Andrzej Duda President signed an amendment to the Pharmaceutical Law, which introduces facilities for sponsors of non-commercial clinical trials, and promotes the development of scientific research in the country by providing the National Health Fund financing of certain medical procedures.
The new regulations are designed to support the Polish academic community in performing clinical trials and modern, innovative therapies for patients suffering from rare diseases or diseases in the case of which a positive effect has not been achieved with standard therapy.
The amendment - as indicated in Tuesday\'s release of the Office of the President - is an attempt to stimulate non-commercial clinical trials in scientific centres in Poland.
Data from the Ministry of Health show that few clinical trials are carried out in Poland. The total number of applications for registration of a clinical trial is between 400 and 500 per year, of which only a few per year concern non-commercial trial, the objective of which is not to obtain documents allowing for mass sale of medicinal products but the development of specific knowledge, for example in paediatric oncology.
In 2011, trials registered by non-commercial sponsors accounted for 0.6 percent of all registered clinical trials, in 2012 - 1.7 percent, in 2013 - 0.4 percent, in 2014 - 2 percent, in 2015 (by the end of July) 0.4 percent. In the European Union this percentage may reach as high as 39 percent of all projects, and on average is 25 percent.
In the justification of the draft amendment the authors pointed out that in 2011-2015 in Poland approx. 3 thousand patients participated in non-commercial clinical trials.
PAP - Science and Scholarship in Poland
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