Quis Custodiet? Who's in Charge of Patients' - and Trial Subjects' - Health in Europe?


Applied Clinical Trials

Europe moved one step closer to a passport for physicians in early October.

Europe moved one step closer to a passport for physicians in early October. The European Parliament gave its backing to creating a virtual professional qualifications card that will allow doctors, pharmacists, and other professionals to practice in another EU country. The system also envisages an alert system, so that health professionals barred in one country are barred across the 28 European Union member states, along with some standardization of training.

The intention is primarily to ease mobility for doctors, so helping to fill gaps in parts of Europe where doctors are scarce. But it has implications for patients, and also for trial subjects.

"The updated rules will enable professions keen to accelerate the recognition of their members' qualifications to opt for European professional qualifications cards", explained Bernadette Vergnaud, the French socialist piloting the legislation through the parliament. In theory, it could also help prevent doctors, nurses or childcare specialists convicted of a relevant crime or facing disciplinary action in one EU country from simply jumping to another one. "All EU member states should be informed of such convictions or decisions to discipline a professional within three days", according to Vergnaud's plan.

Already there is some degree of automatic recognition at EU level for doctors, dentists, pharmacists, nurses and midwives. But there is no public database of these professions, incomplete harmonization of qualifications, and no fast-track system for recognition and alerts.

The draft law still has to be formally approved by EU member states. But it has immediately run into opposition on the ever-sensitive question in Europe of languages – where a journey of only 100 km can easily cross three or even four distinct language zones. In response to scares that have arisen in the past with doctors working across borders, national authorities can introduce language controls in the case of professions with implications for patient safety. The safeguards aim to prevent further cases such as that of German doctor Daniel Ubani, who accidentally killed a patient in the UK in 2008 during his first shift there. Linguistic competence was advanced at the time as a contributory factor.

But even with these safeguards, some MEPs have pointed out that there could be unforeseen consequences – particularly for speakers of languages in bilingual areas such as Brussels and the Basque country. The new arrangements oblige a physician to know one of the official languages of the country they choose to work in – but they deal only with official EU languages. So a Dutch-speaking patient – or trial participant – in bilingual Brussels could be confronted with a physician or investigator who speaks only French or German, either of the other two official languages of Belgium. Flemish MEP Mark Demesmaeker said: "There would be no obligation to speak Dutch in order to work in a Brussels hospital, treating patients who may be Dutch speakers. I know from personal experience how difficult it can be for people to be treated by health workers who don't speak their language. That just doesn't make sense and must be changed."

Similarly, a Basque or Catalan who speaks only the regional language could have difficulty in dealing with a physician legally practicing there but who speaks only Spain's official Castilian, as could a Corsican patient or trial participant treated by a French-speaking doctor.

Not everyone is dismayed by the prospect of the new card. The European Alliance for Personalized Medicine has greeted the parliament's move with enthusiasm, particularly its provisions on continuing professional development and training activities, adapted curricula for undergraduates, post-graduates and specialist education, and training systems to provide for inter-professional collaborative practice and produce inter-disciplinary professionals.

But Europe's obstacle course of diverse qualifications and languages remains ready to trip up anyone unwary, and the potential loopholes even in this new system will need to be taken seriously by anyone planning multi-country border trials.

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