Memorandum by The Association of the British
Pharmaceutical Industry (PI 35)
The Association of the British Pharmaceutical
Industry (ABPI) represents more than 80 pharmaceutical companies
in Britain engaged in the research, development, manufacturing
and supply of prescription medicines. The ABPI brings together
companies producing such medicines, whether branded or generic,
many smaller organisations involved in pharmaceutical and bio-pharmaceutical
R&D and those with an interest in the pharmaceutical industry
operating in the UK. ABPI member companies manufacture and supply
more than 80% of the medicines prescribed through the NHS and
are major exporters to countries all over the world.
TABLE OF
CONTENTS
| Summary |
1. | Introduction |
2. | Innovation in Medicine
|
3. | The Conduct of Medical Research
|
4. | Provision of Medicines Information and their Promotion
|
5. | Professional and Patient Information
|
6. | Regulatory Review of Medicine Safety and Efficacy
|
7. | Product Evaluation, including Assessments of Value for Money
|
8. | Conclusion |
| |
SUMMARY
Positive engagement between the pharmaceutical industry and
the UK health system is both necessary and desirable, on all the
dimensions highlighted by the Committee:
On innovation, the industry is the prime innovator
of new medicines. While all major companies operate research globally,
it is very much in the UK's interest to attract as much research
here as possible, and to ensure strong UK doctor and patient input
into research priorities. A quarter of the world's top 100 medicines
were discovered in Britain, and we want this success story to
continue.
The industry sponsors a large proportion of UK
medical research. New initiatives will bring an increasing volume
of clinical trials to the UK, increasing patient access to new
medicines, especially if some cost and time challenges are tackled
jointly by industry and the NHS. The industry spends £10
million per day on research in the UK, and we would like to see
this increase further.
The majority of information and in-service training
and education on new medicines is provided by the industry. Responsible,
regulated promotion is still the most effective way to get information
into the hands of prescribers, the industry is also active to
ensure comprehensive medicines information is available online
to doctors, patients and their families.
Stringent regulatory review is a cornerstone of
the process for the development of medicines. Since the majority
of safeguards are globally, not just nationally relevant, this
is increasingly an international activity, but one in which the
UK, through the MHRA and the UK-sited EMEA, has a prominent voice.
Product evaluation for cost-effectiveness is an
increasingly important activity, as the need to make difficult
choices about priorities rises. In most cases, medicines represent
an economically superior solutionearlier, less costly intervention
than hospital procedures, for example. However, the industry has
provided input to the NHS and to NICE to help reverse the continued
lower access to innovative medicines in the UK than in other leading
European countries.
All the above interactions are two-way. The NHS and its doctors,
patients and administrators have profound impact on the way the
pharmaceutical industry operates in the UK. This partnership has
helped build a UK industry that directly and indirectly employs
over 300,000 people and contributes a surplus of £3.6 billion
to the annual UK balance of trade. All the key points of contact
between the health system and the industry are subject to regulation
through UK and European laws and by mechanisms as varied as NHS
ethics committees, new medicine approval processes and promotional
codes of practice. There is always room for improvement, however,
and the industry looks forward to the dialogue with the Committee
about ways in which the two-way partnership can be further enhanced.
1. INTRODUCTION
1.1 Most people will take a prescription medicine at
some stage of their lives. Whether commonplace interventions such
as vaccination against childhood disease or an antibiotic to clear
up a painful infection, through to medicines that prevent the
rejection of transplanted organs or sophisticated chemotherapy
that improves the life prospects of someone battling cancer, medicines
are integral to health care. The gradual increases in life expectancy
and quality of life over the past 50 years, with corresponding
improvements in people's overall health, are due in large measure
to the success of modern medicines.
1.2 None of which happens by accident. It typically takes
12 years and £500 million of investment to bring just one
new medicine to the patient. And the pathway is as precarious
as it is long. For every one medicine available to prescribe,
many hundreds of thousands of molecules begin the journey. Of
the factors that determine those medicines that reach the patient,
the health needs of the population is the most important. If there
is insufficient clinical need to justify a new medicine then that
medicine will not be developed. Safety is equally a key consideration
since medicines with unacceptable safety or side-effect complications
are worthless. Regulatory authorities rigorously and independently
assess all potential new medicines for quality, safety and efficacy.
The standards they demand are becoming even higher. To surmount
the regulatory hurdle today, a new medicine must not merely be
adequate: it must demonstrate that it is at least as good, if
not better, than those already available.
1.3 The NHS Chief Executive's 2003 report said that the
increases in the prescribing of medicines "are contributing
to improvements in care and, in particular to the improvements
in survival rates for cancer and coronary heart disease".
The pharmaceutical industry is proud of what it does. Our goalto
bring to patients life-enhancing medicinesis not only necessary
but noble, and there is no reason why the industry should not
use all legitimate means to advance it. We respect the fact that
both Parliament and the public have the right to know that the
medicines they take have been thoroughly researched, independently
approved and are promoted to prescribers appropriately within
clearly laid-down rules.
1.4 Regulation is a fact of life for the pharmaceutical
industry. There can be no industry more closely policed than ours.
At every stage of a medicine's development and then, once it is
licensed, during its commercial phase, the industry and its medicines
are subject to control. So, for example, experiments involving
animals (itself a regulatory requirement since it is illegal,
for obvious reasons, to do basic safety tests on humans) are controlled
by the Home Office and its Animals Procedures Committee. Clinical
trials involving human beings must be properly authorised and
require independent ethical approval. The UK is now subject to
the EU Clinical Trials Directive which, among other things, bolsters
internationally-agreed standards of good clinical practice and
has written them into national legislation. Manufacturing is also
the subject of very rigorous inspection and legislation.
1.5 No medicine can be promoted to prescribers without
a marketing authorisation, which is not granted until the regulatory
authority has examined every line of a medicine's submission dossier,
with documents totalling hundreds of thousands of pages. Sales
and marketing activity is controlled, mainly through the industry's
own ABPI Code of Practice (like the House of Commons, the pharmaceutical
industry works well within self-regulation), and this is backed
up in legislation, notably the European Directive 2001/83/EC,
which, among other things, prohibits the promotion of prescription
only medicines directly to the public. The industry is currently
embarking on a further review of its Codes of Practice across
Europe and hence in the UK, challenging ourselves to keep our
standards high.
1.6 Medicines are regulated for both value and cost.
Increasingly, medicines must also prove their cost and clinical
effectiveness to the National Institute of Clinical Excellence
(and to similar bodies in Scotland and Wales). Prices are controlled
through the Pharmaceutical Price Regulation Scheme (PPRS) as well
as by various market pressures in an increasingly cost-aware NHS.
1.7 The terms of reference of this inquiry are broad
and themselves make the point that the industry is active across
a wide range of endeavour. This response from the ABPI, on behalf
of the industry, follows the headings in the terms of reference
point by point. In each section we seek not only to explain the
industry's approach to the subject matter in hand, but to anticipate
points that the Committee will doubtless wish to explore in this
inquiry. While we have tried to keep our comments as succinct
as possible, the sheer breadth of ground that needs to be covered
means that this submission is somewhat longer than the Committee's
guideline.
1.8 The Committee has acknowledged the contribution of
the pharmaceutical industry not only to improved health, but to
the economic and scientific output of the country. It is worth
stressing a few salient facts:
a quarter of the world's 100 most-used medicines
originated in research and development carried out in the UK;
pharmaceuticals is by far the largest contributor
to R&D in this country (£10 million every day); and
pharmaceutical companies operating here sustain
83,000 jobs directly and a further 250,000 indirectly.
