Central recommendations for a strong health industry in Europe

programmes for promoting start-ups and partnerships in conjunction with the role of coordination and support played by the European Union.

One challenge is posed by the fact that many regulatory areas relating to health and business have up to now been situated on different levels, both nationally (health) and also in the EU (business). Here a coordinated strategy is called for.

Europe has a central function as a reference market and a leading market. More and more decisions are being taken in Brussels, Strasbourg and Luxemburg, decisions which also have a direct impact on the health industry in the EU member states. In the new EU legislative period 2019 – 2024 the health industry should therefore be explicitly recognized and supported as a key industry. For this purpose the BDI has developed concrete recommendations for initiatives and measures designed to strengthen the innovative capacity and strategic independence of the EU in the health sector.

Central recommendations for a strong health industry in Europe

1. Promoting innovation and improving the transfer of knowledge:

▪ Europe requires a coordinated strategy and coherent legislation in the strictly regulated health sector in order to create structures which support the business environment in developing sustainable innovations and in dealing with the process of digital change in the health industry.

▪ We recommend the inclusion of a regular analysis of the effects of

European regulations on innovative capacity in the revised impact assessment procedure of the EU Commission.

▪ The European research area, the EU framework programmes and the

transfer of knowledge between academic and industrial health re-

search should be reinforced in order to facilitate breakthrough innovations in the health industry.

▪ At least 120 billion euros should be provided for the EU research promotion programme “Horizon Europe” (2021 – 2027) in order to make the European ecosystem centred on research and innovation globally competitive.

▪ Based on the model of the IMI structure, a PPP Health and Joint

Undertakings within the framework of Horizon Europe should increasingly integrate partners from the whole of the health industry in addition to the pharmaceutical industry.

▪ We recommend a close involvement by industry in the planned “Digital Europe Programme” in order to create risk-based measures adjusted to the technology in place of uniform blanket solutions in the health industry.

▪ The protection of intellectual property is a key factor in promoting investment in research and development, precisely in the highly innovative field of health-related technologies. Industry should continue to be closely involved in an expansion of this system.

2. Making a success of digitization and cybersecurity in the health industry in Europe:

▪ We recommend a strategy for a “Digital Single Market for Health” (DSM-H) in order to dismantle regulation-induced barriers between the national health markets of the EU member states.

▪ The eHealth Strategy of the European Commission should be equipped with a clear implementation framework with concrete objectives and implementation deadlines in order to accelerate the exchange of health data as one of its goals.

▪ The secure use of data for academic and industrial research should be guaranteed in the interests of patients. This requires the creation of a “European Health Data Space”.

▪ The European Commission should be committed to a legally water-

tight demarcation in anonymising and pseudonymising personal

data in order to promote the exchange of data, for example within the framework of healthcare research.

▪ The European Commission should commit itself to designing a legal

framework for the use of already available data (e.g. for big data

analyses) not only between but also within the EU member states in order to ensure the efficient research and development of innovative therapies.

▪ The interoperability of digital systems in the health sector should be enhanced. This requires a common EU-wide understanding on the mandatory use of international standards and specifications for their implementation.

▪ German industry advocates flexible project groups of interested EU member states for the implementation of innovative services within the framework of the eHealth Digital Service Infrastructure (eHDSI).

▪ In the long term, a Europe-wide uniform solution for trust centres assists in enabling the cross-border exchange of health data.

▪ A successful digitization of the health industry in Europe demands a uniform implementation of the EU basic regulation on data protection and more investment in digital competences.

▪ Medical technology has a special claim to cybersecurity measures. These should be given consideration within the framework of the

“EU Cybersecurity Act” with the active participation of industry in the implementation of the EU medical devices regulation.

3. Smooth implementation of the EU regulations MDR and

IVDR governing medical devices:

▪ In order for industry, especially SMEs, to be able to make comprehensive preparations for the new provisions of the EU medical devices regulations, there is a need for longer transitional periods and speedier state nomination procedures for the bodies designated.

▪ We recommend an active integration of industry and the EU member states in the remaining period leading up to the time when the

EU medical products regulation takes effect in order to avoid any negative impact on the health industry and to prevent bottlenecks in the delivery and supply of medical products.

4. Strengthening interdepartmental cooperation:

▪ We recommend an interdepartmental policy strategy at the European level which makes for enhanced dovetailing between the policy areas of health, research, business, digital and environment.

▪ Tried and tested practices for future evaluations and developments in research and innovations policy should be gathered together within the framework of an interdepartmental European Pharmaceutical and

MedTech Dialogue.