NEWS

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Drug Evaluation and Reimbursement in Poland

In 2017 the pharmaceutical market in Poland posted a 5.4 percent growth. The industry continues to demonstrate value growth with a total market estimated at EUR9bn. The surge in demand for over the counter medicinal products largely contributed to the sector growth.

It is access to innovative prescription pharmaceutical products and improvement of drug reimbursement practices which remains one of the top priorities for Polish health authorities. The country faces strong public pressure to use drug reimbursement to improve patient access to new therapies in areas like cancer, cardiovascular diseases and diabetes. It already commits around 11 PLN billion (approx. EUR2.6bn) to drug reimbursement, 10% of which is spent on new patented medicines. Robust economic growth is expected to fuel further dynamic expansion of reimbursement coverage.

Poland has successfully established a system for evaluating whether new drugs represent “good value for money” - an optimal balance of cost and clinical efficacy - and which merit investment from public resources. Its Agency for Health Technology Assessment, modelled on the English National Institute of Health and Care Excellence (NICE), is often viewed as a regional leader.

Despite the significant progress achieved by the Agency in certain areas, it still lags behind NICE in being clear about the cost-effectiveness and budgetary impact of medicines, where revisions occur in at least half of assessment reports.

Poland continues to face challenges in striking the right balance between expertise and transparency on healthcare policies. Ensuring full transparency of drug evaluation, encompassing all key stakeholders in the process, from manufacturers to clinical experts is crucial for the pharmaceutical sector development in the future.

For further information regarding regulatory submissions, MA approval and national authorisation procedures in Central and Eastern Europe, please contact Jane Smith at Grove Group Pharmaservices janesmith@groveonline.com or visit our website www.groveonline.com