Health
Parliament Cancer Report finalized, HERA heralded, progress in face of Delta and Omicron
Good morning, health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update before the weekend. This week, among other issues, we are discussing a new health sub-committee, support for HERA, reduction of drug shortages, and the passing of a committee vote with good news on Charter, writes EAPM Executive Director Dr. Denis Horgan.
Separate health committee
Manfred Weber, president of the centre-right European People’s Party group, said that his group was pushing for the creation of a new sub-committee on health, effectively splitting ENVI, which now unites both health and the environment, into separate committees. The idea is supported by the EPP, the biggest group in Parliament, but there’s no consensus yet, with the centre-left Socialist and Democrats, for example, opposing it, one parliamentary insider said.
EAPM has been campaigning for this move and working with MEPs towards this end for a number of years - a committee should give a new focused health focus, as previously health care was bundled in the environment committee, so was often playing second fiddle to environment issues.
This discordance of consensus is shown by the EPP group Chairman Manfred Weber, who is likely to be the European Parliament president for the second half of the legislative period, warning the progressives socialist democrats to think twice, arguing an open leadership contest would “seriously damage the cooperation between us [and] it will destabilize the start of the French presidency”.
Cancer report passes committee vote amid clashes over alcohol and
vaping
A report on cancer in the EU was passed in what was the final session of the European Parliament’s Special Committee on Beating Cancer (BECA) today.
The report and its accompanying amendments were voted through with a comfortable majority — 29-1, with four abstentions. But the run-up to the vote wasn’t without controversy, with the political groups clashing on hot-button issues like alcohol, tobacco, and food labeling.
This was a crucial issue of the Charter that EAPM has been demanding for some time concerning early cancer screening linked to access to treatment. This will be a core focus of EAPM work in 2022 linked to the implementation plan of the European Beating Cancer Plan.
French MEP Michèle Rivasi, representing the Greens, said the cancer committee “does not only support the Commission’s Europe’s Beating Cancer Plan, it wants it to be more ambitious”.
With the vote, the cancer committee, which was started in September 2020, closed its last session. The report will now go for a final vote in a plenary session of the European Parliament, expected early next year.
EAPM will have two publications coming out in the next few weeks relating to early cancer screening as well as the use of RWE, and has focused on these amendments to support a compromise with various MEPs from the different political groups.
Support for HERA heralded
The launch of the incubator of the European Health Emergency Preparedness and Response Authority (HERA) is welcomed. It calls for policy options to be looked into that will help guarantee that centrally authorized medicines are marketed in all member states and welcomes a review of pharmaceutical legislation to promote robust and fair competition, to support a stabilizing and balancing of national drug pricing systems, to promote fair national drug pricing systems and to ensure equal access to medicines and medical products across the member states.
Health Commissioner Stella Kyriakides has said that HERA was already supporting the work being done on Omicron by the Commission’s expert group on coronavirus variants, and it was also in talks with drugmakers to discuss possible new drugs and vaccines for the variant.
In the coming weeks, the health authority would help with virus sequencing, including Omicron monitoring, begin building up medical stockpiles, and work with its US counterpart to work on a joint threat assessment.
“HERA is, as we can already see with Omicron, making a significant contribution to our resilience in the face of public health emergencies.”
Better tendering can reduce drug shortages says Commission
Shortages of medicines in the EU could be reduced through a change in drug procurement practices, according to an independent study that was authorized by the Commission and published today.
The study, by consultants Technopolis Group, Ecorys B.V. and Milieu Law & Policy Consulting, will help inform planned changes to the EU’s pharmaceutical rules due in late 2022 as part of the Commission’s broader pharmaceutical strategy.
The authors said that drug shortages in the EU had increased in the past five to 10 years, and that market factors were particularly to blame.
“The large majority of medicines that are permanently withdrawn from a particular market involve products with low sales revenues in those markets,” reads the report. In these cases, the seller may decide that it’s not worth keeping the drug on the market any longer.
