ЕАПМ: Приближава се девети годишњи догађај заинтересованих страна, 17. септембра током премијерне онколошке манифестације, региструјте се сада!

Good afternoon, health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update of the week – the time is now ripe to register for the upcoming EAPM event in September that will take place during the ESMO Congress, details below, пише ЕАПМ извршни директор Дени Хорган.

‘All in it together’

The conference, EAPM’s ninth annual event, is entitled ‘Потреба за променом – и како је остварити: Дефинисање екосистема здравствене заштите ради утврђивања вредности'. Догађај ће се одржати у петак, 17. септембра од 08х30-16х00 ЦЕТ; Овде је линк за регистрацију а ево и линк на дневни ред.

One of the biggest challenges facing Europe today is cancer in its many forms. More to the point, how do we get the best possible cooperation and coordination among the multi-stakeholders in the field, and unite them under one umbrella to ensure access for current cancer patients, as well as citizens who will be future patients and, very likely, future cancer patients?  And with the leaps in genetic technologies, the emergence of biology-based immunotherapy - which helps the immune system fight cancer - there are many reasons to be hopeful going forward.

All stakeholders will have to play their part in discussions and policy formation during the session. And they will all have to accept that the ultimate objective is better health for patients. Their own interests and priorities must adapt to that priority. 

• For patients (and physicians) there are more options, durable clinical benefit, reduced exposure to non-effective drugs and potential to leverage current scientific and technological advances; 
• For the private sector, the potential to tackle core challenges in discovering and developing more effective medicines, to reduce rates of attrition in drug development, and to reduce the associated escalating costs which are central to a more sustainable future and delivery for healthcare needs; 
• And for healthcare systems and payers, improved efficiency through the provision of efficacious and cost-effective care through the avoidance of ineffective and redundant interventions, are again key to a more sustainable and deliverable future system.
• For institutions and member states it could mean more purposeful discussion – taking more account of input from stakeholders, avoiding repetition, and translating decisions into action… 

Ова серија округлог стола о динамици ће размотрити различите елементе овога кроз следеће сесије: 

• Сесија И: Стицање поверења заинтересованих страна у дељење геномских података и коришћење доказа/података из стварног света
• Сесија ИИ: Увођење молекуларне дијагностике у здравствене системе
• Сесија ИИИ Регулисање будућности – Баланс безбедности пацијената и омогућавање иновација – ИВДР
• Сесија ИВ: Спашавање живота прикупљањем и употребом здравствених података

From a stakeholder perspective, speakers amongst others will include Niklas Hedberg, UK Professor Sir Mark Caufield, former chief scientist, Genomics England, Monika Brüggemann, department of hematology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany and Паул Хофман, head of the Laboratory of Clinical and Experimental Pathology at the University Hospital Nice, France.

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Овде је линк за регистрацију а ево и линк на дневни ред.

Reform of EU medicines agency: Where do EU institutions stand? 

The Commission's proposal to reinforce the mandate of the European Medicines Agency (EMA) aims to strengthen the Union’s ability to manage and respond to public health emergencies and to ensure the smooth functioning of the internal market for medicinal products and medical devices. The European Parliament recently adopted a proposal to broaden the mandate of the European Medicines Agency ahead of upcoming talks with member states on EMA’s future role. MEPs endorsed their amendments to the proposal to reinforce the EMA mandate, presented by the Commission in November 2020 as part of the efforts to ensure better preparedness for future health emergencies. 

Повереник за здравство Стелла Кириакидес told the parliament that while EMA is being “absolutely central to our collective efforts to tackle [pandemic]”, a stronger mandate is needed to be “better equipped for the future crisis”. 

Once a compromise agreement is reached in this inter-institutional discussion, known as trilogue, and is confirmed by Parliament’s plenary and the EU Council, the regulation will enter into force. “We need to permanently monitor the shortages of critical medicines, we need to report on the risk of shortages of medical devices during a crisis [and] to catalyse the development and fast approval of medicines with fast track scientific advice and rolling reviews,” Кириакидес рекао. 

Some countries indicated they want to hold off on approving the plans until they’ve seen the HERA proposal, due in two weeks, for fear that the agencies’ roles would overlap. But González Casares doesn’t share that concern. “I see no such risk of conflict between the two agencies,” he said. “The pandemic has highlighted the need for governments, institutions and companies to react quickly and effectively to this type of cross-border threats.”

EU’s infectious disease agency: ‘No urgent need’ for coronavirus vaccine booster shots

There’s “no urgent need” for coronavirus vaccine booster shots “based on current evidence,” the EU’s infectious disease agency said on 1 September.

“Evidence based on vaccine effectiveness and duration of protection shows that all vaccines authorised in the EU/EEA are currently highly protective against COVID-19-related hospitalisation, severe disease and death,” the European Centre for Disease Prevention and Control (ECDC) wrote. 

The agency also highlighted that nearly one-third of adults over the age of 18 in the EU and EEA are still not fully vaccinated: “In this situation, the priority now should be to vaccinate all those eligible individuals who have not yet completed their recommended vaccination course.”

The EU announced on Tuesday (31 August) that 70% of adults are fully vaccinated. 

WHO's Hans Kluge warns of ‘difficult autumn’ 

Regional inequalities, a faltering vaccination campaign don’t bode well for the fall months. Warning of the continued threat of the coronavirus, the WHO's Hans Kluge pointed to one projection that shows some 236,000 more deaths in Europe by 1 December. And he pointed out that mortality is rising already — with an 11 percent increase in the number of deaths over the past week — due to the spread of the Delta variant, an easing of public health measures as well as a seasonal increase in travel. 

Kluge also addressed the difficult question of third doses, signalling a shift from the WHO’s previous position, which had asked for a temporary halt on boosters until the end of September to allow the developing world to catch up. “A third dose of vaccine is not a luxury booster taken away from someone who is still waiting for a first jab,” Kluge explained. “It’s basically a way to keep people safe.” But he added that it’s necessary to share doses so everyone could get vaccinated. 

Good news to finish - BioNTech says COVID vaccine is effective against key new strains

The CEO of German pharmaceutical company BioNTech has said he remains confident the company’s Covid vaccine, developed in partnership with Pfizer, will be effective against the highly-infectious variants of the virus discovered in the UK and South Africa. “We are confident that based on the mechanism of our vaccine, even though there are mutations, we believe that the immune response which is induced by our vaccine could also deal with a mutated virus,” Dr. Ugur Sahin, co-founder and CEO of BioNTech, said. 

That is all from EAPM for now, don’t forget to регистровати for the upcoming EAPM event, and here is the линк на дневни ред.

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