From October 6 to 9, 1999
politicians, scientists, industry and business representatives, health
experts, non-governmental organisations and representatives of affected
groups gathered in Bad Hofgastein to discuss problems of health and
social security with the aim of "Creating a Better Future for Health
from over 30 countries highlighted this event with their participation
and contribution. Just to name a few:
Hajdu Gabor, Romanian
Minister for Health, Caspar Einem, Austrian Minister for Science,
Erwin Jordan, German Secretary of State for Health, Fernand Sauer,
Executive Director of the European Agency for the Evaluation of Medicinal
Products (EMEA), Marlene Haffner, US Food and Drug Administration
(FDA), Prof. Rolf Krebs, Vice-President of the International
Federation of Pharmaceuticals Manufacturers Associations, Ulrich
Bode, President of the Austrian Association of Pharmaceutical Industries,
Prof. Spencer Hagard, London School of Hygiene and Tropical Medicine,
Prof. Albert R. Bakker International Medical Informatics Association,
Mary McPhail, European Public Health Alliance, Albert van
der Zeijden, International Alliance of Patients’ Organisations.
In the numerous contributions
made by the various speakers on different perspectives of health and
social security in Europe, particular attention was given to the following
issues: solidarity for health, the connection of the health industry’s
needs with those of social security systems, the WHO concept of "Health
for All" as a challenge for the health economy, and the role of
non-governmental organisations in the areas of health and social security.
The most important results
of the six Forums that worked on the following topics are presented
1. "Improving the Quality of Care"
access to good health quality for all (in care, treatment, and services)
within reasonable time.
2. "Improving Equity in Health
and Health Care"
The existing gap in access, scope, and quality of health must be studied
and gradually abolished, whereas certain groups of persons (e.g. migrants
and refugees), the adjustment of the membership candidates, and certain
areas (e.g. employment possibilities, alcohol, and drugs) require
3. "The Role of Public Health and
Health Promotion in a Changing Europe"
The proposed EU-declaration of the rights of citizens must include
references to health and public health measures. Further, public health
research must be integrated more efficiently into existing structures,
both within the EU and in the member states.
4. "Information Technology: Health
and Technological Developments"
A system for certification of HC Telematic products at the European
level should be set up, to ensure that these products are medically
cost beneficial, technically interoperable and reliable as well as
beneficial to the patient (directly or indirectly). The certification
is to be carried out by independent neutral bodies.
5. "Rare Disorders and Orphan Drugs:
Research without Return on Investment"
Main recommendation: All efforts (public
and private) on an European level must aim at combining funds, research
programmes, and information initiatives, as well as at reducing relevant
taxes and promoting investment in this area for the benefit of those
6. "The Impact of Biotechnology
on Health Systems and Health Services"
Main recommendation: Basic biotechnological
research will lead to the development of new drugs, vaccinations,
diagnostic methods, and medical procedures. In order to derive practical
benefits from these achievements for those affected, it is necessary
to establish an open dialog and a functioning communication between
researchers in biotechnology, other experts, and the general public.
In detail, the participants
of the six Forums developed the following scenarios and recommendations,
which were adopted and further elaborated upon by the authors of the
Dr. Günther Leiner,
President of the European Health Forum Gastein
Forum I: Improving the Quality of Care
1.1 The quality concept must be defined
on different levels and with different targets: politicians, professionals,
managers, economists, patients, consumers, etc. must co-operate.
The quality concept is about
2.1 Recommendations on national level
2.3 Agenda for EU-action
Forum II: Improving Equity in Health
and Health Care
- Develop quality standards and quality
- Promote the establishment of databases
on quality outcome, using existing expertise in member states;
- Use this information to develop
indicative standard objectives and targets for good practise
- Disseminate the information to
member states and relevant organisations
- Support patient and consumer groups
in getting involved in quality improvement
- Support existing organisations
and bring them together on the European level
- Provide them with information on
quality and benchmarking
- Promote patient advocacy by training
- Promote the involvement of patients
and consumers in meetings on health care
- Support training of health professionals
on quality issues
- Define minimum standards for training
and working conditions
- Provide national authorities and
professional organisations with information concerning training
in quality awareness
- Promote research on quality improvement
- Improve existing methodology on
defining quality indicators and quality evaluation
- Promote inventories and the analysis
of "patient needs", related to consumer-induced quality
- Analyse the effect of cross-cultural
differences on the application of quality standards
Behind the issue of improving the equity
of access to health care lies a vast range of diverging interests.
