FOURTH SECTION

DECISION

Applications nos. 21320/15 and 35837/15 A.M. against Hungary and A.K. against Hungary

The European Court of Human Rights (Fourth Section), sitting on 4 April 2017 as a Chamber composed of:

Ganna Yudkivska, President, Vincent A. De Gaetano, András Sajó, Paulo Pinto de Albuquerque, Krzysztof Wojtyczek, Egidijus Kūris, Marko Bošnjak, judges, and Marialena Tsirli, Section Registrar ,

Having regard to the above applications lodged on 15 April 2015 and 16 July 2015 respectively,

Having regard to the observations submitted by the respondent Government and the observations in reply submitted by the applicants,

Having deliberated, decides as follows:

THE FACTS

1. The applicant in the first case, Mr A.M., is a Hungarian national, who was born in 1978 and lives in Sopron. The applicant in the second case, Mr A.K., is a Hungarian national, who was born in 1968 and lives in Budapest. The President granted the applicants ’ requests for their respective identities not to be disclosed to the public (Rule 47 § 4). The applicants were represented before the Court by Mr T. Fazekas, a lawyer practising in Budapest.

2. The Hungarian Government (“the Government”) were represented by their Agent, Mr Z. Tall ó di.

A. The circumstances of the case

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

1. The first applicant

4. The first applicant suffers from diffuse cutaneous systemic sclerosis, which is an auto-immune disease characterised by thickening of the skin as a result of an accumulation of collagen, and by injuries to the smallest arteries. In its most serious form the illness may progress to the visceral organs, including the kidneys, heart, lungs and gastrointestinal tract.

5. The disease has led to a number of health issues for the first applicant, including respiratory problems, a severe digestive condition and a weight loss of 15 kilograms.

2. The second applicant

6. The second applicant suffers from multiple sclerosis, which was diagnosed in 1998. This disease, which affects the patient ’ s central nervous system, has caused a continuous deterioration in his health.

7. He is now wheelchair-bound and can no longer lift his legs. His eyesight is worsening; he is in serious pain and has frequent urination problems.

3. Situation in Hungary

8. The marketing of cannabis-based medication is not currently authorised in Hungary. However, under domestic law a person wishing to use a medication which has no marketing authorisation can apply – on the basis of a medical prescription issued by a doctor in Hungary – for an individual import licence to the National Institute of Pharmacy and Nutrition (NIPN) (see Relevant domestic law below).

9. The NIPN is the licensing authority for pharmaceutical and public administration matters. It was established by a Government Decree and its main aim is to provide the public with safe, effective and quality medicines in accordance with the applicable regulations. Among many other tasks, the NIPN examines notifications on the quality of medicinal products and adverse drug reactions, and deals with the authorisation of medicinal products and with ensuring that defective batches posing a threat to human health are withdrawn from the market. Furthermore, the NIPN authorises the manufacture and distribution of medicinal products and the activity of parallel importation in accordance with strict considerations. The NIPN is also competent for authorising and supervising clinical trials on investigational medicinal products, “off-label” indications, individual requests for medicinal products and dispensing of medicinal products.

10 . The NIPN ’ s webpage entitled “Authorisation of individual medicine import” contains the following text:

“Medicinal products which have no marketing authorisation in Hungary (but [do have one] in the EEA [ European Economic Area] or outside the EEA) may be imported within the frame of outpatient and bedpatient service.

Application for a requested medicinal product may be handed in only by the medical attendant or the specialist by submitting the appropriate forms for this purpose. The stamped data sheet being filled in correctly and the detailed anamnesis (not older than 6 months) have to be submitted to the Department of Individual medicine import [to the following address ...].

All applications are examined thoroughly within 8 days – if necessary in cooperation with a medical expert advisory panel – and a declaration or a decision is issued by the NIPN dependently whether the medicine is being imported from the EEA or outside the EEA:

• if the product would be imported from the EEA the NIPN will issue a declaration whether the request is reasonable;

• if the product would be imported from outside the EEA the National Institute of Pharmacy will issue an authorisation after the examination of the necessity of the medicine.

