[et_pb_section fb_built=”1″ admin_label=”section” _builder_version=”4.19.2″ width=”100%” custom_padding=”|8px||0px||” da_disable_devices=”off|off|off” global_colors_info=”{}” da_is_popup=”off” da_exit_intent=”off” da_has_close=”on” da_alt_close=”off” da_dark_close=”off” da_not_modal=”on” da_is_singular=”off” da_with_loader=”off” da_has_shadow=”on”][et_pb_row admin_label=”row” _builder_version=”4.19.2″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” width=”100%” custom_margin=”|0px||0px|false|false” custom_padding=”3px|0px||0px|false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.19.2″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text admin_label=”Text” _builder_version=”4.20.0″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” width=”100%” custom_margin=”89px|0px||0px|false|false” custom_padding=”|0px||0px|false|false” global_colors_info=”{}”]\u200b<\/p>\n
In recent months, our team, together with Mr. Alexandru Nicolae from the Bucharest Bar Association, has been involved day after day in a collective action mandated by more than 700 companies operating in the pharmaceutical sector, all of them strongly impacted by the chaos created, accepted and allegedly revealed by state institutions. The chaos we describe has impacted all pharmacies, especially independent pharmacies, which do not have the financial backing of a pharmaceutical chain, a main distributor, etc.<\/p>\n
Empirically, the pharmaceutical industry is presented as a highly profitable industry, but the general public is not made aware of the mechanisms that drive the financial resources generated by this industry, nor what the distribution chain of a drug consists of. In fact, the interface of this distribution chain – the pharmacy – receives a tiny profit compared to the general perception that it earns. Neither at the European level nor in Romania can pharmacies set their mark-ups in a discretionary way, severely limited by European and national regulations in this respect.<\/p>\n
In 2016, following the audit carried out by the Court of Auditors at the National Health Insurance House, the results of which were analyzed in the Audit Report concluded following the mission “Financial audit of the annual budget execution account of the Single National Health Insurance Fund for 2015 at the National Health Insurance House”, the Court of Auditors issued Decision no. 8\/2016 which ordered, inter alia, the recalculation by each county health insurance fund of the maximum retail prices of medicines, in order to quantify the possible damage resulting from the settlements made from the National Health Insurance Fund (FNUASS) above the price margins established by order of the Ministry of Health No. 75\/2009 for the approval of the Rules on the calculation of prices of medicines for human use. The decision of the Court of Accounts of Romania was based on a novel interpretation of the WHO 75\/2009, considering that the CNAS has settled for prescription drugs amounts above the price resulting from the application of the commercial mark-up provided for in this normative act, thus considering that the UNFASS was prejudiced, the argument being that the pharmacies did not include the commercial discounts received to reduce the settlement price.<\/p>\n
At that time, in the pharmaceutical market or the press, there were no echoes of this Court of Auditors’ Decision, as it seemed that a dispute would follow, which would delay the implementation of the Decision. The institutions with the power to regulate and manage drug prices and settlements from the national fund, namely the CNAS and the Ministry of Health, have constantly endorsed the correctness of the settlements made from the FNUASS as being within legally established price margins. Moreover, also at that time, after the Court of Auditors’ decision, CNAS provided a press release confirming that clarifications were required only at the institutional level between the Ministry of Health, CNAS, and the Court of Auditors, which rightly led to medicine suppliers not feeling the possible effects of an interpretation given by the Court of Auditors to the MS Order No 75\/2009, in the sense that the settlements received from the health houses would have damaged part of the state budget.\u00a0\u00a0<\/p>\n
Moreover, in practice, individual pharmacies or even chain pharmacies could not even obtain discounts within limits other than those accepted by CNAS because they are operated by computer programs verified and approved by state institutions so that no drug supplier could anticipate that it would have benefited from any unjustified settlement of drug prices or that it would be guilty of such a settlement.\u00a0<\/p>\n
In recent years, following Decision No. 8\/2016 of the Court of Accounts of Romania, the litigation represented by the challenge of the Decision by CNAS, where the Ministry of Health, several companies and professional bodies of pharmacists (ASSOCIATION OF DISTRIBUTORS AND RETAILERS OF PHARMACEUTICALS IN ROMANIA, FEDERATION OF PATRONATELOR OF PHARMACEUTICALS IN ROMANIA, COLLEGE OF PHARMACEUTICALS IN ROMANIA, ASSOCIATION OF INDEPENDENT PHARMACEUTICALS “ETHICA”, APOTHEKE LOTUS S.R.L., LIBRO PHARMA S.R.L., ALFA PHARM S.R.L., MEDICA FARM S.R.L., EXQUISIT S.R.L., FARMA MYOSYS S.R.L., FARMACEUTICA ARCATIM S.A., REMEDIUM FARM S.R.L., DERYYFARM 200 S.R.L., SANTAL PHARM S.R.L, POPINA PRODIMPEX S.R.L., ASLA FARM S.R.L., CRISTI GRUP S.R.L., IRIS FARM S.R.L., FARMACIA V\u00c2\u021a\u0102 S.R.L., FARMACIA JASMINUM S.R.L., BIOFARM FARMEC S.R.L., TIMOL-EUROFARM S.R.L., ADONIS FARM S.R.L. (FARMACIA DALIVEST), ARGEFARM S.R.L., LARIFARM S.R.L., QUINTA ESSENTIA FARMACIE S.R.L., JASMINE-PHARM S.R.L., MIRAFARM S.R.L., CRESCENS S.R.L., Despite the breadth of CNAS’s defenses supported by third parties, by Civil Judgment no. 2174\/08.06.2017 of the Bucharest Court of Appeal – Administrative and Fiscal Litigation Section VIII, delivered in case no. 7244\/2\/2016*, CNAS’s action was dismissed as unfounded, a solution confirmed by the ICCJ by Civil Decision no. 2858\/19.05.2022.\u00a0<\/p>\n
