The meeting provided a unique opportunity to simultaneously explore these five Horizon Europe-funded projects focused on the development of innovative green pharmaceutical manufacturing methods and served as a platform for engaging with key stakeholders from both institutional and private sectors, fostering discussions on advancing environmentally sustainable practices in the pharmaceutical industry. Within this context, ETERNAL’s principal researcher and co-project coordinator Dr. Paz Sebastiá Luna from AIMPLAS provided a presentation on the highlights of ETERNAL so far. This included a summary of the project’s six industrial case studies which are currently in the process of moving from their initial reesearch phase in the first half of the project towards scale-up considerations towards commercialisation in the second. Read more about this here.
As well as Paz and representatives of the other Green Pharma cluster projects ENVIROMED, IMPACTIVE, SUSPHARMA and TRANSPHARM, distinguished speakers at the meeting included Irene Norstedt, Director DG Research and Innovation, Momir Radulović, Executive Director of the Slovenian Medicines and Medical Devices Agency and a member of the European Medicines Agency Management Board, and Sofie Norager, Head of Unit for Industrial Transformation at DG Research and Innovation.
In welcoming delegates, Irene Norstedt emphasised both the pharmaceutical industry’s track record as a powerhouse of life enhancing innovation and the need to ensure that consideration for the impact of those innovations on the environment are taken into account, allowing the sector to set standards for sustainable practices. Building on this theme, Momir Radulović provided the policy context around how the EU is building sustainability into emerging legislation, and stressed the need to focus on priorty areas where the most impact can be achieved (such as pharmaceutcicals in the environment, plastics and packaging and the carbon footprint of drug manufcature and use). Mr Radulović also made the point that in order to implement European Sustainability initiatives in the highly regulated pharmaceutical industry, the regulatory environment needs to understand and facilitate innovation: specifically incorporating sustainable/biobased concepts into the proposed changes to the Medicines Directive 2001/83/EC. Sofie Norager explained how feedback on the proposed Safe and Sustainable Design (SSbD) framework has been collected and is being used to shape the voluntary framework so that it enhances both the competitiveness and sustainability of the EU sector.
A lively and illuminating discussion session followed, with a panel consisting of Kirsty Reid, Director for Science Policy at the European Federation of Pharmaceutical Industry Associations (EFPIA), Ferenc Marofka, Policy Officer for the Health Industrial Ecosystem at DG GROW, and Momir Radulović for the regulatory perspective, being joined by Associate Professor Evelina Colacino at Université de Montpellier and coordinator of the IMPACTIVE project on behalf of the collective cluster projects. This session, moderated by Carmen Laplaza from DG R&I covered a lot of ground on green pharmaceutical practices and the challenges of balancing innovation whilst at the same time addressing environmental sustainability. In seeking to achieve the transition from inovative research into full commercial approaches, areas flagged where stakeholders can help break down the barrers included provision of data on (for example) current processes, guidance on which innovative technologies are actively considered for real-world application, LCA data for patent expiring APIs; finding ways to avoid the regulatory environment becoming a brake on progress in adopting innovation.
The afternoon session consisted of further break-out parallel discussions with the representatives of EMA and EFPIA which many interesting ideas and useful suggestions were exchanged, paving the way for further dialogue and hopefully early engagement with the broader community of interested parties in both these vital areas.
The meeting as a whole proved to be a hugely valuable opportunity for exchange of information, views and ideas, and it is anticpated that the model will be repeated in 2025 as the Green Pharma projects Cluster continues to work to build synergies and secure impact from the projects’ areas of common interest in sustainable production of pharmaceuticals, life cycle assessment and communication and dissemination.
Paz Sebatia Luna (second from left) is pictured with (from left to right) European Commission host Martin Uriarte Asteinza, and Professors Christian Stevens from TRANSPHARM, Renzo Luisi (SUSPHARMA), Stefan Camarinopoulos (ENVIROMED), and Evelina Colacino (IMPACTIVE). The ETERNAL project was also represented at the meeting by John Henderson from Britest, Belén Monje Martínez from AIMPLAS, Maria Pavlaki and Patrícia Silva from CESAM at the University of Aveiro, Sam Harrison from UKCEH and Micheál Galvin from Enviroeye.
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