t involved in the production or marketing of medicines and those that are not responsible for the organization and management of research contracts, eg. universities, health care settings, patient or researchers organizations, or the investigator himself. The sponsorship aspect of non-commercial trial is defined by the Pharmaceutical Law (Article 37a):
“If the owner of the data obtained during a clinical trial is a sponsor, university, … or other scientific institution, (…) a therapeutic agent, … a researcher, a patient organization, an investigator organization or another natural person … the clinical trial is a study Clinical non-commercial.”
Pharmaceutical law, Article 37a.
The subject of non-commercial trials are drugs already marketed and it is not intended to investigate and introduce new innovative products but to analyze the efficacy of different doses of medication in different indications (eg. pediatric). This approach allows to broaden the knowledge of medicines, find a new application or a more effective dose.
The Pharmaceutical Law states that the data obtained in the study cannot be used for marketing purposes and for changes to existing marketing authorizations.
Non-commercial research may be useful for public authorities that make decisions on reimbursing the cost of medicines available on the market from the state budget, as it is possible to find a new, more effective medicine that is also cheaper.
Number of non-commercial studies in Poland
Non-commercial clinical trials represent only a fraction of all research conducted in Poland.
In Western Europe, these studies account for about 40% of the total clinical trial market.
Non-commercial clinical trials are subject to the same requirements as commercial research, but in Poland, in 2015, there was a change when President Andrzej Duda signed an amendment to the Pharmaceutical Law, which aims to promote non-commercial clinical trials in research centers by
Funding health care services
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Art. 31d of the Act of 27 August 2004 on publicly funded health care services
Financing:
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medicinal products
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the accessibility category described in art. 23a, paragraph 1 (2-5)
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2) issued from doctor’s prescription – Rp;
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3) issued from prescription of a physician for proprietary use – Rpz;
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4) issued from a doctor’s prescription, containing narcotic drugs or psychotropic substances, as defined in separate regulations – Rpw;
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5) used exclusively in closed medicine – Lz.
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Reimbursed (Article 39 of the Act of 12 May 2011 on the refund of medicines)
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Foods for special nutritional purposes
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Medical devices covered by the lists in Article 37 sec. 1 Act of 12 May 2011
The amendment was prepared due to a small number of non-commercial studies that resulted from the same fees for CA (URPL) and EC (KB) as were provided for commercial trials and lack of funding for healthcare and medicinal products.
Current charges:
CA – (URPL)
EC – Bioethics Committee
The fees that are charged for a research project’s validity may differ between bioethics committees.
The new law has additionally simplified and accelerated the procedure for assessing the application to start the study, reduced fees for non-commercial sponsors, and accelerated the dialogue between URPL and the sponsor through electronic communications.
Despite the new law, non-commercial research is still conducted in small numbers, which is most probably the result of the evasion of funding for these studies under public health insurance due to the lack of precise criteria indicating which projects may be financed.
Impact of Regulation 536/2014
Regulation 536/2014 will be implemented in all European Union countries, allowing unification of the law through a single common system of procedures. Procedures for conducting clinical and non-commercial clinical trials will remain the same, however, the Regulation introduces guidelines for Member States’ approach to non-commercial research:
Theme 81
‘In connection with Directive 2001/20 / EC, experience shows that a large proportion of clinical research is conducted by non-commercial sponsors. Non-commercial sponsors often rely on funding that comes partly or fully from public funds or from charities. In order to maximize the valuable contribution of such non-commercial sponsors and to continue to encourage them to conduct research, but should not be at the expense of the quality of clinical trials, Member States should take measures to support clinical trials conducted by these sponsors.‘
Despite the reduction of fees for submitting applications to CA and EC and the introduction of funding for medical care for patients taking part in the study, it will not solve the problem of the preparation of the study documentation itself, such as the study protocol. The entire responsibility for the documentation falls to the sponsor (eg. Investigator), who must have specific know-how to ensure compliance of documentation and procedures with the law such as the registration of the study and its course. Sponsors must also have knowledge of Polish and international grant programs that support research.
In the case of commercial sponsors, all these aspects are fulfilled by special units that are part of the sponsor’s company or by the CRO (Contract Research Organization) specializing in clinical trials from the very beginning where the preparation and completion of the documents is made and submitted to the committee and the authority, through all amendments to the protocol and their acceptance, until the closing of the recruitment, the center and the completion of the study.
The benefits of non-commercial research
For an Investigator, the study means access to modern and innovative therapies for patients that can improve treatment standards and improve their knowledge. Non-commercial trial is associated with publications in reputable journals, which allows them to raise the academic status of the Investigator and the entire team. Young scientists also benefit from this, develop and deepen their medical knowledge exchanging their experience between Polish and international centers.
Recruitment in Poland
Poland has a relatively large population in relation to the surrounding countries, which increases the effectiveness of recruiting patients. The PwC report shows that Poland stands out among other countries in terms of recruitment and low research costs.
In Poland, the number of studies could increase as it is currently more than twice less than in other countries of our region (the number of studies measured per inhabitants). In the Czech Republic on a million inhabitants there are 24.5 studies, in Hungary 22.5 and in Poland there are 10.4 studies per million inhabitants.