Swiss Medtech Report 2012 - Medtech Switzerland

The market counts
The Swiss medtech industry is characterized by its short access process
and its market-friendly reimbursement practice.
Medtech companies achieve more than half their
sales with products that are no more than three years
old. For a new medical device to be sold in the Swiss
market quickly, it still does not have to undergo a
time-consuming official approval process like the
one for drugs. Rather, a declaration by the manufacture
of the product’s conformity with the applicable
standards must be submitted, and the medical device
must be labeled in accordance with CE regulations.
For certain non-hazardous medical devices (in
Class I), the review of conformity may be undertaken
by the manufacturer itself. For those with a
higher risk potential, it must call in an external,
government-certified and recognized conformity
assessment body (also called a Notified Body). Under
the Bilateral Treaties 1, Switzerland has agreed
with the EU on the reciprocal recognition of their
conformity assessment bodies. Thus the 5 Notified
Bodies recognized by the Swiss accreditation body
SAS and the 76 internationally accredited Notified
Bodies of signatory states may be used.
The standards applicable in Switzerland are to be
found mainly in Federal Law 1 on Drugs and Medical
devices (Therapeutic Products Act – “Heilmittelgesetz”),
in the Swiss Regulation on Medical De-
v ices (Medizinprodukteverordnung) and in the Reg -
ulation on Clinical Trials with Therapeutic Products.
FREELY NEGOTIaTED PRICEs In contrast
to the reimbursement for drugs or medications by
the compulsory health insurance (OKP), there is in
principle no approved list for medical devices. Nor
are the prices set by the government, but instead
freely negotiated in a market that is upstream of
the healthcare market. Therefore, service providers
Institutions which might be of interest to you
buchs&sachsse
Innovations-Kommunikation
20
buchs&sachsse
4153 Reinach
www.buchs-sachsse.ch
Creapole SA
2800 Délemont
www.creapole.ch
DePuy Synthes
www.depuysynthes.com
Hocoma
8604 Volketswil
www.hocoma.com
such as hospitals and physicians can in principle
decide for themselves which products they will use,
and pass the cost on to the health insurers as part of
their services to the patient.
EFFECTIvE, ExPEDIENT aND ECONO-
MICaL The insurers are obliged to reimburse
the services described in the Health Insurance Act
(Krankenversicherungs-Gesetz) such as examinations
conducted in hospitals, treatment or care services
(cf. Art. 25 ff. Health Insurance Act). These
must be effective, expedient and economical, i.e. the
so-called “EEE” criteria must be fulfilled (Art. 32
Par. 1 Health Insurance Act), which is, in principle,
assumed. In this system, health insurers generally
do not pay for medical devices as a separate
item, but rather as part of prices that are negotiated
among service providers (doctors, hospitals, etc.).
TARMED – the price schedule for individual medical
services – covers the outpatient sector. For acute
somatic services provided in an inpatient setting,
the diagnosis-related case-based rates pursuant to
the SwissDRG have applied since the beginning
of 2012. This means that costs are no longer reimbursed,
but rather clearly defined medical services.
ExCEPTIONs The exception to the reimbursement
prac tice is materials and items (such as bandages,
measuring devices, stoma supplies, incontinence,
hearing, and vision aids) used by the insured
person at a doctor’s prescription but without the aid
of professionals (Art. 55 Health Insurance Regulation).
For these there is a positive list of materials
and items (MiGeL), with reimbursable product
groups. MiGeL lays down a maximum reimbursement
amount that the compulsory insurance must
pay for each product.
ISS AG
2562 Port
www.iss-ag.ch
Straumann Holding AG
4052 Basel
www.straumann.com
Ziemer AG
2562 Port
www.ziemergroup.com