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#EAPM - Tough questions and mask opposition for health care



Welcome all – as summer finally gets into its swing, here is your second August update from the European Alliance for Personalised Medicine (EAPM) for those of you still to depart on much-needed holidays, writes EAPM Executive Director Denis Horgan. 

Mark your calendars

As ever, a reminder that there is still time to register for the ESMO Virtual Congress 2020, at which EAPM will be organizing a round table on 18 September, bringing its stellar cast of specialists from the patients network, as well as experts from the oncology community and the European Medicine Agency (EMA) and European Parliament.

The agenda is available here, and you can already register here. In addition, there is the Presidency Conference upcoming during the German EU Presidency, which takes place on Monday 12 October from 9h-17h, and which is entitled ‘Ensuring Access to Innovation and Data-rich Biomarker Space to Speed Better Quality of Care for Citizens’. Registration will open in the next few weeks. 

Extraordinary EU summit

Also, on 24-25 September, European Council President Charles Michel will be calling an extraordinary EU summit, in order to discuss topics “that the crisis threw off the agenda in the first semester”. Digital policies, the single market, foreign affairs and the relationships with Turkey and China are all set to feature, with coronavirus making an appearance as well, none too surprisingly. The summit is intended to be in-person – on verras…

Asking tough questions at these events...

Amidst conference season, and in a field as complex as personalised medicine, which involves so many disciplines, dimensions and stakeholders, it is important that tough questions are faced if society is to live in the real world, rather than seeking, out of timidity, to emulate the head-hiding behaviour of the ostrich, the interface between an individual patient and a professionalized and regulated system, is pre-eminently a nexus between private and public interests. And as a major area of continual research and technological development, it produces a constant stream of innovations - and consequently becomes a classic battleground on which conflicting views on the merits of innovation are played out.

The specific field of medical innovation offers a rich display of such conflicts - with controversies over high-profile issues such as the direction of research and how to incentivize it, the morality of medicine pricing systems and practices, the ever-multiplying options for gathering and exploiting health-related data, or the adequacy of regulatory controls. So, in discussions of innovation relating to health, meticulous navigation is needed to chart the best path through a multitude of variables. 

The engagement of the individual too is a point of potential dissension, since for innovations to take effect, they must be accepted. The system may be in place, and society may encourage the citizen to take advantage of an opportunity, but at the end of the day, the citizen must take the responsibility. The controversy sweeping across Europe about rights and duties in respect of vaccination offers a compelling example: many parents, unconvinced of the merits of vaccination for their child, are withholding permission for the conduct of immunisation procedures. 

Here the contrast between private and public interests is also clear, as an individual's insistence on refusing vaccination clashes with the public benefit of herd protection that vaccination affords.

No ‘silver bullet’ 

The World Health Organization (WHO) has warned that, despite strong hopes for a vaccine, there might never be a "silver bullet" for COVID-19, and the road ahead back to normality would be long. WHO Director-General Tedros Adhanom Ghebreyesus and WHO emergencies chief Mike Ryan have strongly encouraged all nations to rigorously enforce health measures such as mask-wearing, social distancing, handwashing and testing. "The message to people and governments is clear: 'Do it all'," Dr Tedros told a virtual news briefing from the UN body's headquarters in Geneva on Tuesday (4 August). He said face masks should become a symbol of solidarity around the world.

Surfing or sinking with a second wave?

Whether or not the much-touted ‘second wave’ is already with the UK, is coming or is not, British researchers have warned the government this week that reopening schools in September without first implementing an effective Test, Trace, and Isolating system (TTI) could result in a second wave of COVID-19 more than twice as worse as the first, while the government warned drugs companies to stockpile on medicine to protect against the risks of a no-deal Brexit. The British researchers, drawn from University College London and the London School of Hygiene and Tropical Medicine (LSHTM), researched the impact of reopening schools and its consequences, such as parents returning to work and increased socializing in society. 

They said that an optimistic scenario would be 68% of contacts of infected people being traced, and a pessimistic scenario being just 40% traced. Currently, they believe the system has 50% coverage. In the best-case scenario with an effective TTI, “an epidemic rebound might be prevented,” but in a worst-case scenario, the second wave could be 2.3 times higher than the first. In Germany, on the other hand, the chairwoman of a major doctors’ association said that the country was already in “a second, shallow wave”, adding: “We all long for normality, but we are in a state that is not normal.” The doctor told citizens to comply with restrictions and wear masks, in the face of coronavirus deniers who have a strong voice in the country. 

