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#EAPM: Bucharest hosts key conference on personalised medicine

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eapm_logo_final_MonoBlueThis week (19 October) saw the Brussels-based European Alliance for Personalised Medicine (EAPM) play a key role in a cutting-edge conference in the eastern-European city of Bucharest, writes EAPM Executive Director Denis Horgan. 

The gathering followed in the wake of an earlier satellite symposium held on October 18th in the Romanian capital, also addressed by EAPM. At the conference in Cotroceni Palace, a key topic was access to, and shortage of, medicines, which is in the news at the moment due to a scandal on the ‘unethical’ over-pricing of cancer drugs in Italy.

This saw a pharmaceutical company, Aspen Pharma, fined €5.2 million last Friday for abusing its dominant position in the cancer-medicine market, and effectively blackmailing the Italian regulatory agency over prices that it attempted to boost by up to 1,500%.

The scandal has seen pressure groups and consumer watchdogs ramp-up calls for the European Commission to launch a probe into medicine shortages.

The purpose of this would be to examine whether these shortages are being used as a tactic to up prices charged to Member State health authorities.

At the Bucharest conference, meanwhile, EAPM’s Executive Director Denis Horgan was joined by Diana Păun, Health Advisor at the Romanian Presidency; Marius Geantă, President and Co-founder, Center for Innovation in Medicine, and Member of the European Parliament Cristian Bușoi in the early addresses.

The USA’s Richard Ablin spoke on the topic ‘Toward the Realisation of Personalised Medicine’, while Elmar Nimmesgern, of the European Commission’s Personalised Medicine Unit, gave a European perspective on personalised medicine.   A multi-dimensional debate followed covering topics such as investment and the role of education in training health-care professionals in order that they come up-to-speed with today’s fast-moving developments in genetics, data and more.

Speakers included Ioanel Sinescu, Rector University of Medicine and Pharmacy, Bucharest; Cecilia Radu, General Manager NovoNordisk Romania; John Milne, Training Director National Institute for Bioprocessing, Research and Training, Dublin, Ireland; Cătălina Poiană, President College of Physicians Bucharest, and Florin Buicu, President Commission for Public Health at the Romanian Parliament.

On the key topic of education, EAPM will hold its second annual summer school for health-care professionals (HCPs) in Bucharest in 2017.  Building on the success of the inaugural Summer School in Cascais, Portugal, the concept will be taken east from 3-7 July next year.

The school is entitled ‘TEACH’, which stands for Training and Education for Advanced Clinicians and HCPs, and the goal is to bring young HCPs up-to-date with developments in this exciting field.  Aimed at young healthcare professionals aged 28-40, TEACH works on the basis 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 it is now.

The school dovetails with EAPM’s call on the European Commission to focus funds to stimulate a Continuous Education and Training Programme for HCPs in the context of personalised medicine  After education was discussed, Hans Lehrach; of the Max Planck Institute for Molecular Genetics Berlin spoke on the topic: 'The Future of Health Care: deep data, smart sensors, virtual patients and the Internet of Humans'.

Lehrach’s address was followed by a debate on Big Data for Personalised Medicine, featuring Dan Gârlașu, of Oracle Romania; Călin Gălășeanu, ARPIM President; Mihnea Costoiu, Rector Polytechnik University Bucharest, and EAPM’s Horgan once again.   Other speakers were Paul Cornes, of NICE; Nikolaos Tsoulos, CEO Genekor; Corina Pop, Secretary of State, Ministry of Health, and; Irina Berechet, Corporate affairs manager, AstraZeneca Romania.  The symposium the day before featured many of the same speakers but focussed more on access to biologics therapies in Romania.

Held at the city’s Casa Titulescu, other speakers included Sol Ruiz, Chair of the Biologics Working Party at the European Medicines Agency; Ioannis Petrakis (Market Access, HEOR and Governmental Affairs Head, MCO Balkans; Vlad Negulescu, of the Romanian National Drug Agency, and; Vasile Cepoi (President of the National Agency for Health Quality.

Speaking today (20 October) EAPM’s Denis Horgan said: “The issue of access to medicines and treatments is huge, and the Alliance and its multi-stakeholders have always been aware of this.  “The problem is unacceptable everywhere but can be even worse in eastern countries.”  Horgan added: “The barriers to integrating personalised medicine into healthcare systems often loom larger in the eastern member states, due to several reasons including the fact that they tend to have less resources than their counterparts and many of their healthcare professionals migrate westwards.

“This is one of the reasons that EAPM was here yesterday and today for these key meetings, and also why we have chosen Bucharest to host our 2017 summer school.”

