In its presentation of the external dimension of the European Health Union, the EU executive introduced a new buzzword – ‘health sovereignty’. However, once you scratch the surface, little new remains.
Exactly a week ago, the European Commission presented the EU Global Health Strategy (and EURACTIV readers already got a sneak peek of its content a few days before its unveiling).
In a nutshell, the strategy mostly consists of replicating the leadership role of the EU in the global response to COVID-19 in future health challenges.
“This is a strategy not for the next year but for the next 10 years,” EU Health Commissioner Stella Kyriakides told reporters on 30 November.
The coining of the phrase ‘health sovereignty’ was a notable aspect of the Commission’s communication.
The combination of words, so unusual in the EU health jargon, is used five times in the text of the strategy, which reads, for instance, that “the EU’s relations with partners must be based on ownership – with the EU and our partners taking the responsibility that is key to achieve health sovereignty.”
In the press material, Commission Vice President Margaritis Schinas summed up the goal of the strategy as “to boost health sovereignty” of EU partners.
While important in the history of political thought, the concept of sovereignty generates mixed feelings nowadays as it is thoroughly beloved, and almost appropriated, by nationalists and far-right parties all across Europe.
It is, however, not immediately clear what ‘sovereignty’ means in the context of public health.
The strategy continues that the EU will “support regional and country efforts to strengthen pharmaceutical systems and manufacturing capacity for vaccines and other medical products and technologies to increase quality, safety, equitable access, and health sovereignty”.
Once again, health stakeholders and policymakers are quite used to concepts such as resilience of the health systems, or access. Quality and safety of medicines are a bit of our bread and butter too.
Health sovereignty, particularly if put on a par with things everyone knows about, sounds weird. If not suspicious.
Are we perhaps witnessing the beginning of a new health sovereignty era? Well, as a matter of fact, once you scratch the fancy surface, nothing really new seems to remain.
Asked to give a specific definition of health sovereignty, a Commission spokesperson told EURACTIV that “for us, health sovereignty includes several dimensions”.
These dimensions range from “the autonomy of having local production facilities that can produce medicines, vaccines or other health technologies to respond to endemic diseases as well as pandemics or other disease outbreaks”.
“These are at the core of pandemic preparedness and the best defence against pandemics,” the spokesperson concluded.
Put in these words, health sovereignty sounds a bit like a mix of ‘strategic autonomy’ and ‘health preparedness’, both of which we all came to know during the COVID crisis.
Indeed, health sovereignty and strategic autonomy are even used together in the Global Health Strategy, as it highlights the importance of “promoting health sovereignty for more resilience and open strategic autonomy supported by partners’ political commitment and responsibility”.
To a ‘healthy’ trained ear, the use of ‘health sovereignty’ sounds more like a cosmetic change to the concept of strategic autonomy and a shift in the Commission language toward a narrative that is so dear to the right-wing parties ahead of the EU elections in 2024.
And that is because not only mere rules but also language is subject to change when policymakers present their legislative initiatives and political actions to an ever-evolving citizenship.
By Gerardo Fortuna
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Ways out of medical devices shortages. With the medical device regulation transitional period set to end in May 2024, stakeholders and politicians warning of potential shortages. To address this Commission is to present ways out of the situation on 9 December at Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) meeting. On Wednesday (7 December) German centre-right MEP Peter Liese released a statement highlighting that the lives of pediatric patients are at risk and rapid action is needed. “The lives of many patients, especially children, are in danger. In consequence, the European Commission must now act very urgently,” Liese said.
Pfizer CEO avoiding MEPs. The boss of pharmaceutical giant Pfizer, Albert Bourla, has once again refused to meet lawmakers on the European Parliament’s Special COVID Committee and answer their questions regarding the vaccine contracts the EU purchased during the pandemic.
Health and treaty change. There are many more accessible actions that can be taken on health before getting onto the bigger question of changing the EU treaties, EU lawmakers said in a health committee meeting on Monday (5 December) in an exchange of views with Troels Petersen, the Conference on the Future of Europe (CoFoE) citizens’ spokesperson for public health matters.
Cross-border telemedicine. The Czech EU Council presidency is expected to reach a common position just on the first two chapters of the European Health Data Space (EHDS) file, in which ministers will propose scrapping the European Commission’s provisions on cross-border telemedicine.
Phasing out ‘forever chemicals’. Investors managing $8 trillion in assets have written to the world’s biggest chemicals companies urging them to phase out the use of so-called forever chemicals that can accumulate in the environment and remain hazardous for generations.
Action to reduce alcohol harm. The World Health Organisation (WHO) is initiating the new €10 million project Evidence into Action Alcohol Project (EVID-ACTION), with the support of the EU. The goal is to increase awareness among the public and policy-makers of the links between alcohol consumption and cancer risks.
