APPENDIX 8
Memorandum by EMG European Medicines Group
(PI 17)
1. THE EUROPEAN
MEDICINES GROUP
1.1 The European Medicines Group (EMG) is
the UK voice of research-driven pharmaceutical companies headquartered
in Europe who develop and supply prescription medicines to the
NHS. It has 21 member companies who employ around 12,500 people
and invest approximately £250 million in medicines research
and development in the UK each year. The purpose of EMG is to
help patients, carers and policy makers understand the contribution
of the European Pharmaceutical industry to the UK and to ensure
that UK patients have the level of access to new, innovative medicines
and to information about their medicines that is currently enjoyed
by their European neighbours.
1.2 The EMG is in agreement with the evidence
submitted to this Inquiry by the Association of the British Pharmaceutical
Industry (ABPI). It offers its own response based on:
— its ability to provide informed comment
on how the UK compares with other European healthcare models that
are based on a mixture of public and private provision and are
more closely aligned with NHS values than many models from elsewhere
in the world;
— the specific interest that EMG has
in patient access to medicines and to medicines information that
has arisen out of marked differences between the UK and neighbouring
European countries with respect to those two important issues;
and
— the intelligence it has accumulated,
working with third party organisations and individuals over the
past three to four years, on the attitudes and behaviours relating
to these marked differences in practice between the UK and other
European countries.
1.3 The EMG is committed to working in partnership
with the relevant stakeholders to promote an environment that
improves access to effective modern medicines and that allows
people seeking medicines information to source it from wherever
they wish. In seeking to attain these improvements, EMG always
works with total regard for the statutory and self-regulatory
controls that provide an appropriate framework of checks and balances
to ensure probity and good practice.
1.4 This paper sets out how EMG approaches
achieving its purpose and provides comment on the Terms of Reference
of the Inquiry that are limited to patient aspects of drug information
and education and to product evaluation.
2. PROVISION
OF DRUG
INFORMATION AND
PATIENT EDUCATION
2.1 Like the Government, EMG believes that
there is considerable potential to improve the health of UK citizens
by giving them direct access to high quality health and medicines
information. The focus of our activity is complementary to the
various Government initiatives and strategies designed to improve
health and medicines information and empower patients to take
more responsibility for their own health.
2.2 EMG does not advocate advertising prescription
only medicines to the general public but does support people's
right to request and receive medicines information from whichever
source they choose, which includes amongst others, information
from manufacturers. The ready availability of good quality information,
appropriate to the patient's needs at the time, is the foundation
for involvement in treatment decisions and supports ongoing self-management
of chronic conditions.
2.3 Although the volume of health and medicines
information from a wide range of sources is increasing, much of
this is not subjected to any regulation or standard and the quality
is often questionable. This is likely to detract from, rather
than improve health outcomes. The quality of information relies
on interested parties agreeing and enforcing a set of standards
and it is this aspect of information provision, as opposed to
controlling the sources of information, that will best serve the
demands of the public.
2.4 The provision of information about medicines
by the pharmaceutical industry is governed by local implementation
and interpretation of European regulations for medicines labelling
and advertising and by the industry's own Code of Practice. EMG
has noted and welcomes the approach taken by the UK Medicines
and Healthcare products Regulatory Agency (MHRA) which is more
supportive of public access to information about medicines than
the approach observed with some other European Regulatory bodies.
It has developed helpful guidelines for providers of disease awareness
programmes to the public and has supported the Medicines Partnership
in the development of Medicine Guides accessible via the Internet.
Although there is potential for considerable improvements in facilitating
public access to medicines information, the UK is in fact amongst
Europe's leaders on this issue. We would recommend that this Inquiry
recognise this leadership role and encourages it to be sustained
and further developed.
2.5 EMG has been, and remains, concerned
that changes to European legislation have the potential to infringe
the public's right of access to information and may represent
retrograde steps for the UK. In particular, the prohibition on
advertising prescription medicines to the public must not be extended
to, or interpreted as preventing, the provision of information
to those people seeking it. The EMG has briefed a number of interested
parties on this position including Health Ministers, UK and European
Parliamentarians, civil servants at the Department of Health and
representatives of health professional bodies and patient organisations.
Support for this position has been strongly received from the
parties consulted, and EMG would encourage further support from
this Inquiry.
2.6 Over the last four years, EMG has also
held discussions with a number of stakeholders from all the above
groups and, in particular those groups who represent the interests
of patients either generally or for people with specific conditions.
The purpose of this ongoing interaction has been to better understand
the information needs of patients and the public, how these are
currently served and what changes are needed to better meet the
increasing demand for good quality information about health and
medicines.
2.7 A consistent view expressed in our interactions
with patient organisations and other interested parties, is that
the industry should be able to provide information to people seeking
it provided that the appropriate quality standards are in place.
It has also been repeatedly put to EMG that the industry is currently
over-interpreting the regulatory framework and unnecessarily restricting
its activities rather than responding to the public demand for
information. A broader engagement between the manufacturers of
medicines and the patients that rely on them is being actively
sought by patient organisations, who point out that it is unrealistic
to expect people to take medicines on a daily basis, often for
the rest of their lives, whilst they are provided with much less
information and support from the manufacturer than is currently
available for most consumer goods.
2.8 Over 30 patient groups attending a Patients
Association meeting jointly sponsored by EMG and ABPI expressed
the view that the currently available patient information on medicines
was inadequate to meet the needs of patients and any limitations
imposed on the sources of information would serve to exacerbate
this situation. This is contrary to the opinion expressed from
some quarters advocating controlling information by limiting the
information providers. Patient groups consider this view to be
both practically impossible and an unacceptable form of censorship.
