Clinical Trials
Currently, the Clinical Trials Regulation is the primary document considering clinical trials and health research. It has a broader scope as it regulates more than “the conduct of trials on pharmaceuticals, or ‘medicinal products’” and includes a different definition of the processes. It also defines a “clinical study” as an investigation that has the purpose of discovering and confirming various effects of medicinal products.
The Regulation also makes a distinction between “low intervention clinical trials” and trials with higher risks, allowing the former to streamline their regulatory process. This change has raised concerns and framed the new Regulation as having a more commercially-driven approach to trials. The Regulation has some procedures that regulate multi-state trials but focuses on the cooperation of States and not a set of specific rules for all of them.
Human Material
The Blood Safety Directive covers human blood, plasma, platelets, and red and white cells but does not regulate any medicinal products with plasma. It mentions such processes as blood collection, testing, storage, distribution, and transfusion in Article 2. All potential donors have to be assessed regarding their health before the start of the procedure, as stated in Article 19. The Directive also asks the Member States to create some common criteria for testing of donated blood in Articles 18 and 29.
Currently, the Directives concerned with organ transplantation and donation do not bring a singular donation model, giving more control to the Member States instead, as stated in Article 14 of the 2010 Directive. The Organ Transplant Directive of 2010 also prohibits commercial dealing and “contributes indirectly to combating organ trafficking.” Areas of Research under Discretion of Member States. Some areas of health research remain under the control of the Member States and are not fully covered in the new Regulation.
Article 76 of the Regulation states that each separate Member State should establish a system of damage compensation. Furthermore, as indicated in the 7 Regulation 536, the approval of such aspects as informed consent, data protection, compensation for participants, liability, and others are still not covered in the document and are delegated to Member states. Member States can choose to apply additional testing for donors. The Human Tissue and Cells Directive, Article 7, give more freedoms to the Member States and allows them to establish appropriate control systems.