IQWiG offers medical device manufacturers a model contract to simplify confidential use of study documents

The German Institute for Quality and Efficiency in Health Care (IQWiG) evaluates about five to ten treatment methods that require medical devices. Previously, for example, laboratory tests for the detection of metabolic diseases, laser for the removal of prostate tissue, stents and monitoring systems for cardiac patients were tested. Health technology assessments (HTAs) are typically ordered by the Federal Joint Committee (G-BA).

For the purpose of benefit assessments, all relevant available information should be taken into account, including studies carried out by the industry. According to the IQWiG director Jürgen Windeler, it is important that complete information is provided by manufacturers and that results can be passed further to assure transparency. This concerns particularly study reports that are available earlier than in journal publications and contain more detailed information.

To regulate the conditions under which information provided by manufacturers can be used and make it available to third parties, IQWiG has now drafted a model contract in the agreement with the relevant manufacturers' associations. The model contract can serve as a basis for bilateral agreements with the IQWiG for manufacturers of medical devices. It offers advantages for both sides: confidential information such as company and business secrets remain protected, while IQWiG can use and publish the methods and results of the studies.

The concrete procedure comprises two stages:

• After signing the contract, the manufacturer sends a list of all potentially relevant studies to the IQWiG.
• The IQWiG then requests documents with detailed information from the manufacturer for the studies it deems relevant. Study protocols and final reports are of particular interest.

A comparable model contract for the evaluation of pharmaceuticals has existed for ten years and is accepted by almost all manufacturers.

The template for the contract is available in German here.

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