Inside EU Health: Parliament votes on Critical Medicines Act; EMA regulatory co-operation; Paracetamol (still) safe during pregnancy
Parliament votes on Critical Medicines Act position; EMA to build on regulatory co-operation piloted under COVID; Paracetamol is (still) safe during pregnancy
Parliament draws the battle lines on Europe’s Critical Medicines Act
With more than 500 votes in favour, the European Parliament has given an overwhelming endorsement to its position on the Critical Medicines Act (CMA), backing a report by MEP Tomislav Sokol that sets out an ambitious negotiating mandate ahead of trilogues.
At the heart of Parliament’s approach are two core objectives: boosting pharmaceutical production within the EU and ensuring more equal access to medicines across member states.
MEPs have sharpened the Commission’s original proposal for a ‘European preference’ by setting a figure of 50% of production in Europe, “Price can no longer be the sole criterion when awarding contracts for medicines,” said Sokol.
The Parliament is also fighting for voluntary solidarity during shortages to become mandatory, for easier access to joint procurement and for orphan medicines for rare diseases to be considered as critical.
Catherine Feore
EMA to build on regulatory co-operation piloted under COVID
In December 2020, the European Medicines Agency (EMA) launched a pilot initiative to expand international collaboration during the assessment of COVID-19 vaccines and therapeutics. This initiative, known as the OPEN Framework, enabled non-EU regulatory authorities to participate directly in EMA’s scientific evaluation processes.
Regulators from Australia, Canada, Japan, Switzerland, and the World Health Organization contributed throughout the full lifecycle of assessments, from rolling reviews to marketing authorisation applications. They participated in the Emergency Task Force and the Committee for Medicinal Products for Human Use meetings.
EMA say that the clear benefits in terms of shared expertise have now been extended to other therapeutic areas, marking an important step toward more open, globally connected regulatory science for the benefit of patients worldwide. EMA have published a short Q&A on how it works.
Paracetamol is (still) safe to use during pregnancy
In April of last year, the US Health Secretary Robert F. Kennedy promised to find the cause of autism by September of the same year. In September, the US administration linked the condition to folate deficiency and the use of paracetamol (acetaminophen) during pregnancy.
The FDA initiated a safety label change for acetaminophen and announced plans to launch a nationwide public service campaign to inform families and protect public health.
The EMA quickly issued a statement that there was no new evidence requiring changes to the current EU recommendations for use.
For those seeking further reassurance, The Lancet has published the results of a meta-analysis, which found no link between paracetamol exposure and an increased risk of autism spectrum disorder.
“Current evidence does not indicate a clinically important increase in the likelihood of autism spectrum disorder, ADHD, or intellectual disability in children of pregnant individuals who use paracetamol as directed, supporting existing recommendations on its safety.”