The European Alliance for Personalised Medicine (EAPM) contiguous (2 July) hailed its latest virtual league “a large success”, attended by 164 delegates, aft its Bridging Event held betwixt the outgoing and incoming EU Presidencies took spot connected 1 July, writes EAPM Executive Director Dr. Denis Horgan.
On the aforesaid day, Portugal was handing implicit the EU Presidency reins to Slovenia and, arsenic that was taking place, EAPM was hosting the 2nd EAPM Bridging Presidency Conference entitled 'Innovation, Public Trust and Evidence: Generating Alignment to facilitate personalized Innovation successful Health Care Systems', which acted arsenic a bridging lawsuit betwixt the EU Presidencies of Portugal and Slovenia, with the cardinal areas speakers and delegates discussed being RWE and nationalist trust, beating prostate crab and lung cancer, wellness literacy, and securing diligent entree to precocious molecular diagnostics.
The problem, arsenic ever, for some presidencies is the intimately guarded subordinate authorities competence successful wellness care, which was a hot topic during the conference. Indeed, we’ve seen caller battles successful this arena regarding the European Commission’s projected mandatory aspects of HTA, though a compromise was reached connected the past day. More connected that below.
What is surely clear, determination is the request for Europe to marque definite that it is overmuch amended coordinated up of the adjacent large pandemic arsenic good arsenic ongoing pandemics specified arsenic successful cancer. As European Commission President Ursula von der Leyen has antecedently said, the champion concern successful the EU’s aboriginal is successful innovators and researchers arsenic the cardinal to competitiveness. This holds arsenic existent successful wellness attraction arsenic successful immoderate different sector, if not much so, which was a cardinal statement for the conference.
A study volition beryllium issued adjacent week.
HTA compromise text
The compromise substance of the statement betwixt negotiators connected the wellness exertion appraisal (HTA) regularisation is simply a large symbolic triumph for Portugal, which was capable to adjacent a woody that had escaped the erstwhile six Presidencies that worked connected associated HTA — including the Germans who were expected to beryllium the ones to get a deal. Besides Portugal, France and Germany got their biggest inquire — namely nary binding wording to encroach connected nationalist powers implicit technological assessments of drugs.
EU’s COVID-19 Digital Certificate yet live
The EU's Digital COVID certificate officially came into unit from 1 July. By Wednesday evening (30 June), 21 EU nations, retired of the full 27, were connected to the system's web and six others were technically ready. Some countries already began utilizing the caller wellness certificate successful June.
According to the European Commission, each subordinate states should present beryllium successful a presumption to contented and judge the pass, but for Ireland which has been delayed by cyber attacks. A gradual implementation play is present successful place, with a grace play moving until 12 August for countries not acceptable connected 1 July. During this period, different states should judge nationalist documents connected information they incorporate information required astatine a European level.
But the motorboat comes nether the unreality of the Delta variant, which is already prompting EU countries to restrict question from countries wherever it is prevalent, specified arsenic the UK, Portugal and India.
European portion COVID cases leap 10%
New COVID cases successful the World Health Organization’s (WHO) 53-country European portion roseate 10% past week aft falling for 10 consecutive weeks, the assemblage has said, informing of a imaginable caller surge earlier autumn and calling for much monitoring of Euro 2020 matches. Infection numbers proceed to autumn successful galore parts of the region, including the EU, but Katy Smallwood, WHO Europe’s elder emergencies manager, said immoderate – specified arsenic Russia – were signaling their highest regular decease tolls of the pandemic. Driven by the much contagious Delta variant, combined with “increased mixing, travel, gatherings, and easing of societal restrictions”, infections were rising portion vaccination levels successful the portion were not precocious enough, the determination director, Hans Kluge, said.
Slovenia’s integer agenda
As mentioned above, the Slovenian Presidency of the EU Council that started connected 1 July volition absorption connected cybersecurity, Artificial Intelligence and Digital Services Package, portion the long-pending ePrivacy Regulation is acceptable to instrumentality a backmost seat. Ljubljana sees cybersecurity arsenic a mode to heighten the resilience of the EU system by establishing cybersecurity standards, reporting procedures, and accusation speech requirements arsenic portion of the revised Directive connected Security of Network and Information Systems (NIS II).
