Limited availability of innovative medicines on the Polish market – problems and challenges

Access to innovative medicines in Poland remains limited by reimbursement barriers, lengthy procedures and high treatment costs. The EFPIA W.A.I.T. 2023 report indicates that Poland has access to 39 per cent of the 173 medicines analysed (often with restrictions) and remains among the EU countries with the longest time from registration to reimbursement (an average of 723 days). The situation is most challenging in the fields of oncology and rare diseases, with the key issues being systemic barriers, HTA and financial constraints.

In this article, you will learn:

• What are the main reasons for the limited availability of innovative medicines in Poland?
• how Poland compares with other European countries in terms of access to and waiting times for reimbursement of new treatments
• To what extent are innovative treatments available in Poland subject to restrictions, and what are the reasons for these restrictions?
• What is the situation regarding access to innovative treatments for cancer and rare diseases?
• What systemic barriers affect access to modern treatment in Poland and Europe?
• how Poland compares with the other Visegrad Group countries in terms of access to innovative treatments and diagnostics
• What measures could improve the availability of innovative medicines on the Polish market?

Abstract

Access to innovative medicines in Poland remains a challenge due to restrictions on reimbursement, lengthy registration procedures and the high cost of modern treatments. Despite the growth of the pharmaceutical sector and progress in introducing new medicines, patients often face delays and restrictions in accessing the most effective treatments. According to the 2023 EFPIA W.A.I.T. report, Poland ranks 20th in Europe in terms of access to innovative therapies, with access to 39 per cent of the 173 medicines analysed, although most of these are available subject to restrictions. The proportion of medicines reimbursed fell slightly compared with the previous year, and the time from registration to reimbursement, although it has shortened, remains one of the longest in the EU – averaging 723 days. The situation is particularly challenging in the fields of oncology and rare diseases, where availability is limited and waiting times are long. Despite progress, Poland still ranks near the bottom of European rankings in terms of the speed of obtaining reimbursement, though it performs better in the registration process for new therapies, particularly in oncology. Within the Central and Eastern European region, Poland stands out, amongst other things, in the treatment of prostate cancer and spinal muscular atrophy, although measures are still needed to level the playing field in terms of access to innovation. Key challenges include systemic barriers, HTA procedures and financial constraints, which affect the quality and availability of modern therapies in Poland.

Keywords

innovative medicines, reimbursement

In today’s world of medicine, the rapid development of technology and science is leading to the creation of increasingly effective and advanced medicines. However, despite this progress, the availability of innovative treatments on the Polish market remains limited, which gives rise to numerous problems and challenges for both patients and the healthcare system.

Possible reasons for the limited availability of innovative medicines in Poland

1. Costs and funding
   Innovative medicines are often characterised by high production and development costs, which translates into their high market price. In Poland, where the healthcare funding system relies mainly on the budget of the National Health Fund (NFZ), access to the latest treatments is limited due to the need to negotiate prices and a restricted budget.
2. The registration and approval
   process: The procedures for registering new medicines in Poland are relatively lengthy and complex, which delays the introduction of innovations to the market. Furthermore, decisions on reimbursement are made on the basis of a detailed cost-benefit analysis, which often results in a lack of funding for the latest therapies.

3. Not available under the reimbursement
   scheme Even if an innovative medicine is authorised in the EU, it is not always reimbursed in Poland. The lack of reimbursement means that patients have to cover the full cost, which is unaffordable for many, particularly in the case of expensive treatments.

4. A limited number of specialist
   centres Access to modern treatments is often only available at selected medical centres, which limits the ability of patients from different regions of the country to benefit from them.

5. The need to strike a balance between innovation and the budget
   The introduction of new medicines requires a balance to be struck between patients’ needs and limited financial resources. Governments and decision-makers must make difficult decisions regarding financial priorities.

6. Ensuring equal access
   Unequal access to innovative treatments exacerbates social and health inequalities, which runs counter to the principles of social justice.

Access to modern, innovative treatments is one of the key challenges facing the contemporary healthcare system in Poland. Despite the rapid growth of the pharmaceutical sector and the introduction of ever newer and more effective medicines onto the market, many patients still face difficulties in gaining access to these innovative therapies. This article analyses the main problems and key challenges associated with the limited availability of innovative medicines on the Polish market.

