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General ABPI
Publications
Animal research for human medicines. Turning a
scientific theory into a new medicine now takes, on average, 12 years. During
that time, computer models of new molecules will be studied, thousands of
variations will be investigated in the test tube and a small number will go on
to be studied in animals. Then, if doctors and scientists are confident they
can do so without undue risks, the potential new medicine will be studied in
people.
How the NHS benefits from medicines. The Pharmaceutical
Industry supports the Governments commitment to quality and the encouragement
of the best use of clinically effective techniques throughout the NHS. This
approach may well involve greater use of medicines, both to prevent and treat
ill health., in the best long-term interests of both patients and
taxpayers.
The cost of Medicines - Good value for patients Far from
spending too much on medicines, there is a strong case to be made that more
spending on medicines would benefit patients, and frequently help drive down
other more expensive health care costs, particularly costly hospital treatment.
Yet we continue to spend five time as much as a nation on cigarettes and
alcohol.
The Development of Medicines. After a potential new
medicine has been discovered, it takes eight to twelve years and around 350
million pounds to develop it. Before it reaches patients, it has to undergo a
complex and lengthy process of selection, testing and development.
Generic
Medicines. Generic medicines are in the main copies of pharmaceutical
products that are no longer protected by patent. This makes them attractive to
the NHS, because they are generally less expensive than branded products. The
prescribing of medicines by their generic name continues to increase, yielding
major savings to the NHS.
Investing in
Medicines. The UK based Pharmaceutical Industry is one of the most
successful in the World. Already credited with the discovery of more leading
medicines than any other country after the USA. It continues to play a leading
role in research and development - re-investing seven million pounds per day in
the search for new medicines.
Marketing and
Medicines Before patients can benefit from the steady stream of modern
medicines flowing from the pharmaceutical industry, an important part of the
fast-moving process of innovation is to keep doctors, pharmacists and other
health care professionals up to date with the work going on in clinical
research and to inform them about the availablility of new medicines.
Nice,
Patients and Medicines Governments proposals to help patients receive
treatments recommended by the National Institute for Clinical Excellence by
placing statutory obligations on Health Authorities are welcome. But they
confirm the fact that - nearly three years on from the launch of NICE - the
problem of postcode prescribing continues.
Parallel trade in
Medicines. The Pharmaceutical Industry has long been exposed to parallel
trade within the European Union. The practice has grown in recent years to a
level that has significant impact on the distribution of medicines in the UK
and is now a major drain on NHS resources to overseas.
The value of medicines. The
UK based Pharmaceutical Industry provides a substantial net contribution to the
UK economy. It is one of the most successful sectors in Britain, researching,
developing and maufacturing for the National Health Service and for millions of
people throughout the World. It contributes significantly to health and quality
of life. As a major contributor to employment, R&D, government revenues and
overseas earnings, it also plays an important part in increasing the wealth of
the nation.
Pharmaceutical Industry Issues - 12
key areas for the pharmaceutical industry
1. The industry in
britain. The Pharmaceutical Industry operating in Britain has
traditionally enjoyed a relatively competitive environment in the UK, and as
demonstrated by its history of balance of trade surpluses, has been able to
compete successfuly for business abroad and for inward investment in R&D
and maufacture.
2. Access to Medicines - NICE The objectives of the
National Institute for Clinical Excellence (NICE) are to encourage faster
uptake of effective new treatments, to promote more equitable access to
treatments, to improve the use of NHS resources, and to promote the longer-term
interest of the NHS in the development of innovative treatments for the future.
NICE has an important job to do: health outcomes in the UK, especially in key
areas such as cancer and heart disease, are significantly lower than those in
comparable countries; the UK is one of the slowest countries in Europe to take
up innovative medicines; and the "postcode lottery" persists.
3.
Prodigy Prodigy, a computerised decsion support system for GP's, was
initially a research project set up to test the overall concept of such
systems. It has since been through two development phases and phase three is
currently in progress, looking at chronic disease management. Despite
Department of Health claims that the system will improve the effectiveness of
prescribing, evidence from the pilot testing provides limited support for this
view.