The physician takes the responsibility for the application of the medicine, it is confirmed by their signature. Please note that the medicinal product is to be applied only in the indication stated in the Summary of Product Characteristics. Off-label use is to be considered as a medical investigation carried out without any licence and will be punished with 5 years ’ imprisonment.”

B. Relevant domestic law

1. The Fundamental Law of Hungary

11. The Fundamental Law of Hungary, insofar as relevant, reads as follows:

Article VI

“(1) Everyone shall have the right to respect for his or her private and family life, home, communications and good reputation.”

Article XX

“(1) Everyone shall have the right to physical and mental health.”

2. The Constitutional Court Act

12 . The Constitutional Court Act No. CLI entered into force on 1 January 2012 and, insofar as relevant, provides as follows:

Section 26

“(1) In accordance with Article 24 (2) (c) of the Fundamental Law, persons or organisations affected by a specific case may submit a constitutional complaint to the Constitutional Court if, due to the application of a legal regulation contrary to the Fundamental Law in their judicial proceedings,

(a) their rights enshrined in the Fundamental Law have been violated, and

(b) the possibilities for legal remedy have already been exhausted or no possibility for legal remedy is available.

(2) By way of derogation from subsection 1, constitutional court proceedings may also be initiated in exceptional circumstances if

(a) due to the application of a legal provision contrary to the Fundamental Law, or when such legal provision becomes effective, rights have been directly violated, without a judicial decision, and

(b) there is no procedure for obtaining a legal remedy designed to repair the violation, or the petitioner has already exhausted the possibilities for obtaining a remedy.

Section 27

In accordance with Article 24 (2) d) of the Fundamental Law, persons or organisations affected by judicial decisions contrary to the Fundamental Law may submit a constitutional complaint to the Constitutional Court if the decision made regarding the merits of the case or other decision terminating the judicial proceedings

a) violates their rights laid down in the Fundamental Law, and

b) the possibilities for obtaining a legal remedy have already been exhausted by the petitioner or no possibility for obtaining a legal remedy is available to him or her.”

3 . The Medicinal Products for Human Use Act

13 . Act No. XCV of 2005 on Medicinal Products for Human Use and on the Amendment of Other Acts Regulating the Market of Medicinal Products (hereinafter “the Medicinal Products for Human Use Act”), insofar as relevant, provides as follows:

Section 25

“(1) Medicinal products may be prescribed in accordance with section 129 of Act No. CLIV of 1997 on Health Care – with the exceptions set out in this Act and in the decree implementing it – in accordance with the indications referred to in the summary of product characteristics as approved in the marketing authorisation , or in the Catalogue of Standard Prescriptions where applicable. Medicinal products may be prescribed by any doctor or dentist (hereinafter referred to collectively as “doctor”) who is qualified to engage in activities subject to a doctor ’ s diploma and who has an official stamp for authorisation , as laid out in other specific legislation, to prescribe medicinal products.

(2) Any medicinal product that has been authorised for marketing in a country other than a State party to the EEA Agreement may be used for a medicinal purpose in exceptional cases if justified by patient-care interests deserving special consideration, and if it has been authorised by the government body for pharmaceuticals in accordance with the requirements set out in other specific legislation. Any medicinal product that has been authorised for marketing in any of the States parties to the EEA Agreement may be used for a medicinal purpose if it has been notified to the government body for pharmaceuticals in accordance with the provisions of other specific legislation. Patient-care interests deserving special consideration shall be determined in terms of the safety and efficacy of the therapeutic procedure following consultation with the competent advisory board where deemed necessary.

(3) Detailed regulations on the prescription of medicinal products by doctors are laid down in other specific legislation.”

