Health brief: The AMR saga continues

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The European Parliament’s health committee (ENVI) has voted in favour of an objection calling on the Commission to withdraw its draft implementing act, continuing the saga of the list of antimicrobials reserved for human use.

The outcome of the vote came as no surprise, as during many debates in the committee – in which the Commission has been present a couple of times to explain themselves – criticism has rained down on the draft implementing act.

As previously reported by EURACTIV, much of the debate around the infamous list of antimicrobials has centred around the disputed antimicrobial colistin, which the European Medicines Agency (EMA) has left off its list of recommended antimicrobials reserved for human use.

It is the EMA recommendation that the Commission’s draft implementing act is based on.

In the objection that the MEPs have now sent for final approval in the short plenary session next week (22-23 June), it says that “the draft Commission implementing regulation fails to achieve a high level of protection of human health” by not putting any antimicrobials currently used in centenary medicine on the list.

This approach was previously met with harsh criticism, with socialist MEP Sara Cerdas calling it “extremely unambitious” and accusing it of maintaining “the status quo” during a debate in May.

The objection then proceeds to urge the Commission to withdraw its draft implementing act and to propose a new one in line with the recommendations in the WHO’s list “Critically Important Antimicrobials for Human Use.”

Back in March, when the MEPs debated the EMAs recommendations, another socialist MEP, Tiemo Wölken, said that “our fear was that the antibiotics listed as a high priority critical important antibiotics (HP-CIA) by the WHO would not be on the list. This fear has become a reality as the EMAs recommendation goes against preserving four out of five HP-CIAs for use in human medicine.”

With the vote on Tuesday (15 June), MEPs called on the Commission to “step up efforts in tackling the connections between human health, animal health and environmental protection, and explore ways to reinforce the application of the ‘One Health’ approach in Europe.”

Necessary action or rejection of scientific advice

While Claire Bury, deputy director-general of the Commission’s health service DG SANTE, did recognise back in May that “there are different scientific views that may be out there”, she said that they “think the scientific advice [from the EMA] is valid and that we have to base ourselves on the scientific advice.”

As a reaction to the MEPs’ vote Tuesday, the European Platform for the Responsible Using of Medicines in Animals (EMPRUMA) said in a statement that they were “disappointed to see members of the European Parliament’s ENVI Committee reject the scientific assessment of the European agencies.”

They also added that the draft implementing act “goes together with a stringent set of legal provisions to fight AMR in the new regulation on veterinary medicines.” They also accuse MEPs of misinterpreting the WHO list and “sticking to outdated beliefs about misuse of antibiotics in the animal sector.”

Withdrawing the implementing act and replacing it with a new one, EPRUMA argues, will only postpone action on addressing antimicrobial resistance even further.

On the other hand, the network Health Care Without Harm Europe (HCWH Europe) sent a letter to Commissioner Stella Kyriakides expressing their concern for the exclusion of colistin back in March.

They drew attention to a joint report by the OECD, ECDC, EMA and EFSA, warning that between 2011 and 2020, the consumption of polymyxins – mainly colistin – in Europe has risen by 67%. The report states that “last-line antibiotics are used mainly in hospitals to treat patients with confirmed or suspected serious infections and are the last line of defence against multidrug-resistant bacteria.”

An EMA spokesperson has previously told EURACTIV that they acknowledge that colistin is “one of the few treatments available for some serious drug-resistant infections in humans.”

Green MEP Martin Häusling previously drew attention to the fact that countries like Denmark and the Netherlands do not use colistin, despite having plenty of intensive farming. In the debate in May, Claire Bury admitted that the Commission still needed to look into why some member states can do without colistin while others still need it.

By Amalie Mersh

 

Subscribe to EURACTIV’s Health Brief, where you’ll find the latest roundup of news covering health from across Europe. The Health Brief is brought to you by EURACTIV’s Health Team Giedrė Peseckytė, Clara Bauer-Babef, Amalie Holmgaard Mersh, and Gerardo Fortuna.

Monkeypox

Health commissioner Stella Kyriakides signed an agreement to purchase around 110,000 doses of a vaccine to be used for monkeypox on behalf of member states, she announced on Tuesday (14 June). The Health Emergency Response Authority (HERA) coordinated the procurement of monkeypox vaccines and therapeutics. 

COVID-19

Digital COVID-19 certificate extension. The Council and the European Parliament have reached a provisional deal to extend the digital COVID-19 certificate for another year.

