EAPM: האַלטן טאַבס וועגן לונג ראַק און קאָמיסיע פאַרממאַ סטראַטעגיע

Good day, and welcome, health colleagues, to the first European Alliance for Personalised Medicine (EAPM) update of the week. We have more news on the upcoming EAPM round table on lung cancer, as well as all the usual health-care updates, writes European Alliance for Personalised Medicine, Executive Director Denis Horgan.

Lung-cancer screening and European Beating Cancer Plan

Yes, we are all aware that by far the best way to reduce numbers of lung cancer patients is to persuade smokers to stop. Although not all sufferers are, or have ever been, smokers. High-risk groups exist, of course, and early diagnosis is vital. Currently, five-year survival rates stand at a mere 13% in Europe and 16% over in America. This will be discussed in our upcoming event on 10 December. 

It is the most commonly found cancer in men and lung cancer in women is being represented by a “worrying rise” according to the World Health Organization.  Some one billion people on the planet are regular smokers. And figures show that lung cancer causes almost 1.6 million deaths each year worldwide, representing almost one-fifth of all cancer deaths. 

The European Respiratory Society and the European Society of Radiology (also a supporter of the event, as is the European Cancer Patient Coalition - ECPC), the societies have recommended screening for lung cancer under the following circumstances: “In comprehensive, quality-assured, longitudinal programmes within a clinical trial or in routine clinical practice at certified multidisciplinary medical centres.”

נעלסאָן און נצחון?

די נעלסאָן לערנען אין קאַמפּיוטיד טאָמאָגראַפי (קאָרט) זיפּונג פון לונג ראַק האט געוויזן אַז אַזאַ זיפּונג ראַדוסאַז לונג ראַק דעטס דורך קסנומקס% אין הויך-ריזיקירן אַסימפּטאַמאַטיק מענטשן.  די פיינדינגז אויך אנגעוויזן אַז, מיט זיפּונג, די רעזולטאַטן קען זיין אַפֿילו בעסער אין פרויען.

אַדווערטייזמאַנט

צו זיין עפעקטיוו זיפּונג, עס דאַרף זיין געווענדט צו אַ ריזיקירן באַפעלקערונג. אין לונג ראַק, דאָס איז נישט פשוט באזירט אויף עלטער און געשלעכט, ווייַל דאָס איז מערסטנס פון זיפּונג פון ברוסט אָדער צווייפּינטל ראַק. אייראָפּע דאַרף אַרייַנציען אַלע שליסל גרופּעס אין דעוועלאָפּינג רעקאַמאַנדיישאַנז און גיידליינז פֿאַר ימפּלאַמענטיישאַן, צוגעפאסט לויט די כעלטקער לאַנדשאַפט פון יחיד לענדער. 

Various member states have already shown a willingness to move forward in lung-cancer screening, and several countries representatives will take part in the event.

The Alliance and its stakeholders realize that, among other elements, what is required in Europe is: continuous screening monitoring, with regular reports; assured consistency and enhanced quality of commented data for the screening reports; reference standards for quality and process indicators should be developed and adopted. 

All of the above will be discussed at the lung-cancer screening event, and it is envisaged that a coordinated plan will emerge, which will make its way to Commission and Parliament policymakers and member state health system chiefs.

איר קענט טשעק די אַגענדאַ פון די 10 דעצעמבער זיצונג דאָ, און רעגיסטרירן דאָ.

EU Pharma strategy on the horizon 

Affordability, availability and sustainability are the main focus points of the EU’s new pharmaceutical strategy, due to be published tomorrow (25 November). Coming in the wake of the COVID-19 pandemic, the EU’s pharmaceutical strategy aims to “future-proof” the European health-care sector. The new strategy, set to be unveiled on Wednesday, is designed to improve and accelerate patients’ access to safe and affordable medicines while also supporting innovation in the EU pharmaceutical industry. 

Health Commissioner Stella Kyriakides has previously described the strategy as a “cornerstone” of health policy over the next five years. It is considered a key pillar of the Commission’s vision to build a stronger health union, as President von der Leyen set out in her 2020 State of the Union speech. It will also inform the newly proposed EU4Health Programme and align with the Horizon Europe programme for research and innovation, as well as contribute to Europe’s Beating Cancer plan. 

And the European Commission has unveiled the first building blocks of a broader health package aimed at increasing the range of preparedness tools to respond to future cross-border health threats. Patient-oriented approach A first part of the strategy underlines that “research priorities should be aligned to the needs of patients and health systems.” 

