European Union

Source : © European Union, 2024 - EP

Author: Pramiti Parwani.

Pramiti Parwani is a PhD Fellow at AIGHD, and is also based at the Amsterdam Law School at the University of Amsterdam (in the Law Centre for Health and Life and the Amsterdam Centre for European Law and Governance (ACELG)). Her PhD examines how the legal and institutional frameworks in the European Union and India influence the ‘capabilities’ of least developed countries to access pandemic vaccines for their populations. She combines third world approaches to international law (TWAIL) with the Capabilites Approach in her work, to examine barriers at different stages of the vaccine supply chain- from research and development, to manufacturing capacity to regulatory approval.

This blog draws from my PhD thesis, and is based on my presentation in a EUHealthGov panel at the UACES 2024 conference. My thanks to the EUHealthGov network for funding to support my participation at the UACES conference, and to the participants for the insightful discussions during the panels. Any mistakes remain my own.

Following the export restrictions and vaccine hoarding during the COVID-19 pandemic, concerns about global vaccine inequity still remain during the mpox outbreak. These health crises have clearly demonstrated the risks of over-reliance on foreign sources for pandemic health supplies, including vaccines, and underscore the urgent need to strengthen local vaccine manufacturing capacity—especially in regions where local production has been minimal or non-existent. While calls to expand local pharmaceutical production, including vaccine manufacturing, have long been prevalent, these efforts have received a significant boost during and after the COVID-19 pandemic. In Africa, while local vaccine production collectively only meets 1% of the total demand of the continent, a new plan for regional vaccine manufacturing intends to scale up vaccine production to be able to supply 60% of the total demand in the continent by 2040.

Consistent with the stated objective in the EU Global Health Strategy to strengthen its leadership as a global health actor, the EU invests in health-related infrastructure projects around the world. In order to mitigate fragmentation of overseas development cooperation from different Member States, the EU has introduced Team Europe Initiatives (TEIs) to develop a streamlined approach to its external financing. Team Europe Initiatives form a crucial part of the Neighborhood, Development, and International Cooperation Instrument (NDICI) – Global Europe (Regulation (EU) 2021/947). By pooling resources from both EU institutions and Member States, TEIs enhance coordination amongst them, enabling more cohesive and structured overseas development assistance. This approach strengthens the EU’s image as a unified actor in its external actions and reinforces its influence on the global stage.

One of the most politically high-profile TEIs is the Manufacturing and Access to Vaccines, Medicines and Health Technologies (MAV+) programme. With the aim of facilitating equitable access to safe, effective, and affordable medicines in Africa, the MAV+ initiative seeks to provide support for scaling-up vaccine production capacity on the continent. The project was announced in 2021, and  brings together the EU, 16 EU Member States, and the European Investment Bank, to provide financial, technical, and policy support across three components –supply aspect, demand aspect, and a broader facilitating environment for pharmaceuticals production.

The supply side focuses on industrial growth by involving the private sector, maintaining quality assurance systems, and supply chain management. The demand side includes trust-building activities and health promotion to overcome vaccine hesitancy. It also tackles the issue of fragmented market demand, which can impede the expansion of manufacturing capabilities across the continent. Lastly, the initiative also aims to improve pharmaceutical development by improving the underlying enabling environment – by facilitating access to finance in order to foster private investment, strengthening regulatory systems to accelerate pharmaceutical approvals, and intellectual property management. The MAV+ project was launched with a €1 billion financial commitment – an amount that has been the subject of some confusion. While this amount was initially understood by African partners as new funding, in reality, the amount mainly consists of previously allocated funds.

It was further understood that the initiative would be complemented by private funds and efforts, although further details are scarce. The most notable private component comes from  BioNTech, a German company, which in 2021 announced its plans to establish mobile vaccine production units – called ‘BioNTainers’ – in Africa. The BioNTainers are shipping containers repurposed for vaccine manufacturing, and were promoted as a “modular system, scalable and turnkey solution for local manufacturing” to provide a fast-track solution to expanding vaccine manufacturing capacity in Africa. The press release announcing the BioNTainers mentioned that BioNTech staff would initially run the BioNTainers, before providing training to local personnel to take over.