Sanofi employees renew strike after failed pay rise talks. Sanofi’s employees decided to renew industrial action on Thursday after negotiations with management for higher wages in the context of inflation failed.
Respiratory viruses
European respiratory viruses cocktail. The European region is currently experiencing increasing circulation of influenza and Respiratory syncytial virus (RSV). Together with COVID-19, these viruses are expected to have a high impact on our health services and populations this winter, said a joint statement by health commissioner Stella Kyriakides, WHO Europe director Hans Kluge and ECDC director Andrea Ammon published last Thursday (1 December). Health chiefs called for vaccination against COVID-19 and seasonal influenza: “We cannot say it enough: Vaccination saves lives.” At the moment an increasing number of people is being admitted to hospitals due to influenza, while COVID-19 case rates, hospital- and intensive care unit (ICU) admissions, and death rates are currently low compared to the past 12 months, “but this situation could change as new variants emerge, and the disease continues to strain healthcare resources,” the statement said.
Global Health
Global health strategy. Giving climate change a more clear role in the EU Global Health Strategy is necessary to plan for future health threats, Alan Dangour, director of climate and health at the Wellcome Trust, said. On Friday (2 December) WHO in a press release announced that the European Commission and WHO agreed to enhance strategic cooperation in global health security and architecture. That includes cooperation on the implementation of the Global Health Strategy.
TRIPS waiver negotiations remain at a standstill
The deadline for a decision on whether to extend the World Trade Organisation (WTO) TRIPS Decision from June from COVID-19 vaccines to include therapeutics and diagnostics, is just around the corner (17 December).
However, once again there was no progress at the latest informal TRIPS Council meeting Tuesday (December 6), according to a Geneva-based trade official. A formal report for the WTO General Council will be prepared by Lansana Gberie, chair of the TRIPS Council, describing how the country delegations have not changed their opinions and are far from a consensus.
According to the trade official, this report will also reiterate many countries’ positions that the discussions have to continue before an extension can be considered. One thing was different in this meeting compared to the previous ones – a number of countries did bring concrete text proposals to the table, which could potentially begin to move the discussions forward. The question is whether it is too late to meet the deadline. There is only one informal TRIPS Council meeting left on December 15.
Disabilities
Disabilities and premature death. WHO’s Global report on health equity for persons with disabilities, published on Friday (2 December), showed evidence of a higher risk of premature death and illness among many persons with disabilities compared to others in society. Many persons with disabilities face the risk of dying much earlier—even up to 20 years earlier—than persons without disabilities, moreover, they have an increased risk of developing chronic conditions, with up to double the risk of asthma, depression, diabetes, obesity, oral diseases, and stroke. The report outlines 40 actions for ensuring health equity for persons with disabilities across the health sector for governments to take.
Rights of disabled people. On Thursday (1 December) the UN OHCHR Regional Office in Brussels and the European Network on Independent Living (ENIL) launched new guidelines on the right of disabled people to deinstitutionalisation. The aim of these guidelines is to guide and support States parties in implementing the UN Convention on the Rights of Persons with Disabilities (UNCRPD) and with it the right of persons with disabilities to live independently and to be included in the community. Following the launch Gerard Quinn, UN Special Rapporteur on the Rights of Persons with Disabilities said: “The European Union can no longer justify the funding of institutions, including group homes, as being in line with the UNCRPD. I encourage the EU to accept this argument as the US Supreme Court did 20 years ago”.
The vote in Council. On December 8, the Council of the EU is scheduled to vote on the European Care Strategy. The European Network on Independent Living (ENIL) on Wednesday (7 December) released a statement saying that the Council’s recommendation on long-term fails to respect the United Nations Convention on the Rights of Persons with Disabilities (UNCRPD). “We urge national governments to insert the necessary changes into the Council recommendation on long-term care or to vote against it on December 8,” the statement said.
Bacterial infections
Lyme disease vaccine. On Thursday (1 December) pharmaceuticals Valneva SE and Pfizer reported antibody persistence data six months after the completion of the vaccination schedule with their Lyme disease vaccine candidate, VLA15 in both children and adults. VLA15 is the only Lyme disease vaccine candidate currently in clinical development. This is the first time antibody persistence data are reported in pediatric populations for this vaccine candidate. There were no safety concerns observed in this six-month observational follow-up. “These six-month antibody persistence data are encouraging, and we hope that the data generated from the Phase 3 studies will further support the positive evidence for VLA15 to date,” said Annaliesa Anderson, Senior Vice President and Chief Scientific Officer of Vaccine Research & Development at Pfizer. Pending successful completion of the Phase 3 studies, Pfizer could potentially submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025.
