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.
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.
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.