Wybrane aspekty prawne prowadzenia badań klinicznych w Polsce
Loading...
Date
2013
Authors
Advisor
Editor
Journal Title
Journal ISSN
Volume Title
Publisher
Wydawnictwo Naukowe UAM
Title alternative
Selected legal aspects of conducting clinical examinations in Poland
Abstract
Description
Clinical tests of pharmaceuticals on people have for long stirred much controversy,
also of legal and fi nancial nature, and, in particular, regarding the obligation put
on the sponsor of the tests to co-fi nance the treatment with the use of tested drugs
together with the National Health Fund. The existing regulations of the above procedure
are not very extensive and the main legal act governing clinical tests today
is the Act of 6 September 2001 called: Pharmaceutical Law. Pursuant to its Art. 37k
para. 1 in force as of 1 May 2011, the sponsor fi nances the work needed to be performed
by health service units to conduct clinical tests that are covered by a clinical
test protocol, and which are not part of the guaranteed health care services referred
to in the Act on health care services fi nanced from public funds. In particular, as
the Act provides, the sponsor is responsible for supply, free of charge, of the tested
pharmaceuticals to all participants of clinical tests, as well as for the provision of
other appliances needed to administer the tested drugs. Another important issue
related to clinical tests is the obligatory insurance when it comes to clinical tests.
This issue is been only recently regulated in Poland. The fi rst relevant ordinance
came in force on 11 May 1999 and it regulates the specifi c principles of creating and
fi nancing bioethics committees and the manner in which they should function. The
ordinance introduced an obligation of insuring the patients participating in clinical
tests. Another Act issued pursuant to Art. 37b para. 3 of the Act: Pharmaceutical Law
was the ordinance of the Minister of Finance of 30 April 2004 on the obligatory civil
insurance of the researcher and the sponsor, which determined a detailed scope of
their civil liability for damages caused or arising from clinical tests, leaving apart,
however, the issues related to the liability insurance of the research centre. Hence,
in spite of the existence of some regulation of the issues connected with conducting
clinical tests in Poland, there is still a need for a more complex regulation to be contained
in one Act on clinical tests.
Sponsor
Keywords
clinical tests, financing of clinical tests, financing of guaranteed health, the National Health Fund
Citation
Studia Prawa Publicznego, 2013, Nr 4, s. 107-125
ISBN
978-83-232-2695-6