Articles

Legal Issues in Clinical Research

Bruce Kriger, CEO of Kriger Research Group International www.kriger.com, leading training institution and clinical research organization told in the interview to our edition that one hundred years ago, any doctor could prepare a new medication without any external approval. Since the beginning of the nineteenth century governments of various countries have tried to regulate the foods and drugs sold to public, to prevent mass poisonings or infections. Only toward the beginning of the twentieth century did legislators realize much success in their efforts to protect public health. In the United States, on June 30, 1906, President Theodore Roosevelt signed the Food and Drug Act into law. It is, however, beyond the scope of this study to examine in depth legislation in individual countries.

Half a century ago, the international community began to realize the need for a universal set of rules to govern clinical trials on a global scale. The realization that it was important to have an independent evaluation of medicinal products before allowing them on the market was reached at different times in different regions. In the United States, a tragic mistake in the formulation of a children's syrup in the 1930’s was the trigger for setting up a product authorization system under the Food and Drug Administration. In Japan, government regulations requiring all medicinal products to be registered for sale began in the 1950’s. In many countries in Europe, the trigger was the thalidomide tragedy of the 1960’s, which revealed that a new generation of synthetic drugs revolutionizing medicine at the time had the potential to harm as well as heal.

In June 1964, the 18th World Medical Assembly adopted the Declaration of Helsinki. The Declaration established a body of international principles to guide the conduct of clinical research.

In later years, the need to harmonize regulation was propelled by concerns over rising costs of healthcare, escalation of the cost of R&D (research and development), and the need to meet public expectations that there should be a minimum of delay in making safe and efficacious new treatments available to patients in need.

The European Community (now the European Union) pioneered the harmonization of regulatory requirements in the 1980’s, as the EC moved toward development of a single market for pharmaceuticals. The success achieved in Europe demonstrated that harmonization was feasible. At the same time, there were multi-lateral discussions by Europe, Japan and the United States regarding the possibility of harmonization. The WHO Conference of Drug Regulatory Authorities (ICDRA), held in Paris in 1989, formulated specific plans of action. Soon afterward, authorities approached IFPMA to discuss a joint regulatory-industry initiative on international harmonization, and the International Committee on Harmonization (ICH) was conceived.
The birth of ICH took place at a meeting in April 1990, hosted by the European Federation of Pharmaceutical Industries Associations (EFPIA) in Brussels. Representatives of regulatory agencies and industry associations from Europe, Japan and the United States attended, to plan an international conference, and to discuss the wider implications and terms of reference of ICH. The ICH Steering Committee, established at that conference, has since met at least twice a year, with the location rotating among the three regions.