1.9 Neither the industry itself, nor those responsible
for creating the environment in which it operates, can afford
to rest on this record. It is an unarguable fact that the focus
of innovation in medicines is shifting to the USA and while the
UK has been less exposed than some other European countries, such
a trend cannot be ignored. The industry is not asking for special
favours; nor should we be immune from public scrutiny. However,
there should be recognition that the influence of the pharmaceutical
industry in this country is overwhelmingly for the good. Where
the industry can get better, so we should. Where the Committee,
and Parliament more generally, is able to recognise the positive
contribution the pharmaceutical industry in the UK makes to health,
wealth and to science, so it should. No one should be in any doubt
that the benefits of having a strong and thriving pharmaceutical
industry in this country are immense.
1.10 As the Prime Minister has said: "A successful
pharmaceutical industry is a prime example of what is needed in
a successful knowledge economy. The UK's pharmaceutical industry
has an outstanding tradition and has contributed very substantially
to our economy and the welfare of our citizens".[17]
2. INNOVATION IN
MEDICINE
The UK is a world-centre for pharmaceutical research
and development.
The industry has a strong record of partnership
in collaborative research with universities that has brought benefits
to both.
Care must be taken to maintain a UK environment
supportive of R&D.
Innovation in pharmaceuticals takes many formsfrom
"wonder drugs" to steady improvements that can revolutionise
a patient's quality of life.
The output of pharmaceutical research is well-aligned
to the priorities of the NHS.
2.1 The UK has a long history of success in pharmaceutical
research and development, with 25 of the world's leading medicines
having their origins in this country.[18]
This success is due to three factors above all: historically strong
research; a strong academic research and clinical base; and a
framework that encourages investment in R&D. The recent introduction
by the Treasury of tax credits to support R&D is an example
of the Government's positive attitude towards this endeavour.
2.2 The combination of a strong history and favourable
environment means that UK pharmaceutical R&D is able to "punch
well above its market weight": only 3% (by value) of the
world's prescription medicines are sold here; yet the UK attracts
around 10% of global investment in pharmaceutical R&D. This
is more than half of the total pharmaceutical R&D investment
in Europe as a whole.
2.3. However, as figure 1 overleaf clearly illustrates,
over the past 10 to 15 years, the USA has opened up a commanding
lead in pharmaceutical R&D investment. This trend will continue
unless a favourable environment exists in the UK, including the
supply of suitably-trained scientists and removing attacks on
the industry and its suppliers by animal rights extremists.
2.4 Overall, what the pharmaceutical industry spends
on R&D has tripled in the last 10 years (over the same period
NHS spending has roughly doubled). The UK remains a world-leader
in the development of new compounds and R&D productivity is
amongst the best in the world. As a proportion of R&D spend,
the UK has one of the largest numbers of first patents filed for
new molecular entities. Such activity has a benefit not only to
medicine, but to science. No other industry sector in the UK comes
close to matching pharma's R&D spend, which represents a quarter
of the overall UK total. We are the country's largest employer
of science graduates: 27,000 employees are directly engaged in
R&D activities.

2.5 As figure 2 shows, the pharmaceutical industry funds
more healthcare-related research in the UK than every other funder
put togethersix times as much as the Department of Health;
five times as much as medical charities; eight times as much as
the MRC.[19]

Collaborative research
2.6 The pharmaceutical sector is also a significant supporter
of academic research. Last year ABPI companies funded over 1,100
collaborations in 80 UK institutions. The Lambert report,[20]
an independent review of business-industry links, commissioned
by HM Treasury, noted that the UK pharmaceutical industry is an
exemplar not just in research intensity, but also in its approach
to collaborative research with universities.
Case study: Dundee Kinase Consortium
Six pharmaceutical companies, GlaxoSmithKline, AstraZeneca,
Pfizer, Boehringer Ingelheim, Merck & Co Inc, Merck KGaA (German
company) have established a consortium collaborating with the
University of Dundee to support the Division of Signal Transduction
Therapies, led by Prof Sir Philip Cohen. The funding, worth £15
million over five years, brings:
Benefits for Industry
Access to know-how from >70 world class scientists.
Screening facility vs panel of kinases.
Electronic information storage/transfer. Production
of proteins and biological reagents.
Custom synthesis of antibodies.
Information on new drug targets.
Benefit to the University
Access to the most selective chemical tools.
Joint publications in top journals.
Intellectual direction from industry.
Increased efficiency of process through semi-industrialisation
and sharing best practice.
Meeting NHS needs
2.7 The pharmaceutical industry's input into research
and development should not therefore be in any doubt. It is legitimate,
however, to ask two questions about all this effort: is the end
result genuinely innovative medicines; and, secondly, how aligned
is pharma's research effort to health priorities, and specifically
to the priorities of the NHS?
2.8 The history of medicines research is punctuated by
landmark discoveries in human health. The discovery of AZT by
Wellcome in 1987, for example, was the moment when humanity first
began to turn the tide of HIV/AIDS. The fact that we can now slow,
or even reverse, the progression of cancer, or bring relief to
people suffering from the debilitating effects of mental illness,
is all due to breakthroughs made by the pharmaceutical industry.
The almost complete disappearance in the UK of childhood diseases,
which used to kill and cripple, could not have been achieved without
vaccines the industry has developed.
2.9 Death rates from heart disease have fallen by more
than 40% in the UK over the past 10 years alone. A review of the
relevant literature has shown that about 40% of this reduction
is due to treatment including secondary prevention, use of thrombolysins
(clot-busters), treatment of angina and treatment of hypertension.
The use of statins to reduce cholesterol levels is estimated by
Government to be saving 6,000 lives a year.
2.10 Nevertheless there is still no "cure"
for many cancers, no "cure" for Alzheimer's disease,
no "cure" for acute psychoses, and no "cure"
for arthritis. These can come in time if the pharmaceutical industry
funds the necessary research and development.
2.11 In the meantime, incremental (and important) advances
are being made. The industry is working closely with the medical
profession in chronic disease managementemerging as one
of the most important priorities for the NHS. Conditions such
as diabetes, asthma and arthritis cannot (at the moment) be eliminated.
However, the quality of life of people with these conditions can
be substantially improved, for example, by medicines that have
fewer side-effects or provide better symptom control or that are
easier to take (which in turn improves compliance). Table 1 below
gives a number of examples where later medicines in a class have
provided innovative advances to patients over and above those
of the first medicine of their type.
2.12 We are also now discovering why different patients
respond differently to different medicines (the so-called "pharmacogenetic"
effect). This knowledge is being used increasingly to choose the
right medicine for the right patient and to discover even more
specific therapies.