The certificate was supposed to expire on 30 June this year but will now be extended until June 2023 to ensure EU citizens’ travelling plans can proceed uninterrupted in the case of another wave of COVID-19 infections with a new variant of concern.

Part of the agreement is that the Commission will assess the digital COVID-19 certificate after six months to evaluate whether it is still necessary.

For the agreement to enter into force, both parties must adopt it formally. Parliament is set to do so during the plenary session on 22-23 June.

Vaccines. French pharmaceutical company Sanofi announced on Monday (13 June) encouraging results for its new generation vaccine against COVID, developed in collaboration with British company GSK, after two conclusive clinical trials.

(Non-)cooperation in EU. During the pandemic, member states were “very selfish” and cooperated “as little as possible” with the Commission, Philippe Juvin, one of the leaders of the French Republicans party and former MEP, told EURACTIV in an exclusive interview.

EU blood directive revision

Public blood management could be a way to address blood shortages as only a third of world patients receive enough transfusions, according to a health expert who also expressed concern that the forthcoming revision of the EU legislation on the topic will not adequately address the issue.

EU treaty reform

Health policy is at the heart of demands for EU treaty reform after MEPs voted on Thursday (9 June) for EU leaders to establish a constitutional convention to reopen the EU treaties.

Abortion

The European Parliament approved a resolution on global threats to abortion rights on Thursday (9 June) in light of the potential overturning of the US Roe v. Wade ruling, following a heated plenary debate on the state of abortion rights, also in the EU.

Czech presidency

Rare diseases. Improving screening tools and strengthening the incentive system for orphan drugs are among the leading suggestions for overhauling the European legislation on rare diseases, a topic included in the health priorities of the forthcoming Czech presidency of the EU.

NCDs

Kidney disease. Although not included in the EU’s list of major non-communicable diseases, chronic kidney disease (CKD) will benefit from an ‘indirect’ impact of the work on other conditions that share common risk factors, according to the European Commission.

Stakeholders’ corner

The European Heart Network (EHN) elected Charmaine Griffiths from the British Heart Foundation as their new CEO. Claire Skentelbery, director-general of the trade association EuropaBio, will take on the new role of vice-chair of the International Council of Biotechnology Associations for two years.

THE HAGUE

Monkeypox cases double in the Netherlands. The Netherlands now has 54 recorded cases of monkeypox compared to 26 registered last Monday, Dutch media NL Times reported. By Sofia Stuart Leeson | EURACTIV.com

MADRID

EU prosecutor to investigate Madrid’s alleged fraud of bloc funds during COVID. The European Public Prosecutor’s Office has agreed to open an investigation into the Madrid region’s allegedly fraudulent use of EU money in 2020 to purchase health materials to combat the pandemic. By Fernando Heller | EuroEFE.EURACTIV.es

LISBON

Portuguese lawmakers approve euthanasia bill at first reading. Parliament approved on Thursday the first reading of four bills from the Socialist party, Left Blocc, IL and PAN regulating the decriminalisation of medically assisted death and are now following the work in the committee stage. By Ana Raquel Lopes | Lusa.pt

LJUBLJANA 

Slovenian opposition proposes mandatory drug testing for public office holders. Members of parliament, ministers, state secretaries, the prime minister, and the president may soon have to undergo annual compulsory drug testing according to a bill tabled by the Democrats, parliament’s largest party in opposition. By Sebastijan R. Maček | sta.si

BUCHAREST

Romania records its first monkeypox case. Romania confirmed its first case of monkeypox with a 26-year-old male from Bucharest currently undergoing treatment and hospitalised in solitary confinement. The 26-year–old in good condition, and the health authorities’ investigations revealed that his partner had recently travelled to several European countries that reported many monkeypox cases.

Health Minister Alexandru Rafila said Romania would receive around 2,500 vaccines against monkeypox after the European Commission finalised the acquisition procedure. By Bogdan Neagu | EURACTIV.ro

16 June | Delivering Value through Innovation in Diabetes Care Delivery

16 June | World Health Summit, regional meeting in Rome

21-24 June | ONE Conference organised by the EU’s food safety agency (EFSA)

22 June | Webinar: Healthier Together – EU Non-communicable diseases initiative

23 June | Combatting zoonoses and addressing AMR on the Planet with a One Health Approach.

23 June | Strengthening European Reference Networks: Ensuring optimal care for all

24 June | Launch of the book ‘Health system performance assessment: a framework for policy analysis’ 

[Edited by Alice Taylor]

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