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Editura Universitara The Right to Live. Medical Treatment. List of Reimbursed Medicines. Collection of Judicial Practice

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Publisher: Editura Universitara

Author: Dragos Calin, Roxana Maria Calin

ISBN: 978-606-28-1141-9

DOI: https://doi.org/10.5682/9786062811419

Publisher year: 2020

Edition: I

Pages: 366

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This volume contains a relevant selection of case law on disputes concerning patients' requests, by presidential ordinance, for the inclusion of medicines used and necessary for the treatment of serious and very serious diseases, on the List of Common International Names of Medicinal Products benefit the insured, with or without personal contribution, on the basis of medical prescription, in the social health insurance system, as well as the common international names corresponding to the medicines that are granted within the national health programs.
  • The Right to Live. Medical Treatment. List of Reimbursed Medicines. Collection of Judicial Practice

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Roxana-Maria Calin
Judge, Bucharest Tribunal, deputy editor-in-chief of the Forum of Judges Magazine, vice-president of the European Association of Magistrates for Human Rights, member of the editorial board of the Jurisclasor ECHR magazine.

Dragos Calin
Judge at the Bucharest Court of Appeal, trainer of the National Institute of Magistracy for continuous professional training European Union law, international judicial cooperation in civil and commercial matters, labor law and social insurance law; associate scientific researcher of the Institute of Legal Research of the Romanian Academy - Center for European Law Studies, director of the Forum of Judges, member of the scientific college of the journal Jurisclasor ECHR, co-editor of the journal iaduer.ro - European Legal Affairs, founding member and co-president Romanian Judges Forum Association (2007-present), member of the GEMME Europe Board of Directors (May 2010-present), vice-president of GEMME Europe - European Grouping of Magistrates for Mediation (May 2010-May 2012), founding member of CIMJ International Conference on Mediation for Justice), October 2009, Paris

Foreword / 15

1. Presidential order. Completion of the negotiation process and conclusion of the cost-volume contract are in the legitimate private interest of the marketing authorization holders of the medicines participating in the negotiation process and are not an exclusive attribute of power of the public authorities to issue such decisions. final conditional inclusion in the list of reimbursed medicines, provided that they do not wish to complete the negotiation process / 25

High Court of Cassation and Justice, Administrative and Fiscal Litigation Section, Decision no. 1231 of March 28, 2017

2. Starting with the date of entry into force of the Order of the Minister of Health no. 861/2014, the evaluation of medical technologies for the inclusion, extension of indications, non-inclusion or exclusion of medicines in / from the respective list, is a continuous process that ensures the access of patients to medicines within the social health insurance system. Demonstrating the intervention of a postponement, respectively of a failure of the negotiations between the public authorities and the holders of the marketing authorizations is decisive for the evaluation of the conduct of the parties / 31

High Court of Cassation and Justice, Administrative and Fiscal Litigation Section, Decision no. 831 of March 3, 2017

3. The analysis of the request for unconditional inclusion in the List can be made only in relation to the norms in force at the time of the analysis. The fact that currently the unconditional inclusion in the List of the medicine proposed by the plaintiff is no longer possible precisely by applying the principle, tempus regit actum ”does not lead to the idea of ​​the lack of an effective remedy within the meaning of art. 13 of the ECHR for the plaintiff to claim and obtain under the law compensation for damage suffered as a result of not including the drug proposed by it in the List at the time of adoption of the injurious decision by the respondent authority / 36

4. Taking into account the concrete circumstances of the case (severity of the disease, the advanced stage in which he is, the very high cost of treatment and the obvious financial constraint in which the plaintiff is), the right invoked by him (right to life) can be realized concretely. only by extending the therapeutic indication for Trastuzumab (Herceptin) and to HER2-positive metastatic gastric cancer (in addition to the indication for breast cancer), so that the drug can be compensated / 45

Bucharest Court of Appeal, Section VIII Administrative and fiscal litigation, Civil sentence no. 4034 of December 14, 2016

5. Presidential order. The drug with DCI Pembrolizumabum included by CNAS in the list of drugs 100% reimbursed for similar oncological diseases. Recommendation of the attending physicians to carry out the treatment with this medicine which works for the applicant's condition. Erroneous analysis of the condition of non-prejudice of the merits / appearance of the right because no stage of the procedure regulated by Order no. 861/2014 regarding the condition from which the plaintiff suffers. Erroneous finding in the sense that, in the situation of these actions, the court would substitute the specialized institutions regarding the prescription of the area of ​​use of a medicine, in order to guarantee its use by the plaintiff, by admitting its action, outside the medical tests. specialized, devoted to medical and pharmaceutical research / 52