Table 1
BENEFITS OF INNOVATION
|
First to Market | Follower
| Class | Benefit of Follower
|
|
Accolate | Singulair | Leukotriene modifiers
| More convenient dosing (once a day vs twice a day
|
Beconase | Flixonase | Intranasal steroid
| Potency; fewer adverse events |
Zovirax | Valtrex | Herpes anti-viral
| More convenient dosing |
Mevacor | Lipitor | Cholesterol lowering
| Potency |
Tagamet | Zantac | H2 antagonists
| More convenient dosing; fewer drug interactions
|
Cozaar | Diovan | Angiotensin Receptor Block
| Potency |
|
2.13 The research output of the pharmaceutical industry
is well-aligned to the priorities of the NHS. Some 43% of new
medicines introduced over the past 10 years by the industry are
designed to support four of the NHS's key health priorities
cancer, coronary heart disease , mental health and illnesses of
the elderly.[21]
Table 2
MEDICINES LAUNCHED OVER PAST 10 YEARS
|
Therapy | Number launched
| Proportion of total new launches
|
|
Heart disease | 111
| 14% |
Cancer | 48
| 6% |
Mental Health | 119
| 15% |
Elderly conditions excluding the above
(eg Type 2 diabetes, arthritis)
| 63 | 8%
|
|
2.14 Hence, in the area of innovation in the UK, the
NHS and the pharmaceutical industry have essentially a common
causean ambitious role for the UK in researching and developing
both "breakthrough" and "better performance"
medicines.
3. THE CONDUCT
OF MEDICAL
RESEARCH
The UK is a world centre for clinical research
which has helped to develop major innovative advances in medicines.
Clinical trials are conducted ethically and safely
and to the highest standards of Good Clinical Practice.
All trial data are provided to the regulatory
authority for its independent assessment.
Publicly-funded research benefits from collaboration
with industry.
Government action is required, however, to ensure
that the cost of clinical research in the UK is not prohibitive
or it will be driven abroad.
3.1 The UK is acknowledged as a world centre for clinical
research involving medicines. The basis of this success is collaboration
between the industry, the NHS and academic institutions. And the
contribution of industry is vital. Industry funding of research
in the UK has helped many research units within NHS Trusts to
continue functioning at a high level. Industry sponsored clinical
trials made up about 40% of all applications to the London Multi-Centred
Research Ethics Committee in 1997-2000, easily the largest grouping
of research applications involving clinical trials.[22]

3.2 In April 2000, the Prime Minister set up the Pharmaceutical
Industry Competitiveness Task Force (PICTF), a joint Government/Industry
task force examining the competitiveness of the UK with regard
to the pharmaceutical industry. One of its work streams related
to clinical research. The group continues to meet to foster collaboration
between the industry and the NHS.[23]
Among its outputs is a partnership agreement[24]
published in March 2002. It sets out guidance for partnership
between the NHS and industry both for commercially sponsored research
and the role of industry in supporting non-commercial research.
3.3 Clinical trials in Britain will receive a major boost
from the recent establishment of the UK Clinical Research Collaboration
(UKCRC). The new body aims to speed up the development of new
medicines from the laboratory to the patient by expanding the
number and range of clinical trials.[25]
It has been developed as a direct result of recommendations from
reports of the Biosciences Innovation and Growth Team[26]
and the Academy of Medical Sciences.[27]
The ABPI welcomes the fact that the pharmaceutical industry is
recognised as a partner in the UKCRC and looks forward to working
to improve the competitiveness of the UK in global medical research
for the benefit of patients, the NHS and, ultimately, the industry
in the UK.
The Development Process
3.4 Following discovery and laboratory research, new
chemical entities (NCEs) undergo toxicological and animal testing.
Animal research is conducted under strict regulation and licensing
by the Home Office and is only conducted when there is no practicable
alternative available. These pre-clinical phases take about three
years but with a high attrition rate.
3.5 Only those compounds that have a positive benefit/risk
ratio go into clinical studies. These begin with healthy volunteer
studies (phase I) involving people, usually under 45, during which
data on how the medicine works and its effects on human systems
are collected. Some early safety data and information about likely
dosage are also collected.
3.6 If the benefit/risk ratio remains positive and there
have been no severe adverse effects, the medicine will now be
given to patients with the disease it has been designed to treat
(phase II) to determine that the medicine works as expected. If
this is confirmed and there are again no major safety issues,
the medicine is used in large phase III trials of up to several
thousand patients to determine its efficacy (that it works) and
safety. A clinical trial will often have two arms, one containing
the investigative medicine and the other a comparator, either
a placebo or current best treatment. Patients entering the trial
are randomly allocated to one arm or other. In a single blinded
trial, the patient doesn't know which arm they are in and in a
double blinded trial, neither the investigator nor the patient
knows, thus eliminating bias. At the end of the study, the blind
is broken and the data analysed. If the outcome of all the clinical
studies together is positive with a good safety record, then a
marketing authorisation is sought from the relevant regulatory
authorities. At the end of the clinical trial process, several
thousand patients will have volunteered to take part in the clinical
trials.
The Governance of Medical Research
3.7 All clinical studies involving medicines are conducted
ethically and safely and the high standards of Good Clinical Practice
(GCP). Standards are international, based upon the Principles
and Guidelines for Good Clinical Practice (ICH GCP) developed
by the International Conference on Harmonisation and launched
in 1997.[28] Both the
ABPI and the UK regulatory authorities are fully signed up to
the standards and there is little or no chance of a product being
licensed if its trials have not complied with them. Before 1997,
other guidelines were in place, including those developed by the
ABPI itself.
3.8 On 1 May, 2004, the UK implemented the European Clinical
Trials Directive, which introduced in the UK the Principles of
ICH GCP into legislation.[29]
This means that all clinical trials, both commercial and non-commercial,
covered by the Directive will be performed to an equally high
standard.
3.9 The Directive means that all industry trial protocols
will be scrutinised by both the MHRA and, as previously, an independent
ethics committee before approval will be given. In addition in
the UK, trials involving secondary care and many involving primary
care also have their protocols assessed within the relevant NHS
Trust. The timelines for scrutiny are laid down in the legislation
for the MHRA and ethics committees but not for the NHS Trusts,
which have now become the major time-limiting factor in clinical
trial start-up. Delay in the NHS Trust process makes the UK less
competitive in comparison with its European neighbours. As a result,
the ABPI and Department of Health jointly launched a Model Clinical
Trial Agreement (MCTA) in January 2003 with the specific aim of
speeding up the contracting process at NHS Trust level and thus
speeding up start-up times for trials.[30]
3.10 The ABPI has recognised for many years the importance
of publication of clinical trials. In 1996, the ABPI published
its guideline on Good Clinical (Research) Practice and stated:
"The investigator must agree a publication policy with the
sponsor before the start of the study". The Model Clinical
Trial Agreement, published by the ABPI and Department of Health
contains a section on publication of the trial and makes this
a contractual duty.
3.11 In May 2003 the ABPI launched its Clinical Trial
Register (https://www.cmrinteract.com/clintrial), which
is a voluntary register of completed phase III trials involved
in a marketing authorisation application three months after launching
the new medicine in its first major market. A number of individual
pharmaceutical companies have also announced proposals to make
public details of their clinical trials.
3.12 In a small minority of cases, standards full below
those required. The ABPI has been at the forefront of prosecution
of research misconduct in the UK. Since 1988, it has reported
26 doctors to the General Medical Council (GMC) for research misconduct
and 25 of these have been found guilty of serious professional
misconduct and about half have been erased from the Medical Register.
The cost of research
3.13 The UK is one of the most expensive places, in the
world, to undertake research. An international annual assessment
of cost comparisons of clinical trials, FastTrack for 2002, showed
that of our major competitors, the UK was second most costly in
both the trials monitored.
