The strategy recognises that achieving strategic autonomy while preserving an open economy is a key objective of the Union. It creates actions to respond to the calls of the European Parliament as well as EU countries to understand and address those aspects that impact the resilience of the whole pharmaceutical manufacturing chain, starting with raw materials, intermediates, active pharmaceutical ingredients and including finished dosages forms. The Pharmaceutical Strategy contributes to the Industrial Strategy for Europe of March 2020. The Industrial Strategy recognises the importance of pharmaceuticals for EU security and autonomy.
The COVID crisis
The reflection on the EU security of medicines supply takes into consideration the EU Pharmaceutical Strategy, the Industrial Strategy and trade policy.
The structured dialogue initiative
The purpose of the structured dialogue initiative is to strengthen the resilience of pharmaceutical supply chains and ensure the security of supply of medicines, without compromising the affordability of medicines. It will do so by bringing together and facilitating discussions with and between the actors in the pharmaceuticals manufacturing value chain, public authorities, research community, health professionals and patient organisations.
The structured dialogue initiative is a two-phase process steered by the European Commission.
The main objective of phase 1 is to close the knowledge gaps, by gaining a better understanding of the functioning of global pharmaceutical supply chains and identifying the precise causes and drivers of different potential vulnerabilities. Building on the evidence gathered in phase 1, phase 2 will result in concrete measures that will address the identified issues.
The structured dialogue initiative aims to deliver results by the end of 2021 and will cover all major steps of manufacturing of medicines, in the EU and globally. Any potential measures will also comply with EU competition and World Trade Organization (WTO) rules.
Focus areas of phase I
Across 4 workstreams, the operational groups will work together to present detailed information on the functioning of global supply chains and identify different potential vulnerabilities and their causes, including dependencies threatening the supply of critical medicines. The 4 workstreams will be coordinated to run in parallel or sequentially, to ensure efficiency. This data collection, analysis and sharing of perspectives, will inform the scope and understanding of the key issues. Based on agreed deliverables, each workstream will produce a written report.
Robust supply chain
The purpose of this workstream is to define a robust supply chain, including analysis of the key criteria to achieve a robust supply chain, with consideration of the need for agility, flexibility and resilience. Where challenges in achieving robustness are identified, these should be explored to determine if they are shared or if solutions have already been recognised.
Critical medicinal products
The purpose of this workstream is to consider available methodologies and criteria and identify medicinal products that are considered to be critical to public health and discuss methodology to trace EU manufacturing capacity for those critical products.
Vulnerabilities
The purpose of this workstream is to reflect on the causes of vulnerabilities, considering at what stage in the supply chain they occur and if they differ for different types of medicines. The discussion should include consideration of disruption challenges most frequently observed/ that pose the greatest threat to supply, to identify the drivers of these vulnerabilities, including dependencies. This workstream will also assess the financial impact associated with addressing the challenges and drivers.
Innovation
The purpose of this workstream is to identify the modernisation needs, including identification of priority R&D areas, to ensure supply chains are adequately robust and resilient to meet EU public health need. This includes innovation needed to address challenges in deployment of new measures and maintain competitive production capacity in the EU. This reflection should integrate considerations of green and digital transition requirements, as well as modernisation of manufacturing processes.
High-level launch event
The structured dialogue initiative was launched on 26 February 2021 in a high-level event, gathering Vice-President Schinas, Commissioner Kyriakides and Commissioner Breton, as well as high-level representatives of EU countries, the chemical and pharmaceutical industry, patients and health professionals’ representatives as well as research community.
The purpose of the event is to discuss the participants’ commitment to the objective of enhancing EU resilience and discuss their contribution to the process of the structured dialogue, which in phase 1 will focus on filling knowledge gaps, as described above. It will also aim to confirm the priority working areas and key questions to be addressed.
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