News & recent work
08 February 2023
THE ROMANIAN COMPETITION COUNCIL LAUNCHES AN INVESTIGATION ON THE EXTERNAL EVALUATION SERVICES MARKET FOR MEDICAL ANALYSIS LABORATORIES
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The Competition Council has launched an investigation into a possible violation of competition rules by the Romanian Accreditation Association - RENAR on the external evaluation services market for quality assurance/supply of competence testing schemes for medical analysis laboratories that have concluded contracts with health insurance houses.
In May 2021, the RENAR Board adopted a procedure regarding the use of competence tests and inter-laboratory comparisons in accreditation, which transposes international policies in the field (International Laboratory Accreditation Cooperation - ILAC/EA), harmonizing the accreditation process with national legislation and international practice.
However, the document provides that, in the accreditation procedure for medical analysis laboratories, only competence testing schemes carried out by providers accredited by RENAR or signatory accreditation bodies of international agreements, both EA-MLA and ILAC MRA, are recognized.
According to ILAC MRA resolutions, each signatory recognizes the accreditation of another conformity assessment body that is a signatory to one of the agreements.
Therefore, the requirement for entities that are not accredited by RENAR to obtain accreditation from other signatory bodies of the two international agreements (EA-MLA and ILAC MRA) cumulatively, is equivalent to establishing a possibly excessive barrier to entry into the external evaluation services market for quality assurance/supply of competence testing schemes for medical analysis laboratories that have concluded contracts with health insurance houses.
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RENAR's behavior may lead to a significant reduction in the supply of external quality control services/competence testing schemes for medical laboratories and, thus, to restricting competition in a market with very few competitors, an oligopoly market, thereby increasing the risk of possible collusion.
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