The solution pronounced on appeal by the ICCJ is not yet drafted. Still, immediately after the High Court\u2019s ruling, i.e., on 31.05.2022, the CNAS issued a control methodology with the imposition of a self-monitoring model on pharmacies internally. The health houses started operational controls on thousands of pharmaceutical entities, imposed practically by the Court of Auditors in 2016, taking into account the address issued by the CNAS in 31.05.2022 on the specific control methodology of this control, having as subject matter the verification of compliance by suppliers of medicines with and without personal contribution with the regulatory provisions on the establishment of sales prices of medicines that have been reported and settled by the C.A.S in the period 2015 – date of the control.\u00a0<\/p>\n
According to the individual contracts concluded between the suppliers of medicines and the health insurance companies, but also according to the CNAS Order 1012\/2013 for the approval of the Methodological Norms on the activity of the control structures within the social health insurance system, the former has an obligation to provide the health insurance companies with all the financial-accounting documents concerning the purchase of medicines and their settlement. The impact on the pharmaceutical market has, therefore, rightly been huge, generated by the need to prepare hundreds of thousands of records over seven years. Moreover, as is visible, many of the companies that owned pharmacies have disposed of their goodwill or have gone bankrupt, so those still operating in the form of 2015 were justifiably questioning how fair treatment would be given to those who were still verifiable compared to those whose documents could no longer be verified for various reasons, or to those who owned pharmacies that had gone bankrupt. Furthermore, the question was raised as to how a fair calculation and verification of the alleged damages could be ensured when it was known that some pharmacies did not have commercial discounts visible on their invoices or that there were discounts in the form of natural rebates.<\/p>\n
It was and still is certain that the CNAS and the health insurance companies were in a position where they could not legally refuse to establish the damages claimed by the Court of Auditors in 2016, given the provisions of Art. 64 Law 94\/1992 on the organization and functioning of the Court of Auditors, and the suppliers of medicines found themselves in the position where they could not refuse the controls, as they would have risked severe sanctions with an impact on their ability to continue to market medicines paid for by the State and to remain in a contractual relationship with the health centers. Still, they were not yet in a procedure where they could invoke their own defenses, including obvious prescriptions.\u00a0\u00a0<\/p>\n
Moreover, the collective frustration in the pharmaceutical market was given by the fact that after the date of the decision of the High Court of Cassation and Justice, no institution or public authority seemed to be concerned about the impact of the Court of Auditors’ Decision no. 8\/2016, the need to carry out thousands of controls by the control structures of the health houses, or the need to engage human resources by private parties in a short period of time in which representatives of Romanian pharmacies were required to summarize information from at least hundreds of thousands of financial-accounting documents. It was legitimately expected that the State, through its institutions, would intervene through constitutional mechanisms, given that medicine suppliers operated in a uniform manner criticized by the Court of Auditors without any warning from the Ministry of Health or the CNAS. Therefore there were no isolated cases of misapplication of the WHO 75\/2009. Moreover, the Bucharest Court of Appeal ruled in Civil Judgment no. 2174\/08.06.2017: “The Court considers that the claimant (CNAS) cannot be exonerated from the measure in para. II 4 of Decision no. 8\/15.07.2016 issued by the defendant (Court of Auditors), as there is a liability of both the applicant and the Ministry of Health in causing the related damage<\/i>“. However, the damage was to be recovered and borne strictly by the pharmacies.\u00a0<\/p>\n
Then, an intervention from the State institutions was legitimately expected, given that although there are contractual relations of a civil nature between the suppliers of medicines and the health houses, they were nevertheless exposed to being asked to quantify the amounts settled in the last 7 years, beyond what the Court of Accounts of Romania considered to be required, even though each supplier had submitted in the past to any control by the health houses and had never been pointed out that they had received amounts from the FNUASS without right. In addition, most pharmacy owners, especially individual pharmacies, were telling the market that they would be bankrupted, unable to afford to cover unintentional losses, on which the Court of Auditors wanted additional interest and legal penalties to be calculated.\u00a0<\/p>\n
