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Member of the European Commission responsible for Enterprise and the Information Society
"Networks and Healthcare"
GIRP (Groupement International de la Répartition pharmaceutique européenne/The European Pharmaceutical Wholesaler Association) Annual Meeting "Network in Healthcare"
Helsinki, 28 May 2001
Ladies and Gentlemen
The title of your annual meeting, "Network in healthcare" is of particular interest today. Dot.com hype is over. But what will remain of the IT- and internet revolution in health sector? It is a real question.
My own responsibilities are at the crossroads of this area, both information technologies and enterprise policy, including the pharmaceutical industry and the whole sector of commerce have a role in this area. So I hope that you allow me to treat the item more broadly than was the proposed subject.
Let us first put the figures to the table: Health is one of the largest single sectors in the economy; the average expenditure on health in the EU is currently 8%. But information technologies have not gained a significant share of health budget, neither in US nor in the EU. In the US ICT has a 2-3 % share of health expenditure. In Europe the figure is only around 1 %.
But it is clear that new innovations, applications and tools which are entering the market, will transform the demand for information and communication technologies (ICT) in the health sector. The internet is creating a great number of new ways to facilitate access, sharing and exchange of information.
We can also note that a growing number of home monitoring devices is commercially available and becoming also affordable. More and more articles with proven clinical benefits are presented in the medical publications.
New IT-applications are beginning to establish a significant, even if still small market presence. As a result a patient is becoming, not only more practically and intellectually involved in his disease management but also economically active in his own health care.
As more sophisticated, portable and discreet mobile applications to assist in the daily disease management of conditions such as diabetes and asthma become available, one would expect that more citizens and their insurers will buy applications for home care.
The benefits of the use of Information Society Technologies in healthcare are evident not only in terms of quality of care and access to services, but also very important in cost-containment.
The fast access to vital patient data through sharable and secure electronic healthcare records in science IT infrastructures facilitate the use of telemedicine services.
That makes possible to reduce waiting times to eliminate physical movement from one care centre to another and second-opinions from distant specialists are available in a single primary setting.
As a result the patient benefits from a wider range of services in shorter time and at no extra cost to the health budget.
eHealth in waiting the major obstacles to the full implementation of Information Society technologies in health
Yet despite the growing supply of products available and the obvious benefits of investing in and using a robust information technology infrastructure in healthcare provision, most EU Member States do not have a high level of integrated Information Society Technologies use in healthcare.
The question we must ask therefore is :
"What is holding the healthcare sector back from fully exploiting the benefits of Information Society applications ?"
Although the health Information Society applications market is regaining strength after the general downturn in the IT market, expenditure on IST in the healthsector still lags behind expenditure on IST in other sectors.
Expenditure on IT applications per employee per annum in the finance sector is more than 10 times that which is spent per employee in the health sector.
While it would be difficult to have the definitive answer to this question, some answers may be found by looking not only at certain specific technological needs particularly to the healthcare sector, but also at non-technological issues such as the regulation and quality assurance required in any public health system, as well as the human and organisational aspects of healthcare provision.
The technological challenges of ICT in healthcare are well known : they are the challenges of the storage, maintenance, communication and retrieval of multimedia information in different technological platforms and heterogeneous database systems.
For that reason the particular challenges of the integration and interfacing of multivendor platforms and the development of health sector specific middleware and applications have recently received lot of effort by Research and Development projects. They are supported through the EU Fifth Framework Programme in Research and Technological Development.
This integration effort is critical since the number of different purpose systems (administrative, insurance, clinical, nursing etc) is rising and it is not uncommon to see within one hospital department three computers, each for one specific part of patient care and management.
As a result of these many legacy systems, standardisation of IT applications becomes one of the key factors in the up-take of new technology. With scarce resources, managers are reluctant to place a purchase order for yet another piece of stand-alone kit, which cannot interface with existing applications.
We need standardised responses. That is why European research consortia have funded under the EU Information Society Technologies to develop standards for health applications. These have been widely taken into account by the relevant standardisation bodies. The most important examples are in field of Electronic Medical Records, Health Smart cards as well as Trusted Third Party and other security infrastructures for the health sector.
At the same time we must ensure that new research initiatives move forward, beyond the current concept on IT tools for healthcare towards a wider concept of knowledge for health.
This will bring together the information technology, neuro sciences and genomics in order to build intelligent systems that can jointly apply the successes of each area in the health sector.
The seed of these interactions have been sown. We have already biochips, which combine the results of research in Information Technology and genomics. For example functional brain imaging systems have been built which combine the experiences of information technology and neuro-science.
And then on regulatory aspects of pharmaceuticals in general and on information technology and health in particular.
Still this summer the Commission will adopt a new regulation to modernize the system of authorisations for medicinal products.
The current marketing authorisation scheme is based on the principle of cooperation and close involvement of Member States. The European Agency, which was created 5 years ago, is based on a Network philosophy.
