Abstract
In Vitro Diagnostic (IVD) Directive aims to Regulate and Standardise IVD
Products
With up to 80 per cent of medical decisions being based on laboratory
diagnostics, IVD test results are a vital aspect in medical decision making.
In acknowledging the need to regulate this area, the European parliament
issued the IVD Directive (98/79/EC) in 1998. The purpose of this directive is
to remove technical barriers to trade and protect the health and environment
of patients and third parties. As the directive looks to harmonise regulations
and reduce workloads for manufacturers and regulators, there lies scope for
further improvements manufacturers and regulators need to share the obligation
to assure the development of safe products with reliable performance and at
affordable prices.
This Frost & Sullivan research service is an analysis of the regulatory
hurdles and reimbursement in European diagnostics markets. It details the IVD
regulatory environment in Europe and discusses healthcare plans, helping
companies capitalise on business opportunities within the existing regulatory
structure. It further looks at emerging and innovative technologies and
critically examines the competitive structure with an overview of the current
infrastructure and ongoing implementation initiatives.
Diagnostic-related Groups (DRGs) could Facilitate Strategic Changes in
Hospital Management
In keeping with the evolving nature of European diagnostics, government
healthcare plans are being aimed at increasing the quality and effectiveness
of care while developing competitiveness among providers. While a stronger
sense of bureaucracy is needed to strengthen the centralization of the
healthcare systems in Europe, countries such as Germany and France are
implementing and promoting diagnostic related groups (DRGs) to bring about
strategic changes in hospital management.
Although DRGs develop modern structures in the outpatient sector, they also
install hurdles for the entry of IVD into the system. Further, the budgetary
restraints of DRGs make it difficult to introduce innovative products,
resulting in a lack of innovation and clinical research. "However, on the
positive side, DRGs encourage specialisation, as hospitals no longer have the
capability of offering a wide range of IVDs to their patients," says the
analyst of this research service. "Due to the concept of reimbursement through
these groups, there is a good chance that the hospitals would now perform an
examination on a patient in accordance to the symptoms, irrespective of the
number of days the patient stays in the hospital."
Regulations Provide a Mix of Advantages and Disadvantages for Market
Participants
In an increasingly regulated environment, companies complying with new
regulations are likely to gain access to new geographical markets and see an
increase in the production and value of their products. Also, as the IVD
Directive specifies essential requirements for protection of health and safety
of patients and users, it reduces the insecurity of companies with respect to
their product quality and creates further scope for innovation. However, the
disadvantages of regulations are in that they increase the cost of products
and their time to enter the market. Regulations additionally limit flexibility
in respect to technical changes and once the regulations are set, the
technical specifications are frozen for the time being, thus leading to a lack
of technical progression.
"Harmonised regulations encourage the development of new technology and
facilitate the availability of state-of-the-art medical technologies that are
in line with the customers needs," says the analyst. "Although predicting the
future can often be uncertain, the IVD industry is expected to continue its
trend of change and improvement."
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