New and needed
Medical products that make life better
A Health Council of the Netherlands publication
New and needed
Medical products that make life better
A Health Council of the Netherlands publication
Foreword
“Which medicins,
methods of treatment,
or devices might be of
assistance to you?”
We put this question to 169 patients and 64
care providers. I am extremely grateful for their
contribution. We made extensive use of these
responses while drawing up the advisory report
entitled Medical products: new and needed!
They have given us a glimpse of their everyday
lives, and of what it means to live with a disease.
Together they drew up an impressive list of
things they felt they needed, such as new
medicins, methods of treatment, and other
medical products.
We then converted this into a research agenda - a list of topics to be addressed by
researchers and product developers as a matter of priority.
This publication is a brief summary of that research agenda. It is intended for all
those who helped establish this agenda, as well as for other patients, care providers,
and those who are closely involved in care. It contains the results of interviews
with patients, as well as the main thrust of our advisory report, and an interview
with the chairman of the preparatory committee, Geert Blijham.
However logical it may seem to involve patients and care providers in research
decisions, this still happens all too infrequently. This is something that, in our
view, has to change. We hope that this advisory report will help to bring this about.
Louise Gunning-Schepers
President, Health Council of the Netherlands
Introduction
The health service is facing enormous challenges. People are living longer and
the number of chronically ill patients is increasing, while there are less and less
young people to provide the care required. Resources that enable people to stay
independent for longer, or that involve fewer trips to the doctor, reduce the strain
on health care. Accordingly, new medical products must be developed as a matter
of priority. Which types of new medical products could help improve health care
in the Netherlands? Also, how can we ensure that these products are actually
developed and marketed? These were the questions put by the Minister of Health
to the Health Council/Advisory Committee on Health Research.
In seeking to answer these questions, the Council initiated a discussion with
patients and care providers. After all, no-one is better aware of which products
are specifically required than the people who would be using them. For fifteen
disease areas, these discussions yielded a list with improvements that are being
awaited by patients and care providers: new medicins and tissue replacement
products, as well as diagnostic and assistive medical devices. This involves
both products aimed at treating the disease and other measures to make it easier
for patients to cope with their disease. In addition, patients mentioned problems
related to the organisation of care. These are issues that require better cooperation
and coordination among care providers. Such problems cannot be solved by
medical products alone, however, which means that these issues do not fall
within the scope of this advisory report. The Council has used the list of proposed
medical products to compile a research agenda. This identifies priorities for further
research and government incentives to encourage such research.
Patients and care providers have their say
From depression to disorders of the locomotor system, and from anxiety disorders
to strokes. For the purpose of its discussions with patients, the Council selected
fifteen disease areas. Given the time restrictions involved, it was only possible
to address selected disease areas rather than the health service as a whole.
In addition, it was important that the patients had enough in common to discuss
shared issues with one another, and to help one another identify the most needed
products. For that reason, diseases such as cancer were excluded, as this actually
involves dozens of diseases. As a result, cancer patients are too different from
one another to be able to speak with a common voice. Aside from patients,
the other groups of medical product users included in this survey were GPs,
medical specialists, nurses and informal carers. Each patient group selected the
three most important products from their own list of suggestions.
Fifteen disease areas:
patients’ top three
Disorders of the locomotor system
• Establish in advance which medication is the most effective, based on
individual characteristics and disease characteristics
• Cartilage and bone restoration using stem cells
• Equipment for movement analysis
Respiratory disorders
• Medication based on individual characteristics, e.g. age
• Method for early and correct diagnosis
• Target for reducing or eliminating fatigue
Anxiety disorders
• Medications based on individual characteristics, such as genetics and blood
values of medication
• Products for biofeedback (visualise bodily functions of which people are
normally unaware, thereby enabling patients to modify their behaviour and
prevent anxiety attacks, for example)
• Medication to combat fluctuating sex hormone levels
Depression
• Improved antidepressants: work faster, more effective, fewer adverse
effects
• System to measure yet to be identified biomarkers in the blood (biological
characteristics that reflect the course of the disorder)
• Neurobiological technology for specific areas of the brain
Diabetes
• Agent to boost the body’s sensitivity to insulin (type II diabetes)
• Combined sensor/pump for the regulation of blood sugar
• Diagnostic tests (biomarkers) to detect complications
Disorders of the stomach, bowels, and liver
• Active substances in food that affect the disorder and the medication, for use
as medicinal products
• Less invasive diagnostic methods to replace endoscopy (via both the anus and
the oesophagus)
• Biomarkers to improve medication
Kidney disorders
• Implantable organic artificial kidney
• Types of dialysis involving fewer complications and restrictions
• Reducing adverse effects of anti-rejection medications
Burns
• Effective medication to treat scar itching
• Use of stem cells to restore skin
• Better prevention and treatment of infections and inflammation in wounds
Muscle disorders
• Effective measures to combat pain
• Brain Computer Interfaces (brain-controlled computers)
• Gene therapy
Cardiovascular disorders
• Stem cell therapy for the cardiac muscle
• Medication based on individual characteristics
• Reduction of adverse effects of statins (cholesterol-lowering agents)
Intellectual disabilities
• Improving early diagnosis shortly after birth
• Improved communication devices
• Medication based on individual characteristics
CVA (stroke)
• Improved alternative to thrombolysis (blood thinning) immediately after an infarction
• Products for rehabilitation at home
• Medical product to combat neuralgia
Visual disorders
• Systems for reading ‘everyday products’
• Improved navigation systems
• Early and accurate diagnosis
Dementia
• Product for the stabilisation of dementia (anti-dementia agents)
• Targets for medicinal products from food
• Agents to minimise the adverse effects of forgetfulness
Rare disorders*
• Gene therapy
• Medications for the short term prevention or alleviation of symptoms
* The patient group’s top three also included ‘centres of excellence’.
