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Mii de medicamente ieftine ar putea dispărea de pe piaţă din cauza taxei clawback. Gentamicina, Oxacilina, Omeprazol - printre ele

Asociaţia Producătorilor de Medicamente Generice atrage atenţia că mii de medicamente ieftine riscă să fie scoase din producţie sau delistate în perioada imediat următoare, printre ele aflîndu-se medicamente precum Gentamicina, Oxacilina, Omeprazol (20 mg), Ranitidina injectabil, Metoclopramid 10 mg şi injectabil. Principală cauza a dispariţiei acestora este taxa clawback, aplicată uniform atît medicamentelor scumpe, cît şi celor ieftine.

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Clawback – o taxă pe cifra de afaceri, introdusă în anul 2009 şi aplicată producătorilor de medicamente – a ajuns la 24,13% în primul trimestru din 2018 şi este cu aproape 4,3 puncte procentuale mai mare decît în aceeaşi perioadă a anului 2017, dar şi cu 8,51 puncte procentuale mai mare decît în primul trimestru din 2016, arată datele trimise de Patronatul Producătorilor Industriali de Medicamente din România pentru Economica.net.

La nivelul din trimestrul I, taxa clawback reprezintă 34% din preţul de producător pentru medicamentele sub 25 de lei. Spre comparaţie, taxa clawback reprezintă 24% din preţul de producător pentru medicamentele care costă peste 3.000 lei (deci cu 10 puncte procentuale mai mare pentru medicamentele ieftine), arată Asociaţia Producătorilor de Medicamente Generice (APMGR).

APMGR estimează că taxa va ajunge la 30% pînă la sfârşitul anului. Aceasta înseamnă că, pentru medicamentele care costă sub 25 de lei, impactul taxei în preţul de producător ar ajunge la 42%.

Producătorii de medicamente generice nu mai pot susține un consum de care nu sunt responsabili şi care crește mai ales din cauza introducerii necondiționate pe lista de medicamente compensate a medicamentelor inovative, atrage atenţia APMGR. 

Printre medicamentele cu risc major de a scădea sub limita profitabilităţii şi de a dispărea de pe piaţa românească se numără: Gentamicinum (infecții germeni rezistenți intra-spitalicești), Theophyllinum (astm), Captopril (hipertensiune, insuficiență cardiaca), Furosemid (insuficiență cardiaca, ciroză hepatica), Ranitidina injectabil (afecțiuni gastrointestinale), Indapamida (afecțiuni cardiovasculare), Tamoxifenul (tumori de sân), Bleomicina (leucemie, afecțiuni hematologice), Fluorouracil (cancer), Cisplatin (cancer), Flutamida (cancer), Memantine (demența).

Citeşte şi Medicamentele sub 25 de lei ar putea dispărea de pe piaţă în 2019, din cauza creşterii la 30% a taxei clawback în trimestrul IV din 2018 - PRIMER

„Nu este echitabil pentru noi să finanțăm un consum pe care noi nu îl generăm. Mai important, nu ne putem permite să finanțăm acest consum, ceea ce înseamnă că trebuie să renunțăm la medicamentele ale căror costuri de producție nu mai pot fi acoperite, sau să închidem facilități de producție. Și pacienții, și economia României vor pierde”, a declarat Adrian Grecu, preşedintele APMGR.

Viorica Predună, vicepreşedintele APMGR, a adăugat: „Cred că suntem cu toții de acord că o taxă pe vânzări de 42% nu este sustenabilă pentru nicio companie. Această taxă pe vânzări, combinată cu politica celui mai mic preț dintr-un coș de 12 țări de referință, cu obligația ca prețul medicamentului generic să fie la maximum 65% din prețul medicamentului inovativ al cărui generic, nu poate să ducă decât la catastrofă pentru pacienți şi faliment pentru industrie”. 

