EU research and innovation funding: Commission consults on radical changes to create more growth and jobs

Friday 25 February 2011

On 9 February 2011, the European Commission DG Research launched a public consultation on major improvements to EU research and innovation funding to make participation easier, increase scientific and economic impact and improve value for money.

In its Green Paper, the Commission proposes a “Common Strategic Framework” which would cover the current Framework Programme for Research (FP7), the Competitiveness and Innovation Framework Programme (CIP) and the European Institute of Innovation and Technology (EIT). This will create a coherent set of instruments, along the whole “innovation chain” starting from basic research, culminating in bringing innovative products and services to market, and also supporting non-technological innovation, for example in design and marketing. The Commission’s Green Paper also provides the basis for far-reaching simplification of procedures and rules. The changes aim to maximise the contribution of EU research and innovation funding to the Innovation Union and the Europe 2020 Strategy.

The Commission is seeking the views of all interested individuals and organisations on these proposed changes and on the specific questions set out in the Green Paper. In parallel, a competition for the name of the Common Strategic Framework is being organised.

Stakeholders have until 20 May 2011 to submit their responses.

More information: http://ec.europa.eu/research/csfri/index_en.cfm

Your chance to sponsor the MedTech Forum 2011!

Friday 25 February 2011

The MedTech Forum is a unique opportunity for you to be in contact with medical technology companies, consultancies, NGOs and any stakeholders active in health, and to gain exposure and interact with hundreds of senior executives and delegates from the medical technology industry and other key healthcare stakeholders in Europe and abroad.

Sponsorship opportunities are wide and will fit your needs.

For more information on the packages available or to confirm sponsorship interest,
please contact Christopher Breyel at christopher.breyel@eucomed.org or +32 2 761 22 84 44

Committee for Advanced Therapies and Interested Parties Focus Group meet on non-clinical development of Advanced Therapy Medicinal Products

Friday 25 February 2011

On 9 February 2011 the European Medicines Agency (EMA) organised the first meeting of the Committee for Advanced Therapies and Interested Parties Focus Group (CAT/IPs Focus Group) on non-clinical development of Advanced Therapy Medical Products. The task of this Focus Group is to improve the interaction of the CAT with Interested Parties and to propose shared solutions on some of the previously identified issues.

As interested parties, Eucomed and other industry organisations such as European Biopharmaceutical Enterprises (EBE) and EuropaBio were also represented at this first meeting which was centred on the pre-clinical data needed when clinical data exists and on the identification of relevant animal models for non-clinical studies.

Eucomed is particularly interested in Tissue Engineered products and more specifically in products which combine medical devices and viable human or animal tissues. The association contributed to the discussion by bringing to the attention of the Focus Group the current requirements applicable to medical devices which should be taken into account during evaluation.

Eucomed wishes to express its satisfaction for the positive exchange of views during the meeting and for the work programme developed.

A full report on the meeting will be published soon on the EMA website

For more information please contact Dario Pirovano (dario.pirovano@eucomed.org)

Eucomed embraces opportunities at major European Commission conference on “Innovation in Healthcare”

Friday 25 February 2011

On 30 & 31 March 2011 European Commission’s DGs Research and Innovation, Enterprise and Industry and Health and Consumers (SANCO) will hold a conference on “Innovation in Healthcare: from Research to Market”. This is the second time that this two-day multi-stakeholder conference is organised.

Eucomed embraces this opportunity to demonstrate the readiness of the medical technology industry to share the responsibility in addressing the current and future challenges in healthcare.

Guy Lebeau, M.D, and John Wilkinson, respectively Chairman and Chief Executive of Eucomed, as well as representative of Eucomed’s SME network have been invited to speak.

The conference will cover a variety of topics; from knowledge creation to knowledge transfer, from fostering entrepreneurship to organisational aspects, and from pricing, reimbursement to uptake of new health technologies.

