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Showing posts with label Health policy. Show all posts
Showing posts with label Health policy. Show all posts

Sunday, 30 June 2019

European cooperation on healthcare discussed at FPM-HPT conference at Erasmus University in Rotterdam

European cooperation is crucial for providing the highest possible quality of healthcare for the ~740 million citizens on the continent. Innovations in European healthcare also have a vital impact on global health.
Many international organizations and institutes participate in European projects and initiatives on research, clinical care and health policy to achieve health goals that would be unattainable when operating solely within one’s own country.
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Donald Singer, Carin Uyl-de Groot, Marlies Wijsenbeek, Liese Barbier, Ken Redekop and Lytske Bakker
There are also funding, ethical and political challenges to effective European cooperation on healthcare, including an impending possible Brexit. 

The latest Fellowship of Postgraduate Medicine conference was held at Erasmus University in Rotterdam in the Netherlands on 21st June 2019 to consider European Cooperation on Healthcare. The aim was to provide a forum for discussing best practice across the above key healthcare domains.

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Donald Singer, Ron de Winter, Marjan Hummel, Marcus Guardian, Lytske Bakker and Ken Redekop
The conference was jointly hosted by the FPM’s Elsevier-published journal Health Policy and Technology and the Erasmus School of Health Policy and Management (ESHPM), with as local organisers Associate Professor Ken Redekop (HPT Editor-in-Chief) and researcher Lytske Bakker (HPT Commissioning Editor).

Content from the meeting will appear in the HPT journal as Editorials, commentaries, review articles and Meet the Expert reports, with associated short video interviews with speakers posted on the HPT and FPM websites.

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Poster prize winner Vivian Reckers-Droog with Ken Redokop (L) and Donald Singer
Ron de Winter from the Department of Epidemiology at the University Medical Center in Utrecht, The Netherlands discussed combating multi-drug bacterial resistance in the multi-country European COMBACTE public-private partnership.

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Poster presenters and European Reference Network Project Managers Olivia Spivack and Renée de Ruiter.
Barbara Pierscionek, Associate Dean for Research at Nottingham Trent University discussed ethical and legal challenges when developing joint programmes involving European cooperation on healthcare. Issues include maintaining confidentiality when sharing real world data within Registries and other Big health Data.

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Pharmacist Liese Barbier, European Medicines Agency, discussed European Medicines Agency perspectives on regulating biosimilars. She stressed the importance of batch-level information when reporting any suspected adverse drug reactions from biosimilars or corresponding biological medicines.
Jorge Gonzalez, Spain, spoke on the EU funding supported inDemand model now operating in Spain, France and Finland, with additional network partners throughout Europe. InDemand makes a virtue of needs-driven rather than technology-driven project commissioning as a more reliable approach to ensuring adoption of new approaches into clinical practice. Examples included mobile health applications to reduce weight in obese children and e-health systems to support management of women in pregnancy.
Marcus Guardian, CEO of EUnetHTA, The European Network for Health Technology Assessment discussed his organisation’s role in cross-border assessment of health technology.

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Ines Hernando from the EURORDIS-Rare Diseases Europe organization discussed the initial impact of the 2017 European Reference Network Directive to improve the care of the ~ 30 million patients in Europe with rare diseases. The new European Reference Networks are already providing virtual common rare disease management support platforms for health professionals across the European region.
Marjan Hummel from Philips in Einthoven discussed early health technology assessment in the medical device industry and resulting international implications for streamlining development of new health technologies.

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Zoltan Kalo, Professor of Health Economics at Eötvös Loránd University (ELTE) in Budapest discussed ways to improve equity in allocation of healthcare research funds by the European Union. Currently there appears to be a disproportionate allocation of EU research awards to EU15 countries. This both disadvantages research capacity development in EU13 countries and leads to a ‘brain drain’ of researchers from EU13 to EU15 research centres.

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Local host Ken Redekop, Editor-in-Chief of the FPM’s Elsevier-published Health Policy and Technology journal, discussed themes and opportunities for publication in the journal on topics from across the diagnostics/drugs/devices/e-health spectrum complemented by papers on health technology adoption and associated health policy implications.



Donald Singer, President, Fellowship of Postgraduate Medicine, London discussed engaging with European health policy makers, including new networking opportunities between health professional and patient and consumer organisations and EU institutions such as the European Medicines Agency.


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 Carin Uyl-De Groot, head of health technology assessment at the Erasmus School of Health Policy & Management in Rotterdam discussed sustainability and affordability of innovative drugs. She described discussion with European policy makers on ways to reduce the cost of expensive biological treatments. Developing cross-border partnerships would create much greater bargaining power for purchasing medicines. For example, the EU region currently provides 40% of the market for most pharmaceuticals.

