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Thursday, January 13th, 2005
A number of key proposals to improve the transparency and effectiveness
of the pharmaceutical industry's relationships with the NHS have
been made to the House of Commons Select Committee inquiry into
the industry's influence by the Association of the British Pharmaceutical
Industry (ABPI), it was announced today.
As well as the recommendations - which range from requiring organisations
engaging in clinical trial work with the NHS to publish the results,
to developing further guidelines on industry's relationships with
patient groups - the ABPI document also responds to some of the
issues raised at the inquiry.
The ABPI document was submitted to the committee in advance of the
oral evidence session being held on Thursday, January 13, at which
the ABPI will be represented by Vincent Lawton, President of the
ABPI, and Dr Richard Barker, Director General.
The recommendations have been made against a background of ABPI
support for and commitment to more openness across the whole of
the healthcare system.
The ABPI's recommendations cover a number of areas, including:
- Clinical trials. There is now international agreement that details
of pharmaceutical industry-sponsored trials will be publicly registered
from their inception, and that summary results of such trials
will also be published. The ABPI recommends to the committee that
all trials involving the NHS should include a requirement to publish
as part of the contract.
- Product safety monitoring. Doctors in the acute sector should
be regularly assessed on their use of the current Yellow Card
reporting system, and direct patient reporting of adverse drug
reactions should be more aggressively promoted. The MHRA should
receive more funds for increased monitoring, and should regularly
publish Yellow Card data.
- Ensuring patient interests are represented. Further guidelines
on relationships between the pharmaceutical industry and patient
groups should be developed.
- Ensuring appropriate prescribing of medicines. Both the National
Institute for Clinical Excellence and the Healthcare Commission
should ensure that NICE guidance is implemented by monitoring
the impact on doctors' prescribing.
- Better information for patients. The MHRA should introduce user
testing of patient information leaflets about medicines to increase
their usefulness to patients, and pharmaceutical companies should
be encouraged to make scientifically reliable information available
to the public.
The pharmaceutical industry is already extremely highly regulated
and committed to the highest standards of ethical and business conduct.
But we recognise that an issue of trust has arisen, and greater
trust needs to be built on increased transparency," said Dr
Barker.
We believe these recommendations are practicable and that they go
a long way towards addressing this issue."
The ABPI document also examines several areas which were identified
by witnesses to the inquiry, including:
- 'Disease mongering'. Diseases are classified by a rigorous process
independent of industry. Preventative care - such as the treatment
of osteoporosis, high blood pressure and high cholesterol, that
were criticised as "disease mongering" - is fully in
line with NHS strategy.
- 'Ghost writers'. As in many other contexts, it is common practice
for specialist medical writers to raise the quality of publications
through their skills in language and communications, expertise
in presenting data, understanding of publication guidelines and
convention, and/or time. But the industry does not support the
presentation of reports that do not reflect the considered views
of the stated authors. No serious investigator would risk their
reputation by simply adding their name to a paper.
- Links with patient groups. Industry works openly with patient
groups to raise awareness of medical conditions and to improve
healthcare delivery. The funding of such groups is transparent,
with patients groups retaining absolute freedom to accept or decline
funding.
- Relationships with doctors. The ABPI's Code of Practice requires
that gifts to healthcare professionals must be relevant to their
work and never above the value of £6, and that hospitality
must be secondary to the purpose of any meeting and not out of
proportion. A review of the ABPI code is currently being undertaken,
and the ABPI is canvassing opinion on this widely.
- Are all new medicines genuine innovation? A new medicine is
not licensed unless it can be proved to be at least as effective
as existing treatments. A particular medicine may be more suited
to a person's genetic make-up than another, both in terms of effectiveness
and/or side-effects.
To view the following document click on it below:
ABPI
Submission to the House of Commons Health Select Commitee inquiry
into the influence of the pharmaceutical industry
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Supplementary evidence
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