A description of the Swedish Medical Technology environment September 2012. osec.ch
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The Swedish Medical Technology environment.
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Title.
A description of the Swedish Medical Technology environment – Opportunities and challenges
Language.
English
Number of pages.
31
Content.
The scope of this report is to describe Swedish Medical Technology environment. The report summarizes and covers topics such as: Swedish Health Care Environment and Medical Technology Market, Regulatory Environment and Accessing the Swedish Market.
Author.
Anders Ternander Medmind AB Barnhusgatan 16 S-111 23 STOCKHOLM SWEDEN
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Table of Contents. 1
Executive summary
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Introduction to Sweden
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2.1 2.2
General facts and figures ................................................... 5 Demographic trends ........................................................... 6
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Swedish Health Care Environment
3.1 3.1.1 3.1.2 3.1.3 3.1.4 3.1.5 3.1.6 3.1.7 3.1.8 3.2 3.2.1 3.2.2 3.2.3 3.2.4 3.2.5 3.2.6 3.3 3.3.1 3.3.2
7 Health Care System ........................................................... 7 Shared responsibility .......................................................... 7 Health care decentralized................................................... 7 Shared medical care .......................................................... 7 How care is organized ........................................................ 8 More private health-care providers .................................... 8 Benchmarking leads to improvement ................................. 8 Eight regional hospitals ...................................................... 8 Six health-care regions....................................................... 8 Health Care Financing System........................................... 9 Case-costing system .......................................................... 9 The Nordic DRG-system .................................................... 9 How the DRGs are used in Sweden ................................ 10 Reimbursement of medical device ................................... 10 High-cost threshold .......................................................... 10 Financing Medical Technology ......................................... 10 Health Care Policy ............................................................. 11 Care within 90 days ........................................................... 11 Free choice in health care ................................................. 11
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Swedish Medical Technology Market
4.1 4.2 4.3 4.3.1 4.4 4.4.1 4.4.2 4.5 4.6
A history of innovation ...................................................... 12 Number of employees ...................................................... 12 Market Volume and Development .................................... 12 Sales on the Swedish Medtech market ............................ 13 Imports and Exports ......................................................... 14 Imports .............................................................................. 14 Exports.............................................................................. 14 Major Manufacturers ........................................................ 15 Short facts Swedish companies ....................................... 15
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Regulatory Environment in Sweden
5.1 5.2 5.3 5.3.1 5.4
CE marking ....................................................................... 16 CE marking in EEA and EFTA countries .......................... 16 An introduction to Swedish rules and regulations ............ 17 One procedure for all EEA-countries ............................... 17 Approval process .............................................................. 18
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5.4.1 5.4.2 5.4.3 5.4.4 5.4.5 5.4.6 5.4.7 5.4.8 5.5 5.6 5.6.1 5.6.2 5.7 5.7.1 5.7.2 5.7.3 5.7.4 5.7.5 5.7.6 5.7.7
Determine the classification of the device ........................ 18 Implement quality management system (QMS) ............... 18 Prepare a technical file ..................................................... 18 Appoint an authorized representative ............................... 18 Third-party assessment - Notified Bodies......................... 18 Prepare a Declaration of Conformity ................................ 19 Post-marketing surveillance and safety reporting ............ 19 Recast of the Medical Device Directive ............................ 19 Combination pharma/device products .............................. 19 Necessary Licenses for import and distribution................ 20 Import ................................................................................ 20 Distribution ........................................................................ 20 IP protection and patent issues ........................................ 20 Intellectual property rights in Sweden............................... 20 Industrial property rights ................................................... 21 Registration authority ........................................................ 21 Protecting intellectual rights abroad ................................. 21 Applying for a patent ......................................................... 21 Applying for design protection .......................................... 21 Applying for trademark protection..................................... 21
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Accessing the Swedish Market
6.1 6.2 6.2.1 6.2.2 6.3 6.3.1 6.3.2 6.4 6.4.1 6.4.2 6.4.3 6.4.4 6.4.5 6.5 6.6
Marketing channels........................................................... 22 Tenders ............................................................................. 22 Procurement of innovation ................................................ 23 Cost pressure and cost-benefit assessment .................... 23 Distribution channels ........................................................ 24 From a County Council perspective ................................. 24 From a company perspective ........................................... 24 Government agencies and associations........................... 25 The Medical Product Agency ............................................ 25 Health technology assessment ......................................... 25 The association for Medical Technology........................... 25 Center for Medical Technology Assessment..................... 26 Other authorities and organizations.................................. 26 Events ............................................................................... 27 Trade shows ..................................................................... 29
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Annex
7.1 7.2 7.3
Sources and references.................................................... 30 Reports ............................................................................. 30 Numbers and exchange rate ............................................ 30
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1 Executive summary Although Denmark, Norway and Sweden are all independent nations, their health care systems and reimbursement practices are very similar. In all of these markets, county- and municipal-level authorities play a large role in administering health care services, as well as setting local health care budgets and overseeing procurement of medical devices and supplies. Health care services in Sweden are overwhelmingly tax-financed, through county and municipal taxes. Since tender business is common in Swedish health care, it is important that it is handled correctly and that tax resources are used in an efficient and proper way. The Swedish clinicians have a strong focus on clinical evidence and have set a high bar for clinical evidence. Even though international expertise is respected it is very important to have a local champion. In general new technologies have to be funded out of existing hospital budgets. This means that if the new technology requires additional funding then the hospital department has to apply for additional funds to be able to use the new technology. Applications are made to the hospital management and benefit from the submission of a business case. There is no separate reimbursement for medical devices in Sweden. All medical devices, excepting custom-made devices and devices intended for clinical investigations must bear the CE-marking in order to be permitted to be placed on the Swedish market. Labeling and instructions for use shall be written in Swedish. This is irrespective of the device being used by a patient or by trained staff or if the device is used in a hospital or in an accommodation. Challenges and opportunities Ageing population and the way we live One of the most important factors from a patient perspective is demography development and general health trends. We all live longer and we require a reasonable quality of life as we age. We have become more impatient and we are therefore also prepared to invest in elective treatments as a way to improve our function and our mobility.
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As Europe and Sweden in particular continues to deal with the demographic challenges posed by an ageing population, demand will increase, as older people and those with chronic diseases are the major users of medical technology. Other important health related problems are overweight and obesity are probably the most important factors leading to increased prevalence of type-2 diabetes and heart diseases. Cost-benefit assessments As governments introduce fiscal measures to reduce national deficits, healthcare expenditure will come and are under pressure. Therefore, the demand on industry to demonstrate the cost/benefit assessments of its products will continue to grow. Health Technology Assessment (HTA) will increasingly be used to appraise and quantify the value of innovation. It is important that the wider benefits of medical technology are acknowledged and recognized as a cost-effective way of delivering extra healthy years to citizens, assisting them in contributing to society for longer Market access Over the recent years, pharmaceutical companies in the Nordics have reduced their staff substantially in a bid to counteract challenging market conditions. Some companies have cut the sales force entirely; others are working to build up new skills in market access teams. To a certain extent similar things are happening for the medical technology industry. Given the changes in health service structure and the creation of a new set of stakeholders, medical technology companies need to take other different approaches to access the market. Irrespective of approach, companies must deal with a new set of Key Opinion Leaders (KOLs), who range from hospital management, senior hospital clinicians to civil servants within the Medical Products Agency (MPA) and Pricing Authorities. With several KOLs, including physicians, civil servants and patient advocates, to consider, it has become clear that simply being able to identify these individuals is not enough. Organizations need to understand how these individuals interact, their motivations – which will often vary across different roles – and their relevance at different times in the product lifecycle.