Recommendations for a strong health industry in Europe

Position

“Recommendations for a strong health industry in Europe”

Bundesverband der Deutschen Industrie e.V.

Stand: 10.10.2019

“Recommendations for a strong health industry in Europe”

Table of contents

The importance of the health industry for Europe ...................................... 3 Central recommendations for a strong health industry in Europe ............ 4 1. Promoting innovation and improving the transfer of knowledge ........ 7 1.1. Promoting the transfer of knowledge between academic and industrial healthcare research ................................................................ 8 1.2. Expanding the EU funding progammes “Horizon Europe”, “Innovative Medicines Initiative” and “Digital Europe Programme” ... 9 1.3.

Protection of intellectual property for innovative research ..... 11

2. Making a success of digitzation and cybersecurity in the health industry in Europe........................................................................................ 12 2.1.

Enhancing data avalilability ........................................................ 13

2.2.

Guaranteeing the interoperability of IT systems ....................... 14

2.3.

Creation of trust centres ............................................................. 16

2.4.

Guaranteeing data protection, IT and cybersecurity ................ 17

3. Smooth implementation of the EU regulations MDR and IVDR governing medical devices ......................................................................... 18 4. Strengthening interdepartmental cooperation .................................... 19 About the BDI ............................................................................................... 21 Impressum .................................................................................................... 21

“Recommendations for a strong health industry in Europe”

The importance of the health industry for Europe On account of its innovative capacity, employment intensity and export strength, the health industry is an important driver of growth and generator of value for Germany and Europe. With its value creation chains ranging from research via production to distribution, the health industry is a key sector for Europe. Its business enterprises develop cutting-edge technology and thus make a crucial contribution to enhanced and more costefficient health care for all patients. The health industry is a source of strength for Europe not only as a centre of knowledge but also as a business location and a place of residence.

The health industry is one of the most research-intensive branches of the economy in Europe and is a key player in driving the European innovation agenda and the goals for the knowledge economy. On average, the pharmaceutical and biotechnology industry invests 16 percent of its sales revenues in research and development (R&D) in Europe.1 In the year 2017 there were more than 13,090 patent applications of medical technologies and around 6,300 patent applications each for pharmaceutical and biotechnological products in Europe.2 Thanks to the high level of research and development in the health sector there is a constant flow of innovations. In addition, the creation and growth of life-science clusters are promoted by small and medium-sized structured enterprises (SMEs) in the fields of medical technology, information and communications technology (ICT), biotechnology, “big pharma” and their partnerships with universities and research centres.

Apart from its economic footprint, the health industry also makes a positive social contribution to Europe. A major role is played by issues relating to education and employment. The medical technology industry records more than 675,000 directly employed persons in Europe and in the pharmaceutical industry the figure is more than 750,000.3 The pharmaceutical industry makes an indirect contribution of as many as 2.5 million jobs in Europe.4 Europe benefits from unique conditions providing it with the capacity to play a leading role internationally in health care. Examples of this are the well developed healthcare systems, excellent performance from expert medical personnel, well developed infrastructure, academic networks along with medical and scientific training, a leading role played by the health industry, high investment in research and development with a broad range of EFPIA – Annual Report 2018: https://www.efpia.eu/media/412957/efpia-2018-annual-report.pdf and EuropaBio – Biotechnology Industry Manifesto 2019: https://www.europabio.org/sites/default/files/Biotechnology%20Industry%20Manifesto%202019.pdf 2 MedTech Europe – Facts and Figures 2019: https://www.medtecheurope.org/wp-content/uploads/2019/04/TheEuropean-Medical-Technology-Industry-in-figures-2019-2.pdf 3 ibid.

4 EFPIA / PwC – Economic and societal footprint of the pharmaceutical industry in Europe June 2019: https://www.efpia.eu/media/412939/efpia-economic-societal-footprint-industry-final-report-250619.pdf 1

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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.

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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.

