Accessing new medicines in Northern Ireland
This guide explains how you can get new prescription medicines in Northern Ireland through the Health and Social Care System (HSC), and how those medicines are developed.
Branded and generic medicines
New medicines are often called branded medicines and are produced by pharmaceutical companies which own the patent or exclusive right to produce these treatments.
Older medicines are referred to as generic medicines. These are usually more than 10 years old and are medicines where the original patent has expired, so many companies can make them.
Generic medicines are usually much cheaper for the HSC to prescribe because lots of different suppliers can offer the same medicine at competitive prices.
Your healthcare professional will decide, in conversation with you, which medicine is suitable for you.
Developing a new medicine
Before any prescription medicine gets to a patient, it has to go through many stages involving different organisations, which work to make sure it meets high standards of safety and effectiveness, and that it is affordable for HSC.
The first step is carried out by skilled researchers in a laboratory, seeking to understand how your body changes when you have a disease or disorder and whether there is a new medicine that might help.
The next step is to test the treatment in humans. These tests are known as clinical trials, and they normally happen in four phases:
Phase one checks the safety of a medicine in a small number of volunteers.
Phase two involves a larger number of volunteers who are selected to receive either the new medicine, or an existing treatment known as the current standard of care.
Researchers look at the safety of the potential new medicine, whether patients experience side effects, how well the medicine works, and what doses are most effective.
Phase three involves repeating phase two but on a larger patient population.
Phase four is carried out once a medicine has been approved. It monitors how effective the medicine is once lots of people are using it in everyday life.
Licensing a new medicine
After successful development, medicines require a licence to be marketed in the UK.
This shows that the medicines have been tested and the results show they meet robust safety, quality and effectiveness standards, and that the dose and the way the medicine is taken are right.
The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency responsible for ensuring that medicines marketed in the UK are safe, high quality and effective.
The MHRA considers evidence from clinical trials and other materials submitted by the pharmaceutical company which developed the treatment. These are required by law.
More information about the MHRA can be found at:
If the MHRA decides that a medicine meets their robust regulatory standards they can issue a licence, also known as a marketing authorisation (MA), which allows the medicine to be marketed in the UK.
The MHRA can also monitor approvals for medicines that have been authorised by trusted regulators in other countries, though the final decision as to whether to grant a UK MA is still made by the MHRA.
Funding new medicines
After the MHRA assesses a medicine’s safety, quality and effectiveness, its price and its benefits must be considered in comparison with existing treatments, so that a decision can be made about whether the HSC should fund it.
If cost were not a consideration, all licenced new medicines would ideally be approved for HSC use. However, the HSC has a limited budget that must be prioritised to offer greatest overall benefit to the whole NI population.
A process called Health Technology Assessment (HTA) is used to consider whether a new medicine is value for money for the HSC. HTAs help the HSC deliver the greatest overall health improvement with its available budget and resources.
The National Institute of Health and Care Excellence (NICE) undertakes a health technology assessment on most new, licensed medicines and recommends whether they should be routinely funded on the NHS in England based on their costs and benefits.
More information about NICE can be found at:
In Northern Ireland, the Department of Health reviews NICE guidance and can endorse it for use within the HSC.
In practice this means that medicines approved by NICE for the NHS in England are also made available in the HSC in Northern Ireland.
The approach to HTA can differ across the UK.
In Scotland, HTA is undertaken by the Scottish Medicines Consortium (SMC) which appraises new medicines and offers advice on their routine use within NHS Scotland.
In Wales, NICE guidance is adopted by NHS Wales but in cases where NICE has not appraised a medicine the All-Wales Medicines Strategy Group (AWMSG) can undertake HTA where there is a clear clinical need.
In circumstances where NICE has not made a recommendation, the HSC can take into consideration recommendations from SMC or AWMSG to inform decisions on access to a medicine for patients.
After NICE recommends a new medicine, there may still be additional steps required before clinicians in Northern Ireland can prescribe it.
These might include agreeing the price with the manufacturer or checking that any necessary support is needed for the medicine to be prescribed safely, such as scans or blood tests.
Clinicians may need to learn about the medicine, include new guidance in their practice or, in some cases, require additional training.
If a medicine Is not routinely available
There are still options if a medicine has not yet been approved or funded.
Off-license, off-label or unlicensed
There are circumstances when a healthcare professional considers that a licensed medicine used to treat one condition can be used to treat another. This can be referred to as ‘off-label’, ‘unlicensed’ or ‘off-license’ prescribing.
Sometimes a healthcare professional may prescribe a medicine that is not licensed in the UK based on their clinical judgement, when they believe the benefits outweigh the risks for an individual patient.
This might be in cases where a licensed medicine may not be available for a particular condition or patient group, or where research is taking place.
Individual Funding Request (IFR)
Your doctor can apply for funding if they feel that a treatment that is not normally available is the best treatment for your individual circumstances and meets the necessary criteria.
Patients cannot apply themselves. Your clinician must do this on your behalf.
You can find out more at:
Early Access to Medicines Scheme (EAMS)
In some cases, manufacturers can make medicines available before MHRA approval for serious or life‑threatening conditions when there are limited treatment options. Your consultant will be able to advise if this is an option.
Clinical trials
Your healthcare professional may be able to advise whether there are any active research studies of potential new treatments that you could take part in.
You can find out more at:
Tips for patients
Ask your healthcare professional about all the treatment options available for your condition. They can help find the right one for you.
Bring information on new treatments you want to ask about to your appointments
Ask your healthcare professional about clinical trials or potentially participating in research.
Patient organisations can also sometimes help with understanding treatment options for your condition.