United front Crime fighters Matters of record

Science
&society
| European Federation of Neurological Associations
Issue 1 | Autumn 2010
The
United front
Why the Alliance for MRI will
stand its ground in the EU
Crime fighters
Europe is waging war on the counterfeit drug criminals
HTA
way
How EFNA is the driving force
behind health technology
assessment and why this is the
only way forward for the European
healthcare system
Matters
of record
How patients’ medical records
can prove vital to their case
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Contents
6
A call for
partnership
10
Features
6 Health technology assessment
How EFNA is playing a vital role within
the increasingly significant HTA process
10 Alliance for MRI
Why a parliamentary coalition is
battling against EU MRI legislation
14 Counterfeit medicines
The facts about the rise of counterfeit
drugs are terrifying. What’s being done?
18 My Health, My Records
One man’s personal campaign to
encourage patients to take control
14
18
Science
&society
Editor-In-Chief Dr Mary Baker MBE
Editor Dominic Graham
Associate Editor Lizzie Graham
Medical Adviser Professor Richard Hughes, President of
the European Federation of Neurological Societies (EFNS)
Political Adviser John Bowis OBE, ex-MEP and
ex-UK Minister of Health
Scientific Adviser Professor Monica di Luca,
Vice-President of the European Brain Council (EBC)
President Dr Mary Baker MBE
Vice-President Audrey Craven Secretary-General Alistair
Newton Honorary Treasurer Bea de Schepper Members
Irem Hattat, Manuela Messmer-Wullen
For editorial and advertising enquiries:
email [email protected]
website www.efna.net
Disclaimer: The information in Science & Society is for
information only and does not represent an endorsement
of any particular treatments, products or companies.
On behalf of the European
Federation of Neurological Alliances (EFNA)
Board, I’m delighted to welcome you to this
launch issue of Science & Society, a publication
focused on neurological debate aimed at MEPs,
healthcare professionals and patient organisations.
Just one look at the magazine’s chief advisers (see
bottom left) – which consist of respected and
admired European politicians and neurologists –
makes it an extremely exciting proposition.
EFNA was established in 2002 in an attempt
to bring together European neurological
patient advocacy groups and to work with other
associations in the field of neurology in what
has been termed a “partnership for progress”.
We try to combine the strength and experience
of each of our member organisations in their
own particular spheres of medical influence
as we firmly believe that
partnership can – and will –
bring progress for millions of
people with brain disorders.
EFNA engages in
numerous activities
that contribute to
the advancement of
neurology (and other
related areas) with a view
to improving the quality of
life of people living with
neurological conditions,
their families and
carers. However, neurology is a deeply broad
subject, and, as a result, our approach to our
respective projects – such as this magazine –
reflects this fact and is equally broad.
The title of this new magazine is, I hope,
self-explanatory: one of our greatest aims is
to promote a meaningful dialogue between
science and society. We want to widen the
understanding of ‘research’ from merely being
a search for cures to instead becoming the
provision of information about quality of life and
health economics – to provide evidence that will
enable policymakers to effect positive change.
Furthermore, we at EFNA want
to extend our partnerships from the
already tried and tested – with clinicians,
pharmaceutical companies and medical
device manufacturers – to other industries
where the economic and human aspects of
neurological illness also have serious effects.
Finally, EFNA wants to establish a network
of MEPs that are interested in cross-nation
and cross-party policies – ones that will be
the voice of people with neurological illnesses
within the European Parliament.
European populations are living longer, which
means only one thing: the longer we live the
more liable we are to develop a brain disease.
We simply must encourage the neuroscientists
to put their minds to the needs of society – and
we hope this publication will bring to the fore
some of those needs and some of the solutions.
In this first issue – timed specifically to launch
at the European Federation of Neurological
Societies’ (EFNS) meeting in Geneva – we
feature some of the challenges we face in 2010
and beyond: on pages 10-13 we put the spotlight
on the challenges of certain legislation that is
threatening MRI scanners, while on pages 1417 we describe the great
work that is being done
to combat the shocking
number of counterfeit
medicines that are available
to an unsuspecting public.
Then we come to our
cover story – the rising
importance of health
technology assessment.
I cannot emphasise
just how essential it is
that patient advocacy
groups, policymakers and
clinicians begin to appreciate the impact that
these assessments are having on patients being
able to access optimal treatments.
To say there are challenging times ahead
would be an understatement, and the last thing
the neurological world needs is for there to be
competition between patient advocacy groups.
Never before has it been so necessary to work
together in order to make all the up-to-date
treatments available for all the people living with
long-term illnesses. We need a healthier Europe,
and to get that we need to be working together.
Don’t miss the next issue – out early next year
– but in the meantime I hope you find this first
edition both informative and stimulating.
“We want
to provide
evidence that
will enable
policymakers
to effect
positive
change”
Dr Mary Baker MBE, EFNA President
2 www.efna.net
EFNA S&S Issue 1 p2-5 editorial & news.indd 2
Is this good enough?
!
11/9/10 09:03:07
neurological news
Paradise does exist
New EC initiative set to co-ordinate existing expertise in eight European
countries to help measure difficulties associated with brain disorders
A new European Commissionfunded ‘co-ordination action’ has been
launched to create a “comprehensive, crosscutting and horizontal epidemiology that can
measure psychosocial difficulties associated
with brain disorders”.
PARADISE (Psychosocial fActors Relevant
to BrAin DISorders in Europe) was launched
under the European Union’s Framework
Programme 7 in Germany in January,
along with a
contributing
website that
provides visitors
with a detailed
overview of
the project.
Nine brain
disorders will
be the focus of
the initiative:
dementia,
depression,
epilepsy, migraine, multiple sclerosis,
Parkinson’s disease, schizophrenia, stroke and
substance use disorders.
“PARADISE has been launched due to the
high burden and cost of brain disorders in Europe,
and evidence suggests that the personal, social
and economic costs and impact of those disorders
have already been deeply underestimated,”
said project co-ordinator Dr Alarcos Cieza.
“Existing European data tends to be derived from
diagnostic criteria, creating information ‘silos’ for
each disorder that are neither comprehensive nor
comparable across brain disorders.”
PARADISE will co-ordinate existing
expertise in eight European countries to
produce literature reviews, data collection and
analysis regarding the nine brain disorders.
“This new approach, therefore, is to draw
new data that allows policymakers to more
accurately calculate the true cost and impact
of psychosocial difficulties on the lives of
Europeans
living with
brain disorders,”
added Dr Cieza.
“Ultimately,
the aim is to
improve quality
of life by means
of more focused
and effective
interventions.”
In the final
months of
PARADISE, all 10 partners will convene a
stakeholder conference – composed of individuals
suggested by the partners, including patient group
representatives and supplemented by appropriate
members of the European and scientific and
policy communities. During the conference, a
report and its recommendations will be discussed
and revisions suggested (WP6). A dissemination
plan will then be implemented (WP7).
For further information on the project visit the
website: www.paradiseproject.eu.
EC holds FP7
Open Info Day
More than 400 participants
attended the European Commission’s Open
Information Day on FP7 [Seventh Framework
Programme] Health Research in June.
The aim of the event was to highlight the
priorities, novelties and special features of
the EU 2011 Work Programme and provide
guidance to participants interested in becoming
involved in EU health-related research projects.
If you were unable to attend the event,
you can view the plenary sessions at: http://
webcast.ec.europa.eu/eutv/portal/archive.
html?viewConference=9437.
One of the most important features of the
2011 Work Programme is the explicit recognition
of patient involvement as an important element
of future FP7-supported health projects,
particularly in the area of clinical trials.
“The early involvement of patients and
their advocacy groups in the planning,
implementation, and monitoring of a clinical
trial is considered important so that patients’
needs are appropriately considered,” said a
spokesman. “The Work Programme
recognises that such early involvement of
patient organisations may also increase the
rate of enrollment of trial participants and can
have a positive effect on the performance of
the clinical trial.”
The final version of the 2011 Work
Programme was published in July and has an
estimated budget of around €650 million.
