Good Clinical Practice: A Question & Answer Reference Guide - May 2012 - (Page 527)

Section 18: GCP and Clinical Research Standards in the European Union by Peter O’Donnell Over the last two decades, the European Union, many of its member states, as well as other European countries such as Switzerland, have put in place their own set of good clinical practice rules, regulations and procedures. In most respects, the overall approach in Europe/EU is consistent with—and indeed has influenced—international approaches, particularly through its engagement in the International Conference on Harmonisation (ICH). The ICH’s consensus GCP guideline (E6) “should be taken into account,” the EU rules state. And “the accepted basis for the conduct of clinical trials in humans is founded in the protection of human rights and the dignity of the human being with regard to the application of biology and medicine, as for instance reflected in the Helsinki Declaration.” It is important to note, however, that despite some moves towards harmonisation at the EU level, there remain differences in the way individual EU countries regulate clinical trials and implement GCP. Background on the Current State of the EU Currently, there are 27 member states of the EU: Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the UK. In addition, Iceland, Norway and Liechtenstein, although not member states, have signed on for much of the EU legislation— including everything relating to pharmaceuticals and, therefore, GCP. Switzerland also cooperates with the EU on GCP inspections and participates in EMA working groups as an observer. Further enlargement of the EU is already planned. Accession negotiations started in 2005 with Croatia (which might accede by 2013) and Turkey (which is unlikely to accede before 2017). Further, Albania, Bosnia and Herzegovina, the former Yugoslav Republic of Macedonia, Montenegro Serbia and Kosovo—as its status is progressively resolved—are all prospective members. Each of them, to a greater or lesser extent, has started to move towards harmonisation of its GCP rules as part of a broader effort to come into line with EU rules in general. While other European countries have indicated their desire to join the union, the EU itself is not currently willing to offer them the chance to negotiate entry. Instead, the EU is offering the possibility, to all its near-neighbours in Eastern Europe and around the Mediterranean, to benefit from the EU’s single market, insofar as these countries bring their rules in line with the EU—and this could, in due course, include alignment with EU GCP. The Incomplete EU Rules on Pharmaceuticals Since 1965, the EU has built a framework governing many aspects of pharmaceuticals. The aim has been to create a single, EU-wide market providing high-quality medicines, while also strengthening the competitiveness of the European pharmaceutical industry by providing a harmonised and supportive base for its operations. The objective has not yet been fully achieved. This is not just because of the obvious conflicts that repeatedly emerge between the various stakeholders such as patient representatives, academic circles, industry, etc. For instance, industry complains it is over-regulated, while patient groups fear the authorities are not ensuring adequate protection. Even more crucially, the limits of the EU’s powers over its own member states have been consistently exposed by the attempts to harmonise the market rules. To understand the character of the EU, it is necessary to bear in mind its nature and history. It is not a federal organization like the USA: its members confer powers on the EU only where they choose to cede their own sovereignty. And in the area of health, the member states have chosen to cede only limited sovereignty, and to confer only limited powers. The regulatory framework, therefore, consists of aweb of instruments of differing force of law. In terms of GCP, the rules that were formalized in 2001, when the EU member states and parliament agreed to specific legislation on clinical trials (i.e., the EU Clinical Trials Directive), remains the relevant standard. The term “Directive” implies and mandates that the rules defined in that documentneed to be “transposed” (a legal technical 527

Table of Contents for the Digital Edition of Good Clinical Practice: A Question & Answer Reference Guide - May 2012

Good Clinical Practice: A Question & Answer Reference Guide - May 2012
Table of Contents
Introduction
Section 1: GCP Regulations, Standards and Guidelines for Clinical Research
Section 2: Investigators/Sites
Section 3: Form FDA-1572/Statement of the Investigator
Section 4: Study Sponsors and Clinical Trial Monitoring
Section 5: Informed Consent
Section 6: Source Data/Documentation
Section 7: Clinical Trial Protocols/Protocol Changes/Protocol Violations
Section 8: Institutional Review Boards
Section 9: Drug/Study Safety and Safety Reporting
Section 10: FDA Inspections, Quality Assurance Activities, and Study Auditing
Section 11: Computerized Systems, e-Clinical Trials, and Electronic Records Rules
Section 12: Patient Recruitment
Section 13: Conflicts of Interest/Financial Disclosure
Section 14: The HIPAA Privacy Rule and FDA-Regulated Clinical Trials
Section 15: Drug Accountability, Administration, and Labeling
Section 16: Fraud, Negligence, and Regulatory Non-Compliance
Section 17: Subject Diaries
Section 18: GCP and Clinical Research Standards in the European Union and An Interview with Fergus Sweeney, Ph.D., EMA Head of Sector, Compliance and Inspection
Section 19: Clinical Trial and GCP Standards in Selected Leading Countries/Regions: Latin America, China, Russia, Ukraine, and India
Section 20: GCP Compliance Statistics and Trends
21 CFR Part 11 — Electronic Records; Electronic Signatures
21 CFR Part 50 — Protection of Human Subjects
21 CFR Part 54 — Financial Disclosure by Clinical Investigators
21 CFR Part 56 — Institutional Review Boards
21 CFR Part 312 — Investigational New Drug Application
ICH Consolidated Guideline on Good Clinical Practice (E6)
ICH Guideline on Clinical Safety Data Management (E2A)
European Union Clinical Trials Directive
European Union Good Clinical Practice Directive

Good Clinical Practice: A Question & Answer Reference Guide - May 2012