On the heels of her reelection in July, European Commission President Ursula von der Leyen tasked her new commissioner-designate for health and animal welfare with a full plate of pharma-related reforms.
In addition to implementing those recently enacted reforms, von der Leyen also called on Olivér Várhelyi to push for a new “European Biotech Act,” proposed legislation that she described as leading to an “environment conducive to innovation” in drug pricing, clinical trials and more.
Várhelyi was originally appointed European Commissioner from Hungary in 2019 by Hungarian Prime Minister Viktor Orbán. This week, he offered written responses to questions about what he’ll focus on as the next health commissioner. He’ll face a confirmation hearing on Nov. 6 before European Parliament.
“We need a regulatory framework suited to the rapid pace of technological change in the healthcare sector,” Várhelyi wrote. “That is the goal of the overhaul of the EU pharmaceutical legislation proposed in April 2023. This would put in place a modern, simplified and supportive regulatory framework that makes it more attractive for companies to invest in research and development for innovative medicines in the EU, including specific incentives for medicines for rare diseases.”
While calling the pharma reform legislation “a cornerstone for the future,” he added that Europe needs to build a “competitive edge” in areas like biotech, and that means “shorter and simplified procedures for authorisation, regulatory support for companies developing new medicines – especially SMEs and start-ups – and support to new approaches such as regulatory sandboxes.”
Várhelyi, who was part of the team that negotiated Hungary’s accession to the EU in 2004, also said that if he’s confirmed, he will seek to attract innovators and investors to conduct research and make it easier “to bring biotechnologies from the laboratory to the factory and onto the market.”
“One of my top priorities will be to bring forward a Biotech Act to reposition the EU biotechnology sector as a global leader,” he said.
Similar to US counterparts that are looking to onshore more manufacturing of essential drugs, von der Leyen stressed that the EU has been confronted with “severe shortages” of medical devices and drugs, including antibiotics, insulin and painkillers.
“To remedy this, we will propose a Critical Medicines Act to reduce dependencies relating to critical medicines and ingredients, particularly for products where there are only a few supplying manufacturers or countries,” von der Leyen wrote.
Várhelyi similarly said he would call for drug shortage prevention plans from companies, earlier shortage and withdrawal warnings, and stronger EU coordination.