eHealth Regulations in Europe: Understanding the Changing European Legislative Landscape

Introduction

The coming year will be one of immense change for the pharmaceutical industry in Europe. The continued development of the eEconomy is critical to the continued growth and success of the European pharmaceutical market. Companies that implement forward-looking strategies will be able to hasten compliance and take full advantage of the opportunities presented by future regulations.

Scope

• Analyzes the changing eHealth regulatory environment in Europe, including general strategies for successful compliance
• Defines six key criteria outlined by the European Commission that attempt to address the quality issues specific to health-related websites
• Assesses the current status of European data protection and data sharing initiatives
• Explores the new clinical trials directive (Directive 2001/20/EC), including practical compliance solutions that can be used to ease the transition

Highlights

It is unlikely that direct-to-consumer advertising will be permitted in Europe in the near future. Pharmaceutical companies should develop other means of reaching their consumers, such as educational websites. Companies that develop websites according to defined quality criteria will foster consumer confidence and brand loyalty.

The European Union is developing increased public and private interoperability initiatives. With enhanced interoperability comes an increase in security risks associated with data sharing. Companies can prepare for the future by examining consumer information collection practices and reviewing their internal security policies.

Achieving compliance with the new clinical trials directive by the May 2004 deadline will be a challenge for the pharmaceutical industry. However, there are many compliance solutions that can be employed to ease the transition. Continued compliance will make it possible to develop better therapies by expediting the progress of products to market.

Reasons to Purchase

• Understand the current and prospective eHealth market in Europe and where the key opportunities for your company lie
• Bolster your company’s online market presence within Europe by providing comprehensive, accurate and reliable health-related information online
• Take full advantage of the opportunities presented by future regulations and hasten compliance by developing forward-looking eHealth strategies