Polish market of clinical trials poised to grow 5% in 2010

The market of clinical trials in Poland (Phase I-IV clinical trials and bioequivalence trials) slowed down in 2009, compared to the previous years. In 2006-2008, it grew at a rate of 8-10% annually, whereas 2009 saw a rise of a mere 1% year on year, based on PMR’s estimates. Evidently, such a poor rate of market growth was caused by the economic crisis, as a result of which companies cut down on expenditure on R&D projects, including clinical trials. On the other hand, the market is already quite saturated, which is why, according to PMR, it is not to be expected to grow at an exponential rate in the future. PMR forecasts that in 2010 the market will expand by around 5% year on year, reaching the value of PLN 718m (€170m).

The Clinical Trials Law has been in preparation for years; the objective of the act consists in the regulation of clinical trials through clarification of the existing regulations and addition of new areas which previously have not been subject to legal regulation. The assumptions underlying the bill were published in December 2009, while the bill is expected to be ready in the first half of 2010.

Among other things, the Clinical Trials Law will clarify and amend the regulations applicable to the proceedings of ethics committees. According to the bill’s assumptions, a clinical research coordinator (chosen from among the principal investigators) will be required to file applications to the bioethics committee having jurisdiction over the coordinator’s registered office and to all the relevant bioethics committees with jurisdiction over the place where clinical trial is conducted. Additionally, the bill proposes to introduce the obligation to publish information on clinical trials run in Poland on publicly available websites.

If the assumptions underlying the bill are reflected in the final version of the Clinical Trials Law, patients will be able to assert claims for bodily injury resulting from participation in clinical trials (non-fault insurance – despite giving their informed consent for a clinical trial, patients will be able to be awarded damages for bodily injury; at present, sponsor’s and investigator’s liability is fault-based).

The assumptions upon which the bill is based also include a proposal of payments not only to healthy subjects, but also to unhealthy patients who participate in phase I trials.

In the opinion of respondents to PMR’s survey, the ‘tidying up’ of the relevant legislation is a factor which can exert the strongest impact on the development of the market over the several years to come. Respondents cited such measures as a clear-cut definition of sponsor’s duties, liberalisation of the law (which now is too detailed), and introduction of transparent and identical guidelines applicable to all the parties involved. There is no single legal act in force in Poland, which would regulate the clinical research market comprehensively. The relevant provisions pertaining to the clinical trials market are contained in various legal acts of various categories, including those relating solely to the pharmaceutical market (e.g. the Pharmaceutical Law), but also the Civil Code and the Penal Code. It is frequently the case that the provisions of various legal acts are inconsistent with each other.

In the opinion of almost 40% of respondents, the key market growth factor is simplification of the trial registration procedure at the CEBK. However, this view was taken by significantly fewer respondents than in the previous surveys conducted by PMR in 2006 and 2008. Compared to 2006 and 2008, significantly more respondents named improving public awareness of clinical trials a key factor to drive the market development. This could have to do with the negative media coverage of clinical trials and unfavourable press reports on the clinical trials market published in the Polish press in the recent years.

Agnieszka Stawarska

Pharmaceutical Market Analyst

PMR Publications