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EAPM: Tuarascáil Uachtaránachta Comhdhála ar fáil anois, nuashonruithe digiteacha, Delta ag tabhairt spící nua

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Úsáidimid do shíniú suas chun ábhar a sholáthar ar bhealaí ar thoiligh tú leo agus chun ár dtuiscint ortsa a fheabhsú. Is féidir leat díliostáil ag am ar bith.

Good afternoon, health colleagues, and welcome to the first European Alliance for Personalised Medicine (EAPM) update of the week, Denis Horgan, Stiúrthóir Feidhmiúcháin EAPM. 

Innovation, Public Trust and Evidence: EU Presidency Conference report 

On 1 July, EAPM held a virtual online bridging conference to inaugurate the shift leadership of the EU Council of Minister to the new Slovenian EU Presidency  – in line with what is now an established EAPM tradition, the conference provided a necessary bridge to ensure smooth continuation of reflections on its priority health issues across the shifts in leadership of the EU Council of Ministers. Coming immediately after the eventful Portuguese Presidency, and right at the start of the Slovenian Presidency, the meeting reviewed recent advances in personalised health-care innovation, in prostate and lung cancer and in securing patient access to advanced molecular diagnostics. 

Its title of ‘Innovation, Public Trust and Evidence: Generating Alignment to facilitate personalized Innovation in Health Care Systems’ also indicated EAPM’s other role as a bridge – in bringing together stakeholders from across the widest spectrum of health care, to seek common ground and consensus, and to candidly identify persisting divergences and challenges still to be overcome in implementing personalised care in Europe and beyond. 

Consequently, its panel of distinguished speakers from the research community, regulatory agencies, public health decision makers, clinicians, patients and industry attracted 164 delegates from an even wider range of disciplines. 

The link to the report is ar fáil anseo, and provides a detailed overview of the insights of each speaker as well as the recommendations. 

ENVI to vote on final HTA agreement 

Aiseolas

Today (13 July), the Environment, Public Health and Food Safety (ENVI) Committee will cast final votes on the Health Technology Assessment (HTA) provisional agreement, following Slovenian Health Minister Janez Poklukar addressing ENVI on Monday to present the Presidency’s work programme in the health field. Poklukar reiterated the country’s health priorities. 

Chief among them is resilience against outside threats, which includes both “pandemic and large scale cyber attacks”. As MEP Veronique Trillet-Lenoir noted, the European Medicines Agency has been the target of hackers in the context of its vaccine approval process. The presidency will also focus on “the added value of EU level collaboration in developing and implementing innovative solutions for resilient health systems,” said Poklukar. HERA — the planned European Health Emergency Preparedness and Response Authority (HERA) — will also be a priority. 

An tAcht um Margaí Digiteacha

“The Slovenian presidency will aim for a targeted Digital Market Act, that is also quickly implementable,” said Slovenia’s Economic Development and Technology Minister Zdravko Počivalšek. He added that Slovenia aimed to achieve a general approach by November for a Competitiveness Council. On the regulatory side, the minister also pointed to the Digital Services Package as the main focus of the next Presidency. 

For both the Digital Services Act (DSA) and the Digital Markets Act (DMA), the Slovenian government has the ambition to broker a general approach at the Competitiveness Council that will take place in November. 

An tAcht um Rialachas Sonraí 

In EU rules to bolster the data economy, the big data era has created valuable resources for public interest outcomes, like health care. In the past 18 months, the speed with which scientists were able to respond to the covid-19 pandemic—faster than any other disease in history—demonstrated the benefits of gathering, sharing, and extracting value from data for a wider good. 

Access to data from 56 million National Health Service (NHS) patients’ medical records enabled public health researchers in the UK to provide some of the strongest data on risk factors for covid mortality and features of long covid, while access to health records sped up the development of lifesaving medical treatments like the messenger-RNA vaccines produced by Moderna and Pfizer. But balancing the benefits of data sharing with the protection of individual and organizational privacy is a delicate process—and rightly so. 