Bucharest Court of Appeal, Section IX administrative and fiscal contentious, Civil sentence no. 1027 of December 27, 2019, final by Decision no. 1564 of March 11, 2020 pronounced by the High Court of Cassation and Justice, Administrative and Fiscal Litigation Section

6. Presidential order. Avastin, according to the summary of product characteristics, is authorized for therapeutic indications: colon or rectal cancer that is metastatic; metastatic breast cancer; lung cancer other than small cell cancer; kidney cancer; epithelial ovarian cancer, but without being authorized for the indication in the treatment of tumor-parieto-occipital formation. The appearance of the right, viewed from the perspective of the utility of the therapy with the molecule in question and of the real chances of success of the treatment requested by the appellant, is justified in the case, the appellate court held - High Court of Cassation and Justice. It results from the content of the leaflet of the drug, submitted to the appeal file, the opposite, namely the therapeutic indication in case of relapsed glioblastoma, an indication recognized since December 2017 by other states / 62

High Court of Cassation and Justice, Administrative and Fiscal Litigation Section, Decision no. 4242 of September 26, 2019

7. Presidential order. It was requested to provide free medical treatment, provisionally, until the substantive solution of the application for inclusion on the Medium List settled payments of the person concerned. The request was rejected considering that the requested temporary condition is not fulfilled on the grounds that the disposition of the treatment would lead to the judgment of the merits. It was considered that the provision of treatment presupposes that, beforehand, that treatment be included in the list approved by GD no. 720/2008 with subsequent amendments and completions, operation for which the applicant must submit to the competent authority - National Agency for Medicines and Medical Devices - a specialized documentation, complex, to be subjected to an opportunity analysis left to the discretion of the competent public authorities from the sphere of executive power, the court cannot be substituted for it.

However, the object of the request for a presidential ordinance was not the inclusion of the drug in the list, but only the provision of treatment, provisionally until the substantive settlement of the action regarding the fulfillment of the obligation to include the drug in the list / 69

High Court of Cassation and Justice, Administrative and Fiscal Litigation Section, Decision no. 871 of March 2, 2018

8. Presidential order. The high price of the requested medicine and the long procedure necessary for its inclusion in the list of reimbursed medicines for the disease suffered by the plaintiff justifies the urgency of taking the necessary measures to insure the respective medicine in 100% / 77

High Court of Cassation and Justice, Administrative and Fiscal Litigation Section, Decision no. 381 of January 31, 2019

9. Presidential order. The disposition of the provisional measure to ensure daily intravenous feeding, according to the indications of the attending physician, and in the alternative, the settlement of intravenous feeding, in 100% compensation regime (without personal contribution), until the date of ruling on the merits of the dispute, is likely to contribute to protection the right to life of the plaintiff, a right enshrined in art. 22 of the Romanian Constitution, as well as art. 2 of the European Convention on the Fundamental Rights and Freedoms of Man, which corresponds to the correlative obligation of the state to ensure the observance of this right by taking the necessary measures in this regard / 86

High Court of Cassation and Justice, Administrative and Fiscal Litigation Section, Decision no. 5164 of October 30, 2019

10. Presidential order. The therapeutic indication for which the respondent-plaintiff requested the treatment with Bevacizumabum DCI, respectively gliosarcoma, not found in the therapeutic protocol corresponding to the administration and monitoring of the treatment with the respective DCI.

Fulfilling the obligation to provide adequate medical care to patients is not a preferential treatment. The condition of non-prejudice of the merits of the litigious legal relationship derives both from the condition regarding the provisional character of the measure to be ordered, and from the legal provision according to which the ordinance can be issued even when there is a judgment on the merits / 96

High Court of Cassation and Justice, Administrative and Fiscal Litigation Section, Decision no. 3269 of June 12, 2019

11. Presidential order. The obligation of the parties to insure in favor of the plaintiff the disputed medicine for a limited period of time does not imply measures to resolve the dispute on the merits nor to make it impossible to restore the factual situation. The appearance of law results from the existence of a positive approval for the inclusion of the requested medicine in the List of reimbursed medicines, resulting from the data transmitted by CNAS but also from the information on the authority's website. / 110

High Court of Cassation and Justice, Administrative and Fiscal Litigation Section, Decision no. 5047 of October 24, 2019

12. The applicants no longer justify an interest in supporting the application, namely a practical, material or moral benefit to which they are entitled to hope in the event of a favorable solution, as long as Yervoy (DCI Ipilimumambum) has been included in the corresponding sublist. medicines benefited by the insured in a 100% / 117 compensation regime

