By SERB Pharmaceuticals
Basile Gorin, Head of Government Affairs EMEA at SERB Pharmaceuticals, highlights the importance of strengthening dialogue with governments on CBRN issues.
Why is it important for a company like SERB pharmaceuticals to engage in constructive dialogue with government decision-makers?
When it comes to dealing with CBRN risks through the provision of medical countermeasures, SERB Pharmaceuticals is a leading company, with unique expertise and know-how in the manufacture and supply of antidotes. Given the nature of these risks, we are used to working with governments, public institutions, and NGOs to address their countermeasure needs.
This leading position and the very nature of the CBRN environment obligate us to engage with stakeholders. Our ambition is to further develop our interactions with government decision-makers and thus move from a position of supplier to a position of partner. In concrete terms, this means strengthening dialogue, better anticipating needs in order to better respond to them, and working together to develop solutions for risks identified as priorities by governments.
These are not just words or posturing. SERB Pharmaceuticals has already demonstrated its ability to act as a partner: we contributed to the creation of European CBRN strategic reserves by providing medical countermeasures, we supported Ukraine in 2022 through a donation of medicines via the Union Civil Protection Mechanism, and we joined the newly created Critical Medicines Alliance.
Now, we want to go further, not only in Europe but also in the U.S. and all the countries and regions where SERB Pharmaceuticals’ medicines are needed.
What is your perception of the government decision-making process when it comes to CBRN medical countermeasures?
At the government level, CBRN issues are complex in that they are often shared between several ministries or departments. First of all, there is a strong military component, particularly given the resurgence of armed conflicts in recent years, and the need to protect troops in the field. There is also a strong health dimension, often led by ministries of health, which anticipate and prepare for crisis situations and organize national stockpiles. In some countries, this approach is often shared with the Ministry of the Interior, as the security dimension is also very critical. For a company like SERB, with a product portfolio that can address both the military and the civilian segments, this means being able to navigate this matrix and meeting different but complementary expectations.
Beyond this complexity, these organizations can vary from a cultural point of view. For example, ministerial departments don’t always have the same cultural understanding when it comes to working with industry. This approach is often much more established in the military sector, where the development of countermeasures and equipment is based on a long tradition of partnerships and collaboration. This creates opportunities for cross-fertilization from one department to another.
Finally, it is important to keep in mind that CBRN markets are very often niche, with a limited number of players able to meet such special demands, and manufacturing capabilities that are themselves constrained and limited. This calls for greater dialogue with industry upstream of the government decision-making process when it comes to the supply of medical countermeasures.
Following the COVID-19 pandemic, there was greater interest in preparedness issues and a more structured response to health threats. Where do we stand today?
The pandemic has undoubtedly accelerated and reinforced the notions of preparedness and resilience, particularly through cooperation between the private and public sectors. This has been especially the case at a European level, with the creation of the Health Emergency Preparedness and Response Authority (HERA). In less than three years, HERA has become a pivotal player in strengthening the European Union’s ability to prevent, detect, and respond to serious cross-border health threats, with the ambition of ensuring the development, manufacturing, procurement, and equitable distribution of key medical countermeasures and equipment.
HERA has identified CBRN threats from accidental or deliberate release as one of the three priorities for preparedness and response, in particular by addressing any gaps in the availability and accessibility of medical countermeasures. Thus, HERA is the driving force behind the construction of EU strategic stockpiles of CBRN medical countermeasures, to which SERB is now contributing.
The various governments are not to be outdone and a number of initiatives have also been launched or strengthened at a national level. But not all governments are at the same stage when it comes to CBRN preparedness. While some have a long-standing culture of strategic stockpiling of medical countermeasures, others still have not embraced this approach. This is also where the expertise of a company like SERB Pharmaceuticals can make a difference, because we know these mechanisms well thanks to our involvement in a number of countries, and can share this know-how with less familiar governments.
On a broader scale, this new reality moves the needle on sovereignty, and raises new questions from a government affairs perspective on CBRN issues: what should be dealt with at regional level, and what should come under national sovereignty? How can governments succeed in sharing a common vision and developing a common strategy on such a critical issue that affects the security of nations? This point will have to be clarified over the coming years.
Precisely, what are the main challenges facing governments and industry players such as SERB Pharmaceuticals?
The first challenge is to secure the continuity and sustainability of measures that have already been implemented, and to ensure that preparedness and strategic stockpiling will continue to be priorities over the coming years. This means securing the dedicated funding allocated to these matters. This is particularly important, as strategic stockpile management requires the ability to develop a medium- and long-term vision, and therefore the availability of sustainable resources. This applies to medical countermeasures against CBRN risks, as well as to the healthcare sector more broadly: the budget’s annual term is a major limitation. For governments, it makes it more difficult to develop a long-term vision and strategy. For industry players, it limits the ability to anticipate orders and ensure the required manufacturing capacity and capabilities. It’s a question we need to be able to address together.
Another area of common interest is securing supplies. In recent years, the issue of drug shortages has been high on the agenda for many governments, leading to initiatives that include drawing up lists of critical medicines and setting stock requirements for them. But this is a complex issue that needs to be tackled in a concerted and coordinated way with the various players involved. SERB Pharmaceuticals has always had a very strong European manufacturing footprint: when we can produce in Europe, we do. For example, all our CBRN medical countermeasures are manufactured in Europe, mainly in France, and most of our active ingredients are also manufactured in Europe. This industrial fabric must be preserved and strengthened, even though additional constraints, combined with rising production costs and the niche nature of some products, are weakening this environment. Resilient supply chains and local production capacities require industrial policy actions to support critical medicine availability.
SERB Pharmaceuticals joined the Critical Medicines Alliance at its launch last April. What is it and what are you expecting from it?
SERB Pharmaceuticals is indeed a member of the Critical Medicines Alliance created by HERA and the European Medicines Agency (EMA). The Alliance will be a consultative mechanism to ensure collaboration between Member States, industry, and all relevant stakeholders with the aim of contributing to the industrial competitiveness of the EU, its open strategic autonomy, and its economic security. Preventing and dealing with medicines shortages will be one of the key focuses of the Alliance, with the EMA having published a list of critical medicines in December 2023 which includes the active substances of medicines from SERB.
This is an important step forward in our ability to partner with European authorities and reflects our credibility as a stakeholder, in recognition of our leading portfolio of critical medicines and our expertise.
The work on identifying supply chain vulnerabilities for a number of critical medicines has already started, and will continue until October before resulting in a Strategic Action Plan to be adopted at the end of the year.
Basile Gorin serves as SERB’s Head of Government Affairs in the Europe, Middle East, and Africa (EMEA) region. Basile holds a master’s degree in public affairs and has over 10 years of experience in the organization of healthcare systems and healthcare industries in pharmaceutical, biotech, and medical devices.