3.14 These facts seriously reduce the competitiveness
of the UK. The key factors for a company in placing its research
are the speed, quality and cost of the research. The Clinical
Trials Directive has had a positive impact with regard to speed
in the UK as the MHRA is one of the most efficient regulatory
authorities in Europe for processing clinical trial applications
and plans to approve 80% of its applications within 30 days (14
days for healthy volunteer studies). As outlined above, the key
factor in timing is now NHS Trust approval. Equally, government
action is required to ensure that the cost of clinical research
in the UK is not prohibitive with regard to the application of
general overheads and payment for standard care.
Research and Paediatric Medicine
3.15 One of the priorities for the UKCRC, referenced
above, is children's medicines. Millions of children receive medicines
every day that are safe and effective. But many older medicines
have not been tested on children, although experience over many
years provides a sound evidence base for their continuing and
safe use. Children may respond differently from adults to medicines
so it is necessary to conduct proper clinical trials in children
of different ages.
3.16 For many medicines, it would be ethically inappropriate
to carry out experimental trials in children of different ages
from new born babies to toddlers to teenagers, before its effect
is well established in the more robust adult population. Parents
have been understandably reluctant to allow their sick child to
participate in the clinical trial of a medicine that is, to a
degree, "experimental". The UK-based pharmaceutical
industry, through the ABPI, has been at the forefront of trying
to improve the situation.
3.17 The pharmaceutical industry is the leading sponsor
of UK clinical trials for children.[31]

3.18 The introduction of a new European Regulation on
Paediatric Medicines in 2006 will require more medicines to be
licensed for use in children. This will mean that more clinical
trials will need to involve sick children in order to ascertain
the safety and efficacy of new medicines that will have potential
benefit for those children. The pharmaceutical industry will inevitably
fund the majority of paediatric trials and we therefore welcome
the principle of incentives in the draft regulation.
3.19 In the UK, paediatric centres that are experienced
in carrying out clinical trials in children are at present few
and far between. Although paediatricians are well versed in managing
the clinical and psychosocial problems that children have, and
have an understanding of the difference in physiology between
children and adults, some of these potential investigators may
be inexperienced in running a clinical trial and there may be
a lack of necessary resource and staffing. The pharmaceutical
industry is keen to work with the Government and regulatory authorities
in developing a better research environment for children.
Clinical Pharmacology
3.20 In the mid-1990s, the ABPI recognised that there
was an increasing shortage of clinical pharmacologists in the
UK, who are vital in the early clinical development of a medicine.
The UK has traditionally led the world in clinical pharmacology
researchhalf of European healthy volunteer studies are
done in the UK. Following negotiations involving the Department
of Health, the Royal College of Physicians of London and the ABPI,
a joint training programme has been set up in Clinical Pharmacology
with the industry partner funding half of the trainees' salary.
So far, 20 trainees are undertaking or have completed the course
at a total cost to industry of over £2 million. Two of the
supported trainees are in Paediatric Clinical Pharmacology.
4. PROVISION OF
MEDICINES INFORMATION
AND THEIR
PROMOTION
Information and promotion are necessary and valid activities
for the pharmaceutical industry:
Informing doctors of new medicines and new indications
for existing medicines for the benefit of patients.
Ensuring that health professionals are aware of
the medicine dosage, side effects etc, allowing them to optimise
their use of medicines for the benefit of patients.
Encouraging value for money and better patient
outcomes.
Strictly regulated by the ABPI Code of Practice.
4.1 Medicines information and promotion are strictly
regulated by UK and European law as well as by the ABPI's own
Code of Practice. Promotion of prescription only medicines (POMs)
to the general public is prohibited in the UK. The provision of
accurate information through marketing to health professionals
is an essential element of a successful pharmaceutical business
and is conducted in an ethical, responsible and professional manner.
4.2 Doctors, pharmacists and other health professionals
need to keep up to date with scientific understanding and new
developments in treatments to ensure that patients can benefit
from advances. Pharmaceutical companies know more about their
own products than anyone else, so the industry has an important
role to play in providing information for prescribers and dispensers,
including about potential side effects to help ensure their proper
use of medicines.
4.3 A recent Taylor Nelson study[32]
of 205 GPs showed that family doctors consistently rated representatives
amongst their top three sources of information:
First as most effective source of awareness of
new medicine information.
First as most effective source supporting educational
or medical meetings for GPs.
Second most effective source of medicine information
(withdrawals, dosage etc).
Third most effective source of clinical trial
results.
4.4 The ABPI Code of Practice is drawn up in consultation
with the British Medical Association, the Royal Pharmaceutical
Society and, importantly, the Medicines and Healthcare Products
Regulatory Agency. It reflects the legal requirements controlling
the advertising and promotion of medicines and extends well beyond
them.
4.5 It is a condition of membership of the ABPI that
companies abide by both the letter and the spirit of the Code.
Observation of the Code is a priority for pharmaceutical companies.
Any breaches have a damaging impact on the company concerned in
terms of both sanctions and company reputation. Companies also
have to divert valuable resources, often over several months,
into investigating every complaint in detail.
4.6 Self-regulation has proved effective for well over
40 years. The industry's own vigilance in observing the Code results
is reflected in the fact that nearly half the complaints made
to the Prescription Medicines Code of Practice Authority emanate
from pharmaceutical companies themselves. The overall number of
complaints (upheld or not) is some 125 a year over the past decade.
This is a modest level, given the scope of the Code and the fact
that it covers relationships and activities with more than 90,000
GPs and hospital doctors and 40,000 pharmacists as well as other
health professionals.
4.7 The pharmaceutical industry worldwide holds the ABPI
Code of Practice in high esteem and actively promotes its use.
In the UK the ABPI and its member companies routinely explain
to health professionals how the Code operates and welcomes comments
on how it could be improved. The ABPI is publishing in September
2004 guidance notes on the Code for health professionals that
will be distributed to all Primary Care and Hospital Trusts.[33]
4.8 All national codes in Europe are currently being
reviewed by the European Federation of Pharmaceutical Industries
and Associations (EFPIA). As part of this the ABPI is carrying
out its own review of the Code and its operation. This will involve
external consultation and the conclusions of the Health Select
Committee inquiry will be taken into account.
Industry representativestraining and qualification
4.9 There are approximately 8,000 pharmaceutical company
medical representatives operating in this country, a number which
has remained fairly stable over the past five years. The medical
representative plays a key role in promoting medicines to health
professionals. Representatives traditionally have scientific or
health-related backgrounds, and receive intensive training within
their own company. All training material has to be approved on
behalf of the company by an employee who is a registered doctor
and one other senior person to ensure that it complies with the
ABPI Code of Practice.
4.10 Company representatives have to pass the ABPI medical
representatives exam within two years of being employed in such
a role. The ABPI course and exam covers:
Basic physiology and anatomy.
In-depth education on their relevant disease area.
Understanding of the NHS and how it operates.
Visiting health professionals
4.11 Health professionals need to balance the responsibilities
of dealing with patients' needs together with administrative and
managerial duties. In addition they need to set aside time to
keep up to date with the latest medical innovations. Information
learnt from visits by medical representatives helps health professionals
to be aware of the latest changes in treatment regimes in a very
time-efficient manner.
4.12 The number of visits by a representative to a doctor
during any year is controlled by the Code and should not normally
exceed three. The primary care medical representative calls on
GPs, usually through a well-managed appointment system. This may
sometimes be with a single GP or a larger group of doctors. Nurses
are increasingly included in such meetings as their involvement,
including prescribing decisions, has grown in recent years.