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The European research area, the EU framework programmes and the transfer of knowledge between academic and industrial health research should be reinforced in order to facilitate breakthrough innovations in the health industry.

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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.

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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.

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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.

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▪

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.

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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”.

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The European Commission should be committed to a legally watertight demarcation in anonymising and pseudonymising personal data in order to promote the exchange of data, for example within the framework of healthcare research.

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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.

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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.

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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).

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

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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.

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Medical technology has a special claim to cybersecurity measures.

These should be given consideration within the framework of the

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“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.

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1. Promoting innovation and improving the transfer of knowledge We need a reliable framework environment in Europe that both promotes and protects innovation. Small, medium-sized and large business enterprises require sufficient planning security with regard to the regulatory setting before they invest in developing new active agents and products.

Against the background of increasing international competition, the EU should create a coherent legal framework in order to dismantle obstacles to innovation. It is necessary to support a speedy conversion of peak scientific achievements into their economic exploitation and industrial competitiveness.

That is why Europe needs a coordinated strategy to create structures that support the corporate environment in developing sustainable innovations and the digital change in the health sector and facilitate both the founding of startups as well as the growth of existing enterprises. At the same time, there is a need for coherent legislation in the strictly regulated area of health. What is urgently required is close cooperation between the EU member states and for uniform standards to be set that are globally competitive. Only by acting jointly can Europe continue in the future to remain globally competitive.

Any effective implementation of innovations in medicines, therapies and medical products requires the legally regulated reliability of market access mechanisms (see 1.), the transfer of knowledge between academic and industrial health research (see 1.1.), a balanced system of promotion measures (see 1.2.) along with the protection of intellectual property (see 2.3.).

In addition, we recommend the implementation in full of the innovation principle throughout the whole policy cycle, from evaluation to implementation, of all European provisions that have an effect on the health industry.

An important step on the road to achieving this goal is the inclusion of a regular assessment of the impact of European regulations on innovative capacity within the revised impact assessment procedure of the European Commission, including the implementation of legal provisions and delegated legal acts.

Central recommendations: ▪

Europe needs a coordinated strategy and coherent legislation in the strictly regulated health field in order to create structures that support the business sector in developing sustainable innovations and dealing with the digital change in the health industry.

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▪

1.1.

We recommend the inclusion of a regular assessment of the effect of European regulations on innovative capacity within the revised impact assessment procedure of the EU Commission.

Promoting the transfer of knowledge between academic and industrial health research

It is necessary to remove the structural obstacles to innovation in Europe and to support innovative and collaborative ecosystems on a wider scale. This applies especially to science-driven sectors in which academic and private cooperation is decisive.

Apart from the research itself, the greatest barrier lies in the transfer of knowledge between research institutes and the private sector. Good basic research leads far too rarely to the founding of companies or to the development departments of large enterprises. To a large part this is due to the conditions for venture and growth capital, which in Europe are less than attractive. Start-ups, which in many areas are the drivers of innovation, find that this curbs them in their growth and curtails their ability to develop rapidly and in a focused manner. The issue of funding is particularly critical in the biotech and medical products industry, where there is a great number of smaller enterprises and start-ups which were founded on the basis of a single innovative molecule or medical product or on account of a new mode of action.

The Europe-wide networking of health research and the development of European research infrastructures promote progress in medicine. That is why it is important to strengthen the European Research Area (ERA) and to integrate it more closely with national research and innovation systems. The successes to date of the EU framework programmes for research and of the ERA should be continued, e.g. the European Research Council (ERC), the opening up of Europe-wide career opportunities, the networking and cooperation of research institutes along with the strengthening of highly promising research regions in Europe.

Furthermore, the European Commission should conduct a review of the Clinical Trials Regulation (CTR) issued in 2014 with a view to ascertaining whether it is still suitable as the basis of the most modern health research.

Illnesses know no borders. That is true of fatal epidemics such as Ebola as well as the worldwide spread of antibiotic-resistant pathogens or the rising number of diabetes sufferers. Only an internationally networked engagement can overcome these challenges. For this reason the existing competences in academic and industrial health research should be merged in interdisciplinary European research associations.