Respiratory physician Marlies Wijsenbeek from the Erasmus Medical Centre discussed patient registry development to improve management of and research into rare lung diseases, based on her work on idiopathic pulmonary fibrosis. She noted the potential value of developing cross-border patient registries for rare diseases, to ensure larger patient populations then possible within individual countries. She also illustrated some of the challenges, e.g. when common data sets are not agreed and when the same patients may feature within different registries.



Tuesday, 12 December 2017

Developing robust common data models to guide safety in medicines in Europe


The European Medicines Agency held a 2 day international workshop in London [11th -12th December 2017] to define the opportunities and challenges around implementation of a common health data model in Europe to support regulatory decision making. The expected outcome of the workshop was agreement of guiding principles for the development of a Common Data Model (CDM) in Europe, including key criteria for validation in the context of regulatory decision-making.

A common data model could help harmonise healthcare data across multiple data sets and provide a mechanism to conduct pan-European studies in a timely manner to address regulatory questions. At the same time, applying a common model to European data has multiple challenges. The meeting brought together regulators with academia, data holders and the pharmaceutical industry.

Sessions included talks from experts from North America (FDA, Harvard, Duke, Georgia Tech ...) and the European region (Erasmus, Utrecht, CBG-MEB, EMA ...) discussing lessons learned and current challenges in very large current clinical data resources, regulatory verification and related issues. Common data model case studies considered included Sentinel – the Harvard-based FDA system for accessing patient data from 16 health data partners across the USA and CNODES (the Canadian Network for Operational Drug Effect Studies) which can access data on 100 million patients – a similar scale to Sentinel.

The U.S. Food and Drug Administration's (FDA) Sentinel Initiative is a long term approach which uses a common health data model to improve the FDA’s ability to identify and explore safety issues for medical products. Sentinel actively surveys pre-existing electronic healthcare data from multiple sources.

Consistent themes included ensuring the relevance of evolving common data models to health policy, keeping timelines as short as practical, interoperability, consent and related ethical issues (data custodians, patient data protection and privacy), and careful internal and external validation of clinical definitions, data, software and analytical models.

From the perspective of health professionals, policy makers, regulators and the public, key questions included whether clinical outcomes from common data models are generalisable or only relevant to specific sub-populations based on geography, genetics, demographics and/or complex co-morbidity.  In the era of precision medicine there is the clear need is to avoid “right” answers from the wrong clinical populations and “wrong” answers from the right populations.

Further key points considered included: what is the cost of developing and maintaining validated CDMs; who should pay; whether updating existing databases is a sufficient approach or rather new more robust databases are needed.

Saturday, 9 December 2017

Developing health policy to protect the heart and circulation

Diseases of the heart and circulation are the commonest preventable cause of disability and death in the UK and elsewhere in the developed world. Heart and circulatory disorders are also rapidly overtaking communicable diseases as serious health problems in less developed countries. Policy makers need to take an increasing interest in encouraging lifestyle approaches aimed at reducing the incidence and severity of these serious disorders of the heart and circulation.

This one day symposium, with speakers from Hong Kong, the Netherlands, Spain and the UK was organised by the healthy heart charity the Cardiovascular Research Trust in partnership with the Fellowship of Postgraduate Medicine.

David Slovick, Leslie Morgan OBE DL, Donald Singer, Wade Dimitri, Ken Redekop, Alison Halliday, Robin Poston
FPM President and CRT chair Donald Singer said: “Despite recent efforts, obesity and diabetes are increasing epidemics in the UK and internationally. Political leaders have a huge opportunity to improve both national health and wealth by a sustained increase in the effective public health measures needed to prevent and address the major risk factors for premature heart, stroke and other vascular disease.”

Speaker Professor Kornelia Kotseva from Imperial College in London said: “Cardiovascular disease (CVD) is a leading cause of mortality accounting for 17.5 million deaths every year globally and 4.3 million deaths every year in Europe. The proportion of all deaths attributable to CVD is greater among women (49%) than in men (40%), with large geographic inequalities between countries.”

Speaker Professor Alison Halliday from the University of Oxford and President of the European Society of Vascular Surgery added: “Stroke causes many thousands of deaths in the UK every year and is the country’s leading cause of disability. Billions of pounds are spent on treating the causes and the results of stroke – hypertension, heart disease, diabetes, smoking, but the greatest risk factor is age, and, despite attention to known modifiable risk factors, the numbers of new and recurrent strokes have not fallen significantly in recent years.”

Professor Bernard Cheung from the University of Hong Kong and Editor of the FPM’s journal the Postgraduate Medical Journal said: “The biggest news in the world of hypertension is the publication of the latest American guidelines (ACC/AHA) on the prevention, detection, evaluation and management of high blood pressure. The most controversial change is in the definition of hypertension, which now includes a systolic blood pressure of 130-139 mmHg or a diastolic blood pressure of 80-89 mmHg. This change will, at a stroke, make a sizeable proportion of the general population hypertensive.”

