A proposed Common Training Framework for Specialists in Laboratory Medicine under EU Directive 2013/55/EC (The Recognition of Professional Qualifications)

1 Setting the scene

It has been estimated that up to 70% of all medical decisions are based on data and information provided by laboratory medicine [1], [, 2]. It is the speciality that underpins modern medicine’s understanding of health and disease. Its disciplines include clinical chemistry/immunology, haematology/blood transfusion, microbiology/virology/ parasitology, reproductive medicine, and genetics. Its contributions include screening for the early detection of disease, differential diagnosis, monitoring, management and treatment of patients, and their prognostic assessment. This contribution continues to grow through research and development, technological advances, and the increasing knowledge and skills base of its specialist practitioners.

The estimated 30,000 specialists in laboratory medicine across the European Union (EU) include medical (∼40%), scientific (∼30%) and pharmacy (∼30%) trained staff [3]. Whilst specialists with a medical background have long enjoyed automatic recognition of their qualifications during cross-border professional migration as one of seven “sectorial professions” identified in EU Directive 2005/36/EU [4] the same is not true for the 60% of scientific and pharmacy-trained specialists under the “general system”. However, through its amendment of the 2005 directive, Directive 2013/55/EU (The Recognition of Professional Qualifications) [5] the European Union:

• Provides opportunities for the mutual recognition of qualifications for the estimated 600 professions in the “general system” which in turn,

• Helps catalyse a more rapid and equitable distribution of human resource and services across the Union,

• Supports individuals seeking unhindered professional migration across EU borders,

• Identifies unique professional contributions that in turn can help obviate the need for “compensation measures” in which Member States impose, for example, re-training, new qualifications, aptitude tests, and adaptation periods on each others’ professionals which may needlessly delay and deter migration.

Recognising that safeguards need to be in place to ensure the health and safety of consumers (for example, patients in the case of healthcare) is protected when professionals migrate to a host/receiving state the 2013 Professional Qualifications Directive allows Member States to decide on a common set of minimum knowledge, skills and competences that are needed to pursue a given profession through a Common Training Framework. To be adopted the framework must combine the knowledge, skills and competences of at least one third of the Member States. Professionals who have gained their qualifications under a Common Training Framework will be able to have these recognised automatically without further ‘compensation measures’ being imposed.

Proposing the recognition of specialist practitioners in laboratory medicine is commensurate with the European Federation of Clinical Chemistry and Laboratory Medicine’s (EFLM) role and contribution in ensuring equitable, high quality, safe services for patients across the European Union’s single market. In 1998, EFLM’s forerunner organisation, the European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) established an Equivalence of Standards amongst the EU Member States based on education, training, qualifications, continuous professional development and professional conduct that it considered commensurate with the role of a European Specialist in Laboratory Medicine (EuSpLM) [6]. Individuals able to meet the standards are invited to join EFLM’s Register of specialists [7]. The Equivalence standards together with the expected knowledge, skills and competencies for practicing at specialist level form the backbone of a proposed Common Training Framework which is outlined here. In setting the scene for the proposed framework an overview is first provided of specialists’ unique contributions and their demographic profile in relation to further stipulations laid down by the 2013 Professional Qualifications Directive for example on regulation status and adoption of professional titles. The proposed Common Training Framework represents EFLM’s position statement and offers the EU Member States a template for submission to the EU Commission.

2 The contribution of specialists in laboratory medicine to better health and best care

3 The demographics of the profession

Information provided by 26 national societies who are members of EFLM indicate that pharmacists and scientists are the majority specialist practitioners in 15 EU Member States. Medical staff predominate in Austria, Belgium, Bulgaria, Denmark, Germany, Greece, Hungary, Ireland, Latvia, Malta and Sweden. Whilst pharmacists predominate in France, Portugal and Spain, scientists predominate in Croatia, Cyprus, Czech Republic, Estonia, Finland, Italy, Lithuania, Netherlands, Poland, Romania, Slovenia and Slovak Republic. There are reportedly no non-medical specialists practitioners in Malta and Austria. In collating the demographic information no response was received from Luxembourg.

The scope of non-medical practice is outlined in Table 1, the unique role that distinguishes non-medical specialists from their medical colleagues in many Member States is the latter’s provision of direct clinical care. It is estimated that over 80% of practitioners working in the Union at specialist level are able to meet the polyvalent scope of practice in clinical chemistry, haematology, and microbiology [3] set by EFLM’s Equivalence of Standards.

