With a prescription drug market valued at $4.7 billion in 2012, Poland holds “strategic importance” for multinational drugmakers looking beyond the major markets for growth opportunities, according to a new report.

Poland is a large and populous nation whose increasing affluence - as well as its myriad reforms and policy initiatives relating to healthcare quality, access, privatisation and financing - have contributed to growth of the national drug market during much of the last decade, according to the report, which is published by Decision Resources. The study also points out that Poland has experienced several years of significant growth in public drug reimbursement spending.

However, the entry of multinationals onto the national market is hampered by a number of challenges. These include Poland’s traditionally low prices for reimbursed drugs, its relatively levels of high patient copayments, a large market share for generic drugs and its relatively low spend on healthcare as a percentage of Gross Domestic Product , the study adds.

Additionally, the introduction in 2012 of the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Purposes and Medical Devices Act (the Reimbursement Act) has caused radical changes in drug assessment, pricing and reimbursement and has – in a very short space of time – become one of the most restrictive reimbursement regulations in the whole of Europe. After several years’ healthy growth in Poland’s prescription drugs sector, the reimbursement legislation drove a sharp 13.4% decline in prescription drug sales last year, says the firm.

Nevertheless, initiatives aimed at improving the transparency of drug pricing and reimbursement in Poland and at the use of health technology assessment (HTA) to foster cost-effective use of drugs can ultimately benefit innovators who can show the clinical and economic benefits of their therapies to the Polish health system, advises Decision Resources analyst Laurie DiModica.

Drug manufacturers operating in Poland now have the opportunity to enter into risk-sharing agreements with the government, based on clinical outcomes and expected cost savings, and this has enabled them to avoid the potential for a hefty payback which is required of manufacturers when the government’s drug reimbursement spending exceeds 17% of the annual public healthcare budget, she adds.

“Further, the next few years will be critical for the industry, as the Polish government has signalled its intention to reallocate savings generated through the Reimbursement Act into increasing access to innovative, cost-effective medicines,” says Ms DiModica.