Europe loses, Asia gains. Will Poland defend its position in clinical trials?

The authors of the report point out that, in the absence of decisive action to support the country's attractiveness to clinical trial sponsors, a decline in the value of this market in Poland over the next decade is practically inevitable, especially since stagnation - or even decline - applies to the whole of Europe: sponsors (commercial companies) are finding more attractive conditions for conducting clinical trials in Asia (especially China) or South American countries. It can be expected that Washington will also fight hard for its position, which will mean further outflows from Europe.

Poland reached a high position in the world ranking in 2020-2022. After that, it stagnated. The negative effects of the slowdown? More than 600 R&D jobs were not created, nearly $250 million in economic value of R&D investment was lost, and more than 3,000 patients did not gain access to state-of-the-art experimental therapies. - Without significant, bold actions and measures to make Poland more attractive to pharmaceutical and biotechnology companies - sponsors of clinical trials - Poland risks losing its market share, which would have serious socio-economic consequences, the report's authors warn.

Poland's competitiveness as a clinical trial site is declining, so it is worth developing a unified strategy to attract clinical trials, as has been the case with other countries, such as European market leader Spain. - Poland is at a particular point in the development of the clinical research sector - an area crucial to a modern economy based on knowledge, data and innovation. Now, with the European Union's declining competitiveness in the research market, geopolitical challenges, as well as a global slowdown in biotechnology investment, Poland has a unique opportunity to respond to these challenges with a long-term strategy," stresses Wiktor Janicki, president of the Association of Employers of Innovative Pharmaceutical Companies INFARMA.

Aneta Sitarska-Haber, vice president of the Association for Good Clinical Practice (GCPPL), recalls that the enactment and implementation of the Clinical Trials Act was an important step toward organizing and modernizing the research system in Poland. - However, the completion of legislative work should not mean the end of cooperation between industry representatives and the Ministry of Health, or the Office for Registration of Medicinal Products and the Medical Research Agency. Recent years have seen a significant strengthening of this cooperation, including through regular dialogue with the ABM and the Supreme Bioethics Commission. These relationships provide a real opportunity to develop solutions that will increase Poland's attractiveness as a location for conducting clinical trials, especially early phase studies, he states.

In her opinion, the clinical research industry should develop cooperation with the patient community and patient organizations, especially in the planning of trials, preparation of protocols and assessment of project feasibility. - Patients are also actively involved in the process of ethical evaluation of clinical trials, which is an important part of building public trust and system quality, she recalls.

Poland's advantage - in Europe, but also in the world - in attracting research is based largely on the availability of modern digital tools (integrated medical records systems, the Internet Patient Account and the P1 platform). - As a country with a high potential for innovation, we do not require significant investment. The biggest barrier is still mental resistance and lack of decision-making," he assesses.

The authors of the report and representatives of innovative pharmaceutical companies unanimously emphasize that a new opening is needed in the area of supporting the development of commercial clinical trials (non-commercial research is dynamically increasing its share of the research market in Poland), and they count on support from the Ministry of Health and other interested ministries responsible for science or economic development.