities .

On DATE ORG re - determined the flight routes for air traffic coming and going from the northeast – by means of an amendment to LAW implementing LAW ( PERSON GPE der Hundertsiebenundvierzigsten Durchführungsverordnung zur Luftverkehrs PERSON ) .

On DATE the applicants lodged a constitutional complaint against this decree .

On DATE ORG refused to admit the constitutional complaint on the ground that the applicants were first to seek protection before the administrative courts .

On DATE the applicants lodged a claim against the decree with ORG .

On DATE ORG rejected the claim as inadmissible .

On DATE ORG quashed that decision and remitted the case .

On DATE ORG rejected the claim as unfounded . It also refused leave to appeal .

On DATE ORG rejected the ORG appeal against the refusal for leave to appeal . It found that they merely criticised the decision in general terms without , however , substantiating any reason justifying leave to appeal as required by section CARDINAL § CARDINAL Federal Code of Administrative Proceedings ( see “ Relevant domestic law ” below ) .

On DATE the applicants lodged a constitutional complaint .

On DATE ORG refused to admit the constitutional complaint . It found that the applicants had failed to comply with the requirement to exhaust domestic remedies in accordance with the formal requirements laid down in domestic law .

The applicants received the decision on DATE .

Under section QUANTITY complaint against a refusal for leave to appeal must lay down either the fundamental importance of the matter , indicate the decision with which the impugned decision does not comply or indicate the alleged procedural shortcomings .


Violation of Art. 5-3;Violation of Art. 5-4;Violation of Art. 8;Non-pecuniary damage - finding of violation sufficient;Costs and expenses award

On DATE the applicant was arrested . On DATE ORG , PERSON , remanded him in custody on suspicion of theft of a car .

The applicant appealed to ORG . On DATE the court dismissed the appeal , finding that there was sufficient evidence to establish that the applicant might have committed the offence concerned and the reasons for which the applicant had been remanded in custody had not ceased to exist .

On DATE ORG prolonged the applicant 's detention until DATE , considering that the evidence gathered in the course of investigations strongly indicated that the applicant had committed the offence in question . An expert opinion had still to be taken .

On DATE ORG dismissed the applicant 's appeal against this decision , considering that the evidence strongly indicated that the applicant had committed the offence in question . Further time - consuming evidence still had to be taken , which justified the prolongation of the detention .

On DATE ORG refused to release the applicant , considering that the investigations had not been completed , further forensic evidence had to be taken and the reasons for which the detention had originally been decided had not ceased to exist .

On DATE the applicant wrote a letter to the ORG , complaining about alleged irregularities in the criminal proceedings against him and about having allegedly been assaulted by the police on his arrest . The prison authorities forwarded this letter to ORG . On DATE ORG informed the applicant that the letter to the ORG had been forwarded to ORG , for the purpose of investigating the alleged assault . It was later forwarded to the ORG . The letter reached the ORG 's office on DATE and was registered there under file number RPO CARDINAL . On CARDINAL DATE the applicant sent a further letter to the ORG .

On DATE ORG dismissed the applicant 's appeal against the decision of DATE . The Prosecutor considered that the evidence strongly indicated that the applicant had committed the offence in question . The reasons for which the detention had been ordered had not ceased to exist . The investigations should be continued and this required that the applicant should remain in detention .

On DATE the applicant filed a request with ORG to have the lawfulness of his detention reviewed as provided for by LAW . This request remained unanswered .

On DATE the ORG convicted the applicant of possessing stolen goods and ordered that he be released from detention on remand . The applicant and ORG filed appeals against this judgment .

On DATE the applicant was rearrested and ORG decided to put the applicant in detention on remand on suspicion of attempted theft of a car on DATE . The applicant appealed to ORG , invoking , inter alia , LAW . On DATE the court dismissed the appeal , considering that the detention on remand had been ordered in accordance with the law . Article CARDINAL § CARDINAL of the Code of Criminal Procedure provides that it is ORG who is competent to decide on detention on remand .

On DATE , in reply to the applicant 's letter of DATE , the ORG informed the applicant that the ratification of the ORG did not automatically entail the derogation of the provisions of NORP law relating to the authorities competent to decide on deprivation of liberty . Thus the courts and prosecutors were still obliged to apply domestic law currently in force in this respect . The relevant amendments to LAW had already been adopted by ORG , but they had not yet entered into force . Current public debate about the possible direct applicability of the LAW in the domestic legal order was of a purely theoretical nature . The decisions concerning the applicant 's detention were therefore in accordance with the law .

On DATE ORG amended the impugned judgment of DATE in that it found the applicant guilty of aiding and abetting the sale of stolen goods and sentenced him to DATE and DATE imprisonment and a fine .