At the same time, despite the public perception of the potential revenues of pharmacies, by reference to what the Court of Auditors has ruled and the ICCJ has confirmed, pharmaceutical entities have found themselves in the position of having their individually negotiated commercial discounts with distributors confiscated by the State. These negotiations have been supported by years of private collaboration. In order to obtain commercial discounts on the purchase of medicines, each representative of a pharmacy knows that he is required to purchase a quantity greater than necessary or to make payments for that purchase long before the price of the medicines is settled by the health insurance companies. It is even customary for medicines suppliers to take out loans to cover the financial shortfall until such time as health insurance companies settle the price of medicines. Among pharmacists, it is already customary for months of delay in the settlements made by the health insurance companies, during which time employees and distributors still have to be paid. It is, therefore, only natural that the outrage of someone who has supported the health system for years by making available his own finances, the knowledge he has acquired, the expertise he has accumulated, and the sustained efforts to draw attention to the lack of medicines in certain specific situations, all in favor of the patient, should be major, at a time when he is being denied, by the interpretation given by the Court of Auditors of Romania, any commercial gain derived from a commercial relationship he has built up individually and in stages.\u00a0<\/p>\n
Our team was requested by the pharmaceutical entities in Romania, where a surprising cohesion was born even for the pharmacists’ guild, to formulate amendments to Order 1012\/2013 and later to provide benchmarks to be taken into account in the actual controls, to attack the methodology adopted internally by CNAS and to request amendments to the current Order of the Ministry of Health regulating the same aspects of maximum prices as WHO 75\/2009. Thus, over the past months, we have worked daily to provide our clients with both collective and individual responses on the approach to each health insurance control, we have identified flaws in the procedure followed by CNAS in adopting that control methodology, and we have built an approach whose aim has been to delay the effective moment of establishing the calculated damage for each pharmacy, with the hope that our latest approach will be successful.\u00a0<\/p>\n
Initially, as mentioned above, we submitted to CNAS a memo containing comments on the proposed amendments to Order 1012\/2013 published by CNAS at the end of June 2022. The main problem that this draft contained was closely related to the control actions to follow, because it allowed the control bodies of the health houses to make only an estimate of the alleged damage created by the suppliers of medicines and not only, practically allowed a new reassessment and verification, affecting the predictability of the rule and exposing the supplier of medical services, medicines, medical devices, and sanitary materials to double requests for the submission of supporting documents and implicitly to repeated controls on the same issue. It is also understandable that the CNAS at the time was in the position of having to manage thousands of checks on amounts settled over 7 years, which empirically speaking leaves room for human error, so it was hoped that later there would be a legal framework to return with the same control, in practice. At the same time as the proposals made by our team representing more than 700 pharmaceutical entities, we also asked for a public debate to be organized, as it was obvious that the subject of future control actions was of major interest compared to any other subject previously raised by CNAS. Subsequently, this public debate was organized, where we had the mandate of our clients to expose in dialogue with the CNAS representatives the criticisms made to the draft amendment of CNAS Order 1012\/2013. The result of this approach materialized at the end of August 2022, the phase of damage estimation being abandoned by CNAS, and the controls started up to that moment would be subject anyway to the applicable provisions of the Order in force at the time of the start of the control.\u00a0<\/p>\n
Further, we criticized, in the representation of the pharmaceutical entities, the fact that they are required to draw up self-monitoring models, a request based on a simple internal CNAS address of 31.05.2022, without such documents being established by a regulatory action or in the individual contract concluded by the provider of medical services, medicines, medical devices, and sanitary materials. Also, at the collective level, because it was understood that what generated the issuance of Decision no. 8\/2016 of the Court of Auditors is likely to subsist in terms of interpretation and under the umbrella of the application of the Order of the Ministry of Health no. 368\/2017, we formulated proposals submitted to the Ministry of Health to amend this normative act, in order to adapt the allowable addition rates in pharmacies for the discounted medicines to the market realities and the role that the Romanian State must recognize pharmacies.\u00a0<\/p>\n