Slovenia besides backs the precocious published Commission plans for an EU Joint Cyber Unit, which aims to co-ordinate responses astatine the EU level for large-scale cyberattacks connected captious infrastructure.
On Artificial Intelligence, the attack is to “create a precocious level of spot successful human-centric AI”, Public Administration Minister Boštjan Koritnik told reporters. The Slovenian authorities purpose to laic the groundwork for a wide attack to the Artificial Intelligence Act. The Digital Services and Markets Acts are the different main priorities, arsenic the nonsubjective is to broker a communal presumption for EU countries by November. The absorption present volition beryllium connected preventing “the vulnerability of citizens to expanding risks and harmful consequences online”, Koritnik added.
The ePrivacy Regulation intends to specify the privateness model for physics communications, pursuing online communications enjoying the aforesaid level of privateness extortion arsenic much accepted telecommunications.
The Commission launched the archetypal draught of the connection successful January 2017, portion the European Parliament reached a communal presumption successful September the aforesaid year. The legislative connection has been stalled successful the Council ever since, arsenic the EU governments held antithetic views connected however to reconcile the close to privateness with method requirements that bash not hamper innovation. The assembly yet agreed connected a mandate for the negotiations connected February 2021, which passed lone for the abstention of Austria and Germany. One of the main points of contention related to the conditions nether which metadata could beryllium processed. Metadata refers to each the accusation related to physics communications, specified arsenic time, place, and radical involved. Another arguable constituent is nether which conditions to let work providers to entree the information stored connected user equipment, for lawsuit successful the signifier of cookies.
UK gets information flows woody from EU — for now
The UK’s integer businesses tin respire a suspiration of alleviation contiguous arsenic the European Commission has officially signed disconnected connected information adequacy for the (now) 3rd country, post-Brexit. It’s a large woody for UK businesses, arsenic it means the state volition beryllium treated by Brussels arsenic having fundamentally equivalent information extortion rules arsenic markets wrong the bloc, contempt nary longer being a subordinate itself — enabling idiosyncratic information to proceed to travel freely from the EU to the U.K. and avoiding immoderate caller ineligible barriers. The granting of adequacy presumption has been each but assured successful caller weeks, aft European Union subordinate states signed disconnected connected a draught adequacy arrangement.
But the Commission’s adoption of the determination marks the last measurement successful the process — astatine slightest for now. It’s notable that the Commission’s PR includes a wide informing that if the U.K. seeks to weaken protections afforded to people’s information nether the existent authorities it “will intervene”. In a statement, Commission Values and Transparency Vice President Věra Jourová said: “The UK has near the EU but contiguous its ineligible authorities of protecting idiosyncratic information is arsenic it was. Because of this, we are adopting these adequacy decisions today. At the aforesaid time, we person listened precise cautiously to the concerns expressed by the Parliament, the subordinate states and the European Data Protection Board, successful peculiar connected the anticipation of aboriginal divergence from our standards successful the UK’s privateness framework.
"We are talking present astir a cardinal close of EU citizens that we person a work to protect. This is wherefore we person important safeguards and if thing changes connected the UK side, we volition intervene.”
That is each from EAPM for present – person an fantabulous weekend, enactment harmless and well, and bash cheque successful with EAPM adjacent week!
Good greeting and welcome, wellness colleagues, to the 2nd European Alliance for Personalised Medicine (EAPM) update of the week – arsenic it stands, much than 150 radical person present registered for our upcoming EAPM Slovenian EU Presidency league connected 1 July, truthful present is the clip to articulation them and publication your spot earlier it’s excessively late, and we besides person an update connected the European Parliament’s draught study connected strengthening Europe successful the combat against cancer, writes EAPM Executive Director Dr. Denis Horgan.
EAPM league approaches - a reminder yet again...
The EAPM league volition enactment arsenic a bridging lawsuit betwixt the EU Presidencies of Portugal and Slovenia. The league is divided into sessions which screen the follows areas: Session 1: Generating alignment successful the regularisation of Personalized Medicine: RWE and Citizen Trus; Session 2: Beating Prostate Cancer and Lung Cancer - The Role of the EU Beating Cancer: Updating EU Council Conclusions connected Screening Session 3: Health Literacy - Understanding Ownership and Privacy of Genetic Data and finally not least, Session 4: Securing diligent Access to Advanced Molecular Diagnostics.
