Major Irish investment in clinical research set to create 3,000 jobs

As many as 3,000 jobs could be generated if the public and private sectors increased investment in clinical research infrastructure fourfold over the next five years, according to a new report. 

Future Investment in Clinical Research advocates for investment to deliver a significant increase in the number of international and multi-centre clinical trial conducted in Ireland to offering increased access to new emerging therapies in Ireland. 

In addition to thousands of direct and indirect jobs the report states that such stimulus could be worth gross value added of €200-300m per year. 

A new report calls for a fourfold increase in clinical research infrastructure over the next five years.

More specifically, it recommends the development of this strategic infrastructure over five years and calls for an initial investment of €22m into clinical research in the first year. It also confirms that the Biopharma and MedTech industries will match government investment. 

The report also highlights that, on average, each patient participating in a clinical trial will generate a benefit of €13,500 to the economy. Additionally, the health service benefits from medicines worth an average of €5,899 per patient for those participating in clinical trials. 

Experts from patient representative bodies, academia, clinical research centres, healthcare delivery, funding agencies and the Biopharma and MedTech industries contributed to the report, which was shared at a seminar in Dublin today. Such investment could create as many as 3,000 jobs.  

Professor Pat O’Mahony, chief executive of Clinical Research Development Ireland (CRDI): ‘Our life sciences sector has grown rapidly over the past half-century, to a point where it now has global significance. 

‘However, our clinical research system, infrastructure or performance do not compare with our growth in the manufacturing sector. A real opportunity exists here now, to enhance Ireland’s level of clinical research to its fullest potential.’ 

Speaking at today’s event, Avril Kennan, CEO of Medical Research Charities Group, said: ‘Investment in the clinical research system will bring economic benefits, will help boost a beleaguered HSE staff and, most importantly, will lead to better health and quality of life for the Irish people. 

She added: ‘The report represents not some vague hope for the future but the potential to make a real difference to our parents, our children, our friends and all those we hold dear.’

Professor Mark Ferguson, the government’s chief scientific advisor, welcomed the report and said it would benefit patients, health care professionals, entrepreneurs and the industry.

 

IMSTA to double in size with expansion into Digital Health

Ireland Can Lead €140 Billion Sector

IMSTA is planning to double in size as it moves into the growing Digital health field.   The decision was announced at it’s 2019 Annual Conference in Dublin.

“It covers everything from the digital infrastructure that is already being put in place in health systems, to cutting edge research into robotic prostheses, rehabilitation assisted through virtual reality and remove healthcare through mobile devices”, explained Mark McIntyre, IMSTA Chairman and Senior Director Boston Scientific.  “IMSTA is ideally placed to help the healthcare system in Ireland create the right landscape for digital health to flourish here and bring about benefits to patients, clinicians and citizens.”  

IMSTA has appointed Clare Harvey Director for Digital Health Transformation.   She is the CEO of Jinga Life, is a former Programme Manager for the RCPI and has worked with HIQA and the Department of Health.  Her broad range of experience puts her at the nexus of ICT and health over the last decade.

See more on Press Release below.

IMSTA Press Release 2019

 

 

IVD OPEN DAY

IMSTA  IVD Open Day

 

IMSTA is planning to provide a forum for discussion on building a new narrative for the value of IVDs.  We are hosting an IVD Open Day on 12 October  in the Clayton Hotel Liffey Valley.   Registration is from 9.15 am. and we would welcome your participation – see Agenda below.

Please reply to admin@imsta.ie a.s.a.p. for the IVD Open Day to register for your place.  

 

 

 

IMSTA Award Winner – ABBOTT DIABETES CARE – Approval given to reimburse FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM

As you may have heard at IMSTA’s Annual Conference, the Minister for Health Simon Harris TD welcomed the HSE PCRS’s decision to reimburse Freestyle Libre for children and young adults

Minister Harris said “Almost 190,000 people in Ireland have diabetes.  This is a chronic disease that takes a lot of management, but we have made huge strides in treating and managing diabetes here and I’m very happy today to welcome the HSE’s decision to reimburse Freestyle Libre for children and young adults.”

“This innovative device will allow blood glucose levels to be monitored without invasive finger prick testing, which will be very welcome news for both parents and children.  I know that some patients have to test their glucose levels up to ten times a day and I hope that inconvenience and discomfort can be minimised for as many children and young adults as possible.”