Defence

Three dead as woman beheaded in France, gunman killed in second incident

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A knife-wielding attacker shouting “Allahu Akbar” beheaded a woman and killed two other people in a suspected terrorist act at a church in the French city of Nice today (29 October), while a gunman was shot dead by police in a separate incident, writes .

Within hours of the Nice attack, police killed a man who had threatened passersby with a handgun in Montfavet, near the southern French city of Avignon. He was also shouting “Allahu Akbar” (God is greatest), according to radio station Europe 1.

In Saudi Arabia on Thursday, state television reported that a Saudi man had been arrested in the city of Jeddah after attacking and injuring a guard at the French consulate.

The French Embassy said the consulate was subject to an “attack by knife which targeted a guard”, adding the guard was taken to hospital and his life was not in danger.

Nice’s mayor, Christian Estrosi, who described the attack in his city as terrorism, said on Twitter it had happened in or near Notre Dame church and was similar to the beheading of French teacher Samuel Paty in an attack this month in Paris.

Estrosi said the attacker had repeatedly shouted the phrase “Allahu Akbar”, even after he had been detained by police.

One of the people killed inside the church was believed to be the church warden, Estrosi said, adding that a woman had tried to escape from inside the church and had fled into a bar opposite the 19th century neo-Gothic building.

“The suspected knife attacker was shot by police while being detained, he is on his way to hospital, he is alive,” Estrosi told reporters.

“Enough is enough,” Estrosi said. “It’s time now for France to exonerate itself from the laws of peace in order to definitively wipe out Islamo-fascism from our territory.”

Reuters journalists at the scene said police armed with automatic weapons had put up a security cordon around the church, which is on Nice’s Jean Medecin avenue, the city’s main shopping thoroughfare. Ambulances and fire service vehicles were also at the scene.

French President Emmanuel Macron is due to visit Nice, Estrosi said.

In Paris, lawmakers in the National Assembly observed a minute’s silence in solidarity with the victims. The mayor of Paris, Anne Hidalgo, said the people of Nice “can count on the support of the city of Paris and of Parisians”.

Police said three people were confirmed to have died in the attack and several were injured. The French anti-terrorist prosecutor’s department said it had been asked to investigate.

A police source said a woman was decapitated. French far-right politician Marine Le Pen also spoke of a decapitation having occurred in the attack.

A representative of the French Council for the Muslim Faith strongly condemned the attack. “As a sign of mourning and solidarity with the victims and their loved ones, I call on all Muslims in France to cancel all the celebrations of the holiday of Mawlid.”.

The holiday is the birthday of the Prophet Mohammad, which is being celebrated today.

Estrosi said the victims had been killed in a “horrible way”.

“The methods match, without doubt, those used against the brave teacher in Conflans Sainte Honorine, Samuel Paty,” he said, referring to a French teacher beheaded earlier this month in an attack in a suburb of Paris.

The attack comes while France is still reeling from the beheading earlier this month of middle school teacher Paty by a man of Chechen origin.

The attacker had said he wanted to punish Paty for showing pupils cartoons of the Prophet Mohammad in a civics lesson.

It was not immediately clear if Thursday’s attack was connected to the cartoons, which Muslims consider to be blasphemous.

Since Paty’s killing, French officials - backed by many ordinary citizens - have re-asserted the right to display the cartoons, and the images have been widely displayed at marches in solidarity with the killed teacher.

That has prompted an outpouring of anger in parts of the Muslim world, with some governments accusing Macron of pursuing an anti-Islam agenda.

In a comment on recent beheadings in France, the Kremlin said on Thursday it was unacceptable to kill people, but also wrong to insult the feelings of religious believers.

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Cancer

EAPM: Cancer is key for health experts as EU Beating Cancer Plan approaches

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Welcome, health colleagues, to the latest update from the European Alliance for Personalised Medicine (EAPM) – November and December will see a renewed focus, both from EAPM and the EU institutions, to issues of cancer mortality and treatment, which have not gone away, pandemic or no pandemic. The EU Beating Cancer Plan is taking shape from 10 December and, ahead of that, EAPM is focusing on its own approach to the disease based on our multi-stakeholder engagement and the role of diagnostics during the month ahead. In addition, the EAPM Newsletter will be available from tomorrow (30 October), writes EAPM Executive Director Denis Horgan. 

Beating cancer – the road to success

While the Europe’s Beating Cancer Plan aims to reduce the cancer burden for patients, their families and health systems. It is set to address cancer-related inequalities between and within member states with actions to support, co-ordinate and complement member states’ efforts.

