Memorandum by GJW Government Relations
Ltd, Health Affairs
1. EXECUTIVE
SUMMARY
One of the aspects of European e-commerce policy
that has received limited attention is how to deliver co-ordinated
health policy using new media techniques. Some parts of this agenda
are overtly e-commercial (such as Internet pharmacies), while
others are less so (such as the National Electronic Library for
Health). However, the online market for self-care medicinal products
is expanding with about one in three e-consumers buying healthcare
products online.[82]
"e-health" is one facet of the expansion in e-commerce
that needs to be addressed by the European Commission and European
Member States in a significantly more informed and co-ordinated
way.
There are three aspects of e-health that the
Committee may wish to consider:
— The quality, accuracy, security and
identification of providers of health information via the Internet.
— Issues of Direct-to-Consumer advertising,
independence of medical advice, the desirability of supplying
Over-the-Counter and prescription drugs via the Internet.
— The role of NHS and independent providers
in "e-health" policy.
At present, neither the European Commission
nor the United Kingdom Government has proposed sufficient measures
to encourage e-health while also attending to the significant
regulatory issues. This submission briefly addresses both sides
of this current debate and offers policy proposals for the Sub-Committee
to consider. The four most important are:
— e-Commercial sites may well lead
to the provision of e-health capability. While initiatives like
the e-Europe programme seek to bring Member States' health provision
up to the speed, the nature of the Internet means that e-commerce
models will drive the agenda. Member States will need to work
in partnership with these businesses to maximise the advantages
of e-health both across Europe and in the UK.
— A series of online kitemarks to act
as guarantees for the quality, providence, and accuracy of the
medical information supplied. While the European Commission should
work with the nascent industry to facilitate these kitemarks,
self-regulation should be the preferred model for the future of
e-health.
— Greater emphasis should be given
by the European Commission to the advantages of the Internet to
deliver social policy online both efficiently and cost-effectively.
The Commission is well placed to act as "cheerleader"
for e-health and e-social policy, providing leadership and collective
experience to all Member States.
— To promote the educational power
of the Internet to inform patients and their carers. As Member
States try to contain healthcare costs and the paternalist model
of "doctor-knows-best" is eroded, patients want to learn
about their condition, its treatments, and preventative measures.
The underlying philosophy of e-health is to empower the individual
to look after his/her own health most effectively.
2. WHAT IS
E-HEALTH?
Put simply, e-health is a wide-ranging area
of social policy that uses new media technologies to deliver both
new and existing health outcomes. In the UK, it incorporates everything
from NHS Direct online to Internet pharmacies to webcast operations
involving consultants in another country. Across Europe and the
United States, studies show that health-related websites are receiving
more hits than even pornography sites.[83]
At the moment, the main focus of e-health is on patient empowerment
and self-care. As the area develops, e-health could expand to
include online long-term disease management, personalised health
checks, and more efficient primary care services due to informed
patients accessing the healthcare system at the most appropriate
point.
Advantages of currently available e-health services
include:
More efficient and cost-effective means of delivering
health services. For example, trials are ongoing in the Midlands
with GP appointment systems that e-mail the patients with convenient
times and proactively send repeat prescription reminders.
Easy and convenient access for patients and
their carers to high quality medical information. NHS Direct online
receives about 100,000 hits each month. The NHS brand offers a
quality guarantee on the information available. In the same way
that the nurses operating the NHS Direct phone line can offer
self-care advice, so the online service will soon include self-care
advice. Information will be available on Over-the-Counter medicines,
medication, and symptoms.
More flexible access to sources of self-care
online. The numbers of community pharmacies are dwindling owing
to the twin effects of out-of-town supermarkets replacing high
street community pharmacies, and large pharmacy chains locating
only in areas of high footfall. Online pharmacies such as "Pharmacy2U"
and "Allcures" will soon offer door-to-door nationwide
delivery at lower cost to the patient.
Disadvantages of e-health include
Lack of face-to-face contact between health
professional and patient. This lack of contact can lead to confusion,
unnecessary worry, and even misdiagnosis (although misdiagnosis
usually stems from erroneous self-diagnosis based on incorrect
information contained on health advice websites).
Concerns over the security of patient information.
Both the UK Government and the European Commission have outlined
plans for a form of Electronic Patient Record in order to deliver
the most appropriate care by the most appropriate health professional
in the most appropriate setting. However, concerns about the security
of patient information have delayed these plans.
The considerable difficulty of enforcing the
current UK and EU regulatory regimes across the international
Internet. These regulatory regimes include a ban on Direct-to-Consumer
advertising, numerous specifications on the quality of the medical
advice given, and differences in legal opinion over the safe delivery
of medicines.