Each league volition comprise sheet discussions arsenic good arsenic Q&A sessions to let the champion imaginable engagement of each participants, truthful present is the clip to register here, and download your agenda here.
Battling crab – Parliament’s cardinal draught report
As mentioned successful erstwhile updates, the European Parliament has acceptable up a peculiar committee connected beating cancer. It has published its archetypal draught study connected the EU Beating Cancer Plan connected the past day, which has included a fig of items which the EAPM has advocated for successful the past months representing cardinal issues representing the multi-stakeholder quality of its membership.
Subdivided into galore articles, nonfiction 66 in the study is of peculiar attraction to EAPM members, saying arsenic it does that immense advances successful biology person revealed that crab is an umbrella word for much than 200 diseases, and that precision oregon personalised medicine tin beryllium made disposable done the cause targeting of assorted mutations.
The study besides considers that precision oregon personalised medicine, consisting of a attraction prime based connected idiosyncratic tumour biomarkers, is simply a promising mode to amended crab treatment, and encourages subordinate states to beforehand the implementation of determination molecular genetics platforms and facilitate adjacent and accelerated entree to personalised attraction for patients.
In addition, article 48 successful the draught study calls connected the Commission to promote, and connected subordinate states to strengthen, the relation of wide practitioners, paediatricians and superior attraction professionals, fixed their value successful diligent referral to diagnostic tests and oncology specialists, arsenic good arsenic during cancertreatment and follow-up care; calls for the improvement of multidisciplinary decision-making successful the model of dedicated concertation meetings bringing unneurotic assorted crab specialists.
According to nonfiction 61, the provisional statement connected the Health Technology Assessment (HTA) Regulation reached by the European Parliament and the Council connected 22 June 2021 is welcomed, to harmonize entree to innovative crab diagnosis and treatments.
Perhaps astir importantly, nonfiction 87 sees an urgent request for a European charter of the rights of crab patients; calls for this charter to specify the rights of crab patients astatine each signifier of their attraction pathway, i.e. entree to prevention, archetypal diagnosis and passim their treatment, and for it to use arsenic to each EU citizens, careless of the state oregon portion successful which they live.
In addition, nonfiction 105 looks to the ‘Cancer Diagnostic and Treatment for All’ flagship and puts a spotlight connected the request for the usage of the ‘next procreation sequencing’ exertion for speedy and businesslike familial profiles of tumour cells, allowing researchers and clinicians to stock crab profiles and use the aforesaid oregon akin diagnostic and therapeutic approaches to patients with comparable crab profiles.
EAPM looks guardant with enthusiasm to each guardant advancement being made successful the combat against cancer. In this context, EAPM is moving connected 2 publications with its experts connected NGS and RWE which volition provide further input/guidance to the European politicians which EAPM is moving with.
HTA governmental agreement
The Commission welcomes the governmental statement connected the Health Technology Assessment (HTA) Regulation reached by the European Parliament and the Council connected 23 June. The Regulation volition amended the availability of innovative wellness technologies specified arsenic innovative medicines and definite aesculapian devices for EU patients, guarantee businesslike usage of resources and fortify the prime of HTA crossed the EU. Examples of wellness technologies see medicinal products, aesculapian instrumentality and diagnostics. It volition besides facilitate concern predictability, trim duplication of efforts for HTA bodies and manufacture and guarantee the semipermanent sustainability of EU HTA co-operation.
Welcoming the agreement, Commissioner for Health and Food Safety Stella Kyriakides made the pursuing statement: “I americium precise pleased that the European Parliament and the Council person reached a long-awaited governmental statement connected the Health Technology AssessmentRegulation. The Regulation volition beryllium a important measurement guardant to alteration associated technological assessments of promising treatments and aesculapian devices astatine EU level.”
Progress connected vaccinations welcomed, but further effort urged
The European Council welcomes the bully advancement connected vaccination and the wide betterment successful the epidemiological situation, portion stressing the request to proceed vaccination efforts and to beryllium vigilant and co-ordinated with respect to developments, peculiarly the emergence and dispersed of variants.
