«The progress made in medicine and surgery and the allied sciences during the last two decades is unparalleled in the history of medicine» .
As implicitly underlined in the above-mentioned quote, scientific and experimental researches are of the utmost importance, especially nowadays. They have to be considered powerfully linked with the freedom of scientific research, as enshrined in article 13 of the Charter of Fundamental Rights and in article 33 of the Italian Constitution (among others).
The methods and the results of the scientific and experimental research influence and have inevitably an impact on some fundamental rights of the people involved i.e. the right to health, the right to privacy, and the right to data protection. Therefore, since clinical studies are crucial to foster knowledge and innovation, they have to be justified in order to safeguard individuals’ fundamental rights and interests, which cannot be undermined nor hurt.
This is explicitly prescribed by the Regulation (EU) No 536/2014 , whose relevant role in the current health emergency will be briefly examined in the following paragraphs.
- A brief insight on the Regulation (EU) No 536/2014
The aim of the Regulation, which has replaced the Directive 2001/20/EC , is to guarantee that Member States cooperate more consistently, thereby harmonizing and simplifying the procedures for conducting clinical studies on medicinal products for human use in different EU Member States.
Since the Regulation adopts a human centric approach, recital 1 explicitly states that «in a clinical trial the rights, safety, dignity and well-being of subjects should be protected and the data generated should be reliable and robust. The interests of the subjects should always take priority over all other interests» .
Furthermore, a clinical trial may be conducted only if some conditions are met. For the purpose of this article, hereafter will be mentioned only letters (a) and (d) of article 25, which are:
«(a) the anticipated benefits to the subjects or to public health justify the foreseeable risks and inconveniences and compliance with this condition is constantly monitored; [omissis] (d) the rights of the subjects to physical and mental integrity, to privacy and to the protection of the data concerning them in accordance with Directive 95/46/EC are safeguarded».
Therefore, the subject performs a relevant position in the Regulation, even more if it is considered that a subject can participate in a clinical trial only after obtaining his/her informed consent .
Another key element of the Regulation is transparency, which has to be linked to the concepts of data access and data sharing: indeed, art. 80 now establishes the EU portal «as a single entry point for the submission of data and information relating to clinical trials» . This EU portal, that was not institutedin the previous Directive, has been described by some scholars as an accessible and centralized tool for the data collection that, hopefully, could prevent and reduce data manipulation cases .
According to this new system, data and information submitted through the EU portal will be stored in the EU database, as specified in art. 81 and whose purpose is «[…] to enable cooperation between the competent authorities of the Member States concerned to the extent that it is necessary for the application of this Regulation and to search for specific clinical trials» . By introducing the EU database, the EU regulators’ aim was, on one hand, to facilitate the communication between sponsors and Member States and, on the other hand, to enable European citizens «to have access to clinical information about medicinal products» . This is the reason why the data contained in the EU database will be publicly accessible, unless confidentiality in required on the grounds stated in art. 81, par. 4.
- Is the current situation enough?
The Regulation (EU) No 536/2014 entered into force on 16 June 2014. However, today the Regulation is still not applicable . Indeed, according to recital 78 «[…] it is appropriate to provide that this Regulation should only become applicable once it has been verified that the EU portal and the EU database are fully functional» . The Regulation will become applicable only six months after the European Commission declares a notice of this confirmation.
As of today, neither the EU portal nor the EU database are completely developed.
As we all know, due to the COVID-19, we are facing a new emergency, both medical and economic. All the European Member States should be put in condition to cooperate and collaborate in order to find a cure as soon as possible and having the support of the EU database could be of the utmost importance.
We, as citizens and Humans beings, need a transparent and reliable system ready to help us when the vaccine will be discovered and patented.
In conclusion, the EU portal and the EU database should be promptly functional in order to let all the European researchers and the drug companies conduct COVID-19 clinical trials across Europe and develop potential treatments in the most efficient way possible.
Regulation (EU) No 536/2014 of the European parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.
For a general overview see ALLEN & OVERY, New Clinical Trial Rules in the EU: a First Overview.
See recital 1 of the Regulation (EU) No 536/2014. See also art. 3 of the Regulation (EU) No 536/2014.
According to art. 2, par. 2, n. 21 «‘Informed consent’ means a subject’s free and voluntary expression of his or her willingness to participate in a particular clinical trial, after having been informed of all aspects of the clinical trial that are relevant to the subject’s decision to participate or, in case of minors and of incapacitated subjects, an authorization or agreement from their legally designated representative to include them in the clinical trial».
See art. 80 of the Regulation (EU) No 536/2014.
See, among others, M. Fasan, Il regolamento UE n. 536/2014: la disciplina della sperimentazione clinica tra uniformità e differenziazione, “BioLaw Journal – Rivista di BioDiritto”, n. 2/2017, pp. 189-193.
See art. 81, par. 2 of the Regulation (EU) No 536/2014.
See art. 81, par. 2 of the Regulation (EU) No 536/2014.
See the webpage of the European Commission, Clinical trials – Regulation EU No 536/2014.
See recital 78 of the Regulation (EU) No 536/2014.