3. THE EUROPEAN
E-HEALTH
PROGRAMME
The draft Action Plan e-Europe: An Information
Society for All is a useful summary of the Commission's vision
for e-health development across Member States. The Lisbon conference
in March 2000 highlighted the difficulties of delivering this
e-health agenda.
Information Society for All stresses that "the
efficient provision of quality health services to all citizens
in the future is one of the most difficult challenges facing all
European governments." The document goes on to note that
"secure [information technology] services have to be developed
linking hospitals, laboratories, pharmacies, primary care centres
and homes of people." The paper concludes that "the
Union has every incentive to co-operate in the protection and
improvement of public health (Article 152 of the Treaty). This
does not mean harmonising health care at European level. However,
it does mean working together by conducting research, agreeing
standards and produce specifications and building pan-European
medical libraries."
The Lisbon conference agreed a number of targets
for European e-health. They are:
By the end of 2000: Best practices of healthcare
regional networks should be identified and priorities for medical
libraries-online set. Health care informatics standardisation
priorities to be implemented by end 2000.
— The development of online medical
libraries, next generation smartcards for healthcare and more
user-friendly infrastructures are included in the Work Programme
for the Information Society Technology programme 2000. However,
this work programme is already out of date. There are a number
of online health libraries already in existence, ranging from
academic libraries to self-care advice. At one end of this spectrum
is the Organising Medical Networked (OMNI) system of kitemarked
biomedical information through to Discern Online targeted at consumers.
Both these sites are linked to NHS Direct online website. However,
a superior online medicines and healthcare compendium will be
launched in May 2000 that could render these libraries redundant.
Will the Commission have the resources, the political will, or
the knowledge to keep up (let alone lead) this development?
— The Commission proposes to encourage
take-up of health information networks at Member State and trans-national
level. How will this encouragement take shape? Is the Commission
considering a comprehensive public education programme about e-health?
In the United States, the Food and Drugs Agency (FDA) has begun
a national campaign to warn consumers of the dangers of buying
medicines online. In part this campaign is to counteract the massive
advertising effort of online health companies such as Healtheon
and Dr Koop. These market leaders created an environment where
there are now approximately 400 online pharmacies in the US. One
option would be for the Commission to work with these start-up
companies to develop self-regulatory models as the market emerges
rather than trying to alter the market once it is established.
— The Commission also proposes that
Member States should implement secure and efficient health telematics
systems and services based on standards as adopted by European
Standards Body (CEN). How will the Commission build a European
consensus on the wider issues of the implementation of health
telematics systems and services such as confidentiality of health
data, quality of service and liability of service providers (including
authenticity of pharmaceutical supply and medical advice)?
By the end of 2003: Implementation of informatics
tools (health cards, health information and education networks)
to facilitate citizens' active involvement in prevention and treatment
of diseases.
— The technology already exists to
mass-produce health smartcards. Indeed, every British citizen
already has an NHS number. However, the political will to introduce
the mandatory smartcards is much weaker in the UK than it is on
the Continent where many citizens already carry the equivalent
documentation. While it is more logical for the Commission to
drive this measure, the Member State will provide the political
will to ensure national comprehensive systems. It will be difficult
for the Commission to co-ordinate this programme.
— Although the UK Government is taking
the lead in facilitating patient information and advice online
through the NHS Direct service, it is the entrepreneurial health
websites and portals that are currently leading the effort to
deliver citizens' active involvement in prevention and treatment
of diseases. UK examples include Pharmacy2U, NetDoctor, and Allcures.
Citizen involvement here suffers from a lack of regulatory standards
about the health information on offer. Following the example of
online financial services, a series of kitemarks could act as
guarantees for the quality, providence, and accuracy of the medical
information supplied. While the European Commission should work
with the nascent industry to facilitate these kitemarks, self-regulation
should be the preferred model for the future of e-health.
By the end of 2004: Health professionals and
managers to be linked to an electronic health infrastructure.
— The trials and tribulations of NHSNet
provide the template for introducing an electronic infrastructure
across Europe. The British Medical Association convincingly diverted
Department of Health plans on the shape of this service; pharmacists
were effectively excluded on cost grounds; nurses are at a clear
disadvantage due to a lack of access and training. This provides
the context for the NHS Information Strategy that centres on Electronic
Patient Records (possibly contained on smartcards) by 2005. Without
these EPRs, a modernised 24-hours healthcare service will not
be able to function due to lack of information about the patient.
— Greater emphasis should be given
by the European Commission to the advantages of the Internet to
deliver social policy online both efficiently and cost-effectively.
