4. Strengthening interdepartmental cooperation

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.

▪ 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

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:

▪ 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.

▪ 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.

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