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Central recommendation: ▪

1.2.

The European Research Area, the EU framework programmes and the transfer of knowledge between academic and industrial health research should be strengthened in order to permit breakthrough innovations in the health industry.

Expanding the EU funding programmes “Horizon Europe”, “Innovative Medicines Initiative” und “Digital Europe Programme”

So far Europe has not made sufficient use of its innovative potential and should step up its pace in order to maintain its position as an important global hub for investment in life-science, research and development and digitization.

For this reason an upgrading of the EU support programmes in the areas of research and development, health and digitization is absolutely essential.

As a central instrument of European research and innovation promotion, the new EU framework programme “Horizon Europe” (2021 – 2027) is intended to make an important contribution to closing this innovation gap. If this objective is to be achieved, the programme should become more industry-friendly and support innovations with market-oriented innovation promotion instruments such as public-private partnerships. The political decisionmakers should press ahead with central key technologies such as artificial intelligence (AI) by making sufficiently protected data available and at the same time permitting unbureaucratic access to the programmes. A high level of participation by industry and early integration is decisive for success. It is only industry that converts basic research and good ideas into genuine innovations.

In order to continue to be globally competitive in key technologies and strategic value creation chains, the EU should support a greater readiness for risktaking and increase its investment in research and innovation. The 100 billion euros proposed by the European Commission for Horizon Europe (2021 – 2027) are not sufficient. At least 120 billion euros should be allocated into order to close the innovation gap.5 This financial incentive provided by the public purse is the key to attracting private funding for investment in research and innovation.

One of the key elements of “Horizon 2020” in relation to health research is the “Innovative Medicines Initiative” (IMI). IMI is the worldwide biggest public-private partnership (PPP) in the health sector with a total budget (IMI 1 and 2) of 5 billion euros, funded in equal shares by the European Union and the European pharmaceutical industry (represented by EFPIA6). The goal of IMI is to enable open cooperation between the public and private sectors in

BusinessEurope Position paper “Research and Innovation in the New European Cycle” (September 2019): https://www.businesseurope.eu/sites/buseur/files/media/position_papers/iaco/2019-09-09_position_paper_research_and_innovation_in_the_new_eu_political_cycle.pdf 6 EFPIA: European Federation of Pharmaceutical Industries and Associations 5

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research. The aim is to press ahead with the development of and the access of patients to innovative medicaments, therapies and products, especially in areas where medical need has so far not been met.

While IMI has been supporting cooperation between pharmaceutical enterprises for more than 10 years, we recommend that in future the integration of partners from other industries should also be advanced. Along the lines of the IMI structure and the ECSEL partnership7 for the microelectronics sector, a PPP Health should reflect the entire range of the health industry. Solutions for the health-related challenges with which our society is confronted do not simply lie within one single branch of industry. The future is patient-centred and patient-integrated with an important role for digital technologies.

The rapid development of key technologies puts the European Union under tremendous competitive pressure. This emerges particularly clearly in the AI area. Simply by consistently focusing on AI, Europe could boost its economic performance by the year 2030 by 2.7 trillion euros or by 19 percentage points.8 And AI is only one of many digital future technologies which enterprises in Europe and around the world will transform into successful business models in the coming years and make use of to solve current social and economic challenges. The economic potential of a deeper digital single market is estimated to lie around up to 415 billion euros annually.9 So far, however, this is not reflected in public funding measures. In the next few years the Federal government aims to invest 3 billion euros in the framework of its AI strategy. The commitments envisaged by the EU are on a similar scale. But that will not be enough to catch up with the world leaders. By way of comparison: over the next eleven years China will support AUI research with 150 billion dollars and a research-friendly research policy.

