Impact of decision to move European Medicines Agency to Amsterdam

As one of many consequences of Brexit, following a very close vote by member states on Monday 20th November, Amsterdam has been confirmed as the new home for the European Medicines Agency. On current plans, the EMA will be operating in Amsterdam from April 2019, following a likely shadow hosting of the EMA there for some months before the formal date for completing the move of the agency.

The EMA's Patients and Consumers Working Party annual meeting

Meantime the EMA's Patients and Consumers Working Party (PCWP) is holding its annual meeting with all EMA eligible patient/consumer consumer organisations to consider relocation preparedness, patient and consumer involvement in EMA activities, highlights from major EMA committees and updates on pharmacovigilance, information on medicines and future work programmes in 2018 and 2019 for the PCWP and the EMA's Healthcare Professionals Working Party.

Effective medicines have both powerful therapeutic actions as well as the potential for serious unwanted adverse effects. The EMA was founded in 1995 with initial funding from the European Union and the pharmaceutical industry, and further support from EU member states. The European Medicines Agency is concerned with regulation, supply chain and pharmacovigilance for medicines and other advanced therapies for 28 countries across the European Union - from the Baltic countries to Ireland and from Scandinavia to the Balkans and the Mediterranean. All these roles concern balancing benefits and risks when it comes to patient safety with regard to medicines.

The EMA has established mechanisms for involving patients in regulatory assessment: patients’ value perception and value systems. The EMA also has an increasing remit to engage with stakeholder organisations and to improve transparency in its activities for the ~510 million citizens of the European Union. Furthermore the EMA has a major role in educating patients, carers and health care professionals about medicines. There have for example been recent workshops on

• combating antibiotic resistance: a partnership with the European Centre for Disease Control 
• biosimilars
• personalised medicine initiatives
• applying big data to improved regulation of medicines in Europe which raises important questions about clinical utility, quality, accessibility and systems for data mining

There remain many decisions and actions for the coming months needed to ensure continuity of the EMA's business. These involve the smooth relocation of the EMA to Amsterdam and either developing systems to retain UK expertise for the EMA or replacing that expertise from other EU member states. For the EMA, priorities include:

• minimising the impact on staff of the move to maximise staff retention
• maintaining capacity to continue the work of the EMA 
• the resulting need to prioritise EMA core and planned further activities
• continuing productive engagement with stakeholder groups: patients, carers, healthcare professionals ...
• maintaining the capacity of the EMA to engage with the public

For the UK, there are pressing questions regarding the future regulation of medicines in the UK post-Brexit, the impact of loss of international influence of UK regulators and other experts on medicines and the impact of loss of biotech and pharmaceutical companies from London to Amsterdam.

The EMA has been based in London for over 20 years. Many staff have strong family and other personal ties in the UK - for example partners' work, children at school, dependent relatives ...  Adapting to a new country is no simple matter. The working language of the EMA is currently English however full integration within Amsterdam will need competency in the native language in the Netherlands. There will also be practical challenges arising from the simultaneous impact of the arrival of up to 800 families on the Amsterdam housing market and schools system.

© Donald Singer 

Global perspectives on the heart: Hippocrates Book of the Heart launched in Toronto

The Hippocrates Book of the Heart edited by Wendy French, Michael Hulse and Donald Singer
ISBN 978-0-9935911-1-2   UK: £12  Ireland: €15  US: $18  CAN: $24  AUS: $24  NZ: $30

Order a printed copy of the book            Order the eBook

Art installation by Rochelle Rubinstein and Alisha Kaplan

This book, made possible by the generous support of the Cardiovascular Research Trust, brings together eighty contemporary poets of the English-speaking world and a dozen medical experts from around the globe to offer their perspectives on the heart.

Since ancient times, the heart has been understood as the seat of the emotions, of the will, even of the soul. Over time, a fuller medical understanding of the organ has gradually evolved too, with Harvey’s first complete account of the circulation of the blood and the heart’s role (1628) and Dr. Christiaan Barnard’s first successful heart transplant (1968) marking key moments in a history that has given us a much better understanding of our hearts – and how to ensure they stay healthy.

In compiling this book, the editors invited poets around the English-speaking world, both prominent and less well-known, to contribute poems about the heart, written from any perspective, whether clinical or fanciful, medical or metaphorical. Among the poets are Griffin Poetry Prize winners Roo Borson and David Harsent, Forward Prize winners Sean O’Brien, Hilary Menos and Nick Mackinnon, former New Zealand Poets Laureate Elizabeth Smither and C. K. Stead, former National Poet of Wales Gwyneth Lewis, and President of PEN International Jennifer Clement. They are joined by many other distinguished and rising poets, including Robert Gray, John Kinsella, Peter Goldsworthy, Stephen Edgar and Geoffrey Lehmann from Australia; Anna Jackson, Jenny Bornholdt and Chris Price from New Zealand; Grace Schulman, Rafael Campo, Matthew Thorburn, Debora Greger and Jeffrey Harrison from the US; Marilyn Bowering and Kenneth Sherman from Canada; Justin Quinn, Mary O’Donnell and John F. Deane from Ireland; and Jane Draycott, Philip Gross, Mimi Khalvati, Lawrence Sail and Penelope Shuttle from the UK.

