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#EAPM: 2018 - Let’s make ‘better health for all’ a New Year’s resolution



Denis Horgan, executive director of the European Alliance for Personalised Medicine (EAPM)
, takes a look at some possible stakeholder New Year resolutions.

New year, new challenges. As we swing into 2018 there are many issues in the arena of health care that will substantially affect the lives and work of patients, health-care professionals, medical researchers, members of the pharmaceutical industry, EU and national regulators, politicians and more.

The field of personalised medicine is among the fastest moving and requires more cross-fertilisation between different disease and policy areas. Within this growing sphere, there is a need to offer up valuable evidence and stakeholder opinion on which policy makers can base their decision making on how better to integrate personalised medicine into EU health-care services.

EAPM already regularly brings together different streams (all of the stakeholders mentioned above, in fact) in order to allow decision makers to understand changes that are required, now and down the line.

Each stakeholder group has its part to play and, perhaps, the same New Year’s resolution is necessary in each case: to step outside their silos and cooperate and collaborate more with each other and across each other’s different disciplines.

Patient groups need to be listened to more, throughout all stages of the medical process (it is about them in the end, after all) yet they also need to be better educated about their illnesses and the potential best treatments (including clinical trial opportunities).

For their part, health-care professionals (HCPs) really do need to get up-to-speed with advances in personalised medicine, so ongoing training is vital.

EAPM’s education working group has noted that if personalised medicine is to be in line with the EU and Member State principle of universal and equal access to high-quality healthcare, then clearly it must be made available to many more citizens than is currently the case.

It is more important than ever to bring Europe together in a way that improves the already significant skills that HCPs possess to enable co-decision making which will effectively empower the patient.

In this modern era, patients are demanding to become more-and-more involved in their own treatments. They know more than ever before and have a right to dialogue with their doctors, nurses and surgeons.

But in the age of personalised medicine it has become clear that neither the patients nor the healthcare professionals (HCPs) know quite enough. Crucially, the same holds true for regulators and policymakers.

The two are definitely linked as more understanding at every level will bring about greater awareness of stakeholder issues and will inevitably lead to better regulation and legislation from on high.

So regulators please take note, just in case you were short of a New Year’s resolution…

Meanwhile, improved health literacy has been proven to save money in healthcare budgets, and the WHO, among others, has called for policy action to strengthen it.

Evidence has been shown that strengthening health literacy builds individual and community resilience, helps to address health inequities and improves health and well-being.

Fortunately, in Europe, health literacy among patient is a key part of Health 2020, the European health policy framework which, in 2012, was adopted by member states in 2012. The bottom line, though is that education among both patients and HCPs needs to be stepped up swiftly.

Indeed, EAPM’s Congress in Milan later this year will address, among many other matters, complex inter-related topics to embrace thinking on the need for improved health literacy (for patients, HCPs and, yes, those regulators), and ongoing training for HCPs.

Meanwhile, in the vital field of research, European researchers have been at the forefront of major scientific healthcare discoveries in areas such as cancer, cardiovascular disease, genetic disorders, and infectious disease.

The challenge now and for each new year is how best to translate this knowledge and expertise into advances that improve outcomes for patients.

In this area, the Alliance working group for a Research Road Map for Personalised Medicine asks the EU to commit to the development of a European Translational Research Platform that enables the efficient translation of research discoveries to innovative diagnostics, therapeutics, products and processes that will benefit European patients, industries and societies.

At the end of the day, though, more collaboration is needed within member states and across borders.

Let’s take genomics from a search angle: Our understanding of genomics has increased substantially since 2000, by which point the majority of the genome had been sequenced as part of the Human Genome Project.

Research since then has greatly improved understanding of the genome’s implications for health. These advances have been matched by a revolution in technology, including the development of next-generation sequencing in which a rapid reduction in costs are making the technology more available for clinical applicability. It is fantastic progress, yet the research must go on, much of which relies heavily on Big Data.

On that topic, EAPM’s working group on Big Data (chaired by INTEL), will resolve to reinforce its key ask which is that, by 2020, the EU should endeavour to achieve widespread benefits for patients and citizens from personalised healthcare by defining, and subsequently executing, a Data Strategy for personalised medicine.

Again, it is vital that legislators and politicians step up to the plate to make the most of this incredible and ever-growing resource.

Also, Europe needs to facilitate the IT infrastructure and processes to provide the necessary evidence base using real-world data, and tech industry players are vital here.

But, lest we forget, as personalised medicine evolves, there needs to be more and better incentives for innovation.

The big question is how to fully integrate Europe's brilliant research into national healthcare systems, especially as the ’system’ of getting efficacious, innovative drugs and treatments affordably to those who need them is no longer fit for purpose.

Obviously, the price of new treatments may cause problems in all countries that provide state-based health-care assistance to their citizens.

Industry clearly has a key role to play here, but not on its own. What is needed is a form of collaboration: pharmaceutical companies have a right to make profit, the state - and therefore its citizens - has a right to obtain access to effective treatments at an acceptable price.