4.13 During the discussion the representative will use
detailed material to explain the appropriate use of the medicine,
provide data on clinical trials and relevant comparative information.
Promotional material must also contain prescribing information
which states the cost of the medicine and be consistent with the
medicine's marketing authorisation. All material is checked for
factual accuracy and must comply with the Code.
4.14 Secondary care representatives use material especially
designed for this level of care. A discussion about cost benefit
or cost effective data allows health professionals to quantify
the potential effect of a new or different medicine on their budgets.
4.15 The Code permits promotional aids to be given to
health professionals provided they are both relevant to the recipient's
work and inexpensive (costing no more than £6).
Wider promotional activities
4.16 Companies regularly advertise in medical journals
to create awareness of a medicine and its role within effective
therapy. All information and comparisons must be accurate, balanced,
objective and unambiguous. They must not mislead and must be capable
of substantiation. Direct mailing is used, often to inform the
profession of changes to prescribing information, new medicines
or new clinical data.
Further improvements
4.17 In providing information to the medical profession
it is becoming increasingly clear that:
there is greater pressure than ever on doctors'
workloads;
the benefits that increased prescribing can bring
in better patient health and lower overall costs to the NHS need
more emphasis alongside the steady feedback to doctors on prescribing
costs alone; and
more efforts are also required to widen patient
access to many newer medicines.
The pharmaceutical industry believes it has a powerful role
to play in partnership with the NHS in delivering better healthcare
for patients.
5. PROFESSIONAL AND
PATIENT EDUCATION
No one knows more about a medicine than the people
who discovered, developed and made it available.
Our principal objective is to provide factual
information for professional and patient education to achieve
the best outcome for patients.
The UK-based pharmaceutical industry funds more
than half of all further education and training for NHS doctors.
Industry collaboration with patient groups under
agreed "rules of engagement" can result in real benefits
for patients.
Patients' own search for more information about
their medicines could be met in part by industry, given some relaxation
of current communication restrictions.
Information Requirements and Offerings
5.1 Professional and patient education is vital to achieving
the best outcome for patients from the most appropriate use of
medicines. As in other areas, in the provision of education and
information, the pharmaceutical industry operates in a highly
regulated environment.
5.2 Pharmaceutical companies are required to provide
information about their medicines, on request, to health professionals
under the terms of the ABPI Code of Practice. Companies are obliged
to have a "scientific service responsible for information"
(Clause 13 of the Code). Over the course of a year, large pharmaceutical
companies in the UK each deal with between 15-26,000 requests
for information directly from health professionals and administrative
staff and some 12,000 indirectly through sales representatives.
This obligation to provide information continues beyond the end
of data and patent exclusivity.
5.3 The industry provides information about medicines
in a variety of other ways as well. It contributes to both the
British National Formulary and the Monthly Index of Medical Specialities,
the two most important and commonly used UK reference works on
licensed medicines. The industry also supports the development
of the Medicines Compendium and its electronic edition, which
provides, via the internet (www.medicines.org.uk), comprehensive,
up-to-date, government-approved technical data on individual medicines,
including safety and dosage information, and patient information
leaflets on individual medicines. This service delivers over 2.5
million documents about medicines per year to health professionals
and to members of the public. The electronic Medicines Compendium
is being incorporated into the National Electronic Library of
Medicines and is widely used throughout the NHS as a primary and
definitive source of medicines information.
5.4 Medicines Guides produced by the industry, both electronic
and in print, are now being developed as additional sources of
information for the general public via NHS Direct.
Professional Education
5.5 Professional education is largely provided through
regulated medical education programmes conducted in various partnership
activities between the industry, academia, health professionals
and their professional bodies, medical publishers, the Government
and the NHS. Such education is directly supported by the industry,
whether by donation, unrestricted educational grants or partnership
programmes, and is of considerable value to the NHS. Without this
high quality educational support from the industry, an additional
heavy burden will be placed on NHS resources.
5.6 In fact, the UK-based pharmaceutical industry funds
more than half of all further education and training for doctors
in Britain and of a quality standard at least as good as non-sponsored
education.[34] This provides
an essential role in helping to build a culture of innovation
and medical knowledge to help the NHS deliver a modern health
service. Internationally, the industry supports symposia that
bring together leading experts from the UK with their counterparts
around the world.
Patient Education
5.7 The industry is prohibited from providing information,
directly to patients, outside the relevant clause in the Code
(Clause 20). This does permit the tightly regulated and formulaic
information available in the summary of product characteristics,
the patient information leaflet inserted in the pack and information
on the packaging of the medicine itself.
5.8 However, under current legislation and guidelines,
pharmaceutical companies can run, partner or sponsor certain kinds
of regulated and strictly non-promotional public health education
and disease awareness activities. This helps make people aware
of the availability of treatment options for a condition and advises
them to seek the advice of a health professional. Any such communications
cannot speak solely about the availability of a specific medicine
or encourage patients to ask their doctors for a specific brand.
Guidelines agreed between the industry and the MHRA mean that
these communications must clearly have public or patient education
about a disease and treatment options for it as their objective.[35]
5.9 This kind of education usually involves partnership
with public and or voluntary sector bodies and informal but wide
consultation with interested stakeholders. Successful public health
education and disease awareness programmes in the UK have covered
subjects such as: allergies, cancer, cardiology, central nervous
system diseases, dermatology, epilepsy, glaucoma, men's health,
multiple sclerosis, respiratory disease, urology and women's health.
The ABPI has produced a CD ROM with examples of such successful
collaborations. A copy is being submitted to the Committee. Patients
often benefit through these disease awareness programmes by having
previously unidentified and sometimes serious conditions diagnosed
and treated in good time.
Working with Patient Groups
5.10 Relationships and partnerships with patient groups,
voluntary sector and other stakeholders are governed by the prohibition
in UK law on advertising prescription only medicines to the public.
Furthermore, they are conducted in accordance with strict published
guidelines or operating principles, such as the Long-term Medical
Conditions Alliance's guidelines for voluntary health organisations
working with pharmaceutical companies.[36]
Many pharmaceutical companies also have in-house rules for working
with patient groups. Above all, companies wish to avoid either
the reality or the perception of improper or undue influence.
5.11 Pharmaceutical companies and patient groups share
a common interest in wanting patients to receive the most effective,
evidence-based treatments, and to do so without unnecessary delay.
It is desirable for patient groups and pharmaceutical companies
to work together towards this end and to educate and inform their
members or a wider public, about particular chronic medical conditions,
their prevention, and new developments in therapy. This co-operation
can take the form of funding by way of donation or unrestricted
educational grant, administrative and technical or logistical
support, advice and consultancy in specific areas of business
or healthcare expertise etc. Two examples are given below.
Arthritis Care has been supported by Pfizer in raising awareness
of the availability of treatments and methods for the management
of arthritis with materials which are comprehensive and go well
beyond the availability of medicinal interventions, looking at
diet and lifestyle etc. A "state of the nation" report
to quantify and provide evidence of the extent of the problem
of arthritis in the UK and a programme to assist in the implementation
of NICE guidelines have also been delivered.
Eleven pharmaceutical companies have worked with CancerBACUP
over the last year to utilise their oncology representatives to
help raise awareness of the new CancerBACUP information and support
line phone number by distributing cards and posters to oncology
centres across the UK.
