‘Building a pan-European ecosystem for generating, monitoring, and providing robust information on medication safety in pregnancy and breastfeeding’.
RIVM participates in the public-private partnership ConcePTION. ConcePTION was awarded a 5-year grant by the Innovative Medicines Initiative (IMI2) to tackle many of the research gaps related to the medicines used by pregnant and breastfeeding women. The start date was 1 April 2019.
The project unites 88 organisations from 22 countries, including the European Medicines Agency, drug manufacturers, academia, public health organisations, and teratology networks to innovate new solutions to a decades-long public health issue.
Pregnant and breastfeeding women have long been overlooked in the medical research community because there have been few avenues available for conducting research; the fear of legal liability has overshadowed the need for reliable information to benefit these women and their families. Nonetheless, up to 90% of women are exposed to prescription medication at some point during their pregnancy. Women and their healthcare providers face difficult choices before, during, and after pregnancy, due to a widespread lack of information. Physicians help women to select the safest medication, but they seldom have robust evidence to allow them to make informed decisions. Today, only about 5% of medications have adequate safety information on use in pregnant or breastfeeding women. Obtaining reliable safety information can take 20 or more years to collect after the medicine is released on the market.
ConcePTION aims to profoundly change this paradigm by improving and unifying currently uncoordinated approaches to data collection, and through the re-use of existing and de-identified health data that is generated during the routine care of patients, this is also called ‘Big Data’.
ConcePTION will create a trusted biomedical ecosystem that can efficiently, systematically, and in an ethically responsible manner, generate reliable evidence-based information regarding the safety of medications used during pregnancy and breastfeeding. ConcePTION aims to provide that information in a form that is usable by both healthcare providers and women to facilitate informed decision making.
ConcePTION is a 5-year, €28.6 million project supported by the Innovative Medicines Initiative (IMI), a public-private partnership between the European Union and the European pharmaceutical industry. The pharmaceutical industry contributes €13.3 million to the project through in-kind contributions, whereas the European Commission funds €15.3 million in cash. The consortium, comprising close to 200 researchers, is governed and managed by a balanced 50/50 split of public and private partners and is jointly led by Novartis and the University Medical Center Utrecht.