Medizinprodukteindustrie

2007-07: The German MedTech Industry in the year 2007

Article for The Regulatory Affairs Journal
July 2007; Report by Joachim M. Schmitt & Manfred Beeres, BVMed – German Medical Technology Association

Medical technologies are indispensable for people's health and quality of life. They save lives. They help heal. They enable millions of patients in Germany to regain their vitality and mobility.

In recent years, major progress towards raising awareness of medical technologies among policy and decision makers in the healthcare market has been made in Germany. This includes comprehensive studies on the situation of medical technology in Germany published by the Federal Ministries of Economics and Research. Federal Health Minister Ulla Schmidt also missed no opportunity to mention the innovative capacity of our industry in the last few months. A so-called "Medical Technology Action Plan", which is to improve the promotion of the industry's innovations, is part of the "High-Tech Strategy" adopted by the German federal government.

These initiatives and the budding strategic approach across governmental departments offer new opportunities for departing from a health policy perspective geared towards cost reduction.

High-Tech Strategy: German government prepares Medtech action plan

The "high-tech strategy" adopted by the German federal government contains a "Medical Technology action plan" intended to improve the promotion of the industry's innovations. The government initiative aims at linking research, politics and industry more closely and turning research results into products at a faster rate.

The high-tech strategy is the first integrated national concept that has been developed across governmental departments. Its aim is to assure a leading position for Germany in future markets in Europe and worldwide. If the strategy is implemented consistently, up to 1.5 million new jobs could be created in the future industries, said Federal Minister of Research Annette Schavan.

Until 2009, the federal government will be investing a total of 14.6 billion euros in high-tech. Part of this will be an additional 6-billion-euro program which is intended by the government as a signal that research and development are of top priority.

The high-tech strategy contains five cross-sectional areas:

• close cooperation between science and industry,
• increase of private commitment to innovation,
• targeted distribution of advanced technologies,
• internationalization of research and development, and
• promotion of talent.

In addition to these cross-sectional areas, 17 fields of innovation using state-of-the-art technologies have been defined. These include health research, medical technologies and optical technologies.

Action plan for the leading market Medical Technology

The government plans to develop an action plan for the promotion of medical technologies under the lead-management of the Federal Ministry of Research in 2006 (to be combined and focused from 2006 to 2009). Medical technology is defined as one of the leading markets by the high-tech strategy.

In the chapter "innovations for a healthy and safe life", the extensive publication on the "High-Tech Strategy for Germany" states that prosperity for the Medtech industry depends essentially on the funding regulations for innovations in private and Statutory Health Insurance:

• In order to facilitate the market launch of new therapies, diagnostics and medical technology products, not only the improvement of healthcare quality but from an economic point of view also long-term savings potentials should be taken into account for coverage considerations.
• According to the report, the introduction of new medical devices depends mostly on whether they are covered by health insurance funds. In future, transparent regulations for reimbursement are needed.
 
Cost reductions and enhanced efficiency

• The report by the Federal Ministry of Research states that innovative medical technologies guarantee not only advantages for patients but also cost reductions and enhanced efficiency in the healthcare system. In future, the economic consideration of cost reductions through new, validated processes would have to gain influence.
• Furthermore, in an aging society, medical technology could contribute to independent lives and societal participation for those with handicaps. "In order to be able to use these developments soon, the early-stage connection between technology and medicine as well as the cooperation between scientists, purchasers and industry must be advanced."
• The report further states that the mainly medium-sized Medtech enterprises in Germany can look back on a long and successful tradition. More than half of the sales volume is generated from products that are less than two years old. These include e.g. surgical instruments and devices for patient support, but also new in vivo and in vitro diagnostic devices that have accompanied the development of new therapies.

Early integration

In order to be able to use these developments soon, the early-stage connection between technology and medicine as well as the cooperation between scientists, purchasers and industry should be advanced further.

The action plan is meant to integrate all activities of the Federal Ministry of Research on medical technology, especially innovations from cross-sectional technologies, such as optical technologies (e.g. biophotonics) or microsystems technology (e.g. intelligent implants).

The schemes will be addressed in joint projects of science, hospitals and industry, mainly under the lead-management of industry.

Analysis

Taking into account long-term savings potentials when deciding on coverage for medical technology products is a step in the right direction.
In addition, the strategic point of view across governmental departments offers connecting factors for departing from a health policy perspective geared towards cost reduction.
The "Medical Technology action plan", which the Federal Ministry of Research will be developing in the second half of the year, is a starting point.

What we need now is a "Health Economy Master Plan" that is aligned across all policy areas and, above all, coordinated with the government's economy, research and health departments as well as with the Federal Chancellery. As a precondition, this would require a broad discussion by society in general on how much health is worth to us. People should be openly informed that the finite resources of Statutory Health Insurance cannot deliver an unending supply of innovative healthcare benefits.

In times of limited resources there is an even greater need for more individual responsibility of the medically insured for their own health and for alternative funding concepts, so that, in the future, medical progress can continue to be made available to all patients in good time. The medical technology companies are gladly prepared to actively participate in this process as a constructive and open-minded partner.