In 2023, the first BioNTainer facility was inaugurated in Rwanda. Although the funding for the facility comes from BioNTech, the MAV+ project provides indirect support by strengthening the business and regulatory ecosystem in Rwanda. In 2022, Team Europe actors launched a twinning project with the Rwandan National Regulatory Authority as part of the MAV+ program, with the aim of enhancing the the regulatory environment for the approval of health products. Around the time of the inauguration of the BioNTainer facility in Rwanda, Team Europe also pledged an additional €40 million through the MAV+ project to support vocational and technical education to cultivate a workforce for pharmaceutical manufacturing in Rwanda, in addition to fostering a start-up ecosystem within the country. Further, the launch of the BioNTainer facility in Rwanda was attended by European Commission President Ursula von der Leyen and a Vice President of the European Investment Bank, another partner in the MAV+ initiative. In her speech at the inaugration, President von der Leyen highlighted the Team Europe approach.

Such support, even where indirect, to private manufacturers from public funds, should include associated requirements for technology transfer and increased access to affordable medicines. Currently, however, there are no binding obligations for BioNTech to share its technology with other manufacturers. Many observers argue that BioNTech could have more effectively facilitated timely access to safe and effective vaccines in Africa by collaborating with existing African manufacturers through the WHO mRNA technology transfer hub and independent licensing agreements. In contrast, the BioNTainer “cut-and-paste model” of exporting portable, modular vaccine production units does not  support technology transfer, and has been criticized for being little more than a “neo-colonial stunt”. Human Rights Watch had previously identified at least seven manufacturing facilities in Africa, and an additional 100 facilities in other low-and-middle-income countries, which had capacity to establish or expand vaccine production at a short notice, provided that existing vaccine manufacturers would be willing to share their technology.

In light of the concerns mentioned above, and given the EU’s considerable external impact through the Team Europe Initiative, some key points need attention as the MAV+ project progresses. First, to ensure the success of the project, it is essential that African partners, such as the African Centres for Disease Control and Prevention (AfricaCDC) and Partnerships for African Vaccine Manufacturing (PAVM), maintain ownership and control over important decision-making processes, considering the unique local circumstances and needs. This approach is crucial for fostering a sustainable production and knowledge ecosystem on the continent while minimizing excessive reliance on external support.

Second, the importance of this ownership becomes even more pronounced when EU support – directly or indirectly – helps establish a favorable business and regulatory environment for EU companies abroad. Further study is necessary to better investigate the indirect market-making effects of overseas development cooperation by the EU.

Third, when EU support indirectly serves the interests of EU private entities, this should be leveraged to better regulate their activities. As discussed above, while BioNTech gains access to new markets in Africa and benefits from an improved drug regulatory authority in Rwanda through the MAV+ project, the BioNTainer model is not best suited for strengthening Rwandan local production capabilities. Therefore, there should be a greater emphasis on technology transfer, which is currently only addressed in a limited and ad-hoc manner in the MAV+ project.

The EU’s commitment to emerging as a global health leader comes with a responsibility to ensure that it oversees development cooperation efforts through the Team Europe Approach to enhance health sovereignty in partner countries. There is a need to optimise efforts under the MAV+ project in a manner that prioritizes local ownership and technology transfer to help foster sustainable health systems.

The post Scaling up vaccine manufacturing in Africa: The Team Europe Initiative appeared first on Ideas on Europe.

Author: Ricardo Pereira, School of Law and Government, Dublin City University. Ricardo Pereira is a PhD candidate in Politics and International Relations at Dublin City University. He serves as a data coder for the project ”EXCEPTIUS Exceptional Powers in Times of Sars-CoV-2 Crisis.”. His research has primarily revolved around topics, such as Private Security Companies, EU Health Security, and Securitization studies.

During the 54th UACES annual conference in Trento, the paper about the collective securitisation process of COVID-19 carried out by the European Union (EU) was discussed under the panel The EU as a Global Health Actor – Between Securitisation and Cooperation organised by the EUHealthGov network. The paper aimed to understand how the Union in March 2020 became empowered by the member states to assume the role of coordinator of the EU response against the pandemic and its consequences across social, economic, and health sectors by asking How the EU discourse, particularly the Commission, did reflect the collective securitisation of COVID-19, between 2020 and September 2021. As argued by the literature in EU Health law and policy, the shared competence of the EU on health was bumbling at the time the pandemic emerged. The pandemic instigated the debate about the competence of the EU on health as stated by the president of the European Commission Ursula von der Leyen as well as by the Commissioner for Health and Food Safety Stella Kyriakides.

The ongoing research has already looked at 52 speeches from the Commission between 2020 and 2021 under discourse analysis. It is possible to identify three paths of securitisation: threat construction; security construction; and announcement of measures. The first relates the EU discourse regarding COVID-19 as a threat to referent objects such as EU citizens, EU values, and EU institutions, while the second describes the call of the Union for a unified front against the pandemic. The third path refers to the implementation of measures. These three paths should be seen as interdependent and overlapped, once the analysed speeches presented the EU’s position as a security actor facing a multidimensional threat such as the COVID-19 pandemic through (extra)ordinary measures.