In terms of its implementation, EAPM have advocated that the European Beating Cancer Plan needs to be realistic and measurable, so it should come with a dashboard of indicators that can be monitored, and which would enable evaluation to monitor the effectiveness of this plan.

In cancer, the important role of high-quality diagnostics as well as pathological expertise is not yet broadly recognized. If you have a symptom or a screening test result that suggests cancer, your doctor must find out whether it is due to cancer or some other cause. The doctor may start by asking about your personal and family medical history and do a physical exam. The doctor also may order lab tests, imaging tests (scans), or other tests or procedures. You may also need a biopsy, which is often the only way to tell for sure if you have cancer. To identify the right treatment, early diagnosis is essential. 

As such for the area of lung cancer, a more targeted approach to screening is warranted and appropriate stratification should be considered.

Taking into account the shortage of expertise within countries, the role of cross-country molecular tumour board will have an important role.  A governance framework for the way that data can be shared between countries will be essentials here.

EAPM has brought these and other issues before MEPs over recent months since our successful seminar series at the European Society of Medical Congress during the recent EU Presidency conference. 

Commission plan receives support from cancer committee for treatment

With more than 40% of cancers preventable, the EU can do more to tackle the disease, one of the leading causes of mortality in Europe, according to the European Parliament’s cancer committee. “By pooling all our talents, knowledge and resources, we can truly join all our forces in the fight against cancer.” So claimed Manfred Weber during the 2019 elections, paving the way for a special committee in the fight against cancer. Today this committee is a reality. This fight will be a priority for many in the coming years. Commission President Ursula von der Leyen announced a European Plan to fight Cancer in her political guidelines and Health Commissioner Stella Kyriakides has shown her ambitions in presenting the EU Beating Cancer Plan in the Parliament, which will be finalised by the end of 2020. This special committee is needed now more than ever. 

By pooling resources and expertise, a comprehensive European cancer masterplan can be created, acting as a catalyst for thorough and innovative cancer care and research, which should be focused on prevention, specialized care and treatment that puts the patients at its heart, as well as a zero-pollution environment. Prevention is key in the fight against cancer, and cancer treatment requires the correct specialized therapy. As early as 2003, the Council issued recommendations to roll out cancer screening programmes for some of the more prevalent cancers, but their implementation is far from complete. Increased investment through programmes such as Horizon 2020, as well as knowledge-sharing bodies like the European Reference Networks, are invaluable policy tools that the EU has at its disposal in the Beating Cancer Plan.

EU needs more power on health policy, says Commission's Irish rep

The European Commission’s representative to Ireland Gerry Kiely, speaking on Wednesday (28 October), told the Irish parliament that the EU’s contribution to fighting COVID-19 was initially limited because member states wanted it so. But the member states must collectively manage a long and difficult shared crisis, he added, going on to say that surveillance across the EU, and indeed within Member States, is still slow, inconsistent and patchy. The ECDC can provide common methodologies for information gathering, but it has no way to ensure that member states provide information in the prescribed manner.

To make information flows more integrated and useful, the EU could direct resources and create obligations for member states to improve surveillance and reporting. As far as the ECDC is concerned, it has very little power, let alone budget, to respond in a way comparable to its US counterpart. The Commission is set to announce just how this agency’s role will change in two weeks’ time. 

COVID-19 co-ordination

European leaders are set to meet online today to discuss COVID-19 co-ordination, following the 15 October European Council. “Even though member states are better prepared and more co-ordinated than in the early months of the pandemic, citizens, families and communities across Europe continue to face an unprecedented risk to their health and well-being,” said a Commission statement.

UK under pressure as COVID-19 epidemic doubles every nine days 

The British government is under pressure to develop a national strategy to combat a surge of COVID-19 cases and "rescue Christmas'' as scientists warn that the number of people hospitalized with the disease in the UK could almost triple by the end of next month unless something more is done now. Mark Walport, a former chief scientific officer, said Britain only needs to look across the English Channel to see what's coming. Britain's current measures are similar to those in France and Spain, where authorities are struggling to control the virus and daily cases have already far outstripped those in the UK. "With our current measures… there's little evidence that there is as much social distancing as there was when we clamped down on the first wave and so we know that the risk is significant that cases will continue to grow," Walport told the BBC. It is "not unrealistic'' that 25,000 people in the UK could be hospitalized by the end of November—up from about 9,000 now, he said. 

