An important piece of the new Pharmaceutical Strategy adopted in November 2020 by the von der Leyen Commission is represented by the structured dialogue with the actors of the pharmaceuticals manufacturing chain in order to better identify causes and drivers of vulnerabilities and to prevent shortages of medicines in the market. The initiative was launched on 26 February 2021 with a high-level event that saw the participation of Vice-President Margaritis Schinas, Commissioner Stella Kyriakides and Commissioner Thierry Breton (presentations given during the event can be found here). 

National authorities, the industry, patients and health non-governmental organisations, and the research community will be part of the stakeholders called to animate the structured dialogue; the first operational meeting was planned for 25 March, and it will be followed by two rounds of meetings for each of the four different workstreams. Transparency and inclusiveness are just two of the many working rules set by the Commission in order to govern the dialogue process (find the complete list here).

How to improve the European autonomy in pharmaceutical manufacturing 

The reinforcement of the EU’s strategic autonomy in the area of pharmaceutical production is a specific request made by the European Council, as it may greatly impact on the avoidance of bottlenecks deriving from stops to imports from extra-EU countries. The structured dialogue initiative will focus on how to ensure enough manufacturing capacity for critical active ingredients, raw materials and medicines in the EU. A theme that gained great attention during the Covid-19, and that is also central for the planning of the activities of the new European Health Emergency Preparedness and Response Authority (HERA).

The structured dialogue will be coordinated by the Commission, and it articulates in two distinct phases. The first one is divided into four different workstreams, and it will focus on identifying current knowledge gaps, and on confirming priority areas of action. Some topics of attention have been raised during the launch event, e.g. the need for regulatory flexibility, the support to public-private collaborations and investments and the avoidance of protectionism. The second phase will examine in deeper detail the identified issues, and it will propose a set of measures for the attention of the European Commission. For each workstream, a specific operational group will discuss under different perspectives the current status of global supply chains to identify potential vulnerabilities. The process is expected to close by the end of 2021; conclusions will be presented in the form of written documents. 

The first workstream will analyse the robustness of the pharmaceutical supply chain, and key criteria needed to achieve this goal (e.g. agility, flexibility and resilience). Already available or potential solutions will be also examined. The second workstream will examine the manufacturing of critical medicinal products, on the basis of available methodologies and criteria. The identification of medicines to be considered “critical” to public health is also a target, together with the ability to trace their EU manufacturing capacity. The third line of discussion will address causes of vulnerabilities of the pharmaceutical supply chain, the stage at which they occur, and the type of medicinal products involved. The more frequent disruption challenges, their financial impact, and the drivers of vulnerabilities, including dependencies, will be object of analysis. The last workstream will focus on how innovation may support the modernisation of manufacturing processes and their integration with the green and digital agendas, starting from R&D up to the integrated supply chain.

Comments from the industry

We welcome Commission’s recognition that collaboration and partnership is key to supply chain security and that health is of strategic importance to the EU. Our recent experience in discovering, developing and delivering Covid-19 vaccines and therapeutics has underlined that resilience begins with our research and development eco-system as well as the paramount importance of resilient global supply chains”, said  EFPIA Director General, Nathalie Moll, after the launch event. The representative association of the research-based pharmaceutical industry released a note, indicating as a critical step for the success of the initiative “that any proposals from the structured dialogue take into account the nuances between the different actors across the medicines and vaccines supply chains”.

According to EFPIA, Europe already possesses a good resilience as for the production of pharmaceutical products, being the 77% of the active ingredients used by the associated companies manufactured in the EU. The remaining is imported from the US (12%) and Asia (9%). EFPIA also recalls the European Union being the largest pharma exporter, with a global market share of 63.8% (Euro 383 billion); manufacturing of vaccines is also healthy, with members of the representative association Vaccine Europe producing in the EU 76% of their products. “To remain competitive, Europe needs longer-term investment, incentives and global regulatory harmonisation in order to build a strong innovative manufacturing and supply ecosystem for the therapies of the future, such as mRNA, cell & gene therapy delivery and other types of highly specialised and innovative technologies”, commented Philippe Luscan, Executive VP Global Industrial Affairs of Sanofi, who participated in the meeting.

Medicines for Europe (MfE) also released a statement in view of the meeting on the new European Industrial Policy. “Despite pronounced EU important dependencies and demand surges in critical areas such as ICU medicines, we have demonstrated the resilience of the pharmaceutical supply chain during this unprecedented time, as well as the power of two-way collaborative work with policy-makers to secure access to critical medicines. With smart policy reforms, Europe can address the current drivers responsible for the growing vulnerabilities of its essential pharmaceutical production and supply. I call on EU leaders to support a vibrant medicines manufacturing sector in Europe. It is now time to act to increase Europe’s resilience, diversity and sovereignty while capitalising on fair and open trade”, said Medicines for Europe president, Christoph Stoller. 

According to MfE, the structured dialogue initiative is a first, positive step towards the strengthening of the European manufacturing and critical medicines supply chain resilience, but some other reforms are needed. Lowest-price purchasing policies, for example, are considered by MfE incompatible with the target of the essential medicines manufacturing resilience and security of supply. The association suggests to use instead the Most Economic Advantageous Tender (MEAT) criteria, such as environmental and supply reliability, manufacturing resilience and/or product specific characteristics criteria. Pricing and reimbursement should also recognise the importance of manufacturing security for affordable generic medicines.

The regulatory system should undergo a profound digitalisation to improve its efficacy and scientific robustness, while reducing administrative burdens. Faster cross border movements of medicines are considered another possible tool to prevent shortages. According to Medicines for Europe, the Recovery and Resilience Facility (part of the Next Generation EU recovery instrument) may facilitate dedicated investments in medicines manufacturing at the national level, to be managed through the single Member State National Plans. Automation, green and digital manufacturing processes should be the focus of the upgrading of manufacturing plants.