4. The Decree on prescribing and issuing medicinal products

14 . The relevant provisions of Decree No. 44/2004 (IV.28) ESzCsM of the Minister of Health, Social and Family Matters on prescribing and issuing medicinal products for human use (hereinafter “Decree on prescribing and issuing medicinal products”) read as follows:

Medicinal products that can be prescribed by physicians

Section 3

“(5) Pursuant to section 25(2) of the Medicinal Products for Human Use Act, a physician may prescribe any medicinal product that has not been authorised for marketing in Hungary but has been authorised for marketing in a European Economic Area (hereinafter referred to as EEA) Member State or in any State with legal status identical to that of an EEA Member State pursuant to an international treaty concluded with the European Community or the EEA, only if he or she notifies [the National Institute of Pharmacy and Nutrition (“NIPN”)] about it before issuing the prescription and obtain a declaration [from the NIPN], stating that:

(a) the medicinal product to be prescribed is authorised for marketing for the indication specified by the physician in a State signatory to the EEA agreement specified by the physician,

(b) the competent authority has not withdrawn the marketing authorisation or suspended the distribution of the medicinal product to be prescribed, and

(c) in his or her opinion, the patient-care interests deserving special consideration, as specified in section 23(1) of the Medicinal Products for Human Use Act, prevail pursuant to the data supplied by the physician.”

Request for the purchase of an individual medicinal product

Section 4

“(1) Based on the request of the doctor of the institution providing inpatient care or the treating doctor and when the conditions specified in section 3 prevail, the purchase of individual medicinal products not specified in section 3 and not having a marketing authorisation in the EEA Member States or other Member States signatory to the EEA agreement but having a marketing authorisation in other countries may be authorised by [the NIPN] following a review of the need for the application.”

5. The Criminal Code

15 . The relevant provisions of the Criminal Code (Act No. C of 2012) read as follows:

Drug trafficking

Article 176

“(1) Any person who offers or supplies narcotic drugs or is engaged in the distribution of or trafficking in narcotic drugs is guilty of a serious offence punishable by imprisonment of between two and eight years.”

Possession of Narcotic Drugs

Article 178

“(1) Any person who produces, manufactures, acquires, possesses, imports or exports, or transports narcotic drugs in transit through the territory of Hungary is guilty of a serious offence punishable by imprisonment of between one and five years.

...

(6) Any person who consumes narcotic drugs, or acquires or possesses a small quantity of narcotic drugs for his or her own consumption is guilty of a minor offence punishable by imprisonment not exceeding two years, insofar as the act did not result in a more serious criminal offence.”

Article 180

“(1) Any person who produces, manufactures, acquires or possesses a small quantity of narcotic drugs for his or her own consumption shall not be prosecuted if the perpetrator has admitted to having committed the criminal offence and if he or she is able to produce a document before being sentenced in the first instance to verify that he has been treated for drug addiction for at least six consecutive months or that he has participated in a drug rehabilitation programme or a preventive consultation service relating to dependency.”

C. Relevant international material

1. The World Health Organisation

16 . The World Health Organisation ’ s information document entitled “Cannabis and cannabis resin”, prepared for the 36 th meeting of the Expert Committee on Drug Dependence held in June 2014, insofar as relevant, reads as follows:

“(9) Therapeutic applications, extent of therapeutic use and epidemiology of medical use

Since the last decade of the twentieth century, evidence for medical uses increased considerably. Indications being considered among others include spasticity, chronic pain and some neuropsychiatric symptoms. In different ways, various countries recognized a role for safe and effective medicinal use of cannabis.

Currently, medical use of cannabis is allowed in a number of countries. In the past 20 years, its (legal) medical consumption has gone up from almost non ‐ existent to 23.7 tonnes in 2011 and 77 tonnes in 2014.

The United Kingdom produces cannabis for the production of a dronabinol ‐ cannabidiol combination preparation for the treatment of spasticity due to multiple sclerosis (Sativex®) that is prepared using cannabinoids extracted from plant material. This preparation has been approved as a medicine in 24 countries ...”

2. The United Nations Office for Drugs and Crime

17 . In March 2012 the United Nations Office for Drugs and Crime (UNODC) published a Discussion paper entitled “Cannabis: a short review”, the relevant part of which reads:

“ Cannabis for Medicinal Purposes

Over the past two decades, the idea of cannabis as medicine has become increasingly popular. Citizens of several U.S. states, beginning in 1996, voted by referenda to allow the use of “medical” cannabis. Countries such as Austria, Canada, Finland, Germany, Israel, Portugal and Spain also have some form of “medical” cannabis regulation. This section provides a very brief synopsis of the current situation.

First, it is important to distinguish between the whole cannabis plant material and individual components within the cannabis plant. Some constituents of cannabis, including THC, are available today in pill form ...

