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The pharmaceutical industry plays a key role in Poland’s healthcare system and economy. It was valued at $8.6 billion in 2013 and is projected to reach $15 billion in 2020 at a Compound Annual Growth Rate (CAGR) of 8.3% (AESGP, 2014). The pharmaceutical market had decreased from $8.8 billion in 2011 to $7.1 billion in 2012 due to the implementation of the new Reimbursement Act by Poland government in 2012, but has since partially recovered. According to the new act, the prices of the reimbursed drugs were decreased and the profit margins for wholesalers and retailers were also reduced, which impacted the pharmaceutical market negatively. The highest mark-up possible for reimbursed medicines was reduced from 9.78% in 2011 to 7% in 2012 and then to 6% in 2013. The VAT on pharmaceuticals and medical devices was 8% (ISPOR, 2013; EC, 2014). In 2013, the pharmaceutical market recovered and reached $8.6 billion due to an increase in demand for and consumption of pharmaceuticals (ISPOR, 2013). |
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Generic drugs have a dominant position in the pharmaceutical market. In 2012, the share of generic drugs was 66% of the pharmaceutical market, which increased from 62.2% of the total pharmaceutical market in 2011. |
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The prices of pharmaceuticals are lower in Poland than in other European Union (EU) member countries. These low prices enhance the affordability of pharmaceuticals, boosting the pharmaceutical market.
The cap on the reimbursement budget for drugs was decreased from 21% in 2010 to 17% in 2011 of the National Health Fund (Narodowy Fundusz Zdrowia, NFZ), so patients now have to pay more for their treatment. The NFZ administers funding and contracts providers to provide healthcare services, both for prophylaxis and therapy. The majority of resources are allotted to in-patient treatment, followed by reimbursement of medications, out-patient general care and specialized out-patient care. The value of the NFZ’s total drugs reimbursement decreased from PLN8.8 billion ($3 billion) in 2011 to PLN6.9 billion ($2.1 billion) in 2012. The decrease in the reimbursement budget would negatively affect the overall pharmaceutical market.
In Poland, the government has taken steps to increase R&D expenditure. In 2013, the expenditure on research in healthcare has been estimated at $633.5m, from $300.8m in 2008. The healthcare R&D Poland Pharmaceutical Market Growing at 8.3% CAGR to 2020 |
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The main regulatory authority for pharmaceutical products is the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych Rzeczpospolitej Polskiej (URPL)), which works under the guidance of the Ministry of Health (MoH). Obtaining Marketing Authorization (MA) for a new drug requires the execution of Good Laboratory Practice (GLP) and satisfactory compliance reviews for safety, efficacy and quality by the URPL and the MoH. It takes the URPL 210 days from the date of application to approve a new drug, and authorization is valid for five years (MPI, 2009).
The MA process for pharmaceuticals in Poland is aligned with the EU process of registration, which increases the transparency in the regulatory process. |
The healthcare system in Poland is financed mainly by health insurance contributions from state and local government budgets. The percentage of Gross Domestic Product (GDP) spent on health was estimated at 6.7% in 2013 (World Bank, 2014i).
The MoH offers universal access to healthcare, covering the entire population. The public healthcare insurance system is provided by the NFZ under the MoH. The NFZ is responsible for negotiating with regional healthcare service providers and supplying health services to the Polish population, but is not permitted to operate or own healthcare institutions. It is supervised by the Fund Council, and covers health services such as primary healthcare, out-patient specialized medical procedures, dental care, in-patient care, mental healthcare and long-term medical care. |
