The EU: Manufacturing and Preparing for the Next Health EmergencyBy
The European Commission has launched the European Health Emergency preparedness and Response Authority (HERA) for ensuring the development, production and distribution of medicines, vaccines and other medical countermeasures in health emergencies. What does the bio/pharma industry think of the plan, including from a manufacturing view?
The EU: preparing for the next health emergency
In her State-of-the Union Address made last week (September 15, 2021), Ursula von der Leyen, President of the European Union (EU), underscored the commitment and resources being made by the EU to prepare for future health emergencies.
“Last year, I said it was time to build a European Health Union,” she said in her 2021 State-of-the-Union Address. “Today, we are delivering. With our proposal, we get the HERA [European Health Emergency preparedness and Response Authority] up and running. This will be a huge asset to deal with future health threats earlier and better…So I am proposing a new health preparedness and resilience mission for the whole of the EU. And it should be backed up by Team Europe investment of EUR 50 billion [$59 billion] by 2027.”
Role of HERA
Part of that EUR 50 billion ($59 billion) investment will be used to fund the newly established European Health Emergency preparedness and Response Authority (HERA), whose goal is to strengthen Europe’s ability to prevent, detect, and rapidly respond to cross-border health emergencies by ensuring the development, manufacturing, procurement, and equitable distribution of key medical countermeasures, which includes therapeutics, vaccines, diagnostics, and other products such as personal protective equipment. HERA is starting up now in a transitional phase and will become fully operational by early 2022. It will receive EUR 6 billion ($7 billion) from the EU budget over a six-year period and additional funding of EUR 24 billion ($28 billion) from other EU programs.
HERA will complement the work conducted by the European Center for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA). Compared to the ECDC, HERA, according to the European Commission, will have a stronger anticipatory, forward-looking and response-focused dimension in terms of threat assessments and foresight. EMA’s scientific advice on the safety, effectiveness and quality of medical products will be a key input to the work of HERA’s much broader work on development and production capacities, stockpiling, and deployment mechanisms for vaccines, therapeutics and diagnostics.
Building the EU’s bio/pharma manufacturing infrastructure
Manufacturing plays an important role in the mission of HERA. One of HERA’s objectives is to identify and ensure the availability of critical technologies and production sites for medical countermeasures in the EU capable of increasing their production in times of need.
“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 a lack of diversification of sources of dependencies from third countries [non-EU countries] can quickly result in shortages of essential medical countermeasures,” said the European Commission in a September 16, 2021 Communication to the European Parliament, the European Council, and other EU governmental bodies. “This must be addressed through enhancing the EU’s industrial resilience.”
That “industrial resilience,” says the European Commission, is to be achieved through “longer-term investments, strategic planning and strategic alliances with industry…to make the Union more resilient to external shocks and maintain an adequate supply base in the EU. By coordinating EU and Member State efforts to reduce supply risks, secure resilient supply chains, and [reduce] excessive external dependency to increase potential production capacity, Member States and their citizens will get access to vaccines, therapeutics and diagnostics earlier and at a greater scale.”
Figure 1 outlines the key goals of HERA as they pertain to manufacturing. To have a clear and dynamic view of which critical production facilities in the EU are capable of upscaling their production, HERA, with the support of EU member states, is charged with systematically mapping EU and international market and supply chains and monitoring current and potential manufacturing capabilities. HERA will also act to address the identified bottlenecks and supply-chain dependencies of medical countermeasures.
HERA will also build on several planned or ongoing initiatives to help it achieve its goal, including the Pharmaceutical Strategy for Europe and its structured dialogue on the security of medicines’ supply and actions aim to address systemic shortages, which includes reducing the EU’s dependence on non-EU sources of production. It will also factor in the EU’s updated Industrial Strategy, which pays particular attention to small and medium-size enterprises that contribute to the development of solutions addressing public health needs as well as Important Projects of Common European Interest (IPCEI), which represents investments by the EU in key strategic value chains. EU member states and industry are in the process of designing a future IPECEI Health for developing new medical countermeasures or breakthrough manufacturing technologies, such as for flexible and modular production, and supporting for their first industrial deployment.
In addition, to support large-scale production of medical countermeasures and ensure access to sufficient production capacity, the European Commission is setting up an EU FAB flexible manufacturing project, a network of so-called “ever-warm” single and/or multi-technology production capacities for vaccine and therapeutics manufacturing in the EU. The EU FAB facilities will be reserved for surge manufacturing capacity and will establish an inventory of production facilities, raw materials, consumables, equipment, and infrastructure. The participating production sites will have to make qualified staff available and have clear operational processes and quality controls in place. The EU FAB is intended to quickly and easily activate its network of manufacturing capacities to meet demand for vaccines and/or therapeutics needs until the market has scaled up production capacities. The European Commission has published a Prior Information Notice to provide advance information to vaccine and therapeutics manufacturers as it prepares a call for competition to particpate, which is planned for early 2022.
Both the innovator-based and generic-drug industry are supportive of the creation of HERA. The European Federation of Pharmaceutical Industries and Associations (EFPIA), which represent innovator-drug companies in Europe, suppports the establishment of HERA and its goal to increase the EU’s preparedness. “Addressing global health crises begins with planning and preparation. EFPIA and VE [Vaccines Europe] support HERA’s inclusion of an end-to-end approach from surveillance and horizon scanning to facilitating the research and development of medical countermeasures, through production and distribution to enhancing Member State capacity and facilitating international cooperation,” said EFPIA in a September 16, 2021 statement.
Medicines for Europe, which presents generic-drug and biosimilar companies in Europe, supports the creation of HERA, but highlighted several elements that the organization thinks important for HERA to do, including with respect to manufacturing. The association made its comments in a September 16, 2021 statement. To be successful, Medicines for Europe says HERA must do the following:
- Ensure coordination between manufacturing associations and EU authorities via the Joint Industrial Cooperation Forum;
- Make sure EU regulations are adjusted to prioritize supply of essential medicines;
- Eliminate the proposal for redundant manufacturing capacity;
- Since it is not possible to predict which medicines will be needed in a future crisis and maintaining redundant manufacturing capacity is neither feasible nor a good use of taxpayer money, pharmaceutical policy should encourage the sustainability of manufacturing investment in a wide range of medicine production types as outlined in the EU’s structured dialogue;
- In a crisis, regulatory flexibility and competition-law adaptations are more successful tools to enable manufacturers to respond to surges in demand for medicines;
- Include provisions for efficient strategic reserves of medicines that factor in waste and costly destruction that should be avoided;
- Reserve policies must be coherent and avoid distorting supplies of medicines to certain (smaller) EU countries;
- Overcome the significant regulatory differences applied by EU member states to most emergency (nationally licensed) medicines, which limits the possibility to allocate stock efficiently in a crisis; and
- Digitalize the sector and its regulatory systems; this includes putting order onto existing digital health initiatives.
Medicines for Europe also said the changes to the EU’s joint procurement policy must be made and that it should be corrected before using it for HERA. Key changes suggested by Medicines for Europe are: (1) providing accurate demand estimates with clear volume commitments in joint tenders; (2) having procurement practices operate only under an exclusivity principle where participating countries commit to source their supplies from the winners of the joint procurement procedure; (3) efficiently and swiftly make contracts awarded to suppliers and provide clear timelines and specifications for delivery of purchased goods; and (4) be more transparent with the possibility for industry to comment on tender criteria and the obligation for the European Commission to clarify that criteria publicly and to reply to individual queries from companies in a timely manner.