The Commission must not view e-health as about electronic data
interchange between health professionals but as a much wider tool
of social policy. The Commission is well placed to act as "cheerleader"
for e-health and e-social policy, providing leadership and collective
experience to all Member States. However, the Commission will
be aware that electronic health infrastructures will develop at
different speeds both within and between Member States. Is the
Commission concerned that UK healthcare companies will seek new
markets in Europe and enter these markets by offering cut price
IT systems both to health professionals and to patients? The implications
of this US expansion range from importing US health models like
Health Management Organisations (HMOs) to challenge the tax base
upon which mixed healthcare markets operate across Europe. The
UK's NHS will be particularly affected by HMOs restructuring primary
care arrangements.
— It is interesting to compare the
Commission's aspirations on "e-education" and "e-health".
Whereas the former looks to all pupils being digitally literate
by the time they leave school, the latter looks only to professionals
rather than patients to have the equivalent health digital literacy.
The educational power of the Internet to inform patients and their
carers needs to be promoted. As Member States try to contain healthcare
cost and the paternalist model of "doctor-knows-best"
is eroded, patients want to learn about their condition, its treatments,
and preventative measures.[84]
The underlying philosophy of e-health is to empower the individual
to look after his/her own health most effectively.
4. REGULATING
E-HEALTH
IN THE
GLOBAL ECONOMY
Regulators of the global Internet pharmacy market
appear to be converging towards a common approach. Democrat Members
of the House of Representatives are leading the Clinton Administration
efforts to put Internet pharmacies under the supervision of the
Food and Drug Agency from October 2000. This "crack down"
has been sufficient to cause market predictions to be cut back.
Researchers now estimate that the American Internet pharmacy markets
will be worth $10 billion by 2004.[85]
The European Commission, on the other hand, is moving to deregulate
e-commerce and e-health in the hope of kick-starting growth in
an inactive market.
However, the Internet is renown for rewriting
existing rule books on working practices and revenue streams.
This will be seen with a succession of partnerships between pharmaceutical
or communications companies and health care providers to develop
computer-based decision support systems. These new technologies
will be used in surgeries, pharmacies, shopping centres, and high
streets to provide patient information on medical treatments.
Certainly, this fits in well with UK Ministers' stated intentions
on NHS Direct Online and Walk-In Centres.
Some form of active self-regulation by e-health
providers within a framework of European Commission standards
may be the best way forward. The established methods of self-regulation
can protect vested professional interests. This may push consumer-orientated
patients to more open, accessible services where the standards
are not so vigorous. Yet legislative regulation can never keep
pace with rapid Internet innovations and officials are rightly
reluctant to try. Instead, could the Commission take the lead
in persuading individual e-customers to accept a responsibility
to seek the best professional advice even if it means greater
effort and expense on the customer's behalf?
5. POSSIBLE STRUCTURAL
CHANGE AT
EUROPEAN LEVEL
TO ACCOMMODATE
E-HEALTH
There is an overwhelming need to establish which
DG is leading on e-health. At the moment, it is split between
DG XXIV (Consumer Health Protection), DG XIII (Information Society),
and DG III (Consumer Affairs). The result, predictably, is a lack
of clear priority setting. This can be seen in the lack of response
to regulatory issues for e-health. In January 2000, the European
Parliament published a draft report on ways of regulating the
marketing and sale of prescription pharmaceuticals on the Internet.
The report—by the Parliament's Scientific and Technology
Options Assessment (STOA) Unit—recognised that e-commerce
will affect the pharmacy sector and states that the European Parliament
should take the lead in legislating for a regulatory framework.
This report proposed two useful policy options:
— Modification of current EU legislation
on advertisement of and commerce in medicines by explicitly considering
the particularities of the electronic media and services.
— To push the pharmaceutical industry
to establish agreements on "Good-Internet-marketing-practice".
This code of practice would serve as a self-control instrument
for the pharmaceutical industry in order to safeguard consumers'
interests.
The number of e-commerce initiatives, proposals,
and draft directives that touch on this area can gauge the impact
of e-health. Affected areas include: the draft Electronic Commerce
Directive, the Data Protection Directive, the Copyright Directive,
the Brussels Convention, Online dispute resolution, Internet governance,
the Electronic Signatures Directive, Internet and broadcasting,
Trademarks, and the Electronic Communications Review. Almost every
Directorate-Generale is affected by at least one of these issues.
Without co-ordination, e-health may at best develop as an unregulated
patchwork of online services across Europe, confusing the patient
and frustrating Commission efforts to deliver improved health
outcomes online. At worst, across Europe "e-health"
could become a byword for unpredictable quality, unprofessional
medical advice, and patients' health outcomes becoming prey to
unscrupulous profiteers.
29th March 2000
82 Forester Research, May 1999. Back
83
Datamonitor, November 1999. Back
84
Cyber Dialogue (December 1999) reported that one-third of
American chronic disease sufferers who seek disease information
online report taking their medications more regularly following
a visit to a disease-specific website. Back
85
Jupiter Communications (January 2000). Back
|