High Court of Cassation and Justice, Administrative and Fiscal Litigation Section, Decision no. 3574 of October 26, 2018

13. Presidential order. Obligation of CNAS to grant, on the basis of a medical prescription, in a 100% compensation regime some medicines. Given the severity of the disease, as well as the prohibitive price of the requested treatment, the lack of insurance for these medicines endangers even the applicant's right to life, guaranteed by the Romanian Constitution / 124

Bucharest Court of Appeal, Section VIII administrative and fiscal contentious, Civil sentence no. 2865 of October 4, 2016, final by Decision no. 45 of January 10, 2019 pronounced by the High Court of Cassation and Justice, Sectia of administrative and fiscal contentious

14. As long as the criteria for inclusion in the list are objectively substantiated, their choice falls within the discretion of the Romanian legislator, whether he exercises his attribution at main, delegated or secondary level, belonging to the legislative and executive authority to establish the relevant policy. for financing health programs, the court being empowered only to verify the application of existing legal norms, and not to adopt or modify them / 133

Bucharest Court of Appeal, Section VIII administrative and fiscal contentious, Civil sentence no. 1499 of April 26, 2017, final by Decision no. 47 of January 10, 2019 pronounced by the High Court of Cassation and Justice, Administrative and Fiscal Litigation Section 15. Presidential Ordinance aimed at ensuring free treatment with the drug Erivedge. There is no legal appearance in favor of the applicant, given that the medicine in question was evaluated by the National Agency for Medicines and Medical Devices with 50 points and is not recommended for the therapeutic indication sought by the applicant, bringing a minor clinical benefit compared to the other existing therapies / 146

Bucharest Court of Appeal, Section VIII administrative and fiscal contentious, Civil sentence no. 4481 of November 5, 2018, final by Decision no. 2702 of May 22, 2019 pronounced by the High Court of Cassation and Justice, Administrative and Fiscal Litigation Section

16. Presidential order. Obligation to insure the medicine Avastin on the basis of a prescription, in a 100% compensation regime. The severity of the disease (operated left temporo-parietal brain tumor - Glioblastom) requires the administration of medication prescribed by specialists, the applicant's life being obviously endangered / 151

Galati Court of Appeal, Administrative and Fiscal Litigation Section, Civil Sentence no. 175 of December 2, 2019

17. Presidential order. Obligation of the defendants to insure to the insured persons indicated above the medicine SYNAGIS on the basis of medical prescription, in 100% compensation regime. Failure to administer the drug would bring serious health problems to the minor diagnosed with chronic lung disease of the premature baby, irreversible problems, both respiratory and infectious and, compared to the young age of the girl, such diseases are life-threatening. Impossibility, for the plaintiff parents, to pay the value of the medicine / 157

Galati Court of Appeal, Administrative and Fiscal Litigation Section, Civil Sentence no. 68 of April 2, 2019, final by Decision no. 4137 of September 19, 2019 pronounced by the High Court of Cassation and Justice, Administrative and Fiscal Litigation Section

18. Presidential order. Obligation of the defendants to insure to the plaintiff with an established diagnosis recurrent multiple sclerosis, on the basis of a medical prescription, in a 100% compensation regime (without personal contribution), of the drug Fingolimod (trade name Gylenia). The cost of the medicines necessary for the applicant to delay the evolution of the disease and to avoid episodes of severe crisis requires a major financial effort, impossible to bear. These costs constitute an important obstacle to the applicant's access to therapy, in the context in which any delay may have serious consequences for the course of the disease.

Bucharest Court of Appeal, Section IX administrative and fiscal contentious, Civil sentence no. 95 of April 5, 2019, final by Decision no. 4622 of October 10, 2019 pronounced by the High Court of Cassation and Justice, Administrative and Fiscal Litigation Section

19. Presidential order. Provision to the claimant, on the basis of a medical prescription, in a 100% compensation regime (without personal contribution), of the medicine Ocrelizumab. Extremely high price that makes it impossible for the plaintiff to purchase it from its own resources. Failure to adopt, until the date of pronouncing, a decision of definitive inclusion or non-inclusion under the aspect of the list approved by GD no. 720/2008, the maximum term for its adoption being deposit / 172

Bucharest Court of Appeal, Section VIII administrative and fiscal contentious, Civil sentence no. 157 of January 17, 2019, final by Decision no. 4764 of November 16, 2019 pronounced by the High Court of Cassation and Justice, Administrative and Fiscal Litigation Section

