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Belgium-Woluwe-Saint-Pierre: Medical software development services
Notice for changes or additional information
(Supplement to the Official Journal of the European Union, 2020/S 037-087741)
Section I: Contracting authority/entity
Section II: Object
Horizon Scanning System
Procurement of horizon scanning system.
Section VI: Complementary information
Section VII: Changes
Procurement of a horizon scanning system.
The horizon scanning system entails the following missions and elements:
— the contractor will develop a horizon scanning system and supply it to IHSI. The horizon scanning system entails a database of information on pharmaceuticals. The contractor is responsible for the further development, adaptation and maintenance of the system, following go-live, including the IT service management;
— IHSI envisages (indicatively) the following structure of intellectual property rights for the horizon scanning system. Intellectual property rights relating to any pre-existing software or materials developed by the contractor and incorporated into the horizon scanning system and/or database are and shall remain the exclusive property of the contractor. The contractor shall grant IHSI a non-exclusive, worldwide, non-transferable, royalty-free license to use the incorporated pre-existing materials, for the entire duration of the intellectual property rights concerned. Furthermore, IHSI will acquire all intellectual property rights worldwide relating to all creations and developments developed for the horizon scanning activities of IHSI, as from the moment of their creation and for the entire duration of the intellectual property rights concerned. To the extent the contractor incorporated into the (customized software of the) horizon scanning system and/or database any third party software or materials, the contractor warrants that it shall obtain the necessary consents from all relevant third parties to grant IHSI a non-exclusive, worldwide, non-transferable, royalty-free license to use the incorporated third party materials, for the entire duration of the intellectual property rights concerned;
— the contractor is responsible to complete the database with medical substantive inventories, analyses, and associated activities. These services require substantive medical and pharmaceutical expertise throughout the contract term;
— at the outset, the horizon scanning system will contain data on pharmaceuticals that are under development. Not only substances but also new/extended indications, pharmaceutical forms etc. are included in the expression ‘pharmaceuticals’. In principle, the contractor will need to make use of open source/publicly available materials (royalty free-). The system may be extended in the future to non-public sources. The information will be presented to users by way of on-demand access to the overall database of unfiltered information on pharmaceuticals, accessible through a user-friendly inter-face. In addition, the contractor will provide a bi-annual high-impact report containing a general overview of high impact products, derived from the information in the database. Other ways of presentation might be envisaged during the course of the contract. The aim is to identify new pharmaceuticals that are expected to enter the international market within a pre-defined time horizon. Identification should be organised on an international level, as most drugs in development are not country-specific and market authorisation in, e.g., Europe is likely to happen on a European level,
— during the contract, the contractor shall develop, prepare, and submit value engineering change proposals (VECP's). Value engineering is a contractual arrangement that requires the contractor to identify and submit methods to optimise the value and the cost of the contract. The contractor shall attempt to add features that add value and/or eliminate, without impairing essential functions or characteristics, anything that increases acquisition, operation or support costs,
— at the outset, the contractor will develop a minimum viable product, that will be further developed during the course of the contract.
The aim of setting up a horizon scanning system is twofold (see also Annex 1):
— to inform decision makers on emerging and new pharmaceuticals for reimbursement decisions and policy development and on issues that are relevant for the managed introduction and monitoring of pharmaceutical products. This is mostly relevant to national decision-makers and allows for example the facilitation of budget impact, budget planning, early dialogue with industry, price negotiations, health technology assessment, registries, etc. However, the horizon scanning database does not contain information on the member state level, such as national guidelines, patient volumes, etc. It will be up to member states to collect this data themselves,
— to enhance collaboration in selecting relevant issues and pharmaceutical products to collaborate on.
With this erratum, IHSI is uploading the Q&A document and a correcting message to the RFC which replaces the initial RFC.