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Page last updated at 13:07 GMT, Monday, 18 August 2008 14:07 UK

How drugs are distributed via the NHS

Find out how medicines get from drugs manufacturers to UK patients within the National Health Service.

Drugs manufacturerLicensingAvailable case by caseAccess for allEngland/Wales/Northern IrelandScotlandReduced availabilityNICESMCStill available case by caseNHS PCTs and Health BoardsScottish NHS and Health BoardsDrugs available to patient


Drugs manufacturers are commercial companies which work to develop, market and distribute drugs. They must have been approved and licensed as a drugs manufacturer. Their products must also each be licensed by one of two bodies depending on whether the drug is set to be available just within the UK or throughout the European Union.


If a drugs manufacturer wishes to supply the UK market they must apply either directly to the Medicines and Healthcare products Regulatory Agency (MHRA) which is a government agency and licenses drugs for the UK. Alternatively they can apply to the European Medicines Agency (EMEA) which is a scientific advisory body and looks at drugs for the European market.

The MHRA can issue a license which is legally binding and makes it available to the UK market. The EMEA passes its recommendations on to the European Commission which has the power to turn the recommendations into law. This then applies in all 27 member states including the UK.

Both bodies are responsible for ensuring a drug is safe and efficient. Clinical trials are carried out by the drugs manufacturer, but are assessed by the MHRA or EMEA.


Once a drug has been licensed by either the MHRA or the EMEA, it can be prescribed on a case by case basis privately or by local Primary Care Trusts (PCTs) at their own discretion using their own local procedures. At this stage it has been deemed safe and beneficial by the licensing bodies, however it has not been assessed by regulatory organisations which look at cost efficiency alongside what benefits the drug brings.


To ensure equal access to medicines irrespective of where you live, and avoid what has been termed a postcode lottery, two bodies have been set up in the UK. They report their findings directly to the NHS and NHS Scotland.

The National Institute for Clinical Excellence (NICE) operates in England, Wales and Northern Ireland. The Scottish Medicines Consortium (SMC) operates in Scotland. NICE and the SMC differ in their methods and NICE takes an average of two years to issue guidance whereas the SMC aims to get their guidance out within three months. However, the SMC may later amend their guidance in accordance with NICE if it differs. While this regulatory process is ongoing individual Primary Care Trusts (PCTs) can continue with their own prescribing methods.


The National Institute for Clinical Excellence (NICE) operates in England, Wales and Northern Ireland. Once a drug has been made available in the UK by the licensing bodies, it is up to the Department of Health to decide whether to refer a drug to NICE. This decision is based on how many people are affected by a disease and whether different prescribing practices exist across the country.


Once a new drug has been licensed and referred to NICE by the Department of Health, NICE carries out a "technology appraisal". This assesses a drug for its clinical benefits, in other words how effective it is, and for its cost efficiency. Once NICE publishes its recommendations PCTs have three months before they must adhere to the guidance, except in very rare circumstances. If NICE decides against a particular drug and publishes a recommendation to not prescribe it, then it cannot be obtained free through the NHS by patients in England, Wales and Northern Ireland except in exceptional circumstances.


The Scottish Medicines Consortium (SMC) operates in Scotland. Once a drug has been licensed for the UK market it is up to the drugs manufacturer to apply to the SMC for guidance. Before this occurs it is available on a case by case basis to patients in Scotland, but NHS Scotland are expected to await SMC guidance before a drug is made routinely available.


It is up to the drug manufacturer to apply to the Scottish Medicines Consortium (SMC) for them to issue guidance on use of the drug in Scotland. Once a drug manufacturer has made their application, the SMC aim to issue its guidance within 12 weeks and to make its recommendations public within 16 weeks.

The SMC's advice is issued to Scottish Health Boards, but it is not mandatory and the final decision about the provision of drugs is made by the Health Boards themselves, giving doctors scope to exercise their clinical judgement.


NICE passes its recommendations on directly to NHS Primary Care Trusts (PCTs) and Health Boards. PCTs and Health Boards are given a grace period of three months to adhere to the guidance which must be followed except in exceptional circumstances. This means that if a PCT or Health Board has been prescribing a drug and NICE rule against it, the PCT or Health Board must fall in line and stop prescribing the drug. Equally, if NICE rules in favour of a drug then that drug must be made available in all PCTs and Health Boards across the country. This should prevent a postcode lottery whereby a patient's access to medicine is determined by where they live.


NICE guidance is mandatory except in exceptional circumstances. If NICE have issued guidance that does not recommend a particular drug, a patient either independently, or with the support of a health professional, can appeal the decision through their local Primary Care Trust (PCT) or Health Board and apply for exceptional funding. This is only an option if it can be proven that a patient's circumstances are special. This allowance for exceptional funding has reintroduced the possibility of a postcode lottery. Some PCTs and Health Boards have a stronger record for overruling NICE guidance than others, which means where you live can make a difference to the treatment you will receive.


The Scottish Medicine Consortium's (SMC's) advice is issued to Scottish Health Boards but it is not mandatory and the final decision about the provision of drugs is made by the Health Boards themselves. Although the advice is not binding, doctors and individual clinicians are expected to take it into account and should only prescribe against it if they can justify their decision in light of evidence about a patient's particular needs or circumstances.


The Scottish Medicine Consortium's (SMC's) guidelines are not binding. If the SMC advises against the use of a particular drug it can still be obtained by patients through their local Health Boards. However, there must be justification for not abiding by the SMC's guidelines.


Once a drug has been recommended by NICE or the SMC it is available to all NHS patients across the country. Similarly, if a drug has not been recommended it should not be widely available anywhere in the country. This is to ensure a uniform approach to drug prescription practices across the UK and to avoid a postcode lottery whereby a patient's access to medicine is determined by where they live.

However, exceptional circumstances do exist which allow the NICE and SMC guidelines to be overruled and for local Primary Care Trusts (PCTs) and Health Boards to act in a local capacity for individual patients.

Panorama: The Postcode Lottery: It Could Be You will be on BBC One at 8.30pm on Monday 18 August.

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