For more information on the 2011 Work
Programme and updates on the upcoming FP7
Health Research Call, visit the website:
http://cordis.europa.eu/fp7/health.
Academy of Medical Sciences to review research
The UK Academy of
Medical Sciences has been
commissioned to conduct an
independent review of the
regulation and governance
of medical research, with a
focus on clinical trials, the
UK government announced.
Former UK Health Secretary
Andy Burnham (left) confirmed
in March that the decision
follows a recommendation in the
Academy’s report, Reaping the
rewards: a vision for UK medical
sciences, published earlier this year.
The report highlighted concerns that the
regulatory framework for medical research
had “become over-burdensome” and that
streamlining and improving current regulation
would represent a cost-effective approach to
creating a more fertile and productive research
environment in the UK.
The review will be undertaken by a working
l make recommendations with
respect to the regulatory and
governance framework that will:
increase the speed of decisionmaking, reduce complexity,
and eliminate unnecessary
bureaucracy and cost.
group chaired by Sir Michael Rawlins (right) and
including EFNA president Mary Baker and will:
l review the regulatory and governance
environment for medical research in the UK,
with a particular focus on clinical trials
l identify key problems and their causes,
including delays, barriers, costs, complexity,
reporting requirements and data collection
The review will concentrate
largely on research involving
human participants, particularly
their tissues or data. It will not,
however, deal in detail with
the regulation and governance
surrounding the use of animals
in research. The review will, nevertheless,
consider experimental medicine and
epidemiological studies.
The Academy aims to publish a final report,
containing conclusions and recommendations,
by the end of the year. Further information on
the review and its scope is available at
www.acmedsci.ac.uk/p47prid80.html.
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EBC playing the brain game
The European Brain Council is hoping to raise the profile of all brain diseases across Europe with its plan to
launch the first ever European Year of the Brain in 2013. But for it to be successful, it needs support
The European Brain Council
(EBC) and its member organisations are
issuing a rallying call for 2013 to be made the
European Year of the Brain (EYOB).
The EBC’s mission is to promote brain
research in Europe and to improve the quality
of life of those affected by brain diseases. As
a co-ordinating council formed by the major
European societies for neurology, neurosurgery,
psychiatry and basic research (neuroscience) –
in partnership with patient organisations and
industry – the EBC has a unique structure that
encompasses a vast network of patients, doctors
and scientists, and works in partnership with the
medical devices and pharmaceutical industry.
“The EBC and our member organisations
are ideally placed to address fragmentation in
European brain research; attract young people
to work in brain research in Europe; attract
investment; and bring science and society
closer together to meet the needs of patients,”
said Dr Alastair Benbow, EBC executive
director (pictured).
“EYOB would provide a pan-European
opportunity to improve the quality of life of
the 127 million Europeans currently living
and in the future
l lead to an increase in funding for brain
research through the framework programmes,
and increase efforts to educate, inform and
advise all those living with brain diseases
l draw attention to the many health inequalities
in brain disease across the continent
l develop action plans at local, regional,
national and European level to address the
specific areas related to brain diseases and
influence policy decisions over the next five
to 10 years.
with brain-related diseases. This number
is likely to dramatically increase over the
coming years and therefore urgent action is
necessary to address this.”
A EYOB has the potential to:
l increase the profile of all brain diseases in
every member state and draw attention to
the costs and impact of brain disease now
Themes likely to be addressed during a EYOB
would include brain research and the place of
science in improving the lives of those with brain
diseases; equitable access for patients; ethics;
education; stigma; societal impact and economic
imperatives; health technology assessment;
patient-reported outcomes; and the role of
industry. “Everybody involved and/or affected by
brain diseases need to support this call. Together
we can make this happen.”
For much more detailed information and to
support the EYOB campaign, visit
www.europeanbraincouncil.org.
Debut initiative Baker given neuroscience honour
for EARLS
The newly created European
Alliance for Restless Legs Syndrome
(EARLS) is launching its first major
initiative – a pan-European survey into the
health economical aspects of diagnosis and
treatment of the condition.
The questionnaire will be sent to national
RLS groups, covering many thousands of
patients living with the condition. It is hoped the
survey will provide useful insights into difficult
aspects such as misdiagnosis, unnecessary
medical treatment and sick leave in each of the
participating countries. The first results of the
study are expected before the end of 2010.
EARLS was formed in the European
Parliament in November 2009 and consists
of several European RLS patient groups.
It became an officially registered patient
advocacy group in March.
Its main goals, according to its president
Joke Jaarsma, is to increase international and
national awareness of the illness across Europe
and to improve the quality of life for those living
with the syndrome by ensuring better and more
rapid diagnosis; better and more appropriate
treatments; and better care. “RLS is a common
neurological illness, yet despite this the general
public know very little about it,” she said.
EFNA president Mary Baker HAS
been awarded the British Neuroscience
Association’s (BNA) ‘Outstanding contribution to
British neuroscience public service’ award.
At the event, held in London in December last
year, BNA president Professor Trevor Robbins
(right) said that Baker
had for more than 25
years “campaigned for
improved treatment
and care for people
with neurological
disorders, and has
worked closely with
scientists, clinicians,
patients (and their
carers), charities and
governments. She
continues to promote
a better understanding
of mental illness to
shed the stigma and prejudice that this label
conjures up in people’s minds.”
Baker (left) has in recent years wholeheartedly
supported neuroscience and its advances and her
promotion of it forms a large part of her endless
campaign for better care. “It is quite unusual that
someone who is primarily an advocate for patients
has never lost sight of the value of research,” said
Prof Robbins. “She speaks forcefully and publicly
that research will eventually lead to better diagnosis,
treatment and care of neurological disorders.”
Baker is also vice-president of the European
Brain Council (EBC), which unites European
organisations in neurology, neurosurgery,
psychiatry, neuroscience, as well as patient
organisations and
industry. “Mary has
undoubtedly shaped
the EBC into an
organisation that
can speak with one
voice to the European
Parliament,” added
Prof Robbins.
Baker commented
on receiving her
award: “I would
like to express my
deep gratitude to all
the neuroscientists
for their contribution to the understanding
and treatment of brain disease. I feel that the
most exciting and potentially useful work is my
involvement with the EBC, which demonstrates
clearly what can be achieved politically by different
disciplines coming together and working in
partnership. I sincerely hope that all our combined
efforts will result in the Year of the Brain 2013,
supported by the European Commission.”
4 www.efna.net
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neurological news
EHA uses its head
‘Madrid manifesto’ launched in a bid to encourage European politicians
to acknowledge that healthcare system has failed migraine sufferers
The role of government is a central theme of
The European Headache ALLIANCE
the manifesto, which calls for the adoption of
(EHA) launched its ‘Madrid manifesto’ on
the annual European Migraine Day of Action;
headache/migraine disorders at a conference held
increased support for research; protection under
in the Spanish parliament in Madrid in May.
employment and disability laws; and funding for
The manifesto is a call to governments and
multi-disciplinary headache teams in each country.
health policymakers across Europe to recognise
Healthcare professionals are also to play
the fact that the failure of healthcare systems to
a part. The manifesto’s targets include an
provide effective treatments to migraine sufferers
is causing an unnecessary socio-economic burden. educational module in headache to be run in
every GP training school; it also states that
The World Health Organisation places
every patient diagnosed with migraine should
migraine as the 12th leading cause of disability
receive a proper explanation of the condition
in women and 19th overall. The condition affects
and appropriate treatment on their first visit to a
12-15% of the population and costs the EU
healthcare professional.
economy approximately €27 billion annually due
Experts from all over Europe spoke at the
to reduced productivity and workdays lost.
conference, including Professor Jes Olesen,
The Madrid manifesto aims to reduce this
founder of the
burden by meeting a
European Brain
set of agreed targets
Council; Professor
– approved by leading
Fabio Antonaci,
experts in the field
president of
of headache – over
the European
the next five years.
