Following our monitoring of the Romanian Government's activity, FACIAS found serious deficiencies in the area of competence of the Ministry of Health in terms of violation of the Romanian State's positive obligations under Article 22 of the Constitution and Article 2 of the ECHR Convention to ensure the right to life of citizens, in the component relating to the provision of free treatment recommended in cases of serious illnesses, without therapeutic alternatives.
FACIAS calls on the Minister of Health to urgently issue the Order on the establishment of the Commission for the approval of the settlement of medicines for therapeutic indications not included in the summary of product characteristics, published in the decision-making transparency on the website www.ms.ro on 04.09.2018.
The functioning of this commission would facilitate timely access to treatment for patients with no therapeutic alternative or for whom there is a contraindication to medicines through "off-label" prescription and would avoid the numerous lawsuits pending before the national courts aimed at forcing the responsible institutions (Ministry of Health, ANMDMR, CNAS) to provide on a compensated basis the medicines essential to restore life expectancy to patients diagnosed with serious diseases.
FACIAS notes with concern the inertia of the responsible Romanian authorities in supplementing the list of compensated medicines for conditions other than those authorised, for which there is a prescription from the treating doctors and which have proved their effectiveness, thus infringing Directive 89/105/EEC/1988, which has not been transposed into national law within the time-limit laid down in Article 6, as well as the case-law of the CJEU handed down in interpreting Article 6 of the Directive, according to which the time-limit of 90/180 days laid down in Article 6(1) of Directive 89/105/EEC /1988 is "a binding time-limit which the national authorities are not entitled to exceed" (Case C-245/03 Merck, Sharp & Dohme v Belgium and Case C-296/03 Glacxosmithkline v Belgium).
Moreover, the above-mentioned authorities consume significant human and financial resources in trying to oppose the justified requests of patients to be provided with the medicines they absolutely need to survive, by formulating inadmissible objections and exceptions, as well as by exercising appeals in the approximately 110 cases pending before the High Court of Cassation and Justice since 2018 and to date. This is at a time when the practice of the national courts is to oblige the said authorities to provide the medicines requested in the cases in question free of charge, on the grounds that the procedure for listing the medicines for which insured persons benefit, with or without personal contribution, involves several public authorities, the competence being shared between the Ministry of Health and CNAS, which have the right and the obligation to draw up the list, at the proposal of ANMDMR, and the Romanian Government, which decides on the approval of the list by decision, in accordance with Art. 242 of Law no. 95/2006; at the same time, on the basis of the approved list, the CNAS structures are responsible for the settlement of the medicines in question.
It should be noted that the practice of the national courts is in line with the case law of the ECHR, which, since 2012, has found a violation by the Romanian authorities of Article 2 of the Convention in the case of Panaitescu v. Romania, noting that the first sentence of Art. 2 imposes a positive obligation on Member States: "The obligation of States to protect the right to life is not confined to refraining from the intentional and unlawful taking of life, but also implies an obligation to take the necessary measures to protect the lives of those within their jurisdiction (see L.C.B. v. the United Kingdom, 9 June 1998, para. 36, Reports of Judgments and Decisions 1998-III)". The Court has also considered, in this respect, that "just as a State authority is not entitled to invoke a lack of funds or resources as an excuse for not honouring an obligation arising from a judgment (see, mutatis mutandis, Burdov v. Russia, no. 59498/00, para. 35, ECHR 2002-III), the same principle applies a fortiori when there is a need to ensure the practical and effective protection of the right guaranteed in Article 2, a fundamental right in the structure of the Convention. Therefore, while being aware of the serious and complex nature of the applicant's illness, the Court cannot ignore the fact that, according to the medical information available, the recommended medication proved to have positive effects while it was administered and the doctor noted a "partial remission of the disease" while the treatment was followed; for this reason, the Court considers that the State authorities knew or ought to have known of the need for appropriate treatment in the applicant's case, in the absence of which there was a real and immediate risk to the applicant's life. This point was also highlighted by the findings of the domestic courts. However, the authorities did not take timely measures within their powers which would have been, indeed were, expected of them, as confirmed by the judgment of 12 December 2005, to avoid this risk. The Court therefore cannot exclude that the State's failure to provide the applicant with adequate treatment contributed to the aggravation of his illness. The Court therefore rules that, in the particular circumstances of the present case, the State failed to prevent the applicant's life from being put at avoidable risk by providing him with adequate medical care as required by the national courts, in breach of its procedural obligations under Article 2 of the Convention."
After approximately 10 years after the ECHR judgment, patients in Panaitescu's situation are still facing the bureaucracy of the Romanian authorities, having to endure the agony and costs of lengthy court cases in order to obtain life-saving drugs, including the drug covered by the ECHR judgment, Avastin.
Last but not least, FACIAS calls on the National Agency for Medicines and Medical Devices to initiate, ex officio, the medical technology assessment procedure for the inclusion, extension of indications, non-inclusion or exclusion of medicines in/from the List of International Nonproprietary Names of medicines available to insured persons, with or without personal contribution, on prescription, in the social health insurance system, in the following situations: (d) DCI compensated corresponding to medicines with a new indication, other than those for which applicants have applied, for medicines frequently recommended on prescription for serious diseases, for which there are applications from insured persons and for which the procedure has been ordered by national court decisions (e.g. Avastin).