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International Clinical Trials

Different Country, Different Rules?


As innovative pharmaceutical companies looking for the next blockbuster become more active in the clinical trials market in Poland, understanding the nuances of the legislative landscape in the country is a critical component for successful drug development.

Recently, the pharmaceutical industry has been facing major issues because of the patent expiry of many of their blockbuster drugs. Once drugs lose patent protection, low-price generics are likely to enter their market and grab a large portion of their sales. With that in mind, innovative firms have been looking for replacements for their pipelines and so have been more active in the clinical trials market.

Pharmaceutical companies seeking to control costs have increased their presence in the central and eastern Europe (CEE) market, an increasingly popular region in which to conduct clinical trials. Poland is the largest market in this region, and has the potential to meet this ever-growing demand. Currently, Phase 3 studies are particularly popular in Poland, although one can see a gradual increase in Phases 1-2.

Poland’s potential can be measured primarily against the size of the potential trial subjects’ population and a raised profile of participation in clinical studies due to the chance to access better quality medical services and innovative therapies. Poland is also known to have a substantial number of specialist clinical centres with good technical bases and well qualified personnel. It is first among the emerging clinical markets in terms of site numbers. Sponsors are often impressed by the relatively low costs of such studies, quick patient recruitment and high clinical standards, which are essential within the EU.

Poland’s accession to the EU in 2004 triggered an adjustment of Polish law to meet EU standards. This has made Poland more attractive for sponsors compared to other CEE countries with similar populations of potential study subjects, such as Ukraine or Russia. This is due to the implementation of ICH-GCP standards and approximation of regulations related to clinical trials and IP rights to European standards, which have reassured sponsors and guarantee that clinical studies are carried out to those standards, making the whole process more predictable.

The fact that a large number of studies are carried out in Poland also affects public perception towards the process of drug testing; potential study subjects are more willing to participate. Polish legislative and administrative bodies are more open to adjusting regulations accordingly, recognising the advantages that clinical trials can bring to Polish society and its economy.

Use of Clinical Research Organisations (CROs)

In Poland, clinical studies are carried out either directly by sponsors or through specialist CROs. In recent years, CROs have become more active in the market and are currently engaged in the majority of clinical trials in Poland. The co-operation between CRO and sponsor can be different to elsewhere. Sponsors that are interested in clinical studies in Poland, and which are not established in any of the EEA countries must nominate a legal representative in Poland. Such legal representatives act in the name of, and on behalf of, the sponsor. Often CROs themselves act as legal representatives; they are party to the agreements with sites and investigators. On the other hand, some sponsors, mainly those from the EU, use CROs only for study monitoring, including in-sourcing when employees of CRO are seconded to a specific clinical study and work in the sponsor’s offices.

Procedure

A clinical trial can only commence following positive feedback from the ethics committee and a permit from the president of the drug registration agency. These should be issued within 60 days from the date of application, and should comprise the full set of required documentation. This term can be extended by up to a maximum of 90 days if there is a need to supplement data or consult an expert. If the president of drug registration gives a negative decision or the ethics committee gives a negative opinion, sponsors have the right to appeal.

Informed Consent Form and Case Report Form

The documentation should include information on the study drug, study protocol, template of the Informed Consent Form (ICF) and Case Report Form, as well as information related to the site and investigators, sponsor’s and investigator’s insurance policies and relevant contracts signed with investigators and sites. The proof of payment of the application fee must be attached to the application. These documents can be supplied in English. The only exception relates to the documents that are to be read by patients – for example the ICF, which must be in Polish. From the sponsor’s perspective, it is crucial to make sure that the ICF includes provisions allowing the sponsor and other persons authorised by the sponsor to have access to the medical records of the study subject, both during the clinical trial and after its completion.

Costs

Submission of the application is subject to an application fee. Currently, for clinical trials from Phase 1 through to Phase 3, this is 8000 zł. In the case of bioequivalence studies and Phase 4 clinical trials, fees are lower. Before commencing a clinical study, both sponsors and investigators need to have an insurance policy against civil liability arising in connection with the clinical study. This obligation arises at the moment of submission of such application. In practice, the insurance cost is covered by the sponsor. Minimum guarantee sums are determined in the Decree of the Minister of Health and are dependent upon the planned number of study subjects. As an example, if there are fewer than 10 study subjects, the minimum guaranteed sum will be €500,000.