Further information on the high-tech strategy is available on the internet at:
http://www.ideen-zuenden.de (German language only)

The complete publication is available at:
http://www.bmbf.de/pub/bmbf_hts_lang.pdf


Promoting Medtech Innovation: What Needs to be Done?

What precisely needs to be done to utilize the potential of medical technologies as a driving force for growth?

:: We need a new health economy with more competitive elements, increased freedom of choice and more individual responsibility of patients for their own health. Our vision is a new health economy in which everyone is free to "buy" their own individual health insurance coverage. Accordingly, this would include the provision of basic care as well as voluntary supplementary insurance options – with premiums emphasizing prevention or with deductible rates, with or without free choice of doctor, a range of alternative options in specific fields of healthcare, etc. This adds up to more individual responsibility. This would be a system with a great number of competitive elements - and most assuredly also with favorable effects on Germany as a business location.

:: We need the clear will to introduce innovations into the German healthcare system and to establish processes for their timely adoption. For this purpose, we suggest the establishment of a cross-departmental "Medical Technology Task Force".

:: Many innovations are initially applied in hospitals. Medical technological innovations in hospitals are subject to reimbursement by Statutory Health Insurance, unless there has been a negative decision of the Joint Federal Committee (JFC – Gemeinsamer Bundesausschuss). This principle of "permission with the reservation of prohibition" in the inpatient sector must be adhered to, so that innovative medical technologies can be made available to all patients who require them without delay.

:: The Medtech companies are still insufficiently involved in the proceedings of the JFC and a more active industry participation is called for. As a first step, BVMed has suggested a case-related designation of medical expert participants from industry in the committee's relevant key deliberations.

:: The introduction of innovations into the system must not be impeded by too restrictive requirements for the provision of evidence. While randomized controlled clinical trials are considered "gold standard" for medical devices, they are not ethical or even necessary in every case. Lower evidence levels can also provide the data necessary for demonstrating a technology's real benefit. The required evidence level should be adapted to the technology and disease in question.

:: We must optimize the general conditions for research and development through improved research management. This requires the establishment of a network of companies, users and scientific research, particularly in the fields of bio, micro and nano technology. We plead for regional clusters including medical technology companies, research institutes and educational establishments, manufacturers of important preliminary products up to software as well as suppliers of venture capital.

The dynamic change of medical possibilities and services must now be followed by a change of the healthcare system that is just as dynamic.

Current legislative procedures on Medtech

At the end of March 2007, the "SHI Competition Strengthening Law" was signed by the German Federal President. Substantial parts of the law have come into effect on April 1, 2007 (see MedInsight No. 17). Next to numerous new provisions for the medically insured - such as the introduction of optional benefit rates of the health insurance funds, compulsory insurance for those without insurance, or vaccinations and mother/child convalescent care as obligatory services – extensive changes have come into force in the technical aids sector in particular.

Statement of the health insurance funds on the Medtech aids sector

The medically insured can no longer choose their provider of technical aids themselves but must rely on the care with technical aids provided by a contractual partner of their health insurance fund. This contractual partner is to be determined by means of obligatory tenders. There are to be exceptions in the case of custom-built technical aids or aids marked by a high service ratio. In April 2007, the health insurance funds published a statement on how the implementation of the law is to be handled in detail. There is some dissent on whether the transitional period for previously licensed care providers until the end of 2008 is to apply in the case of tenders as well.

Amendment of the Medical Devices Act

A legislative procedure still under way is the amendment of the Medical Devices Act (Medizinproduktegesetz - MPG). A hearing on the amendment took place in the parliamentary health committee at the end of March 2007. One aim of a statement of Medtech trade association BVMed was that the legal clarification intended by the legislators on the scope of benefits with regard to so-called medicinal product-like medical devices (such as irrigation solutions or special gels) was not to turn into the opposite. BVMed pointed out that the planned equal treatment of OTC drugs and medicinal product-like medical devices was not sensible due to the latters' particularities. Furthermore, industry is calling for a clarification that medical devices containing pharmaceuticals remain subject to reimbursement by Statutory Health Insurance.


About the authors

Joachim M. Schmitt has been Director General of the Berlin-based German Medical Technology Association, BVMed, since 1990 and member of its board since 2002.  The association represents over 200 manufacturers and trade companies. In addition, he has been Director General of MedInform, a Conference and Seminar Services for the Medical Devices Industry, since its founding in 1992. He was born in 1951 and is a graduate of economic and social sciences. He was scientific staff member at Deutscher Industrie- und Handelstag (DIHT), Bonn, a scientific staff member of the German-Swiss Chamber of Industry, Zürich, and member of the management of the German-Tunisian Chamber of Industry and Commerce, Tunis.

Manfred Beeres has been Communication Director of BVMed since 1998. Since January 2004, he is alsoDeputy Director General of MedInform, an Information and Seminar Service for Medical Technologies. He is also Editor of MedInsight, a Monthly Report on the German Healthcare Market & Advanced Medical Technology  in English language. He studied communication and political sciences and law in Munster and Mainz and has been working as a journalist and editor since 1986.


Contact:

BVMed -German Medical Technology Association
Reinhardtstr. 29 b, D -10117 Berlin
Internet: http://www.bvmed.de 

 


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