20. Presidential order. The condition of "appearance of right" is met, given that the drug Nivolumab (commercially called Opdivo) is authorized for marketing, including in Romania, by the centralized procedure in the European Union "for the therapeutic indication" monotherapy for the treatment of recurrent classic Hodgkin's lymphoma or refractory after autologous stem cell transplantation and treatment with brentuximab vedotin in adults ”, but in order for patients to benefit from this drug free of charge, a decision (Government decision) must be made to include it in the List of reimbursed medicines / 189

Bucharest Court of Appeal, Section VIII administrative and fiscal contentious, Civil sentence no. 315 of June 27, 2019, final by Decision no. 4825 of October 16, 2019 pronounced by the High Court of Cassation and Justice, Administrative and Fiscal Litigation Section

21. Presidential order. At the time of the settlement of the lawsuit, in connection with the medicines Dabrafenib (trade name Tafinlar) and Tramenitib (trade name Mekinist) there is no decision of the National Agency of Medicines and Medical Devices regarding the inclusion or not in the list for the two diagnoses of the plaintiff. The possible obligation of the parties to insure in favor of the plaintiffs the medicines Dabrafenib (trade name Tafinlar) and Tramenitib (trade name Mekinist) for a limited period of time does not imply measures to resolve the dispute on the merits nor to make it impossible to restore the factual situation / 206

Bucharest Court of Appeal, Section IX administrative and fiscal contentious, Civil sentence no. 377 of August 8, 2019, final by Decision no. 865 of February 13, 2019 pronounced by the High Court of Cassation and Justice, Administrative and Fiscal Litigation Section

22. Presidential order. The condition of the appearance of the right found unfulfilled because the manufacturer of the drug would not have registered with the European pharmaceutical authorities any application to authorize the placing on the market of this drug for the treatment of anaplastic astrocytoma, glioblastoma or oligodendroglioma, as such it is not recommended for these categories. . Ignoring the appearance that the doctors recommended to the applicants to continue the therapy with the targeted drug. Unnecessary analysis of the procedure for placing the drug on the DCI list, although the object of the case was to ensure 100% compensatory treatment, provisionally, until the action to include in the list the common international names of the drug Bevacizumab (commercially called Avastin) for the therapeutic indication Glioblast.

Note: By the decision of 05.06.2020, the High Court of Cassation and Justice partially overturned the sentence pronounced and in the retrial of the case, admitted the request for presidential ordinance / 223

Bucharest Court of Appeal, Section IX administrative and fiscal contentious, Civil sentence no. 31 of January 14, 2020

23. Presidential order. The alleged alternative treatments, with drugs that already exist in the list of reimbursed drugs, have no relevance, the assessment of the best treatment for each patient being made in terms of his situation, and not by reference to the case of other patients / 238

Bucharest Court of Appeal, Section IX administrative and fiscal contentious, Civil sentence no. 387 of August 8, 2019, final by Decision no. 170 of January 15, 2020 pronounced by the High Court of Cassation and Justice, Administrative and Fiscal Litigation Section

24. Presidential order. The non-granting of the treatment is not determined by the lack of the right of the plaintiff to the 100% compensation of this medicine but by administrative considerations, respectively the non-elaboration of the therapeutic protocols, by the defendant authorities. However, administrative procedures may not be invoked in order to delay the granting of a legitimate right or interest and the application of medical treatment to the applicant may not be refused, as a matter of urgency, only for non-completion of administrative procedures / 253

Bucharest Court of Appeal, Section VIII administrative and fiscal contentious, Civil sentence no. 3780 of November 29, 2016, final by Decision no. 3054 of October 18, 2017 pronounced by the High Court of Cassation and Justice, Administrative and Fiscal Litigation Section

25. Presidential order. Providing free treatment with (i) Abraxane (DCI - Paclitaxelum), (ii) Avastin (DCI - Bevacizumabum), (iii) Kevtruda (DCI - Pembrotizumabum), (iv) Carboplatin (DCI -Carboplatlnum) for metastatic negative triple breast cancer IV. The impossibility of enforcing the sentence cannot be retained on the grounds that the medicines are not sold on the open market, but only in certain hospital units, since there are possibilities for the plaintiff to benefit from the respective 100% compensated treatment, the medicines existing being supplied in within the health insurance system, but for other conditions. / 263

Ploiesti Court of Appeal, Administrative and Fiscal Litigation Section, Civil Sentence no. 239 of December 23, 2019