Working with the NHS
5.12 The relationship between the NHS and the pharmaceutical
industry is constantly changing. To support these changes teams
within pharmaceutical companies work with NHS management to develop
NHS partnership activities.
5.13 The ABPI and the NHS Alliance have recently produced
a suggested framework for joint working between the pharmaceutical
industry and the NHS. Among its provisions are:
The interests of individual patients should be
protected.
Clinical aspects of care should be under NHS control,
although industry input is legitimate and offers benefits to patients
and the NHS.
Joint working should not be seen as an endorsement
or promotion of a specific medicine or technology.
5.14 The framework also includes a selection of case
studies of successful partnership working in a variety of different
areas, ranging from educational support to the implementation
of National Service Frameworks.[37]
A copy is being supplied to the Committee but an example is extracted
overleaf.
http://medicines.mhra.gov.uk/inforesources/publications/gn26.pdf).
www.lmca.org.uk/docs/pharmgds.htm.
In 2003 Lilly launched the "Well-being Support Programme"
as a pilot scheme for mental health services in the UK. Organisers
from various PCTs will seek to enrol a total of 1,200 patients
over two years at eight sites across the UK. The programme will
aim to improve the lifestyles of patients suffering with a serious
and enduring mental illness. These objectives comply with the
recommendations made by the National Institute for Clinical Excellence
and the NSF for Schizophrenia. Lilly's programme addresses these
issues by concentrating on three key areas:
Lifestyle assessments and interventionseg
smoking, weight management and physical activity.
Side effect assessment and managementeg
understanding the impact of side effects and helping patients
manage them.
Physical health assessmentproviding a basic
physical health check including blood pressure, weight, height
and pulse rate.
The outcomeby the end of 2003, eight national sites
had enrolled over 1,000 patients. Each trust has set up groups
for weight management and physical activity. Over 100 patients
are now benefiting from these groups each week.
Areas for development and improvement
5.15 The Government recognises that better health outcomes
are generated when patients are entrusted with responsibility
for their own healthcare. Through initiatives such as the Expert
Patient Programme or NHS Direct, it is promoting policies that
focus on increasing patient choice and advancing the self-care
agenda. At the same time, the desire of patients for reliable
and balanced information about their health needs and the options
available for treatment has never been greater. Health-related
subjects are at the top of the list of the most searched for items
on the Internet. It is in this context that the debate about whether
the pharmaceutical companies should be allowed to communicate
directly with patients becomes significant.
5.16 The ABPI's Informed Patient Initiative Task Force,[38]
believes that pharmaceutical companies could help patients be
better informed if current restrictions on industry providing
scientifically reliable information on healthcare, medicines and
treatments directly to patients were relaxed.
5.17 This position is supported by many patient groups
and is consistent with the position of the MHRA on the provision
of health information to consumers. The UK government does not
support direct to consumer advertising of prescription medicines
but is supportive of the provision of information to patients.
This shows that there is common ground between regulators, Government,
and industry.
5.18 An opinion survey conducted by MORI[39]
last year asked the general public if they thought it was valuable
to have a range of different types of information about medicines
from different sources. An overwhelming 81% agreed with the statement.
5.19 There are still understandable concerns about the
regulation of patient information on the Internet. The Times
reported (3 August 2004) a study warning that thousands of
cancer patients are risking their health by following the advice
of websites promoting bogus cures.[40]
The industry could play an important role here, working in conjunction
with the regulators, health professionals and patients.
5.20 This greater public demand for information about
their health is also reflected in increasing coverage of healthcare
issues by the press and broadcast media. Everything that the industry
says to the media about medicines is governed by the Code. The
media has a genuine interest in reporting health news and producing
features on healthcare and related advice. However, editorial
control rests with the media organisations and companies have
no control over final headlines, content or slant.
5.21 Given the above, a key issue facing the industry
is how best to legitimately (and legally) participate in the healthcare
information revolution. Industry and Government are therefore
in active discussion to explore ways to improve public access
to good quality information on licensed medicines.
5.22 For example, within the NHS Strategy Document "Pharmacy
in the FutureImplementing the NHS Plan", the Government
has established a joint task force to lead the implementation
of a national strategy on partnership in medicine taking. There
is pharmaceutical industry representation on the task force and
its working groups. For the first time last year this partnership
supported a very successful "Ask About Medicines Week"
campaign for the general public. The ABPI and individual pharmaceutical
companies participated in this event, which will be repeated later
this year (November 1-6, 2004).
5.23 We would support changes to allow pharmaceutical
companies to communicate scientifically reliable information directly
to the ultimate consumers of its medicines and would welcome the
opportunity to explore this in further work with regulators, policy
makers and other stakeholders. No one knows more about a medicine
than the people who discovered, developed and made it available.
6. REGULATORY REVIEW
OF MEDICINE
SAFETY AND
EFFICACY
The pharmaceutical industry operates within one
of the most complex and stringent regulatory frameworks of any
industry.
Good communication between regulators and companies
is essential to ensure the regulatory system is efficient and
effective.
Companies are legally required to monitor continually
the use of a medicine throughout its lifetime to maintain a positive
benefit/risk balance.
Future funding models for the MHRA must ensure
that the agency can continue to operate as a European Centre of
Excellence.
Regulatory Framework
6.1 Public health and medicine safety are important issues
around the world. Governments have responded by placing requirements
on manufacturers to obtain marketing authorisations before placing
medicines on the market and to monitor them closely thereafter.
6.2 All aspects of activities in these areas are tightly
regulated and legally controlled, and the European and international
regulatory framework is constantly updated to reflect new scientific
and medical progress. The amount of pharmaceutical regulation
has increased significantly over the past 20 years with greater
international exchange of medicines information to increase the
protection of patients.
6.3 The pharmaceutical industry, medical community, patients
and government all have a common interest in ensuring that the
regulatory system in the UK is transparent, efficient, meaningful
and robust, and bases its decisions on a high standard of scientific
evidence. The aim should be to regulate effectively but efficiently:
over-regulation is a disadvantage to both to patients and industry.
The regulatory system should provide timely access for patients
to effective medicines, while ensuring patient safety and stimulating
research into new treatments.
Marketing Authorisation Application
6.4 Before a company can market a medicine in the UK,
it must be approved by expert committees within the Medicines
and Healthcare Products Regulatory Agency (MHRA) or the European
Medicines Evaluation Agency (EMEA). Before a marketing authorisation
is issued, the agencies will carry out close scrutiny of all the
technical reports that must be generated by a pharmaceutical company
during the development of the medicine. They will also review
the proposed manufacturing methods, quality control procedures
and evidence of pharmacological activity, clinical safety and
efficacy.
6.5 The average regulatory submission for a new medicine
consists of several hundred volumes of technical and scientific
reports and data, including details of animal research, clinical
trials and manufacturing processes.
Role of Independent Experts and Industry in the Provision of
Advice
6.6 The MHRA is assisted by advisory committees in making
licensing decisions and in reviewing the safety of marketed medicines.
It is in the interest of all stakeholders to make sure that the
highest level of medical and scientific expertise and excellence
is available to the MHRA through these committees.
6.7 There is, however, only a limited pool of experts
in any given area at any given time. Industry seeks their expertise
during the development process for a new medicine and the MHRA
benefits from their advice during the regulatory assessment. Consequently,
it is essential to have in place a robust, transparent and effective
system to avoid any potential conflicts of interest for experts
in relation to a specific medicine. The MHRA operates just such
a system, whereby committee members are subjected to a high level
of transparency and rigorous declaration of personal interest,
to ensure that their expert scientific opinion is independent
and unbiased. Independent experts with a declared personal interest
in a particular pharmaceutical company are excluded from assessments
involving that company's medicines.