APMG propune implementarea imediată a două măsuri pentru a opri dispariţia medicamentelor ieftine de pe piaţă: 

Introducerea imediată a calculului diferenţiat al taxei clawback, în funcţie de prețul medicamentelor: în prima categorie ar trebui incluse medicamentele scumpe, cele pentru care nu există aprobat un preț de referință generic sau biosimilar, sau la care prețul este mai mare decât prețul de referință generic sau biosimilar; iar în cea de-a doua categorie, medicamentele mai ieftine, pentru care există aprobat un preț de referință generic sau biosimilar, iar acesta este mai mic sau cel mult egal cu prețul de referință generic sau biosimilar.

Taxa clawback ar trebui să fie mai mică pentru medicamentele ieftine şi mai mare pentru cele scumpe. Amintim că prețul de referință al medicamentului generic reprezintă 65% din prețul medicamentului inovativ al cărui generic este.

  • O astel de măsură ar fi mai echitabilă pentru medicamentele cu preț scăzut, fie că sunt generice sau medicamente ieșite de sub patent. Mai mult, ar fi neutră bugetar, ușor de implementat de către autorități și ar asigură disponibilitatea medicamentelor pe piață, dacă ar fi combinată cu a două măsură propusă, spune APMGR. 

A două măsură se referă la aprobarea introducerii de noi medicamente pe lista celor compensate doar cu alocare de finanțare suplimentară, sau prin contracte Cost-Volum sau Cost-Volum-Rezultat.

  • Măsura ar îngheța cuantumul taxei clawback prin controlul eficient al consumului, protejînd medicamentele ieftine, și ar fi și eficientă pentru bugetul de stat, întrucât ar acorda discount-uri mai mari prin acest tip de contracte, explică APMGR.

Lista medicamentelor nerentabile care e foarte probabil să nu mai fie disponibile în România, conform Asociaţiei Producătorilor de Medicamente Generice:

Claritromicina suspensie 125 şi 250;
Ciprofloxacina 500 şi 250
Gentamicinum;
Oxacillin;
Cefalexin;
Adrenalina injectabil 50 fiole;
Metoclopramid 10 mg şi injectabil;
Omeprazol 20 mg;
Ranitidina injectabil;
Metoprolol succinate;
Clarithromycin;
Claritromicina 250 mg şi 500 mg;
Captropril 25 mg şi 50 mg;
Ampicillin;
Amoxicillin;
Amoxicillin şi Acid Clavulanic;
Cisplatin;
Cinnarizina 25 mg;
Cefaclor susp 125;
Cefaclor 250 mg şi 500 mg;
Carvedilol;
Carbamazepina 200 mg;
Candesartan 8 mg şi 16 mg;
Bleomicina;
Azithromycin;
Atorvastatina 10 mg, 20 mg, 40 mg, 80mg;
Amlodipina 5mg şi 10 mg;
Amlodipine;
Acenocumarol 2mg;
Rivastigmine;
Simvastatina 10 mg şi 20 mg;
Spironolactona 25mg;
Telmisartan;
Theophyllinum;
Sucralfatum;
Sulfasalazinum;
Rosuvastatin;
Nebivolol;
Clopidogrel;
diazepam injectabil şi 10 mg;
Donepezil 5 mg, 10 mg;
Doxepin 25 mg;
Enalapril 5 mg, 10 mg, 20 mg;
Esomeprazol 10 mg şi 20 mg;
Felodipine;
Furosemid;
Flutamida;
Fluorouracil;
Hidroclorotiazida;
Indapamida 1,5 mg;
Irbesartan 150 mg şi 300 de mg;
Lansoprazol 15 mg şi 30 mg;
Levetiracetam 500mg;
Lisinopril 5 mg, 10mg, 25 mg;
Nifedipin 20mg;
Ofloxacin 200mg;
Olanzapina 5 mg şi 10 mg;
Pantoprazol 20 mg şi 40 mg;
Ramipril 10mg.

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