EU PHARMA COMPANIES MAYBE REQUIRED TO DISCLOSE SIDE-EFFECTS DATA, ECJ RULES

THE EUROPEAN Court of Justice (ECJ) has ruled that European Union (EU) member states can insist pharma companies yield data of side-effects of their medicines, when demanded by a disgruntled patient. The ECJ was assessing whether member states could pass such laws under EU directive 85/374/EEC on consumer protection liability for defective products. The case, which sets an EU-wide precedent, focused on a German diabetic taking ‘Levemir’, manufactured by Denmark-based Novo Nordisk Pharma. It caused lipoatrophy, the loss of subcutaneous fat tissue. She was ...


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