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#EAPM - #HTA debate moves to Sofia for key conference



As the debate on EU-wide health technology assessment (HTA) reaches Council level after a positive vote on the Commission’s proposals at the latest Strasbourg plenary, the Bulgarian capital Sofia will host a conference on HTA’s implications for personalised medicine,
writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan. 

The Brussels-based EAPM, and its associate the Bulgarian Alliance for Precision and Personalised Medicine (BAPPM), will be among the key players at the event on 12-13 October.  EAPM and its colleagues are now dealing at member state-level directly in respect of the HTA dossier as well as engaging regions in the EU to convey key points to policy makers.  The Sofia gathering comes before a roundtable meeting in Brussels (6 November) which will feature health attachés from member state permanent representations, as well as patients’ groups.  Stakeholders will come together with a shared aim of focusing on member state and regional collaboration to facilitate innovation finding its way swiftly into health-care systems.  The onus is on the benefit of enhancing coordination between all players as medical science moves swiftly.

BAPPM’s Jasmina Koeva-Balabanova explained that the conference will present and discuss the specifics of HTA in respect of personalised medicine products as well as target therapies, companion diagnostics, and innovative pharmaceutical products for personalised treatment.  "The discussion will include representatives of the European Commission, working groups for HTA and many more including industry representatives, professors, students and postgraduates from health faculties," she said.

She added: “Improving HTA and strengthening cooperation across countries will provide better estimates of the medical and social value of new therapies and medicines.”

Debates at the conference will cover various sectors of HTA, including current trends and development, principles and practice, specific requirements on necessary information, unsolved issues and consequences from inappropriate methodologies, plus the sharing of good practices.  Also on the agenda are HTA in rare diseases, IVD and companion diagnostics, while a hot topic will be the role of HTA for better patient access to personalised medicine.  The conference in Bulgaria comes on the back of the  European Parliament vote which acknowledged that opportunities to improve HTA quality are currently being missed.

This was underlined in a joint statement from EAPM and the European Cancer Patient Coalition, who expressed regret at the decision by Parliament to reject formal patient organisation involvement “as equal and credible members of the Coordination Group” for the new legislation.   Parliament adopted the file by 576 to 56 (with 41 deputies abstaining) on the back of the institution’s Environment, Public Health and Food Safety Committee (ENVI) recommendations.

ENVI had thrashed out a broad set of compromises under the guidance of rapporteur Soledad Cabezón Ruiz.  And although patient participation has been addressed in compromise amendments during the ENVI meetings earlier, “the legislation is short on providing for adequate patient participation in the EU-HTA co-operation framework,” said Horgan. Horgan explained that patients have unique knowledge, perspectives and experiences, and are the ultimate beneficiaries of medical technologies.

Therefore, patient representation is essential at all levels of decision-making when legislation directly affects their health and lives.  As part of the vote in Strasbourg, MEPs agreed to send the file back to ENVI to let the committee prepare for negotiations with other institutions, but the clock is ticking to get detailed talks underway before the May 2019 Parliament elections.  Prior to the vote in Parliament, the Expert Group on Health Systems Performance Assessment met in Brussels, with representatives from Austria, Belgium, Croatia, the Czech Republic, Denmark, Estonia, France, Greece, Hungary, Ireland, Italy, Malta, Norway, Poland, Portugal, Romania Slovakia, Slovenia, Sweden, the European Observatory on Health Systems and Policies, and the European Commission. The group agreed that a forthcoming report on efficiency of care should aim to present “a multidimensional and exhaustive picture of health-care systems”.

It cited its own 2016 report on quality of care and said that the forthcoming report should cover current measurement gaps in the monitoring of efficiency. This, the group says, calls for better use of currently existing indicators and data, something that EAPM has repeatedly called for. The expert group added that the future report should also cover the issue of intended and unintended consequences of various actions focused at improving efficiency, ad gave examples such as how shortening length of hospital stay impacts primary care volumes of utilization.

The group agreed that efficiency in health is difficult to quantify since health services have many intangible consequences which only come to light in the long term. The group noted that this is why, in many instances, policy makers opt for short-term solutions, such as limiting expenditure. It flagged up that efficiency in healthcare is possible thanks to already-available innovations, but there is a need for considerable investment.

“If efficiency is understood as an objective that should be attained principally via reducing expenditure levels, innovation in the long run will be stifled, and higher efficiency levels will not materialize,” the group said.  EAPM and its Bulgarian partner BAPPM share this opinion and all the above issues, and more, will all be on the table in Sofia this month.


Amid France-Turkey row, UK calls on NATO allies to defend free speech




Britain’s Foreign Secretary Dominic Raab called on NATO allies to stand shoulder-to-shoulder on values of tolerance and free speech, in a veiled rebuke to Turkey which has been calling for a boycott of French goods, writes Estelle Shirbon.

