As you already know from my post “New Polish Law on Clinical Trials: easier to win damages?”, Polish Ministry of Health (MoH) supported by the group of experts, prepared a draft of new law on clinical trials: the Act Clinical Trials of Medicinal Products Used in Humans (AoCTMPUH). In the previous entry, I wondered why this new law was drafted and whether the person who agreed to participate in a clinical trial of a new drug could expect easier way to win damages from either the pharmaceutical company or a doctor leading the research project. However, this facilitation in awarding damages for patients’ injury or damage is not the only novelty introduced in the draft of AoCTMPUH because MoH also plans to revolutionize the in the principles of insuring the risk associated with a participation in clinical trials. So clinical trial insurance – should us, patients, expect any changes for the better?
Clinical trial insurance in Poland: who is insured and against what exactly at the moment ?
As I have already written, there is none insurance for patients testing new drugs in clinical trials in Poland at the moment.
This means that, as a participant in such a study, you are not insured against the risks associated with your participating in such a project.
For the time being only the civil liability of the pharmaceutical company and the leading doctor’s (investigator) of the study is insured. Of course, I talk here about the liability for injuries and damage based on the fault rule.
Most importantly, the amount of this insurance varies from 500,000 up to maximum 5 million Euros depending on how many patients participate in the study.
Of course, these numbers are impressive, but as I wrote in the previous post: under the applicable laws, it will be very difficult for you to prove that your damage or injury was caused in connection with your participation in a clinical trial of a new drug and due to the fault of the pharmaceutical company and/or the investigator. And that means that in practice you can say goodbye to any compensation from this liability insurance.
AoCTMPUH is to change that. But if you think that as a patient, you will be protected by some sort of risk insurance associated with your participation in a clinical trial, then you are wrong.
Polish MoH proposed Two Pillars of insurance covering the liability for damage and/or injury suffered in connection with the participation in a study of a new drug.
New clinical trial insurance – Two Pillars
The First Pillar would be a type of a Guarantee Fund and will cover only the pharmaceutical company’s liability for damage and/or injury done to patients participating in a study under this new type of liability for patients’ damage and/or injury based on the risk rule . There is to be a special committee created to decide on whether any compensation from the Guarantee Fund will be paid to a patient.
Since the AoCTMPUH draft has not been made public yet, I have no idea who would be seating at those committees and how specifically they would work.
I may only assume that this Guarantee Fund will be funded either by a company conducting a specific clinical trial for this very trial or it is going to be some sort of a general clinical trial related Guarantee Fund funded by all pharmaceutical companies conducting clinical trials of new drugs in Poland.
We shall see when the AoCTMPUH draft is disclosed, and this must take place, because the legislative process has still to be transparent and public in Poland.
The Second Pillar would already be a classic civil liability insurance for a pharmaceutical company and an investigator conducting the study of the new drug. And here the liability insured is of course the liability based on the rule of fault.
How would this be regulated in the details in this new law, and especially how this mixed liability of the pharmaceutical company: a little bit based on the fault rule and a little bit based on the risk rule is regulated and insured ?
Here’s the question. I shall gladly learn the details as this design is very exotic to me.
How this new law going to look like when it leaves Polish parliament and what will be its impact on clinical trials, this is even a bigger question.
We will just need to wait and see.
Best regards, Prawstoria
I used the following sources when preparing this post:
- Strategy for the development of new medicines research in Poland, namely the resolutions of the Council of Ministers on the adoption of the Clinical Research Development Plan 2020-2025 (Monitor Polski 2019, item 1024),
- Statements by ABM representatives for the Health Market portal contained in the article: “Clinical trials: there is a program, there will be a law. Are we opening a new chapter?”
- And materials on the work on AoCTMPUH posted on the ABM website presented at the December conference “WHERE ARE WE? WHERE ARE WE GOING?” . Unfortunately, only videos are available now, and the slide presentation in pdf has already disappeared.