Also, precisely because we have received many requests on the effective approach to the controls initiated by the health insurance companies, in order to provide concrete support to the pharmacies that have requested our support, we have developed a guide on every aspect of the control, from the verification of the documents to be submitted by the control team of the health insurance company, to the procedures for challenging the acts issued by these bodies. In addition, we have prepared a draft widely used by pharmacies to request legal clarifications on how they are required to draw up mock-ups of amounts from their accounting documents on the subject of control and on the extension of the deadlines for submitting documents.\u00a0<\/p>\n
At the end of the steps taken in support of the pharmacies, we have drafted a proposal for a draft regulatory act containing provisions exempting from the payment the alleged damages created by the mechanism retained by the Court of Auditors in 2016, with legal explanations and arguments imposed by the pharmaceutical market, which we have submitted in a memorandum to the bodies that could offer their constitutional assistance for implementation, as trustees of the pharmaceutical entities involved in this collective approach. This approach was materialized in September 2022, and subsequently, the decision-makers at the level of the Romanian Senate found viable the option in which the exemption from payment requested by us to be transposed into what was the Draft Law on the approval of Government Ordinance no. 14\/2022 for the amendment and completion of Law no. 95\/2006 on health reform. In October 2022, the draft reached the Chamber of Deputies, which was the decision-making chamber, and as a result of our amendments requesting that the exemption should cover both amounts settled under the Ministry of Health Order no. 75\/2009 and the Ministry of Health Order no. 368\/2017, the form sent to the President of Romania for promulgation contained all the aspects we requested namely both exemption from payment for amounts unlawfully settled by CNAS according to the opinion of the Court of Accounts of Romania, and the application of this exemption for the entire period from 2015-2022.<\/p>\n
Finally, our efforts and the trust of our customers have been translated into a real success with the publication in the Official Gazette of Law 308\/2022 on the approval of Government Ordinance No. 14\/2022 amending and supplementing Law No. 95\/2006 on health care reform, which includes all the required aspects.\u00a0<\/p>\n
We are delighted with the experience of making a sustained effort on such a large scale. Still, even more so with every contact we have had with the representatives of the pharmacies and the public institutions involved, without whom our ideas for building a successful tactic would not have been born and would not have been crowned with the success we can celebrate today, with all of us. [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"
\u200b In recent months, our team, together with Mr. Alexandru Nicolae from the Bucharest Bar Association, has been involved day after day in a collective action mandated by more than 700 companies operating in the pharmaceutical sector, all of them strongly impacted by the chaos created, accepted and allegedly revealed by state institutions. The chaos we describe has impacted all pharmacies, especially independent pharmacies, which do not have the financial backing of a pharmaceutical chain, a main distributor, etc. Empirically, the pharmaceutical industry is presented as a highly profitable industry, but the general public is not made aware of the mechanisms that drive the financial resources generated by this industry, nor what the distribution chain of a drug consists of. In fact, the interface of this distribution chain – the pharmacy – receives a tiny profit compared to the general perception that it earns. Neither at the European level nor in Romania can pharmacies set their mark-ups in a discretionary way, severely limited by European and national regulations in this respect. In 2016, following the audit carried out by the Court of Auditors at the National Health Insurance House, the results of which were analyzed in the Audit Report concluded […]<\/p>\n","protected":false},"author":3,"featured_media":4581,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_et_pb_use_builder":"on","_et_pb_old_content":"\u00cen ultimele luni, echipa noastr\u0103 al\u0103turi de domnul avocat Alexandru Nicolae din Baroul Bucure\u0219ti s-a implicat zi de zi \u00eentr-un demers colectiv mandatat de peste 700 de societ\u0103\u021bi ce activeaz\u0103 \u00een domeniul farmaceutic, toate acestea fiind puternic impactate de un haos creat, acceptat \u0219i pretins relevat de institu\u021bii ale statului. Haosul pe care \u00eel vom descrie a impactat toate farmaciile, dar \u00een special farmaciile independente, care nu au sus\u021binerea financiar\u0103 a unui lan\u021b farmaceutic, al unui distribuitor principal, etc.\r\n\r\nEmpiric, industria farma este prezentat\u0103 drept una extrem de profitabil\u0103, \u00eens\u0103 publicului larg nu \u00eei sunt scoase la iveal\u0103 mecanismele de dirijare a resurselor financiare generate de aceast\u0103 industrie \u0219i nici \u00een ce const\u0103 lan\u021bul de distribu\u021bie a unui medicament. \u00cen concret, interfa\u021ba acestui lan\u021b de distribu\u021bie \u2013 farmacia \u2013 beneficiaz\u0103 de un profit infim comparativ cu ceea ce percep\u021bia general\u0103 consider\u0103 c\u0103 s-ar c\u00e2\u0219tiga din aceast\u0103 activitate. Nici la nivel european \u0219i nici \u00een Rom\u00e2nia, farmaciile nu \u00ee\u0219i pot stabili adaosurile comerciale \u00een mod discre\u021bionar, fiind drastic limitate de reglement\u0103rile europene \u0219i na\u021bionale \u00een acest sens.