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Enhancing the resilience and the competitiveness of the pharma supply chains to secure access to critical medicines and other medical countermeasures

When the COVID-19 pandemic hit, countries around the globe were caught off guard. In Europe, each country initially responded on its own before realizing the need for a coordinated approach. Thankfully, with the lead of the European Commission, and thanks to the solidarity of EU Member States, vaccines were quickly made available to everyone in the Union at the same time. Early investments through a number of “Vaccines Advanced Purchase Agreements” supported the development and production of COVID-19 vaccine, at scale, in record time. This did accelerate the availability of a large portfolio of effective and safe vaccines that benefited not only European people but the world population. Around two-thirds of COVID vaccine doses produced in the EU have been exported to the rest of the world. Europe was the world’s pharmacy when others closed their doors.

COVID-19 will not be the world’s last public health emergency. Europe needs to be better prepared for future crises, whether they are pandemics or other threats like bioterrorism. We have learned some important lessons from the current pandemic. Acting quickly and working together is crucial.

At the occasion of the publication of the EU Economic Security Strategy on 21 June 20231, President von der Leyen recalled that global integration and open economies were a force for good, for Europe. Recognising that the world has become more contested, she also called for reducing Europe’s excessive dependencies in certain essential sectors. Europe’s heavy reliance on external sources for essential medical supplies has been particularly clear during the COVID-19 pandemic as well as due to the ongoing increase in geopolitical tensions, leading to alarming shortages of essential medicines.

 

Creation of HERA

In September 2021, to improve Europe’s ability to respond to health emergencies, the European Commission established HERA, the European Health Emergency Preparedness and Response Authority. HERA’s job is to strengthen Europe’s readiness to prevent, detect, and respond rapidly to health emergencies. It focuses on making sure we have the necessary medical supplies and countermeasures, coordinating efforts between EU Member States, industry, and other stakeholders. HERA is also tasked to address vulnerabilities and strategic dependencies within the Union related to the development, production, procurement, stockpiling and distribution of medical countermeasures.

 

A strong international dimension

To ensure the availability of medical countermeasures, HERA works closely with partners outside the EU, to benefit from relevant efforts of other entities, and create synergies with scientific and industrial powers. But to strengthen preparedness and response at the global level, HERA also contributes to the international efforts for the development of regional or local capabilities for the production of vaccines, medicines and medical supplies whenever the need arises. HERA is not only working closely with the World Health Organization, funding clinical trials for emergency medicines in Africa, but also looking for synergies in epidemic intelligence with the WHO Berlin Hub2.

 

Closed partnerships are being established already with similar entities across the world: BARDA3, the US Biomedical Advanced Research and Development Authority, as well as with new or in-the-making entities in South-Korea4, Singapore and Japan.

Joint efforts are essential to ensure the development of innovative medicines. Building on existing structures, HERA is for example funding CEPI5, a global partnership working to accelerate the development of vaccines against epidemic and pandemic threats. In Africa, HERA is liaising closely with the Africa Centres for Disease Control and Prevention while coordinating with other EU initiatives to support the development of local capabilities for detecting threats, monitoring epidemics, and producing medical supplies.

 

Industrial dimension

Promoting research on pathogens as well as incentivising research, innovation and development of relevant technologies and countermeasures is important during preparedness phase. For this, HERA relies mainly on Horizon Europe, the EU’s research and innovation programme. In June 2023, as part of the mid-term assessment of the European budget, the Commission put forward a proposal to mobilise additional money on the resilience and the competitiveness of our economy, including for the biotech sector, together with deep tech and clean tech6.

HERA works also closely with the European Medicines Agency (EMA) to create an EU clinical trials network to facilitate the authorisation process of new medicines. Special procedures and financing are being prepared for crisis times.

As shown by the COVID-19 pandemic, a lack of industrial reserve manufacturing and supply capacities, complex global value chains for production and distribution of pharmaceuticals, and lack of diversification of sources of dependencies from third countries can quickly result in shortages of essential medical countermeasures. This must be addressed through enhancing the EU’s industrial resilience. Longer-term investments, strategic planning and strategic alliances with industry are required to make the Union more resilient to external shocks and maintain an adequate supply base in the EU. HERA aims at coordinating EU and Member State efforts to reduce supply risks, secure resilient supply chains, and shrink excessive external dependency. Initiatives like HERA’s EU FAB concur at increasing, or securing existing production capacity.

Finally, the high-risk nature of investments into the development and production of innovative medical countermeasures against cross-border health threats which are hard to predict, leads to a lack, or at the very least insufficient private investment. Teaming up with the European Investment Bank, HERA is launching in 2023 a pilot investment scheme called HERA Invest to de-risk private investments in this field.

 

Shortages of medicines

Shortages of medicines are an ongoing concern in the EU and affect all EU Member States. Their root causes are diverse, including manufacturing issues, supply chain disruptions, unexpected increases in demand and commercial decisions by companies. In their meeting of 29-30 June, EU Leaders in the European Council invited the ‘Commission to propose an initiative for urgent measures to ensure sufficient production and availability of the most critical medicines and components in Europe and to diversify international supply chains’. During an informal meeting in Stockholm organised by the rotating Presidency, a large number of Ministers for Health supported the idea of a Critical Medicines Act.

HERA is working closely with the European Medicines Agency, EMA, in the Executive Steering Group on Shortages of Medicines. Together, EMA and HERA are liaising with key suppliers to better understand their manufacturing capacity and demand forecasting for the next winter.

Antimicrobial resistance has been identified by HERA to be one of its three priority health threats. HERA’s actions against antimicrobial resistance focus on promoting innovation and access to medical countermeasures: antibiotics but as well alternatives (e.g. phages and microbiome-modulating agents) and diagnostics, to rapidly identify or exclude bacterial infection. Shortages of antibiotics have been a recurrent issue. They can harm patients either directly or indirectly, due to the unavailability of effective therapeutic options for bacterial infections, or through the potential increase of antimicrobial resistance linked to an increased use of reserve antibiotics when first-line antibiotics are in shortage.

In this pilot phase, HERA and EMA are focusing their efforts on a number of antibiotics regularly used in national health systems for respiratory diseases and known to be at risk of shortages.

To ensure swift access to essential medical supplies, diversify supply chains, and stimulate the market, public procurement plays a vital role. The EU Vaccines Strategy for COVID-19 is an example of how it can be effective. HERA is working on building stockpiles of critical products to prepare for future emergencies. Joint procurement allows us to pool resources, reduce bureaucracy, and support each other among EU Member States.

By learning from the challenges of the COVID-19 pandemic, we are taking steps to ensure that Europe is better prepared for future health emergencies. Through cooperation, research, and strategic measures like HERA, we can strengthen our ability to respond swiftly and protect the health of our citizens.

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1 https://ec.europa.eu/commission/presscorner/detail/en/ip_23_3358

2 https://health.ec.europa.eu/latest-updates/global-health-hera-and-who-hub-strengthen-cooperation-pandemic-and-epidemic-countermeasures-2022-12-06_en

3 https://ec.europa.eu/commission/presscorner/detail/en/IP_23_2771

4 https://health.ec.europa.eu/latest-updates/global-health-hera-and-republic-korea-strengthen-cooperation-preparedness-and-response-cross-border-2023-05-23_en

5 https://health.ec.europa.eu/latest-updates/health-hera-and-cepi-agree-stronger-cooperation-development-medical-countermeasures-2022-10-24_en

6 https://ec.europa.eu/commission/presscorner/detail/en/ip_23_3345