26. A procedural approach is not without object, in the context in which the event that justifies such a support is not one of nthe subsequent modification of the action, as well as the fact that even until the date of pronouncement no administrative act was issued by which to perform a real and effective analysis of the criteria for inclusion of the DCI in the List approved by GD no. 720/2008, the death of the plaintiff not constituting an element that lacks practical utility, the temporary granting of access to this treatment under a presidential ordinance leading to the conclusion that it will be subsequently confirmed on the merits in the context in which the defendants' refusal was issued in unjustifiably / 278

Bucharest Court of Appeal, Section VIII administrative and fiscal contentious, Civil sentence no. 3981 of December 12, 2016

27. The insured benefit from the package of basic services in case of illness from the first day of illness and medicines, in a non-discriminatory way. The fault of the county insurance house due to the fact that it unjustifiably delayed the settlement of the request, sine die, conditioning the moment of approving the treatment by certain prioritization criteria that could not produce effects in the absence of publication in the Official Gazette of Romania / 297

Giurgiu Tribunal, Civil Section, Civil Decision no. 51 of February 24, 2016 28. The obligation of the Ministry of Health and CNAS to introduce the drug enzalutamide on the List of reimbursed drugs, the obligation of CNAS to provide free treatment with enzalutamide for the entire period prescribed by the doctor. In the appeal, the finding that the claims for updating the list of medicines in order to introduce enzalutamide (as a result of its introduction in the List) and to ensure, free of charge, the treatment with this medicine for the period prescribed by the doctor (as a result of death of the applicant).

The refusal of CNAS and CAS Hunedoara to grant the plaintiff free treatment does not represent an unjustified refusal, motivated by the fact that at the time of the request, the drug was not included in the list, and the defendants can only provide free treatment under H.G. no. 720/2008 / 302

High Court of Cassation and Justice, Administrative and Fiscal Litigation Section, Decision no. 774 of February 19, 2019

29. The diagnosis of the applicant appellant, for which the request for approval for the imaging investigation consisting of the PET-CT examination was made, is that of "cervical neoplasm". Both at the date of the request and at the date of its resolution there is a list of diseases, but the diagnosis of cervical cancer (neoplasm) is not on the list, this being the only reason, obviously well-founded, for which the CNAS respondent did not endorse the investigation in question. The omission of the legislator (even debatable) to include in the list, together with the diagnosis of ovarian neoplasm, and that of cervical neoplasm, is not likely to lead to the conclusion of the illegality of the contested decision / 309

High Court of Cassation and Justice, Administrative and Fiscal Litigation Section, Decision no. 1543 of April 18, 2018

30. Obligation of the defendants the Ministry of Health and the National Health Insurance House to issue the final decision regarding the inclusion / non-inclusion of the drugs Vemurafenibum, Ipilimumabum and Fingolimod in the list approved by H.G. no. 720/2008. The active procedural quality of the plaintiff "A." Association whose status provides for the promotion and protection of the common interests of patients suffering from chronic diseases and ensuring their socio-professional integration, in accordance with the law / 317

High Court of Cassation and Justice, Administrative and Fiscal Litigation Section, Decision no. 3292 of October 12, 2018

31. Stem cell transplantation is not among the services that are part of the package of basic services in the Romanian social health insurance system. Order no. 1591/1110 of 2010 for the approval of the Technical Norms for the implementation of the national health programs for the years 2011 and 2012 establishes that the stem cell transplant represents a subprogram of the national transplant program of organs, tissues and cells of human origin, which is financed from the budget Ministry of Health. These services are among those that are not supported by the Single National Health Insurance Fund and, therefore, are not included in the package of basic services in the Romanian social health insurance system / 325

Cluj Court of Appeal, Section III of administrative and fiscal contentious, Decision no. 178 of January 15, 2018

32. Presidential order. Recognition, on a provisional basis, of the right deriving from the procedure regulated by art. 232 of Law no. 95/2006. Inclusion of Nivolumab / 331 in the List of reimbursed medicines

Bucharest Court of Appeal, Administrative and Fiscal Litigation Section, Civil Sentence no. 125 of April 23, 2018

This volume contains a relevant selection of case law on disputes concerning patient requests, made by presidential ordinance, to include medicines used and necessary for the treatment of serious and very serious diseases, on the List of Common International Names of Medicines benefit the insured, with or without personal contribution, on the basis of medical prescription, in the social health insurance system, as well as the common international names corresponding to the medicines that are granted within the national health programs.

The actions formulated by the patients in these litigations, by means of a presidential ordinance, concern in various ways: the obligation of the defendant to pay a sum of money and / or to approve the free treatment until the final solution of the same request in the system of administrative and jurisdictional channels. providing a certain oncological treatment with a certain drug; insurance of medicines, based on prescription in 100% compensation regime, inclusion on the DCI List of some medicines.