<\/span>\r\n\r\n\u00cen anul 2016, \u00een urma controlului efectuat de c\u0103tre Curtea de Conturi la nivelul Casei Na\u021bionale de Asigur\u0103ri de S\u0103n\u0103tate, ale c\u0103rui rezultate au fost analizate prin Raportul de audit \u00eencheiat \u00een urma misiunii de \u201dAudit financiar asupra contului anual de execu\u021bie a bugetului Fondului Na\u021bional Unic de Asigur\u0103ri Sociale de S\u0103n\u0103tate pentru anul 2015 la Casa Na\u021bional\u0103 de Asigur\u0103ri de S\u0103n\u0103tate\u201d, a fost emis\u0103 Decizia Cur\u021bii de Conturi nr. 8\/2016 prin care s-a dispus, \u00eentre altele, recalcularea de c\u0103tre fiecare cas\u0103 jude\u021bean\u0103 de asigur\u0103ri de s\u0103n\u0103tate a pre\u021burilor cu am\u0103nuntul maximale ale medicamentelor, \u00een vederea cuantific\u0103rii eventualului prejudiciu rezultat ca urmare a decont\u0103rilor realizate din FNUASS (Fondul Na\u021bional Unic de Asigur\u0103ri Sociale de S\u0103n\u0103tate) peste marjele de pre\u021b stabilite de Ordinul Ministerului S\u0103n\u0103t\u0103\u021bii nr. 75\/2009 pentru aprobarea Normelor privind modul de calcul al pre\u021burilor la medicamentele de uz uman. Decizia Cur\u021bii de Conturi a Rom\u00e2niei s-a bazat pe interpretarea cu caracter de noutate a OMS 75\/2009, consider\u00e2ndu-se c\u0103 CNAS a decontat pentru medicamente cu prescrip\u021bie medical\u0103 sume peste pre\u021bul rezultat din aplicarea adaosului comercial prev\u0103zut \u00een acest act normativ, apreciindu-se astfel c\u0103 ar fi fost prejudiciat FNUASS, argumentul fiind reprezentat de faptul c\u0103 farmaciile nu au inclus reducerile comerciale primite, pentru a diminua pre\u021bul de decontare.<\/span>\r\n\r\nLa acel moment, \u00een pia\u021ba farmaceutic\u0103 sau \u00een pres\u0103, nu s-au resim\u021bit ecouri ale acestei Decizii a Cur\u021bii de Conturi, \u00eentruc\u00e2t p\u0103rea ca va urma \u0219i un litigiu care va temporiza punerea \u00een aplicare a Deciziei, iar institu\u021biile cu putere de reglementare \u0219i gestionare a pre\u021burilor medicamentelor \u0219i a decont\u0103rilor din fondul na\u021bional, respectiv CNAS \u0219i Ministerul S\u0103n\u0103t\u0103\u021bii, au girat permanent corectitudinea decont\u0103rilor realizate din FNUASS ca fiind \u00een marje de pre\u021b stabilite legal.<\/span> Mai mult, tot la acel moment, ulterior Deciziei Cur\u021bii de Conturi, CNAS furniza un comunicat de pres\u0103<\/span> care confirma faptul c\u0103 se impuneau clarific\u0103ri doar la nivel institu\u021bional, \u00eentre Ministerul S\u0103n\u0103t\u0103\u0163ii, CNAS \u015fi Curtea de Conturi, ceea ce a determinat ca pe bun\u0103 dreptate, furnizorii de medicamente s\u0103 nu resimt\u0103 posibile efecte ale unei interpret\u0103ri date de Curtea de Conturi Ordinului MS nr. 75\/2009, \u00een sensul c\u0103 prin decont\u0103rile primite de la casele de s\u0103n\u0103tate ar fi prejudiciat parte a bugetului statului.\u00a0\u00a0<\/span>\r\n\r\nDe altfel, \u00een mod practic, farmacia individual\u0103 ori chiar farmacia de lan\u021b nici nu putea ob\u021bine decont\u0103ri \u00een alte limite dec\u00e2t cele acceptate de CNAS, pentru c\u0103 acestea sunt operate prin programe informatice verificate \u0219i agreate de institu\u021bii ale statului, astfel c\u0103 niciun furnizor de medicamente nu a putut anticipa c\u0103 ar fi beneficiat de vreo decontare nejustificat\u0103 a pre\u021burilor medicamentelor sau c\u0103 ar fi culpabil pentru o atare decontare.\u00a0<\/span>\r\n\r\nPe parcursul ultimilor ani, ulterior Deciziei nr. 8\/2016 a Cur\u021bii de Conturi a Rom\u00e2niei, s-a derulat litigiul reprezentat de contestarea Deciziei de c\u0103tre CNAS, unde au intervenit Ministerul S\u0103n\u0103t\u0103\u021bii, c\u00e2teva societ\u0103\u021bi \u0219i organisme profesionale ale farmaci\u0219tilor (ASOCIA\u0162IA DISTRIBUITORILOR \u015eI RETAILERILOR FARMACEUTICI DIN ROM\u00c2NIA, FEDERA\u0162IA PATRONATELOR FARMACEUTICE DIN ROM\u00c2NIA, COLEGIUL FARMACI\u015eTILOR DIN ROM\u00c2NIA, ASOCIA\u0162IA FARMACIILOR INDEPENDENTE \"ETHICA\", APOTHEKE LOTUS S.R.L., LIBRO PHARMA S.R.L., ALFA PHARM S.R.L., MEDICA FARM S.R.L., EXQUISIT S.R.L., FARMA MYOSYS S.R.L., FARMACEUTICA ARCATIM S.A., REMEDIUM FARM S.R.L., DERYYFARM 200 S.R.L., SANTAL PHARM S.R.L, POPINA PRODIMPEX S.R.L., ASLA FARM S.R.L., CRISTI GRUP S.R.L., IRIS FARM S.R.L., FARMACIA V\u00c2\u0162\u0102 S.R.L., FARMACIA JASMINUM S.R.L., BIOFARM FARMEC S.R.L., TIMOL-EUROFARM S.R.L., ADONIS FARM S.R.L.( FARMACIA DALIVEST), ARGEFARM S.R.L., LARIFARM S.R.L., QUINTA ESSENTIA FARMACIE S.R.L, JASMINE-PHARM S.R.L., MIRAFARM S.R.L., CRESCENS S.R.L., MINISTERUL S\u0102N\u0102T\u0102\u0162II). \u00cen ciuda anvergurii ap\u0103r\u0103rii CNAS sus\u021binute de ter\u021bi, prin Sentin\u021ba civil\u0103 nr. 2174\/08.06.2017 a Cur\u021bii de Apel Bucure\u0219ti \u2013 Sec\u021bia a VIII-a contencios administrativ \u0219i fiscal pronun\u021bat\u0103 \u00een dosar nr. 7244\/2\/2016*, ac\u021biunea CNAS a fost respins\u0103 ca nefondat\u0103, solu\u021bie confirmat\u0103 de ICCJ prin Decizia civil\u0103 nr. 2858\/19.05.2022.