Medicine shortages

The COVID-19 health crisis has highlighted a growing problem: shortages of medicines and medical equipment that put patients at risk and national health systems under pressure. In April 2020, the European University Hospital Alliance warned that rising demand in intensive care units for certain anaesthetics, antibiotics, muscle relaxants and medicines used in a way they were not originally approved for to treat COVID-19 could mean stocks run out. 

Decreased production, logistical problems, export bans and stockpiling due to the health crisis further increased the risk of bottlenecks. Recently, Parliament’s Environment and Public Health Committee adopted a report calling for European health “independence”by securing supplies, restoring local drug manufacturing and ensuring better EU coordination of national health strategies. Between 2000 and 2018, shortages in the EU increased 20-fold and according to a note by the European Commission are rising for widely used essential products. 

The reasons are complex, ranging from manufacturing problems, industry quotas, legal parallel trade and unexpected peaks in demand following epidemics or natural disasters to pricing, which is decided at national level. The EU is increasingly dependent on non-EU countries – mainly India and China – when it comes to the production of active pharmaceutical ingredients, chemical raw materials and medicines.

Orphan’ status could prove costly for COVID-19 treatments 

Scientists are turning to rare disease medicines, so-called orphan drugs, as possible treatments for COVID-19, with at least 17 of these treatments being trialed to fight coronavirus infections. However, the orphan status tends to push the prices higher, according to STAT, which could be an obstacle to access for the drugs.

Spanish coronavirus epicentre located

According to Spanish daily El Pais, the northern Spanish city of Zaragoza has become the epicentre of the coronavirus pandemic in Europe . The region of Aragón, which has Zaragoza as its capital, has reached 567 reported cases of infection per 100,000 people, the highest in Europe. 

Anti-maskers mock French government on mandatory mask-wearing 

In France, an anti-mask movement has emerged, insisting that wearing a face covering to prevent the spread of COVID-19 is inefficient and an infringement on their personal freedom. This comes as authorities in several more cities decreed masks mandatory in all public spaces. 

The French scientific council, which published its seventh recommendation to the government on Tuesday (4 August), warns that France is at a tipping point and could see a runaway situation with regards to COVID-19 if social distancing and testing is not sustained adequately. Among the followers of this new movement, particularly active on social media, there are those who boycott shops, complain to their local mayors and call for acts of civil disobedience. "Believing that a paper or cloth mask will stop us catching the virus is just as outrageous as saying that a swimsuit will keep us dry when we go swimming," one follower said in a video.

And that’s all for this week – don’t forget to register for the ESMO Virtual Congress 2020 here and check out the agenda here. Have a lovely, safe weekend, stay well, see you next week.


EU's Barnier still hopes trade deal with Britain possible, sources say




The European Union’s Brexit negotiator told the bloc’s 27 national envoys to Brussels that he still hoped a trade deal with Britain was possible, stressing that the coming days would be decisive, diplomatic sources with the bloc told Reuters, write and

Michel Barnier addressed the gathering on Wednesday (16 September) and the three sources either participated in the discussion behind closed doors or were briefed on its content.

“Barnier still believes a deal is possible though the next days are key,” said one of the EU diplomatic sources.

A second diplomat, asked what Barnier said on Wednesday and whether there was still a chance for a new agreement with the UK, said: “The hope is still there.”

The first source said tentative concessions offered by the UK on fisheries - a key point of discord that has so far prevented agreement on a new EU-UK trade deal to kick in from 2021 - were “a glimmer of hope”.

Reuters reported exclusively on Tuesday (15 September) that Britain has moved to break the deadlock despite that fact that publicly London has been threatening to breach the terms of its earlier divorce deal with the bloc.

A third source, a senior EU diplomat, confirmed the UK offer but stressed it was not going far enough for the bloc to accept.

Brexit talks descended into fresh turmoil this month over Prime Minister Boris Johnson’s plans to pass new domestic laws that would undercut London’s earlier EU divorce deal, which is also aimed at protecting peace on the island of Ireland.

US Democratic presidential candidate Joe Biden warned Britain that it must honour the Northern Irish peace deal as it extracts itself from the EU or there would be no US trade deal for the United Kingdom.

The third EU source, who spoke under condition of anonymity, said that the bloc would take a more rigid line in demanding a solid dispute settlement mechanism in any new UK trade deal should Johnson press ahead with the Internal Market Bill.

“There is unease about what Britain is doing but Barnier has stressed he will keep negotiating until his last breath,” said a fourth EU diplomat, highlighting the bloc’s wariness about being assigned blame should the troubled process eventually fail.

Asked about an estimate by Societe Generale bank, which put at 80% the probability of the most damaging economic split at the end of the year without a new deal to carry forward trade and business ties between the EU and the UK, the person said:

“I would put it around the same mark.”

Barnier is due to meet his UK counterpart, David Frost, around 1400 GMT in Brussels on Thursday.