Lawmakers to vote on Digital Services Act on 13 December
The European Parliament’s internal market committee will vote on the Digital Services Act (DSA) on 13 December.
Coordinators for the committee agreed to vote on the EU’s content moderation rulebook at an extraordinary meeting during the week of the plenary.
EU countries in the Council approved their version of the bill on 25 November.
World’s first AI treaty
On 7 December, and following an intense plenary last week, the Council of Europe’s Ad hoc Committee on Artificial Intelligence (CAHAI) has finished its recommendation for a legally-binding treaty on artificial intelligence that would protect democracy, human rights and the rule of law. The treaty could be ratified by the Council of Europe’s 47 member countries, which also include Russia and Turkey. The US, Canada, Japan and Mexico have also been involved in the AI initiative.
WHO Euro boss presents plan to stay safe in face of Delta and Omicron
Hans Kluge, head of the World Health Organization’s (WHO) Europe office in Copenhagen, presented the WHO plan for Europe to stay safe in the face of the threats of Delta and Omicron on Tuesday (7 December). And this is the reason why:
4,100: The number of deaths per day currently recorded in the WHO Europe region, which comprises 53 countries including Russia.
2x: That’s twice the number of deaths per day on average that were recorded at the end of September.
Advice 1 — The basics: According to Kluge, countries need to shift from reactive to stable modes in the pandemic in order to keep mortality down. That means increasing vaccine uptake; administering booster or third doses; doubling the rate of mask-wearing indoors; ventilating crowded spaces; and adopting rigorous therapeutic protocols for severe cases.
But, despite Kluge’s words of warning, more member countries are turning to vaccine mandates, with the German parliament debating amendments proposed by the incoming government to require health and other essential workers to be jabbed by 15 March 2022. Olaf Scholz, due to be sworn in as chancellor, backs a general vaccine mandate although this is still under discussion.
Commissioner Stella Kyriakides said: “I cannot stress enough the urgency to vaccinate.”
Slovenian Health Minister Janez Poklukar said discussions on joint procurement of vaccines were positive. One of the main themes was HERA — with Kyriakides telling ministers that health crisis response agency was already supporting work on Omicron.
Lest we forget, COVID-19
And the first laboratory data landed on Wednesday (8 December), assessing how well vaccine-induced immunity protects against infection with the Omicron coronavirus variant. While each of the four studies differed, the overall impression is that Omicron evades immunity from a standard two-dose course. Data from South Africa suggests that those who had received two doses of a vaccine as well as having had prior infection were better protected against Omicron.
Governments will no doubt be monitoring the vaccine escape data, but there were further suggestions from Botswana on Wednesday that Omicron may not cause the same severity of disease as seen with other variants. The country, which has vaccinated 71% of its eligible population and was among the first to detect the variant, has not seen a rise in COVID-19 hospitalizations, Reuters reported.
The WHO sought to emphasize that what needs to be done now is focus on those primary courses as we know they protect against severe disease and death. “No matter which way you look at it, primary doses always outperform booster doses for people who are at risk. The primary attention here has to be on ensuring that everyone who has not yet had a primary series of vaccination has access to that vaccine,” said Kate O’Brien, director of the WHO’s vaccines department.
Good news to finish - EU extends roaming rights to 2032
European citizens will be able to use their mobile phones without excessive extra costs when traveling abroad in the EU, negotiators agreed today.
The European Parliament, Commission and EU Council gathered Wednesday evening (8 December) for a crunchtime negotiation to extend the roaming rules, which were originally agreed in 2017 but would expire end June next year.
Roaming “is one of the greatest success stories of the digital single market,” said Boštjan Koritnik, Slovenia’s minister for public administration who negotiated the extension. “Both consumers and businesses can continue to enjoy this tangible benefit,” he added.
Negotiators agreed in the early hours of Thursday to extend the rules and add obligations for operators to guarantee quality and speed of calling, texting and using mobile data abroad.
The new regulation will enter into force July 1, 2022, extending rules until end June 2032.
And that is all from EAPM for this week, stay safe, stay well, have a very enjoyable weekend, see you next week.
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