Evidence submitted by the Association
of the British Pharmaceutical Industry (EPR 39)
EXECUTIVE SUMMARY
1. Safety and the increased health of the
nation are of paramount importance. Significant safety and research
improvements are now possible through the effective use of the
detailed electronic patient record. Procedures such as record
coding promote patient confidentiality whilst allowing vital healthcare
data to be collected and analysed. Patient confidentiality should
remain totally protected and patient consent via continuation
of the current opt out arrangements is preferred. Industry's commitment
to patient health and safety is demonstrated by active partnership
in the UK Clinical Research Collaboration (UKCRC) vision for the
benefit of UK integrated health research data.
1.1 We believe that Connecting for Health
(CfH) has run into cost and time over-runs and so we consider
that it is important that the right specification for increased
safety and research effectiveness while different from that currently
being put in place, does not necessarily drive up costs or raise
additional security issues. Indeed the only requirement would
be access to the detailed electronic patient record.
1.2 Whilst CfH is a very considerable undertaking,
it should be recognised that there is an international race for
benefit and competitive advantage in research where the UK could
have a significant Unique Selling Point (USP), if research interests
are given priority. This is not the case currently so radical
changes are necessary for the UK not to lose out as a centre for
R&D in competition with other countries. The implementation
of the research programme envisaged in the recent Cooksey review[19]
and by the UKCRC whilst making use of the full electronic patient
record will provide substantial benefits to patients, the NHS
and the economy.
SAFETY AND
THE INCREASED
HEALTH OF
THE NATION
ARE OF
PARAMOUNT IMPORTANCE
2. ABPI members' interests related to the
electronic patient record are to increase patient safety through
the active monitoring of safety and efficacy of new and existing
medicines and to provide additional health benefits from research.
These aims cannot be achieved without access to the detailed electronic
patient record. This will not be provided by CfH in the proposed
centrally-held Summary Care Record.
SAFETY IMPROVEMENTS
ARE NOW
POSSIBLE
3. There is strong interest from several
parties to improve patient safety through better pharmacovigilance
as highlighted in previous reports from the Health Select Committee
(HSC), [20]the
BMA[21]
and the NHS R&D Directorate. [22]Future
improvement to keep up with US and other European safety conscious
countries will require up to date detailed and complete patient
data of good quality, accessible to the regulator (The Medicines
and Healthcare products Regulatory Agency (MHRA)). Safety systems
would then need to be able to send alerts to GPs about specific
patients without their identity being known at a central level.
DETAILED RECORD
ACCESS FOR
SAFETY AND
BEST HEALTH
THROUGH RESEARCH
4. It is our understanding from CfH that
the proposed central Summary Care Record will be only a small
subset of the complete patient record held on the current GP systems
and will not contain specific data to be of much use to improve
safety and to enhance clinical research.
4.1 The Summary Care Record will be an abstract
from the existing detailed primary care record, together with
abstracts from hospital care patient records which will be provided
through the National Care Records Service (NCRS). Over 95% of
the UK population already has an electronic record through their
GP's system.
4.2 We are unaware of any significant changes
being proposed to local patient record systems. Initiatives such
as GP Systems of Choice (GPSoC) may be moving to a more standardised
and accessible record. Such moves could potentially offer greater
patient safety, pharmacovigilance and research quality.
PATIENT CONFIDENTIALITY
SHOULD REMAIN
PROTECTED
5. Mechanisms to promote patient confidentiality
during pharmaceutical research are well-established. For example,
only coded-data is supplied to the researcher who has no direct
access to the patient or identifying details such as name, address
etc. It is therefore essential that confidentiality is maintained
in any future electronic system.
5.1 Additionally, the ABPI has recently
developed comprehensive guidelines for the secondary use of data
for medical research purposes, providing guidance to its members
(Appendix). There is also a body of opinion suggesting that electronic
data will allow greater security than paper-based systems.
PATIENT CONSENT
VIA CONTINUED
OPT OUT
ARRANGEMENTS PREFERRED
6. As with current international research
practice today in the use of existing databases, future systems
should support use of patient level data via an opt out patient
consent protocol. Patient identification at GP level to enhance
pharmacovigilance will be vital, a topic that has previously been
identified for action by the HSC. The Cooksey recommendations
and those of Best Research for Best Health will not be delivered
without access to patient level data being fully optimised in
terms of data quality and speed of access.
INDUSTRY COMMITMENT
TO PATIENT
HEALTH AND
SAFETY
7. Industry is actively engaged with UKCRC
and DH to identify the future vision for enhanced patient safety
and more effective clinical research use of patient data in work
sponsored by Professor Sally Davies, the Director of the National
Institute for Health Research and Richard Jeavons. A fully integrated
detailed patient record for research use would be a major USP
for the UK in competition with other countries as a centre for
clinical research to advance the health of the nation. As noted
above, patient confidentiality and privacy will be promoted through
the existing research mechanisms of data coding effectively providing
an anonymised patient record to the end user.
A VISION FOR
THE BENEFIT
OF UK INTEGRATED
HEALTH RESEARCH
DATA
8. We consider that the provision of internationally
competitive research services would require the creation of a
secure network and regulated services provision, building on initiatives
such as the NCRS, as well as those in Scotland, Wales and at the
primary care level, databases such as the General Practice Research
Database (GPRD). A possible model is shown below.
THE RIGHT
SPECIFICATION DOES
NOT NECESSARILY
DRIVE UP
COSTS OR
RAISE SECURITY
ISSUES
9. Industry is interested primarily in the
actual detailed patient record, not the Summary Care Record held
on the SPINE. Research needs will therefore not add to the costs
or specification of central records but research does need access
to specific fields held in local records in order to make advances
in clinical care and medicines for patient benefit. Provision
of this data will support much more of that research taking place
in the UK.
THE INTERNATIONAL
RACE FOR
BENEFIT AND
COMPETITIVE ADVANTAGE
IN RESEARCH
10. Nobody should underestimate the complexity
of what CfH have set out to do and, when all the systems are in
place, the potential is for considerable benefits to healthcare.
It is for this reason that parallel initiatives are well advanced
in many countries around the world, driven by the wish to enhance
patient health through the advancement of research, and to attract
the best international research to their respective country. The
UK has a real opportunity to attract more of the best research
projects through the use of UK integrated health data.
Dr Richard Tiner
The Association of the British Pharmaceutical Industry
16 March 2007
19 A review of UK health research funding December
2006. Back
20
House of Commons Health Committee Report "The Influence
of the Pharmaceutical Industry Session 2004-05. Back
21
Reporting Adverse Drug Reactions: A guide for healthcare professionals
May 2006. Back
22
Best Research for Best Health. January 2006 published by DH. Back
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