Headache
“Migraine needs to
Federation;
be put firmly on the
Dr Cristina
political agenda,” said
Tassorelli, EHA
Audrey Craven, EHA
vice-president;
president. “For too
and Mary Baker,
long the condition
EFNA president.
has been seen as
The chair was D
‘just a headache’
Gaspar Llamazares,
and migraineurs
president of the
have been left to
Health Commission
suffer in the silence
Clockwise, from top left: EFNA president Mary Baker, EBC founder
in the Congress
and isolation of the
Jes Olesen, EHA president Audrey Craven, EHF president Fabio
Antonaci and EHA vice-president Cristina Tassorelli
of Deputies.
darkened room.”
Major award
for European
neuroscience
Danish not-for-profit
organisation Grete Lundbeck European Brain
Research Foundation is to hold its inaugural
‘Brain Prize’ in the spring of 2011.
The €1m prize is intended to raise the
visibility of European neuroscience and to
be a stimulus to the vital field of research by
recognising a highly original and influential
advance in brain research. If several researchers
have contributed significantly to this
achievement, more than one individual may be
nominated. Nominees can be of any nationality
but the research for which they are nominated
must have been conducted in Europe or in
collaboration with researchers in Europe.
The prize and the foundation are both named
after Grete Lundbeck, visionary founder of
the Lundbeck Foundation. More details can
be found at http://www.thebrainprize.org/flx/
the_brain_prize/.
news in brief l news in brief l news in brief l news in
EUFAMI launches online forum
The European Federation of Associations
of Families of People with Mental Illness
(EUFAMI) has launched an online forum to
encourage relevant issues and information to
be disseminated and debated. It can also be
used to share examples of good practices and
actions that are taking place across Europe. The
virtual network is called ‘Friends of the forgotten
children’ and is designed to tackle the issues and
challenges faced on a daily basis by children across
Europe whose parents are affected by mental
illness. For more information about this initiative,
visit: www.eufami.org.
time to talk about the brain
The Study Group Brain Tumours Belgium
(Werkgroep Hersentumoren vzw) has planned to
hold a round table debate – entitled “Round Table
about Treatment and Support of Brain Tumour
Patients and their Families” – to try and formulate
a consensus about brain tumour treatment in
Belgium. Following a special request by Belgian
Minister of Health Laurette Onkelinx for the
event to be organised, it was due to take place in
Brussels on 11 September (before going to press).
Its scope was to define a common platform for
tackling the “huge problem called brain tumours”.
TIME to Recognise the meps
The sixth annual The Parliament Magazine MEP
awards will be announced on 29 September
in Brussels; the event celebrates the work and
achievements of MEPs over the past 12 months.
For more details about the event and the awards,
go to www.theparliament.com/mepawards2010.
numbers boost for meps
The number of MEPs is set to rise from 736 to
751, which effectively means 18 new members
(due to Germany being allowed to keep its three
extra MEPs during this mandate). The new
MEPS will be as follows: four from Spain; two
each from Austria, France and Sweden; one
each from Bulgaria, Italy, Latvia, Malta, Poland,
Slovenia, the Netherlands and the UK. The
Member States now have to ratify this protocol
that will come into force on 1 December.
strong words from Dalli
In his opening speech at the EU Open
Health Forum, Health Commissioner John
Dalli urged delegates to help foster a “Europe
of health”, which, he argued, could only
become reality if decision makers and policies
“worked together”. The forum took place in
Brussels in June and was dubbed “Together for
Health – a Strategy for the EU 2020”. He added
that building synergies between policies and
players is particularly important to stave off the
current healthcare crisis, and it is vital that health
is not sidelined – especially amid the present
difficult economic situation.
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“
The road to health
Policymakers face uncomfortable challenges every day and their decisions can often
be controversial when looked at from a patient’s perspective. As EFNA policy lead
Jean Mossman explains, not only does health technology assessment provide the
evidence to inform these vital decisions, but EFNA is also leading the HTA way by
ensuring healthcare is heading in the right direction
6 www.efna.net
EFNA S&S Issue 1 p6-9 HTA.indd 6
11/9/10 09:20:06
health technology assessment
“H
ealth technology assessment
(HTA)? That must be about
computers and they don’t
interest me, so I don’t need
to worry about this.” That is
how Mary Baker, EFNA president, responded
when told HTA was going to be very important
for patient groups and that she should get to
grips with it. That conversation was several
years ago and in the intervening time Mary has
changed her view. She now believes it is vital
for patient groups – not to mention physicians
– to really understand the process and take an
active role in it. And she’s right.
HTA is a sign of how our society is
changing – and is changing rapidly. Indeed,
healthcare is becoming increasingly complex:
seemingly every day there are new techniques
being introduced that can prevent disease,
such as flu vaccines; new ways of diagnosing
illnesses, including population screening for
colorectal cancer; and new ways of treating
people living with illnesses, such as new
approaches to treating diabetes.
However, within a healthcare system that has
limited resources, there is a huge dilemma: how to
ensure these resources get the best return on their
investment? Put another way, there is a public
health need to prevent disease wherever possible,
and at the same time people facing the challenge
of illness need to receive effective treatment and
care to give them the best possible chance of
health. Yet there is an obvious and understandable
conflict of interest here. For example, should
every available treatment for rheumatoid arthritis
be provided or should some of those resources
instead be used to give home care to people with
dementia? These are the sort of challenges faced
by policymakers every day – and this is where
HTA can contribute the most: it can provide a
synthesis of evidence to inform these decisions.
Traditionally this evidence is derived from
clinical trials and economic evaluations; however,
EFNA is leading the way in pressing for the
patient voice to be heard as part of the evidence
(see box on page 9). Gone are the days when
patients are the passive recipients of healthcare;
now they want to be active partners in decisions
about their care. And for this to happen their
evidence needs to be given the same weight as
any other evidence considered in HTA. EFNA
believes that MEPs can take a lead in ensuring
that as HTA is harmonised across Europe,
patients are involved in every step of the process.
What is a health technology?
Health technology is a term used to cover any
aspect of healthcare. Examples include:
l prevention programmes
l diagnostic tests
l a device or piece of equipment
l a drug
l a procedure.
“There is an
obvious and
understandable
conflict of
interests in the
healthcare
system. This is
where HTA can
contribute”
What is HTA?
HTA is a form of policy research that examines
the short- and long-term consequences
of using a healthcare technology. It is a
multidisciplinary process that summarises the
available information about the medical, social,
economic and ethical issues related to the use of
a health technology in a systematic, transparent,
unbiased and robust manner.
However, HTA is also a broad concept. For
example, in reviewing a drug it may include
efficacy (how it works in the ideal setting of a
clinical trial), safety, real-world effectiveness,
and the likely social, legal, ethical and political
impact of using the drug. In other words,
assessment is not always straightforward.
For example, the National Institute for Health
and Clinical Excellence (NICE) – a special health
authority in England and Wales – is in the process
of reviewing a treatment for an uncommon blood
cancer called myelodysplastic syndrome. It is the
first treatment that has been shown to be effective
in controlling some of the symptoms of the disease,
particularly the need for blood transfusions.
When NICE considered the treatment it did
not understand that blood transfusions can have a
significant impact on a patient’s quality of life and
did not recommend the treatment. Patient groups
have since worked together to appeal this decision,
and as recently as July this year it was announced
that NICE will review its recommendation.
In Sweden, meanwhile, the HTA agency, SBU,
has recently looked at the role of group education
programmes for people with ‘type 2’ diabetes and
found that they can substantially reduce blood
glucose levels in patients after one to two years.
How is HTA carried out?
The assessment process and the way the
assessment is used vary from organisation
to organisation and country to country, but
➤
Is HTA new?
The concept of making
treatments available based on
evidence is not new; doctors
have been doing this for many
years. Clinical trials, meanwhile,
which are one of the main
sources of evidence, have been
around for several centuries but
the concept of randomisation
in trials was introduced by
Austin Bradford Hill with the
publication of a 1948 paper
entitled Streptomycin treatment of
pulmonary tuberculosis: A Medical
Research Council investigation.
Yet while clinicians have long
used trials to provide reliable
evidence of how well treatments
work, they have usually only
considered efficacy and not the
broader use of a treatment.
The more formal
development of HTA
started in the 1970s with the
primary interest of ensuring
the effectiveness and safety
of new health technologies.
