Eu Pricing and Reimbursement for Medical Devices and Diagnostics 2006

Eu Pricing and Reimbursement for Medical Devices and Diagnostics 2006

The European market for medical devices is the second largest in the world after the US and is forecast to be worth approximately €55.2 billion in 2006.

However, despite the aims of the EU to bring about some sort of harmonization between the laws of its individual Member States there are still a great many variations between the individual nations with regards to how their health services are operated and the manner in which medical device companies must approach them to sell products.

The situation within the EU was made even more complicated by the accession of ten new Member States in 2004. In order to gain entry to the EU, and receive all the benefits that open access to this huge market provides, the new Member States had to show that their legislation and internal governing structures were brought into line with those of the rest of the EU. While this caused a number of reforms in the structures of the nations' health systems, the story did not end with accession. Indeed gaining entry to such a large market has proved to be a double-edged sword for some countries as increased competition and increased access to their home markets from larger and frequently more sophisticated medical market players has caused the costs within their health services to soar. As a result many of the new entrants to the EU are currently undergoing further reforms to their health systems in an attempt to rationalise their services and bring their costs down.

The state of affairs in the health systems of the older members of the EU is not that different to those of the newer members. Although the overhaul of their health system organisations may not be as radical or sudden, they are still under pressure to reduce costs and increase efficiency and are implementing schemes to rationalise their approaches to healthcare provision.

The processes of reform have some commonalities and some differences.Many are introducing forms of classification based on diagnosis related groups (DRGs) to track and allocate resources, health technology assessment procedures to evaluate the efficiency of technologies and increased accountability of healthcare insurers. However whereas some countries are seeing the decentralisation of processes as a means to introduce increased competition and so reduce prices, others are bringing them under more central control in order that they can be better monitored.

As the health budgets allocated to health systems within each nation very infrequently have large changes in the levels of investment, this situation is akin to cutting the same cake up in different ways to see if it can be made to look bigger and stretch further.The structures of the health systems affect the purchasing decisions and purchasing mechanisms for medical devices within a country, and although there are some similarities brought about through membership of the EU such as the provisions for public tendering, given in Directive 93/36/EEC of 14 June 1993, there are many differences. For example in Belgium, all medical procedures and devices are reimbursed on the basis of a national list, the Nomenclature INAMI/RIZIV whereas in the Netherlands there is no such list.

Dr Mark Charny, managing director of Translucency Ltd, a consultancy specialising in supporting medical device and pharmaceutical clients to obtain funding for their products in the EU, sums up the situation thus:Reimbursement depends very much on the product being discussed.Therefore if a client came to me and said, 'I am a manufacturer of scalpel blades and I want to sell them and be reimbursed for them in the UK,' what I would say to them would be very different to what I would have to tell a customer who wanted to be reimbursed for a drug eluting stent. And that's just the situation for the UK; each other country has major differences in how they treat products.

Despite this there are some commonalities:

• Clinicians have less say in the decision making process of purchases.
• They can say no, but they cannot say yes to a purchase.
• Health technology assessment is having more of a profound effect.

The same pressures are on every market and generally the fundamental dynamics of all reimbursement systems are the same, therefore if a set of questions is drawn up to assess the reimbursement potential for a product in the UK the answers will do for Germany and Spain as well. That is not to say that do not have to be put into a different format and submit them to different people, but the questions are the same. These questions are essentially how much does it cost, how well does it do its job and how much evidence is there to support those claims.

This report assesses the major routes of procurement and the reimbursement mechanisms that are in operation in each of the 25 EU Member States and two candidate countries (Bulgaria and Romania) as well as discussing the structure and size of the individual markets, which act as positive spurs or negative pressures to medical device and diagnostics reimbursement.

This report is an extension of the Clinica Report Gaining Reimbursement for Medical Devices and Diagnostics 2004 (CBS 924) and the authors of that report were contacted to gain an insight into the changes that have taken place in the European markets that it covered: Germany, France, Italy, Spain and the UK. In addition consultants, analysts, national health and medical associations, statistical databases, and journals were consulted in each of the other Member States to create this profile of the EU.

The report aims to help you meet the challenges represented by each country's unique reimbursement requirements, by describing each system and although reimbursement is an issue that has traditionally been limited to the marketing and accounting departments of companies; in the current changing environment it is an issue that should be disseminated and understood by all the members of a company. This report is therefore of importance to all medical device and diagnostic company employees, but its specific target is the executive officers, product development, marketing and sales personnel of medical device and diagnostic companies who should be working together to incorporate an understanding of reimbursement within the process that leads from product conception through to product distribution.

