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Decision in case 107/2020/EWM regarding risk minimisation measures, related to pregnancy, set out by the European Medicines Agency for a medicine for treating epilepsy and bipolar disorder

Thursday | 20 August 2020

The case concerned risk minimisation measures, related to pregnancy, that were set out by the European Medicines Agency (EMA) for valproate, a medicine used for treating epilepsy and bipolar disorder. These measures include a so-called ‘pregnancy prevention programme’, which aims to prevent the use of valproate during pregnancy, due to the risks for the foetus and children of those who become pregnant while taking valproate. The complainant considered the wording ’pregnancy prevention programme’ and the terminology used in this programme to be offensive and inappropriate.

EMA adopted the updated risk minimisation measures in 2018, in response to growing concerns about the risks associated with valproate and the failure of measures enacted following a 2013/2014 review by the agency sufficiently to alert relevant healthcare professionals and their patients to the risks attached to taking the medicine in pregnancy,

The widely used medicine, which first came on the market in 1962, has been found to cause malformations in a significant number of foetuses and, in further cases, development problems for children in later life. Despite growing evidence of such risk from the very early days of its usage the medicine continued to be prescribed to women. Some became pregnant while taking valproate, with at times devastating consequences. In 2014, EMA recommended strengthened warnings on the use by women and girls of medicines containing valproate. However, evidence of the medicine being prescribed to women who became pregnant continued, leading EMA to adopt the new risk minimisation measures in 2018.

The Ombudsman acknowledges that, for those who wish to have children, it is a considerable source of distress that medicines they need may pose serious risks to a foetus. She is also mindful of trauma caused to women who became pregnant while taking valproate, and who did not feel sufficiently informed about the risks. The subsequent effects both on them and on their families cannot be underestimated. The Ombudsman considered, however, that EMA has clearly and appropriately explained why it considers the terminology used in the new risk minimisation measures to be proportionate. As such, the Ombudsman concluded that there was no maladministration by EMA. She has however – in the context of EMA’s work in reducing risk - suggested that EMA might further reflect on the serious concerns around the reported failures of General Practitioners in communicating the agency’s multiple warnings about valproate to their patients, and counselling appropriately. This matter falls outside of the Ombudsman’s mandate, but in this regard, the July 2020 UK Independent Medicines and Medical Devices Safety Review contains much that may be relevant. Trust in medical providers is critical in healthcare and the burden of making fully informed choices about medical treatment cannot be left to the patients alone.

Decision in cases 1056/2018/JN and 1369/2019/JN on the European Commission’s actions regarding the respect for fundamental labour rights in Bangladesh in the context of the EU’s Generalised Scheme of Preferences

Tuesday | 24 March 2020

The case concerned the actions taken by the European Commission regarding Bangladesh in the context of the EU’s Generalised Scheme of Preferences. The complainants considered that Bangladesh does not fully respect fundamental labour rights and that, therefore, the Commission should start the procedure allowing it to withdraw Bangladesh’s trade preferences under the scheme.

The Commission informed the Ombudsman of how it has engaged with Bangladesh on the issue so far and the actions it has taken. It said that it may decide to withdraw Bangladesh’s trade preferences as a measure of last resort.

The decision as to whether or not to launch a withdrawal procedure involves complex policy judgments. The Commission has a broad margin of discretion in determining when to do so. The Ombudsman took the view that the explanations the Commission had provided for its chosen course of action were reasonable. She closed the inquiry with a finding of no maladministration.