APPENDIX 5
Memorandum by the American Pharmaceutical
Group (PI 13)
1. THE AMERICAN
PHARMACEUTICAL GROUP
The American Pharmaceutical Group (APG) was
set up in 1985 to improve understanding of the industry, and the
healthcare contribution of the American companies.
The APG companies include all the major UK-based
pharmaceutical companies with American parents. They account for
over 35% of National Health Service (NHS) sales of prescription
medicines by the UK-based industry, making it the largest national
grouping in the country. As the US is the most competitive market
for medicines in the world, responsible for over half of the developed
world's R&D, the APG adds a special perspective.
The aims of the APG are to:
— Ensure an overriding commitment to
better patient care and information.
— Maintain a reputation and standing
as a high quality, responsible and well-informed Group, making
a constructive contribution to health care policy and debate.
— Advise how the UK can attract inward
investment from the US.
— Take a lead role on policy issues
affecting health care and pharmaceuticals, such as patient empowerment
and competition.
THE INFLUENCE
AND ACHIEVEMENTS
OF APG COMPANIES
It is almost impossible to imagine an NHS without
modern vaccines, without medicines for pain and infection, for
diabetes and gastric disorders, for cancer and heart disease,
and for a multitude of other conditions. It would be a service
in which the large mental NHS hospitals of the 1950s—the
so-called Cinderella services—would still be with us today.
This is a world that has been transformed for
NHS patients. The pharmaceutical industry in general and APG companies
in particular are proud of their massive contribution towards
the reduction of suffering among patients in the UK. The industry
has done more good for the public than probably any other sector
in the country.
The APG believes that these tremendous successes
should be understood, appreciated and encouraged. It is recommended
that this should be the base from which the industry should be
viewed by the Health Committee.
The positive aspects of the pharmaceutical's
industry's influence can also be seen in medical education, clinical
guidelines and supporting non-directed research.
All APG companies will do even more for patients
in the future. Advances in all the main diseases will flow from
APG research and innovative medicines, assuming that the right
conditions for the industry are provided. If the right conditions
are absent, the industry will suffer but, more to the point, so
will a large section of the patient population.
2. INFLUENCE
THROUGH PUBLIC/PRIVATE
PARTNERSHIPS
The APG has always welcomed and supported the
principles of co-operation and partnership between the private
sector and the NHS, within a framework in which the service to
the NHS patient remains almost entirely free at the point of delivery
and is based on clinical need. This co-operation is very true
of the pharmaceutical sector, but has been greatly extended in
recent years and has very often involved companies with US parents.
This was illustrated by the present Government
bringing in the private sector to work with the public sector
in the design and construction of new NHS hospitals and healthcare
centres, to such an extent that currently 90% of new hospital
schemes now operational under the NHS Plan were delivered under
the Private Finance Initiative.
However co-operation does not stop there. 80
Treatment Centres will provide at least 250,000 additional NHS
operations a year by end-2005, almost half of them provided by
the private sector; and extra use of the independent sector is
being made by the NHS, particularly in orthopaedics.
In many ways, the pharmaceutical industry has
been the trail-blazer in this development. Co-operation with Government
was developed in the 1990s through the Ministerial Industry Strategy
Group and later through the Pharmaceutical Industry Competitiveness
Task Force. This has helped provide the stability and understanding
that is required.
In addition, co-operation on the ground has
been achieved by APG companies working with the NHS on such projects
as:
— A personal development programme
for Mental Health Act Commissioners.
— Palliative care pain management for
advanced and/or metastatic cancer.
— Nutritional screening of older patients.
— Review of medications by pharmacists
and improving prescribing for over 65s.
— Implementing medicines-taking concordance.
— An induction programme for Primary
Care mental health link workers.
The boundaries between the public and private
sectors are being blurred in these areas, so that a more balanced
approach to the policy-making and delivery of healthcare is being
achieved.
3. THE CHALLENGE
TO THE
UK-BASED INDUSTRY
Yet despite the strengths of the UK-based pharmaceutical
industry, of which the APG is a leader, and the co-operative approach
between the industry on the one hand and the Government and the
NHS on the other, the future of the pharmaceutical industry in
this country cannot be taken for granted.
The biggest rival to the UK is no longer found
in the continent but across the Atlantic. The last decade has
seen a significant shift in the pharmaceutical industry away from
Europe and in favour of the US:
— Europe was responsible for discovering
97 new molecular entities between 1988-92 but, by 1998-2002, this
had fallen to 68. Over the same periods the US numbers rose from
52 to 77, overtaking Europe (source: July 2003 G10 Medicines Conference).
— Between 1990 and 2002 pharmaceutical
spending in Europe on R&D rose from
7,941 million to
19,800 million; but over the same period spending
in the US rose from the
5,342 million to an enormous
27,890 million, far above the level of Europe (source:
ibid).
