The EU On Pandemic Prevention, Preparedness And Response, In Brussels And Geneva: A Comparison
Newsletter Edition #197 [The Files In-Depth]
Hi,
Today we bring you a brief analysis on the EU’s PPR plans in Brussels and put it in context with the discussions here in Geneva. Remember that the EU is one of the most influential actors in global health, and possibly the most decisive of the regional bloc of countries.
My colleague Skander Essafi, who is a part of our annual Fellowship program, brings this story for our readers.
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We will soon resume our regular reported editions.
Until later!
Best,
Priti
Feel free to write to us: patnaik.reporting@gmail.com or genevahealthfiles@protonmail.com; Follow us on Twitter: @filesgeneva
I. ANALYSIS
The EU On Pandemic Prevention, Preparedness And Response, In Brussels And Geneva: A Comparison
By Skander Essafi & Priti Patnaik
In the aftermath of the COVID-19 pandemic, the discussions in Brussels and Geneva, on ways to prevent, prepare and respond to health emergencies, now have more in common than ever before.
In this article we try to see some areas where policy discussions seem to converge, those where they do not.
Member states of the World Health Organization and the European Union (EU) are both undertaking joint and parallel efforts to anticipate future pandemics and plan a rigorous strategy in order to achieve its mission of pandemic preparedness, prevention and response (PPR). In this regard, the EU released its Global Health Strategy (GHS) in November 2022 (previously covered in this article), with a particular focus on pandemic preparedness by contributing to an international legally binding pandemic agreement and using a One Health approach. The European Parliament has also adopted a regulation on serious cross-border threats to health in November 2022.
The EU’s PPR institutions: HERA, EMA, ECDC
One of the major milestones of the EU response to COVID-19, and in the field of medical countermeasures was the creation of Health Emergency Preparedness and Response Authority (HERA), which was established as a new Directorate-General at the European Commission (EC) on 16 September 2021 with a budget of € 6 billion for the 2022–2027 period.
The core function of HERA is described thus:
“When an emergency hits, HERA will ensure the development, production and distribution of medicines, vaccines and other medical countermeasures – such as gloves and masks – that were often lacking during the first phase of the response to the COVID-19 pandemic.”
HERA operates in 2 phases: the preparedness phase where it will “work closely with Member States to analyse, identify, and priorities possible health threats”, and in the crisis phase where it will “rely on its anticipatory overall management system and deploy it in the context of an emergency framework activated by the Council on a proposal of the Commission where that is appropriate to the economic situation”.
HERA is endowed with an intelligence system that allows a comprehensive coordination mechanism of the initiatives in place and clinical trials addressing the countermeasures that are being tested. A close cooperation with the European Medicines Agency (EMA) is envisioned for technical guidance, regulatory and scientific purposes. HERA is expected to take an international dimension, by contributing to global health security and collaborating with partners working on a similar scope in Africa (African CDC), the US, but also with the WHO.
In December 2022, HERA and the WHO initiated a new partnership with a € 15 million allocation under the EU4Health programme to boost capacities at national, regional, and global levels for better preparedness and response to health emergencies. This includes initiatives for strengthening the fight for COVID-19 countermeasures, tackling Antimicrobial Resistance and building capacity and expertise in African Countries.
Furthermore, the COVID-19 lessons learnt in the EU pushed for stronger roles of the EMA and the European Center of Disease Control (ECDC):
● The EMA, has played a leadership role 1995 across the EU to assess medicines for human and animal health according to rigorous scientific standards. It made crucial efforts to manage the approval of COVID-19 vaccines and medicines. It was also responsible for monitoring the effectiveness and side-effects of these countermeasures (including the dedicated pharmacovigilance plan for COVID-19 vaccines) and advising on their use in the EU. However, EU Member States had the freedom to not follow these recommendations. In the new EU strategy, EMA is mandated to be in charge of “further controlling and monitoring the shortages of vaccines and medical devices”.
● Similarly, the ECDC has played a pivotal role since 2005 in strengthening European defences against infectious diseases and epidemics. More recently, the ECDC took an early responsibility to monitor and evaluate the course of the COVID-19 pandemic by coordinating not only a threat risk assessment but also risk management, beyond its limitations, such as the implementation of lockdowns and the use of Personal Protective Equipment. According to the EU strategy, ECDC should have a “strengthened function in epidemiological surveillance for better pandemic preparedness and response”.
