Drugs are a cornerstone of treatment for breast cancer. We know that you may have questions about drug treatment following the transition period ending on 31 December 2020. We take a look at what this means for medicines supply, medicines licensing, and clinical trials.
The potential for medicines shortages has received a lot of media coverage. The government has taken steps to prevent this happening by asking suppliers to build up stockpiles in the UK, securing capacity on alternative sea crossings, and air freight for urgent medical supplies.
There can often be issues with the supply of medicines for a range of reasons including manufacturing problems, difficulties getting hold of raw materials and increases in demand. The Department of Health and Social Care is responsible for medicines supply across the whole of the UK and works with manufacturers and other stakeholders to prevent and manage shortages.
If the government decides there is a serious shortage of a medicine, a Serious Shortage Protocol will be developed with clinicians. This enables community pharmacies to make changes to a patient’s prescription in line with the Protocol. This could include providing a different quantity of a medicine, a different strength (for example you may have to take two 10mg tablets instead of one 20mg tablet) a different form (like a tablet rather than a capsule) a generic equivalent of a branded medicine or vice-versa, or in exceptional circumstances a different medicine which has the same clinical effect. Breast cancer medicines dispensed by community pharmacies include tamoxifen, aromatase inhibitors and oral bisphosphonates.
If you are having problems getting hold of your medicines, speak to your doctor. We’ll be keeping a close eye on medicines supply issues and will raise any problems with breast cancer medicines with the Department of Health and Social Care.
You can also call our Helpline on 0808 800 6000 to discuss any concerns you have.
The European Medicines Agency (EMA) assess applications for licences (also known as marketing authorisations) for new drugs within the EU to ensure they are safe and effective. The Medicines and Healthcare products Regulatory Agency (MHRA) is now the UK’s standalone medicines regulator.
Drugs that have already received a licence through the EMA’s centralised process can automatically be converted to a MHRA licence.
What does this mean for new breast cancer drugs?
- For new licence applications from 1 January, for two years the MHRA may adopt decisions made by the EMA.
- For licences that were pending on 1 January there are a couple of options, including the same process as for new licence applications above.
- Companies can apply directly to the MHRA for an accelerated assessment of a medicine which will take 150 days.
On 1 January, the MHRA introduced a new Innovative Licensing and Access Pathway (ILAP). This is for medicines for conditions that are life-threatening or seriously debilitating, or where there is significant patient need, which have the potential to offer benefits to patients. The Pathway will enable medicine developers to benefit from targeted support from stakeholders including the MHRA, National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) from a very early stage to accelerate patient access. The Early Access to Medicines Scheme (EAMS) which aims to speed up access at later stages will also continue.
We’ll be monitoring what all of this means in practice for new breast cancer drugs. Whatever route is used to licence a drug, it will still need to be approved for use on the NHS by NICE in England, Wales and Northern Ireland and the SMC in Scotland.
Medicines being used in clinical trials could be subject to the same potential issues with disruption to supply as other medicines, and the Department of Health and Social Care will work to prevent and manage any shortages in the same way.
The MHRA authorises and regulates clinical trials in the UK, and until now it has done this in accordance with EU law in this area. A new EU Clinical Trials Regulation is expected to come into force later this year. It willwill make improvements to processes and requirements. Although the UK will not be required to implement the Regulation, the government has previously said it wishes to align as closely as possible with it.
We will be working with other medical research charities to ensure that cross border trials continue to be able to operate easily and that the UK remains an attractive location for clinical trials.
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