The European Commission is currently planning the “Digital Europe Programme” which provides for direct investment to the tune of a total of 9.2 billion euros for the application of innovative digital technologies in five key areas: supercomputing (2.7 bn. euros), artificial intelligence (2.5 bn. euros), cybersecurity (2 bn. euros), advanced digital capabilities (700 million euros) and the guarantee of a broad use of these digital technologies in industry and society in accordance with the European sustainability goals and values (1.3 bn. euros). We recommend major participation by industry in order to make a success of the programme.

It is important that European policy does not allow itself to be bounced into regulatory uniform solutions (“one size fits all”). For example, on account of their graver consequences for the consumer in the case of incorrect decisions, medical AI applications must be treated differently than, for example, the AIbased optimization of production processes. Europe needs a regulatory

7

ECSEL Joint Undertaking: Electronic Components and Systems for European Leadership BDI (2019): https://bdi.eu/themenfelder/europa/which-europe/ 9 ibid.

8

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framework that is open to innovation and minimizes risk but does not block opportunities.

Central recommendations: ▪

At least 120 billion euros should be allocated for the EU research programme “Horizon Europe” (2021 – 2027) in order to make the European eco-system for 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 close participation by industry in the planned “Digital Europe Programme” in order to create risk-based measures adjusted to technology instead of uniform solutions in the health industry.

1.3.

Protection of intellectual property for innovative research

The protection of intellectual property is the key to creating an innovationdriven economy and to strengthening Europe as a research location. Research into and the development of new medications, therapies and medical products always go hand in hand with major risks of failure, high levels of investment and lengthy periods of development. In the case of every research approach it is initially not clear whether it will be successful.

In order to create incentives for such risky investment, there is a need for a protection of innovation through statutory protective mechanisms until innovations also become available to competitors at a later date. When patents are granted, companies are simultaneously obliged to publish certain results, to share them and make them publicly accessible. This social contract for the good of patients, society and industry should be reflected in sound statutory provisions and their enforcement for the health industry.

In order for the health industry to continue to be able to bring considerable added value for the European Community it is essential that the legal and regulatory environment promotes innovation and growth. The EU has already laid the necessary foundations by the introduction of patent protection incentives (IP incentives), e.g. supplementary protection certificates (SPCs), licensing exclusivity, regulatory data protection (RDP), exclusivity for orphan drugs and paediatric rewards.

Patent protection incentives, rapid market access and the immediate refunding in the case of market availability are the most important factors affecting investment decisions on research and development. Additional IP incentives could support and accelerate the development of new therapeutic approaches – for example, in the fields of gene technology, oncology and psychological disorders. Any cutback in the present incentive model would have a negative impact on the research-based investment activity of www.bdi.eu

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the health industry in the EU. That is why the current system of patent protection incentives should be retained. The EU should ensure fair and internationally competitive systems for the protection of intellectual property in order to attract investment and promote innovations. Any expansion of the existing system of the protection of intellectual property should take place in close coordination with industry.

Central recommendation: ▪

The protection of intellectual property is an important factor in promoting investment in research and development particularly in the highly innovative field of healthcare technologies. Industry should continue to be closely involved in any expansion of this system.

2. Making a success of digitization and cybersecurity in the health industry in Europe The current digital transformation is also revolutionizing the health sector.

New technologies in the health system permit better and more efficient medical care. Electronic health services form an essential component of the strategy of the European Commission for the digital single market.

Their development within the EU takes place on the basis of the measures set out in the action plans of the European Commission for electronic health services and in the eHealth strategy of 2018.10 Although the eHealth strategy 2018 touches upon new challenges such as the introduction of the EU general data protection regulation (EU-GDPR) and threats to cybersecurity, nonetheless this strategy contains no concrete implementation plan with binding time limits.

In order to remove regulatory-induced barriers between the national health markets of the EU member states we recommend a strategy for a “Digital Single Market for Health” (DSM-H). This should be rapidly implemented by means of a uniform legal framework and increased investment in digital infrastructures. For example, a common European infrastructure allows its citizens cross-border and safe access to their health data as well as to high-quality digital health services. Moreover, a DSM-H makes it possible for researchers and other specialists to pool resources (data, expertise, data processing and storage capacities) in the whole of the EU, for example in order to make advances in personalized medicine.

