Draft EU legislation seeks to bring services under the European standardisation system, with a view to improving their free movement in the single market. Yet in the case of healthcare, such standardisation threatens patient safety, says Dr Konstanty Radziwill.
Konstanty Radziwill is president of the Standing Committee of European Doctors.
"It is in the nature of healthcare that it is a very individualised and specialised service which would put the patient at risk if reduced to a market-oriented technically simplified standardisation.
In past years, healthcare has benefited greatly from an increase in European joint action working towards deeper cooperation between member states. This collaboration has gained all the more importance since the adoption of Directive 2011/24/EC on patients’ rights in cross-border healthcare, which codifies patients’ options to receive healthcare outside their own member state. National healthcare systems are now more than ever expected to fulfil patients’ expectations for coherent quality and safety standards of care, no matter what member state that care is delivered in.
European standardisation has an important role to play in this context. In the field of medicines, for example, it has worked well for many years. In the case of medical devices, efforts to establish standards applicable to all member states’ technology directly contribute to the objective of ensuring equitable and safe care. Similarly, the advantages of eHealth applications can only be fully enjoyed if interoperability between systems based on common standards becomes a reality. National and European standardisation bodies have vital knowledge to contribute to this process.
When it comes to the services provided in healthcare however, a different approach is needed.
Every patient in Europe has the right to receive the care and treatment best suited to his or her specific case. Consequently it is necessary that healthcare services are of a highly individualised nature, while fully respecting norms of technical quality, ethical integrity and professional duty at the same time.
In order to ensure patient safety, regulations governing healthcare professionals’ practice are put in place all across Europe. In order to safeguard that these regulations are developed with the optimal expertise and coherence for each national context, member states are entrusted with this competence. Through national legislation, self-regulation of the professions (often fulfilled by setting professional guidelines, standards and ethical codes), rules governing procedure and substance of professional practice are provided. This ensures that the reference for the highest possible quality of care is enshrined in national legislation and forms an integral part of the healthcare system.
Opening the door to regulating healthcare services through European standardisation bodies would not only infringe this professional and national competence, but would also equate services delivered in healthcare to those pursued in a purely commercial context. The majority of healthcare services are not subject to market forces nor can they be, if equitable and high-quality healthcare is to be safeguarded. Indeed, the European Union has acknowledged this special character of healthcare services by exempting them from Directive 2006/123/EC on services in the internal market.
Similarly, the standardisation of healthcare services by European standardisation bodies may confuse the distinction between services delivered by professionals and qualifications held by professionals to perform that service. This entails the risk of developing provisions which apply in parallel or – worse – in contradiction against Directive 2005/36/EC on the recognition of professional qualifications.
An explicit exemption of healthcare services from the scope of the draft regulation on European Standardisation must therefore be the way forward. The EU institutions are called upon to recognise the need to prevent standards for healthcare services being developed outside the professional and national bodies best placed to perform this task and thus effectively safeguard equitable and high-quality healthcare in Europe.