HTA agencies, however, are
certainly new. For example,
the Swedish Council on
Technology Assessment
in Health Care (SBU) was
established as recently as 1987
as a government agency and
only later, in 1992, became an
independent public authority.
In the US, the term HTA
is less commonly used than
comparative effectiveness
research (CER) and is a relatively
new approach to healthcare
decision making. President
Obama’s recent US health
reform plan included CER and
concluded that it can improve
care for all Americans. As a
result, a Federal Coordinating
Council for Comparative
Effectiveness Research has been
appointed to assist government
agencies in research in this area.
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“there is increasing European
co-operation on HTA. In 2004
the European Commission and
Council of Ministers targeted
the issue as ‘a political priority’”
it is generally acknowledged that four core
components are considered in HTA:
l t he existing medical need (which in this
case is not being met, hence the need for
alternative strategies)
l the clinical process that addresses this need
l t he evidence about the technology being
considered and the subsequent interpretation
of this evidence
l the value for money of the technology
(although this is not always considered).
It is this analysis of context that distinguishes
HTA from other disciplines and allows the
assessors to make relevant recommendations
to policymakers in individual countries with
regards to their own healthcare system. This
explains why some countries make certain
technologies available while others don’t.
How is HTA used?
HTA supports the allocation of resources, based
on affordability and effectiveness. However, in
a continent as economically diverse as Europe,
this does not always mean the same thing. In
some countries, for example, such as the UK
and Sweden, there is a formal requirement for
economic evaluations (that is, cost-effectiveness
assessments) to be part of HTA in order to
support reimbursement and access decisions. In
other countries, such as Denmark and France,
there is a different approach, and HTA is generally
used to inform how (in which circumstances and
in which patients) a technology should be used.
HTA, therefore, has to take account of the
complexities of healthcare: it is not uncommon,
for example, for an effective treatment for
an illness to prove ineffective in some of the
patients who live with the condition; equally,
some medications may cause side-effects
that some patients find intolerable making it
important for other treatments with different
side-effect profiles to be available.
In theory, HTA can be used by individual
patients to make decisions about what treatment
they receive. In other words, they can use HTA
reports to decide what benefit and what risk
best suits their needs. At the same time, HTA
can also be used by companies developing new
technologies to decide whether the likely level
of benefit is worth their investment to pursue its
development. What all this amounts to is that
HTA cannot in any way be seen as a “one size
fits all” approach or solution.
Why is HTA important for
European policymakers?
For many patients and patient groups, HTA
is not only seen as a barrier to treatment but
also as a way of rationing healthcare. HTA
recommendations about what technologies
should or should not be used, or how they should
be used, can result in a negative recommendation.
NICE has often said that new treatments are not
value for money and as a result are not available
in the UK. Patients, meanwhile, find it hard to
understand why a treatment can be considered
worthwhile in one country but not another.
HTA is carried out at a country level – or even
at a regional level within some countries, such as
in Spain – and is the responsibility of national
governments. However, there is increasing
European co-operation on HTA. In 2004 the
European Commission (EC) and Council
of Ministers targeted the issue as “a political
priority”, recognising there was “an urgent need
for establishing a sustainable European network
on HTA”. As a result, with EC funding, a group
of 35 organisations throughout Europe – led
by the Danish Centre for HTA – formed the
European network for Health Technology
Assessment (EUnetHTA) in 2006. And there
was more to come when this initial project led to
a Joint Action on HTA (2010 – 2012) for which
the EUnetHTA collaboration has joined forces
with other partners within the European Union
(EU) member states and the EC.
Discussions about HTA have also featured
in the deliberations on cross-border healthcare
reform in Europe in the early part of this
century, which includes an aim to establish a
framework for European co-operation in HTA.
Together, the EUnetHTA Joint Action
partners – in co-operation with the EC – will
undertake activities that will focus on scientific
co-operation on HTA in Europe with the aim
of delivering high-quality, transparent and added
value for the EU member states. In other words,
the HTA machine is still gathering pace and
looks set to take on increasing significance both at
the national and regional levels within Europe. n
Why HTA is important
HTA produces systematic
reviews of evidence from
published trials and other
sources, and its analyses
accordingly have an impact on
what healthcare physicians can
use and patients can receive. In
England, for example – where
HTA is explicitly used to
make recommendations about
which technologies should be
publicly funded – a number
of new technologies have not
been recommended based on
such reviews.
However, this issue has
proved controversial, particularly
in the UK. For example,
a number of patients and
physicians believe that such
regulation can have an adverse
effect on the quality of care. As
a result, many patient groups
have spoken out about NICE
as a rationing body in England
and Wales. In reply, NICE’s
chairman Sir Michael Rawlins
has claimed that the institute
“…. seeks a balance between
efficiency (utilitarianism) and
fairness (egalitarianism)”, which
essentially means that hard
decisions are having to be taken
about which technologies should
– or should not – be available on
the National Health Service.
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“EFNA wants
patient groups
across Europe
to fulfil their
role as patient
advocates and
fight for better
treatments. and
is providing the
training to make
this happen”
EFNA and HTA
EFNA has taken a lead in
trying to increase the skills and
capacity of patient groups to
contribute to the HTA process.
EFNA president Mary Baker
coined the phrase “distress is
not enough” to try to illustrate
that patient groups need to
robustly demonstrate the
impact that a new technology
can have on the lives of patients.
In a proactive move, a few
years ago Baker began chairing
a small group of patient group
representatives, healthcare
professionals, health economists
and HTA professionals that
in 2008 produced a toolkit
for patient groups on how to
contribute to the HTA process
(the toolkit is available at
www.htai.org/index.php?id=85).
However, it soon transpired
that more in-depth training
was needed. As a result, she
has since worked with Panos
Kanavos of the London School
of Economics and EFNA policy
lead Jean Mossman to establish
and deliver a training course for
patient groups on HTA.
The course has had
participants from 14 European
countries – from patient groups
as diverse as Guillain-Barré
syndrome, pain and rheumatoid
arthritis – and has been funded
by contributions from a range
of pharmaceutical companies.
Speakers at the course have
included Sir Michael Rawlins
(NICE), Dr Thomas Lönngren
(European Medicines Agency,
the EU regulatory body
responsible for providing
marketing authorisation for new
medicines) and Jerome Boehm
(European Commission).
EFNA has also applied –
as part of a joint application
from HTA agencies, academic
institutions and patient groups
– for funds to run the training
course elsewhere in Europe.
When EFNA took a lead
in educating patient groups
on HTA, it was a lone voice
calling for groups to improve
their skills and engage with
the process in their country.
EFNA wants patient groups
across Europe to fulfil their
role as patient advocates and
fight for better treatments, and
it is providing the training to
make this happen.
www.efna.net 9
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Allied
forces
Since its launch more than three years ago, the Alliance
for MRI has been embroiled in a fierce campaign to
revise the European Union’s 2004 MRI Directive.
Arguing it creates a serious threat to the life-saving
treatment’s future use, it courageously won a fine
political victory in 2008, but, as Sonja Guttenbrunner
and Monika Hierath from the Alliance for MRI secretariat
explain, support for the campaign is still as vital as ever
10 www.efna.net
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The Alliance for MRI
R
arely have technological
advances caused such a furore
in the medical world. On
the one hand we have at our
disposal the wonder that is
Magnetic Resonance Imaging (MRI) – a
powerful diagnostic tool that has been at the
cutting edge of treatment and research of
diseases in Europe for more than 30 years.
Back in the 1970s it was discovered that
detailed images of the interior of the human body
can be produced by electromagnetic waves, and
since then MRI has become vital for patients with
a variety of conditions and disorders, especially
neurological diseases including brain tumours,
Parkinson’s disease and multiple sclerosis.
Reflecting the fundamental importance and
applicability of MRI in medicine, American
chemist Paul Lauterbur and the British physicist
Sir Peter Mansfield – both major contributors to
the science – were awarded the 2003 Nobel Prize
in Physiology or Medicine. The medical world
was excited and expectant – and for good reason:
Europe was at the forefront of the development
of this technology and MRI was widely believed
to be a valuable key in helping us understand
much more about neurological, musculoskeletal,
cardiovascular and oncological conditions than
ever before. It represented the future.
