Polish Ministry of Health prepared with the help of experts a draft of a new law on clinical trials – the Act Clinical Trials of Medicinal Products Used in Humans (AoCTMPUH). The work on the new law was shrouded in mystery. Is the new law on clinical trials a change for the better? Will it help the patients participating in clinical trials in Poland? If you choose to participate in such tests, will it be easier for to win damages from a powerful pharmaceutical company?
The Law on Clinical Trials – where does this idea come from?
The basic legal act governing the conduct of clinical trials on new drugs in Poland is currently the Act on the Pharmaceutical Law (AoPL). Naturally, in addition to AoPL, a clinical study conduct is also regulated by regulations issued by Polish Minister of Health, Polish Minister of Finance, Polish Civil Code and other laws as well as international and local pharmaceutical industry guidelines.
Various experts and pharmaceutical industry representatives have been suggesting for years that the conduct of clinical trials on new drugs in Poland should be regulated separately – not in AoPL. And I assure you that there are as many reasons justifying this idea, as many interested parties exist.
Anyway, a good opportunity to change the situation has arrived recently with regards to EU Regulation 536/2014 which is expected to become effective with EU in the second quarter of 2021.
The full title of this EU law is “Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials of medicinal products for human use and repealing Directive 2001/20/EC” (Regulation 536/2014)
The Regulation will apply directly in all EU countries. Its provisions aim to e.g simplify and harmonize of administrative rules governing clinical trials and to minimise differences in the approach to the registration of clinical trials on new drugs amongst EU member countries.
However, the Regulation also leaves a lot to be decided by national legislators. Among others: who and on what terms will be responsible for the damage and/or harm done to patients participating in a clinical trial of a medical product ( i.e. new drug).
The Law on Clinical Trials drafted in strict secrecy
In August 14, 2019 The Minister of Health issued a decree setting up team of experts to draft the law on clinical trials of medicinal products used in humans. This decree can be found in the Official Journal of the Minister of Health year 2019, item. 62. Once I had read though this decree, I drew two conclusions.
First, experts from the Medical Research Agency(MRA) played a significant role when the draft of AoCTMPUH was being prepared.
Secondly, all those who worked on the initial content of the new law were required to maintain strict confidentiality. The latter is not unique at this stage, but it means that the public opinion does not know the content of this project yet.
If you think” what the hell? How can it be that a draft of a new law is not released publicly, then calm down. Polish legislative process has to be fully transparent to the citizens, so when the legislative machine truly kicks off, you and I will know the details. Under the condition that this drafts indeed proceeds to the full legislative process though Polish parliament.
Until then, let’s see what we can expect based on “leaks”.
Only joking. The list the sources of these “leaks” can be found at the end of this post.
Who and on what terms are liable for the patient’s injury or damage ?
One of the changes we have to see in AoCTMPUH is to change the rules of responsibility of the pharmaceutical company investigating the new drug for damage to the study participant.
Polish Act on Pharmaceutical Law is highly imprecise in this regard.
The issue of possible patients’ injury or damage is governed by only one provision of – art. 37j AoPL states that: ” The sponsor and investigator shall be liable for damage caused in connection with clinical trial conduct. “
The investigator is a lead physician conducting a trial, and the sponsor is. of course, a pharmaceutical or biotechnology company that has developed a study, finances and co-manages its conduct with a lead physician.
The trouble is that as you see yourself, you do not know how much the doctor and company respond.
I have already written about the principles of liability in Polish civil law in my post on who shall bear the liability for the damage caused by AI.
After numerous debates and considerations of more and more prominent lawyers, now there are basically all in agreement that as AOPL does not indicate what principle of liability is meant there, then it is the basic one set forth in Polish Civil Code (PCC) – the principle of fault.
The fault principle is stated in art. 415 of PCC which stipulates that whoever is at fault at causing damage to another person is obliged to repair it.
Now, what is important: Polish civil law does not distinguish between damage and injury in the sense of common law. It means this damage referred to in art. 415 of PCC covers also an injury.
In practice this means that if you as a patient participating in a clinical trial have suffered any damage of injury related to your participation in the trial then then first of all you need to prove that you have suffered it. Secondly, it is also up to you to prove that your damage or injury was indeed caused by your participation in this trial. There must be a damage on an injury caused by your participation in a trial and additionally this damage or injury needs to result from an unlawful action.
As you can easily imagine, in practice, proving that there is a direct link between a patient’s participation in a trial and their damage or injury may be extremely difficult. Not mentioning the difficulty in proving the unlawfulness of a pharmaceutical company’s or a lead physician’s actions.
Let us do not forget that each patients signs so called “ informed consent form (ICF)” before she or he decides to participate in a clinical study of a new drug. By signing ICF , you as a patient acknowledge you have been informed and you are fully aware of all the risks described in detail in ICF and associated with your participation in the trial.
The Law on Clinical Trials – a revolution in liability?
The AOCTMPUH draft proposes to change the rule of liability of a pharmaceutical company co-conducting a study with a doctor.
Now such a company is to be liable for a damage or an injury suffered by patients participating in a study on the basis of the principle of risk not the principle of fault.
In practice, this means a significant facilitation for you as a patient participating in a clinical trial. Of course, you need to prove that you have actually suffered a damage or an injury, but now it would be a pharmaceutical company who is obliged to prove that your damage or injury was completely unrelated to your participation in the study.
If this company fails to do so, then it will be found liable and will have to pay you damages.
It looks good, right? But in practice it is not so cool, because the AoCTMPUH project assumes only the “partial” liability of the pharmaceutical company will be based on the principle of risk.
Since my imagination is limited and the draft of the law has not yet been made public: I have no clue what this peculiar construction of “partial risk liability” means and how in practice it will work.
As for the lead physician, the terms of her/his liability towards patients is not going to change. It still be based on the principle of fault.
Very interesting and quite amazing proposal of regulating the pharmaceutical company running a clinical trial liability, isn’t it?
How was all this stipulated in the details of this new law draft, – it is the question.
But even bigger is: what becomes of the Act Clinical Trials of Medicinal Products Used in Humans provided it leaves Polish parliament.
We shall 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.