After five years of operation it is time to take into account both technological and economic changes. These changes are for example:
Two examples of changes we plan to introduce :
Firstly, the authorisation of medicines is based on intense exchanges of data and on clinical trials. The new regulation will provide that the exchange of information between all parties will exclusively be dealt electronically in the future, and
Secondly, the pharmaceutical regulation today provides for a restrictive regime on promotion and publicity on medicine. This regime does not even permit that patient organisations could obtain information on available medicines from companies. There is more and more justified demand for information from the public, especially on the specific diseases like AIDS, asthma or diabetes.
As a derogation to the restrictive rule on advertising, increased possibilities for information should be permitted. If the legislative authority agrees, we are ready to allow through Internet better information of all parties.
Can we create a win-win situation between health sector and innovation and competitiveness of Pharmaceutical industries?
The fragmentation of the internal market is one of the main obstacles to the expansion of ehealth. The diversity of cultural, medical and social traditions, combined with different public health policies, have shaped different structures for demand of medicines.
And also different health insurance systems have resulted in divergent approaches how to ensure patients the best possible access to medicines.
The EU Commission published a report in the end of last year, which confirmed that even if the EU represents 27 % of the global market for pharmaceuticals, it is not a real single market. Healthcare belongs to subsidiarity, and each Member State runs their own pricing and regulatory framework. This splits the internal market into 15 separate national markets.
In March, I invited together with Commissioner David Byrne representatives from governments and industries to a round table to discuss about a major challenge: How can we ensure right medicines to patients at a reasonable price while creating good conditions for innovation to the industry. The objective was to bring together the public health policy and innovation of the pharmaceutical industry, often dealt with in isolation.
So the work has started. It remains to be seen if new win-win visions can be opened.
On regulations concerning eHealth
Users of IT-tools in the health sector sometimes complain about the burden of EU privacy legislation. (enshrined in European legislation such as the Data Protection Directive (95/46/EC)). This gives a right of consent, verification and correction to individuals and a duty of adequate information and secure storage to data processors.
Some recent changes in legislation can produce a significant health benefit. Let us take the example of digital signatures. Deaths occur every year due to medical mistakes, sometimes as a result of the administration of the wrong drug or wrong dosage of drug, mistakes which often stem from misread hand-written instructions and prescriptions.
Electronic prescriptions, authenticated through a digital signature, can diminish the number of the mistakes in electronically produced prescription becomes a crystal clear document.
The changes in legislation can in fact touch upon such a wide range of issues in the the practice of eHealth - privacy, distance contracting, e-Commerce, advertising, use of medical devices and so on.
As a result it is often argued that the nascent eHealth market is choked with legislation and that potential new actors in ehealth are fearful that eHealth practices could contravene existing legislation.
In order to address this issue, the European Commission will later this year present a Communication on Legal Issues in eHealth. The Communication will provide a stock-take of existing EU level legislation which could have an impact upon the practice of eHealth, in order to allow those entering the field to have a clearer picture of the legislative requirements.
Human and Organisational Challenges
Some of these limitations of many current health IT applications may be solved with new gadgets such as pen-based data input, speech recognition, mobile systems, multimodal, tailorable and adaptable interfaces, user identification procedures, and user interfaces for mobile services. A lot, however, will depend on simple user education and training.
A significant effort must be made to produce convincing cases which will persuade often reluctant clinical staff to adopt new methods of working.
Few clinicians, and even fewer patients, receive formal training and updates on the use of information technology.
While for clinicians the emphasis in training may be on technical aspects of systems, for citizens and patients the emphasis should be on developing the necessary skills to get the most out of the wealth of health information available on the internet.
While most clinicians will have undergone some training in assessing medical and scientific information, the uninitiated citizen has no way of readily telling valid medical advice from quackery.
Health related information is amongst the most frequently accessed information on the Internet. Still the European citizen has very few resources to assess the quality and authenticity of this vital information. To improve this situation, the European Council at Feira has supported an initiative within the eEurope2002 to develop a core Quality Criteria for Health Related Websites.
Drawing together key players from Government departments, International Organisations, NGOs and industry, a series of meetings will be held to explore current practices and pilots with the objective of developing a shared set of key quality criteria. They can be used by Member Sates to form the basis of future policy tools for assuring quality of information on health related web sites.
Such tools can be user guides, voluntary codes of conduct, trustmarks, accreditation systems, or any other initiative adopted by relevant parties, at European, national, regional or organisational level. The idea is to learn from what exists already, to harness current activities and to move forward in a coherent manner.
To conclude I would come back to my original question: why has the Information Society Technologies sector not gained a significant foothold in the healthcare markets?
We have the potential to build a very strong European presence in that market. The technological challenges are being worked on everyday in our research laboratories. Robust, inter-operable, and user-friendly applications and are being developed.
The regulatory aspects are being addressed through framework directives that seek remove the legislative uncertainties as we move from paper based face to face business to the virtual business community fostered by the information society. The users at every point in the healthcare chain are slowly becoming more educated in their use of Information Society technologies.
But in addition to this, real challenge is to have the best practices of eHealth, which speak for themselves, to ensure that the dissemination of European best practice in eHealth is loud, clear and convincing.
It is time to move from pilot projects to applications, only real applications are convincing. eHealth is a huge opportunity in waiting, the challenge for us all is to bring it out of the wings and to establish it as a key actor at the centre of the healthcare stage.