Overall, these three organizations are expected to work in synergy in the preparedness phase together with EU countries and international partners.
Comparison of EU and WHO institutions
The EU has set the scene through the three institutions and the shared responsibilities towards PPR, however it is difficult to define an international counterpart of these institutions, and within the WHO:
● HERA would have as a close counterpart in the EU-backed ACT-Accelerator, the COVID-19 tools for countermeasures development, less active now than before. However, it is not clear if their missions converge at any point, and if yes it would be only related to COVID-19. In addition, it also appears that the HERA is intended to play a key role in WHO’s new Medical Countermeasures Platform – a reiteration of the ACT-Accelerator. The status of such a platform is not yet fully clear.
● EMA is considered as a medicines institution reference together with other recognized national medicines approval agencies such as the US FDA and other European agencies. In this sense, an international Medicines Consortium is needed.
● ECDC seems to be a very important actor, together with the US CDC, contributing to WHO efforts of global health threats tracking.
It is also difficult to draw a line between the EU institutions' European versus international mandates. In its GHS document, the EU aims to commit to shaping the global health governance; it is stated that it “should drive the essential process of filling the existing gaps in global governance, avoiding duplication and ensuring coherence of action”. However, this statement raises the question on whether a centralized tracking system exists to make sure there isn’t any duplication of the work being done by the different regional or global institutions towards supporting pandemic prevention mechanisms, especially regarding initiatives in LMICs and EU partner countries for the medical countermeasures. These efforts could be redundant between the EU and the WHO and should be subject of a joint coordination mechanism (While the EU already has substantial investments in this direction, some of these could be ironed out in the negotiations in Geneva.)
This can be the role of HERA, where it is perceived to contribute to global efforts, although we would expect more contribution of WHO mechanisms, including the hub of pandemic and epidemic intelligence, towards a global coordination of efforts.
The EU’s priorities at WHO:
While the larger goals of self-sufficiency in the production of medical countermeasures and overall preparedness are common goals, the EU has different approaches at the regional and at the international level.
Remember that the EU is composed of different kinds of member states, not all with the same priorities. Some of this gets reflected internationally as well.
The reasons for this are not surprising. Differing commercial and political motivations are but one of many factors. In addition, there are different institutions involved in these discussions at each of these levels.
The discussions on PPR, in Brussels at the EU and in Geneva at the WHO, began approximately at the same time, albeit with different plans and scopes for implementation.
In this sense, the EU is taking actions in a decentralized manner, where its assigned institutions, HERA, EMA and ECDC, are acting separately but reporting to the European Commission.
For the Geneva negotiations, the European Council authorized the European Commission “to negotiate on behalf of the Union, for matters falling within Union competence, in accordance with the Treaties, an international agreement on pandemic prevention, preparedness and response, as well as complementary amendments to the IHR” in March 2022.
At the regional level, the EU seems to have taken a stance on COVID-19 from different perspectives, including the recognition that the pandemic affected people and increased vulnerability. In the European Parliament resolution of 12 July 2023 on the COVID-19 pandemic: “lessons learned and recommendations for the future”, an emphasis is put on the need to provide a coordinated and holistic support in the social and education systems, for the essential workers, while preserving the freedom of its citizens. It also states that there are many spillovers from the lessons learnt of the COVID-19 pandemic to other health disciplines and for a more resilient healthcare system.
At WHO, in the context of the Pandemic Accord, the EU has suggested extensive language connecting PPR, AMR and One Health towards tackling future health threats and pandemics.
MEDICINES SHORTAGES AND COMPULSORY LICENSING AT THE EU LEVEL
The European Parliament Resolution from July 2023, also addressed the issue of medicines shortages which is hitting both the region and internationally, particularly in the context of the COVID-19 pandemic with respect to the access to vaccines among other medical products. In fact, the European Parliament is calling for an assessment of the vulnerabilities of the global value chain for medicines at both the European and the international levels.