Improving health care demands the exchange of health data while taking proper account of personal privacy and data protection. Only with appropriate and robust data networks can innovation develop its full force. For this reason there is an urgent need for a uniform and innovation-oriented legal framework in the whole of Europe. The safe use of data for academic and industrial research should be guaranteed for the benefit of patients.

10

Communication from the European Commission (COM(2018) 233) on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society ( 25th April 2018): https://www.eca.europa.eu/Lists/ECADocuments/SR19_07/SR_HEALTH_CARE_DE.pdf

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This requires the creation of a “European Health Data Space”, which is also envisaged in the Mission Letter 11 to the new EU Commissioner for Health.

Central recommendations: ▪

We recommend a strategy for a “Digital Single Market for Health” (DSM-H) in order to eliminate regulatory-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 enforcement framework with concrete goals and implementation periods with one of its objectives being to accelerate the exchange of health data.

▪

For the good of patients, the secure use of data for academic and industrial research should be guaranteed. This also requires the creation of a “European Health Data Space”.

2.1.

Increasing data availability

Data availability and data use are the basic preconditions for the research and development of digital medical therapies and products. The health industry should be in a position to make use of personal health data from both outpatient and inpatient care as well as from statutory health insurance schemes in order to acquire new findings about efficient methods of treatment and ensure better care.

The health industry therefore recommends that there should already be at national level a legally defined framework for the use of personal health data for research purposes. Digital, data-based health care will only develop when legally watertight opportunities exist to process data for research purposes apart from the original reason why the data was collected.

The EU GDPR already makes many special privileges available for scientific research, especially in cases of the further processing of personal data for these objectives. The aim now must be to implement this conception at all levels in order to take full account of the wishes of the regulatory authority.

Furthermore, the European Commission and the EU member states should provide a binding definition of when there is no longer any reference to actual persons in health data. A uniform regulation governing anonymising and pseudonymising personal health data for extended purposes is therefore absolutely imperative. Some countries, for example, see pseudonymized data within the framework of clinical trials as anonymized data. In Germany

11

Mission Letter Stella Kyriakides: https://ec.europa.eu/commission/sites/beta-political/files/mission-letter-stellakyriakides_en.pdf

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data protection insists that all pseudonymized data are still personal data or are potentially so. Here there is a need for uniform provisions.

The European Court of Auditors also takes the view that there is a need for a clear strategy and implementation framework supported by the EU member states in order to create mechanisms for the Europe-wide exchange of patient data. In the process clear objectives should be set out and performance regularly monitored. Furthermore, conclusions should be drawn from previous pilot projects in the health area.12 Amongst other countries, Estonia and Croatia are considered to be positive examples. These countries implement European regulations in such a way that, for example, clinical-genomic data bases can be created with wide-ranging access rights.

The European Commission should continue to advocate the devising of a legal framework for the use of data already available (including within the framework of big data applications) between but also within the EU member states themselves in order to ensure efficient research and the development of innovative therapies.

Central recommendations: ▪

The European Commission should commit itself to a legally secure 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 be committed to the devising of a legal framework for the use of already existing data (e.g. for big data analyses) between but also within the member states in order to guarantee efficient research and the development of innovative therapies.

2.2.

Safeguarding the interoperability of IT systems

Apart from long-term planning security (also financially) for innovators, in order to ensure the necessary attractiveness of a location there must also be the preconditions for a networking capability and connectivity of IT systems across sectoral and national borders. Uniform data formats and software interfaces are a basic precondition for interoperable systems.

Only by means of a high degree of interoperability can the potential of IT in the health system be exploited in the best possible way in the interests of better health care. At the same time it remains true that industry and further stakeholders affected should jointly define corresponding uniform data formats and software interfaces – this is not the job of the legislative authority.