2.9 EMG recommends this Inquiry encourage
interpretations of the existing regulatory framework that realise
the benefits of better access to medicines information for people
that seek it. A modern interpretation developed by a broad church
of stakeholders, including patients, representation from the industry,
the MHRA and other interested parties needs to ensure the information
needs of today's patients are properly taken into account throughout
the course of the conditions that they have to live with.
2.10 Members of EMG wish to make available
clear, accurate and relevant information in user-friendly formats
both in response to direct personal requests and through access
to a library of health and medicines resources available via company
websites and other gateways available to those seeking information.
It believes a modern interpretation of the current regulations
would enable this to be achieved without the need for legislative
change.
2.11 In response to desires expressed by
patient organisations with whom we have worked over recent years,
EMG is planning to facilitate a workshop, inviting all the relevant
stakeholders, the purpose of which will be to agree how to progress
and improve health and medicines information for UK citizens in
the future to better serve their requirements and assure against
any retrograde steps emanating from future changes to European
legislation.
3. PRODUCT EVALUATION,
INCLUDING ASSESSMENTS
OF VALUE
FOR MONEY
3.1 EMG welcomes the various Government
initiatives to improve the utilisation of medicines in the UK.
NICE, the Scottish Medicines Consortium and latterly the All Wales
Medicines Strategy Group have been set up as a means of assessing
the clinical and cost effectiveness of new medicines across the
UK and enabling patients to gain faster access to innovative treatments.
3.2 In practice however, Government intentions
have not yet been realised and the UK still has one of the slowest
uptakes in Europe of innovative new medicines with health outcomes
in areas such as coronary heart disease and cancer being poorer
than in other comparable European countries.
3.3 To examine the variation in medicines
uptake between the UK and other European countries in more detail,
EMG has interrogated the relevant data to produce a series of
nine case studies for specific medicines.[19]
Some, but not all, of these medicines have undergone review by
NICE that, in the majority of cases, resulted in the Institute
setting out the circumstances in which their use represented reasonable
value for money to the NHS and recommending such use. The points
below summarise some of the findings (full copies of the case
studies are available on request):
— Uptake of cancer medicines launched
in the five years from 1997-2001 ranges from 8.7-12.9% of the
average of seven major markets in Europe; uptake of new medicines
to tackle serious neurological conditions ranges from 17-23.5%.
— On average, other major European
countries treat more than twice as many patients with Herceptin®
per head of population compared with the UK, while Switzerland
treats more than three times as many patients.
— Over four times as many patients
in France and Belgium receive newer chemotherapy agents for colorectal
cancer as in the UK, three times as many in Switzerland and Italy,
2.5 times as many in Germany and Finland, and twice as many in
Norway.
— Patients with cancer-related anaemia
in the UK are the least likely to be treated with recombinant
human erythropoetin compared with other major countries in Europe,
where usage is at least seven times higher than in the UK.
— Young people with cystic fibrosis
have one of the lowest levels of treatment with Pulmozyme®,
the only licensed treatment proven to improve the clinical parameters
of the disease.
— Uptake of angiotensin-II receptor
blockers, the latest generation of medicines to control high blood
pressure, is at least half that of France, Spain, Germany, and
Italy.
— France treats almost nine times more
patients with standard therapy for Hepatitis C than the UK; on
average, other EU countries treat more than six times more patients.
— The UK spends less than any other
EU country on Photodynamic Therapy with Visudyne®, the only
proven treatment for age-related macular degeneration, the most
common cause of blindness in the over 50s. UK spend is one third
of the average use per head of population in other EU countries.
3.4 EMG has discussed these case studies
with a wide variety of interested parties including Health Ministers,
Parliamentarians, civil servants at the Department of Health and
representatives of health professional bodies and patient organisations.
In order to better understand why the uptake of new medicines
in the UK is slower relative to comparable European countries,
EMG has also facilitated discussions with local NHS organisations
at a range of levels and is in the process of sharing its findings
with the relevant stakeholders.
3.5 The reasons for slow uptake identified
in these discussions are varied and highlight that there is no
solution that can be applied to all local NHS organisations. Three
key areas that could impact on better utilisation of new medicines
and local implementation of national policy and guidance emerged
as:
— The impact of NICE evaluation of
the value of medicines to the NHS and in particular, the need
for a clear definition of what implementation of its guidance
means in practice as well as clear accountability and responsibility
for managing NICE guidance in local organisations.
— A need for dedicated and accessible
funding specifically to support innovative interventions, with
the proviso that such funding does not lead to budget distortions
in other areas of healthcare.
— A need for processes for sharing
good practice within an agreed set of criteria amongst local NHS
organisations in order to overcome the variations in patient access
to treatment that currently exist.
3.6 EMG believes the pharmaceutical industry
has a legitimate and valuable role to play, alongside NICE, the
Department of Health and other organisations to promote consistency
in access to innovative medicines between different parts of the
country and comparable access to other European countries. Our
interactions with other organisations suggest greater involvement
from the industry in ensuring implementation of guidance and thereby
improving access to medicines for patients would be welcomed and
should be encouraged.
3.7 EMG welcomes the recent appointment
to the NICE Board of an Implementation Systems Director and is
planning to facilitate a discussion group of interested stakeholders,
including NICE and the DoH, with the purpose of considering how
NICE implementation can be taken forward and better delivered
at the local level, specifically, whether the role of a local
NICE liaison officer might be a practical solution and if so,
what that role might look like. We would encourage this Inquiry
to support the need for clearly defined local accountability to
improve implementation of national policy and guidance at the
local level.
19 The case studies were developed between 2001-04
and do not include comparison with the countries joining the EU
in 2004. Back
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