Select Committee on Health Written Evidence


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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