European Court of Auditors: Special report: “EU actions for cross-border health care” (2019): https://www.eca.europa.eu/Lists/ECADocuments/SR19_07/SR_HEALTH_CARE_DE.pdf 12

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Of particular importance are the infrastructural framework conditions for the electronic cross-border exchange of data. The electronic exchange of data between all areas presupposes that the communication procedure is as uniform and transparent as possible. The basis is provided by longstanding and internationally recognized standards and norms which are jointly developed and published in a defined process with the inclusion of all participants. All participants in the health system should jointly describe efficient, intersectoral, interoperable processes and technical specifications on the basis of international norms, for example within the framework of an interoperable electronic patient record.

In no EU member country alone can access to structured data sets be generated in sufficient numbers. In order to combine these data sets across national borders, medicine requires a clear, generally accepted and widespread terminology such as SNOMED CT (Systematized Nomenclature of Medicine). Without such a terminology system there can be no efficient, interoperable communication, no reliable access to and no reliable analysis of all important patient data, neither within the European Union nor throughout the world. This applies to research and care purposes in which both the scientists and the health industry have a special interest. An EUwide mutual understanding on the mandatory use of international standards and of the funding for their use in all EU member states is necessary. The recommendations of the European Commission for the specifications of an Electronic Health Record are an example of this.

At present the European Commission, together with the member states, is constructing an EU-wide voluntary eHealth Digital Service Infrastructure (eHDSI) in order to enable the exchange across national borders of patient health data, in particular of electronic prescriptions and patient records. In order to promote the development of the eHDSI, there should be greater efforts to advance innovative services in various groups of EU member states, with this to be coordinated by a “leading nation”.

Central recommendations: ▪

The interoperability of digital systems in the health sector should be enhanced. This requires an EU-wide common 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.

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2.3.

Creating trust centres

Health data in particular is an area which calls for an exceptionally high level of protection. The responsible handling of data, the protection of privacy rights and the guarantee of IT security are therefore indispensable.

A 2016 survey carried out by TNS Infratest revealed that 61 percent of all Europeans would be willing to make their anonymized data available for research purposes.13 However, this is hardly possible on account of the purpose-related restrictions governing consent to data processing within the framework of the EU GDPR. In a first step the EU member states should collect health data in accordance with a standardised approach. This data could subsequently be placed at the disposal of a socalled trust centre.

A trust centre links health data from several heterogeneous and geographically dispersed data sources and conducts a structured processing into large data sets. In addition, a trust centre offers services with regard to data quality, data processing and the data management of health data and makes them available in high quality for use. This makes it possible for the health industry and other research institutions to make use of high-quality, structurally processed and up to date health data for research and development.

Technologically, many deployment models and platform services are possible for implementing a trust centre. Yet all this is currently not possible on account of diverse barriers, although it could be technologically realisable.

In the long term a Europe-wide uniform solution for trust centres is desirable in order to accelerate and expand cross-border access to data. However, in order for this to be achieved, separate data collection systems should be better coordinated and their data sets harmonised. Here close cooperation among the EU member states is crucial. A European campaign to boost the readiness of citizens to make their data available can provide additional support for this project.

Central recommendation: ▪

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

13

TNS Infratest (January 2016): https://www.vodafone-institut.de/wp-content/uploads/2016/01/VodafoneInstitute-Survey-BigData-en.pdf

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2.4.

Ensuring data protection, IT and cybersecurity

There is a growing debate about the advantages and disadvantages of accessible patient and care data for the individual and society. That is why it is becoming more and more important to inform the public about the form a responsible handling of data would take and what kind of patient services and social services can result from it. Data protection, IT and cybersecurity are major challenges which all players in the health sector must step up to meet. People will only consent to data-based health care when their privacy rights are not endangered. Data protection is important but must not be a spur to holding back research and innovation designed to be beneficial to society. The European Commission should therefore ensure a uniform implementation of the EU GDPR in all EU member states.