Therefore, the whole EU system of pharmaceutical incentives should be reoriented to stimulate innovation in areas of unmet medical needs, such as neurodegenerative and rare diseases as well as pediatric cancer. An example of unmet medical needs mentioned in the document is antimicrobial resistance (AMR), which decreases a doctor's ability to treat infectious diseases and perform routine surgery. By 2022, the Commission will explore new types of incentives for innovative antimicrobials, as well as measures to restrict and optimise the use of antimicrobial medicines.

COVID 'mabs'

The US drug regulatory agency, FDA (Food and Drug Administration), has just issued an Emergency Use Authorization (EUA) for the treatment of mild to moderate intensity COVID-19 in adult and pediatric patients who they have not been hospitalized. The therapy, still under investigation, is based on monoclonal antibodies and goes by the name of bamlanivimab. This therapeutic agent, developed by the pharmaceutical company Eli Lilly, is a monoclonal antibody (mab) similar to those that were part of the cocktail of drugs for COVID-19 that was administered to Donald Trump. 

Beginning EU Health Union

The European Commission is beginning the building of the new European Health Union to help strengthen the EU’s health security framework, and to reinforce the crisis preparedness and response role of key EU agencies. The creation of the European Health Union was announced by the European Commission‘s President, Ursula von der Leyen, in her State of the Union address. The Commission is putting forward a set of proposals to reinforce Europe’s health framework as more co-ordination is needed at an EU level in order to step up the fight against the COVID-19 pandemic and future health emergencies. 

Protecting the health of European citizens

The proposals focus on revamping the existing legal framework for serious cross-border threats to health, as well as reinforcing the crisis preparedness and response role of key EU agencies such as the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA). President of the European Commission, Ursula von der Leyen stated: “Our aim is to protect the health of all European citizens.

The coronavirus pandemic has highlighted the need for more coordination in the EU, more resilient health systems, and better preparation for future crises. We are changing the way we address cross-border health threats. Today, we start building a European Health Union, to protect citizens with high quality care in a crisis and equip the Union and its member states to prevent and manage health emergencies that affect the whole of Europe.” 

Von der Leyen urges gradual lifting of coronavirus lockdowns

European governments should lift coronavirus lockdowns and other social restrictions gradually to prevent a third wave of infections, according to European Commission President Ursula von der Leyen. Europe has been grappling with a second surge in Covid-19 infections since September which has led to the re-introduction of lockdowns in certain countries and an overall stepping up of restrictions across the region. 

Despite a slowdown in cases in some countries in recent days, the numbers are still high and are not yet showing clear signs of a cresting. In the meantime, Europeans are pondering whether they’ll be able to gather with their families over the holiday period.

Vaccine hope

News that the AstraZeneca/Oxford vaccine is effective and could have up to 90% efficacy was met with widespread joy on Monday (23 November). “We expect COVID-19 vaccines to develop into a significant market as new products gain approval and begin to meet the high demand for protection from the disease,” according to a brief analysis by Fitch Solutions. It notes that with more products looking likely to pass regulatory hurdles, “these products will help to develop COVID-19 vaccines into a multi-billion-dollar commercial opportunity”. 

"Prices are expected to rise in the short-term as countries look to secure access in light of positive Phase 3 trial results, but over the long-term are expected to fall back as new products enter the market,” the briefing added. “Companies will soon be in a position to capitalize on success in Phase III trials through commanding high prices for vaccines,” the analysis states.

Extra plenary session between Christmas and New Year’s Eve

The European Parliament is preparing for an extra plenary session between Christmas and New Year’s Eve to give its consent to a possible post-Brexit trade deal with the UK, according to several EU officials and diplomats. It is likely to be held on 28 December, to give EU governments the opportunity to have the very last say, as foreseen by the bloc’s procedures, before the end of the UK’s Brexit transition period on 31 December.

Private Greek hospitals compelled to take COVID-19 patients

The Greek government took over two private hospitals in Thessaloniki on 19 November in which transmission of the coronavirus has been particularly widespread. The decision was reached after the private clinics failed to voluntarily provide 200 beds for COVID-19 patients despite appeals by the Health Ministry. Public hospitals in Thessaloniki and other parts of northern Greece have been struggling to cope with the influx of coronavirus patients, adding beds from other wards and setting up isolation tents after reaching their official capacities.

And that is everything from EAPM for now, do stay tuned during the week for further updates on all health-related issues, stay safe, and remember to check out the agenda of EAPM’s 10 December lung cancer round table דאָ, און רעגיסטרירן דאָ.

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