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Proposed changes to the reimbursement of pharmaceuticals and medical devices in Poland and their impact on market access and the pharmaceutical industry

Karolina Badora, Aleksandra Caban, Cécile Rémuzat, Claude Dussart and Mondher Toumi ()
Additional contact information
Karolina Badora: Creativ-Ceutical Poland, Cracow, Poland.
Aleksandra Caban: Creativ-Ceutical Poland, Cracow, Poland.
Cécile Rémuzat: Creativ-Ceutical, Paris , France
Claude Dussart: P2S - Parcours santé systémique - UCBL - Université Claude Bernard Lyon 1 - Université de Lyon, Faculté de Médecine Laennec, Université de Lyon, Lyon, France.
Mondher Toumi: AMU MED - Aix-Marseille Université - Faculté de médecine - AMU - Aix Marseille Université

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Abstract: In Poland, two proposed amendments to the reimbursement act are currently in preparation ; these are likely to substantially change the pricing and reimbursement landscape for both drugs and medical devices. Proposed changes include: alignment of medical device reimbursement with that of pharmaceuticals; relaxing the strict reimbursement criteria for ultra-orphan drugs; establishment of an additional funding category for vaccines; introduction of compassionate use, and a simplified reimbursement pathway for well-established off-label indications; appreciation of manufacturers' innovation and research and development efforts by creating a dedicated innovation budget; introduction of a mechanism preventing excessive parallel import; prolonged duration of reimbursement decisions and reimbursement lists; and increased flexibility in defining drug programmes. Both amendments are still at a draft stage and many aspects of the new regulations remain unclear. Nonetheless, the overall direction of some of the changes is already evident and warrants discussion due to their high expected impact on pharmaceutical and device manufacturers. Here we evaluate the main changes proposed to the reimbursement of drugs, vaccines, and medical devices, and examine the impact they are likely to have on market access and pharmaceutical industry in Poland. ARTICLE HISTORY

Keywords: Pricing and reimbursement; reimbursement policy; drug policy; medical devices; pharmaceuticals; Poland (search for similar items in EconPapers)
Date: 2017-07-26
New Economics Papers: this item is included in nep-com and nep-hea
Note: View the original document on HAL open archive server: https://univ-lyon1.hal.science/hal-01722743
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Published in Journal of Market Access & Health Policy, 2017, 5 (1), ⟨10.1080/20016689.2017.1381544⟩

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Persistent link: https://EconPapers.repec.org/RePEc:hal:journl:hal-01722743

DOI: 10.1080/20016689.2017.1381544

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