In an intervention at the recent ARPIM event, “The health of Romanians between hopes, challenges, investments, and innovation: a European vision,” Danish Member of the European Parliament (MEP, EPP) Pernille Weiss, who serves as the rapporteur for the Pharmaceutical Directive, addressed the crucial role of the ”Pharma” package in shaping the future of pharmaceutical innovation in the European Union (EU).
Weiss emphasized the significance of the Pharmaceutical Directive within the broader ”Pharma” package, underscoring the need for a common shared language and toolbox to navigate the legislative landscape effectively. She articulated the anticipation within the European Parliament and numerous member states for the European Commission’s proposal, expressing hope that it would propel the EU toward becoming a ”global hub for pharmaceutical innovation”.
As the rapporteur for the Pharma Directive, Weiss outlined her vision for the legislation, placing a strong emphasis on promoting innovation while ensuring patient access to medicines. Drawing on her background as a nurse and a lineage of healthcare professionals, Weiss envisioned the European Union as a community of lawmakers, healthcare systems, universities, and education institutions working together to make the EU ”the most attractive place on earth for not only pharma industries, an important part of our industries but also the adjacent industries that as a total system can be labeled as the life science industries”.
Weiss highlighted the two central components of the ”Pharma package”—the directive and the regulation. She emphasized the lengthy wait for the Commission’s proposal and the collective aspiration for it to enhance the EU’s ability to foster pharmaceutical innovation, provide access to medicines, and strike a balance between affordability and rewarding innovation.
The MEP expressed her hope of making the EU the first choice for the pharmaceutical sector in terms of production, research and development facilities, and collaboration opportunities. Weiss acknowledged the pivotal role of small and medium-sized enterprises (SMEs) as ”the backbone of innovation” in Europe’s pharmaceutical landscape and stressed the importance of legislation tailored to accommodate their unique needs.
Weiss proposed a nuanced approach to data protection, advocating for predictability, fairness, and alignment with global standards. She challenged the Commission’s concept of tying data protection to product launches in individual member states, emphasizing the need for a more comprehensive and fair negotiation position.
In particular, Weiss highlighted the potential for countries like Romania to attract pharmaceutical investments by creating a conducive environment for SMEs. She called for a streamlined process for innovators and entrepreneurs, ensuring that directives and regulations support their efforts and contribute to a faster, more efficient pathway for market authorization and pricing agreements. In this sense, the Danis MEP proposed an application model for pricing and reimbursement in member states expressing interest in specific medicines. This, she argued, would facilitate faster access for citizens and incentivize innovative companies, especially SMEs, to invest in countries like Romania.
As the European Parliament moves towards interinstitutional negotiations with the Council, Weiss expressed her hope for an agreement before the European elections in June next year. She concluded by emphasizing the need for a legislative package that not only meets high expectations but also reflects the true interconnections between the diverse elements of pharmaceutical innovation. Her proposed legislative adjustments aim to ensure that Europe remains a global leader in pharmaceutical innovation, delivering timely and affordable solutions to citizens across member states, regardless of their size or economic status.
Pernille Weiss MEP (since 2019) is a politician from the Conservative People’s Party of Denmark. Hereby she is a Member of the Group of the European People’s Party in the European Parliament (EPP Group).
Ms Weiss is a Member of the Committee on Industry, Research & Energy Committee and of the Committee on the Environment, Public Health and Food Safety. She is also a Substitute Member of the Committee on Women’s Rights and Gender Equality.
Prior to being an MEP, Ms Weiss served eight years as a County Council Member. She holds several degrees: she is a nurse (RN), has a Master’s of Science (health), is a certified sexologist and holds a Master’s Degree in Innovation and Leadership (LAICS). She is an acknowledged Nordic expert in architecture and health. Ms Weiss has been a Board Member of SME Europe 2019.
She was Head Manager in the public healthcare sector and the building consultancy industry before establishing her own consultancy firm in 2008.