Table 2 highlights that EFLM’s Equivalence of Standards can be met in 19 of the EU’s 27 Member States. In 15 (53% of EU Member States) of these the profession or specialist training is regulated at government level, a pre-requisite to proposing a Common Training Framework. The table also highlights the professional titles that would benefit from automatic recognition under the Professional Qualifications Directive on adoption of a Common Training Framework. The diversity of professional titles reflects a profession that is identified and/or regulated at Member State level rather than at EU level albeit with overlapping qualifications frameworks that meet requirements of the European Qualifications Framework. In support of a unified approach to proposing a Common Training Framework EFLM’s affiliated societies adopted the term ‘Specialist in Laboratory Medicine’ as the unifying descriptor of specialist practice amongst medical, scientific and pharmacy trained professionals in 2012 [8]. Whilst not intended as a precursor to identifying a newly regulated profession at EU Level the name forms the central descriptor within a Common Training Framework.

4 The shape of a Common Training Framework

5 Discussion

In line with three key conditions of the Professional Qualifications Directive that need to be fulfilled for being subject to a Common Training Framework, non-medical specialists:

1. can be identified as a regulated profession and/or a profession whose training is regulated in at least one third (33%) of the EU member states,

2. are not already subject to automatic recognition as a sectorial profession nor to another level Common Training Framework

3. would possibly have their professional mobility enhanced with the adoption of a Common Training Framework

The proposed Common Training Framework builds on EU guidance [12] for a ‘bottom up’ approach in which professional organisations or competent authorities from at least one third of the Member States may submit suggestions for a framework to the Commission. Such an approach is meant to ensure that proposals respond to real needs felt by the profession and benefit from the in-depth knowledge and understanding of the area concerned. At the time of writing 19 of EFLM’s affiliated national societies in the EU highlight their country’s ability to meet the federation’s Equivalence of Standards, the expected level of knowledge, skill and competency, and the code of conduct. Amongst these 19 Member States 15 (53%) are also able to meet the requirements of the proposed Common Training Framework in that the profession and/or training is regulated and their national qualification frameworks are formally linked (referenced) to the European Qualifications Framework for lifelong learning [13], a further EU Commission requirement for submission of the framework.

In progressing a submission the opportunity arises for the EU Commission to adopt a Common Training Framework by “delegated act” (a delegation granted in the text of an EU law such as the Professional Qualifications Directive that allows consideration of a suggested framework by delegated authorities within the Commission) followed by an implementing act to list the national professional qualifications and national titles that benefit from automatic recognition under the adopted Common Training Framework [14]. However, whilst laboratory medicine has established key building blocks for the mutual recognition of its specialist practitioners’ qualifications a current ‘a priori’ challenge across the EU is determining the ‘proportionality’ of the professional regulatory frameworks held within the individual member states which may have been built up and/or modified over many years [15]. The uneven scrutiny of the regulation of professions across the EU has been deemed to have a negative impact on the provision of services and the mobility of professionals in a single EU market - the need for a mutual evaluation exercise facilitated by the Commission was identified within EC Directive 2013/55/EC to ensure greater transparency and justification [16]. Within the exercise Member States provide a list of their regulated professions, the activities reserved for them and a justification of the need for regulation. The subsequent 2018 Proportionality Directive [17] supplements provisions within the 2013 Directive and now requires Member States to review existing regulations of professions or when proposing new ones.

Conclusions

Through the engagement of professional organisations 15 EU Member States have been identified as candidate signatories to a Common Training Framework for Specialists in Laboratory Medicine. Achieving recognition is an ongoing project in part dictated by external timelines and jurisdictions but crucially also by professional organisations and competent authorities who recognise the catalytic effect the Professional Qualifications Directive brings to harmonising the education and training that enhances patient safety when professionals migrate across country borders. Whilst Common Training Frameworks do not replace national programmes unless a Member State decides otherwise [5] it is of note that the EFLM syllabus has been adopted as the template for education and training in 19 Member States. Pending progress with achieving proportionate professional regulation and further guidance from the EU Commission the onus is on national societies and competent authorities to capitalise on opportunities to submit suggestions for a Common Training Framework as and when they arise. EFLM’s proposed framework carries the support of more than one third of its professional organisations in the EU Member States. In turn the framework supports and contributes to the Directive’s enabling goals for increasing professional mobility, enhancing patient safety and ensuring a more equitable distribution of skills and expertise across the Member States.