A case in which the courts based the obligation to ensure the treatment requested by the presidential ordinance concerned the disposition of the provisional measure to ensure daily intravenous feeding, according to the indications of the attending physician, and in the alternative, the settlement of intravenous feeding. The applicant referred a question concerning the method of granting and settling intravenous feeding, claiming that parenteral nutrition is provided in Romania only in the anesthesia and intensive care units of hospitals, not at the patient's home, a circumstance which, in relation to the applicant's need to receiving intravenous food daily is a measure that can seriously affect his right to life (case 9). The request for the inclusion on the DCI List of a certain drug, formulated by presidential ordinance, was rejected by the courts. They analyzed the conditions to be fulfilled within the common law (presidential ordinance - art. 997 C.pr.civ.) - urgency, non-prejudice of the fund and appearance of the right. Although they ruled that the fulfillment of the condition of urgency in the disposition of the presidential ordinance, which is fulfilled in relation to the medical condition, as well as the temporary nature of the requested measures - granting treatment in 100% compensation, but also including drugs on the DCI list, however, they did not retain the condition of non-prejudice of the fund / appearance of the right, because the drugs are proposed to be included in the DCI List by the holders of marketing authorizations - not by patients, the proposals receiving from the competent authorities unconditional inclusion, conditional inclusion and non-inclusion in the list, the analysis being made by reference to international evaluations, to the compensation status of DCI in EU member states and to the costs of therapy.

In order to introduce new DCIs in the List of medicines, by GEO no. 77/2011 on establishing contributions for the financing of health expenditures, with subsequent amendments and completions, provided in art.12 that for medicines for which, following the evaluation performed by the National Agency for Medicines and Medical Devices, were issued conditional entry decisions in the List, cost-volume / cost-volume-result contracts may be concluded within the limits of the funds obtained from the exclusion and / or modification of the compensation percentage of some drugs included in the above-mentioned list, from the application of pharmaceutical policies, from the amounts resulting from the changes of the therapeutic models, as well as from additional amounts allocated in the budget of the Single National Health Insurance Fund under the law. Under the conditions of not concluding the cost-volume / cost-volume-result contracts, the medicines will not be included in the list of medicines approved according to the law by Government decision. The courts analyze in the second situation if the authorities have fulfilled their legal obligations during the negotiation process, respectively if the necessary steps have been taken for the patients' access to therapy.

By Annex 2 letter. b of the Order of the Minister of Health no. 861/2014, a new double mechanism was established regarding the inclusion of medicines in the List: unconditional inclusion in the List; inclusion conditioned by the existence of a cost-volume / cost-volume-result contract. Order of the Minister of Health no. 861/2014 provides in Annex 2, at letter b points 1 and following, the fact that only drugs that obtain at least 80 points in the evaluation process can be unconditionally included in the DCI List, while those whose score is between 60 and 79 points obtain a decision from NAMMD conditional inclusion in the List and may be included in the DCI List, only on the basis of a cost-volume contract or a cost-volume-result contract within the limits of the funds obtained from the exclusion and / or modification of the compensation percentage of some medicines included in the mentioned list, from the application of some pharmaceutical policies, from the amounts resulted as a result of the changes of the therapeutic models. as well as from additional amounts allocated in the budget of the Single National Health Insurance Fund under the law.

Under the conditions of not concluding the cost-volume / cost-volume-result contracts, the medicines will not be included in the list of medicines approved according to the law by Government decision. The completion of the negotiation process and the conclusion of the cost-volume contract belong to the legitimate private interest of the marketing authorization holders of the medicines participating in the negotiation process and are not an exclusive attribute of power of the public authorities to issue such decisions. conditional inclusion in the List, provided that they do not wish to complete the negotiation process.

The aim of the patient is to effectively benefit from the granting, in a 100% compensation regime, of a certain treatment with a certain medicine - prescribed by doctors and which is proven with medical documents as possible favorable, a drug that due to the negotiation process with the marketing authorization holder is not included in the DCI List.

Patients cannot appeal in the current legislative context except to the provisions of art. 997 C.pr.civ., Therefore, the analysis of the request for inclusion in the list of a drug can be performed only in the context of the conditions imposed by this text. The courts thus analyze the existence of steps taken by CNAS and the Ministry of Health to ensure financial support for patients by conducting and concluding the negotiation process for the listing of drugs - either unconditioned or conditioned. The finding of the existence of these approaches leads to the rejection of the requested presidential ordinances.