This has not been included, as it is not a medical product.
Care providers: their priorities
GPs
• Improved drug delivery systems for patients who take many different
medication at the same time (polypharmacy)
• Agents to treat pain and incontinence (not medication)
• Improved systems for information exchange between GPs, and between GPs
and their patients
• Quick and simple diagnostic tools for primary care, such as mobile X-ray and
ultrasound equipment with image recognition
Informal carers
• Tools to boost patient independence, such as communication devices,
software, user-friendly devices
• Home automation for remote care, such as smart gadgets in the home,
equipped with GPS, sensors, and software
Medical specialists
• Improving imaging technology to obtain greater contrast at lower radiation
levels
• Diagnostic tests based on metabolic changes
• Improved medication, enabling the number of pills to be reduced
• Improved stents for sites that are not easily accessible
• Biomarkers to improve diagnosis and therapy
• Gene therapy and stem-cell therapy
• Behavioural tools for the prevention of major disorders such as diabetes and
cardiovascular diseases
• Tools for the early risk diagnosis of major disorders such as diabetes and
cardiovascular diseases
• Device for measuring and promoting patient compliance
Nurses
• Improved information systems, such as mobile bedside recording systems, data
accessible anywhere, full patient dossier in a single system
• IT systems for the storage and dissemination of protocols for evidence-based
practice
• E-learning modules
• Tools for remote care, such as a webcam
• Tools for interactive patient education
From a list of topics to a
research agenda
Listing the needs of patients and care providers is an important first step.
The Council then explored the question of what needs to be done to ensure that
these products are actually produced.
To start with, it is necessary to choose between the items on the list. Which
products should take precedence? This involves a range of issues. For instance,
it is important to know what health gains are delivered by a given tool. Does
it contribute to a longer and happier life for patients, and how big is the group
which stands to benefit from the product in question? Another factor to be taken
into account is whether a new tool would reduce the cost of care. Also, would the
product reduce the numbers of health care staff needed, by making patients more
independent, for example.
A major consideration here is the extent to which the government should get
involved in the development of a given tool. If a medical product has good selling
potential, then the chances are that industry will undertake the development
work itself. If there are doubts concerning profitability, or some other reason for
industry to neglect a given topic, then there may be a need for the government to
provide an incentive, in the form of research funding.
Finally, the Council considered whether the Netherlands has sufficient expertise
to develop the product. In the case of topics for which, as yet, no expertise is
available, development would have to start from scratch. In such cases, it might
be better if product development were to be carried out in another country.
The products identified by the patients as most important have been assessed by
the Council in terms of the above-mentioned points. The topics were subsequently
reclassified into clusters of products which, in terms of content, appear to be a
good match for one another. Some additional topics have been added which,
while they did not feature in the user lists, are nevertheless considered important
by the government. These are products that help to prevent disease and promote
health, and better agents for combating infections. Together, all of these topics
have resulted in the ‘research agenda’.
Medical products
research agenda
A.
Regenerative medicine
For example: biological artificial kidney, skin restoration, gene therapy for
neglected diseases.
The patient’s view: ‘Osteoarthritis is eroding my cartilage layer, so every
movement is painful. Also, I am always tired. If cultured cartilage could be
inserted into the joints, that would make an enormous difference.’
B.
Therapy based on individual characteristics
For example: medication tailored to age, gender, blood values, genetics, etc.
The informal carer’s view: ‘The course of Alzheimer’s differs from one person
to another. Progression also varies considerably, and there are good days and
bad days. So needs vary. Treatment has to be highly tailored.’
C.
New medicinal products and devices targeting the effects of
disorders
For example: medications to treat fatigue, pain and itching.
