BVMed presents 10-point plan for use of advanced medical technology in Germany

20 August 2009

BVMed has published a 10-point plan for the care of patients with advanced medical technology as a basis for the health policy discussions that are to come during the German general elections in the next few months.

The points presented provide so called "Wahlprüfsteine" for the Bundestag election campaign on September 27 and should give impetus for the elaboration of the new government program.

BVMed’s plan, 10 points for providing patients with advanced medical technology, includes:

  1.  The quality rating of medical devices must be demonstrated by means of the CE quality mark.
    The CE quality mark for medical devices differs from that for other products in that it does not only guarantee the safety of the product, but in addition stands for a proven performance capability. A distinctive CE-Med quality mark should, therefore, be introduced for all medical devices.
  2.  Access to medical-technical innovations should be designed to be unbureaucratic and flexible.
    In order to enable patients to gain more flexible and faster access to medical-technical progress, BVMed suggests simplifying and deregulating the remuneration of new examination and treatment methods (Neue Untersuchungs- und Be-handlungsmethoden, NUB) within the Statutory Health Insurance (SHI).
  3.  It must be possible to introduce medical-technical innovations into hospitals without restrictions
    When launched onto the market, many medical-technical innovations are first used in hospitals because these have suitable staff and adequate technical infra-structure. This process must be continued in order to make innovative medical technologies available to all patients in Germany who need them, without delay. If similar structures exist in the outpatient sector, the same procedure should be possible for this sector as well.
  4.  We advocate an innovation pool to accelerate the introduction of medical-technological innovations into the SHI
    Medical-technical progress should be made available to patients as soon as possible. At present, it takes up to four years to assure adequate remuneration. In order to accelerate the introduction into the SHI service catalog, funds should be paid by the SHI into a so-called "innovation pool" to be used for the purpose of medical-technical innovations. The inclusion of additional funds, e.g. from research funding, should be considered as well.
  5.  We campaign for a tax-advantaged innovation savings scheme (Steuer-begünstigtes InnovationsSparen, SIS)
    There is great demand for additional services outside the range of the SHI service catalog. In this context, we suggest granting tax privileges for savings schemes in the healthcare sector, similar to those for the pension savings scheme “Riester-Rente”. This would create an important incentive to make provisions in time, especially for younger people. Certain innovative and desirable services that exceed the care provided by the SHI benefits would be supported. Such optional schemes increase the freedom of choice for patients.
  6.  We consider health services research a useful and necessary joint task for all players in the healthcare system
    Health services research is the basis for decisions that are relevant to health and can increase the plan-ning assurance for all those involved in the healthcare system. Actively involving all players in the healthcare system in the process is impor-tant if health service research is to be generally accepted.
  7.  Cooperation between medical institutions and industry is desired and essential for the improvement of patient care
    An idea for a device or procedure is often jointly realized by physicians and the engineers in the companies. The cooperation leads to excellent products. Together with its partners in the hospitals and among physicians, BVMed has been working for many years on providing a secure and transparent basis for the necessary cooperation in the healthcare market. This includes extensive information and advisory services.
    In the area of medical care, profitable cooperation takes place between companies, service providers, SHI-physicians, hospital physicians, hospital operators. This is now being restricted unnecessarily by the amendment of section 128 Social Security Code V (SGB V). Regarding this situation there is urgent need for action.
  8.  Emphasis must again be on the quality of medical devices (eg regarding aids and appliances). Patients must be able to freely choose their service provider and their products
    The MedTech companies recommend competition for the best quality in medical care, not for the lowest price without consideration of quality and qualification. Therefore, we advocate developing and establishing criteria for a proper quality competition in cooperation with the health insurance funds, in order to counter the trend towards cheap medical care.
  9.  Homecare should become regular part of SHI
    Six million people in Germany use aids and appliances supplied by homecare companies — and the number is rising daily. We live in a society where people are getting older and older, not least thanks to medical-technical advances. Older patients mostly have several chronic diseases. Changes in hospitals mean that they are transferred to ambulatory care as soon as possible. Homecare companies have successfully been meeting the challenges this poses for years. Trust and professional counseling require that services are provided close to home. Therefore, the patient should be entitled not only to the product (medical device) but also to comprehensive homecare treatment.
  10. Telemedicine should become part of regular care
    E-Health, telemedicine and telemonitoring by means of medical technologies and the required net-working lead to better, safer, optimized, and more cost-effective care and must therefore become part of standard care.

From BVMed’s point of view, it is of particular importance that medical devices are distinguished from pharmaceutical products:

  •  With pharmaceutical products the effect is mainly reached in a pharmacological way. The effects that medical devices have on the human body are mostly of physical nature. Effectiveness in medical devices must, therefore, be understood in terms of functionality.
  •  Pharmaceuticals interact with complex biological systems and their therapeutic effect consists of an interaction between drugs and the human body. Medical devices on the other hand have an effect on the human body — and not the other way round.
  •  Undesired effects from pharmaceutical products are often not predictable. Only very limited predictions can be made about when they will occur, how severe they are, and whether they are reversible. Undesired effects of medical devices, however, can be predicted to a greater extent and are usually reversible.

“Therefore, medical devices and pharmaceutical products need to be treated differently”, states BVMed Director General Joachim M. Schmitt. His core message is: “Medical devices are indispensable for health and a better quality of life. Medical technologies are an investment in life and productivity of people. Innovative medical technologies must be made available to all patients who require them without delay.”

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