On the other hand, however, a disaster struck
in 2004 when the European Union (EU) adopted
health and safety legislation that created a serious
threat to the use of such life-saving examinations
– a threat that still exists very much today.
MRI makes use of powerful magnetic fields
that, though not known to cause direct biological
damage, can interfere with metallic and
electromechanical devices. The EU’s Directive to
protect workers from electromagnetic fields – the
’EMF’ Directive1 – was therefore designed to
limit workers’ exposure to electromagnetic fields.
Such an act immediately caused fierce
controversy and outcry among MRI
practitioners. “MRI has been used for more
than 25 years with no evidence of harm from
electromagnetic fields to either patients or
workers,” said Dr Stephen Keevil, reader in
medical physics at King’s College London, at the
time. “Radiologists work with MRI scanners on
a daily basis. The EMF Directive was adopted
with inadequate consultation, an outdated impact
assessment and a lack of scientific evidence, and
was rushed through the legislative process prior
to the enlargement of the EU in 2004.”
As soon as frustrated and fearful MRI experts
were made aware of the legislation, they sought
to inform policymakers that it would severely
curtail the use of MRI scanners for healthcare
and research purposes. This led to a study2,
undertaken by the UK Health and Safety
Executive and published in June 2007, which
clearly demonstrated that healthcare staff would
be prevented from assisting or caring for patients
during imaging. “The study made very clear that
some patients – such as the very young, elderly,
“The Directive
was adopted
with inadequate
consultation, an
outdated impact
assessment and a
lack of scientific
evidence”
frail or confused – would be denied MRI scanning
and have to undergo alternative procedures such
as X-rays or computed tomography (CT), which
are proven to be much more harmful,” says Keevil
today. In short, MRI-guided surgery – which
had proved to be particularly important in brain
surgery over the previous decade or more – would
be impossible and could prove to be a major
setback for scientific research.
The launch of the Alliance
Disappointingly, there were no signs that the
evidence generated – evidence that argued that
the clinical and research use of MRI would be
severely curtailed by the legislation – would sway
policymakers. As a result, the Alliance for MRI
was born in March 2007, a group of engaged
neurological advocacy groups, patient groups from
different disease areas, leading European scientists
and members of the medical community,
healthcare professionals, and various leading
Members of the European Parliament (MEPs).
The Alliance’s chief objectives were – and still
are – to effect an exemption from the limits set
in the EMF Directive3, while campaigning for
the development of guidelines to support the
hopefully updated safety guidelines. The creation
of suitable guidelines, the Alliance argues, would
allow for the incorporation of changes to ensure
that working practices remain constantly in line
with technological developments, now or in
the future. (There are already strict MR safety
standards in place – regulation IEC/EN 606012-33, as required under EU law and amended
and harmonised under the Medical Devices
Directive – that establish criteria for minimising
physiological effects, namely peripheral nerve
stimulation, which is where a person may
experience a tingling sensation as a result of
changing magnetic fields. The Alliance, however,
supports the development of user guidelines to
complement these legal requirements.)
“MRI is a powerful, non-invasive and safe
diagnostic and research tool,” says Gabriel Krestin, ➤
What is the Alliance for MRI?
The Alliance for MRI was
created in March 2007 and
is a coalition of European
Parliamentarians and patient
groups as well as leading
members of the European
science and medical
community. Together they
are seeking to avert the
serious threat posed by
European Union (EU)
health and safety legislation
to the clinical and research
use of Magnetic Resonance
Imaging (MRI). It aims to do
this by raising the awareness
of policymakers and the
general public through the
following means:
1
Campaigning for an EUwide exemption for medical
use of MRI and related research
from any exposure limit values
set in the Physical Agents
2004/40/EC (EMF) Directive.
2
Calling for guidelines
to support the existing
MR safety standard (IEC/
EN 60601-2-33) as these
would allow changes to ensure
working practices are in line with
technological developments.
(IEC/EN 60601-2-33 currently
establishes limit values for timevarying electromagnetic fields
that have been set so there is no
danger to patients and workers.)
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“There has
been no proven
harmful effect
of MRI to either
patients or
workers over
the past 25 years”
professor of radiology at University Medical
Center Rotterdam in the Netherlands, 2nd vicepresident of the European Society of Radiology
and leading member of the Alliance. “However,
its application often relies on the presence of a
healthcare worker or researcher. Worker protection
is naturally taken very seriously; however, the
current legislation threatens patient access to the
benefits of MRI. This would mean thousands of
patients would have to undergo other diagnostic
procedures, such as conventional X-rays or CT,
which have proven adverse health effects.”
EFNA president Mary Baker, who has been
involved in advocating on behalf of the Alliance
since its launch, is another high-profile figure
to campaign against the EMF Directive. “This
Directive severely limits MRI procedures
in clinical and research work to the serious
detriment of patients’ interests,” she says. “We
must ensure that an amendment is introduced
to exempt MRI as swiftly as possible.”
Frank Boeye, president of the Belgian Brain
Council, is another voice behind the campaign
and argues: “MRI is an essential tool that has
been instrumental in saving the lives of thousands
of patients. Being a brain tumour patient myself,
I would not be here today without this diagnostic
option that allowed doctors to discover my illness.
The truth is my condition could not be detected
by other imaging techniques such as CT.”
Mounting pressure
Following an intense campaign by the Alliance
for MRI – which included forging contacts
with key European decision makers within
the EU’s Directorate General Health and
Consumers Affairs, and former European
Commissioner Vladimír Špidla as well as a
strong media campaign across the continent – the
implementation date of the EU’s Directive was
finally postponed in April 2008 until April 2012
in a landmark case: it was the first time ever that
the implementation of a Directive was delayed.
Meanwhile, the European Commission (EC)
– the EU’s executive body that was responsible for
proposing the original legislation – also made clear
that it was never its intention to impede the use of
MRI and was committed to undertaking studies
to evaluate the impact of the legislation on the
technology. This success was the first milestone in
the work of the Alliance as it was essential that the
EC assessed closely the full impact of the Directive,
taking into consideration the social, economic and
environmental impact of the legislation.
“Any new legislation must be evidence-based
The role and benefits of MRI
Currently, MRI is the most
sensitive imaging method
for the head in routine
clinical practice and is
essential to help diagnose
and/or document:
l tumours of the brain
l developmental anomalies of
the brain
l vascular anomalies of the
head (such as aneurysms)
l disorders of the eyes and the
inner ear
l stroke
l trauma patients
l disease in the pituitary gland
l certain chronic disorders of
the nervous system, such as
multiple sclerosis
l causes of headache
l brain abnormalities in
patients with dementia.
MRI also has a number of
benefits compared to other
imaging modalities, such
as X-ray and computed
tomography (CT):
l MRI is non-invasive and
does not involve exposure to
ionising radiation.
l MR images of the brain
and other cranial structures
are clearer and more
detailed. This detail makes
MRI an invaluable tool
in early diagnosis and
evaluating many conditions,
including tumours.
l MRI can help physicians
evaluate the structures of
the brain and help give
functional information
(fMRI) through mapping
certain areas of the
brain and their function.
l MRI enables the discovery
of abnormalities that might
be obscured by bone with
other imaging methods.
l The contrast material used
in MRI exams is less likely
to produce an allergic
reaction than the iodinebased materials used for
conventional X-rays and
CT scanning.
l A variant of MRI called
MR angiography (MRA)
provides detailed images of
blood vessels in the brain –
often without the need for
contrast material.
l New MRI systems can
depict brain function, and
thus detect a stroke at a very
early stage.
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EFNA S&S Issue 1 p10-13 MRI Alliance v2.indd 12
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The Alliance for MRI
“The Alliance
is about to
embark on a
crucial phase
of its campaign
in supporting
the EC proposal”
and founded on sound science,” said Professor
Krestin in the Alliance’s first statement after
the postponement. “There has been no proven
harmful effect of the time-varying electromagnetic
fields as used in MRI and addressed in the
Directive to either patients or workers over the
past 25 years, during which time more than 500
million examinations have been undertaken.”
