Market Access Tracker Program

December 2013

Poland: Market Access Tracker - 2013

Report Authors
Jonathan Chan, M.MedSc.
Neil Grubert, M.A.
Michael Latwis, M.B.A.
Gilan Megeed, M.P.H.
Nikhil Mehta, M.Eng.
Lulu Pickering, Ph.D.
Andreia Ribeiro, Ph.D.
Michael Yeung, M.Sc.

Introduction:

Last Updated 3 December 2013
Poland is the largest and most populous country in central Europe. Almost a quarter of a century after the ending of communist rule, the country has a flourishing economy and increasing levels of affluence. Investment in healthcare is a political priority for the government, but recent legislation—most notably, the Reimbursement Act—has created a challenging market access environment for manufacturers of branded drugs. The pharmaceutical industry waits anxiously to see if the government will introduce amendments to its reform program.

Scope:

Socioeconomic trends: Gross domestic product (GDP), nominal per capita gross national income (GNI).

Demographics: Overall population (projected to 2030); life expectancy at birth (projected to 2030); median age and number of senior citizens (projected to 2030); urban population (projected to 2030).

Healthcare system: Healthcare spending; public sector administrative framework, funding, and providers; private sector funding and provision.

Regulatory affairs: Clinical trial regulation; registration process for new drugs; biosimilars regulations.

Intellectual property protection: Patent and data protection; compulsory licensing; counterfeit and falsified drugs.

Health technology assessment: Responsibilities of the Agencja Oceny Technologii Medycznych (AOTM; Agency of Health Technology Assessment); recent changes to the HTA process; current HTA guidelines.

Pricing and reimbursement: Requirements for public sector pricing and reimbursement applications; scope of AOTM recommendations; role of the Komisja Ekonomiczna (Economic Commission) in pricing and reimbursement.

Cost containment: Cap on pharmaceutical spending; internal reference pricing; out-of-pocket payments; prescription monitoring; measures to promote the use of generics.

Proposed amendments to the Reimbursement Act: Introduction of a grace period following increases to patient copayments; abolition of the requirement for healthcare providers to buy reimbursed medicines at prices that do not exceed the reimbursement ceiling; easier access to innovative medicines; expanded generic substitution; periodic reevaluation of drugs by the AOTM.

Outlook and implications for the pharmaceutical industry: Government goal to increase access to innovative medicines; increasing use of HTA; multinationals’ growing interest in the Polish market; unresolved questions for hospitals; impact of reforms on the private healthcare sector.

Exhibits: 17 data-rich tables and figures.

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Mentioned in this report:

  • Organizations
  • - Agencja Oceny Technologii Medycznych (AOTM; Agency of Health Technology Assessment, also called the Agency for Health Technology Assessment in Poland [AHTAPol])
  • - European Free Trade Association
  • - Główny Inspektorat Farmaceutyczny (GIF; Main Pharmaceutical Inspectorate)
  • - Główny Urząd Statystyczny (GUS; Main Statistic Office)
  • - IMS Health
  • - International Monetary Fund
  • - Kasa Rolniczego Ubezpieczenia Społecznego (Agricultural Social Insurance Fund)
  • - Pharmaceutical Research and Manufacturers of America
  • - Pracodawcy Rzeczypospolitej Polskie (Employers of Poland)
  • - Narodowy Fundusz Zdrowia (National Health Fund)
  • - Naczelna Rada Lekarska (Supreme Medical Council)
  • - Ogólnopolski Związek Zawodowy Lekarzy (National Physicians’ Association)
  • - Organization for Economic Co-operation and Development
  • - Supplementary protection certificate
  • - United Nations Population Division
  • - Urząd Nadzoru Ubezpieczeń Zdrowotnych (Health Insurance Supervision Office)
  • - Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (Office of Registration of Medicinal Products, Medical Devices and Biocidal Products
  • - United States Trade Representative
  • - World Bank
  • - World Health Organization
  • - World Trade Organization
  • - Zakład Ubezpieczeń Społecznych (Social Security Institution)
  • - Związku Pracodawców Innowacyjnych Firm Farmaceutycznych (INFARMA; Employers’ Association of Innovative Pharmaceutical Companies)
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