\u00a0<\/span>\r\n\r\nSolu\u021bia pronun\u021bat\u0103 \u00een recurs de ICCJ nu este redactat\u0103 nici \u00een prezent, \u00eens\u0103 imediat dup\u0103 pronun\u021barea \u00cenaltei Cur\u021bi, respectiv la data de 31.05.2022, CNAS a emis la nivel intern o metodologie de control cu impunerea unei machete cu efect de auto-control al farmaciilor, iar casele de s\u0103n\u0103tate au demarat controale operative la mii de entit\u0103\u021bi farmaceutice, impuse practic de Curtea de Conturi \u00een 2016, \u021bin\u00e2nd seama de adresa emis\u0103 de CNAS \u00een 31.05.2022 privind metodologia de control specific\u0103 acestui control, av\u00e2nd ca tematic\u0103 verificarea respect\u0103rii de c\u0103tre furnizorii de medicamente cu \u0219i f\u0103r\u0103 contribu\u021bie personal\u0103 a dispozi\u021biilor de reglementare privind stabilirea pre\u021burilor de v\u00e2nzare a medicamentelor care au fost raportate \u0219i decontate de C.A.S \u00een perioada 2015 \u2013 data efectu\u0103rii controlului.\u00a0<\/span>\r\n\r\nConform contractelor individuale \u00eencheiate \u00eentre furnizorii de medicamente \u0219i casele de s\u0103n\u0103tate, dar \u0219i potrivit Ordinului CNAS 1012\/2013 pentru aprobarea Normelor metodologice privind activitatea structurilor de control din cadrul sistemului de asigur\u0103ri sociale de s\u0103n\u0103tate, cei dint\u00e2i au obliga\u021bia de a pune la dispozi\u021bia caselor toate documentele financiar-contabile privitoare la achizi\u021bia de medicamente \u0219i decontarea lor. A\u0219adar, pe bun\u0103 dreptate, impactul \u00een pia\u021ba farmaceutic\u0103 a fost unul imens, generat de necesitatea de preg\u0103tire a sute de mii de \u00eenscrisuri de pe parcursul a 7 ani. Mai mult, a\u0219a cum este vizibil, multe din societ\u0103\u021bile ce au de\u021binut farmacii \u0219i-au \u00eenstr\u0103inat fondurile de comer\u021b sau au intrat \u00een faliment, astfel c\u0103 cei care desf\u0103\u0219urau \u00eenc\u0103 activitate sub forma celei din 2015 \u00ee\u0219i puneau fondat semne de \u00eentrebare cum se va asigura un tratament echitabil fa\u021b\u0103 de cei care erau verificabili \u0219i \u00een prezent \u00een compara\u021bie cu cei ale c\u0103ror documente nu mai putea fi verificate, din diverse motive, ori cu cei care au de\u021binut farmacii intrate \u00een faliment. Mai mult, se punea \u00eentrebarea cum se va putea asigura un calcul \u0219i o verificare echitabil\u0103 a pretinselor prejudicii c\u00e2t timp se cunoa\u0219te c\u0103 unele farmacii nu au avut reducerile comerciale vizibile pe factur\u0103 ori au existat reduceri sub forma rabatului natural.<\/span>\r\n\r\nEra \u0219i este \u00een continuare cert c\u0103 CNAS \u0219i casele de s\u0103n\u0103tate se aflau \u00een pozi\u021bia \u00een care nu puteau refuza legal stabilirea prejudiciilor pretinse de Curtea de Conturi \u00een anul 2016, date fiind dispozi\u021biile art. 64 Legea 94\/1992 privind organizarea \u0219i func\u021bionarea Cur\u021bii de Conturi, iar furnizorii de medicamente s-au v\u0103zut \u00een ipostaza \u00een care nici nu puteau refuza controalele, \u00eentruc\u00e2t ar fi riscat sanc\u021biuni severe cu impact asupra posibilit\u0103\u021bii de a mai comercializa medicamente decontate de stat \u0219i de a mai r\u0103m\u00e2ne \u00eentr-o rela\u021bie contractual\u0103 cu casele de s\u0103n\u0103tate, dar nici nu se aflau \u00eenc\u0103 \u00eentr-o procedur\u0103 \u00een care ar putea invoca ap\u0103r\u0103ri proprii, inclusiv prescrip\u021bii v\u0103dite.\u00a0\u00a0<\/span>\r\n\r\nMai mult, frustrarea colectiv\u0103 \u00een pia\u021ba farmaceutic\u0103 a fost dat\u0103 de faptul c\u0103 ulterior datei pronun\u021b\u0103rii solu\u021biei \u00cenaltei Cur\u021bi de Casa\u021bie \u0219i Justi\u021bie, nicio institu\u021bie ori autoritate public\u0103 nu a p\u0103rut s\u0103 fie preocupat\u0103 de impactul pe care l-a generat Decizia Cur\u021bii de Conturi nr. 8\/2016, de necesitatea efectu\u0103rii a mii de controale de c\u0103tre structurile de control din cadrul caselor de s\u0103n\u0103tate, ori de necesitatea angren\u0103rii de resurse umane de c\u0103tre priva\u021bi \u00eentr-un termen scurt \u00een care li s-a pretins reprezentan\u021bilor farmaciilor din Rom\u00e2nia s\u0103 procedeze la sintetizarea informa\u021biilor din cel pu\u021bin sute de mii de documente financiar-contabile. \u00cen mod legitim s-a a\u0219teptat ca Statul, prin institu\u021biile sale s\u0103 intervin\u0103 prin mecanisme constitu\u021bionale, \u00een condi\u021biile \u00een care furnizorii de medicamente au func\u021bionat unitar de maniera criticat\u0103 de Curtea de Conturi, f\u0103r\u0103 nicio aten\u021bionare din partea Ministerului S\u0103n\u0103t\u0103\u021bii ori a CNAS, nefiind a\u0219adar vorba despre cazuri izolate \u00een care s-ar fi aplicat gre\u0219it OMS 75\/2009. De altfel, chiar Curtea de Apel Bucure\u0219ti a \u0219i statuat \u00een Sentin\u021ba civil\u0103 nr. 2174\/08.06.2017: \u201d<\/span>Curtea apreciaz\u0103 c\u0103 reclamanta (CNAS) nu poate fi exonerat\u0103 de m\u0103sura de la pct. II 4 din Decizia nr. 8\/15.07.2016 emis\u0103 de p\u00e2r\u00e2t\u0103 (Curtea de Conturi), exist\u00e2nd o r\u0103spundere at\u00e2t a reclamantei, c\u00e2t \u0219i a Ministerului S\u0103n\u0103t\u0103\u021bii \u00een producerea prejudiciului aferent<\/span><\/i>\u201d. Cu toate acestea, faptic, prejudiciul urma a fi recuperat \u0219i suportat strict de la farmacii.\u00a0<\/span>\r\n\r\nApoi, se a\u0219tepta legitim o interven\u021bie din partea institu\u021biilor Statului, \u00een condi\u021biile \u00een care de\u0219i \u00eentre furnizorii de medicamente \u0219i casele de s\u0103n\u0103tate exist\u0103 \u00eencheiate raporturi contractuale de natur\u0103 civil\u0103, totu\u0219i ace\u0219tia erau expu\u0219i la a li se solicita chiar s\u0103-\u0219i cuantifice singuri sumele decontate \u00een ultimii 7 ani, peste ceea ce a considerat Curtea de Conturi a Rom\u00e2niei c\u0103 se impunea, cu toate c\u0103 fiecare furnizor s-a supus \u0219i \u00een trecut oric\u0103rui control al caselor de s\u0103n\u0103tate \u0219i niciodat\u0103 nu i s-a atras aten\u021bia c\u0103 ar fi primit sume din FNUASS f\u0103r\u0103 drept. \u00cen plus, cei mai mul\u021bi de\u021bin\u0103tori de farmacii, \u00een special farmacii individuale, transmiteau \u00een pia\u021b\u0103 faptul c\u0103 vor fi falimenta\u021bi, neput\u00e2nd s\u0103-\u0219i permit\u0103 acoperirea unor prejudicii neinten\u021bionate, la care Curtea de Conturi dorea s\u0103 fie calculate suplimentar dob\u00e2nzi \u0219i penalit\u0103\u021bi legale.