The patient’s view: ‘Other types of itching simply cannot be compared to the
itching experienced by burns patients, which is much more intense. At its most
extreme, it feels as if someone is using you as a pin cushion. There is no effective
agent to combat this.’
D.
Improved versions of existing medication
Mainly aimed at reducing adverse effects, but also at increased effectiveness.
The patient’s view: ‘Even a small dose of an anti-psychotic can knock you
sideways. Sure, it works, but it makes me completely listless. The side effects
are simply awful. Someone should do something about that.’
E.
New medicinal products and devices targeting the disorder
For example: anti-dementia drugs, drugs to enhance insulin sensitivity.
The patient’s view: ‘Most diabetics are ill because their bodies have become
insensitive to insulin. They should find some way to deal with that.’
F.
Early, accurate diagnosis involving less discomfort
For example: replacing endoscopy, systems for measuring existing and new
biomarkers.
The patient’s view: ‘It would be great if they could invent a blood test to
measure a sort of depression factor. If, for example, your doctor could say ‘your
depression factor is 11.9 - you really are suffering from depression.’ Something
a bit like a thermometer. That way, people with higher depression factors could
be treated more quickly, or their medication could be adjusted to suit.’
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G.
Patient toolkit to enhance self-management and self-reliance
For example: movement analysis, biofeedback, communication tools.
The patient’s view: ‘For my bowel disorder, I wish there was an instrument
that I could use to measure inflammation values in my blood and stools when
I feel ill. This would help me to better monitor the course of the disease, and
to avoid more surgery.’
H.
Improvement and expansion of existing therapeutic interventions
For example: an alternative to thrombolysis, types of dialysis involving fewer
complications.
The patient’s view: ‘For me, haemodialysis is literally a matter of life and
death. At the same time, however, dialysis is very bad for my veins and
arteries. But I’ll need them to be OK if it ever comes to a kidney transplant.
So my wish would be for a less harmful dialysis technique.’
I.
Home automation systems for remote care
For example: camera systems, sensor systems, interactive information systems.
The nurse’s view: ‘Some patients are visually oriented, while others rely
more on their hearing. Using interactive education materials, we would be
able to provide a more customised service to our patients.’
J.
Information processing systems and information exchange
systems
For example: improved information systems between carers and between carers
and patients, e-learning modules.
The GP’s view: ‘Much of what I am currently required to do is not possible
using the GPs’ information system. I am getting behind with my work. I can’t
scan anything in, nor can I print anything out.’
K. New products aimed at preventing disease and promoting health
L. Improved resources aimed at preventing and treating infections
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The usefulness of the agenda
The research agenda is a list of medical products that need further development,
and that involve research. It is based on a set of diseases which is far from
comprehensive, so new consultations with patients and care providers will be
needed to complete the agenda. Given that it is divided into clusters of products
that broadly serve the same purpose, it will be a simple matter to incorporate the
results of the additional surveys into the agenda. The clusters are intended to be
used for a period of approximately eight years. In the meantime, regular checks
should be carried out to determine whether the listed products still merit priority,
whether other products should be added, or whether existing products should be
deleted.
The agenda is intended to aid decisions concerning the selection and funding
of research. Numerous institutions throughout the Netherlands are engaged in
medical research. It is vital that they be guided in the choices that they make by
the needs of users, i.e. by the agenda. The government should take part in this
process by providing targeted incentives.
Accordingly, the Council suggests the establishment of a new programme
(referred to in the advisory report as a meta-programme) with the following two
objectives. Firstly, the programme should help and encourage researchers to take
serious note of consultations with users (patients and care providers) when they
are selecting future lines of research. Secondly, the programme should provide
the incentives required to ensure that this research is actually carried out. Both
goals require money, from the government and elsewhere. The Council therefore
feels that the Minister should persuade other parties of the need for joint funding
for this new programme.
What can patients and care
providers do?
The advisory report is addressed to the Minister. For implementation,
however, the Minister will require the assistance of those in the field,
including researchers, research funders, industry and – last but not least
– patients and care providers. The establishment of a research agenda
does not mark the end of contributions by patients and care providers.
Their initiatives will continue to be very welcome in future.
Some examples of specific activities are:
Seeking dialogue with researchers, both in the academic
world and in industry.
Seeking contact with researchers and facilitators to set
up a consultation round.
Contacting health funds and other research donors to
release funds for consultation rounds and research via
the new programme
Cooperation between all of the parties involved should help to ensure that products
introduced to the market are both wanted and needed. The government can
make use of the proposed programme to encourage such cooperation. Equally
important, however, are commitment, initiative and dedication on the part of
patient organisations, care providers, industry, and researchers. The first step is
to foster an awareness of the importance of cooperation and of the power of the
jointly developed research agenda. This power derives not only from its content
(the priorities mentioned above) but also from the ongoing discussion about the
agenda. Patient organisations and professional organisations can help by taking
part in this process.