Financial Structure of the MHRA
6.8 The Evans-Cunliffe report[41]
recommended that the full cost of the then Medicines Directorate
should be charged to the pharmaceutical industry. Therefore, the
Medicines Control Agency (the predecessor of the MHRA) was established
as a Trading Fund that had to be self-sufficient and recoup its
costs through fees charged to the industry for its assessment
and control activities. The pharmaceutical industry has no choice
but to pay the fees levied by Government.
6.9 The ABPI is supportive of the MHRA being properly
funded so that it can operate efficiently and effectively as a
centre of regulatory excellence in Europe. There are sufficient
checks and balances in place to ensure independence from industry.
Fee levels are set by the Treasury, following public consultation,
and are detailed in the relevant UK statutory instruments.[42]
However, the pharmaceutical industry has asked for greater transparency
from the MHRA on how income from fees is allocated. This is particularly
important since the merger of the MCA and Medical Devices Agency,
as most of MDA's activities were previously funded by the Government.
Fees for the control of medicines should not subsidise activities
related to medical devices.
6.10 The industry would welcome any proposal to review
the financing of the MHRA if this would help dispel any perception
of undue influence.
Post Marketing Authorisation Phase
6.11 If a medicine is approved and obtains a licence
to be marketed, this does not mean that the assessment of the
medicine is finished. It marks the beginning for the applicant
company of a legal obligation continuing throughout the lifetime
of the medicine to provide the MHRA with information about the
medicine both at regular intervals and on an ad hoc basis. The
benefit/risk assessment of a medicine is a continuous process.
6.12 At the time of approval there will be extensive
clinical data on the use of the medicine. However, companies have
pharmacovigilance systems in place to monitor and assess the safe
use of the medicine in the wider population after its launch and
risk management plans to deal with any problems.
6.13 Newly approved medicines and significant changes
to existing medicines are subject to intensive monitoring by the
MHRA as part of the Committee on the Safety of Medicines (CSM)
Yellow Card/Black Triangle scheme. This scheme allows rapid monitoring
of potential new risks as medicines become more widely used in
patients. The CSM is currently considering the introduction of
direct reporting by patients of side effects through the Yellow
Card scheme. Whilst the ABPI supports any improvements to strengthen
the scheme, the reporting of side effects by patients without
validation by a health professional could inundate the MHRA with
reports of side effects that all require validation by the MHRA,
and make accurate signal detection of actual ADRs difficult. Patient
reporting has been introduced in the US, but required a significant
increase in resource at the FDA in order to collect, analyse and
validate the increased numbers of reported side effects.
6.14 Pharmaceutical companies and the MHRA continuously
monitor Adverse Drug Reaction reports which companies submit expeditiously
to the MHRA and also summarise regularly in Periodic Safety Update
Reports (PSURs) submitted to the MHRA for in-depth review. Changes
to the approved product information or labelling have to be based
on evaluated scientific evidence, which involves open interaction
between the relevant parties. The aim of this is to ensure that
the medicines are used as safely as possible, without restricting
access to patients who could benefit from the medicine. The requirement
for pharmacovigilance is embodied in the pharmaceutical legislation
and there are severe penalties for non-compliance. MHRA also conducts
regular inspections and has enforcement powers if serious non-compliance
is found.
Communication between Industry and Regulatory Authorities throughout
the Lifecycle of a Medicine
6.15 There are clearly defined legislative requirements,
which necessitate communication, dialogue and the submission of
data from industry to the MHRA during the life-cycle of a medicine.
Such regular dialogue is in the public interest to ensure that
effective and safe new medicines reach the patient as quickly
as possible. It is essential that this integral part of the regulatory
framework is continued throughout the various regulatory processes,
including pharmacovigilance.
6.16 It takes an average of 12 years to develop a new
medicine and various issues of a technical or scientific nature
might arise during this process where written guidance is not
available. It is important to ensure that the right development
programme is carried out to enable registration of safe and effective
new medicines in the most efficient way and avoid unnecessary
clinical trials or delays in getting new medicines to the patients.
6.17 During the regulatory review of a new medicine,
or a change to an existing medicine, there is an on-going dialogue
between the applicant company and the MHRA. The applicant company
explains the data, provides clarifications and answers questions
based on the scientific evidence provided. Through such dialogue,
the MHRA is able to make decisions on the safety, quality and
efficacy of the medicine based on the totality of the evidence
available and the proposed usage.
6.18 Good communication channels between the MHRA and
the company are also essential when the MHRA requires information
from companies, often at very short notice (eg the safety review
on TSE[43]).
6.19 Input from the industry and other stakeholders during
the drafting of guidelines on issues such as clinical trials and
manufacturing standards is essential to highlight the practical
implications of such guidance particularly given industry's knowledge
of future likely scientific developments.
Future improvements
6.20 Not only is a strong, efficient and effective UK
regulatory agency necessary for ensuring the safety of public
health, it is also fundamental to drive a competitive UK-based
pharmaceutical industry that will develop innovative medicines
for the benefit of patients. The impact of the establishment of
the European Medicines Evaluation Agency on the EU regulatory
environment has been significant. Companies now have the possibility
to select any one of the 25 Member States to assess their medicines.
Experience shows that companies select European regulatory agencies
that not only provide high scientific excellence, but also consider
customer service and efficient performance. In order to be selected
by companies the MHRA must promote their specialist expertise
in particular therapeutic areas in order to distinguish themselves
from the other leading regulatory agencies.
6.21 The MHRA is considered to be one of the top five
leading regulatory agencies in Europe. Findings in the National
Audit Office Report on the MCA[44]
(the MHRA's predecessor) indicated that the Agency would be looking
to improve the quality of the services it provides to industry
in order to attract more business. The ABPI strongly supports
the ongoing development of the MHRA as the leading regulatory
agency in Europe but this will require dedicated high-quality
staff who are sufficiently senior and experienced to chair key
European scientific committees.
6.22 The Medicines Commission has appointed individuals
to its membership who have expertise in the pharmaceutical industry
since it was formed in 1968 and the industry has also provided
advice to the previous MCA Executive Board on the Agency's performance
through representation on the Ministerial Advisory Board. The
ABPI believes that the presence of such persons on these advisory
bodies has been essential in providing information about the practical
implications of medicines regulation policy and feedback on the
Agency's performance from one of its major stakeholders. The continued
presence of people with industry expertise on the MHRA's Board
and the Medicines Commission, or its replacement, is recommended.
7. PRODUCT EVALUATION,
INCLUDING ASSESSMENTS
OF VALUE
FOR MONEY
Industry's participation in NICE health technology
assessments are vital in developing effective guidance for the
NHS.
NICE has itself sought the participation of industry
in various consultative groups.
Lack of implementation of NICE recommendations
remains a major issue.
Faster patient access to clinically and cost-effective
technologies would be promoted by a number of initiatives.
Industry should be engaged as a full partner both
in these initiatives and in implementation activities more generally.
Varying processes in England, Scotland and Wales
need to avoid duplication to achieve best outcome for patients.