Professor Ken Redekop from Erasmus University in Rotterdam and Editor-in-Chief of the FPM’s journal Health Policy and Technology noted that “Precision medicine (PM) refers to the separation of patients into more homogeneous subgroups, with the rationale being that patients who will benefit from a treatment should receive the treatment while patients who will not benefit should not.” He added: “When all factors (including cost-effectiveness) are considered, a precision medicine strategy may or may not be the best one in the effort to improve cardiovascular health, and health outcomes in general.”

Heart surgeon Wade Dimitri commented that: “heart surgery in the UK has led the development and refinement of many techniques and health technologies and has resulted in significant reduction in cardiovascular mortality and morbidity. Such progress and improvements have not followed in the developing world where mortality and morbidity remain high, approaching 60% in certain countries. Urgent efforts are needed to reverse this trend and improve outcomes of adults and children with heart disease undergoing heart surgery in less developed countries.”

Professor Ramon Estruch, Barcelona said: "The Mediterranean diet has strong research evidence as an effective healthy lifestyle approach to protect the heart and brain. Similar healthy diet cultures are found in other regions on the 40th parallel in both the north and southern hemispheres around the world."

Papers from the symposium will be published in the journals of the Fellowship of Postgraduate Medicine (Postgraduate Medical Journal and Health Policy and Technology.

Note for Editors
For more on the themes of the event,
email: fpm.chandos@gmail.com or call 07494 450 805.


Speaker abstracts and biographies

Meeting programme: Health policy for the heart and circulation

Thursday, 13 November 2014

Diet, Lifestyle and Cardiovascular Risk: from Evidence to Policy

Three weeks to go to this Evidence and Policy Symposium organised by the healthy heart charity the Cardiovascular Research Trust in partnership with the Fellowship of Postgraduate Medicine, publisher of the Postgraduate Medical Journal and Health Policy and Technology.

Authoritative, evidence-based information on how to protect cardiovascular health is vitally important for researchers, clinicians, policy makers and the public.

Symposium Sessions include Mediterranean diet and cardiovascular health; the impact of voluntary and mandatory policy; cardiovascular risk in childhood;  cardiovascular effects of dietary bioactives; evidence on risks and benefits of new dietary approaches.

Attendance is limited to 90 delegates.
See the online registration link and the full programme below. 

Friday 5 December 2014 at the Medical Society of London – Map of venue
11 Chandos St, Cavendish Square, London W1G 9DRT
5 minutes walk from Oxford Circus


Register for the Symposium

9.00 – 9.30  Registration and coffee

9.30 – 10.10 am
Impact on cardiovascular disease of voluntary and mandatory policy on diet and lifestyle. See abstract
Dr Martin O’Flaherty, University of Liverpool


10.10 – 10.50 
Emerging ethnic differences in cardiovascular risk in childhood
Professor Peter Whincup, St George’s University of London


10.50 – 11.25 Coffee

11.25 – 11.40
Alcohol consumed ‘with a meal’ or ‘without a meal’ is differently associated with risk of coronary heart disease in a UK prospective population study. See abstract
Lentjes MAH, Khawaja AP, Mulligan AA, Luben RN, Bhaniani A, Wareham NJ and Khaw KT.
Department of Public Health & Primary Care, University of Cambridge.


11.40 – 12.20
Impact of dietary nitrates on blood pressure
Professor Amrita Ahluwalia,
William Harvey Research Institute, Queen Mary’s University of London


12.20 – 13.00
Diet, lifestyle and cardiovascular risk
Professor KT Khaw, University of Cambridge


13.00 – 14.00 Lunch

14.00 – 14.40
Is chocolate good for you? Health claims versus evidence-based nutrition
Professor Roger Corder, William Harvey Institute


14.40 – 15.30
Effects of Mediterranean diet on cardiovascular outcomes in high risk people
Professor Ramon Estruch, University of Barcelona


15.30 – 16.00
Policy implications of current evidence on diet, lifestyle and cardiovascular risk
Speakers’ Round Table


16.00 Close

Sunday, 22 December 2013

First test of new French artificial implantable heart


A first patient has been fitted with a new French artificial heart
Watch interview on @AJEnglish:  
Heart failure is one of the commonest causes of urgent admission to hospital. Modern drugs – and their effective use in combination - have dramatically improved treatment of heart failure. However in many patients heart failure is a progressive disorder and perhaps 100,000 patients in USA and Europe alone are candidates for a new heart. Conventional organ transplantation is limited by availability of a donor heart, the complexity of immunosuppression and other major risks of the procedure.

The dual ambition of the company behind this new technology is an implantable heart which will both allow return to good quality of life for at least 5 years, and be subject to a lower risk of serious complications then earlier devices.

