| | | | | fault-based). |
| Market worth PLN 718m in 2010 | | | | The assumptions upon which the bill is based also |
| | | | | include a proposal to pay not only healthy |
| The clinical trials market in Poland[1] slowed in | | | | subjects but also patients suffering from illness |
| 2009, in comparison with previous years. Between | | | | who participate in phase I trials. |
| 2006 and 2008, it grew at a rate of 8-10% per | | | | |
| annum, whereas 2009 saw a year-on-year | | | | "Tidying up" of legislation to stimulate market |
| increase of only 1%, based on PMR estimates. | | | | growth |
| "This poor market growth rate was, evidently, | | | | |
| caused by the economic crisis, as a result of | | | | In the opinion of the respondents to the PMR |
| which companies cut down on expenditure on | | | | survey, the "tidying up" of the relevant legislation |
| R&D projects, including clinical trials. On the | | | | is a factor which could have the most extensive |
| other hand, the market is already quite saturated, | | | | effect on the development of the market in the |
| which is why, according to us, it is not expected | | | | next few years. "Respondents cited measures |
| to grow at an exponential rate in the future" says | | | | such as a clear-cut definition of a sponsor's duties, |
| Agnieszka Stawarska, a PMR Pharmaceutical | | | | the liberalisation of the law (which is too detailed), |
| Market Analyst and the report co-author. PMR | | | | and the introduction of transparent and consistent |
| forecasts that in 2010 the market will expand by | | | | guidelines applicable to all of the parties involved" |
| around 5% year on year and will be worth PLN | | | | says Monika Stefanczyk, a PMR Head |
| 718m (€170m). | | | | Pharmaceutical Market Analyst and the report |
| | | | | co-author. |
| Work on Clinical Trials Act still in progress | | | | There is no single statutory instrument in force in |
| | | | | Poland which could regulate the clinical research |
| The Clinical Trials Act has been in preparation for | | | | market comprehensively. The relevant provisions |
| years; the objective of the act is the regulation | | | | pertaining to the clinical trials market are contained |
| of clinical trials through the clarification of existing | | | | in a number of legal instruments of various |
| regulations and the addition of new areas which | | | | categories, including those relating solely to the |
| have not previously been subject to legal | | | | pharmaceutical market (e.g. the Pharmaceutical |
| regulation. The assumptions underlying the bill | | | | Act), but also to the Civil Code and the Penal |
| were published in December 2009, whereas the | | | | Code. It is frequently the case that the provisions |
| bill is expected to be ready in the first half of | | | | of legal instruments are inconsistent with each |
| 2010. | | | | other. |
| Among other things, the Clinical Trials Act will | | | | In the opinion of almost 40% of respondents, the |
| clarify and amend regulations applicable to the | | | | key market growth factor is the simplification of |
| proceedings of ethics committees. The bill is based | | | | the trial registration procedure at the CEBK. |
| on the assumption that a clinical research | | | | However, this view was taken by significantly |
| coordinator (chosen from among the principal | | | | fewer respondents than in previous surveys |
| investigators) will be required to file applications | | | | carried out by PMR, in 2006 and 2008. In |
| with the bioethics committee with jurisdiction over | | | | comparison with 2006 and 2008, significantly more |
| the coordinator's registered office and with all of | | | | respondents identified improvements in public |
| the relevant bioethics committees with jurisdiction | | | | awareness of clinical trials as a key factor which |
| over the location at which the clinical trial is carried | | | | could drive market development. This could be |
| out. In addition, the bill proposes the introduction | | | | because of the negative media coverage of clinical |
| of an obligation to publish information on clinical | | | | trials and unfavourable reports on the clinical trials |
| trials run in Poland on publicly available websites. | | | | market published in the Polish press in recent |
| If the assumptions underlying the bill are reflected | | | | years. |
| in the final version of the Clinical Trials Act, | | | | This press release is based on information |
| patients will be able to claim for bodily injury | | | | contained in the latest PMR report entitled "Clinical |
| resulting from participation in clinical trials (non-fault | | | | trials in Poland 2010. Development forecasts for |
| insurance – despite giving their informed | | | | 2010-2012". |
| consent for a clinical trial, patients may be | | | | |
| awarded damages for bodily injury; at present, | | | | [1] Phase I-IV clinical trials and bioequivalence trials. |
| the liability of sponsors and investigators is | | | | |