According to the draught European Council conclusions for the June 24-25 meeting, the Council stated that it “reaffirms the EU’s committedness to planetary solidarity successful effect to the pandemic”.
“All producing countries and manufacturers should actively lend to efforts to summation worldwide proviso of COVID-19 vaccines, earthy material, treatments and therapeutics, and coordinate enactment successful lawsuit of bottlenecks successful proviso and distribution,” the draught substance declares.
The conclusions besides notation caller agreements connected question wrong the EU, stating that subordinate countries would use these measures “in a mode that ensures the afloat instrumentality to escaped question arsenic soon arsenic the nationalist wellness concern allows.” The Council besides plans to invited the determination to acceptable up a peculiar league for the World Health Assembly to sermon a pandemic treaty, with the EU saying that it volition proceed to enactment toward a extremity of a treaty.
WHO, WIPO and the WTO hold connected intensified co-operation to tackle COVID-19 pandemic
On 15 June, the directors wide of WHO, WIPO and the WTO met successful a tone of co-operation and solidarity to representation retired further collaboration to tackle the COVID-19 pandemic and the pressing planetary challenges astatine the intersection of nationalist health, intelligence spot and trade. Acutely conscious of the shared work to communities crossed the satellite arsenic they face a wellness situation of unprecedented severity and scale, the organizations pledged to bring the afloat grade of the expertise and resources of the respective institutions to carnivore successful ending the COVID-19 pandemic and improving the wellness and well-being of each people, everyplace astir the globe.
Commitment to universal, equitable entree to COVID-19 vaccines, therapeutics, diagnostics, and different wellness technologies was underscored – a committedness anchored successful the knowing that this is an urgent motivation imperative successful request of contiguous applicable action. In this spirit, determination was an statement to physique further connected the long-standing committedness to WHO-WIPO-WTO Trilateral Cooperation that aims to enactment and assistance each countries arsenic they question to measure and instrumentality sustainable and integrated solutions to nationalist wellness challenges.
Within this existing cooperative framework, it was agreed to heighten and absorption our enactment successful the discourse of the pandemic done 2 circumstantial initiatives - the 3 agencies volition collaborate connected the enactment of practical, capacity-building workshops to heighten the travel of updated accusation connected existent developments successful the pandemic and responses to execute equitable entree to COVID-19 wellness technologies. The purpose of these workshops is to fortify the capableness of policymakers and experts successful subordinate governments to code the pandemic accordingly. The archetypal store successful the bid volition beryllium a store connected exertion transportation and licensing, scheduled for September.
Long COVID concerns
More than 2 cardinal adults successful England person experienced coronavirus symptoms lasting implicit 12 weeks, specified arsenic respiratory problems and fatigue, authorities information suggests. It is treble the erstwhile estimation for agelong Covid. The probe by the React-2 study, which has not yet been peer-reviewed, recovered that 37.7% of those who had symptomatic Covid experienced astatine slightest 1 grounds lasting 12 weeks oregon more, portion 14.8% had 3 oregon much persistent symptoms. “The standard of the occupation is rather alarming,” said Professor Kevin McConway, emeritus prof of applied statistic astatine the Open University. It comes arsenic much than 16,000 caller confirmed Covid cases were reported successful the UK connected Wednesday (23 June), the highest regular fig since aboriginal February. The newest figures showed different 19 radical had died wrong 28 days of investigating affirmative for Covid-19, bringing the UK full to 128,027. While decease figures stay comparatively low, the crisp emergence successful reported cases would look to marque it little apt that ministers volition scrap astir remaining Covid restrictions earlier the existent four-week hold ends connected 19 July.
Switzerland to re-open
While countries specified arsenic the UK hold their planned lifting of restrictions (as it stands, until 19 July successful the lawsuit of the UK), Switzerland has announced an adjacent much wide-ranging lifting of restrictions than antecedently planned. Citizens volition nary longer beryllium required to enactment from home; they won’t person to deterioration masks oregon societal region astatine taste and sporting events; and wide events tin spell up without restrictions connected numbers oregon the request for masks if there’s a request for coronavirus certificates.
And that is each from EAPM for this week – person a beauteous weekend, enactment harmless and well, and don’t hide to register here, and download your agenda here, for the EAPM EU Presidency league connected 1 July.