Health Brief – Extreme makeover: EU health agencies special

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In the wake of the COVID pandemic, the face of EU health institutions is rapidly changing. 

The EU public healthcare system is ruled by the holy trinity: the European Medicines Agency (EMA), the European European Centre for Disease Prevention and Control (ECDC) and the new kid on the block, HERA, the European Health Emergency preparedness and Response Authority. 

The COVID pandemic has highlighted the urgent need to reshape the EU health agencies and reorientate resources towards new priorities, as pointed out by last week’s European Court of Auditor’s report. 

And, as we’ve seen in the past week, decision-makers are wasting no time putting their money where their mouth is.

Plans stepped up a gear with the announcement that the Parliament and the Council have come to an agreement on Thursday (28 October) to strengthen the EMA’s role to avoid potential future shortages of medicines and medicines devices. 

To do so, two new mechanisms were agreed upon. 

First, two “shortage steering groups” will be created, one for medicines and one for medical devices. 

Both of these groups will work closely with representatives of health care professionals, representatives of patients, but also with marketing authorisation holders and wholesale distributors. 

These steering groups will meet on a regular basis and when the situation requires, before or during a public health emergency, the Parliament said in a press release.

A European shortages monitoring platform will also be created to easily collect information on shortages, supply and demand of medicines, including a public web page to allow citizens access to potential ongoing shortages. 

“With the new European Shortages Monitoring Platform, we provide the Agency with a key tool to monitor medicines supply and prevent shortages”, rapporteur Nicolás González Casares (S&D) said in an online statement

Also, for more transparency, during a public health emergency clinical trials of treatments or vaccines in Europe will have to make the study protocol publicly available by publishing the results in the EU clinical trials register.

“With this agreement, Parliament makes both the agency and all actors in the supply chain more transparent, involving them more in the process and fostering synergies between EU agencies”, González Casares concluded.

But the fun doesn’t stop there.

On Wednesday (27 October), tensions rose (once again) between the Parliament and the Commission over the role of HERA during an ENVI committee meeting.

In efforts to placate the Parliament, who have long complained about being left out of the decision-making process when it comes to the new health authority, the Commission’s Matthew Hudson was there to allay concerns and “make sure that there is involvement in the European Parliament”. 

MEPs also expressed concerns about HERA potentially taking resources from the €5.1 billion EU4Health programs, of which €2.8 billion is earmarked for HERA.

“I would like a statement and a description of how the €5.1 billion is being shared out between the various activities of the agency”, centre-right MEP Pernille Weiss said.

French MEP Veronique Trillet-Lenoir added that in just a few weeks, the specific budget for the period of six years has gone from €360 million for the severe cross border threats, to €2.8 billion for HERA.

“Over 50% of the EU4Health budget is therefore being earmarked for only one priority,” she pointed out. 

She highlighted that another 30% from €5.1 billion is going to the backup plan, and 8% should go to the result for covering administrative expenses, while the rest should finance the development of the ECDC and the EMA according to their new mandate.

This led Green MEP Michèle Rivasi to remark that this means this should “not be named the EU4Health program, but just the EU health agency and backup program”, adding that she was afraid the Commission was “making fun of” MEPs.

“Do we have plans as to how the money will be used? What will be used for and can the European Parliament be told and informed about what’s going to happen?” Weiss added.

While the Commission’s Hudson conceded that it is a considerable chunk of money that has been designated, he stressed that the creation of HERA “does not, in any way, change what is laid down in the regulation on EU4Health.”

“What we’re looking to do is to make sure that that budget is spent as effectively as possible,” he also said. 

But, as the chair of the ENVI commission Pascal Canfin concluded last week, time will tell if talks are “on the right track or not.”

(C.B.)

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EU NEWS

EU lawmakers from the Greens/EFA group announced on 29 October that they have filed a case application to the European Court of Justice stating “implicit refusal” from the Commission to provide access to information in the context of vaccine contracts between the European Commission and vaccine manufacturers.

The EU’s Health Commissioner Stella Kyriakides has promised that the European Commission will reinstate operating grants for health NGOs in the EU4Health programme after European health NGOs joined forces in an online campaign this week.

The COVID-19 pandemic has negatively impacted gender equality, mental and reproductive health across Europe, with little to no progress being made over the last 12 months, according to a report presented on Thursday (28 October) by the European Institute for Gender Equality (EIGE).

COVID-19

The COVID-19 pandemic has negatively impacted gender equality, mental and reproductive health across Europe, with little to no progress being made over the last 12 months, according to a report presented on Thursday (28 October) by the European Institute for Gender Equality (EIGE).

The ‘Access to COVID-19 Tools’ (ACT) accelerator launched its strategic plan and budget for the next 12 months on Thursday (28 October), outlining the urgent actions and funding needed to address deep inequities in the COVID-19 response. New ACT-Accelerator strategy calls for over US$23 billion in international investment to make COVID-19 vaccines, tests and treatments globally accessible. 

A study of over 600 people in the UK with mild COVID-19 infections published in The Lancet on Thursday (28 October) showed that COVID-19 vaccines lower the risk of infection by the delta variant, but infection can still be passed on in household settings. The analysis found that 25% of vaccinated household contacts tested positive for COVID-19 compared with 38% of unvaccinated household contacts. The infectiousness of vaccinated cases with breakthrough infections was similar to unvaccinated cases.

