A First-class Service - Quality in the New NHS

Comments from the Association of the British Pharmaceutical Industry

There is no excuse or justification for delaying access to new therapies and technologies once their safety, quality and efficacy have been demonstrated. Delayed access to new therapies and technologies, once their safety, quality and efficacy have been demonstrated, would have a significant impact on healthcare services and constitute a disservice to patients. Realistic evaluation cannot be made until 2-5 years experience of use exists.

The establishment of the National Institute of Clinical Excellence offers an opportunity to provide clinical guidance immediately when new therapies become available. The guidance must be based on best information, experience and practice available and must draw on all sources of information and advice, including the significant knowledge base which exists in industry. It is important that guidance from NICE should encourage innovation and be based on an integrated and holistic view of healthcare delivery, as well as clinical and cost effectiveness. Its criteria should be transparent with a clear recognition of patient need, both in groups and as individuals, and support the twin aims of quality and equity in the NHS.

Innovation, and a competitive pharmaceutical industry, offer significant advantages for the National Health Service and British patients. The industry wishes to collaborate with NICE, the establishment of National Service Frameworks and the strengthening of quality standards through the Commission for Health Improvement (CHI). These bodies should improve uptake of medicines, extend their use and availability and not constitute a barrier to innovation.

These issues, particularly with regard to the detailed mechanisms for assessment of new therapies and interventions, cannot be reviewed fully in the absence of the second consultative paper to supplement "A First-Class Service" which will set out detailed aspects of the proposed new frameworks.

The industry, however, has set out below core principles which are essential to ensuring that every patient in the NHS can expect high quality care.

1. Setting Quality Standards - National Institute of Clinical Excellence

Scope
The National Institute of Clinical Excellence should cover both therapeutics and other health technologies. In the case of medicines, very few should require detailed evaluation given that safety, quality and efficacy have been validated by the MCA/ EMEA prior to launch. The selection of candidates for evaluation should be based on careful prioritisation and focus on major new therapeutic and technology advances, as well as significant current technologies which would be expected to have significant impact on patient care.

All health interventions should fall within the scope of NICE, including those developed in the public sector, as well as private sector innovation.

Condition-based, rather than individual, therapy-based guidelines are preferable as they are based on a more holistic view of a disease and patient care.

Membership
Different types of clinical and scientific experience should contribute to decision making within NICE. Industry should be an active participant in this process, particularly given the substantial body of data and expertise which exists within companies. The membership of the National Institute of Clinical Excellence Board should reflect this balance of expertise, and include experts from industry or with industry experience.

Basis of evaluation
All new medicines are approved by the MCA/EMEA on the basis of an extensive dossier of scientific data gathered over an 8-10 year period. The standard of evidence is high and is the subject of international guidelines, including randomised controlled and double-blind clinical studies.

The consultation document suggests that the new interventions appraisal process would start with the submission of evidence 4-6 months before launch. At this stage, for medicines a substantial dossier of data will have been submitted to the MCA/EMEA. At this time, only limited modelling information is available for more extensive populations. However, the more extensive clinical experience in larger and more varied patient populations needed as a basis for comprehensive evaluation can only be developed in the post-launch period.

Any requirement for more extensive data prior to launch would delay access to new products, interfere with clinical development and research and have a consequential disbenefit to the NHS, both in terms of cost as well as patient benefit.

Industry remains firmly of the view that, as evidence supports use in specific indications and patient populations at the time of launch, access to a new medicine for patients with these indications should not be delayed.

Decision criteria
NICE should be constituted as a broadly-based multi-disciplinary, clinically expert body operating in an independent and advisory capacity. Evaluation procedures must be transparent and based on sound evidence. The criteria adopted must recognise the needs, not only of groups of patients, but also individuals.

Where the evaluation concerns a medicine or group of medicines, the company(s) concerned should be fully consulted, invited to submit evidence as appropriate, and normal hearing and appeal procedures be available. The review process should be transparent and timely.

Status of guidance and dissemination
Industry supports the availability of NICE guidance consistently within the NHS. Clinical standards and patient care can be improved significantly by dissemination of appropriate guidance and its integration into local frameworks.

Advice or guidance issued by NICE should not constrain clinical freedom.

2. Life-long Learning and Training

Continuing professional development at a local level is essential, and industry wishes to continue to maintain its involvement in these areas.

Clinical governance must be backed by life-long learning and professional self-regulation, including clinical audit which is an essential adjunct to clinical governance.

3. Clinical Governance

For clinical governance to be successful, it must be seen to be an inclusive process which is owned by local healthcare professionals. It should encourage Primary Care Groups to determine local priorities and direct resources appropriately. Central guidance should be assessed against local need and integrated with appropriate modification. This freedom, and flexibility, is an essential prerequisite to maintaining commitment from local healthcare professionals and allowing local needs to be met.

The industry welcomes recognition that the process of clinical governance should be reflective of, and supportive of, healthcare professionals, and also welcomes the early involvement of patient groups. These processes must be open and accountable to the local population.

The pharmaceutical industry strongly supports the statement that responsibility for clinical governance rests with the senior doctor or nurse. These individuals, and the staff that work with them, will need support and training in this demanding role. The industry is globally regulated and has a sound understanding and skills base with regard to risk management and governance. Industry would be able to share this in a collaborative manner with Primary Care Groups. Partnerships and collaborative working should be encouraged.

National Service Frameworks, and national prioritisation of healthcare needs, will help to focus the activities of Primary Care Groups. However, this focus in clinical governance should reflect the more rounded debate about improving the quality of services to achieve better clinical outcomes rather than be directed simply towards cost reduction. Pressures to meet short term financial targets and, hence, reduce expenditure will have a negative impact on both quality and clinical outcomes. This, of course, would be the opposite of what is intended in "A First Class Service".

4. What can Industry Contribute?

The pharmaceutical industry spends more than £6 million a day in the UK in research and development of new medicines - more than 70% of all UK medicines research. The industry also plays a significant part in supporting university research and clinical studies in the NHS. The pharmaceutical industry makes a huge contribution to the UK economy - more than 300,000 jobs, exports of over £5.5 billion and a trade surplus of £2.3 billion are generated by the industry each year. Overall, this results in a net total contribution to the UK economy worth nearly £2 billion every year.

The industry does have a substantial contribution to make to the quality of care in the NHS and wishes to work closely with the NHS in the development of policies on NICE, National Service Frameworks, and in collaboration with the Commission for Health Improvement on life-long learning, education and improvement of standards.