iPAAC Roadmap on Implementation and Sustainability of Cancer Control Actions

Problem: In Germany the nation-wide mammography screening programme (already implemented between 2005 and 2009) is an organized, quality-assured breast cancer screening programme in line with the EU-Guidelines. However, colo-rectal and cervical cancer screening was opportunistic up to July 2019 and January 2020, respectively. In the area of cancer registration, there was a lack of consistent, compatible and valid clinical cancer registry data to evaluate the quality of oncological care.

Objective: The rationale for the legislative initiative was (1) to transfer the former opportunistic screening programmes for cervical and colo-rectal cancer into organized quality-assured cancer screening programmes in line with the EU-Guidelines, at the same time, creating the legal framework for (a) any future introduction of risk-adjusted cancer screening on the basis of valid evidence, (b) any future introduction of organized screening-programmes for other cancer entities on the basis of valid evidence – with explicit reference to existing and future EU-Screening Guidelines. Therefore, any future policy action in the area of cancer screening in Germany should be in line with the EU-Cancer Screening Guidelines; 2) to establish nationwide clinical cancer registries complementing the already existing epidemiological cancer registries. Provision of standardised and valid data for quality assurance and evidence-based and scientific evaluation of routine cancer care as well as research, covering the whole patient pathway (starting at the point of diagnosis).

Implementation status: Fully implemented and ongoing

Key Contextual Factors

Federal Ministry of Health is responsible for policy making at the federal level. Its focus is predominantly on the drafting of bills, ordinances and administrative regulations. The Ministries of Health in the 16 Federal States are primarily concerned with the provision of health care. The Federal Joint Committee (G-BA) is a public legal entity comprising the national organizations of purchasers and providers within the self-governing German healthcare system. Responsible bodies for the Cancer Screening And Registries Act (CSRA):

Federal Ministry of Health: initiation/preparation of CSRA (adopted at the federal level in 2013).
16 Federal States and Federal Joint Committee: Implementation of CSRA and the “Unified Collection and Merging of Cancer Registry Data Act”.

The recommendations of the National Cancer Plan Expert Groups were instrumental in developing the CSRA.

Key Components/Steps

The Cancer Screening And Registries Act (CSRA) was a key initiative of the German National Cancer Plan:

2008: Launch of the German National Cancer Plan: On the basis of a needs assessment the further development of cancer screening and the establishment of nationwide clinical cancer registries were put forward as specific objectives of the National Cancer Plan.
2008-2011: Setting-up of multi-disciplinary Expert Groups on cancer screening and cancer registration (scientific societies, health care providers, patient advocacy groups) within the National Cancer Plan.
On the basis of the recommendations put forward by the Expert Groups, the Federal Ministry of Health developed the legal framework of the CSRA. It came into force on 9 April 2013.
At the federal level and Laender/regional level the CSRA was implemented by way of secondary legislation (guidelines, regulations, contractual agreement, legal acts).
2021: The “Unified Collection and Merging of Cancer Registry Data Act” extended in particular the legal framework created by the CSRA. It came into force on 31 August 2021. The rationale is to exhaust more fully the potential from (epidemiological and clinical) cancer registry data for the benefit of the patients and to further research on cancer care.

Main Impacts / Added Value

The CSRA has been introduced with a view to improving access to organized cancer screening programmes as well as improving their quality and effectiveness. Likewise, now there is nationwide coverage of epidemiological and clinical cancer registries. The registry data will allow consistent analyses of the quality of cancer care.

Lessons Learned

In a federal system formal approaches (e.g. legislation) are effective to implement programmatic public health policy. However, for the formal approaches to succeed, it is extremely important to involve all relevant stakeholders and levels of decision making despite it being a time-consuming and difficult process.

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References and Documentation

Contact

Institution/organization: Federal Ministry of Health, Germany
Department/lead: Inquiries relating to registry data: Division 311 “Medical Databases and Registers” / Inquiries relating to cancer screening: Division 324 “Cancers”
E-mail: 311@bmg.bund.de / 324@bmg.bund.de