— Europe accounted for 37.8% of the
world pharmaceutical market in 1990, falling to 25.4% in 2002.
By contrast, the percentage for the US and Canada rose from 31.1%
to 50.9% over these years (IMS World Review 2003 and IMS Consulting).
The consequences of a further decline of the
industry in the EU are that competitive R&D resources are
reduced, which means slower development of new medicines and hence
a lower standard of care for patients than would otherwise be
the case. The EU and the UK in particular would also carry less
weight in the global pharmaceutical economy and hence in their
international work on access to medicines in developing countries.
Low utilisation of new medicines
There are specific areas of concern in the UK.
Out of 10 comparator developed countries (Australia, Canada, Germany,
France, Italy, Japan, Switzetrland, UK and US), the UK had the
lowest take-up of new medicines launched within the last five
years, and the proportion is falling. On current trends, the UK
has been already or soon will be overtaken soon by Japan, the
only country with a worse record, so UK patients will receive
more dated medicines than any other comparator country. (PICTF
Indicators 2003, published April 2004)
One aspect (but only one aspect) of this poor
take-up is the persistence of postcode prescribing across the
NHS, although NICE was established in part to eliminate this.
All patients should have the right to know about the best medicines
that are available and to receive them, so that postcode prescribing
is eliminated. However patients suffering from diseases such as
cancer and rheumatoid arthritis, and conditions like schizophrenia,
and many others, are not receiving the medicines they need. Professor
Mike Richards, the NHS Cancer Director, has found that although
variation in usage of cancer drugs lessens over time:
. . . it does exist across the country and
cannot be accounted for by differences in casemix and, for most
drugs, is unlikely to be accounted for by cross boundary flows
alone. (Report of the review undertaken by the National Cancer
Director, June 2004)
4. RELATIONS
WITH VOLUNTARY
BODIES AND
HEALTH PROFESSIONALS
The APG takes seriously its relations with voluntary
bodies, which are open and transparent.
APG member companies believe that patients are
entitled to and should receive proper information, as allowed
by law. Patients increasingly expect this and that a new generation
of "informed patients" is on the rise. The All-Party
support given to this concept is welcome.
There is a commonality of purpose in informing
patients between voluntary bodies and APG member companies. Both
sides work together towards a common aim, to empower patients
and their families, putting into practice the aims of patient
information.
The APG abides by the Association of the British
Pharmaceutical Industry's (ABPI) Code of Practice, (April 2003,
Clause 19) which requires that:
— There must be a declaration of sponsorship
of meetings and in related papers.
— Meetings must have a clear educational
content.
— The hospitality associated with meetings
must be secondary to their nature.
The APG endorses the Guidelines set out in June
2000 by the Long-term Medical Conditions Alliance, which includes
the following statement:
We encourage the use of available
funding so long as the [Voluntary Health Organisation's] independence
is not compromised in any way and so long as there is total transparency
in the relationship. Contracts between the parties are helpful
in this respect, and indeed are sometimes required by law.
In its dealings with health professionals, APG
members are governed by the ABPI Code of Practice. All APG members
belong to the ABPI. The Committee may wish to note that this Code
of Practice was created almost half a century ago, goes beyond
UK legal requirements, is widely regarded as successful and effective,
and is regularly reviewed and updated.
APG members are also members of the Pharmaceutical
Research and Manufacturers of America (PhRMA), and abide by its
strict Code on the Interactions with Healthcare Professionals
(July 2002) in relation to marketed products and related pre-launch
activities.
5. CLINICAL TRIALS
All clinical trials are made available by APG
companies to the licensing authorities so that they can judge
the safety, quality and efficacy. Information is also made available
to health professions through scientific journals and medical
publications.
The APG is attracted by the concept of a publicly
available register of late-stage clinical trials, on the grounds
that patients should have more information about medicines. This
could be achieved by building upon the ABPI Clinical Trials Register.
This should be in respect of licensed medicines,
as those which fail to obtain approval are of most interest only
to competitors and might deter companies from testing products
in sensitive areas if publication was obligatory.
However there are some serious issues to be
resolved:
— Whether the trials registered should
include not just those carried out in the UK, but should be extended
to all trials in the EU and, in the medium term, to those elsewhere.
After all, the industry is a global one.
— Achieving agreement with the potential
audiences on what information is most useful. For the general
public and healthcare professionals not participating in trials,
a short summary of the final data may be of value, with any database
being most effective if the details to be included are agreed
across the industry. For patient participants in clinical trials,
the existence of plans for certain studies may be important, and
the opportunity to participate in such studies is a clear benefit
from early awareness.
— Whether the writing and circulation
of summaries of clinical trials should be drafted and made available
by the companies themselves or by a responsible third party (perhaps
at European Union level). The perceptions of the public would
be an important factor.
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