BVMed presents 10-point plan for use of advanced medical technology
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
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:
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- Cooperation between medical institutions and
industry is desired and essential for the improvement of patient
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.
- 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.
- 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.
- 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
- 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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