Different financial capacities and competencies in national health
care systems as well as the presence of social security systems of
extremely varying capacity can be found. Moreover, political and economic
interests from various areas collide, each with an impact on the actual
health policy situation in a region, a country, or within the EU.
Enhancing the social value of "health" by targeted and co-ordinated
efforts from the various levels may constitute a remedy. The forum’s
objective was to demonstrate how this can be achieved and for whom
it would require a change of views.
The majority of the participants stressed
the large gap between the access, scope, and quality of national health
care systems in EU member countries as compared to those existing
in the candidate countries. The identification of regional problem
zones in health care as well as a regional or national definition
of poverty limits would enable a better targeting of EU interventions
and of national or regional efforts. The participants believe that
health gaps can be filled by increasingly identifying interfaces of
interest with other socio-political areas of action. As a result,
both supranational aid, particularly in the area of research, and
national policy action could ensure that in future the people affected
no longer fall through the social net. By presenting regional examples,
various participants pointed to the fact that some parts of the EU
are still too slow in combating the link between structural poverty,
poor health, and more difficult access to diagnosis and treatment.
On an abstract level, health care systems are often seen as distribution
systems for funds, and important references to other areas with a
direct or indirect impact on the quality of life and health care are
not sufficiently understood.
2.1 General recommendations
- The creation of employment and the
establishment of dignified living conditions constitute political
and social priorities. This eminent social responsibility is considered
the duty of the Community and of national and regional decision-makers.
- The existing gap in access, scope,
and quality of health care must be studied and gradually abolished.
- A social understanding of disease must
be established and developed, and the value of moral principles in
health matters must be enhanced.
- Disease is not merely a personal state
of emergency but is also determined by social factors – particularly
among the unemployed and the disabled.
2.2 Recommendations on a national level
- There is need to establish more and
better information on the social determinants of disease and to develop
health perspectives, particularly for the poor and the elderly.
- Research on the causes of disease and
dissemination of knowledge must increasingly replace the mere treatment
of symptoms in the health sector.
- Interfaces with other social areas
of responsibility must be defined and health gaps must be filled.
2.3 EU objectives in connection with
"Equity in Health and Health Care"
- Approximation of the candidate countries
to EU standards is to be achieved through increasing efforts to enhance
the value of health and social policy in those countries.
- The creation of employment opportunities
is of utmost significance.
2.4 Objectives for EU campaigns
- EU standards must be established in
the areas of health insurance and old-age pension provision as well
as in the area of other social benefits – in particular for migrants
- Health regions with comparable health-related
situations must be defined.
- Social tasks with an impact on the
health situation must be identified on an EU level as well as on a
national and regional level. A "Think European, Act Local"
approach is necessary.
- There is need to develop information
on issues with a high social impact like alcohol, nicotine, and drugs.
This information must then be disseminated in a manner which encourages
people to act.
FORUM III: The Role of Public Health
and Health Promotion in a Changing Europe
1.1 The health status of European Union
citizens today is better than it has ever been before. However, there
is still room and need for improvement, especially considering the
big differences between and within member states. These differences
are even more striking , when one looks at Europe as a whole.
1.2 Public Health, which has been defined
as the "organised attempt by society to prevent illness, lengthen
life and to promote health on the basis of scientific evidence",
has a key role in meeting this challenge.
1.3 Health promotion is an important
delivery mechanism for public health activities. It should not be
regarded as a cost, but rather as an investment for society, making
society more conducive for health and leading to health gain. This
will also enable society to support excluded groups and elderly people
and to help them to engage in economic activities which would again
lead to further economic gain.
2. Recommendations at EU and member state
2.1 There is a need to generate public
pressure and to mobilise concerns so that public health issues receive
higher priority in Europe – both in the EU and within individual countries.
In order to be effective, public health actions must promote change
at all levels.
2.2 At Community level, the proposed
EU-declaration of the rights of the citizens must include references
2.3 Health inequalities as a major
crosscutting theme could become a major topic of the next European
Health Forum Gastein.
2.4 Health impact assessments can
be an important tool in order to understand the health consequences
of certain policy measures. Policies on nutrition are an important
example illustrating how a better understanding of policies and actions
can influence dietary habits and the quality of foods.
2.5 Stronger structural linkages
between public health action and public health research – be it in
the Member States, be it in the EU – have to be established. Research
has a key role in determining and addressing public health priorities.
2.6 General objectives and priorities
of public health policy should not be subordinated to single-issue
concerns and health scares. Work on food safety, communicable diseases
and health information must be integrated into a coherent health policy
2.7 Public health concerns must play
an important role in the enlargement process of the EU. The Community’s
public health policy must address the needs and requirements of applicant
2.8 NGOs are of crucial importance
in public health, in terms of their advocacy work and their involvement
in specific public health activities.