At the relevant time , the authorities competent to decide on detention on remand were provided for in ORG CARDINAL and CARDINAL of LAW Code of Criminal Procedure of DATE , which read as follows :

" CARDINAL . Preventive measures [ i.e. detention on remand , bail and police supervision ] shall be imposed by the court ; before a bill of indictment is lodged with the court , they shall be ordered by the prosecutor ( ... ) . "

" CARDINAL . A decision concerning preventive measures may be appealed [ to a higher court ] ....

NORP A prosecutor 's order on detention on remand may be appealed to the court competent to deal with the merits of the case .... "

These provisions were amended on DATE by LAW DATE on LAW to LAW and Other Criminal Statutes , which entered into force on DATE . Pursuant to this amendment , detention on remand could be imposed only by a court order .

A new Code of Criminal Procedure was enacted by the PERSON ( ORG ) on DATE . Its Article CARDINAL , in its relevant part , reads :

“ CARDINAL . Detention on remand shall be imposed by a court order .

NORP In the investigative stage of proceedings , detention on remand shall be imposed , on a prosecutor 's request , by a district court in the jurisdiction of which investigations are being conducted . After a bill of indictment is lodged with a court , a decision to impose detention on remand shall be given by a court competent to deal with the merits of the case .

NORP The prosecutor , when submitting to a court a request referred to in § CARDINAL , shall at the same time order that the suspect be brought before a court . "

At the relevant time the presence of the parties at court sessions other than hearings was regulated in Articles CARDINAL and CARDINAL of the Code of Criminal Procedure of DATE , which , insofar as relevant , provided :

" The ORG pronounces its decisions at a hearing if the law provides for it ; and otherwise , at a court session held in camera . ... "

" A court session in camera may be attended by a prosecutor ( ... ) ; other parties may attend if the law provides for it . "

Pursuant to LAW , before deciding on the application of the preventive measures , the court shall hear the person charged with offence . The lawyer of the detainee should be allowed to attend in the court session , if he or she is present . It is not mandatory to inform the lawyer of the date and time of the court session , unless the suspect so requests and if it will not hinder the proceedings .

The court shall inform the lawyer of a detained person of the date and time of court sessions at which a decision is to be taken concerning prolongation of detention on remand , or an appeal against a decision to impose or to prolong detention on remand is to be considered .

At the material time the relations between the organs of the NORP State were set out in interim legislation , i.e. LAW of DATE ( Mała PERSON ) . LAW laid down the principle of the separation of powers in the following terms :

" The legislative power of the ORG shall be vested in the PERSON and the ORG of GPE ; the executive power shall be vested in the President of GPE and ORG ; and judicial power shall be vested in the independent courts . "

Under LAW , ORG ( PERSON ) shall be composed of the Prime Minister , Deputy Prime Ministers and Ministers .

In pursuance of LAW of DATE ( Ustawa o sądach powszechnych ) , the courts are entrusted with administration of justice in GPE . The courts are courts of appeal , regional courts and district courts . Under LAW , the ORG exercises supervisory jurisdiction over lower courts .

Article CARDINAL of the Act of DATE on ORG ( Ustawa o Prokuraturze ) which determines general principles concerning the structure , functions and organisation of prosecuting authorities , at the material time read as follows :

" CARDINAL . The prosecuting authorities shall be ORG , prosecutors and military prosecutors . Prosecutors and military prosecutors shall be subordinate to ORG .

The Prosecutor General shall be the highest prosecuting authority ; his functions shall be carried out by the Minister of ORG . "

LAW reads :

" The prosecuting authorities shall ensure the observance of the rule of law and the prosecution of criminal offences . "

Under LAW , in carrying out his statutory duties , a prosecutor shall abide by the principles of impartiality and equality of citizens before the law .

Pursuant to LAW , a prosecutor is independent in carrying out his or her duties , within the limits set out in this LAW . A prosecutor shall abide by the instructions , guidelines and orders of his superiors . However , if an order relates to the substance of any action to be taken in proceedings , a prosecutor may request [ his superior ] to issue the order concerned with reasons in writing , to alter the order , to relieve him from performing an act prescribed by that order , or to remove him from conducting the case in question . The requests to be removed from a case shall be decided by a hierarchical superior of the prosecutor who issued the order . "

Chapter III of LAW of DATE , applicable at the material time , entitled " Parties to proceedings , defence counsel , representatives of victims and representatives of society " , described a prosecutor as a party to criminal proceedings . According to all the relevant provisions of the LAW read together , a prosecutor performed investigative and prosecuting functions in the course of criminal proceedings . In particular , after completing the investigation , he drew up a bill of indictment and represented the prosecuting authority before the court competent to deal with the case .