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Biden warns UK on #Brexit - No trade deal unless you respect Northern Irish peace deal




US Democratic presidential candidate Joe Biden warned the United Kingdom that it must honour the Northern Irish peace deal as it extracts itself from the European Union or there would be no US trade deal, write and

“We can’t allow the Good Friday Agreement that brought peace to Northern Ireland to become a casualty of Brexit,” Biden said in a tweet.

“Any trade deal between the US and UK must be contingent upon respect for the Agreement and preventing the return of a hard border. Period.”

Johnson unveiled legislation that would break parts of the Brexit divorce treaty relating to Northern Ireland, blaming the EU for putting a revolver on the table in trade talks and trying to divide up the United Kingdom.

He says the United Kingdom has to have the ability to break parts of the 2020 Brexit treaty he signed to uphold London’s commitments under the 1998 peace deal which ended three decades of sectarian violence in Northern Ireland between pro-British Protestant unionists and Irish Catholic nationalists.

The EU says any breach of the Brexit treaty could sink trade talks, propel the United Kingdom towards a messy exit when it finally leaves informal membership at the end of the year and thus complicate the border between Northern Ireland and EU-member Ireland.

The EU’s Brexit negotiator told the bloc’s 27 national envoys that he still hoped a trade deal with Britain was possible, stressing that the coming days would be decisive, three diplomatic sources told Reuters.

Michel Barnier addressed the gathering on Wednesday and the three sources either participated in the discussion behind closed doors or were briefed on its content.

“Barnier still believes a deal is possible though the next days are key,” said one of the EU diplomatic sources.

Johnson told The Sun that the EU was being “abusive” to Britain and risking four decades of partnership.

He said the UK must “ring-fence” the Brexit deal “to put in watertight bulkheads that will stop friends and partners making abusive or extreme interpretations of the provisions.”

Societe Generale analysts said on Thursday they now see an 80% chance that Britain and the EU will fail to strike a trade deal before the end of the year.

Biden, who has talked about the importance of his Irish heritage, retweeted a letter from Eliot Engel, chair of the Foreign Affairs Committee of the US House of Representatives, to Johnson calling on the British leader to honour the 1998 Good Friday peace deal.

Engel urged Johnson to “abandon any and all legally questionable and unfair efforts to flout the Northern Ireland protocol of the Withdrawal Agreement.”

He called on Johnson to “ensure that Brexit negotiations do not undermine the decades of progress to bring peace to Northern Ireland and future options for the bilateral relationship between our two countries.”

Engel said Congress would not support a free trade agreement between the United States and the United Kingdom if Britain failed to uphold its commitments with Northern Ireland.

The letter was signed by Representatives Richard Neal, William Keating and Peter King.

Johnson is pushing ahead with his plan.

His government reached a deal on Wednesday (16 September) to avert a rebellion in his own party, giving parliament a say over the use of post-Brexit powers within its proposed Internal Market Bill that breaks international law.

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UK sees 'a way through' parliamentary maze for #Brexit treaty breach bill




British Prime Minister Boris Johnson’s government sees a ‘way through’ the parliamentary maze for his bill that would break the Brexit divorce treaty as it talks with rebels in the Conservative Party, a minister said on Wednesday (16 September). write Guy Faulconbridge and Kate Holton.

Johnson’s Internal Market Bill, which the EU has demanded he scrap by the end of September, is currently being debated in parliament, though he is facing a rebellion by some members of his Conservative Party.

“I believe there is a way through,” Robert Buckland told the BBC when asked about negotiations with rebels in parliament over the bill, adding that London wanted a deal with the EU.

“In terms of shared understanding, I have already seen quite a difference,” he said when asked about a possible compromise in parliament.

Asked if he had been involved in negotiations with Bob Neill, a Conservative lawmaker, Justice Secretary Robert Buckland said: “There are lots of discussions going on with all MPs from all parts of the debate, not just Bob Neill.”

“We want to get this bill through, we want to make sure that we are ready for any disagreements or disputes that might arise if we don’t get agreement in the joint committee,” he said. “For me, I just want Brexit sorted.”

Buckland told Times Radio that the bill was needed as an insurance policy in case the EU made a “material breach” of their obligations but that the talks were not yet at that stage and that London would use current mechanisms to find a compromise.

The EU says Johnson’s bill could collapse trade talks and propel the United Kingdom towards a messy Brexit while former British leaders have warned that breaking the law is a step too far that undermines the country’s image.

Johnson said it was essential to counter “absurd” threats from Brussels including that London put up trade barriers between Britain and Northern Ireland and impose a food blockade - steps he said threatened the United Kingdom’s unity.

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