2.9 Health promotion is a new tool
in addressing health issues and problems at different levels. Further
investments in health promotion are needed to develop mechanisms to
include the societal context into interventions and evaluation of
projects. Health promotion should be seen as a learning activity.
While there is a pan-European dimension, it is heavily culturally
2.10 New fields of action need to
be explored and new instruments need to be developed to reach the
Forum IV: Information Technology:
Health and Technological development
1. General conclusions and actual situation
Basically the required technology is
available, the emphasis should be now on implementation rather than
on experiments and prototypes (although there still is a need to develop
products based on the knowledge and experience gained).
To harvest the potential benefits of
telematics, adaptation of the processes will be necessary (this will
probably lead to adaptation of the organisational structures as well;
similar effects have occurred in other industries). This could represent
an unique opportunity to put the citizen in the centre of the adapted
To allow for successful application
of telematics accompanying measures will often be necessary with respect
to: education, financing, infrastructure.
Internet exists and is growing rapidly,
with its regulations based on the market. Some special regulations
will be necessary in the domain of security. As a minimum Codes of
Conduct must be defined.
The countries, which are candidates
for enlargement of the EU, may be in a favourable position to take
advantage of this new technology because there will be less opposition
from existing structures.
2. Recommendations for action
2.1 At the regional/national level
- The definition of the implementation
plans should involve all the various partners (health care professionals,
HCEs, patients’ organisations, technicians) and not only the latter.
- Both initial and continuous education
should be organised for all professions and for the patients. This
will also contribute to reducing the risk of social exclusion.
- In the implementation plans, the targets
to be achieved have to be clearly formulated. Systematic assessment
of the degree in which the targets have been met must be established.
- Regulations and legislation should
be adapted to allow for the effective use of telematics in health
care in all the necessary areas (e.g. electronic signatures, electronic
media, coding systems).
2.2 At the EU level
- European co-operation in developing
educational programmes should be stimulated.
- The development of tools for evaluation
should be stimulated as well as exchange of assessment results.
- A system for certification of HC telematics
products at the European level should be set-up, to ensure that these
products are medically cost-beneficial, technically interoperable
and reliable, as well as beneficial to the patient (directly or indirectly).
The certification to be carried out by independent neutral bodies.
- The development of Codes of Conduct
for the use of Internet in Health Care and the definition of info-ethical
regulations for the use of telematics in health care should be stimulated.
- Standardisation in health telematics
should get a higher priority. In addition, a system should be set
up to make specifications of products and solutions widely available
(de facto standards).
Forum V: Rare Disorders and Orphan
Drugs: Research without Return on Investment
Rare diseases are defined in Europe
as those which affect 5 in 10,000 of the population or less or those
which need special measures to combat their effects because of the
small numbers involved. Although individually a disease may not be
rare there are very many different conditions - over 8000 have been
identified - so the number of people affected (either directly or
indirectly) is large. It has been estimated that in the EU this number
may add up to 30 million.
For many patients with rare diseases,
hopes for a cure rest on orphan drugs. Orphan drugs are those which,
due to the small number of those who need them, are not economically
viable to develop under normal commercial consideration and which
need special incentives in order for the patients to benefit from
Not all rare diseases need to be treated
by orphan drugs. Some will be able to benefit from new uses of existing
drugs. Most rare diseases will remain untreatable for the foreseeable
future due to a lack of knowledge about their basic biology and the
need for much more fundamental research.
In response to the needs of those affected
with rare disorders the EU is in the process of introducing two measures,
the Rare Diseases Programme and Orphan Medicinal Products Regulations.
Rare diseases are also a feature of the 5th Framework Programme.
The Rare Diseases Programme is foreseen
for a period of five years. A budget of 6.5m Euro (1.3m/yr) was allocated
and three areas of activity were defined, namely the creation of information
databases on rare disorders, support for patient groups for those
affected and for umbrella bodies and -investigation of clusters of
Orphan medicinal product regulations
will give to the European Agency for the Evaluation of Medical Products
(EMEA) the power to stimulate the development of orphan products and
to approve their use by granting market authorisation. Orphan products
will benefit from a ten-year period of market exclusivity, during
which time no similar product will be licensed for use in respect
of the use claimed by the orphan product. The USA has had orphan drug
laws for seventeen years and in that time almost 200 new drugs have
been authorised. The FDA’s Office of Orphan Drugs has a substantial
budget to stimulate research and to waive the fees normally charged
for granting market approval. The European Parliament has just approved
a budget for EMEA which does not include any funding for the operation
of the orphan medicinal products regulations when they come into force
early in the New Year. Without proper budgetary provisions the Agency
will be unable to be proactive, nor will it be able to waive fees
normally charged to applicants.