“This is another very positive step in the management of diabetes, along with the Diabetes Cycle of Care, which is a great example of how joined-up primary care and expanding the scope of general practice can be so effective in reducing hospital visits and admissions.  The Cycle of Care allows adult patients with Type 2 Diabetes, who hold a medical card or GP visit card, to be managed in the community, by their own GP and practice nurse, rather than in a hospital clinic.”

“We know from the National Healthcare Quality Reporting System (NHQRS) that hospitalisation rates that have decreased substantially for diabetes, and I want to see that downward trend continue.  My Department is progressing more work in the area – the National Clinical Effectiveness Committee (NCEC) prioritised the development of a Diabetes Type 1 clinical guideline for adults during 2017. The HSE’s National Clinical Programme for Diabetes plan to complete this guideline and submit to the NCEC for quality assurance early this year, and I hope to see it published soon after.”

“The HSE will now make arrangements for the reimbursement of Freestyle Libre on an individual basis where specific criteria are satisfied in line with the recommendations of the Health Technology Assessment Group and I look forward to its being available for patients in the coming months.”

An Expert Group, under the auspices of the HSE’s Health Technology Assessment Group (HTAG), considered the Free Style Libre application by Abbott for addition to the Reimbursement List in line with the Health (Pricing and Supply of Medical Goods) Act 2013.

The Health Technology Assessment Group recommended that reimbursement for the device should be considered, subject to certain conditions (see here for further information).

The HSE has accepted its recommendations in principle and will be developing an application suite for hospital clinicians to use when proposing suitable patients for consideration of individual reimbursement support.

This will be confined to children and young adults who require multiple dose injections of insulin in the first instance, with a review after twelve months. The HSE has indicated that it will take some months to build the application suite for reimbursement support which will be endocrinologist / Hospital Clinic initiated.

See Abbott winning their IMSTA AWARD here https://youtu.be/A3Nj85O6PTc

 

MedTech Europe Board Recommendations on Brexit

The Board of MedTech Europe has issuing the following recommendation to IMSTA/its members:

If you have any business interaction with the UK, consider this as a critical and urgent situation requesting all your attention. Anticipate business continuity plans including a “hard Brexit” scenario that should include no recognition of your UK CE marked products in the EU27 after the end of the transition period. This includes not only products originating in the UK but products from other countries who used UK Notified Bodies to gain CE marking, e.g. BSI (Italics added by IMSTA).

These plans need to take into consideration the possible delays in product re-certification by Notified Bodies due to the transition into the new Medical Device Regulation (2020) and IVD Regulation (2022).

The dynamic of the negotiations will evolve as we get closer to the end of the transition period and to a possible “cliff”.  Rest assured that MedTech Europe will continue to put all their effort in advocating their proposition up to and even after the end of the transition period. We will keep you informed on the evolution of the situation, which is fully monitored by the Board of MedTech Europe and its dedicated Brexit Task Force.

 

 

IMSTA Annual Conference Speaker Presentations Available HERE

Following our very successful Annual Conference 2018, the following presentations are now available:  

Measuring outcomes in Ireland – Prof. Charles Normand, Trinity College

Slaintecare and Value-Based Health Care – Dr. Thomas Kelley ICHOM

HTA as a driver: HIQA’s Health Technology Assessment of Mechanical Thrombectomy in Strokeusing  – Dr. Máirín Ryan, Director HTA and Deputy CEO HIQA

Appllying Value Based Health Care to MedTech  – Yves Verboven, Director Market Access & Economic Policies, Medtech Europe

CASE STUDIES- How value-based health care strategies are delivering better outcomes 
2 Examples from MedTech Europe’s Value-Based Procurement pilot studies
(a) HCB MEAT TAVI Pilot – Ameer Ally Edwards UKI
(b) UniHA – Hypothermia – Kevin Bellenger

Value Based Health care in Wales – Alan Brace, Director of Finance, Health & Social Care, Welsh Government

Assessing the Value of Medical Devices in the HSE – Dr. Anne Dee, Health Technology Assessment Group Lead and Specialist in Public Health Medicine, Department of Public Health

Collaborative approach to Procurement – John Swords, Head of Procurement, Health Business Services, HSE.

ICHOM Challenge – Dr. Kemi Okunade