It was evident that during this campaign
patient groups, scientists, practitioners and
MEPs acted in concert with one another on an
unprecedented level. Such a powerful connection
secured the attention not only of the relevant
stakeholders, but also the general public.
The journey continues
For the Alliance, however, its campaign was
anything but over. Since the 2008 triumph, it is
still trying to ensure that a revision of the Directive
includes a vital caveat: an exemption from the limit
values for exposure for the MRI operating staff.
Following engagement with key decision
makers in the EC, including Commissioner
Laszlo Andor (the Hungarian commissioner
responsible for employment and social affairs)
and decision makers responsible for public
health and research, the Alliance for MRI is
now optimistic that the EC will propose an
exemption for MRI from the binding exposure
limit values in the Directive. The Commission
is currently in the final stage of preparing a
proposal to revise the EMF Directive, which is
expected to be published in the autumn of 2010.
Despite the Alliance’s unprecedented victory
in 2008, however, there are opposing views from
trade unions, industry lobbies and a number of
member states that have already implemented
the Directive in their regions due to the
legislation remaining on the statute book.
Industry lobbies oppose because they do not
want an exemption purely for the medical use
of MRI – they also want one for numerous
other sectors affected by the Directive too. Trade
Unions, meanwhile, want to secure an equal
protection of all workers and therefore oppose
an exemption purely for the clinical use of MRI
despite it being proven that no harm is done to
healthcare workers and they would still remain
within the scope of the Directive.
Added to this, the safe use of the technology is,
as has already been explained, already regulated for.
The established MRI safety standard (IEC/EN
60601-2-33) establishes criteria for minimising
physiological effects of exposure to time-varying
electromagnetic fields that have been set so that
any danger to patients and workers is excluded.
In short, there is still a widespread lack
of understanding and awareness regarding
the implications of the EMF Directive. As
a result, it is likely that the forthcoming EC
proposal will be contentious with different
lobbying groups advocating for different
changes to the Directive. As a result, the
Alliance is braced for the next offensive.
“The Alliance is about to embark on a crucial
phase of its campaign to ensure that member
states and the European Parliament – all of whom
have to agree to the final text – support the EC
proposal to exempt MRI from the limits,” says
Krestin. “It is essential that we ensure member
state governments as well as MEPs understand
what is at stake for the future of patient care,
public health, research and innovation.
“The Alliance for MRI relies on the activism
of its members across Europe and we very much
hope that they will all engage on this issue in
each of their respective countries as well as in
their meetings with the EU institutions. The
Alliance trusts that the Hungarians – who will
take on the six-month rotating EU presidency
from January to June 2011 – will prioritise this
dossier and work to find an agreement in the
Council of Ministers [the council that represents
the member states] to safeguard the future use of
MRI. We hope that by June 2011, the European
Parliament and the Council agree on a final text
so that the amendment can be adopted into EU
law and remove the current uncertainty regarding
the use of MRI. Any legal restrictions on its
use in Europe would put patient safety severely
at stake and prevent access of patients to this
technology. This cannot be allowed to happen.” n
For more information, visit www.alliance-formri.org, and to join the Alliance, sign the
online petition at http://petition.myesr.org.
EU Physical Agents Directive 2004/40/EC
(Electromagnetic fields).
2
Assessment of electromagnetic fields around
magnetic resonance imaging (MRI) equipment
(Crozier Study), June 2007.
3
The EU Physical Agents (EMF) Directive 2004/40/
EC puts limits on the exposure of operating staff
(including those maintaining equipment) from
zero frequency up to 300GHz. The limits proposed
are huge extrapolations from largely hypothetical
possible conditions and are an overcautious
interpretation of very limited experimental data.
1
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EFNA S&S Issue 1 p10-13 MRI Alliance v2.indd 13
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Web of
deceit
According to the European Alliance for Access to Safe
Medicines (EAASM), counterfeit drugs are a crime
on a grand scale and a threat to global public health.
Here, the Alliance’s chair, Jim Thomson, reveals the
astonishing truth behind the rise of ‘the fakers’ –
particularly via the internet – and explains the EAASM’s
vital role in campaigning for progressive European
legislation that will help counter the criminals
I
n early 2007 “Annie” was looking
forward to a “normal” life. Having
battled and learnt to manage
schizophrenia in recent years, the fact
that she had been cleared to study a
full-time university course was, to her, formal
recognition of her progress. Then Annie began
to notice subtle changes in her behaviour
and, specifically, the efficacy and side-effects
associated with her medicine. One strategy for
managing her condition involved keeping a
diary. Her entries in the coming days were to
become more and more disturbing. Eventually,
Annie drove to a secluded spot and attempted
to take her own life, having written that “the
Lady of the Lake” was calling to her. Annie
was sectioned under the Mental Health Act
and spent the next six months institutionalised.
She is now well on the road to recovery.
In May 2007, counterfeit versions of three
mainstream medicines – for prostate cancer,
heart attack and stroke, and schizophrenia
respectively – entered the legitimate UK
distribution system; the system that you and
I rely on for our prescription medicines. The
latter medicine was the one taken by Annie
at exactly the time she began to diarise her
changes. After testing, it had only 60% of the
active ingredient and was therefore sub-potent.
Can we say with certainty that Annie
took the sub-potent fake? No, we cannot. As
is often the case with this unseen crime, the
evidence was, quite literally, eaten. What we
do know is that a young woman, who had
been managing extremely well, was glimpsing
a brighter future and very nearly died.
Around 30,000 packs of that fake medicine
remain unaccounted for. “Unaccounted” is
regulatory speak for “eaten”.
Counterfeit medicines are a crime on a
grand scale and a threat to global public
health. One in two GPs in the UK believe they
might have seen a patient who has received
a counterfeit. This is an astonishing statistic.
In other words, 50% of GPs are suspicious
when it comes to fake medicines. To confirm
their suspicions, in 2008, during the course of
Medifake – a European Union (EU) Customsled initiative that targeted illegal medicines
entering the region – 34 million fakes were
found by customs officials. One shipment
alone, at Brussels Zaventem airport, contained
1.6 million fakes, many of them anti-malarials
bound for the developing world.
Where’s the risk?
So who are these criminals that are risking the
health of patients everywhere? Well, they are
the very same crooks involved in large-scale
trafficking of people, narcotics and weapons,
and include the very largest organised crime
gangs and terrorist organisations around
the world. The reason they have turned to
medicines is, quite simply, the favourable
risk-to-benefit ratio. Counterfeit medicine
trafficking is phenomenally profitable while
being very low-risk. Counterfeit Viagra,
for example, is 2,000 times more profitable
than real cocaine, and the penalties if caught
are, at present, laughable.
While the holy grail for the criminal is
penetrating the legitimate supply chain, it
is when we look to the internet that we see
exactly how easy it is to find counterfeit
medicines. In 2008, the European Alliance
for Access to Safe Medicines (EAASM)
undertook a covert test-purchase programme,
buying more than 30 prescription-only
medicines without prescription. More than
60% were fake or substandard, ranging
in quality from “perfect” fakes – those
indistinguishable from the original without
forensic analysis – to heart medicine wrapped
in the sports pages of the Mumbai News.
A year earlier, the EAASM commissioned
Dr Jonathan Harper, the author of a previous
high-level report for the Council of Europe
and staunch campaigner for safe medicines,
to produce a report analysing the legitimate
supply chain in Europe. His findings
sent shock waves throughout the system.
He described the environment as one of
“invisibility, biohazard and system failure”.
Clearly, it was time for change, and Gunter
Verheugen, then vice-commissioner of the
EU, recognised this when his department
14 www.efna.net
EFNA S&S Issue 1 p14-17 counterfeit.indd 2
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counterfeit medicines
“In 2008,
the EAASM
undertook a
covert online
test-purchase
programme.
More than
60% of the
drugs bought
were fake or
substandard”
produced a piece of draft legislation in
2008, which, in addition to dealing with
pharmacovigilance and information to patients,
proposed specific measures to protect patients
in Europe from counterfeit medicines by
tightening the supply chain.
