A recent live survey conducted during the European Health Check event has raised serious concerns over the future of the generics industry in Europe. The survey, which included input from policymakers, healthcare professionals, and industry leaders, found that 77% of participants believe the current systemic framework for generics is neither sustainable nor effective in ensuring the availability and accessibility of medicines for EU patients.
The generics sector plays a crucial role in Europe’s healthcare system, with generics accounting for 70% of medicines across the continent, including 9 out of 10 treatments on the critical medicines list. Despite their importance, generics face a range of challenges, from fragmented regulations and price caps to the bureaucratic complexities of the European Green Deal.
Ines Windisch, Head of Communications, Corporate Affairs, and Sustainability at Zentiva, one of the event’s sponsors, opened the discussion by emphasising the importance of generics in ensuring accessible and affordable healthcare. She highlighted that the existing regulatory framework needs urgent reform, with a call for the introduction of manufacturing incentives under the proposed Critical Medicines Act.
“The Critical Medicines Act is a necessary step forward, but it must modernise the regulatory framework to support the generics industry. We need to ensure that medicines remain accessible, affordable, and sustainable for patients who rely on them,” Windisch said. “Let’s move beyond theoretical discussions and focus on real, impactful change.”
The event gathered top EU officials, representatives from the European Parliament, and national government offices, as well as experts from the Medicines for Europe association. They discussed the regulatory, economic, and societal challenges currently facing the off-patent pharmaceutical sector. One of the key issues raised was the emerging risk of medicine shortages. Despite progress in reporting and mitigation measures, fragmented stockpiling policies in larger EU member states were seen as a potential risk for smaller countries. This imbalance could not only jeopardise the solidarity principle within the EU but also lead to higher costs and wasted resources.
Another contentious issue addressed was the Urban Waste Water Treatment Directive. Despite opposition from 16 EU member states, the directive has now passed, requiring the pharmaceutical industry to pay fees related to the human consumption of medicines and subsequent waste release into sewage systems. Adrian van den Hoven, Director General of Medicines for Europe, called the new directive “a medicines consumption tax,” warning that it could make production economically unviable for the generics sector and lead to further medicine shortages.
The directive, along with selective cost-sharing mechanisms applied solely to medicines and cosmetics, has raised concerns about fairness and the broader impact on the industry.
In response, Zentiva and industry representatives are urging EU leaders to make changes that will safeguard the sustainability of the generics sector. They are calling for a re-evaluation of pricing frameworks to account for inflation, harmonisation of stockpiling policies, and fair cost-sharing mechanisms that do not place undue pressure on specific industries.
“Generic medicines are not just cost-effective alternatives; they are essential lifelines for millions of people across Europe. We must work together to ensure that they remain available and sustainable for future generations,” Windisch concluded, underlining the need for decisive action to secure the future of the generics industry and the health of Europe’s population. For additional information about Zentiva, please visit www.zentiva.com.