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“I hope this advisory report
will motivate everyone to
start work on a research
agenda like this”
Prof. Geert Blijham is Professor of Internal Medicine at UMC
Utrecht, where he served as chairman of the board for many
years. He is also a member of the Health Council. Renowned for
his managerial skills, he was an ideal candidate to chair the
Committee that, at the request of the Minister of Health, Welfare
and Sport, started work on the ‘medical products research agenda’.
Why did you opt to consult users?
The development of medical products involves a ‘push’ side and a ‘pull’ side.
The push side is made up of researchers and industry, whose innate curiosity and
drive generate ideas. They are already well represented. We wanted to get better
acquainted with the pull side (the users). This is the side that wants to draw out
into the open those things that can be of real use to them.
Surely this approach is already in common use?
I won’t say it never happens, but it does not take place as a matter of course, nor
is it as systematic as the approach that we used here. In the context of scientific
research, doctors are often asked about the needs of patients, yet their impressions
may be coloured, and even somewhat limited. Some research groups maintain
contact with patients’ associations, but that is certainly not the case everywhere.
While the pharmaceutical industry does engage in market research, it does not
do so until it already has a clear idea about what it wants to market. Our own
consultation exercise was devoid of any research objective or commercial
consideration.
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What, in your view, were the most surprising outcomes?
The discussion within the visual disorders group (those who have problems with
their eyesight) must have been very interesting. Sadly, I was unable to attend.
It was a diverse group, ranging from elderly people with poor vision caused by
clouding of the lenses in their eyes, to younger people who had been blind from
birth. They spoke of their need for navigation systems for visually impaired
pedestrians, and for new reading systems for the blind. These are clearly themes
for the research agenda that is to be sent to the Minister! Another compelling
example originated from the group of people with burns. A great many people in
the Netherlands have suffered burns at some point in their lives. Many continue
to suffer unbearable itching. Accordingly, one of our recommendations to the
Minister is to approve research into ways of combating itching.
There have been extensive consultation rounds with patients, regarding their
needs. This may have encouraged them to hope that their ideas will now be acted
on without delay. Is such hope justified?
We attempted not to give rise to unrealistic expectations. The participants are well
aware that their input could not be decisive, and that it would ‘only’ be used as a
source of information for other decision makers. Some will recognise their specific
wishes in our advisory report, for instance navigation systems for people with
little or no vision. Others will feel that our recommendations are still very abstract.
Overall, the patient groups we consulted seemed to understand that their wishes
could not be fulfilled straight away.
What are your hopes for the future, in terms of changes brought about by
this advisory report?
Our ideal was not to re-jig or further expand the enormous research potential of
the Netherlands. Instead, we wanted to provide targeted incentives that would
encourage existing research groups to develop products that patients and care
providers would very much like to have. The views of many groups of patients
have yet to be heard. We therefore hope that these patient consultation rounds
will be continued, employing the same thorough approach that we have used
in the past. Once you know what is needed, and are aware that the requisite
research will only be carried out if the government provides the necessary incentives, then - in the interest of public health - money must be made available to
fund work by research groups.
I hope this advisory report will motivate everyone to start work on a research
agenda like this. A process like this consists of many small steps, of course, but
we have to start with a very big step. I hope the new minister seizes the opportunity presented by this advisory report and says “On my watch, this is something
that I am determined to do for my constituents. They have told us what they
need to improve their lives. In response, I will give a financial incentive to those
researchers who help to develop medical products of which there appears to be a
considerable need.”
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Further details
This publication is based on a Health Council advisory report entitled
“Medical products: new and needed! An investment strategy for research into
innovative and relevant medical products”.
Are you interested in learning more about the background to this advisory report
and about how the agenda was created, or about the method used during the
patient consultation rounds? The full text of the advisory report is available at the
Health Council website: www.gezondheidsraad.nl. Here, you can request or
download a copy of the advisory report.
Extracts may be reproduced, provided that these are furnished with clear
acknowledgements.
The preferred citation of this publication is as follows:
Health Council. New and needed. Medical products that make life better.
The Hague: Health Council, 2010; publication no.A10/11E.
ISBN: 978-90-5549-824-6
Contact
Health Council of the Netherlands
P.O.Box 16052, 2500 BB The Hague, The Netherlands
E-mail: [email protected]
Internet: www.gezondheidsraad.nl
Colophon
Text
Health Council of the Netherlands
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Richard Sluijs Design, The Hague, The Netherlands
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Vijfkeerblauw, Rijswijk, The Netherlands
The Health Council of the Netherlands, established in 1902,
has the task of ‘informing the government and Parliament
concerning the current level of knowledge with respect to
issues in the realms of public health, health research, and
health care research’ (Article 22 Health Law).
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