2.1 Recommendations for the EU
- Tax credits and other fiscal incentives
to stimulate R & D of orphan products should be introduced.
- Rules for the prescription and/or reimbursement
of orphan products should be such that all those who need them can
benefit. Furthermore, products are not to be denied to patients on
grounds of cost.
- Medical education programmes should
be developed to increase doctors’ knowledge of rare disorders.
2.3 Recommendations for others
- Public understanding of the potential
benefits of biotechnology and genetic medicine should be encouraged
and enhanced through the media and other channels.
- The investment potential afforded by
orphan medicinal products from private sector sources should be publicised
- Solidarity and the willingness of society
to respond to the health care needs of all its members should be emphasised
when considering the use of health care resources (and also when working
out the economic, social and human costs associated with not treating
when potentially treatment would be possible).
- Patient groups should be recognised
and supported in their role of reducing the isolation and improving
the services and support for those with rare disorders.
Forum VI: The Impact
of Biotechnology on Health Systems and Health Services
Biotechnology and research
in genetics will have a large impact on medicine through an increased
knowledge base. An important milestone will be reached in about 2
-years, when the whole human genome will have been sequenced.
These data together
with bio-informatics are opening up the path for genomics, which in
many years to come will expand our understanding of how the human
body functions at the cellular and molecular level. Genomics are leading
to a constant flow of new drugs, diagnostics and vaccines.
At the same time, new
medical procedures such as cellular therapies, bio-surgery, organ
transplants as well as gene therapy are being developed and are becoming
available to patients. Some of these new (not all genetics based)
techniques are increasingly posing novel challenges for the health
care system and are raising fundamental questions about the nature
and value of human life.
2. Recommendations to be enacted both
at national and European levels:
2.1 Both basic and problem oriented
research need to be increasingly funded. There will be no applied
research without continuing basic research. The competent authorities
should take note of the fact that government funding for biomedical
research is massively on the increase in the USA. Nations ought to
have clear ethical and legal guidelines on research. These should
be derived from broad societal deliberations. A common European standard
2.2 The authorities should encourage
industries to develop new drugs, diagnostics, vaccines and medical
procedures, including those needed by small groups of patients with
rare diseases. These rare diseases represent a major health care problem
affecting in total approximately 25-30 million Europeans. Such encouragement
needs financial backing. The health care system needs to be flexible
enough to allow the rapid introduction of new beneficial materials
and procedures. National governments will have to ensure that those
who need the innovative products and services can afford them.
2.3 There needs to
be a more open dialogue between researchers in biotechnology, the
medical profession and the general public. Without a broad understanding
of what science and technological innovation can offer, individuals,
groups and political decision-makers may have difficulty in making
balanced and informed judgements with the risk that worthwhile opportunities
will be lost. Professionals need to take the concerns and worries
of patients seriously. They should communicate with the patient and
the general public, accepting them as equal partners - communication
is a two-way process: each side can and should learn from the other.
This is also important in Eastern Europe, where open public debates
don’t have a long tradition.
2.4 Governments are
encouraged to address ethical issues raised by the application of
new technologies. Society depends on a "contrat social"
based on common ethical principles founded on human rights, solidarity
and diversity. Many of the ethical issues appear to be novel, and
although in some cases there are underlying similarities to issues
long discussed (if not resolved), each society, each generation will
have to confront them. Again, a good level of understanding and access
to information will contribute to resolving differences and balanced
use of innovation.
2.5 There is an urgent
need for the EU to introduce and enact (or adapt) science-based legislation
that will allow Europeans to benefit from products and services generated
through biotechnology (as discussed in the workshop, it is not biotechnology
but its applications that are being discussed). At the same time the
maintenance of a high level of safety is imperative. Without a reliable
and rational regulatory framework, the European industrial base is
likely to erode in this area. This also applies to the area of patenting,
where discoveries may not be patented (nobody is attempting to obtain
"Patents on Life"). However inventions need the possibility
of being patented in order to maintain the incentive for investment
in research and development, while ensuring prompt and effective diffusion
of the new knowledge and techniques. To further this aim, patents
should be available on useful innovations, but not on genetic material
(human or other) in its natural state.