\u00a0<\/span>\r\n\r\nTotodat\u0103, \u00een ciuda percep\u021biei publice asupra veniturilor poten\u021biale ale farmaciilor, prin raportare la ceea ce a decis Curtea de Conturi \u0219i a confirmat ICCJ, entit\u0103\u021bile farmaceutice s-au v\u0103zut \u00een postura de a li se confisca de c\u0103tre Stat reduceri comerciale negociate individual cu distribuitorii, negocieri care au fost sus\u021binute de ani de colaborare \u00eentre priva\u021bi. Pentru a ob\u021bine reduceri comerciale la achizi\u021bia de medicamente, fiecare reprezentant al unei farmacii cunoa\u0219te c\u0103 i se impune achizi\u021bia unei cantit\u0103\u021bi mai mari dec\u00e2t necesarul ori efectuarea de pl\u0103\u021bi pentru acea achizi\u021bie cu mult anterior momentului decont\u0103rii pre\u021bului medicamentelor de c\u0103tre casele de s\u0103n\u0103tate. Este chiar o cutum\u0103 faptul c\u0103 furnizorii de medicamente se angajeaz\u0103 \u00een credite pentru a acoperi deficitul financiar ce exist\u0103 p\u00e2n\u0103 la un moment incontrolabil \u00een care casele de s\u0103n\u0103tate deconteaz\u0103 pre\u021burile medicamentelor. Printre farmaci\u0219ti, este o uzan\u021b\u0103 deja, ca la nivelul decont\u0103rilor ce trebuie s\u0103 fie realizate de casele de s\u0103n\u0103tate, s\u0103 existe luni de zile de \u00eent\u00e2rziere, timp \u00een care salaria\u021bii \u0219i distribuitorii trebuie totu\u0219i pl\u0103ti\u021bi. A\u0219adar, este firesc ca revolta celui care a sus\u021binut sistemul de s\u0103n\u0103tate ani de zile, prin punerea la dispozi\u021bie a finan\u021belor proprii, a cuno\u0219tin\u021belor dob\u00e2ndite, a expertizei acumulate, prin demersuri sus\u021binute de atragere a aten\u021biei asupra lipsei medicamentelor \u00een anumite situa\u021bii specifice, toate \u00een favoarea pacientului, s\u0103 fie una major\u0103, \u00een condi\u021biile \u00een care i se neag\u0103, prin interpretarea dat\u0103 de Curtea de Conturi a Rom\u00e2niei, orice c\u00e2\u0219tig comercial derivat dintr-o rela\u021bie comercial\u0103 construit\u0103 de el, individual \u0219i etapizat.\u00a0<\/span>\r\n\r\nEchipa noastr\u0103 a fost solicitat\u0103 de entit\u0103\u021bile farmaceutice din Rom\u00e2nia \u00een cadrul c\u0103rora s-a n\u0103scut o coeziune surprinz\u0103toare chiar \u0219i pentru breasla farmaci\u0219tilor, pentru a formula amendamente fa\u021b\u0103 de Ordinul 1012\/2013, iar ulterior pentru a furniza repere pentru a fi avute \u00een vedere \u00een cadrul controalelor efective, pentru a ataca metodologia adoptat\u0103 la nivel intern de CNAS \u0219i pentru a solicita modific\u0103ri ale actualului Ordin al Ministerului S\u0103n\u0103t\u0103\u021bii ce reglementeaz\u0103 acelea\u0219i aspecte ale pre\u021burilor maximale precum OMS 75\/2009. Astfel, \u00een decursul ultimelor luni, am conlucrat zilnic la a furniza clien\u021bilor no\u0219tri at\u00e2t r\u0103spunsuri colective, c\u00e2t \u0219i individuale, pe marginea abord\u0103rii fiec\u0103rui control al caselor de s\u0103n\u0103tate, am identificat vicii ale procedurii urmate de CNAS \u00een adoptarea acelei metodologii de control \u0219i am construit o abordare al c\u0103rui scop a fost acela de a temporiza momentul efectiv al stabilirii prejudiciului calculat pentru fiecare farmacie, cu speran\u021ba ca ultimul nostru demers s\u0103 se bucure de succes.\u00a0<\/span>\r\n\r\nIni\u021bial, a\u0219a cum am men\u021bionat anterior, am transmis c\u0103tre CNAS un memoriu cuprinz\u00e2nd observa\u021bii aduse propunerilor de modific\u0103ri ale Ordinului nr. 1012\/2013 publicate de CNAS la finalul lunii iunie 2022. Principala problem\u0103 pe care acest proiect o con\u021binea era \u00een str\u00e2ns\u0103 leg\u0103tur\u0103 cu ac\u021biunile de control ce urmau, pentru c\u0103 se permitea ca organele de control ale caselor de s\u0103n\u0103tate s\u0103 realizeze doar o estimare a prejudiciului pretins creat de furnizorii de medicamente \u0219i nu numai, ceea ce permitea practic o <\/span>nou\u0103 reevaluare \u0219i verificare, afect\u00e2nd previzibilitatea normei \u0219i expun\u00e2nd furnizorul de servicii medicale, medicamente, dispozitive medicale \u015fi materiale sanitare la solicit\u0103ri dublate de prezentare a documentelor justificative \u0219i implicit la controale repetate pe aceea\u0219i tematic\u0103. Este de \u00een\u021beles \u0219i optica CNAS de la acel moment, care se vedea \u00een postura de a gestiona mii de controale cu privire la sume decontate pe parcursul a 7 ani, ceea ce empiric vorbind las\u0103 loc de erori umane, astfel c\u0103 se dorea ca ulterior s\u0103 existe cadru legal pentru a reveni cu acela\u0219i control, practic. Concomitent cu propunerile formulate de echipa noastr\u0103 \u00een reprezentarea celor peste 700 de entit\u0103\u021bi farmaceutice, am solicitat \u0219i organizarea unei dezbateri publice, \u00een condi\u021biile \u00een care era evident c\u0103 subiectul ac\u021biunilor de control viitoare suscita un interes major comparativ cu orice alt subiect pus \u00een discu\u021bie de CNAS anterior. Ulterior, s-a organizat aceast\u0103 dezbatere public\u0103, unde am avut mandatul clien\u021bilor no\u0219tri pentru a expune \u0219i \u00een dialogul cu reprezentan\u021bii CNAS criticile aduse proiectului de modificare a Ordinului CNAS 1012\/2013. C\u00e2\u0219tigul acestui demers s-a concretizat la finalul lunii august 2022, sintagma de estimare a prejudiciilor fiind abandonat\u0103 de CNAS, iar controalele demarate p\u00e2n\u0103 la acel moment urmau a fi supuse oricum dispozi\u021biilor aplicabile din Ordin \u00een vigoare la momentul demar\u0103rii controlului.