Greetings colleagues, and welcome to the final European Alliance for Personalised Medicine (EAPM) update of the week. We hope you are looking forward to your weekend, and that you enjoy news of the upcoming B1MG Conference on 21 October and the update of recommendations from our recent German EU Presidency Conference, writes European Alliance for Personalised Medicine, Executive Director, Denis Horgan.

B1MG Stakeholder Co-ordination Group Meeting

Registration is still very much open for the B1MG meeting on 21 October. The aim of the the B1MG is to support the connection of national genomics and data infrastructures, co-ordinate the harmonization of the ethical and legal framework for sharing data of high privacy sensitivity, and give practical guidance for the pan-European co-ordination of implementing genomic technologies in national and European health-care systems. 

Thus, the B1MG is a means to bring the different stakeholders together on Oct 21st so as to act as a catalyst to provide a benchmark approach for alignment of complex, fractionated health-care provisions into health-care systems.  The objective of the meeting is to discuss the key drivers which are the stakeholders to make this a reality. Register here and read the full agenda here.

German EU Presidency Conference

 Held during the auspices of the Germany Presidency of the Council of Ministers on 12 October, EAPM’s conference was very successful in its own right, with an agenda packed with insights from distinguished speakers on ‘Ensuring access to innovation and data-rich biomarker space to speed better quality of care for citizens’. 

The report, which will be issued on Monday (19 October), delivered a message on the immediate need for a new way of thinking about health care. It presented this urgency through discussions on adequate health care frameworks, better allocation of resources, the potential of advanced testing, co-ordinated approaches to cancers and of the deployment of advanced therapy medicinal products – all against the background of the ongoing battle against COVID.

More than 200 delegates attended, and there were contributions from European politicians, officials from the European Commission and the European Medicine Agency, and a multitude of key stakeholders from countries including Germany, which is presently hosting the EU Presidency.

Principal Recommendations:Although there was no formal process of agreeing recommendations at the meeting, the following are among the recurring elements from the discussions which will be elaborated on the report which will be issued on Monday. 

  • Inequalities in access to testing and treatment across Europe must be addressed.
  • Adequate data infrastructure and processing capacity must be available.
  • Real-world evidence must be developed and acceptance criteria agreed with regulators, HTA agencies and payers.
  • Greater flexibility in regulatory requirements is needed to accommodate evaluation of products destined for small populations.
  •  Multi-stakeholder collaboration must be developed to agree research priorities, standards and quality assurance of testing, and evaluation criteria for testing and treatments.
  • Trust must be developed among citizens about the security and possible use of their data.
  • Communication must be developed by healthcare stakeholders to persuade policymakers to effect constructive change

No Strasbourg plenary…again

European Parliament President David Sassoli has cancelled next week’s trip to Strasbourg. The Parliament plenary “will not take place in Strasbourg, but will be held remotely,” he wrote on Twitter. “The situation in France and Belgium is very serious and travelling is not advised.” Sassoli said his decision to cancel “was a very difficult choice for me because I was convinced this time that I could manage the transfer to Strasbourg.” But it’s about something bigger than managing a move, he suggested: “We must do everything possible … to avoid the closure of the Parliament” and commit to “make sure that democracy is not blocked, above all in a moment like this one.”

Spain imposes state of emergency in Madrid 

The Spanish government has ordered a 15-day state of emergency to bring down Covid-19 infection rates in the capital, after a court overturned a partial lockdown imposed a week ago. Madrid and nearby cities will see restrictions enforced by 7,000 police. The capital has been at the centre of a political row, with the centre-right city authorities challenging the Socialist-led government’s demands. Cases are down and a state of emergency is unjustified, say city officials. Madrid health minister Enrique Ruiz Escudero insisted that measures already in place were working and that the national government order was “a measure no Madrileño will understand”. 

World Health Organization (WHO) reform

 The German Council presidency has set October 30 as its date for a formal meeting of health ministers. Officials have given member states an overview of the COVID-19  response to date and provided updates on the changes that have taken place within the organization to support coronavirus response efforts. These changes include the creation of WHO’s science division — which initiated the Solidarity Trial to compare COVID-19 treatments and assess their effectiveness — and the new emergency preparedness division under the WHO Health Emergencies Programme.

Great and good in place

The Council is meeting for a two-day summit today (16 October) and COVID-19 is obviously high on the agenda. Conclusions ahead of the EU summit read: “The Council calls on the Commission and the member states to continue the overall coordination effort, notably regarding quarantine regulations, cross border contact tracing and the joint assessment of testing methods.” Vaccines are also on the list of topics up for discussion.  The Council will discuss “overall co-ordination and the work on the development and distribution of a vaccine at the EU level”.

UK government has ‘powers to enforce Manchester restrictions’ in lockdown row 

 The government has the power to impose tougher COVID restrictions in Manchester and other towns amid a growing row over tough new measures, foreign secretary Dominic Raab has said. Raab told Sky News that Westminster will “keep talking” with local leaders over further coronavirus restrictions but said the “government has the powers to proceed in any event” should these talks fail. He accused Labour of sending mixed messages and accused the opposition of “political confusion”. 

Worried Merkel lays down the law in Germany 

Germany’s states agreed on Wednesday (14 October) to extend measures against the spread of the coronavirus to larger parts of the country as new cases soared, but Chancellor Angela Merkel warned even tougher steps may be needed. “What we do in the coming days and weeks will be decisive for how we get through this pandemic,” Merkel said at a news conference after a meeting with the heads of Germany’s 16 states, adding that the goal was to safeguard the economy. 

Under Wednesday’s agreement, the threshold at which tougher measures such as late-night curfews on bars and tighter restrictions of private gatherings kick in will be lowered to 35 new infections per 100,000 people over seven days, compared with 50 before. If these measures fail to halt the rise in infections, further measures will be introduced to avoid a second full lockdown that could have a devastating impact on the economy.

Catalonia closes restaurants and bars for two weeks

The Catalan government on Wednesday approved the closure of all bars and restaurants in the region in a bid to slow the spread of the coronavirus. According to data from the regional health department released earlier today, the 14-day cumulative number of coronavirus cases in Catalonia has risen to 290 per 100,000 inhabitants – a figure not seen since the beginning of April. 

Netherlands in ‘partial lockdown’

 Dutch Prime Minister Mark Rutte announced a ‘partial lockdown on Tuesday (13 October), adding that masks will become mandatory in places such as stores and museums — a departure from the country’s longstanding resistance to requiring them in public. Furthermore, restaurants and bars will temporarily shut their doors. The new measures are expected to last for four weeks, but will be re-evaluated in two weeks.

Not so dolce-vita

Italy’s nightlife is under new restrictions with the latest act signed by Prime Minister Giuseppe Conte and Health Chief Roberto Speranza. New rules include closure of all bars and restaurants by midnight, while patrons are required to be served sitting down at a table from 9 p.m. Masks are required inside private businesses and on the street.

Belgium set to tighten restrictions as well

The Belgian government may well announce tighter restrictions today (16 October) as the number of cases reported in the country continues to rise. Options may include a stricter mandate for home working to tighten rules on bars and restaurants. Restrictions on sports are also coming into effect.

And that is everything for this week – have an excellent weekend, stay safe and well, and remember: Register here and read the full agenda here for the B1MG meeting on 21 October. 

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