Though the whole cannabis plant is not medicine, several governments including Canada, the United States, the United Kingdom, the Czech Republic, Spain, and other European countries have robust research programs to determine the medical efficacy of some of the constituents within cannabis. In some of these countries, cannabis ‐ based medicines have been approved to treat neuropathic pain related to cancer and spasticity related to Multiple Sclerosis (MS ) ...

Constituents of cannabis have been cited as helpful for some medical conditions, though the evidence is scarce when compared to sample size and length of studies required for new drug approval. Cannabis constituents have shown promise in studies relating to multiple sclerosis, pain, glaucoma, and as an anti ‐ nausea drug for patients undergoing chemotherapy. These studies, however, have lacked standardization of the active ingredients, and have used small sample sizes and a variety of administration routes. New drug approval requires standardization in purity, potency, and quality, and multiple controlled clinical trials ...”

COMPLAINT

18. The applicants complained under Article 8 of the Convention that domestic law did not allow for medical use of cannabis-based products.

THE LAW

A. Joinder of the applications

19. Given their similar factual and legal background, the Court decides that the applications should be joined under Rule 42 § 1 of the Rules of Court.

B. The applicants ’ complaint under Article 8 of the Convention

20. The applicants argued that the existing legal framework for requesting cannabis-based products in Hungary had a chilling effect on doctors who would seek to prescribe such treatment to their patients. Both applicants were suffering from conditions which could be treated or alleviated by use of such medicines, but under Hungarian law any possession and use of cannabis remained illegal.

21. The applicants relied on Article 8 of the Convention, which, in so far as relevant, reads:

“1. Everyone has the right to respect for his private and family life (...).

2. There shall be no interference by a public authority with the exercise of this right except such as is in accordance with the law and is necessary in a democratic society in the interests of national security, public safety or the economic well-being of the country, for the prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and freedoms of others.”

1. The parties ’ submissions

(a) The Government

(b) The applicants

2. The Court ’ s assessment

38. The Court does not consider it necessary to reach a conclusion on the Government ’ s objection of non-exhaustion of domestic remedies (see paragraph 22 above), since the case is in any event inadmissible for the following reasons.

(a) General principles

39. The Court reiterates that “private life” is a broad term, encompassing, inter alia , aspects of an individual ’ s physical and social identity, including the right to personal autonomy and personal development, and to establish and develop relationships with other human beings and the outside world (see, among many other authorities, Pretty v. the United Kingdom , no. 2346/02, § 61, ECHR 2002 ‑ III ). It has already examined cases concerning the inability of patients to access certain medical treatment under Article 8, the interpretation of which covers notions of personal autonomy and quality of life (see Hristozov and Others , and Durisotto, both cited above).

40. The essential object of Article 8 is to protect the individual against arbitrary interference by public authorities. In addition to this negative obligation, there may also be positive obligations inherent in effective “respect” for private life. These obligations may involve the adoption of measures designed to secure respect for private life even in the sphere of relations between individuals, including both the provision of a regulatory framework of adjudicatory and enforcement machinery protecting individuals ’ rights and the implementation, where appropriate, of specific measures (see Tysiąc v. Poland , no. 5410/03 , § 110, ECHR 2007-I).

41. However, the boundaries between the State ’ s positive and negative obligations under this provision do not lend themselves to precise definition. The applicable principles are nonetheless similar. In both the negative and positive contexts, regard must be had to the fair balance that has to be struck between the competing interests of the individual and of the community as a whole; and in both contexts, the State enjoys a certain margin of appreciation (see Różański v. Poland , no. 55339/00, § 61, 18 May 2006 and, mutatis mutandis , Dubská and Krejzová v . the Czech Republic [GC], nos. 28859/11 and 28473/12, § 175-178, 15 November 2016 ).

42. The Court would also reiterate that where an interference with an applicant ’ s private life emanates directly from legislation, the maintenance in force of the impugned legislation constitutes a continuing interference with the exercise of the right in question (see Parrillo v. Italy [GC], no. 46470/11, § 117, ECHR 2015 ).