Implanting an artificial heart while awaiting a heart transplant is not a new idea. The first sustained success was for the Jarvik device, first used over 30 years ago. And current implantable devices have been reported to be successful for almost 4 years.

The new Carmat heart is lined with a combination of synthetic polymers and treated tissues from the heart sac (pericardium) of the cow. This aims to reduce the chance of blood clotting on the internal lining of the heart – an important potential risk from an artificial heart. And partnership with aerospace engineers has lead to new biofeedback sensors in the Carmat device.

If experience over the next year or so of the heart in patients confirms the promise of laboratory studies, patients and health professionals might have access to the new device for clinical use by 2015.

However it will of course take at least until 2020 to confirm whether, in general use, the hoped for 5 year lifespan of the device is confirmed for patients who have severe heart failure.

For the benefit of patients, health services and policy makers, there will need to be serious engagement with the biotech industry to ensure that economies of scale in clinical practice reduce dramatically the current huge cost per device - estimated at 140-180,000 €  ie around $240,000.

Saturday, 20 October 2012

Meet Senior Policy makers in Health Policy and Technology


@HealthMed @FPGMed
The UK Fellowship of Postgraduate Medicine, in partnership with international publisher Elsevier, has launched a major new international journal - Health Policy and Technology, now coming to the end of its first year of publication

Initial issues have included papers on UK Biobank and on the pioneering new Centre for Health Technology Assessment of Devices and Diagnostics within the UK’s National Institute for Health and Clinical Excellence (NICE), and papers on health policy, and technology from drug discovery to personalised medicine and e-health from the USA, Europe, the Middle East and India. 

There is also a series of interviews in print, online and as podcasts, with international leaders in the field of health policy and technology.

Listen to the first 4 podcasts
Sir Michael Rawlins, Chairman of NICE
Since Sir Michael Rawlins was appointed its founding Chairman in 1999, NICE has released 800 individual pieces of guidance covering not just guidelines and technological appraisals but also public health matters. NICE has also recently started looking at medical devices started to assess diagnostics, and the quality, safety and effectiveness of new interventional procedures.

Gonzalo Calvo, Chairman of EACPT
The European Association of Clinical Pharmacology and Therapeutics represents the National Clinical Pharmacology Societies from the 29 established and accession countries in Europe and their ~4000 clinical pharmacologist members.

Alexander von Gabain, Chairman of EIT
The European Institute of Innovation & Technology is an Agency of the European Union established in 2008 to address Europe's innovation gap. The EIT budget from 2008-2013 is 308.7million.

Andrew Kicman on Drugs in Sport
Dr Andrew Kicman is Head of Research and Development in the Drug Control Centre, Kings College, London, which is a World Anti-Doping Agency accredited laboratory, dedicated to drug control in sport. 

Background to the new journal and to the FPM

Home page for Health Policy and Technology

Monday, 16 April 2012

Health Policy and Technology launched by FPM and Elsevier

@HealthMed The Fellowship of Postgraduate Medicine, in partnership with international publisher Elsevier, has launched the first issue of a major new international journal - Health Policy and Technology.

The first issue includes a paper on the pioneering new Centre for Health Technology Assessment of Devices and Diagnostics within the UK’s National Institute for Health and Clinical Excellence (NICE), and papers on e-health from the USA, India and Europe. 

There is also the first of a series of interviews in print, online and as podcasts, with international leaders in the field of health policy and technology, beginning with Sir Michael Rawlins, Chairman of NICE.

The next policy maker to be featured in this series (June 2012 issue of HPT) will be Professor Gonzalo Calvo, former chair of the European Medicines Agency Cardiovascular Working Party, and Chair of the European Association of Clinical Pharmacology and Therapeutics, which represents the national clinical pharmacology societies from the 29 established and accession countries in Europe and their ~4000 clinical pharmacologist members.

Background to new journal and to the FPM.

Thursday, 15 March 2012

Online launch by Elsevier of FPM journal - Health Policy and Technology

@HealthMed Health Policy and Technology was launched online on 14th March by the international publisher Elsevier on behalf of the Fellowship of Postgraduate of Medicine (see Editorial on Launch). The print version of the journal will be published later in March.
The first issue of the journal features editorials, reviews and original research by an international range of contributors from USA, Norway, Holland, UK and India. 

Key themes of papers in the issue include diagnostics, technology for drug discovery, e-Health, and health technology assessment, and health policy.
There is also the first in a series of interviews with senior health service, research and industry professionals, and policy makers, starting with Clinical Pharmacologist Sir Michael Rawlins, Chairman of the UK's National Institute for Health and Clinical Excellence.

Helpful links
Podcast of interview with Sir Michael Rawlins, Chair of NICE
HPT website
Background to FPM and the launch of HPT
Fellowship of Postgraduate of Medicine website