Caroline BOESHERTZ

What Caroline BOESHERTZ has said (1)

• “Please, thank you Miss. Thank you Mister Chair, thank you honorable members of the European Parliament and representatives of the industry for this insightful exchange of views. While my colleague from Digitrade will specifically address the developments around the UA EU US joint statement, I would like to briefly start by outlining the broader EU US bilateral relations in the health area. The EU and US are longstanding partners in health-related areas. There is good cooperation between the two sides, including between agencies and more specifically between the European Medicines Agency and the US Food and Drug Administration, as well as between the European Center for Disease Prevention and Control and the US Center for Disease Control and Prevention. The collaboration between the FDA and DG Sante and EMA has in particular evolved over the years into a critical partnership aimed at improving global public health. This cooperation stems from the recognition that both regions regulate vast pharmaceutical and medical device markets with overlapping goals, ensuring the safety, efficacy, and quality of health care products for their population. Firstly, the collaboration promotes regulatory harmonization to international standards and guidelines and enhanced information sharing. This collaboration also led to the signing of a mutual recognition agreement for good manufacturing practice inspections, allowing the US FDA and the EU to recognize each other's pharmaceutical inspections results. This agreement, which entered into force in 2017, initially including only pharmaceuticals intended for human use, its scope was extended in 2023 to veterinary pharmaceuticals. These agreements create efficiencies for both sides by reducing duplication, speeding up product approvals, and strengthening supply chain oversight of the EU. Secondly, our partnership accelerates the availability of innovative treatments for European patients. By working together, the FDA and EMA may conduct parallel scientific assessment or rely on each other's evaluation. Finally, the ongoing cooperation strengthened public health protections in the EU beyond premarket approval. The FDA and EU agencies coordinate in pharmacovigilance efforts, monitoring drugs and devices when they are in widespread use. The US are not only an important partner on regulatory cooperation matters but also a key commercial partner, including in the area of pharmaceuticals. The volume of EU US trade of pharmaceutical products and active pharmaceutical ingredients is very large. We are each other's main trading partners for pharmaceutical products. Pharmaceutical products are the EU's most significant export to the US and the second most significant US export to the EU. I would like to conclude by saying that our bilateral cooperation is mutually beneficial and contributes to improving health for both EU and US citizens and we strive to continue it. Thank you very much.”
  EU-US relations