Turkish President Tayyip Erdogan has urged Turks to stop buying French goods and has accused France of pursuing an anti-Islam agenda. Britain, France and Turkey are all NATO members.

Erdogan is one of several leaders in the Muslim world angry with France over its response to the murder of teacher Samuel Paty, who showed pupils cartoons of the Prophet Mohammad as part of a lesson on free speech.

“The UK stands in solidarity with France and the French people in the wake of the appalling murder of Samuel Paty,” Raab said in a statement. “Terrorism can never and should never be justified.

“NATO allies and the wider international community must stand shoulder-to-shoulder on the fundamental values of tolerance and free speech, and we should never give terrorists the gift of dividing us.”

Paty, a teacher at a state-run school in the far outskirts of Paris, was beheaded on 16 October by a man of Chechen origin. The teacher had been criticised by some in the local community for showing his pupils the cartoons because Muslims view images of the prophet as blasphemous.

The French government, backed by large numbers of citizens, saw the beheading as an attack on free speech and said they would defend the right to display the cartoons.

President Emmanuel Macron called Paty a hero and pledged to fight what he described as Islamic separatism, saying it was threatening to take over some Muslim communities in France.

The reaction to Paty’s murder has caused widespread anger in Muslim countries, where there have been anti-French demonstrations and calls for boycott. France has warned its citizens in several Muslim-majority countries to take extra security precautions.

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Customs Union: Commission proposes new ‘Single Window' to modernize and streamline customs controls, facilitate trade and improve co-operation



The European Commission has proposed a new initiative that will make it easier for different authorities involved in goods clearance to exchange electronic information submitted by traders, who will be able to submit the information required for import or export of goods only once. The so-called 'EU Single Window Environment for Customs' aims to enhance co-operation and co-ordination between different authorities, in order to facilitate the automatic verification of non-customs formalities for goods entering or leaving the EU.

The Single Window aims to digitalize and streamline processes, so that businesses will ultimately no longer have to submit documents to several authorities through different portals. The proposal is the first concrete deliverable of the recently adopted Action Plan on taking the Customs Union to the next level.

It launches an ambitious project to modernize border controls over the coming decade, in order to facilitate trade, improve safety and compliance checks, and reduce the administrative burden for companies. Economy Comissioner Paolo Gentiloni said: “Digitalization, globalization and the changing nature of trade present both risks and opportunities when it comes to goods crossing the EU's borders.

"To rise to these challenges, customs and other competent authorities must act as one, with a more holistic approach to the many checks and procedures needed for smooth and safe trade. Today's proposal is the first step towards a fully paperless and integrated customs environment and better cooperation between all authorities at our external borders. I urge all member states to play their part in making it a true success story.”

The proposal, the press release, the Q&A and the factsheet are available online.

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Merkel plans circuit-break lockdown as German virus cases surge




Chancellor Angela Merkel pressed regional leaders on Wednesday (28 October) to agree to a partial lockdown in Germany which would see restaurants and bars closed but keep schools open, a draft document seen by Reuters said, write and

The drastic measures, to take effect from 4 November, are aimed at curbing the spread of the coronavirus in Europe’s biggest economy as the number of new cases hit a record high.

Under the planned new restrictions people would only be able to go out with members of their own and one other household. Fitness studios, discos and cinemas would close, as would theatres, opera houses and concert venues.

Restaurants would only be allowed to offer takeaways, the document said. Shops could remain open if they implement hygiene measures and limit customer numbers.

Merkel will hold a virtual conference with the country’s 16 state premiers later to try to agree the nationwide rules and ditch a confusing patchwork of regional measures.

Almost all regions of Germany face an exponential increase in infection rates, said the document to be discussed, and local health authorities can no longer trace all infections.

“The aim is to interrupt the dynamic of the infection fast so no far-reaching limits on personal contact and economic activity are needed over the Christmas period,” it said.

Germany was widely praised for keeping infection and death rates below those of many of its neighbours in the first phase of the crisis but is now in the midst of a second wave. Cases rose by 14,964 to 464,239 in the last 24 hours, the Robert Koch institute for infectious diseases said on Wednesday.

Deaths jumped by 85 to 10,183, fuelling fears about the health system after Merkel warned on Tuesday it could hit breaking point if infections continue to spiral.

“If we wait until intensive care is full, it is too late,” Health Minister Jens Spahn, who last week tested positive for the virus, told broadcaster SWR.

The government has long insisted it wants to avoid a second blanket lockdown after an initial one this year hit economic growth, with the economy shrinking by a record 9.7% in the second quarter.

While economists expect a rebound for the July-Sept period, they warn that a further lockdown could wipe out growth in the last quarter. Third quarter data is due on 30 October.

Under the plans, the government aims to provide aid to firms hit by closures, including the cultural event sectors.

Only necessary overnight stays would be allowed, according to the document. Brothels, swimming pools, beauty and tattoo studios would close but physiotherapists and hairdressers could stay open. The steps would run until the end of November but are subject to review.

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