Press Release

International Women’s Day (IWD)

Monday,8th March 2021.



International Women’s Day (IWD) – 8th March 2021.



More than 5 million women get pregnant in the EU every year and a majority take at least one medication during pregnancy. Yet there is almost no evidence-based information available on most medications to guide a woman’s and her healthcare professional’s fully informed decision. Even less information is available regarding medication exposure through breastfeeding.

Today only about 5% of available medications have been adequately monitored, tested and labelled for use in pregnant and breastfeeding women. The field, while inherently difficult to study, has suffered from a lack of systematically gathered insights that could lead to more effective data generation methodologies. Currently, fragmentation and misinformation abound, resulting in confusing and contradictory communication and perception of risks by both health professionals, women and their families.

In real life, pregnant women become ill and ill women become pregnant. Medication use is not uncommon in pregnancy and physicians are advised to select the safest drugs, but often data are not robust or lacking altogether. Moreover, the trend of later age pregnancies and the higher prevalence of some chronic conditions, such as for example chronic hypertension, obesity, diabetes, multiple sclerosis, systemic lupus erythematosus, result in a rapidly increasing proportion of pregnant women who need medications to treat their chronic disease during pregnancy.

The World Health Organization recommends exclusive breastfeeding for infants to six months of age to achieve optimal growth, development and health. Women living with severe and chronic illness may need to take medications before, during and after pregnancy, but little to no adequate and well-controlled studies have been conducted to characterize the levels of maternal medications in human breast milk.

Uncontrolled disease in pregnancy can lead to suffering and irreversible damage to the mother and for some conditions may also be harmful to the foetus. With the dearth of scientifically-based information on medication transfer through breastfeeding, women may be counsel led not to breastfeed if they are on a prescription medication, or a mother may decide to forgo post partum treatment of her illness in favour of breastfeeding her baby.

Given the lack of solid evidence, neither pregnant or breastfeeding women, nor their doctors, can adequately assess the risk, which challenges informed choice and decision- making. The availability of more detailed and reliable information related to the safety and effectiveness of medications in pregnancy and breastfeeding may assist healthcare professionals and patients in making more evidence-based decisions.

The ConcePTion research project objective is to help bridge the knowledge gap about the safety of medicines in pregnancy and breastfeeding.

ConcePTION will create a trusted biomedical ecosystem that can effectively, systematically, and in an ethically responsible manner, generate reliable evidence-based information regarding the safety of medications used during pregnancy and breastfeeding.

ConcePTION is a 5-year European research project supported by the Innovative Medicines Initiative (IMI), a public-private partnership between the European Union and the European pharmaceutical industry. It brings together 88 public and private organisations, including universities and researchers from 22 countries. The EIWH is a member of the Project’s Managing Board and involved in 4 different Work Packages.

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