What is also striking is the nature of the discussions at the regional level on the issue of intellectual property (IP).
At the regional level, the European Commission has opened up the discussions on a proposal for a EU-wide compulsory licencing mechanism: a regulation on compulsory licensing for crisis management. The rationale behind this regulation is to enable a rapid response to health emergencies and allow a free movement of crisis-critical patented products in the Single Market. But as before, such a move is already being opposed by the pharmaceutical industry.
Medicines’ Law expert, Ellen t’ Hoen, said in a post recently, “Intellectual property protection is increasingly harmonised in the EU, but the mechanisms to protect the public interest—part and parcel of any balanced IP system—are not.” She notes that EU rules offer both data and market exclusivities for medicines registered in the EU. Such market monopolies make it harder for the effective use of compulsory licensing, t’ Hoen says.
Various groups of pharmaceutical companies have raised their concerns regarding EU compulsory licencing proposal. They argued that this regulation would “suppress innovator IP rights and goes against the EU mandate” (European Pharmaceutical Industries and Associations (EFPIA)), and also said that it goes against international trade agreements, including the TRIPS Agreement at the WTO. Industry maintains that “it wouldn’t solve the issue of access to medicines” as in the case of COVID-19 vaccines where the distribution was more problematic compared to the production (Japan Pharmaceutical Manufacturers Association).
The industry favors the voluntary licencing approach where the power to license technology lies with originator companies, even during global health emergencies. The language on voluntary licensing also features in the discussions at the WHO in Geneva, competing with calls on compulsory licensing and even temporary waivers of IP rules. (In Geneva, the EU has opposed waivers on IP rules. At the WTO last year, the EU worked to clarify existing compulsory licensing rules in the TRIPS agreement.)
The coming months will witness difficult discussions on IP at the on-going negotiations at WHO. It will remain to be seen whether the EU will be open to making compromises on these issues – the same principles that it seeks to introduce at the regional level.
The EU at the WHO
The EU was one of the early champions of the Pandemic Treaty project at the WHO, (first mooted by European Council President Charles Michel in 2020/2021), in order to gain legitimacy and leadership in global health at a time when the Trump administration was walking away from multilateralism and WHO. But given the difficult and somewhat slow progress on the Pandemic Accord, the EU is now also actively engaged with the amendments to the International Health Regulations, alongside other WHO member states.
The EU’s PPR plans at the regional level seem more straightforward with assigned institutions, reinforcing existing mechanisms as well as creating a new one, and an overall willingness to support the WHO. The discussions at the WHO, where the EU plays a decisive role, are undoubtedly more complex given the dynamics of multilateralism.
II. PODCAST CORNER
Dialogues: a conversation with Daisy Hernández
Dialogues is a new series from the Global Health Matters podcast that includes interviews with some of the world’s sharpest global health minds and brightest thinkers. The goal of each Dialogue is to go beyond the echo chambers that exist in global health and to have in-depth conversations with guests who have explored global health issues from their multi-disciplinary perspectives.
In this episode of Dialogues, host Garry Aslanyan speaks with Daisy Hernández about her personal experience with Chagas disease and the journey she undertook to understand it while writing her book. Daisy is an essayist, memoirist and journalist. Her work focuses on the intersections of race, ethnicity, immigration, class and sexuality. She is the author of “The Kissing Bug: A true story of a family, an insect and a nation’s neglect of a deadly disease” (Tin House, 2021), which won the PEN/Jean Stein Book Award and was named a top 10 nonfiction book of 2021 by Time magazine. This conversation reminds us, as global health professionals, to go beyond our public health silos and to present our work in a way that motivates experts, policy-makers and lay audiences towards greater action.
Listen to the episode.
Garry Aslanyan is the host and executive producer of the Global Health Matters podcast. You can contact him at: aslanyang@who.int
This podcast promotion is sponsored by the Global Health Matters podcast.
If you wish to promote relevant information for readers of Geneva Health Files, for a modest fee, get in touch with us at patnaik.reporting@gmail.com.
III. POLICY UPDATES
WHO initiative signs new licensing agreements on COVID-19 technologies
Election of Regional Director 2023
IV. NEXT WEEK:
INB Drafting Group Meeting: WHO
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