AbstrAct The number of clinical trials per year carried out in Poland is relatively high, however, the Polish regulations related to performing and funding of clinical trials are not very extensive. The NIK in its audit report conlcuded &quot;a lack of a comprehensive system of regulations concerning conducting, financing and financial control of clinical research&quot;. The National Health Fund is an authority responsible for, among others, planning and purchasing publicly financed health services. The sponsor is obliged to manage and finance clinical trials, however many procedures performed during the research can be classified as standard medical care guaranteed by the Act on health care services financed from public funds. There is still a need of solving the problem of financing standard health care services being a part of a clinical trial by a proper legal act

Monika Urbaniak

CiteSeerX

28 Journal of HealtH InequalItIes 2015 /  Volume 1 / Number 1, December
review paper J Health Inequal 2015; 1: 28–30
Submitted: 05.11.2015, accepted: 10.12.2015
Controversy over conducting clinical trials  
in poland
Monika Urbaniak
Department of Medical Law, Univeristy of Medical Sciences, Poznan, Poland
AbstrAct
The number of clinical trials per year carried out in Poland is relatively high, however, the Polish regu-
lations related to performing and funding of clinical trials are not very extensive. The NIK in its audit 
report conlcuded “a lack of a comprehensive system of regulations concerning conducting, financing and 
financial control of clinical research”. The National Health Fund is an authority responsible for, among 
others, planning and purchasing publicly financed health services. The sponsor is obliged to manage 
and finance clinical trials, however many procedures performed during the research can be classified as 
standard medical care guaranteed by the Act on health care services financed from public funds.  
There is still a need of solving the problem of financing standard health care services being a part of a clin-
ical trial by a proper legal act.
Key words: clinical trial, the National Health Fund, sponsor, financing of clinical trials.
address for CorrespondenCe: Monika Urbaniak, Department of Medical Law, Univeristy of Medical Sciences,  
4 Rokietnicka St., 61-806 Poznan, Poland, phone: +48 61 658 42 01/02, e-mail: monikaba@ump.edu.pl
Trials of drugs in humans, including the legal aspects, 
have been controversial for a  long time. First and fore-
most, the problem is financing of clinical trials. Without 
a  doubt clinical trials contribute to the development of 
medicine and the improvement of already existing drugs, 
hence the improvement of health care quality. Indis-
putably, Poland is one of the top countries, not only in 
Europe but in the world, where a number of clinical trials 
conducted is the highest. China and India are the most 
attractive locations outside the United States to perform 
clinical trials. It should be noted that the pharmaceutical 
industry in the United States [1] has a great impact on 
the European markets of clinical trials, including Poland. 
According to A.T. Kearney’s Country Attractiveness 
Index for Clinical Trials, Poland is ranked eighth [2].
Clinical trials are generally initiated and funded by 
the pharmaceutical industry. The cost of initiating, per-
formance monitoring and regulatory fees is similar across 
countries. The difference between the countries is most-
ly the statutory regulation regarding the co-funding of 
clinical trials by the competent national authority. For 
example, in the United States, Medicare covers the costs 
of patients classification for clinical trials which are con-
sidered as routine therapy. In some countries conducting 
of marginal clinical trials with insignificant commercial 
effect is financed by the competent authority (eg. in Ita-
ly the responsibility of the Italian Medicines Agency – 
Agenzia Italiana del Farmaco [AIFA] is to run research 
programmes and to finance experiments and monitoring 
in the clinical trials).
Until now the regulations in Poland related to per-
forming and funding of clinical trials are not very exten-
sive [3]. The main legal act governing clinical trials in 
Poland is the Act of 6 September 2001 “Pharmaceutical 
Law” [4]. In addition, it must be noted that the rules on 
their conducting are dispersed through various legal acts 
with different legal value: Act on professions of doctor 
and dentist, the Code of Medical Ethics, as well as the 
Order of the Minister of Health of 2 May 2012 concern-
ing detailed requirements of Good Clinical Practice [5]. 
Issues related to the financing of health care services are 