The results of a new randomised clinical trial, published in The Lancet Global Health, have demonstrated that treatment of COVID-19 with fluvoxamine reduces the risk of prolonged hospitalisation.  Of the 741 participants treated in an emergency setting for COVID-19 after receiving fluvoxamine, 79 required physician treatment for more than six hours or were hospitalised, compared to 119 out of the 756 participants who received the placebo. The results represent an important step in understanding the role of fluvoxamine as a treatment for outpatients with COVID-19 and finding inexpensive, widely available, and effective therapies against this disease. 

G20

On Saturday 30 and Sunday 31 October, the heads of state and government of the world’s major economies, together with invited countries and representatives of international and regional organisations, met in Rome to discuss several key topics of the global agenda, including COVID. The Guardian reports that leaders were supportive of the WHO’s goal of vaccinating at least 40% of the world’s population against COVID-19 by 2021, and 70% by the middle of next year.

WHO

On Thursday (28 October), the WHO launched their ‘Decade of Action for Road Safety 2021-2030’ with the target of preventing at least 50% of road traffic deaths and injuries by 2030. Globally, over 3,500 people die every day on the roads, which amounts to nearly 1.3 million preventable deaths and an estimated 50 million injuries each year – making it the leading killer of children and young people worldwide.

On Wednesday (27 October), the World Health Organisation (WHO) and Unitaid welcomed the signing of a voluntary licensing agreement by the Medicines Patent Pool (MPP) and MSD to facilitate affordable access to molnupiravir, a new medicine being tested in clinical trials for treating COVID-19 in adults. Molnupiravir, an investigational oral antiviral medicine, was reported to reduce the risk of hospitalisation in patients with mild to moderate COVID-19 by 50% in interim phase III clinical trials. It is currently being evaluated for inclusion into the WHO’s guidelines on COVID-19 therapeutics and is pending authorisation for its use from regulatory bodies. If approved, it will be the first oral medicine for non-hospitalised mild-to-moderate COVID-19 patients.

RESEARCH FINDINGS

A UK study of over a million births published in the Lancet on Tuesday (2 November) found that socioeconomic inequalities account for a quarter of stillbirths, a fifth of preterm births, and a third of births with fetal growth restriction, a condition in which babies are smaller than expected for their gestational age.

As much as 40% of healthcare providers (HCPs) (oncologists and respiratory specialists) surveyed across five countries in Europe and the US feel less than well equipped to care for non-small-cell lung cancer (NSCLC) patients with brain metastases, according to a new survey, presented on 27 October, carried out by Ipsos MORI in collaboration with the European Cancer Organisation (ECO). 

SOFIA
Former PМ Borissov accused of spreading faке news about vaccines. Health Minister Stoycho Katsarov accused former Prime Minister Boyko Borissov of spreading fakе news that expired vaccines are being administered in Bulgaria. (Krassen Nikolov |  EURACTIV.bg)

PRAGUE
Czechia refuses ‘Italian way’, says no to obligatory COVID pass for workers. Representatives of the Czech government, employers, and trade unions have refused to impose any restrictions on unvaccinated workers, agreeing on Wednesday that it is impossible to effectively enforce such a measure. (Aneta Zachová |  EURACTIV.cz)

ATHENS
COVID-19: Half Greece in the red. On Wednesday (27 October), Greek health officials reported 3,651 new coronavirus cases, a reduction from 4,165 the day before, and 63 deaths, a recent high. Half of the country is now at the “red” epidemiological level while vaccinations remain stagnant at 59%. (Mattahaios Tsimitakis |  EURACTIV.gr)

PARIS
One in five French public hospital beds unavailable due to labour shortage crisis. One hospital bed in five is currently unavailable in French public hospitals, newspaper Libération revealed on Wednesday, referring to an inquiry earlier this month by the president of the scientific council, Jean-François Delfraissy. The government had previously promised to take action to tackle this labour shortage crisis. (Magdalena Pistorius |  EURACTIV.fr)

BRATISLAVA
COVID conspiracy theories impact Slovakia’s vaccination rate. Conspiracy theories about COVID-19 are popular in Slovakia. They are significantly affecting the vaccination rate in the country, which is the third-lowest in the EU after Bulgaria and Romania, a recent poll carried out by the Slovak Academy of Sciences shows. (Michal Hudec |  EURACTIV.sk)

BRUSSELS
Belgium tightens coronavirus rules again as new infections soar. Belgium has reinstated the requirement to wear masks in indoor public spaces and the strong recommendation to work from home, following a 109% increase in new coronavirus infections in the past fortnight. EURACTIV’s partner Bulletin reports.

SOFIA | BUCHAREST
The two Balkan countries have the lowest vaccination rates across the bloc, and the epidemiological situation is getting out of control again. Our reporters in Sofia and Bucharest analyse the reasons behind the failure of both countries to tackle the pandemic. (Bogdan Neagu and Krassen Nikolov |  EURACTIV.bg and EURACTIV.ro)

BERLIN
Don’t drink that wasser! Passengers travelling via Berlin’s new airport have been warned not to drink from taps in the terminal after bacteria that can cause vomiting and/or diarrhoea were found in the water, according to Berlin’s BBC correspondent. (Natasha Foote | EURACTIV.com)

4 November | A delegation of 7 members of the European Parliament’s special committee on cancer (BECA) will visit the Hospices Civils in Lyon.

9 November | European Rare Disease Ecosystem: A Collaborative Path Forward, virtual event organised by Alexion in cooperation with EURORDIS, the European Joint Programme on Rare Diseases (EJP RD), EUCOPE, and EuropaBio.

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