43. Lastly, in the assessment of the present case it should be borne in mind that the Convention is intended to guarantee not rights that are theoretical or illusory but rights that are practical and effective (see Airey v. Ireland , 9 October 1979, § 24, Series A no. 32).

(b) Application of these principles to the present case

44. The Court would start by observing that Hungarian law provides a legal avenue for requesting individual permission to import cannabis-based medication. Specifically, under section 25 (2) of the Medicinal Products for Human Use Act (see paragraph 13 above), doctors may prescribe any medicinal product that has not been authorised for marketing in Hungary but has been authorised in an EEA State if they notify the National Institute of Pharmacy and Nutrition (NIPN) about it before issuing the respective prescription and obtain a declaration from the NIPN as to whether or not the use of such medication is reasonable in the circumstances.

45. The gist of the applicants ’ complaint is that the above possibility provided for in domestic law remains largely hypothetical because any doctor assisting them in applying for such medication would risk criminal or other sanctions due to the lack of legal certainty of the legislation (see paragraph 36 above).

46. The Court reiterates that, where choices related to the exercise of a right to respect for private life occur in a legally regulated area, the State should provide adequate legal protection of that right within the regulatory scheme , notably by ensuring that the law is accessible and foreseeable, enabling individuals to regulate their conduct accordingly. It is true that, in this regard, the State has a wide margin of appreciation; however, the regulation should ensure a proper balance between societal interests and the right at stake (see, mutatis mutandis , Ternovszky v. Hungary , no. 67545/09, § 24, 14 December 2010 ).

47. In the circumstances of the applicants ’ case, the above would mean that the provisions regulating the availability of cannabis-based medication should be formulated in such a way as to avoid provoking any chilling effect on doctors when deciding whether the patient ’ s interests in an individual case could justify the use of medicinal products based on cannabinoids. If this were not so, Hungarian doctors would in reality be excluded from potentially prescribing a whole range of medicines available internationally.

48. The Court observes in this respect that the applicants failed to show that their doctors or any other medical professionals were of the opinion that their respective conditions required or were suitable for treatment with cannabis-based products. Instead, they submitted a number of articles and medical studies containing information about the potential benefits of cannabis-based products relating mainly to the conditions suffered by the second applicant.

49. It was not disputed between the parties that the applicants were receiving medical care generally available to insured persons in Hungary. Although it is by no means the Court ’ s function to speculate on what would be the best course of treatment for the applicants ’ respective medical conditions (see, mutatis mutandis , Hristozov and Others , cited above, § 105), it nonetheless considers that their use of any other medicinal products – including those based on cannabis derivatives – would have to be based on an individualised medical finding rather than on general research conclusions or a mere belief on the part of the applicants that a medicine available elsewhere could alleviate their symptoms.

50. Moreover, the Court notes that the applicants did not indicate whether treatment using cannabis-based medication had ever been discussed with their respective doctors or refused by them. Nor did they provide anything to indicate that either of them had ever tried to avail themselves of the legal procedure available in Hungary with a view to obtaining such medication lawfully. Indeed, as submitted by the Government, the NIPN has never received a single application for individual importation of such substances from any patient in Hungary (see paragraph 23 above).

51. In view of the above – coupled with the fact that no evidence has been adduced before the Court to show that any doctor in Hungary has ever been prosecuted for prescribing cannabis-based medication (see, by contrast and mutatis mutandis , Ternovszky , cited above, § 26) or has ever refused to do so for fear of prosecution – the Court cannot infer that the legislative avenue existing in Hungarian law was inaccessible, not foreseeable in its effects or was formulated in such a way as to create a chilling effect on doctors wishing to prescribe such medications.

52. Under these circumstances, and having regard to the fact that the applicants have failed to properly substantiate their allegations before it, the Court cannot discern any appearance of violation of the rights guaranteed by Article 8 of the Convention.

53. It follows that the application is manifestly ill-founded within the meaning of Article 35 § 3 of the Convention and must be rejected pursuant to Article 35 § 4.

For these reasons, the Court, by a majority,

Decides to join the applications;

Declares the applications inadmissible.

Done in English and notified in writing on 27 April 2017 .

Marialena Tsirli Ganna Yudkivska Registrar President