regulated by the Act of 27 August 2004 on health care 
services financed from public funds [6]. Until 2011 there 
had been no clear legal regulation governing perform-
DOI: 10.5114/jhi.2015.56823 
29Journal of HealtH InequalItIes 2015 /  Volume 1 / Number 1, December
Controversy over conducting clinical trials in Poland
ing of clinical trials. This had caused many significant 
problems in interpretation of legal acts regarding the 
accounting of health care services. In particular, they 
concerned the cost of health care financed from public 
funds. As a result of the audit performed by the Supreme 
Audit Office of Poland (NIK), regulations on performing 
clinical trials in the Act of 6 September 2001 Pharma-
ceutical Law, have been superseded by regulations in the 
Act of 18 March 2011 on the Office for Registration of 
Medicinal Products, Medical Devices and Biocidal Prod-
ucts, which governs the issue of financing the clinical tri-
als in greater detail. The new regulation, which specifies 
the rules of funding of health care services related to 
clinical trials came into force on 1 May 2011.
A  public payer in Poland does not guarantee the 
patients that all the health care services will be financed. 
The Art. 15 paragraph 2 of the Act on health care services 
financed from public funds lists the health care services 
free of charge for patients and financed from the public 
funds, however clinical trials are not mentioned there. 
Without a doubt they are not paid for by the National 
Health Fund (NFZ). The problem, however, arises when 
the health care services are related to both, the usual 
treatment of a patient financed by the National Health 
Fund, and a  clinical trial carried out in parallel and 
financially supported by a sponsor of the trial. A sponsor 
is entitled to manage and finance clinical trials. Accord-
ing to the amended Article 37, paragraph 1 of the Phar-
maceutical Law, a sponsor finances health care services 
related to the clinical trial and covered by a clinical trial 
protocol, and which are not listed in the Act on health 
care services financed from public funds. In particular, 
the sponsor provides the participants with a pharmaceu-
tical product, comparators or any device used for their 
administration. 
Moreover, the Art. 37 paragraph 1 of the Pharmaceu-
tical Law states that for the health care services, which are:
•	 necessary in the treatment in case of adverse drug 
reaction,
•	 required by the tested pharmaceutical product,
•	  essential in order to qualify a patient as a participant,
are funded by a sponsor if the services are also guaran-
teed by the Act on health care services financed from 
public funds.
It should be noted that by the time the amendment of 
the Pharmaceutical Law came into force, a sponsor had 
had no knowledge of the costs of the health care services 
to be beared but only the expenses covered by the NFZ. 
Undoubtedly, managing of clinical trials triggers costs of 
health care services which are beared by both, the spon-
sor and a research centre. The NFZ is of the opinion that 
the fact that the patient is qualified for the trial makes 
it necessary to finance all the services by the sponsor. 
Patient’s acceptance of the participation in a clinical trial 
automatically obliges the sponsor to pay for all the health 
care services the patient will be provided with.
In case of clinical trials in cardiology the problem of 
separating the health care services provided as a part of 
a clinical trial from the services which are financed from 
public funds, is of increasing importance. For example, 
in a  comparative study for ACS (acute coronary syn-
dromes) for the groups taking tenecteplase but not as the 
emergency service prior to admission, the NFZ is of the 
opinion that in the case of the drug is administered in an 
ambulance when taking a patient to hospital, the costs of 
health care services, including the guaranteed services, 
should be covered by the sponsor. Also, in a clinical trial 
for evaluation the safety and efficacy of rivaroxaban when 
combined with aspirin or with aspirin and tienopiridine 
in patients with acute coronary syndromes undergoing 
coronary angioplasty, the NFZ questions accounting of 
the ACS treatment and takes the view that for all services 
provided by a research centre to the patients, they should 
be paid by the sponsor. It should be noted that there is 
no legal basis, both in the law as it stands and the status 
that was in force before the amendment to the Pharma-
ceutical Law, for the way of accounting for the health 
care services provided during a  clinical trial with the 
NFZ. In all the clinical studies described above, patients 