\u00a0<\/span>\r\n\r\n\u00cen continuare, am criticat, \u00een reprezentarea entit\u0103\u021bilor farmaceutice, faptul c\u0103 acestora li se solicit\u0103 s\u0103 \u00eentocmeasc\u0103 machete cu valen\u021b\u0103 de auto-control, solicitare bazat\u0103 pe o simpl\u0103 adres\u0103 intern\u0103 a CNAS din 31.05.2022, f\u0103r\u0103 ca atare documente s\u0103 fie stabilite de un act normativ sau \u00een contractul individual \u00eencheiat de furnizorul de servicii medicale, medicamente, dispozitive medicale \u015fi materiale sanitare. Tot la nivel colectiv, pentru c\u0103 s-a \u00een\u021beles c\u0103 ceea ce a generat emiterea Deciziei nr. 8\/2016 a Cur\u021bii de Conturi este posibil s\u0103 subziste din punct de vedere al interpret\u0103rii \u0219i sub cupola aplic\u0103rii Ordinului Ministerului S\u0103n\u0103t\u0103\u021bii nr. 368\/2017, am formulat propuneri transmise Ministerului S\u0103n\u0103t\u0103\u021bii de modificare a acestui act normativ, \u00een scopul adapt\u0103rii cotelor de adaos permise \u00een farmacii pentru medicamentele decontate, la realit\u0103\u021bile pie\u021bei \u0219i la rolul pe care Statul Rom\u00e2n trebuie s\u0103-l recunoasc\u0103 farmaciilor.\u00a0<\/span>\r\n\r\nDe asemenea, tocmai pentru c\u0103 am primit multe solicit\u0103ri pe tema abord\u0103rii efective a controalelor ini\u021biate de casele de s\u0103n\u0103tate, pentru a putea oferi sprijin concret farmaciilor ce ne-au solicitat suportul, am elaborat un ghid relativ la fiecare aspect al controlului, de la verificarea \u00eenscrisurilor ce trebuie prezentate de echipa de control a casei de s\u0103n\u0103tate, p\u00e2n\u0103 la procedurile de contestare a actelor emise de aceste organe. Suplimentar, am \u00eentocmit un draft utilizat la scar\u0103 larg\u0103 de farmacii pentru solicitare de l\u0103muriri legale privind modalitatea \u00een care li se solicita s\u0103 \u00eentocmeasc\u0103 machete cu sume din documentele lor contabile, privind tematica de control, dar \u0219i de prelungire a termenelor impuse pentru prezentarea documentelor.\u00a0<\/span>\r\n\r\n\u00cen finalul demersurilor \u00eencepute \u00een sprijinul farmaciilor, am conceput o propunere de proiect de act normativ care s\u0103 cuprind\u0103 dispozi\u021bii de exonerare de la plat\u0103 a pretinselor prejudicii create prin mecanismul re\u021binut de Curtea de Conturi \u00een 2016, cu explica\u021bii juridice \u0219i cu argumente impuse de pia\u021ba farmaceutic\u0103, pe care l-am transmis \u00een cadrul unui memoriu c\u0103tre\u00a0organismele ce puteau s\u0103-\u0219i ofere concursul constitu\u021bional spre implementare, \u00een calitate\u00a0de\u00a0mandatari ai entit\u0103\u021bilor farmaceutice angrenate \u00een acest demers colectiv. Acest demers l-am concretizat \u00een luna septembrie 2022, iar ulterior, factorii decizionali de la nivelul Senatului Rom\u00e2niei au g\u0103sit viabil\u0103 varianta \u00een care exonerarea de la plat\u0103 solicitat\u0103 de noi s\u0103 fie transpus\u0103 \u00een ceea ce reprezenta Proiectul de Lege privind aprobarea Ordonan\u0163ei Guvernului nr. 14\/2022 pentru modificarea \u015fi completarea Legii nr. 95\/2006 privind reforma \u00een domeniul s\u0103n\u0103t\u0103\u0163ii. \u00cen cursul lunii octombrie 2022, proiectul a ajuns la Camera Deputa\u021bilor, ce reprezenta camera decizional\u0103, iar ca urmare a amendamentelor noastre prin care am solicitat ca exonerarea s\u0103 vizeze at\u00e2t sume decontate \u00een baza Ordinului Ministerului S\u0103n\u0103t\u0103\u021bii nr. 75\/2009, c\u00e2t \u0219i a Ordinului Ministerului S\u0103n\u0103t\u0103\u021bii nr. 368\/2017, forma transmis\u0103 Pre\u0219edintelui Rom\u00e2niei spre promulgare a con\u021binut toate aspectele pe care le-am solicitat, respectiv at\u00e2t exonerare de la plat\u0103 pentru sumele decontate de CNAS \u00een mod nelegal conform opticii Cur\u021bii de Conturi a Rom\u00e2niei, c\u00e2t \u0219i aplicarea acestei exoner\u0103ri pe \u00eentreaga perioad\u0103 cuprins\u0103 \u00eentre 2015-2022.<\/span>\r\n\r\nFinalmente, eforturile noastre \u0219i \u00eencrederea clien\u021bilor no\u0219tri s-au concretizat \u00eentr-un veritabil succes prin publicarea \u00een Monitorul Oficial a Legii 308\/2022<\/span> privind aprobarea Ordonan\u021bei Guvernului nr. 14\/2022 pentru modificarea \u0219i completarea Legii nr. 95\/2006 privind reforma \u00een domeniul s\u0103n\u0103t\u0103\u021bii, ce cuprinde astfel toate aspectele solicitate.\u00a0<\/span>\r\n\r\nNe \u00eenc\u00e2nt\u0103 experien\u021ba depunerii unui efort sus\u021binut \u0219i de o asemenea anvergur\u0103, dar cu at\u00e2t mai mult ne bucur\u0103 fiecare contact avut cu reprezentan\u021bii farmaciilor \u0219i cei ai institu\u021biilor publice angrenate, f\u0103r\u0103 care nici ideile noastre \u00een a construi o tactic\u0103 de succes nu s-ar fi n\u0103scut \u0219i nici nu ar fi fost \u00eencununate de succesul pe care \u00eel putem s\u0103rb\u0103tori azi, cu to\u021bi.\u00a0<\/span>\r\n\r\n\u00a0\r\n\r\n\u00a0<\/span>\r\n\r\n
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