Governments and businesses are increasingly collecting vast amounts of data, prompting investigations, concerns around privacy, and calls for stricter regulation. In a letter to TranspariMED dated 8 July, the Heads of Medicines Agencies (HMA), a network of the head of regulators in the European Economic Area, said it would be initiating joint action with the European Medicines Agency and the Commission to improve compliance. 

The letter comes just days after a report indicated that medicines regulators in 14 European countries are failing to ensure that data on new medicines is rapidly publicly available as required under EU rules. Explaining the reason for the non-compliance, the HMA said that it’s “a lack of knowledge of the European rules itself on the part of the sponsors that constitute the root cause.” The HMA’s management board is preparing an overview of actions that member countries are taking to improve compliance, to be circulated as a best practice document. 

WHO urges regulation on ethical genome editing 

On Monday (12 July), a World Health Organization (WHO) advisory committee called on the world’s largest public health authority to stand by the 2019 statement of its director-general urging a halt to any experiments that might lead to the births of more gene-edited humans. The committee — established in December 2018, weeks after news broke of the birth of twin girls whose genomes were edited by Chinese scientist He Jiankui — said in a pair of long-awaited reports that the germline editing technology that led to the ‘CRISPR babies’ scandal is still too scientifically and ethically fraught for use. But for other, less controversial forms of gene-editing, the reports offer a path to how governments might establish the technology as a tool for improving public health.

 “The framework recognizes that policies governing the technology will likely vary from country to country,” committee co-chair and former U.S. Food and Drug Administration commissioner Margaret Hamburg said at a virtual press conference. “Nonetheless the framework calls on all countries to incorporate key values and principles into their policies, such as inclusiveness, equal moral worth, social justice, responsible stewardship of science, solidarity, and global health justice.” 

Dealing with Delta - new EU spikes

The delta variant is the fourth variant of concern identified by the World Health Organization (WHO), first identified in India (April 2021) and it's quickly becoming the dominant variant across the world. It has now overwhelmed the medical ecosystem globally. Since then it has made its way to many countries in Europe. As per research, the Delta variant is the most transmissible form of the virus and mostly deadlier too. 

What makes Delta variant different and more dangerous from the other mutations is that it has many spike proteins that enable it to bind to our body cells more rapidly and efficiently. People infected with this mutation tend to transmit more of this virus around, and as a result of which it affects about 60% plus efficiently more than previous variants. 

Factually, all the coronavirus variants share many similarities, however, recent findings show that the delta variant causes more headache to start with, along with sore throat, runny nose, and fever. It was striking to notice that the traditional early symptoms of COVID-19 were observed lesser in this new variant, such as cough and loss of smell. People infected with this new variant have higher chances of being hospitalized as compared to the alpha variant. This can be easily understood considering the alarming death tolls all over the world. 

COVID still ‘troubling and dangerous’ WHO warns 

Dr David Nabarro of the World Health Organization (WHO) has told the UK’s Radio 4's Today programme the virus is "troubling and dangerous", that the "pandemic is advancing ferociously around the world" and that "I don't think we've anywhere near got through the worst of it". Asked about the government's switch to personal responsibility, as of 19 July, he said: "All this doesn't quite fit with the position that was taken by Britain, along with other nations, some months ago when there was a real effort to try to prevent large numbers of people getting the disease, partly because of the risk of death and partly because of the recognition of the risk of long COVID. 

"Yes, relax, but don't have these mixed messages about what's going on. This dangerous virus hasn't gone away, it's variants are coming back and are threatening those who have already been vaccinated - we have to take it seriously."

Is é sin go léir ó EAPM as seo amach - ná déan dearmad ár dtuarascáil ar ár gcomhdháil fhíorúil is déanaí a sheiceáil ar fáil anseo, and make sure you stay safe and well and have an excellent week, see you soon.

Comhroinn an t-alt seo:

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