Under LAW of DATE ” organs conducting criminal proceedings [ including a prosecutor ] shall examine and take into account evidence in favour of as well as against the accused . ”

Under LAW of DATE , it is the ORG 's task to examine , in his capacity as the guardian of human rights , whether the acts or failure to act on the part of the authorities , organisations and institutions whose functions necessarily impinge on these rights , breached the law or the principles of equity . The ORG may undertake measures provided for by law if he receives information from which it transpires that human rights have been breached . Pursuant to LAW , he is competent to investigate individual complaints . When investigating such complaints he may , inter alia , demand that the judicial , prosecuting and administrative authorities submit to him information about a concrete individual case . Under LAW , once the investigation is completed , the ORG may , if a breach of human rights and liberties has been found , present his opinion to the authority conducting the proceedings . The ORG 's actions must be compatible with the principle of the independence of the judiciary . He may also inform a superior authority of his findings and request that appropriate measures provided for by law be taken in respect of the person whose actions amounted to a violation of human rights .

At the relevant time the situation of persons detained on remand was governed by LAW of DATE . Under LAW that Code , all correspondence of a person detained on remand was subject to censorship , unless a prosecutor and a court decided otherwise . No provision of the Code provided for any remedy to contest the manner or scope of the censorship of a detainee ’s correspondence .

The rights of persons detained on remand as regards their correspondence were further set out in Rule CARDINAL of the Rules on Detention on Remand , adopted in DATE . They provided that the correspondence of persons detained on remand was subject to censorship by the authority conducting the criminal proceedings , i.e. either a public prosecutor or a court , depending on the stage reached in the proceedings .

On DATE a new LAW was enacted by parliament . LAW , which entered into force on DATE , provides that the convicted persons are entitled to uncensored correspondence with the ORG authorities and with the ORG . LAW further provides that convicted persons and their lawyers may lodge complaints with the international agencies established under international treaties on protection of human rights , ratified by GPE . ORG correspondence in such cases shall be dispatched with no delay and is not subject to censorship .

Pursuant to LAW , the rights of persons detained on remand shall , in principle , be at least equal with those of persons convicted by a final judgment .

Article CARDINAL of the GPE , which was later repealed , provided that the President of ORG carried out supervision over administrative aspects of the administration of justice by district courts within the jurisdiction of ORG , whereas DATE provided that the President of ORG carried out supervision over administrative aspects of the administration of justice by regional courts within the jurisdiction of ORG .


Violation of Art. 6-1;Violation of P1-1;Remainder inadmissible;Pecuniary damage - financial award;Non-pecuniary damage - financial award;Costs and expenses (Convention proceedings) - claim dismissed

The applicant was born in DATE and lives in the Sakha ( GPE of GPE .

On DATE and DATE ORG granted the applicant ’s claims against his former employer , a public company “ LOC ( ORG Авиакомпания « PERSON , “ the company ” ) , and ordered payment of wage arrears and court fees .

It appears that the judgments could not be enforced as the company went bankrupt . In DATE the court bailiffs forwarded the writs of execution to the company ’s receiver .

On an unspecified date the applicant sued the receiver . He claimed that the amounts outstanding should be adjusted for inflation .

On DATE the ORG discontinued the proceedings on the ground that the applicant had failed to appear at the hearings of DATE and CARDINAL DATE , despite having been duly notified thereof . The applicant did not appeal against that decision .

In DATE the applicant for the second time sued the company ’s receiver , asking to increase the amounts to take account of the inflation .

On CARDINAL DATE ORG dismissed his claim because the company had been declared bankrupt in DATE and had ceased to exist . On DATE ORG of the Sakha ( GPE upheld the judgment on appeal .

The applicant brought a civil action against ORG . He sought to enforce a ORG - issued promissory note for the purchase of a NORP - made car or to recover the monetary value thereof .

On DATE ORG of GPE granted the applicant ’s action and awarded him MONEY ( “ RUR ” , EUR CARDINAL ) . The judgment was not appealed against and it became final and enforceable .

The applicant was issued with a writ of execution which he submitted to the court bailiffs’ service . On DATE a bailiff of the CARDINALnd ORG of LOC of GPE refused to accept the writ because the law on budget for DATE and the implementing Government regulation , introduced in DATE , established that writs against the ORG were to be submitted directly to ORG .

On DATE the applicant sued ORG of the ORG seeking enforcement of the judgment of DATE and adjustment of the judgment debt for inflation . His claim was dismissed in the final instance on DATE by ORG of GPE as having no grounds in the domestic law .

On DATE the applicant also complained about the allegedly unlawful decision of the GPE bailiff ’s service to ORG of GPE . On DATE ORG dismissed the applicant ’s complaint in the final instance . It found that the bailiff had acted lawfully . The applicant received a copy of the judgment on DATE .

The judgment of DATE remains unenforced to date .