Cyber threats to health data are growing. In order to speed up the successful digitization of the health industry in Europe, the new European Commission should ▪

coordinate a European reaction to the growing threat from organised, in some cases state-funded, cyber espionage and cybercrime,

▪

within the framework of the “EU Cybersecurity Act” and with the active participation of industry take account of the specific productgroup requirements for medical products (e.g. insulin pumps, heart pacemakers, OP technology) in the implementation of the EU regulation on medical devices,

▪

encourage the EU member states to invest in digital capabilities in order to close the current capability gap in natural sciences, technology and mathematics,

▪

encourage the EU member states to pursue a coordinated European approach for the expansion of 5G networks in order to obtain the strategic advantages that this new technology can bring to the whole of the European economy. Here the BDI points to its general demands relating to the security of data, services and networks in the 5G area.

Adherence to these requirements is also essential for the health industry.14

Central recommendation: ▪

The successful digitization of the health industry in Europe requires the uniform implementation of the EU General Data Protection Regulation and greater investment in digital competences.

BDI: „Daten-, Dienste- und Netzsicherheit im Bereich 5G“ (25.02.2019): https://bdi.eu/media/publikationen/#/publikation/news/daten-dienste-und-netzsicherheit-im-bereich-5g/ 14

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▪

Medical technology has a special claim to cybersecurity measures.

This should be taken into account within the framework of the “EU Cybersecurity Acts” in the implementation of the EU medical devices regulation and with the active participation of industry.

3. Smooth implementation of the EU regulations MDR and IVDR for medical devices The health industry welcomes the goals of the new EU regulations for medical devices (MDR) and in vitro diagnostics (IVDR) directed at achieving greater patient safety and assured-quality access to innovations in medical technology. In order for industry, particularly SMEs, to be able to make comprehensive preparations for the new regulations, there is a need for open and transparent communication for implementing the regulations.

As a result of MDR and IVDR, there are major changes to the demands placed on market access to medical devices. The intention is for patients to benefit from innovative, high-quality products. For this to be guaranteed, there must be an end to the current legal uncertainty resulting from a lack of implementation instruments as well as a deficiency in the number of competent certification institutions (socalled notified bodies).

The hesitant implementation of the MDR by the EU Commission and member states, in particular the continuing inadequate notification of the notified bodies (so far only 5 out of 58 bodies have been notified, as of October 2019), is impeding preparations for the new requirements to be taken by the manufacturers of medical devices. Policy-makers are urgently requested to take the corresponding necessary measures to make it possible for enterprises to carry out timely implementation. On no account must neither patients nor manufacturers be the ones to suffer from planning errors by the authorities.

With the application of the MDR from May 2020 and the IVDR from 2022 small and medium-sized enterprises are threatened with stranding on excessive bureaucracy. The additional efforts for documentation and the increased demands require a substantial amount of additional personnel and thus cause higher costs. In order to secure their livelihoods, SMEs will have to withdraw from the market products with low turnover, especially niche and specialized products. In future, users (hospitals, doctors, dentists, laboratories) will have to go without this much appreciated product variety.

In some cases there will be a lack of suitable products for special indications. Opportunities should be created for these products to continue to hold their place in the market.

The regulatory requirements are very complex. The health industry criticizes the speed in applying the “Implementing & Delegated Acts”, which results in the necessary guidance documents being missing. Unclear procedure processes mean major legal uncertainty for industry. That is why a speedier implementation of the most important elements is necessary.

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We recommend active integration of industry and the EU member state in the remaining period before the date of application of the MDR and IVDR in order to avoid any negative impact on the SMEs of the health industry and bottlenecks in the supply of medical products. Pragmatic steps for implementing the new regulations should be taken so that industry can make comprehensive preparations for the new regulations. This requires speedier state notification procedures for the certification bodies and substantially longer transitional periods.

Central recommendations: ▪

In order for industry, in particular SMEs, to be able to fully prepare for the new provisions of the EU medical devices regulations, there is a need for longer transitional periods and faster state notification procedures for the notified bodies.