Germany shuts up shop

On Wednesday (28 October), Chancellor Angela Merkel and Germany’s state premiers agreed to close bars, restaurants, gyms, pools, cinemas and other non-essential businesses nationwide for the month of November. “We have to act now to avoid an acute national emergency,” Merkel said. “The experts told us we have to reduce the number of contacts by 75% — that’s a lot.”

France est fermé

President Emmanuel Macron has announced his own national lockdown starting Friday (30 October), with restaurants and bars to be closed but schools, public services and some factories remaining open. Unlike in the first lockdown, visits to nursing homes will be allowed. 

Von der Leyen: EU could vaccinate 700M people against coronavirus

The EU could vaccinate 700 million people with large supplies of vaccines due to begin in April 2021, Commission President Ursula von der Leyen has said today (29 October). Von der Leyen also reiterated her call for the harmonization of countries’ vaccination plans. “There are many issues to be considered for an effective vaccine deployment,” she said, pointing to questions around infrastructure, such as cold chains. 

Health data space en route

The Commission is pushing forward plans for a European health data space, with an interim report from recent expert workshops to be published before the end of 2020, said Health Commissioner Stella Kyriakides on Monday (26 October) during the World Health Summit. However, important questions remain about public trust and whether people will be willing to share their data on a pan-EU platform.

And that is everything from EAPM for now – do stay safe and well, look out for the EAPM Newsletter from tomorrow, and have a splendid afternoon.

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EU

'Ethical concerns' raised at Kazakhstan’s $63 billion Samruk-Kazyna Fund

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Akhmetzhan Yessimov, the chairman of Samruk-Kazyna, has been criticized by Kazakhstan’s public accounts committee over ethical issues at the $63 billion sovereign wealth fund.

Kazakhstan’s accounts committee said that the huge state-owned fund lacked transparency and its profitability was falling in real terms.

Samruk was established in 2008 to help develop the Kazakh economy but under Chairman Yessimov the fund has seen its earnings before tax, depreciation and amortisation (ebitda) margin fall from 18.7% in 2017 to 16.5%.

“There is still no transparency in procurement procedures, most of the holdings funds continue to be placed in a non-competitive way,” the committee’s report said. "Systemic problems have been identified, which are the reasons for the ineffective use of state resources and restraining the development of the market economy.”

The accounts committee also raised concerns about Samruk’s 144bn tenge ($350 million) of cash deposits with ATF Bank, which is run by Yessimov’s son-in-law Galimzhan Yessenov.

The committee highlighted that Samruk’s rules require it to hold cash only at financial institutions with an 'A' credit rating but ATF has a rating of 'B-', which is considered junk status by analysts.

A Samruk subsidiary, Kazmunaygas, holds a further 80bn tenge ($190m) in deposits at ATF, also in breach of credit rating requirements.

The committee noted that Samruk’s chairman, Yessimov, is the father-in-law of ATF’s boss Yessenov – a revelation that has raised concerns over governance and possible corruption at the giant sovereign wealth fund.

The cash deposits were among a number of “ethical issues” raised by the accounts committee in its annual assessment of state-owned enterprises.

According to the committee, Samruk claimed profits of 1,141 billion tenge ($2.6 billion) in 2018, up 534 billion tenge on the previous year. However, the committee said that this increase in profits was inflated by a non-cash change for subsidiaries consolidated into its accounts, an increase in oil prices and positive exchange rate movements.

“Without considering these factors, the factual profits even decreased,” the committee said. “This is confirmed by a significant deterioration in the EBITDA indicator with margins falling from 18.7% in 2017 to 16.5% in 2018.” The margin was 25.3% in 2014.

Yessimov has been under pressure from Kazakhstan’s government to increase the dividends paid out by Samruk. Following scrutiny of Samruk’s poor profitability and the illegal deposits at ATF Bank, Yessimov was forced in July to increase its dividend payments to 120bn tenge, 10 times more than in 2017.

Samruk has also agreed to help with Kazakhstan’s COVID response and has bought personal protective equipment, ambulances and ventilators.

Yessimov, 69, has held a number of prominent roles in Kazakhstan’s government including deputy prime minister and mayor of Almaty. He is a close ally of former President Nursultan Nazarbayev and it is thought that his wealth stems from his political connections.

In 2007, Yessimov helped his son-in-law, Galimzhan Yessenov finance the $120m acquisition of a fertilizer company called Kazphosphate.

Samruk’s assets include the Kazakh postal service, and rail network, the oil and gas producer Kazmunaigas and Air Astana. The fund was founded to mirror the success of Singapore’s sovereign wealth funds, Temasec and GIC, in developing national business champions.

 

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