Guy Lebeau, M.D, will be a key speaker in the opening ceremony on 30 March. In his speech, he will demonstrate the huge value that the medical technology industry has to offer to increase the efficiency of healthcare systems and the ability of patients to better manage their own health. John Wilkinson will be part of a session on the second day where he will speak about opportunities to reorganise healthcare delivery by aiming for new holistic care models and how the medical technology industry can support them. Dr. Torbjörn Kronander, Co-founder of Sectra, will speak on behalf of Eucomed’s SME network about entrepreneurial challenges to bring a research idea to the market. There are indeed thousands of medical technology SMEs in Europe which are constantly developing innovative solutions for the benefits of citizens and which are facing hurdles hampering their potential for innovation.

The conference is open to public. More information and registration: http://ec.europa.eu/research/health/events-04_en.html

Five-Minute interview with Prof. Rosanna Tarricone

Friday 25 February 2011

On 11 February 2011, EMDT (European Medical Device Technology) published an interview with Prof Rosanna Tarricone, EHTI Executive Director, on “The Metrics of Living Well”. During the “Five-Minute” interview, she was asked about her daily work, her career in the medical technology industry and how this has led her to become part of EHTI.

When asked “What should people give more attention to?”, Prof Tarricone responded that “Quality is what makes the difference between ‘just living’ and ‘living well’. Technological innovation is one of the most important drivers of quality of life and it is therefore EHTI’s and my personal commitment to carry out qualitative and robust research projects. Only then can we make this still too-green field of economic science as relevant as more mature health economics applications and put it high on the agenda of policy-makers.”

Her full interview is available on the EHTI website

Shaping the future role of Medical Technology in Innovation and Healthcare

Friday 25 February 2011

Eucomed firmly believes that the upcoming High Level Conference on “Innovation in medical technology” taking place on 22 March 2011 in Brussels will be a decisive event in the shaping of both the near and future medical technology business environment in Europe.

Given the current crisis facing national Health systems and the importance of medical technology to future health policy and financing in the EU, the event is expected to include not only Health Ministers but also MEP’s, senior decision makers and stakeholder group representatives including patient’s organisations, clinician groups, payers and industry.

Alain Coudray, Eucomed’s Vice-Chairman, will be speaking at the Ministerial event and will be supported by a high-level Eucomed delegation including Board representatives.

This conference is the first time that Health Ministers will be afforded the opportunity to set standards and frame future policy at EU level in this area. As such it could help bring a clear EU level political vision for this sector, something which has been missing up until now, and become a pivotal moment in fostering collaboration between National Governments, industry and other stakeholders to use innovation in medical technology as a key tool in tackling the enormous health challenges facing us: Doing more with less.

The outcome of the conference could help set the frame for future high-level initiatives on innovation in medical technology and services, and how it can be used to deliver both national health system efficiency and effectiveness, and jobs and growth in Europe.

For more information, please contact John Brennan, Director Regulatory and Technical Affairs, Eucomed

ABHI & GS1 UK conference on UDI – The next big thing

Friday 25 February 2011

On 15 February, the Association of British Healthcare Industries (ABHI) organised together with GS1 UK a joint event on Unique Device Identification (UDI). UDI is coming and will affect all types of medical technology products. It is no longer just a question of bar coding products for the supply chain.

The European Commission defines UDI as a unique number pertaining to a medical device that enables the identification of different types of devices, and the access to useful and relevant information stored in a UDI database. Due to the UDI’s specificity, it can make traceability of devices more efficient, allow easier recall of devices, fight against counterfeiting, and improve patient safety.

