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Parliamentary questions
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7 June 2018
E-001561/2018(ASW)
Answer given by Mr Andriukaitis on behalf of the Commission
Question reference: E-001561/2018

Valproate-containing medicines have been approved nationally in the EU to treat epilepsy and bipolar disorder and in some countries for prevention of migraine. It is known that if taken during pregnancy they can cause malformations in the baby and developmental disorders after birth.

It is therefore important to avoid exposure of babies to valproate medicines in the womb.

As with any medicinal product, the side effects (and their frequency) related to valproate used during pregnancy are clearly reflected in the summary of product characteristics and patient leaflet.

A recent scientific review by the European Medicines Agency(1) recommended new measures to avoid valproate exposure in pregnancy (e.g. ban on use for migraine or bipolar disorder during pregnancy, a ban on treating epilepsy during pregnancy unless no other effective treatment available). These recommendations were sent to the Commission at the end of March 2018 which will be followed up with a legally binding decision.

The Commission does not have figures on the number of people affected in the EU. However, data may be available in some Member States.

Regarding compensation, it should be stressed that health policy, as well as the organisation and delivery of healthcare, is a Member State competence under Article 168 of the Treaty on the Functioning of the EU(2).

Overall, the Commission takes the view that the legal framework to monitor medicines has been continuously strengthened to ensure that the medicines which are made available to patients in the EU correspond to high standards of quality, safety and efficacy.

(1)http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Valproate_and_related_substances/human_referral_prac_000066.jsp&mid=WC0b01ac05805c516f
(2)https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:12012E/TXT&from=EN

Last updated: 8 June 2018Legal notice