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COVID-19 lessons learned: stronger role for EU medicines regulator

June 23, 2021 by Leave a Comment
Today, the European Commission decided to refer Romania to the Court of Justice of the European Union (CJEU) for failing to ensure that the National Health Insurance House (CNAS) pays pharmacy operators within the deadlines set by the Late Payment Directive (Directive 2011/7/EU). The Commission considers that late payments owed to pharmacy operators in Romania to be both systemic and persistent. Under Article 4(4)(b) of the Directive, public entities providing healthcare must settle commercial transactions within a maximum of 60 calendar days. CNAS has consistently exceeded this deadline in its payments to pharmacies supplying medicinal products to patients. By failing to ensure that CNAS pays pharmacy operators within the prescribed time limit, Romania has breached its obligations under the Directive. The Commission sent Romania a letter of formal notice in April 2024, followed by a reasoned opinion in February 2025 and an additional reasoned opinion in January 2026. The Commission considers that efforts by the authorities have, to date, been insufficient. Therefore, the Commission is referring Romania to the CJEU. Payment delays weaken supply chains, hamper the growth and competitiveness of businesses, and impede their ability to innovate and grow. As late payments constitute a major critical barrier to the Single Market's competitiveness, the decision is part of the Commission's enforcement efforts to remove barriers in the Single Market in 11 focus areas, as announced in the Communication “A simpler, clearer and better enforced EU Rulebook”. Similarly, in its Annual Single Market Competitiveness Report 2026, the Commission has announced its intention to prioritise enforcement against late payments by public authorities. The Commission's proactive stance aims at ensuring that all companies, and in particular SMEs that represent 99% of European businesses, receive timely payments, enabling them to maintain healthy cash flows and invest confidently in their future. Background In Romania, the reimbursement of medicines is part of the public healthcare system, which operates under CNAS. Romanian pharmacies play a key role in this respect. They purchase medicines from manufacturers and distributors at their own expense, then dispense them to patients under the national public health insurance scheme. CNAS later reimburses pharmacies for the medicines dispensed. In effect, pharmacies finance the supply of medicines upfront, while ensuring patients have timely access to the treatments they need. Following complaints from pharmacy associations representing over 500 independent pharmacies, the Commission decided to launch an infringement procedure against Romania in April 2024. According to the most recent information provided by the Romanian authorities, pharmacies are paid on average between 62 and 79 days later than the 60-day deadline. More information Late Payment Directive EU infringement procedure  Infringement decisions database and infringements map and graphs   July 2026 infringement package  Infringement decisions Romania (INFR(2024)4004)This article is brought to you in association with the European Parliament. Public health MEPs agree to change the European Medicines Agency’s mandate to reinforce its role and better equip the EU to manage future health crises. The Committee on the Environment, Public Health and Food Safety (ENVI) adopted on Tuesday, with 68 votes in favour, […]
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Falsified medicines: new rules to enhance patients’ safety

February 8, 2019 by Leave a Comment
This article is brought to you in association with the European Commission. The falsification of medicines has remained a serious threat to public health in the EU for too long. As of tomorrow, the new rules on safety features for prescription medicines sold in the EU will apply. From now on, the industry will have to […]
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