In September 2007, the US Food and Drug Administration (FDA) Amendments Act of 2007 was signed into law. This Act sets out measures for implementing the UDI system, requiring devices to carry a unique identifier which allows identification both during use and distribution.
In Europe, UDI regulations are likely to be brought in as part of the Review (Recast) of the Medical Device Directives. UDI programmes are also underway in other major markets around the world. In recognition of the huge importance of these developments, ABHI and GS1 UK held this conference to cover developments in Europe and the USA along with an assessment of their impact on industry. UDI and Patient Safety, UDI and the Clinical Environment and UDI and the Hospital Supply Chain were also part of the programme of the day, as well as implementation issues from the point of view of industry and a regulator (MHRA), and a case study from the retail sector.

eHealth: Eucomed joins Advisory Board

Friday 11 February 2011

Eucomed has joined the Renewing Health Industry Advisory Board. Renewing Health is a large scale pilot which is implementing a series of real-life pilots for the validation and evaluation of innovative telemedicine services in nine European regions. The test sites are piloting telemonitoring and treatment for patients living with diabetes, chronic obstructive pulmonary or cardiovascular disease from 2010 to 1012.

The Industry Advisory Board is chaired by Continua and will inform and educate the project consortium members about industry trends and offerings and disseminate technical recommendations developed in the project. Renewing Health falls under the Competitiveness and Innovation Framework Programme and more info can be found at www.renewinghealth.eu

European Commission opens consultation on EU Public Procurement

Friday 11 February 2011

On 27 January 2011, the European Commission launched a public consultation on the Modernation of EU public procurement policy towards a more efficient European Procurement Market. This initiative could become of significant importance for the medical device industry as up to 80% of the market is procured through public tenders.

The Europe 2020 strategy for smart, sustainable and inclusive growth sets out a vision of Europe’s competitive social market economy over the next decade that rests on three interlocking and mutually reinforcing priorities: developing an economy based on knowledge and innovation; promoting a low-carbon, resource-efficient and competitive economy; and fostering a high-employment economy delivering social and territorial cohesion.

Public procurement plays a key role in the Europe 2020 strategy as one of the market-based instruments that should be used to achieve these objectives. More specifically, the Europe 2020 strategy calls on public procurement to:

° Improve framework conditions for business to innovate, making full use of demand side policy,

° Support the shift towards a resource efficient and low-carbon economy, e.g. by encouraging wider use of green public procurement, and

° Improve the business environment, especially for innovative SMEs.

This open consultation focuses on modernisation of the rules, tools and methods for better and smarter public procurement. It also identifies a number of key areas for possible reform and asks for stakeholders’ views on options for legislative changes.

Responsible for EU procurement law in the EU Commission is the Directorate General Market. Deadline for submitting responses to the consultation is 18 April 2011.

More information:

http://ec.europa.eu/internal_market/consultations/2011/public_procurement_en.htm

EPPOSI starts rolling out programmes on Chronic Conditions and HTA

Friday 11 February 2011

During two half-day workshops on 2 February 2011, members of the European Platform for Patients’ Organisations, Science and Industry (EPPOSI) brainstormed on content and deliverables for two of the four programmes that EPPOSI defined as key topics that will drive its work for the next 1-3 years (see What’s new 17 December 2010 ).

For chronic conditions the aim is to develop a holistic care model that can serve as a benchmark for national disease management plans. Eucomed successfully stressed that each generic model should consider all relevant phases of the pathway of people with chronic conditions. This goes from prevention over early diagnosis to treatment and secondary prevention. Preventing complications, managing co-morbidities and dealing with the “silo budgeting” approach is amongst the key elements to be addressed. It can only be achieved through a better integration of community and hospital care with the aim to build more efficient care models. This is true for main chronic diseases such as cardiovascular disease or diabetes. Moreover, if chronic conditions were fully integrated into a holistic care model, potential side effects could be treated more quickly and – in some cases – even prevented.

A topic of discussion during the Health Technology Assessment (HTA) session was the level of stakeholder involvement in HTA processes on the one hand, and its impact on these processes on the other hand. Eucomed supports the idea of stakeholder involvement and emphasises that HTA needs to follow appropriate methodologies befitting the unique characteristics of medical technology. Furthermore, Eucomed stressed that any HTA should, when assessing the value of medical technology, embrace a holistic approach that considers not only economical value, but also takes into account ethical, organisational, social and legal aspects.

Another workshop, which will take place in March, will concentrate on health innovation.