For each country this report provides a review of:

• The medical device market
• The structure of the healthcare system
• Current and future reforms
• The reimbursement structure
• Key contacts for reimbursement issues

Contents

• Chapter 1 Introduction
• Chapter 2 Europe
  • 2.1 Introduction
  • 2.2 Reimbursement
  • 2.3 Public Tendering
  • 2.4 Commonalities to Some Reimbursement Systems
    • 2.4.1 Diagnosis Related Groups
    • 2.4.2 Health Technology Assessment
  • 2.5 Other Commonalities
• Chapter 3 Austria
  • 3.1 Reimbursement System
    • 3.1.1 Coding
    • 3.1.2 Purchasing
  • 3.2 Key Contacts
• Chapter 4 Belgium
  • 4.1 Reimbursement System
  • 4.2 Key Contacts
• Chapter 5 Bulgaria
  • 5.1 Reimbursement System
  • 5.2 Key Contacts
• Chapter 6 Cyprus
  • 6.1 Reimbursement System
  • 6.2 Key Contacts
• Chapter 7 The Czech Republic
  • 7.1 Reimbursement System
    • 7.1.1 Purchasing
  • 7.2 Key Contacts
• Chapter 8 Denmark
  • 8.1 Reimbursement System
    • 8.1.1 Coding
    • 8.1.2 Purchasing
  • 8.2 Key Contacts
• Chapter 9 Estonia
  • 9.1 Reimbursement System
  • 9.2 Key Contacts
• Chapter 10 Finland
  • 10.1 Reimbursement System
    • 10.1.1 Coding
    • 10.1.2 Purchasing
  • 10.2 Key Contacts
• Chapter 11 France
  • 11.1 Reimbursement System
    • 11.1.1 Coding
    • 11.1.2 Reimbursement Process
  • 11.2 Key Contacts
• Chapter 12 Germany
  • 12.1 Reimbursement System
    • 12.1.1 Coding
    • 12.1.2 Health Technology Assessment
    • 12.1.3 Reimbursement Process
  • 12.2 Key Contacts
• Chapter 13 Greece
  • 13.1 Reimbursement System
  • 13.2 Key Contacts
• Chapter 14 Hungary
  • 14.1 Reimbursement System
    • 14.1.1 Coding
    • 14.1.2 Procurement
  • 14.2 Key Contacts
• Chapter 15 Ireland
  • 15.1 Reimbursement System
    • 15.1.1 Health Technology Assessment
    • 15.1.2 Coding
    • 15.1.3 Purchasing
  • 15.2 Key Contacts
• Chapter 16 Italy
  • 16.1 Reimbursement System
    • 16.1.1 Coding
    • 16.1.2 Health Technology Assessment
    • 16.1.3 Other Issues
  • 16.2 Key Contacts
• Chapter 17 Latvia
  • 17.1 Reimbursement System
  • 17.2 Key Contacts
• Chapter 18 Lithuania
  • 18.1 Reimbursement System
  • 18.2 Key Contacts
• Chapter 19 Luxembourg
  • 19.1 Reimbursement System
  • 19.2 Key Contacts
• Chapter 20 Malta
  • 20.1 Reimbursement System
  • 20.2 Key Contacts
• Chapter 21 The Netherlands
  • 21.1 Reimbursement System
    • 21.1.1 Coding
    • 21.1.2 Health Technology Assessment
  • 21.2 Key Contacts
• Chapter 22 Poland
  • 22.1 Reimbursement System
  • 22.2 Key Contacts
• Chapter 23 Portugal
  • 23.1 Reimbursement System
    • 23.1.1 Coding
    • 23.1.2 Procurement
  • 23.2 Key Contacts
• Chapter 24 Romania
  • 24.1 Problems and Reforms
  • 24.2 Reimbursement System
    • 24.2.1 Coding
    • 24.2.2 Procurement
  • 24.3 Key Contacts
• Chapter 25 Slovakia
  • 25.1 Corruption and Reform
  • 25.2 Reimbursement System
    • 25.2.1 Coding
    • 25.2.2 Procurement
  • 25.3 Key Contacts
• Chapter 26 Slovenia
  • 26.1 Reforms
  • 26.2 Reimbursement System
    • 26.2.1 Procurement
  • 26.3 Key Contacts
• Chapter 27 Spain
  • 27.1 Reimbursement
    • 27.1.1 Health Technology Assessment
  • 27.2 Key Contacts
• Chapter 28 Sweden
  • 28.1 Reimbursement System
    • 28.1.1 Coding
    • 28.1.2 Procurement
    • 28.1.3 Health Technology Assessment
  • 28.2 Key Contacts
• Chapter 29 The United Kingdom
  • 29.1 Reimbursement System
    • 29.1.1 Coding
    • 29.1.2 Purchasing
    • 29.1.3 Health Technology Assessment
  • 29.2 Key Contacts
• List of Tables
  • Table 1.1 European Medical Device Markets Ranked by Size, 2002
  • Table 1.2 Eu New Member States' Markets for Medical Devices Ranked by
• Size, 2002
  • Table 15.1 Irish Procurement Guidelines
  • Table 16.1 Regional Drg Reimbursement in Italy 2004
  • Table 17.1 Hospital Reduction Plan in Latvia
  • Table 21.1 Differences between US Drg and Dbc
  • Table 27.1 Products in Annex I or Annex Ii of Royal Decree 9/1996
• List of Figures
  • Figure 7.1 The Financing of The Czech Republic's Health System
  • Figure 9.1 The Financing of Estonia's Health System
  • Figure 10.1 The Financing of Finland's Health System
  • Figure 11.1 Submission of Reimbursement Application
  • Figure 12.1 German Reimbursement System as Applied to a Drug Eluting Stent
  • Figure 13.1 The Financing of The Greek Health System
  • Figure 14.1 The Financing of Hungary's Health System
  • Figure 16.1 Changes in Italy's Funding Structure
  • Figure 24.1 Funding for Medical Devices

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