The present analysis took the work of Bengtsson and Rhinard (2019) about the collective securitisation of health in the EU as the initial status quo to analyse the evolution of the Union’s response to the pandemic. Following the model of collective securitisation of Sperling and Webber (2019), the research aims to analyse how the organisation constructed COVID-19 as a threat; how the Union developed its role as a health security actor capable of responding in a coordinated and cooperative approach to such a threat; and understand the recursive interaction between EU institutions that led to the implementation and possible routinisation of measures into new practices, agendas, and vocabulary.

In this vein, the research has tracked four periods of securitisation carried out by the EU already. The first comprehends the period between February and March 2020. During this time, COVID-19 was described as a test of EU core values of cooperation and solidarity. The Commission discourse constructed COVID-19 as a brutal threat by defining the pandemic as a global health crisis, following the international community discourse of main organisations such as WHO and NATO. Furthermore, the EU called for attention to pandemic consequences for the EU as an institution and its values by highlighting the impact that a sanitary nationalist approach could have. At the same time, the Commission called for a central response to the pandemic by appealing to a European memoir of cooperation and coordination. Historical memories such as the reconstruction of Europe after World War II were used to develop a sentiment of unity across member states. Consequently, this move would result in the beginning of the EU’s empowerment to respond to the pandemic in one voice, despite existing punctual divergences across time such as in the cases of Poland and Hungary. The joint procurement of personal protective equipment based on a stockpile under rescEU, as well as the development of financial mechanisms such as green lanes, and the activation of the general escape clause, are some examples of this move.

The second period between April and September 2020 could be named as the Marshall Plan for the post-COVID-19. Although the decrease in infections and deaths, the concern regarding the damages caused in the economic and financial sectors, led the Commission to describe the pandemic event as “the largest recession in 100 years”. The COVID-19 pandemic should be seen this way as a multidimensional event. It has not just impacted people’s health, but also the social and economic spheres around the globe. The Commission’s construction of COVID-19 as a multidimensional threat, relying on the interdependence between health, economic, social, and environmental sectors, would create a space for the discussion about the competence of the EU on health. In the summer of 2020 mechanisms such as SURE aimed to support jobs across the Union, also, during this time the draft for a European BARDA started. During the third period, the number of infections and deaths rose and the brutal threat discourse was back in the daily EU vocabulary. The role of the EU as an actor in the fight against the pandemic was established and its agenda was focused on strengthening the public health structure of the Union by empowering institutions such as ECDC and EMA, as well as implementing a strategy for vaccination across the EU territory at the end of the year.

During 2021, the fourth and last period of analysis, the Commission framed COVID-19 variants as the new exceptionality of the pandemic. The international role of the EU was coined by the Commission as “the pharmacy of the world” due to its move from scarcity at the beginning of the crisis to one of the main exporters of protective equipment and vaccines in the world. In this regard, the EU’s role in the African continent should be also underlined with the construction of vaccine factories, although critique can be addressed to the process of how it was designed. There has not been effective investment in logistical processes to deliver these vaccines to remote populations, and the know-how has not been shared with the communities where these factories are located. At the EU level, extraordinary measures of surveillance were implemented through the use of the digital certificate or the creation of Health Emergency Preparedness and Response Authority (HERA).

To conclude, preliminary conclusions can be highlighted. Regarding the threat construction, the characterisation suis generis by the EU of COVID-19 as a brutal threat through the classification of a global health crisis. As a securitising actor, the EU showed a more stable process of conducting the process. In the words of Charles Michel and Ursula von der Leyen, the EU member states during the pandemic agreed to empower the Union to respond to the pandemic under three keywords: coordination, cooperation, and solidarity. Moreover, the pandemic represents a window of opportunity to discuss the competence of health in the EU as well as new approaches to public health in the Union. To conclude, the next steps of this research will contemplate, empirically, the analysis of the following years of the EU4Health programme. The research aims to assess if measures developed to respond to COVID-19 were routinised on the Union structure. Furthermore, theoretically, the present research pretends to look for representations of security integration in the health domain, arguing this way for the utility of collective securitisation for security and integration studies.

The post Between a breeze and a storm of change: EU collective securitisation of COVID-19 appeared first on Ideas on Europe.

Source : © European Union, 2024 - EP

Source : © European Union, 2024 - EP

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