NHS Legislation

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NHS Legislation

It has taken me two years to navigate through the bureaucratic maze to uncover the commissioning structure in the UK. There is still much to learn and legislation seems to change on a biannual basis. However the agencies involved in making treatments available on the NHS are below. I have also compiled a list of key documents which provide information on Department of Health legislation, including your rights as a patient to treatments.

EMEA – The European Medicines Agency

This is the first port of call for all new treatments. It is here that they are licensed for use. The EMEA –The European Medicines Agency is a decentralized body of the European Union with headquarters in London. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.

The EMEA is responsible for the scientific evaluation of applications for European marketing authorisation for medicinal products (centralised procedure). Under the centralised procedure, companies submit a single marketing authorisation application to the EMEA. Once granted by the European Commission, a centralised (or ‘Community’) marketing authorisation is valid in all European Union (EU) and EEAEFTA states (Iceland, Liechtenstein and Norway).

Most private medical insurers in the UK will fund EMEA licensed products.
See www.emea.europa.eu for further information.

MHRA – The Medicines and Healthcare Products Regulatory Agency

Once EMEA license is gained, for a treatment to be prescribed through the NHS it needs approval by The Medicines and Healthcare products Regulatory Agency (MHRA). This is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.

When a product gains an EMEA licence and MHRA approval it is legal for a UK clinician to prescribe. However this is historically when the problems begin with patients’ access to treatment, as the treatment will now be assessed for cost effectiveness by NICE. See www.mhra.gov.uk for further information.

NICE – National Institute for Clinical Excellence

NICE is an independent body which decides if a treatment is cost effective. There is much confusion on the role of NICE and the powers it has, or more pertinently doesn’t have. It is not a licensing body. It looks primarily at the cost effectiveness of a treatment to the NHS as a whole. It may take up to three years for NICE to appraise a treatment; this does not mean that patients cannot access this treatment until a positive guidance is issued. However many Primary Care Trust managers fail to understand this and believe that without positive NICE guidance a treatment is effectively banned. This is incorrect. Once a treatment is licensed and awaiting NICE appraisal it is up to individual Primary Care Trusts to decide on funding the treatment.

The Department of Heath issued guidance to all PCT managers in 1999 and reissued it in 2006 explaining the role of NICE:

Reiterating the Message of HSC 1999/176

It is not acceptable to cite a lack of NICE guidance as a reason for not providing a treatment. A key role of the NHS is to make decisions about the use of new interventions and this has always been the case, long before NICE was established.

NICE underpins the decision making processes of the NHS in reaching a decision as to what new interventions are the most appropriate to use and under what circumstances. Guidance from NICE exists to provide advice to NHS clinicians, commissioners and patients as to those treatments that are clinically and cost effective. Clinicians are not obliged to follow NICE guidance in every case if they feel that alternative courses of treatment are more appropriate for an individual patient, though they will need to be able to account through clinical governance arrangements for decisions to depart from NICE guidance.
NICE does not exist to “kite mark” all the interventions which are introduced for use in the NHS and decisions are taken by Ministers against published criteria as to which products NICE should be asked to assess. Not all new interventions will be referred to NICE for appraisal and for those interventions that are referred to NICE there may be a time lag whilst NICE guidance is being developed, though the new NICE Single Technology Appraisal process should help to minimise this lag. Therefore, the NHS will have to continue to make informed decisions about the use of these interventions under either circumstance.

For further information on Primary Care Trust commissioning please click here Postcode Lottery page.

More than ever each individual cancer patient needs a friend - an experienced navigator in a sea of bureaucracy and chaos. Kate Spall has tirelessly served hundreds of patients to help them achieve optimal care within the NHS. Increasingly the attitude of those making funding decisions within the NHS is passive. If you don't ask you don't get. And how you ask has assumed immense importance to the chances of success. Patient advocacy has never been more important than in 2010. By her work Kate is enhancing not just the quality of care for those she helps directly but also the lives of many other cancer patients.

Professor Karol Sikora

Clinical Advisor

D&H Guidance on Interventions

DH Human Rights in Health

The NHS Constitution

Richards Review on Access to Medicines

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