Litigation Portal: Is Poland a good place to conduct clinical trials?
Joanna Krakowiak: So far it has gotten good reviews. Pharmaceutical companies appreciate especially the professionalism of the medical staff and the large number of centres where they can conduct trials. Beyond that, Polish patients visit their doctors quite frequently, which helps gather a sufficient number of participants.
But a July report from the Polish government accounting office turned up many irregularities. Why is that?
The greatest threat to clinical trials is the lack of transparency in the financial arrangements among the parties to agreements on conducting clinical trials and the unclear split of duties between the institution, which is typically a hospital, and the chief researcher, on one side, and the sponsor of the trials or contract research organisation (CRO) on the other.
There have also been problems with obtaining proper informed consent from patients participating in clinical trials. This procedure is regulated in detail in the Pharmaceutical Law, but the practice may leave a lot to be desired. Sometimes patients are not aware that a clinical trial is not a form of therapy, but a medical experiment designed to verify the safety and effectiveness of a new drug.
This is why the patient must be informed not only about the possible benefits, but also about the risks, the purpose of the trial, the duration, the option of withdrawing from the trial early, or, conversely, the option of continuing the treatment after the trial is complete but before the medicine is registered. One of the principles of clinical trials in Europe is for participants to have the opportunity to continue receiving the treatment as a form of “compassionate use.”
How did these violations go unnoticed? Are clinical trials not monitored?
It is true that inspections of clinical trials in Poland have been conducted only sporadically, probably because of a shortage of staff at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, which is responsible for supervision of clinical trials. The inspections that were carried out, however, have been very thorough. They have often been conducted jointly with the US Food and Drug Administration or the European Medicines Agency. So inspections are rare but painstaking.
The Polish office itself operates effectively, so it is too bad there isn’t a specific Act on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. It is only on the basis of such a specific law that the office would be able to issue administrative decisions, which would significantly streamline authorisations for new trials as well as registration of new medicines. Now the office drafts the decision and in fact does most of the work, but formally the decisions are issued by the Minister of Health, which prolongs the whole procedure.
Is there a chance to improve the situation?
Guidelines are now being worked up for a completely new Act on Clinical Trials. It is supposed to be a comprehensive regulation, covering issues not regulated so far in this area, such as personal data protection. So far clinical trials have been conducted under the Pharmaceutical Law, but now there is to be a separate law, which will most likely introduce more restrictive rules than we have now. It will still take many months of work in the Ministry of Health, the Government, and then in the Parliament, in order to hammer the guidelines out into a specific bill and then enact it. I hope that comments from the clinical trials community are taken into consideration so that the final bill is as good as it can be.
Interestingly, work is underway at the same time to draft an amendment to the Pharmaceutical Law. In addition to certain corrections in the area of rules for conducting clinical trials, the draft provides for changes in the data exclusivity period for innovative drugs. For many years Polish law in this field has not been harmonized with EU law. Here there is still a 6-year data exclusivity period in place, whereas elsewhere in Europe the rule is 8 + 2 + 1, so that the exclusivity period may run as long as 11 years. Polish law also allows for the possibility of reducing the data exclusivity period if the patent protection expires earlier. Poland is one of just a few countries in which administrative protection, in other words data exclusivity, is linked with patent protection.
So legal changes are in the pipeline. Is there any way to prepare for the changes?
Sponsors who want to conduct clinical trials in Poland should review their standard form contracts against the guidelines for the new regulations. It is worth doing that now in order to be prepared for the upcoming changes. It is particularly important to define clearly the duties of the sponsor, the hospital, and the researcher. The separate contracts with the hospital and with the researcher that have been used so far should be replaced with one trilateral agreement setting forth clear terms related to fees. Attention should also be paid to issues of personal data protection and protection of medical documentation that is processed during the course of a clinical trial.
What will the changes mean in practice? Will the costs of conducting clinical trials increase?
First and foremost, the fees for researchers and hospitals will be based on objective economic indicators, such as the actual work input in the case of a researcher or depreciation of equipment in the case of a hospital. Relevant fee schedules will probably be developed.
Costs may be affected by a change in the grounds for liability on the part of the sponsor and the researcher for deleterious effects on the health of participants. Currently the sponsor and the researcher are liable on the basis of fault, meaning that the participant must prove negligence in conducting the trial. If the new Act on Clinical Trials is adopted, the liability would be stricter, as the sponsor or researcher would be liable for injury even if the trial was conducted properly. The sponsor or researcher would be released from liability only if injury to a participant’s health were caused by an act of the injured person, a third party for whom the researcher or sponsor is not responsible, or force majeure.
Because of this, the scope of mandatory insurance for clinical trials would increase, which would have an impact on the overall cost of conducting a clinical trial. Insurance for participants is also being considered, which would increase their level of security and their ability to enforce claims in the event of injury.
Thus it is expected that trials will be more expensive, but the quality of the results should also be higher, and that is the issue that is the number one priority for a pharmaceutical company commissioning a clinical trial. The safety of patients should also increase. So costs will rise, but quality too.