Leading medical professionals whose practice and research has led them to a keen interest in the health of the heart contribute information and advice to the book. In clear, crisp mini-essays they illuminate the nature of heart disease, the key risk factors, the history of cardiac surgery, and the most important steps every one of us can take in trying to maintain a healthy heart. Our medical professionals, based in Russia, Finland, The Netherlands, France, the UK, Australia and Hong Kong, agree in their core message: maintaining a healthy heart is possible for every one of us, and is crucial to our overall health and well-being throughout our lives.

The result is that rare thing, a book that satisfies the Horatian dictum that writing should both delight and instruct.

Makom, Toronto, 16.11.17: 
Donald Singer, Ron Charach, Kenneth Sherman, Roo Borson, 
Kim Maltman, Ronna Bloom and Alisha Kaplan

The Canadian launch of the book was held at Makom in Toronto on Thursday 16th November. The programme included readings by Canadian poets Alisha Kaplan, Kenneth Sherman, Roo Borson and Kim Maltman. There was also a lively discussion panel on "More poetry: just what doctors and the public need?" In addition to the above poets the panel was joined by poet and psychotherapist Ronna and poet and psychiatrist Ron Charach, with a co-chairs: Alisha Kaplan and Donald Singer.

See more about the Toronto launch of the Heart book

Ronna Bloom is the author of 5 collections of poetry including The More (Pedlar Press, 2017). Her poems have been translated into Spanish and Bengali, recorded by the CNIB, and used in films, by architects, in education and health care. Her work appears in "Poetry is Public" and in the Toronto Public Library Poetry Map. She is currently Poet in Community at the University of Toronto and Poet in Residence in the Sinai Health System in Toronto. In these roles she offers students, health care professionals, patients and visitors opportunities to articulate their experiences through reflective writing and poetry. A meditator and psychotherapist, she lives in Toronto. 

Roo Borson's work has received the Griffin Poetry Prize and the Governor General's Award. Her most recent book of poetry is Cardinal in the Eastern White Cedar (2017), published by McClelland and Stewart/Penguin Random House. With Kim Maltman, she writes under the pen name Baziju, whose first book, Box Kite, was published in 2016 by House of Anansi Press.

Ron Charach is a poet, essayist, novelist and practicing psychiatrist. Born in Winnipeg, he has lived in Toronto since 1980 with his wife Alice, who is also a psychiatrist and researcher. His medically related poems are featured in two world anthologies of physician poetry published by the University of Iowa Press, Blood & Bone and Primary Care. His most recent books of poetry are Forgetting the Holocaust and Prosopagnosia, the latter of which was published by Toronto’s Tightrope Books. His poetry draws from the twin streams of literature and the healing arts.

Alisha Kaplan: The daughter of a printmaker and a psychiatrist, Alisha is very interested in the convergence of art and medicine, and the healing possibilities of poetry. She is a Torontonian poet, an editor for Narrative Magazine, and the winner of the 2017 Hippocrates Prize in Poetry and Medicine. She taught creative writing at New York University, where she received an MFA in Poetry. Her writing has appeared in Fence, DIAGRAM, Carousel, PRISM, The New Quarterly, and elsewhere.

Kim Maltman is a poet and theoretical particle physicist who teaches mathematics at York University. A past winner of the CBC Prize for Poetry, he has published five solo collections of poetry and three collaborative books, including Introduction to the Introduction to Wang Wei, written under the pen name Pain Not Bread and published by Brick Books.

Born in Toronto, Kenneth Sherman is the author of three books of prose and ten books of poetry. His most recent publications are Wait Time: A Memoir of Cancer and the poetry collection Jogging with the Great Ray Charles.

Donald Singer and Michael Hulse co-founded the Hippocrates Initiative for Poetry and Medicine in 2009. Singer is a clinical pharmacologist who has published over 200 articles, chapters and books on medicines, on cardiovascular research, prevention and treatment, and public understanding of health. He is an editor and contributor to The Hippocrates Book of the Heart (Hippocrates Press, 2017). He co-authors the prescribing safety guide Pocket Prescriber (Taylor & Francis) now in its 8th edition since 2004. He is President of the Fellowship of Postgraduate Medicine. He is also on the Executive Committee of the European Association of Clinical Pharmacology and Therapeutics.