It is found, from the cases presented, that the analysis of the company of steps to conclude the negotiations does not lead to a concrete result for the patients. One of the litigations invoked by CNAS to exemplify the undertaking of negotiations - the litigation having as object the action filed by CNAS to oblige the defendant B., legally represented by the distributor of the necessary medicine for the treatment needed by cancer patients in advanced condition and who do not have a therapeutic alternative, to conclude the cost-volume contract for the drug Yervoy (trade name Ipilimumabum) - ended by rejecting the CNAS application, because the offer variant sent to the applicant did not identify the number of patients eligible to benefit from the drug Yervoy, aspect on the basis of which the costs of the contract for the defendant are established, emphasizing the fact that before finalizing the negotiation process it is necessary to clarify this aspect, CNAS's fault in not finalizing the negotiation process being obvious (civil sentence no. 1171 / 03.04.2017 Bucharest Court of Appeal you are - Section VIII administrative and fiscal contentious, final by non-appeal).

On the other hand, in another litigation (until the resolution of which a request for a presidential ordinance was formulated) having as object an action formulated by the Association "Alliance of chronic patients in Romania", together with other individuals, in contradiction with the defendants Romania, the Ministry of Health and the National Health Insurance House, for the inclusion of some drugs on Sublist C
"INNs corresponding to medicines benefited by insured persons in 100% compensation regime", Section C2 "DCIs corresponding to medicines benefited by insured persons included in the national health programs for curative purposes in outpatient and hospital treatment", CODE "P3: National Oncology Program ”from the Annex to the Government Decision no. 720/2008, the court found:
„According to art. 6 of Council Directive 89/105 / EEC on the transparency of measures governing the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems: “The following provisions shall apply if a medicinal product is included in the system National health insurance only after the competent authorities have decided to include the medicine in question in a certain list of medicines covered by the national health insurance system. 1. Member States shall ensure that decisions are taken on applications submitted in accordance with the requirements laid down in the Member State concerned by marketing authorization holders for the inclusion of medicinal products in the list of medicinal products covered by the health insurance system, and that these decisions are common to applicants within 90 days of receipt of applications. Where a request based on the provisions of this Article may be made before the competent authorities have agreed on the price to be charged for that product in accordance with Article 2 or if a decision on the price of a medicinal product and a decision on its inclusion in the list of products included in the health insurance system are taken following a single administrative procedure, the deadline is extended by another 90 days. The applicant shall provide the competent authorities with the appropriate information. If the information supporting the application is inadequate, the deadline shall be suspended and the competent authorities shall immediately inform the applicant of any additional detailed information that may be required. If a Member State does not allow an application to be made under this Article before the competent authorities have agreed on the price that may be charged for the product in accordance with Article 2, the Member State concerned shall ensure that the total period required the two procedures do not exceed 180 days. This time limit may be extended in accordance with Article 2 or suspended in accordance with the provisions of the preceding paragraph. (…).


In interpreting these provisions, the European Court of Justice established in its judgment of 20 January 2005 in Case C-245/03 Merck, Sharp & Dohme v. Belgium, that the time-limit laid down in the first subparagraph of Art. 6 paragraph 1 of Directive 89/105 / EEC is a mandatory deadline which national authorities are not entitled to exceed (point 1 of the operative part, decision posted on www.curia.europa.eu); in the same judgment, the European Court also pointed out that the mentioned text does not require an automatic inclusion of medicines in the list that falls under the incidence of the health insurance system when the minimum term provided by the Directive has been exceeded. In addition, "Community law does not deprive Member States of the right to organize their social security systems (…) and, in the absence of harmonization at Community level, it is for the Member States' domestic legislation to determine the circumstances in which the insurance scheme is granted. of health (…)". (§28) Consequently, compared to the regulation of Council Directive 89/105 / EEC, as interpreted in the case law of the Luxembourg court, the obligation imposed on each Member State of the European Union is to adopt a decision in time. 90 days from the receipt of the requests regarding the inclusion of some medicines on the list of those included in the health insurance system, a term that can be extended in certain conditions by a maximum of 90 days, without the non-observance of this term giving rise to a right to automatic inclusion of those drugs in the list, the states keeping according to the European jurisprudence on the margin of appreciation. However, the breach of the said term cannot remain without legal effect, since in such a case the European norm itself remains without legal effect. Thus, in interpreting the flow of evaluation and negotiation terms established by the Orders of the Minister of Health no. 861/2014 and no. 3/2015, respectively of the total term for adopting a decision regarding the request to include the medicines in the list, the court must take into account the limit established by art. 6 of the Directive, this being 90 days from the date of the request, with the possibility of extension for another 90 days, the European norm being clear and precise in this respect, clarified in the jurisprudence of the Luxembourg court.