EAPM’s working group on access and value, chaired by industry giant Roche alongside the European Patient Forum, aims to ensure that healthcare resources are allocated to development and utilisation of personalised medicine, and to effect a paradigm shift in pricing and reimbursement to recognize the societal value of a medicine.

Overall in the field of personalised medicine, there is certainly a need for a responsive regulatory environment that responds to the needs of all stakeholders whilst ensuring patient safety, with the end result of ensuring development of treatments for patients.

Politicians, such as MEPs and member state health ministers, need to carry on the good work that has brought about necessary Council Conclusions on personalised medicine as well as new, updated regulations on everything from data protection to IVDs to clinical trials.

In the end, though, every stakeholder should resolve and strive this year (and into the future) to put the patient at the centre of his or her own health care and to deliver the right treatment to the right patient at the right time.

Happy New Year!


EAPM and ESMO bring innovations to health policymakers



For the eighth year in succession, the European Alliance for Personalised Medicine (EAPM) has held a high-level conference series alongside the annual ESMO Congress, writes EAPM Executive Director Denis Horgan.

The EAPM conference was opened with the announcement that the following article was published and contributed to by more than 40 experts across the EU on how to bring Greater Accuracy to Europe’s Healthcare Systems: The Unexploited Potential of Biomarker Testing in Oncology.  Please click here to have access.

Sessions include: Session I: Tumor Agnostic, Session II: Biomarkers and Molecular Diagnostics, and Session III: Utilising Real-World Evidence in a health-care setting.  The conference runs from 08.00 – 16.00. Here is the link to the agenda. The conference aims to bring  key recommendations to the EU level, so as to shape the EU Beating Cancer Plan, EU health Data Space, the updating EU Pharmaceutical Strategy as well as the EU Health Union. 

The conference is held following the first State of the Union address by European Commission President Ursula von der Leyen on Wednesday (16 September) – in her first annual address, von der Leyen said the coronavirus pandemic had underlined the need for closer cooperation, stressing that people were “still suffering”.

For me, it is crystal clear – we need to build a stronger European Health Union,” she said. “And we need to strengthen our crisis preparedness and management of cross-border health threats.” Von der Leyen said her commission would try to reinforce the European Medicines Agency and European Centre for Disease Prevention and Control.

And she also raised the importance of the European Beating Cancer Plan as well as European Health Data Space. “This will show Europeans that our Union is there to protect all,” she said.

Fabrice Barlesi, medical director of Gustave Roussy, said: “RCTs are no longer the way to go. A way ahead could be EU support for trialing a new drug and delivering data to a centralised registry, which could give good consolidated data from across Europe.”

Divided into three sessions, the EAPM conference at the ESMO Congress, as mentioned,  dealt with such diverse issues as tumour agnostics, biomarkers and molecular diagnostics and real-world evidence in a health-care setting. Concerning cancer, specifically tumours, the congress stated that  tissue-agnostic cancer drugs are antineoplastic medicines that treat cancers based on the mutations that they display, instead of the tissue type in which they appear.

These drugs include, for example, Entrectinib, Pembrolizumab and Larotrectinib. Former Spanish health minister and MEP Dolors Moseratt highlighted her support for the work of EAPM and looks forward to getting the recommendations of the outcomes from the conference.  “The European added value of health is obvious. It would avoid duplication and enable a better allocation of resources. And it will minimize the risk of fragmented access to therapy across member states.”

And the EAPM conference is at pains to seek the best ways forward for the implementation of Real-World Evidence (RWE) into health care in Europe – looking to find consensus with key decision makers, including at member state level, not least with representatives in the European Parliament, on how to proceed in this area. RWE for health care is a simple concept – harnessing various health data in real time to help make faster and better medical decisions.

Real-World Evidence is an umbrella term for different types of health-care data that are not collected in conventional randomised controlled trials, including patient data, data from clinicians, hospital data, data from payers and social data.

Rosa Giuliani, consultant in medical oncology at the Clatterbridge Cancer Center, said: “Key elements to advance the use of TACs is to conduct dialogue that transcends silos, and to explore re-engineering of the development pathway.” And, as far as biomarkers and molecular diagnostics are concerned, a lot has been said about testing, and often the lack of it, in terms of the COVID-19 outbreak, with different countries adopting different strategies and, also, having different resources when it comes to acquiring necessary kits.

The key focus in the ESMO session was on better and more equitable access to biomarkers and molecular diagnostics across Europe.  This is a must, but, as the attendees acknowledged, we’re a long way short of it. Access to personalised medicine and new diagnostic technologies can help resolve many inefficiencies, such as trial-and-error dosing, the potential for increased hospitalisation time due to adverse drug reactions and the problem of late diagnoses. It may also enhance the effectiveness of therapies through better tailored treatment administration.

In conclusion for the morning session, Giuseppe Curigliano, associate professor of Medical Oncology at the University of Milano, and head of the division of Early Drug Development, at the European Institute of Oncology said: “A real challenge to overcome is the different endpoints between investigators and payers. Policy frameworks and co-operation is essential.” The session in the afternoon will focus on utilizing real-world evidence in a health-care setting.

A report will be available next week. 

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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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