Reimbursement restrictions, lengthy registration procedures and the high prices of new medicines mean that some innovative treatments do not reach the Polish market, or only do so after a considerable delay. This situation presents a number of challenges for policymakers, doctors and patients. On the one hand, it is essential to ensure the sustainable financing of the healthcare system; on the other, to provide access to state-of-the-art therapies that can significantly improve patients’ quality of life and life expectancy. Developing an optimal model for the reimbursement of innovative medicines whilst ensuring the rational management of limited public funds is one of the key tasks facing the Polish healthcare system.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published the latest W.A.I.T. (Waiting to Access Innovative Therapies) report, which assesses the availability of innovative therapies to patients in Europe. According to data from 2023, Poland ranks 20th out of the 36 countries analysed, although the number of reimbursed medicines has fallen slightly – from 69 to 68. As a result, the accessibility rate has fallen from 41 per cent to 39 per cent. Although Poland has climbed as many as five places compared with the previous year, the report suggests that this may signal the beginning of a slowdown in the positive trend seen so far in terms of access to innovative therapies [1].

Figure 1. The W.A.I.T. (Waiting to Access Innovative Therapies) report.

The W.A.I.T. report, which has been analysing the availability of innovative medicines since 2004, now covers more than 30 countries. Over time, the role of the reimbursement list itself has begun to wane, as patients are increasingly turning to alternative channels to access treatments or encountering various types of restrictions. This year’s report retains the core accessibility indicators, but also provides context regarding Poland’s position within the broader European landscape, as well as detailed information on the extent of restrictions, such as availability being limited to selected patient groups.

The report includes data on 173 innovative medicines centrally authorised between 2020 and 2023, with a one-year delay, enabling an analysis of the latest trends as at 5 January 2025. This information shows that 68 of these innovative therapies were reimbursed in Poland, meaning that patients have access to 39 per cent of them. By way of comparison, last year this percentage stood at 41 per cent, and the number of reimbursed therapies was 69 out of the 167 medicines analysed.

Despite a slight change in the number of reimbursed medicines, the report emphasises that the availability of innovative therapies in Poland remains a challenge, and the current findings may indicate a need to take measures aimed at improving availability and shortening the time it takes for modern medicines to become widely available.

Figure 2. Overall availability of innovative therapies by year of authorisation [1].

Figure 3. An accessibility indicator that also includes treatments with limited availability [1].

Poland remains high up in the rankings, ahead of Hungary, Romania, Bulgaria and the Baltic states, as well as Ireland and Norway. However, in the rankings we outperform not only Western European countries, but also countries such as Slovenia, Bulgaria and the Czech Republic, which occupy the top seventh position in the Central and Eastern European region.

As regards the availability of treatment, although there are 68 reimbursed treatment methods available in Poland, as many as 85 per cent of them are subject to restrictions – for example, they are only available to patients at a specific stage of the disease or who meet additional criteria under the medicines programme. Compared with the previous year, when the proportion of treatments with restrictions stood at 83 per cent, and two years ago – 78 per cent – this figure remains one of the highest in Europe. Nevertheless, access to these treatments is characterised by shorter waiting times.

Figure 4. Number of medicines authorised in the EU between 2020 and 2023 that are available in individual European countries as at 5 January 2025, broken down by access regime [1].

One positive sign is the reduction in the average time taken from a medicine’s registration to its reimbursement. It currently stands at 723 days – 81 days less than a year ago. Despite this improvement, Poland still ranks near the bottom of the list, ahead of only Bulgaria, Slovakia, Lithuania, Romania, Portugal and Malta within the EU.

By way of comparison, patients in Germany wait an average of 128 days, and in Austria – 309. However, the EU average has risen from 531 to 578 days, and the differences between countries still amount to more than two years – a patient in one country may receive an innovative treatment up to seven times faster than in another.

