EU-standards can be useful for healthcare products, however, they do not add any value to health and long-term care services.

Joint press release of the BÄK, DKG, GKV-Spitzenverband and DSV from 12th October 2017

Standardisation of social and health services is increasingly the focus of discussions at EU level. The standardisation of these areas is being driven forward by the private European Committee for Standardization (CEN), an association representing the standardisation bodies of the Member States. At a joint conference in the German Permanent Representation to the European Union in Brussels, the German Social Insurance, represented by the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), the German Hospital Federation (Deutsche Krankenhausgesellschaft) and the German Medical Association (Bundesärztekammer) clearly stated their opposition to European Standards being established for services in the healthcare sector. Under the Treaty of Lisbon, responsibility for social and health systems lies with the Member States. For this reason, it is crucially important for the three institutions to send out a clear message against European standardisation being extended to these services. 

EU standards created by private standardisation violate legal requirements

‘We are strongly against medical services being standardised by private standardisation institutes’, said Georg Baum, Director General of the German Hospital Federation, at a joint information event for health insurance funds, hospitals and doctors. ‘In Germany, quality requirements for the provision of services are set by specific organisations. This includes the members of the plenum of the Federal Joint Committee (G-BA) as well as the medical-scientific community which specifies the clinical requirements for good medicine. EU standards created by private standardisation institutes cannot fulfil this task. Worse still, they violate legal requirements. Therefore, they must not be further advanced using public funds from the EU budget’, stated Baum. 

EU-standards for healthcare services do not add any value

Dr Doris Pfeiffer, Chair of the Board of the National Association of Statutory Health Insurance Funds and representative of the German Social Insurance emphasised: ‘European standardisation can be useful for healthcare products such as medical devices or syringes. However, European Standards do not add any value to health and long-term care services – not to patients, service providers nor the system as a whole. The statutory health insurance funds already invest considerable resources into the quality of care and patient safety. We want to further develop our system in conjunction with the national healthcare service providers. The European Union can help with this by encouraging the Member States to exchange information and experiences about quality and patient safety. It is also important that the EU pursue these goals primarily through its own regulation of medicinal products and medical devices.‘ 

Quality assurance in medical care is based on the principle of evidence-based medicine

Dr Günther Jonitz, Chair of the Quality Assurance Committee of the German Medical Association stressed that personalised, state-of-the-art medical care based on standards for health services is de facto an impossibility. Quality assurance in medical care is based on the principle of evidence-based medicine. ‘Thus, standards for health services, which are mainly developed by non-specialists in private standardisation organisations, do not meet the high requirements demanded by this and are a danger to patient care’, warned Jonitz. The Treaty of Lisbon guarantees EU Member States the right to structure and organise their own healthcare systems in order to reflect the unique circumstances in each country. In Germany, for example, high quality medical care is assured by medical associations and chambers, as is also the case in other EU countries via country-specific structures. ‘We will not allow this right to be undermined by the standardisation of health services via a back door’, stated Jonitz. 

 

The joint press release is also available here.