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We recommend the active integration of industry and the EU member states in the remaining period up to the date of application of the EU medical devices regulation in order to avoid negative effects on the health industry and bottlenecks in the delivery and supply of medical products.

4. Strengthening interdepartmental cooperation The health industry is a highly regulated and complex branch which is affected by many areas of public policy. Governments should devise their health policy targets on the basis of a holistic approach (health in all policies) and expand them into all policy areas. A sustainable Europe can only be successful if industry policy can be harmonized with social, digital and ecological objectives. In line with this approach, health aspects should be integrated into all publicly funded programmes.

A universal and non-discriminatory access to health care should be achieved (universal health coverage) by means of a cross-thematic, interdisciplinary and intersectoral consideration of all health aspects (such as the One Health approach) in conjunction with the adequate funding of health systems. This concerns all areas of patient care, ranging from prevention and diagnostics via treatment and rehabilitation up to aftercare.

In future we will continue to need a sustainable research and innovation policy which supports academic excellence, inventiveness and entrepreneurial courage. This will entail the strategic interlocking of the policy areas of industry, research and science, health, digitization and environment.

Against this background the health industry recommends a greater degree of an interdepartmental policy strategy at the European level.

So far we see little or no progress in the increased coordination that was announced between the various directorates general of (DGs) the European Commission. An innovation-friendly environment goes beyond a strict “silo mentality” and requires the coordination of several departments. The

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new European Commission should set up the right organizational structures within the Commission in order to ensure good coordination between the various DGs and with the member states. The merging of the topics of medical products from the DG GROW (internal market, industry, entrepreneurship, SMEs) into the GD SANTE (health and food safety) was a first important step.

The BDI calls for greater internal administrative cooperation between the competent directorates general of the European Commission, especially in the areas of health (DG SANTE), research (DG RTD), industry (DG GROW), digital (DG CONNECT) and environment (DG ENV). We suggest a consultation process of the EU Commission focusing on an interdepartmental strategy of the European Commission for strengthening the health industry with which the goals of the new European Commission in the health area can be supported.

In the discussion on a European benefit review (Health Technology Assessment, HTA), the health industry considers it necessary that such a process should lead to an genuine simplification of procedures and does not impose any additional burdens on the health industry. 15 We would like a complete understanding to be developed of what is required in order to achieve success as an innovator and of what obstacles stand in the way of entrepreneurship. That is why the health industry also advocates a regular exchange with players in the public and private sector covering the whole spectrum of research and science, SMEs and large multinational corporations. Within the framework of a European pharma and medtech dialogue we wish to gather together proven practices in research and innovation policy in order to promote acceptance both at the level of the member states and at the European level.

Central recommendations:

15

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We recommend an interdepartmental policy strategy at the European level which provides a better dovetailing of the policy areas of health, research, industry, digital and environment.

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Within the framework of an interdepartmental European pharma and medtech dialogue, there should be a compilation of proven practices for future evaluations and developments in research and innovation policy.

The BDI is currently working on its own position paper on the EU-HTA.

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About the BDI The BDI conveys the interests of German industry to the various policy-makers responsible. In this way it supports German business enterprises in global competition. It has at its disposal an extensive network in Germany and Europe in all important markets and in international organisations. The BDI ensures the political back-up needed for opening up international markets. It also offers information and economic policy advice for all topics relevant to industry. The BDI is the umbrella organisation of German industry and of industry-related service providers. It speaks for 40 trade associations and more than 100,000 enterprises with around 8 million employees. Membership is voluntary. Its 15 offices in the federal states represent the interests of industry at regional level.

Impressum Bundesverband der Deutschen Industrie e.V. (BDI) Breite Straße 29, 10178 Berlin www.bdi.eu T: +49 30 2028-0 Contacts Felix Esser Head of Industrielle Gesundheitswirtschaft Department Telephone: +49 30 2028 1495 f.esser@bdi.eu Antonia Menzel Referentin Industrielle Gesundheitswirtschaft Telephone: +49 30 2028 1790 a.menzel@bdi.eu BDI document number: D 1097

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