Increase of diphtheria cases among migrants. On Tuesday (6 October) ECDC reported that an increased number of diphtheria cases among migrants is still being observed in the EU/EEA. Moreover, the bacteria that cause diphtheria, Corynebacterium (C.) diphtheria, has unusually broad predicted resistance to common oral and parenteral antibiotics. Diphtheria is an infection that can lead to difficulty breathing, heart rhythm problems, and on some occasions even death. Since the beginning of 2022, and as of 2 December 2022, 154 cases of diphtheria have been reported by eight EU/EEA countries bringing the overall number for Europe to 232 cases. The majority of cases have been diagnosed among migrants residing in or exposed to reception centres for migrants. This is an increase of 140 cases since the publication of the Rapid Risk Assessment on 6 October 2022, when 92 cases of diphtheria among migrants were reported by seven European countries and one fatal case was identified.
AMR burden. On Monday (5 December) Andrea Ammon, Director of ECDC, released a statement calling for further efforts to address antimicrobial resistance, including improved infection prevention and control practices, the development of new antimicrobial drugs, and reducing the unnecessary use of these medicines. “We are seeing concerning increases in the number of deaths attributable to infections with antimicrobial-resistant bacteria, especially those that are resistant to last-line antimicrobial treatment,” she warned. According to a report published by ECDC on European Antibiotic Awareness Day (EAAD), more than 35 000 people die from antimicrobial-resistant infections in the EU/EEA each year. “This means that nearly 100 people die from these infections each day in the EU/EEA. The health impact of antimicrobial resistance is hence comparable to that of influenza, tuberculosis and HIV/AIDS combined,” Ammon warned.
EMA news
Bivalent mRNA vaccines. The European Medicines Agency’s (EMA) Emergency Task Force (ETF) has concluded that adapted mRNA bivalent vaccines targeting the original strain and Omicron BA.4-5 subvariants of SARS-CoV-2 can be used for primary vaccination. At the moment these vaccines are only authorised to be used as booster vaccines.
Pholcodine medicines withdrawal. On Friday (2 December) EMA recommended the withdrawal of pholcodine medicines from the EU market. Medicines containing pholcodine are used in adults and children to treat dry) cough and, in combination with other active substances, for the treatment of symptoms of cold and flu. Direct healthcare professional communication (DHPC) will inform healthcare professionals of EMA’s recommendation to revoke the EU marketing authorisation for pholcodine-containing medicines. Healthcare professionals should re-evaluate their patients, consider other treatment alternatives, and advise patients to stop using pholcodine-containing medicinal products.
Unmet medical needs
A call for a multi-stakeholer approach. On Friday (2 December) EuropaBio’s 2022 Patient BioForum called for a multi-stakeholder approach to address unmet medical needs. The participants unanimously asked to proceed with a multistakeholder approach and create a structure allowing stakeholders to exchange their views and identify a set of criteria for unmet medical needs.
Rehabilitation care for health conditions. A report from the WHO’s Office for the European Region, warns that almost 400 million people across the European Region (53 countries, including in Central Asia) are in need of rehabilitation care for health conditions. However, many do not receive it, resulting in big effects on people’s lives, including their ability to work, along with a big economic cost in lost productivity.
Mental health. On Wednesday (7 December) Eurofound published a factsheet on Living, working and COVID-19 in the European Union and 10 EU neighbouring countries, which found that health and mental well-being are a major concern across all countries, with many respondents reporting high risks of depression. The results showing 75% of those aged between 18 and 44 are at risk of depression in the EU neighbouring countries is especially alarming. The factsheet highlighted that concrete policy measures to protect families against homelessness, improve childcare facilities and ensure access to quality health services, including mental care, will be critical to achieving progress in these areas.
Technology and health
AI and healthy eating. The EU should move on from ‘outdated’ debates over front-of-pack labelling and instead focus on tailor-made technological solutions for the future of nutrition, experts told a recent panel – but critics say this privileges only the richest in society.
Neuralink brain chip. Elon Musk said he expects a wireless brain chip developed by his company Neuralink to begin human clinical trials in six months, after the company missed earlier timelines set by him.
Children’s safety online. World Health Organization (WHO) published a report on Friday (2 December) What works to prevent online violence against children, presenting ways to address the growing worldwide concern of keeping children safe online. The report focuses on two forms of online violence: child sexual abuse including grooming and sexual image abuse; and cyber aggression and harassment in the form of cyberbullying, cyberstalking, hacking and identity theft. “This new document provides for the first time a clear direction for action by governments, donors and other development partners, showing that we must address online and offline violence together if we are to be effective,” said Etienne Krug, Director of Social Determinants of Health at WHO.
8 December | European Health Summit
8 December | Meeting in the European Parliament’s Special Committee on COVID-19
8 December | WHO’s World Malaria Report 2022 launch.
8 December | The Global Antimicrobial Resistance and Use Surveillance System (GLASS) Report launch.
8-9 December | Meeting in the EU Council’s Employment, Social Policy, Health and Consumer Affairs Council configuration (EPSCO)
13 December | EU-US Conference on Long COVID
15 December | Informal meeting of the WTO TRIPS Council