European Union Health Law on Clinical Trial & Human Material
The history of creating regulations for pharmaceutical trials was impacted by the events of the 1960s when pregnant women were given Thalidomide which led to them having children with major disabilities. This situation is reflected in the case of Distillers v Thompson. Health law on clinical trials and research before 28 May 2016 was guided by the Clinical Trials Directive, adopted in 2001. It regulated such aspects as “planning, performance, reporting and archiving of research for new pharmaceuticals or ‘medicinal products.’” Rules of monitoring and inspection were also anticipated on the basis of GCP (good clinical practice).
The main focus of the Directive was to comply with the Helsinki Declaration. The Clinical Trials Regulation then replaced this Directive. Some older concerns included the focus on risk aversion, which slowed down research and led to the reduction of undertaken trials. The cost was also increased, along with the number of needed staff. The Directive did not cover many aspects of multi-state trials, generally discouraging such efforts. The Regulation was adopted to address these problems, help differentiate between large and small-scale trials to speed them up, address multi-state trials, and focus more on the scientific and ethical rationale.
Changes in the EU law were triggered by the events of 2011 and 2012 when the Poly Implant Prothese incident resulted in the further need for discussions about the reform of national and international regulations. The concerns about blood donation were linked to HIV infections and occurrences with hemophiliacs. In 2000, the Blood Safety Directive emerged as a response to these events. It covers human blood, plasma, platelets, and red and white cells but does not regulate any medicinal products with plasma.
The great concern with safety resulted in such cases as Geoffrey Léger v Ministre des Affaires socials, where a man was refused as a blood donor due to his homosexuality. The fear of the man having or potentially being infected with HIV in the future was linked to the protection of public health. The court ruled that this decision was under the Member State’s jurisdiction. The Human Tissue and Cells Directive was established in 2004. It deals with all types of human tissue and products derived from it. In 2010, a more detailed description of inspections was added into the Directive.
The idea of protection of human dignity arose from such cases as Büstle v Greenpeace, where the legitimacy of work with human embryos was called into question. Historically, the regulations of organ donation systems varied from one Member State to another. The international EU policy was created between 2009 and 2015 as an “Action plan on Organ Donation and Transplantation.” The Organ Transplant Directive from 2010 regulates the quality and safety of human organs for transplantation.
Change in Priorities
The focus in research and clinical trials shifted from fear and precaution that slowed the process of research to a more advanced scientific outlook that values safety but considers the need for new developments. The new Regulation now has a simplified version of the submission process for reporting results and an increased level of availability of such findings to the general public. However, it is possible that these changes may be linked to the rising influence of the market. The 2004 Blood Safety Directive is more focused on technical safety than the previous version.