Introduction
7.1 The pharmaceutical industry is committed to ensuring
equitable access to clinical and cost-effective treatments and
to achieving faster uptake of new technologies. Through partnership
and constructive engagement and with appropriate probity, the
contribution of the pharmaceutical industry to Health Technology
Assessment (HTA) is vital to the production and dissemination
of robust, evidence-based guidance for the benefit of both patients
and the NHS. The following comments relate principally to NICE
but separate sections have been included on industry engagement
with HTA bodies in Scotland and Wales.
The pharmaceutical industry as a NICE stakeholder
Submission of evidence
7.2 The ABPI welcomes NICE's collaborative approach towards
HTA. Company submissions are considered by the independent Appraisal
Committees of NICE alongside those of patient/carer groups, health
professional groups and NHS organisations.
7.3 NICE itself recognises the value of the industry
submission in the appraisal process. NICE has declined to adopt
the WHO's recommendation[45]
that NICE should be presented with a single set of analyses (incorporating
manufacturers' input via consultation rather than separate submissions).
Partnership
7.4 The pharmaceutical industry is represented on the
group which helps to develop NICE's work programme (the Advisory
Committee on Topic Selection). Industry contributes specialist
knowledge and expertise helping to ensure that the most appropriate,
suitable and relevant topics are referred.
7.5 NICE welcomes the contribution of pharmaceutical
industry consultees on the Appraisal Committees, as they share
experience which enhances the depth and quality of the appraisal.
The probity of industry representation on both of these committees
is assured by the Department of Health's procedures with regard
to conflicts of interest.
Constructive engagement
7.6 Industry has worked with NICE to achieve a more efficient,
fair and transparent appraisals process, through regular dialogue
between NICE and the ABPI's National Health Technology Assessment/Clinical
Guidelines (NHTA/CG) User group.
7.7 A good example of this constructive engagement has
been the development of a framework on the use of confidential
data, in response to the Health Select Committee's concerns in
2002[46] about the transparency
of the appraisal process. The framework sets out guidelines on
what company data should be made public during a technology appraisal.
Further improvements
Ensuring quality and maintaining standards
7.8 The Health Select Committee's 2002 report raised
the issue of the quality of the work undertaken by the independent
academic groups which produce the Health Technology Assessment
(HTA) reports. This remains an issue, with variability in performance
between the groups, and one on which the ABPI will collaborate
further with NICE and the National Coordinating Centre for Health
Technology Assessment.
7.9 There is a need for a common framework to improve
consistency and quality control. The industry shares the Health
Select Committee's concerns with regard to the resourcing of the
HTA centres.
7.10 There is also a need for the appeals process to
be independent, robust and transparent. In particular by the nomination
of an independent share of the appeals committee (which is currently
chaired by the chairman of NICE). The appropriately constituted
appeals committees are also restricted in the evidence they can
consider by narrow and limiting criteria. This means that they
cannot reach a fully informed decision on the issue at hand.
Clinical Guidelines
7.11 The development of NICE's clinical guidelines programme,
which industry supports, has helped to shift the focus in the
direction recommended by the Health Select Committee. However,
further clarity is necessary in the relationship between technology
appraisals and clinical guidelines and the criteria for choosing
between them.
7.12 The pharmaceutical industry has not been treated
equitably by NICE in the development of NICE Clinical Guidelines.
It is the only stakeholder that does not have access to or membership
of the Guideline Development Groups which are responsible for
compiling the guidelines. Approaches to NICE to improve this situation
have been repeatedly rejected.
7.13 Increasingly, HTA guidance is being put into guidelines
rather than going through the rigorous HTA development process
which includes an opportunity for appeal. The process by which
these decisions are made is opaque and of considerable concern
to industry.
Implementation
7.14 The most important measure of the work of HTA bodies
is their ultimate impact on patient access to new technologies.
Industry has worked with patient groups and NICE to develop the
evidence base which has identified inconsistent take-up of NICE
guidance around the UK (see, for example, the relevant papers
linked to the NICE website),45,[47]
46,[48] 47,[49]
[50] and has contributed
to Professor Richards's report on cancer services.[51]
A significant portion of this extensive evidence base was not
available to the NHS without the contribution from the industry.
7.15 The UK still lags behind most other major countries
in the adoption of new medicines. Industry looks forward to collaborating
with NICE, the Health Care Commission, the Department of Health
and NHS organisations to promote greater consistency between different
parts of the country in patient access to clinically effective
and cost effective technologies.
HTA in Wales and Scotland
All Wales Medicines Strategy Group (AWMSG)
7.16 The ABPI Cymru Wales Therapeutic Development Assessment
(TDA) User Group has begun to meet regularly with the Welsh Medicines
Partnership (WMP) in order to develop a more effective and workable
assessment process. These changes in process are then considered
by the All Wales Medicines Strategy Group (AWMSG)Steering
Committee "in camera", before final public consideration
by AWMSG.
Specifically the industry is working in Wales on the need:
for early clarification of the scope of the assessment;
to establish a means of treating "in confidence"
material;
to ensure retention of a transparent and robust
appeals process; and
for clearer timelines for the assessment process.
Scottish Medicines Consortium (SMC)
7.17 The SMC's process for appraising new medicines has
been developed in consultation with industry through constructive
dialogue and active industry participation from its inception.
7.18 The SMC operates to the highest standards of probity,
basing its policy on declaration of interests (in common with
NICE) on that of the Medicines Commission, and publishes a register
of interests for SMC members.
Future developments
7.19 Constructive engagement between industry and HTA
agencies has helped to shape and establish fair and robust processes
which are open to the sometimes conflicting views of a variety
of stakeholders.
7.20 Faster patient access to clinically and cost effective
technologies would be promoted by a number of initiatives:
The Department of Health, in conjunction with
NICE, the Health Care Commission, the NHS and industry, should
actively promote NICE's implementation support plan and act on
the recommendations of Professor Richards's report. Industry should
be engaged as a full partner both in these initiatives and in
implementation activities more generally.
The Department of Health and local NHS organisations
should work with industry to investigate instances of "NICE
blight" and continue to develop mechanisms to address this
issue in order to maintain and increase access to new medicines.
The Department of Health and NICE, in conjunction
with the National Coordinating Centre for Health Technology Assessment,
should ensure that the HTA groups have sufficient professional
capability to complete their work for NICE to the highest standard.
Collaborative working between industry and the HTA groups should
be promoted to ensure that NICE's Appraisal Committees focus on
the most important aspects of the decisions they are required
to make.
Multiple technology appraisal processes have developed
as a result of devolution. The Department of Health, Welsh Assembly
Government and Health Department of the Scottish Executive should
review these processes and devise a mechanism for sharing best
practice across the three separate technology appraisal systems
to avoid duplication of effort and achieve the best outcome for
patients.
The Department of Health should periodically review
the operation of NICE, as recommended by the 2002 Health Select
Committee report on NICE, at least every three years.
Official documents referring to technology appraisals
should highlight the value of industry submissions in assembling
the evidence on which appraisals are based.
8. CONCLUSION
8.1 We trust this submission has highlighted to the Committee
the indispensable nature of the partnership between the NHS and
the pharmaceutical industry that serves it. Each needs the other.
Interactions between the two are subject to stringent regulation
in a wide variety of respects. However, it is critical for both
the NHS's effectiveness and the performance of this vital industry
that the partnership be continuously enhanced to develop and deliver
optimum treatment for the benefit of patients. We therefore look
forward to discussing this with the Select Committee.
August 2004
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