Under the leadership of the S&D Group, the European Parliament achieved a significant milestone today with the approval of its position on the long-awaited 'pharmaceutical package,' aimed at enhancing access, availability, and affordability of medicines within the European Union.
Since March 2020, the S&D Group has been advocating for a European Health Union, with the 'pharmaceutical package' as its centrepiece. The Covid-19 pandemic underscored critical shortages and discrepancies in medicine access across EU member states, exposing inequalities between citizens and member states alike—an intolerable situation for the Socialists and Democrats.
Throughout rigorous negotiations, the S&Ds have spearheaded efforts to bridge the access gap to medicines among all EU member states, address neglected disease areas, and foster pharmaceutical research and innovation particularly in the field of antimicrobials and rare diseases.
Tiemo Wölken, S&D coordinator for the environment, health, and food safety committee and lead negotiator on the 'pharmaceutical package' regulation, said:
"Today’s vote on the 'pharmaceutical package' is a significant stride towards a fairer, more accessible healthcare system for all EU citizens and a robust pharmaceutical framework. We advocated for enhanced medicine access while tackling pressing issues like shortages and antimicrobial resistance. This legislation update is crucial not only to fortify our healthcare infrastructure but also to bolster our collective resilience against future health crises.
"Under S&D leadership, the package introduces measures to combat medicinal product shortages, including robust transparency and reporting requirements for manufacturers and wholesalers. Additionally, we've significantly enhanced communication and transparency towards patients and healthcare professionals, while encouraging innovation, particularly in rare diseases research.
"Thanks to the S&Ds, the legislation emphasizes the prudent use of antimicrobials and the development of novel solutions to counter antimicrobial resistance – a menace responsible for over 35,000 deaths annually in the EU. By incentivising companies through milestone payments, we aim to support the entire antimicrobial development process and delink sales volume from contracts, addressing market failures.
"Drawing lessons from the Covid-19 crisis, this law streamlines the regulatory framework by expediting marketing authorisation and approving medicines, benefiting regulators and pharmaceutical companies alike."
Nicolás González Casares, S&D MEP and negotiator on the 'pharmaceutical package' directive, said:
"The revision of pharmaceutical legislation is a crucial step towards a more robust European Health Union. This legislative package strives for innovative, safe, and accessible medicines for all Europeans, fostering research and innovation while mitigating pharmaceutical pollution.
"At the heart of our amendments were patients' needs, aiming to rectify the unacceptable disparities in access among member states. We advocated for greater transparency in pharmaceutical companies' public funding, ensuring fair pricing and returns on public investments. Moreover, we pushed for the swift entry of generic medicines into the market, fostering competition and accessibility.
"During negotiations, the S&Ds bolstered environmental protection measures, advocating for comprehensive environmental risk assessments throughout a medicine's life cycle. We also maintained control over excessive data and market protections to ensure innovation incentivisation without burdening public health systems or impeding patient access."
