歐洲診斷市場的規範壁壘與補償

Abstract

In Vitro Diagnostic (IVD) Directive aims to Regulate and Standardise IVD Products

With up to 80 per cent of medical decisions being based on laboratory diagnostics, IVD test results are a vital aspect in medical decision making. In acknowledging the need to regulate this area, the European parliament issued the IVD Directive (98/79/EC) in 1998. The purpose of this directive is to remove technical barriers to trade and protect the health and environment of patients and third parties. As the directive looks to harmonise regulations and reduce workloads for manufacturers and regulators, there lies scope for further improvements manufacturers and regulators need to share the obligation to assure the development of safe products with reliable performance and at affordable prices.

This Frost & Sullivan research service is an analysis of the regulatory hurdles and reimbursement in European diagnostics markets. It details the IVD regulatory environment in Europe and discusses healthcare plans, helping companies capitalise on business opportunities within the existing regulatory structure. It further looks at emerging and innovative technologies and critically examines the competitive structure with an overview of the current infrastructure and ongoing implementation initiatives.

Diagnostic-related Groups (DRGs) could Facilitate Strategic Changes in Hospital Management

In keeping with the evolving nature of European diagnostics, government healthcare plans are being aimed at increasing the quality and effectiveness of care while developing competitiveness among providers. While a stronger sense of bureaucracy is needed to strengthen the centralization of the healthcare systems in Europe, countries such as Germany and France are implementing and promoting diagnostic related groups (DRGs) to bring about strategic changes in hospital management.

Although DRGs develop modern structures in the outpatient sector, they also install hurdles for the entry of IVD into the system. Further, the budgetary restraints of DRGs make it difficult to introduce innovative products, resulting in a lack of innovation and clinical research. "However, on the positive side, DRGs encourage specialisation, as hospitals no longer have the capability of offering a wide range of IVDs to their patients," says the analyst of this research service. "Due to the concept of reimbursement through these groups, there is a good chance that the hospitals would now perform an examination on a patient in accordance to the symptoms, irrespective of the number of days the patient stays in the hospital."

Regulations Provide a Mix of Advantages and Disadvantages for Market Participants

In an increasingly regulated environment, companies complying with new regulations are likely to gain access to new geographical markets and see an increase in the production and value of their products. Also, as the IVD Directive specifies essential requirements for protection of health and safety of patients and users, it reduces the insecurity of companies with respect to their product quality and creates further scope for innovation. However, the disadvantages of regulations are in that they increase the cost of products and their time to enter the market. Regulations additionally limit flexibility in respect to technical changes and once the regulations are set, the technical specifications are frozen for the time being, thus leading to a lack of technical progression.

"Harmonised regulations encourage the development of new technology and facilitate the availability of state-of-the-art medical technologies that are in line with the customers needs," says the analyst. "Although predicting the future can often be uncertain, the IVD industry is expected to continue its trend of change and improvement."

Table of Contents

• 1. Executive Summary
  • 1. Executive Summary
    • 1. Executive Summary
• 2. Research Scope and Methodology
  • 1. Research Scope and Methodology
    • 1. Research Scope and Methodology
• 3. Introduction and Background
  • 1. Introduction and Background
    • 1. European Policies on the Regulations of In vitro Diagnostic Medical Devices
• 4. The Key Regulatory IVD Environment in Europe
  • 1. The IVD Directive
    • 1. Purpose of the Directive
    • 2. IVD Directive and Intended Effects in Key Actors
    • 3. Postmarket Surveillance
    • 4. The European Data Bank
    • 5. CE Marking
    • 6. Translation into Local Languages
    • 7. Symbols
    • 8. Labelling Solutions
    • 9. National Interpretations and Additional Requirements
    • 10. Impact of Regulations on the IVD Market
    • 11. Regulatory Challenges for the IVD Manufacturer in the European IVD Market
    • 12. Seeking Harmony
• 5. The Healthcare Plans
  • 1. Healthcare Plans and Reimbursement Issues
    • 1. Healthcare Plans
    • 2. Diagnostic Related Groups--The German Way
    • 3. Impact of the Diagnostic Related Groups on the European IVD Industry
    • 4. Impact of Diagnostic Related Groups on Rest of Europe
• 6. Towards the Future
  • 1. The Future
    • 1. Advantages and Disadvantages of Regulations
    • 2. The Next 10 Years
• 7. Key Regulatory Organisations and Industry Participants
  • 1. Key Regulatory Organisations and Industry Participants
    • 1. Key Regulatory Organizations and Industry Participants
• 8. Decision Support Databases
  • 1. Decision Support Databases
    • 1. Decision Support Databases