EU pharma companies may be required to disclose side-effects data, says ECJ
If they are challenged by patients who have had adverse effects after taking a medicine
The European Court of Justice (ECJ) has ruled that European Union (EU) member states can insist that pharma companies reveal 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 precedent, focused on a German diabetic taking Levemir, which is manufactured by Denmark-based Novo Nordisk Pharma.
The drug caused lipoatrophy, the loss of subcutaneous fat tissue. The patient brought a legal action demanding that the company release data on 'the adverse and other effects of Levemir [relating] to lipoatrophy'. She won, citing German legislation, but Novo Nordisk appealed and the case was referred to the ECJ for advice on whether Germany’s law complied with the directive.
The ECJ concluded that it permits national laws enabling a 'consumer…to require the manufacturer of the medicinal product to provide…information on the adverse effects of that product'.