Sponsors will also be obliged to cover the cost of the purchase and delivery to the site of the study drug, comparators and devices necessary to administer both. Additional costs will include any medical treatment that is indispensable to qualify the patient for the clinical study, covering the cost of treatment at the stage of screening and the cost of medical procedures which have to take place in connection with the study drug or which are necessary to eliminate the effects of health complications resulting from the application of the study drug. Where the given medical procedures do not take place in connection with the recruitment to the clinical study or bear no relation to the administration of the study drug, their cost should be covered by the National Health Fund.

Clinical Trials Agreements

Unlike British legal jurisdictions, where clinical trials are conducted by the sites employing medical doctors-investigators who conduct the clinical studies, in Poland it is the investigator him or herself who is responsible for conducting such studies. The role of clinical centres, most commonly major hospitals or clinics, is only of a supportive nature. It is worth pointing out that specialist sites are also being established where doctors are only employed to conduct clinical studies. Such centres, however, are engaged mostly in less complicated clinical studies that, in principle, do not require the patients’ hospitalisation.

It is a legal requirement that the sponsor should sign a clinical trial agreement with both investigators and the site. These can be two separate agreements (a contract between sponsor and investigator and a contract between sponsor and the site) or, as is becoming more and more popular, a tripartite agreement.

Under Polish legislation there is no official template for clinical trial agreements. However, after years of practice certain standards have been developed and are in common use. Apart from obvious confidentiality provisions (in particular as regards statutory audits) and provisions aimed at protection of intellectual property rights, the contract should primarily focus on the rights and obligations of the parties. The principal obligations of the investigator are to:

  • Conduct the clinical study in compliance with the protocol
  • Run study documentation in a timely manner
  • Secure the proper storage and supervision of the study drug

It is the investigator who selects the team of co-investigators and is responsible for their performance. In light of the significance of IP protection and confidentiality requirements, sponsors often sign separate agreements with co-investigators. The site, on the other hand, commits to give access to hospital premises/wards and to the equipment needed for the purpose of About the authors conducting clinical trials. The site is also obliged to allow monitors to monitor the whole process and to allow hospital employees to perform duties connected with clinical trials during their working hours.

In the early days, the negotiation process with clinical centres and investigators was very difficult and time consuming. This has changed during recent years – both sites and investigators have become more familiar with the whole process and gained the necessary knowledge and experience, which allows them to approach contracting and conducting clinical studies in a more professional manner.

New Regulation

Currently some changes are under way at the European level in relation to the regulation of clinical trials in medicinal products for human use, with the proposed adoption of a new regulation repealing Directive 2001/20/EC. As a regulation is binding directly with no need to implement at a national level, all EU countries will have to comply with the same provisions for clinical trials that are covered by the regulation. The regulation will be effective from 2016.

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Bozena Ciosek is a Partner at Wierzbowski Eversheds where she leads the Life Sciences team. She is a specialist in pharmaceutical and competition law and co-operates with pharmaceutical companies and CROs on preparation and negotiations of clinical trial agreements. Bozena has published articles in the business and law dailies Puls Biznesu and Gazeta Prawna, as well as the healthcare industry magazine Słuzba Zdrowia. She completed her post-graduate studies in Competition Law at the Jagiellonian University in Krakow, and in EC Competition Law at King’s College, London and in Pharmaco-Economics, Marketing and Pharmaceutical Law at Warsaw University of Technology.

Marta Gadomska-Gołab is a Legal Advisor in Wierzbowski Eversheds’ Life Sciences team. She advises domestic and foreign companies in pharmaceutical and food law, product liability, unfair competition and IP law. Marta provides legal services to pharmaceutical companies on various issues connected with advertising, clinical trials and distribution, as well as reimbursement and pricing issues. She is the author of a number of articles in Rzeczpospolita and Słuzba Zdrowia. She holds a Certificate in American Law Studies from the Centre for American Law Studies at Warsaw University and the Levin College of Law at the University of Florida, and a Certificate of Postgraduate Studies in Intellectual Property Rights at the University of Warsaw.

 
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Bozena Ciosek
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Marta Gadomska-Gołab
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