4.
Affordable Medicines New medicines offer more effective treatment for a
whole range of conditions. They also provide a means of delivering preventive
care in a cost effective way. Yet some people are still not convinced that
society can, or is willing to, afford the medicines that can improve the
quality of life for patients.
5. Modernising the
Regulations (Deregulation) Deregulation is typically understood as
changing regulations so that the market operates with less Government
involvement. Deregulation is a rightful part of the Government's modernistic
agenda for the NHS as a whole, and the medicines market is a part of this
move.
6. Patient Information Patients are taking an increasing
interest in their health and want to know more about the medicines they are
prescribed. This interest is being encourged by Government, doctors,
pharmacists and patient groups. The Information Age offers ever more
opportunities to gather information about health and health care.
7. Parallel
Trade Parallel trading happens when a product on the market in one
country is re-exported to a second country. In the European Union, this is
quite legal. The trade is based on the fact that medicines are sold at
different prices in different countries and that under EU rules, they can be
moved around at will.
8. Generic Medicines The prescribing of generic
medicines in Britain is increasing. It is higher than in many other EU
countries - more than 66% of all prescriptions are written generically. This
compares with 35% only 15 years ago. In some GP surgeries generic prescribing
is more than 90%.
9. Research and the Science Base The Pharmaceutical
Industry's long history of innovation in the UK has always been supported by
intensive research activity. The vast majority of medicines research carried
out in the UK is funded by the pharmaceutical industry, and the continuing
strengths of the industry's UK activities are dependent upon the quality of
graduates and post graduates emerging from the countries
universities.
10. Animal Research The UK pharmaceutical industry has a
well deserved reputation for high standards of animal welfare. The UK already
has the most stringent and effective controls in the world, but these are
implemented via an unwieldy process that is increasingly making research here
unfeasable.
11. Clinical Research Traditionally, the UK has been an
important location for the pharmaceutical industry to carry out its clinical
research. For many years the UK has been an important place for the development
of new medicines, the NHS has provided a good environment in which to do
clinical research and the Medicines Control Agency has provided an efficient
regulatory review of clinical trials.
12.
Childrens Medicines About half the medicines prescribed to children are
either unlicenced or are not licenced for that specific indication in that
particular child. This problem has been recognised for some years and the
pharmaceutical industry has been at the forefront of trying to improve the
situation.
ABPI Articles
Complying with
the ABPI Code - Promotional Material (Published 07 June 2004)
Before any material is given to you to use, it will have been approved and
certified by senior members of your company to make sure that it complies with
the Code. The following is intended to give you an understanding of the points
which will have been considered. It is NOT intended to be a guide to help you
to produce your own material.
Representative
calls (Published 10 May 2004)
Under the ABPI Code of Practice,
the principle is that doctors and other health professionals should not be
subjected to unacceptable selling techniques. The Code covers the timing and
convenience of calls, and prohibits offering any sort of incentive to see a
representative.
Running sales
meetings in line with the ABPI Code of Practice (Published 02 April
2004)
The main requirement for company organised or sponsored meetings
is that they must be primarily educational activities, rather than social
events. Hospitality can be provided, but it must comply with Code requirements
in relation to cost, form and appropriateness to the occasion and to the
attendees. The principle is that there should be no suggestion that doctors are
being wined and dined by pharmaceutical companies and hence being
unduly influenced in favour of their products.
ABPI Code of Practice
- an Overview (Published 19 January 2004)
All promotional
activity undertaken by pharmaceutical companies is covered by the requirements
of the Association of the British Pharmaceutical Industry (ABPI) Code of
Practice. The aim of the Code is that all promotion should be responsible,
ethical and professional (It is probably only a coincidence that this
abbreviates to R.E.P., but it is an easy way to remember it.) The
Code itself is a self-regulatory system, but it reflects the requirements of
the Medicines Act and the European Advertising Directives, which are legally
binding. The Code only covers pharmaceutical companies, while the legislation
also covers doctors, pharmacists and other health professionals.
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