In the case, although the requests for inclusion in the list show that they were formulated by the holders of marketing authorizations since August 2014, until the date of settlement of this case no decision of final inclusion or non-inclusion was adopted in terms of the list approved by GD no. 720/2008. Compared to art. 242 para. 1 of Law no. 95/2006 republished, text according to which "The list of medicines that benefit the insured with or without personal contribution is elaborated by the Ministry of Health and CNAS, with the consultation of CFR, and is approved by Government decision.", Respectively of the Orders of the Ministry of Health no. 861/2014 and no. 3/2015, the Court can only conclude that the final decision is the result of the shared competence of the Romanian Government, the Ministry of Health, the National Health Insurance House and the National Agency for Medicines and Medical Devices, being necessary for this purpose, ie for inclusion in the list. including the manifestation of will of the first three public authorities mentioned, not being able to appreciate that the decision indicated by art. 6 of Council Directive 89/105 / EEC would be the one issued at the level of NAMMD, as the legal effects occur only after the proposal ii MoH and CNAS and the adoption by the Government of an appropriate decision.

Under these conditions, the 90-day period, which may be extended exceptionally by a further 90 days, shall be calculated from the date of application for inclusion in the list until the date of issue of that decision by which the medicinal product is actually included in that list or is certainly rejected. In the present case, such a decision does not exist, although the maximum term for its adoption has already been significantly exceeded by almost once again its duration. In conclusion, although the plaintiffs do not have a right to request the inclusion of the molecules / drugs indicated in the List approved by GD no. 720/2008 with the subsequent amendments, they have a certain legitimate interest to request the obligation of the public authorities holding the competence in the matter to finalize the regulated procedure in the implementation of Directive 89/105 / EEC, given that the mandatory term, established in this respect, has been exceeded.

In the case, although the requests for inclusion in the list show that they were formulated by the holders of marketing authorizations since August 2014, until the date of settlement of this case no decision of final inclusion or non-inclusion was adopted in terms of the list approved by GD no. 720/2008. ” (civil sentence no. 3025 of 16.11.2015 of the Bucharest Court of Appeal - Administrative and fiscal contentious section, final by the rejection by the High Court of Cassation and Justice, by decision no. 3598 / 29.10.2018, of the appeals filed by CNAS and the Ministry Health, the same solution being adopted and another substantive file until the solution of which the issuance of a presidential ordinance was requested, the same statutes being retained in the civil sentence No. 543 / 19.02.20216 of the Bucharest Court of Appeal - Administrative and Fiscal Litigation Section).

The need to ensure as soon as possible a potentially beneficial treatment for the life and health of the person determines the imperative to amend the legislation in the sense of adopting a special procedure to ensure the maximum speed of applications for inclusion in the DCI List of drugs, on the merits. Given that such procedures have been regulated for public procurement, especially for the protection of life and health of persons, it is necessary to regulate a fast procedure for judging applications for drugs necessary for the treatment of serious and very serious diseases, by compensating and by inclusion in the DCI List.

Requests were also made for approval of free treatment with a specific drug for the treatment of a serious illness, the drug being included in the List of reimbursed drugs, but with a different therapeutic indication than the one requested. A solution that we consider fully appropriate to the principle of ensuring the right to life and health (see civil sentence no. 4034 of December 14, 2016, Bucharest Court of Appeal, Section VIII administrative and fiscal litigation) held that: "Taking into account the specific circumstances of the case, namely the severity of the disease, the advanced stage in which he is, the very high cost of treatment and the obvious financial constraint in which the applicant is, the court notes that, in essence, the right invoked by him the right to life, a right that can only be achieved in concrete terms by extending the therapeutic indication, so that the drug can be compensated for the plaintiff, and he can continue the treatment. However, the procedure is laborious, which involves gathering scientific, technical and financial evidence from multiple sources (for example, it is necessary to demonstrate the widespread use of the product in the Member States of the European Union and maintain a unified approach, it is necessary to demonstrate that DCI has been evaluated by the Haute Autorité de Santé, the institution that evaluates medical technologies in France and has found that there is an important therapeutic benefit, etc.), which implies a long period of time. "

However, the court considered that time is exactly the missing element of the applicant, due to the fact that the disease was detected for a very short time (summer 2016 and after failed attempts in Romania), and it is currently in a state very advanced, so that any delay can have very serious consequences, endangering even the applicant's right to life.

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