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New Innovation Fund for the German Healthcare Market

A New Entry Pathway for Innovative Medical Devices?

According to section 92 of the law to strengthen healthcare services under the statutory health insurance (SHI healthcare strengthening act - SHI VSG), enacted by the German Bundestag on June 11, 2015, the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) wishes to encourage new forms of healthcare that go beyond the current standard of care. To do so, it plans to establish an 'Innovation Fund', which will provide funding for particular projects. Such projects should improve cross-sectoral healthcare services and present sufficient potential to be incorporated permanently into the healthcare system.

The Fund

The innovation fund may spend up to €225M annually from 2016 to 2019, in addition to €75M annually, which are allocated to project evaluation.

The Federal Insurance Office (Bundesversicherungsamt) will collect and manage the Innovation Fund, and allocate funding based on the decisions of the Innovation Committee (Innovationsausschusses), which will be formed by the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) by January 1st, 2016.

Innovation Committee

The Innovation Committee will include the following members:

  • 3 representatives of the association of the statutory health insurance sickness funds (GKV-Spitzenverband).
  • 1 representative of the federal association of statutory health insurance physicians (KBV).
  • 1 representative of the federal association of dentists (KZBV).
  • 1 representative of the German hospital federation (DKG).

An impartial chairman of the Federal Joint Committee (G-BA) as well as two representatives of the Federal Ministry of Health and a representative of the Federal Ministry of Education and Research. Patient organizations, with no voting rights, will be consulted with.

The innovation committee will be assisted by an Expert Advisory Group, consisting of up to 10 representatives of science and healthcare practice appointed by the Federal Ministry of Health. The Expert Advisory Group will:

  • Make recommendations for the issuance of calls for proposals,
  • Carry out short assessments of applications for funding,
  • Provide recommendations to assist the Innovation Committee in its funding decisions.

Who may apply?

Although an application for funding should typically involve a health insurance company, applicants for funding can also be independent physicians, approved medical centers, approved hospitals, state hospital associations, physicians' associations, pharmaceutical companies, medical device manufacturers and patient organizations.

Funding criteria

In order to be eligible for funding, suggested projects should be scientifically evaluated and demonstrate in particular:

  • Improvement of the quality and efficiency of providing healthcare services,
  • Elimination of supply shortages,
  • Optimization of the cooperation within and between different areas of care, utilities and professional groups,
  • Interdisciplinary and multidisciplinary care models,
  • Transferability of knowledge, in particular to other regions or indications,
  • Proportionality of implementation costs and benefits,
  • Evaluability.

Next steps

Medical device manufacturers, who believe their technology could impact the quality and efficiency of healthcare services in the German market, should prepare a dossier, demonstrating their product's benefits and approach relevant German health insurance funds in order to explore potential collaborative projects.

Mediclever can assist by preparing the required dossier and leveraging its contacts in the German healthcare market to introduce you to the appropriate decision makers within the relevant health insurance funds.

For more information about the Innovation Fund or in order to coordinate a call or a meeting with our consultants, click here.