According to the latest EFPIA report, Germany, Italy and Austria recorded the highest percentages of reimbursed treatments, at 156, 143 and 142 respectively. However, the average waiting time for reimbursement in the European Union has increased from 531 to 578 days, highlighting the disparities in access between individual countries – patients in one country may gain access to modern treatments up to seven times faster than in another.

The report confirms that barriers to access to treatment are primarily systemic in nature, encompassing varied reimbursement procedures, complex HTA assessments, and financial and infrastructural constraints at local level. The challenge for Europe is to ensure equal opportunities for access to innovative therapies, regardless of country of residence.

In May 2025, the latest version of the Access GAP platform was published, enabling a detailed analysis of the availability of medicines and diagnostics in the Visegrad Group countries. Poland scored 61 points on the Access GAP 2025 index, representing an increase of three points compared with 2024 and 19 points compared with 2022. At the same time, the other countries in the region recorded declines: the Czech Republic fell from 69 to 64 points, Hungary from 62 to 54, and Slovakia from 61 to 53, causing it to drop from second place to last.

In terms of the time taken from registration to receiving reimbursement, Poland retains a leading position in the region, although the average period has increased to 1,086 days (up from 1,029 days). In the Czech Republic, the average is 2.3 years; in Hungary, 3.3 years; and in Poland, approximately 3.22 years (1,176 days).

The process of registering new treatments in the field of oncology is proceeding particularly effectively. Despite a slight increase in the average time taken, Poland continues to play a leading role in the region, particularly in the treatment of prostate cancer. In the field of rare diseases, the access gap has been reduced to 72 points thanks to significant progress in the treatment of spinal muscular atrophy (SMA).

Unfortunately, Poland continues to face challenges in the area of chronic diseases. Despite a gradual improvement in access, the country remains the weakest in the region, which highlights the need to step up efforts to ensure equal access to innovative treatments.

It is worth noting that Poland has made the greatest progress in areas where comprehensive solutions have been implemented, such as the reimbursement of molecular tests, maintaining a rate of 95 per cent, which makes us a leader within the V4 group (alongside the Czech Republic). The rate of access to advanced diagnostics is one of the key elements of the strategy to improve the quality of healthcare and represents a significant area of development for the country’s medical market.

To improve the availability of innovative medicines on the Polish market, action is needed on several fronts:

1. simplifying and speeding up registration and reimbursement procedures,
2. the introduction of mechanisms to support the funding of innovation,
3. the development of national funding schemes for advanced therapies,
4. enhancing the role of public-private partnerships in clinical research and the implementation of innovation,
5. international cooperation in price negotiations and the exchange of experiences.

The limited availability of innovative medicines on the Polish market poses a significant challenge to the healthcare system in Poland. Despite progress in the development of the pharmaceutical sector and the growing number of registered modern therapies, patients often face barriers related to reimbursement procedures, high costs and restrictions on access. European reports, such as W.A.I.T. and the Access GAP platform, highlight relatively long waiting times for reimbursement and high levels of restrictions, particularly in the fields of oncology and rare diseases.

Although Poland maintains a strong position in Central and Eastern Europe and within the V4 region, the challenge remains to reduce the time from registration to the availability of medicines and to increase unrestricted access. The rise in accessibility indicators and improvements in registration processes point to positive trends; however, further action is needed to ensure that patients have equal opportunities to access modern therapies at a European level. The need to continue implementing systemic solutions, make procedures more flexible and increase funding is emphasised, in order to ensure more equitable and rapid access to innovative medicines in Poland.

To increase the availability of innovative medicines on the Polish market, action is needed on several fronts, including the simplification and acceleration of registration and reimbursement procedures, the introduction of mechanisms to support the funding of innovation, the development of national funding programmes for modern therapies, an increased role for public-private partnerships in clinical trials and implementation, as well as international cooperation on price negotiations and the exchange of best practice.

1. https://efpia.eu/media/oeganukm/efpia-patients-wait-indicator-2024-final-110425.pdf
2. https://www.infarma.pl/biuro-prasowe/informacje-prasowe/w.a.i.t.-indicator/
3. https://www.ema.europa.eu/en/about-us/how-we-work/european-medicines-regulatory-network
4. https://www.iqvia.com/