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Impact of Healthcare Regulatory Reforms on Medical Device Procurement in EU-5 Countries : Healthcare Reforms and the Impact on MedTech Companies

The objective of the research is to present a comprehensive landscape of healthcare structure of EU-5 countries of Europe with respect to their governing and regulatory healthcare bodies. The regional scope of analysis is focused primarily on the United Kingdom, Germany, France, Italy, and Spain. The study captures the latest healthcare reforms, major healthcare stakeholders, funding, procurement, and payment structure per country with special focus on the medical device sector. Country-wise funding structure has also been provided. Impact analyses have been presented for the major stakeholders and their role in healthcare policy implementation in the respective countries. The base year of the study is 2015.

Key Findings—EU-5 Healthcare System

UK

Emergence of clinical commissioning groups (CCGs) as a more powerful body is expected to facilitate and enhance the healthcare outcomes in the UK.

-Payment by results (PBR) introduction is set to reform the national tariff of fixed prices that reflects the national average prices for hospital procedures

Germany

G-BA’s coverage with evidence development program (CED) reform is expected to boost the entrepreneurial med tech firms.
-Changes in SHI funding by Health Financing Act (FinG) are expected to strengthen the role of private healthcare insurance in the country.
-SHI reimbursement permits provision of new medical services through the prohibition right, which promotes inpatient sector innovations in medical devices.

France

Authorisation by French Health Authority to carry out medico-economic evaluation for medical device will promote effective commercialisation of medical devices in France.

Spain

The Royal Decree passed by Spanish Healthcare Ministry has drastically affected Spanish healthcare coverage as large section of the population remains uncovered by health insurance.

Italy

Health Pact Act, 2014 has laid the foundation for financial structural reform in healthcare system of Italy, and has allocated funds to the NHS for € Billion during 2014–2016.



Table Of Contents

Impact of Healthcare Regulatory Reforms on Medical Device Procurement in EU-5 Countries 
1 IMPACT OF HEALTHCARE REGULATORY REFORMS ON MEDICAL DEVICE PROCUREMENT IN EU-5 COUNTRIES

Executive Summary
1. Key Findings—EU-5 Healthcare System
2. EU-5 Healthcare System Indicators—2012
3. Country Analysis—Funding of Healthcare: EU-5

Healthcare Market Overview—United Kingdom
1. Healthcare Structure—The United Kingdom
2. Healthcare Structure—The United Kingdom
3. Healthcare Structure and Major Stakeholders—The United Kingdom
4. Fund Flow for Healthcare Provision—The United Kingdom
5. Procurement Process for Medical Devices—The United Kingdom
6. Reimbursement and Coverage of Medical Device—The United Kingdom
7. Provider Organisation and Payment—The United Kingdom
8. Healthcare Reforms and their Impact—The United Kingdom

Healthcare Market Overview—Germany
1. Healthcare Structure—Germany
2. Healthcare Delivery System—Germany
3. Healthcare Structure—Germany
4. Healthcare Structure and Major Stakeholders—Germany
5. Fund Flow for Healthcare Provision—Germany
6. Procurement Process for Medical Devices—Germany
7. Reimbursement and Coverage of Medical Devices—Germany
8. Provider Organisation and Payment—Germany
9. Healthcare Reforms and their Impact—Germany

Healthcare Market Overview—France
1. Healthcare Structure—France
2. Healthcare Delivery System—France
3. Healthcare Structure—France
4. Procurement Process for Medical Devices—France
5. Healthcare Structure and Major Stakeholders—France
6. Reimbursement and Coverage of Medical Devices—France
7. Provider Organisation and Payment—France
8. Healthcare Reforms and their Impact—France

Healthcare Market Overview—Spain
1. Healthcare Structure—Spain
2. Healthcare Delivery System—Spain
3. Healthcare Structure—Spain
4. Fund Flow for Healthcare Provision—Spain
5. Procurement Process for Medical Devices—Spain
6. Healthcare Reforms and their Impact—Spain

Healthcare Market Overview—Italy
1. Healthcare Structure—Italy
2. Healthcare Delivery System—Italy
3. Healthcare Delivery System—Italy
4. Healthcare Structure and Major Stakeholders—Italy
5. Fund Flow for Healthcare Provision—Italy
6. Procurement Process for Medical Devices—Italy
7. Reimbursement and Coverage of Medical Devices—Italy
8. Provider Organisation and Payment—Italy
9. Healthcare Reforms and their Impact—Italy
10. Legal Disclaimer

Appendix
1. List of Acronyms Used

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