are admitted to hospital because of a  specific disease 
they suffer from, not due to the fact they participate in 
clinical trials. In this situation it is difficult to separate 
health care services provided in a clinical trial from the 
services being a standard therapy, therefore the sponsor 
must finance all of them. Imposing additional burdens 
on sponsors often leads to their resignation from pub-
lic centres as a location for a clinical trial and choosing 
a private centre or even a medical centre abroad. At this 
point, it is worth referring to the Art. 13 of the draft law 
on clinical studies, which describes funding of clinical 
trials extensively. The Art. 13 states that the sponsor 
funds all the health care services related to the clinical 
trial and covered by a clinical trial protocol and which 
are not listed as guaranteed in the Act on health care 
services financed from public funds, and also provides 
the participants with a pharmaceutical product and any 
device used for its administration. Courts tend to apply 
a  similar jurisdiction rule in Poland. In the court case 
of a  teaching hospital vs. the NFZ in regards to fund-
ing the guaranteed of health care services, in September 
2013 the Appeal Court in Poznan decided that all the 
participants had the right to the guaranteed health care 
services even if they were also used for patients qualifi-
cation. The sponsor is only responsible for financing the 
services which would not be provided if a  patient was 
not a participant1 
To conclude, despite the fact that organization of 
clinical trials in Poland is regulated by many norma-
tive acts there is still a need for a comprehensive regu-
1The Appeal Court judgement in Poznan, dated 17 Sep 2013, file 
no. I ACa 650/13.
30
Monika Urbaniak
Journal of HealtH InequalItIes 2015 /  Volume 1 / Number 1, December
lation as a  single act on clinical trials. Passing such an 
act would clarify the existing legal solutions dispersed 
through various legal acts. It should be noted that the 
current legal solutions regarding the clinical trial fund-
ing and insurance does not help stimulating medical 
progress. Financing of clinical trials is partially regulated 
in the Art. 37 of the Pharmaceutical Law, nevertheless 
further clarification should be considered. The authors 
believe that the public payer should cover the costs of all 
the health care services provided to patients admitted to 
a  research centre which are related to a  particular dis-
ease they suffer from, whereas the sponsor should only 
finance the services which would not have been provid-
ed if a patient did not participate in the clinical trial. It 
should be emphasized that the participation does not 
deprive a patient of the right to guaranteed health care 
services as it is constitutionally protected. It can possibly 
be abridged only by legislation and in accordance with 
Art. 31 paragraph 3 of the Polish Constitution if such 
a  restriction is “necessary in a democratic country (...) 
for (...) health protection (...). Such limitations shall not 
violate the essence of freedoms and rights”. The consent 
of the patient to participate in a  clinical trial does not 
mean resignation from health care services financed 
from public funds. Such consent as well as participation 
in a  clinical trial cannot be interpreted as a  reason for 
deprivation of constitutionally guaranteed rights to the 
health care services as such rights can only be revoked 
by a legal act and only when it is justified in light of con-
stitutional norms.
references
1. Staszewski R. Research centres in the process of clinical trials – 
legal and organizational requirements. In: The clinical trials law 
in general terms. Plum M (ed.). Torun 2013, p. 73.
2. http://www.atkearney.com/documents/10192/312631/EA+ 
vol+IX+no+1-Make+Your+Move.pdf/bb05c14b-2709-4ff1-
828f-8ef851f303de, Access 25.11.2013, p. 58.
3. Urbaniak M. New rules of financing of clinical trials. Głowac- 
ka MD, Zdanowska J (ed.). Public health. Current conditions and 
changes, Poznan 2011.
4. Act of 6 September 2001 Pharmaceutical Law. Journal of Laws 
from 2008 No. 45, item 271.
5. The Ordinance of the Minister of Health of 2 May 2012. On 
the detailed requirements of Good Clinical Practice Journal 
U. 2012, item 489.
6. Act of 24 August 2004 on health care services financed from 
public funds. Journal of Laws from 2008 No. 164, item 1027.


Controversy over conducting clinical trials in poland

http://citeseerx.ist.psu.edu/viewdoc/download;jsessionid=9FFD3CDB1CBF288F5845B20A733760FE?doi=10.1.1.1037.4378&rep=rep1&type=pdf

Controversy over conducting clinical trials in poland

Abstract

Similar works

Full text

Available Versions

CiteSeerX