The legislation stalled in 2009 when
controversial proposals to ban the
repackaging of medicines moving between
countries through parallel trade – the legal
arbitrage of medicines between EU countries
that takes advantage of price differences – led
to 18 out of 27 votes going against the draft
directive. European elections delayed any
further progress until, with the new parliament
formed, Marisa Matias MEP took on the role
of rapporteur for the directive.
Timed to coincide with her appointment,
the EAASM produced its third milestone
report, Packaging Patient Protection, and five of
its seven key recommendations found their way
into the draft-approved legislation. Finally, we
were moving in the right direction – together.
logical progression
The EAASM recommendations that were
adopted were simple, straightforward common
sense. Specifically, we called for the legislation to:
define the term ‘equivalence’ with
l
reference to the level of safety protection
and security categorisation of Europe’s
prescription medicine packs. The original
draft contained such a proviso but the
EAASM and others believed that the
legislation needed to be specific and
prescriptive and, that if a medicines
repackager destroyed the security features
of a pack, then the new pack should have
features of exact equivalence
introduce universal agreement – by all holders
l
of manufacturing and marketing licences
– to apply at the very least a ‘minimum
categorisation by law’ of effective traceable and
tamper-proof anti-counterfeit technology
andate the introduction and provision
lm
in law of ‘continuing accountability’ along
the medicines’ supply line. In other words,
every actor who packages or repackages a
➤
Another string to the EAASM bow
The EAASM has once again
been recognised for its success in
raising public awareness of the
dangers of counterfeit medicines
after winning a prestigious
award for its continued public
health campaign.
The 2010 Communiqué
award for Best Corporate
Communications is the latest
evidence and recognition
for our collective impact on
patient safety, building on our
past successes:
l 2009 PMEA Public Health
Marketing Award (winner)
l 2008 PMEA European
Marketing Campaign of the
Year (finalist)
l 2008 Communiqué Best Use
of Surveys and Data (finalist).
The Communiqué judges
said the following about the
EAASM campaign:
“The EAASM success in
improving and protecting
public health through
education has been incredible
and as an organisation they
are fast becoming a hugely
effective and highly respected
force for good in healthcare.”
I have to add, though,
that what the EAASM does,
and the impact we have on
public health, would not be
possible without the support
of every one of our member
organisations and we would like
to thank each of them for their
help, support and input over the
past few years.
Throughout the rest of
2010 and into 2011, we plan
to continue to better inform
patients about fake medicines
and will soon be sending round
the first output from our latest
campaign, Counterfeiting the
Counterfeiter. We hope this
will raise the bar even further
by communicating the risks
of purchasing prescription
medicines from illegal online
pharmacies to as many
European patients as possible.
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EFNA S&S Issue 1 p14-17 counterfeit.indd 3
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The two images below show real and fake packaging from drugs
the EAASM bought online. Can you tell the difference? Could a
patient? The other images show the not-so-sophisticated production
facilities where criminals somehow produce seemingly perfect
product. This cement mixer pictured had traces of other medicines
as well as cement from previous days’ labours
The Online Clinic makes an example of the UK
The facts are terrifying. According
to the Center for Medicine in the
Public Interest, counterfeit drugs
sales will reach $75bn globally in
2010, an increase of more than 90%
from 2005. So how can patients
spot a legitimate service? Well,
according to a 2008 study from
pharmaceutical firm Pfizer called
Cracking Counterfeit, not easily.
It not only highlighted the risk
consumers – especially men – were
taking by purchasing counterfeit
medicines, but also revealed that one
in 10 men admitted to purchasing
prescription-only medicines online
without a prescription.
According to the UK’s Royal
Pharmaceutical Society of Great
Britain (RPSGB), the lack of
consumer awareness about online
regulations is a huge problem with
a third of people not knowing what
to look for. This is a sentiment
echoed by many legitimate online
medical service providers, such as
Robert MacKay from the UK’s The
Online Clinic, who believes the
UK is at the forefront of European
efforts at good practice. “Buying
medication online is extremely
discrete and convenient but it is very
important that people make sure
they are dealing with a legitimate
healthcare provider and not some
criminal gang hiding behind a welldesigned website,” he says.
“All organisations in England and
Wales that provide prescriptions are
required to be registered with the
Care Quality Commission so that is
a good place to start; if the service
is not registered then you are not
dealing with a legitimate supplier.
In addition, all UK pharmacies are
required to be registered with the
RPSGB. If the supplier is able to
demonstrate these two qualifications
then you will be in safe hands.”
To this end, The Online
Clinic is working to ensure
that consumers are much better
informed, and has therefore
created a checklist of things to
look for when selecting an online
healthcare provider, which other
countries could adopt too:
l All clinics must be registered with
the Care Quality Commission
and you can check whether they
are at www.cqc.org.uk
l All pharmacies must be registered
with the RPSGB. If the website
is legitimate then they will tell
you the name and registration
number of the pharmacy, which
can be checked at
www.rpsgblist.org/premises.asp
l Make sure the website can provide
you with an address and a phone
number – call the number and
check you are purchasing from a
true supplier. It isn’t necessarily
illegal to buy medication abroad
but it is much safer to choose a
supplier within your own country
so you can check their credentials
with the regulators
l Websites that offer to supply
prescription-only medicines
without a prescription are to be
avoided. Not only is this illegal
in the UK, it is also unsafe, and
customers are highly unlikely to be
supplied with a genuine product
l No legitimate UK website will
allow customers to purchase
medicines without a consultation
with a registered doctor. This
can usually be done online,
and ethical practioners will
refer patients for an in-person
appointment if they suspect a
fuller consultation is needed. The
UK’s General Medical Council
rules state that an online doctor
registered with them must
disclose their details to the patient
l A clinic or pharmacy that obeys
the law will not advertise prices
until a consultation with a
medical professional has been
carried out. To do otherwise
contravenes regulations laid down
by the Medicines and Healthcare
Regulatory Agency, which
regulates the sale and supply of
medications in the UK.
In a world where counterfeit
medicines now look so authentic
that often only a laboratory
can detect if they are genuine,
consumers are strongly advised to
shop with caution. “People tend to
take their health for granted and
assume that prescription ‘lifestyle’
drugs such as Viagra are simply
recreational – they aren’t,” says
MacKay. “Taking any drug needs
to be a well-considered choice
rather than a quick-fix peddled by
someone who is not interested in
the wellbeing of the customer.”
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counterfeit medicines
“The EAASM will
remain focused
on its task until
counterfeit
medicines are
eradicated from
our continent”
medicine for European patients should hold
full liability for the authenticity of that pack
and the entirety of its contents at the time
of release to another actor (“actors” include
manufacturers, wholesalers, distributers,
logistics providers, pharmacists and so on;
in effect, anyone handling prescriptions who
would be equally accountable in law)
l e stablish an Active Pharmaceutical
Ingredient (API) Guarantee. This is critical
as much API is sourced from within the
very countries where counterfeiting is rife.
Considering a single batch of counterfeit
API would produce many thousands of
packs of finished product, the EAASM
believes that the API must be guaranteed
to be legitimate. Unfortunately, the need for
this measure was tragically demonstrated
when 81 people in the US died as a result of
substandard API found in Heparin. There
were more than 60 further deaths in 11 other
countries between January and May 2008
l allow for a set of interim measures – such as
mandatory security features and continuing
accountability if a medicine is deemed at
high risk of being counterfeited – to be
agreed and implemented as a matter of
significant urgency that provides European
patients with protection from counterfeit
medicines until the European parliamentary
process arrives at a final legislative solution.
a massive step forward
The draft legislation is now with the Council
of the EU and it is hoped it will become law in
2013. It will mandate security features on all
prescription medicines, the level of which will be
decided on a risk-assessed basis. It will introduce
equal and continuing accountability across
the entire supply chain, harsher penalties for
those found guilty of counterfeiting, and more
stringent licensing protocols. It will also seek to
regulate the internet and support programmes to
educate and raise awareness around the dangers
of illegitimate online drug selling.
In its present form – which the EAASM
will be campaigning to preserve and strengthen
– the draft legislation represents a massive
step forward in patient safety. The road to
safe medicines for all Europeans is a long and
difficult one but we are some way along it.
The EAASM, with the support of its member
patient groups such as EFNA, has been central
in navigating that road, and its pledge to
Europe’s patients is that it will remain focused
on this task until counterfeit medicines are
eradicated from our continent, until we can be
sure of the quality of our medicines, and until
we can answer with confidence the question
of whether “Annie” was a victim of this most
cowardly of criminal ventures. n
A Wellcome relief for researchers
Global charity the Wellcome
Trust has awarded £473,000
to a team of international
researchers to create a system
that can identify counterfeit
and substandard drugs.
The team, from King’s
College London, will work in
collaboration with scientists
from Lund University,
Sweden, with the aim of
producing an inexpensive and
robust instrument for lowincome countries, where the
problem of drug counterfeiting
is particularly acute.
Dr Kaspar Althoefer, from
the Division of Engineering at
King’s and who will lead the
programme, comments: “There
is a growing awareness that
counterfeit and substandard
drugs constitute a fastgrowing threat to public
health the world over. To take
just one example: the use of
substandard drugs – drugs that
contain an incorrect amount
of active ingredient due to
poor manufacturing controls
or losses due to ageing – can
lead to fatalities as well as
the emergence of drugresistant forms of infectious
agents, which have disastrous
consequences for medical
treatment programmes.”
According to current
estimates, around 1% of drugs
in high-income countries –
and anywhere from 10% to
30% of drugs in low-income
countries, are counterfeit.
In addition, the proportion
of substandard drugs is
thought to be even higher
still. There is, therefore, a
pressing need for reliable
methods of authenticating
pharmaceutical products before
they reach the patient.
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The record
collector
More than 10 million people in the UK alone
live with long-term illnesses, and according
to Dr Mohammad Al-Ubaydli they would all
benefit if they asked for a copy of their medical
records – and actually read them. Prior to the
launch of his new campaign My Health, My
Records – which will allow patients to gain
valuable understanding and empathy with how
medical professionals approach their jobs –
Dominic Graham spoke to him to learn more
tell us about yourself
“I like to help people take control of their
lives. To put this in context, I have a long-term
condition – a genetic immune deficiency that
I was born with. But if it was not for the help
from my parents and my clinicians, I should
not be alive today. Thanks to them, I became
healthy enough to go to medical school and
graduate as a doctor, and also train to be a
medical software programmer. I want to use
all these experiences to good effect.
“It was when I spent a few years as a researcher
in the US – working with 2,700 hospitals – that
I noticed my clinicians were asking me what to
do next in terms of my condition. Not because I
had trained as a doctor but because as the patient
– and crucially a patient with access to my own
records – I sometimes knew what was best.
“I combined this observation with the
knowledge of what doctors needed, what
programmers could create, and what hospitals
were already succeeding with in the US.”
What happened then?
“Back in 2007, I heard a story from Jim Jirjis,
a US doctor who gave patients access to their
medical records. He had recently had a patient
who used these records in a way that completely
transformed how he approached patient care.
“The patient complained of chest pain, so
Jirjis ordered a CT scan to rule out a tear in the
largest blood vessel, the aorta. The radiologist’s
report came back among all the other reports and
Jirjis confirmed to the patient there was no tear
and all was well. However, the patient also read
the report. Although he could not understand all
the medical language, he did enquire about an
incidental finding of a ‘thyroid lump’.
“Jirjis had originally scanned past this
finding but now instantly understood the risks
such a lump could hold and ordered a biopsy
sample, which showed early-stage thyroid
cancer, too small for the patient to have any
symptoms but small enough that removing it
would prevent future late-stage cancer, which
could have been fatal. Fortunately, we got
there early enough – this time.
“From that point onwards, Jirjis insisted that
his patients have access to their records. He
needed their help, and they needed the access
of their records for their health. It has proved
essential for providing safe healthcare.
“This is what prompted me to kick-start
my own movement for patients to ask for their
records. And so I founded Patients Know Best.”
What exactly is the campaign?
“It will start as a website – myhealthmyrecords.
org – at the end of October, which will house
educational material, including videos. We’ve
already won some great support, including a
PR agency that is donating its time pro bono,
a web company that is donating hosting space,
and we are regularly receiving other offers of
help from different people and groups.
“It’s exciting. The PR company wants to
record patients talking about why they want their
medical records, and the firm will also provide
them with media training to answer questions
from journalists following the launch. We hope
the charities will also encourage their members
to back the campaign too. The intention is to
pool together all these resources onto the website
and provide toolkits, including leaflets, videos
and petitions, that allow individuals to contribute
to the hopefully many grassroots campaigns.”
What is Patients Know Best?
“It is my latest effort at making change happen.
Established in 2008, it combines technology
and patients’ access to their medical records.
Clinicians want patients involved in their own
care but technology and legal barriers often
prevent this. Patients Know Best therefore
complies with all the laws and technical
requirements that clinicians need to be allowed
to use software that puts patients in charge.
“We are now working in collaboration with
others – including EFNA, Channel 4, Leonard
Cheshire Disability, the Thalidomide Trust, and
the Cure Parkinson’s Trust – to launch a national
campaign called My Health, My Records. Other
organisations will also be joining over time.”
Why do you need patient
organisations on board?
“Patient charities such as EFNA help
teach patients that access to their records is
important, and to legitimise to clinicians the
request for them is valid. At the moment, many
patients simply do not ask for records because
they don’t know they should. They think
doctors read the notes – but they don’t – so
patients don’t think they have to – but they do.
“In contrast, the few patients that do want
to ask for their records are often worried about
‘bothering’ their doctor, believing they may get
stigmatised as being ‘difficult’. For the record,
such requests never bother doctors: informed
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my health, my records
The homepage of Dr
Al-Ubaydli’s Patients
Know Best website
patients help doctors immeasurably. In fact, the
UK Department of Health’s recent guidance
confirmed this [visit http://bit.ly/crotF3]. Patient
charities are vital for raising awareness – and
publicly backing our campaign will contribute to
healthcare and help remove this stigma.
“Furthermore, at present patients do
not understand the medical terms – they
are jargony and too academic for the most
part – while doctors’ often illegible notes are
themselves difficult to contend with. All this
is an opportunity for programme creators to
create user-friendly and simple software such as
patientslikeme.com (which shows patients the
data of other patients), reliefinsite (which allows
patients to show clinicians where their pain is)
and patientsknowbest.com of course, our own
tool, which can layer on explanations from the
UK’s NHS website, NHS Choices.”
What else can you tell us?
“It is our ambition to use My Health, My
Records to recruit as many celebrities and citizens
as we can. We aim to recruit one supporting
patient from each illness and ask them to share
what they learned from the campaign. Of course
there are many hundreds of illnesses, but that is
all the more reason to get patients to step forward
and help others with the same condition. We will
start small, but we intend to grow bigger as more
charities and patients back us.
“Elsewhere, we would like to explore other
avenues of collaboration that each organisation
feels comfortable with. For example, a charity
could make explanatory videos with the My
Health, My Records team, work with celebrities
EFNA S&S Issue 1 p18-19 Mohammad v2.indd 3
to increase visibility, or co-author position papers
that would be presented to national governments.
“Whenever possible, I will get permission to
upload information onto our website so anyone
in the world can use them.”
of drugs. There are so many possibilities. All I
am saying is that we are excited about them. It
should be a fascinating endeavour.” n
Visit myhealthmyrecords.org and
www.patientsknowbest.com.
What are your long-term
hopes for the campaign?
“I plan to start by approaching charities and
convince them to reach out to their celebrity
patrons for the next phase of public support. This
is definitely a long-term campaign, and every few
months we will announce further support and
“patients don’t
ask for their
records because
they don’t
know they
should. They
think doctors
read them – but
they don’t”
new twists. For example, we have
already had one charity approach us
asking if they can use our software
with their members so patients
can pool their medical data and
make it available to researchers
and pharmaceutical firms to
develop the next generation
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