Asked by: Chris Stephens (Scottish National Party - Glasgow South West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure the supply of medications for rheumatoid arthritis in the event that the UK leaves the EU without a deal.
Answered by Stephen Hammond
Our number one priority is to ensure patients continue to have unhindered access to medicines as we exit the European Union and we are working with all sectors in the supply chain to ensure this happens.
We understand that medicines for rheumatoid arthritis are vitally important to many people in this country. Our ‘no deal’ medicines supply contingency plans include sensible mitigations for medicines that come to the United Kingdom from or via the EU/European Economic Area (EEA) to ensure that the supply of essential medicines, including medicines for patients with rheumatoid arthritis, is not disrupted.
In August 2018, the Department wrote to all pharmaceutical companies that supply prescription-only and pharmacy medicines, including those for rheumatoid arthritis, to the UK that come from, or via, the EU/EEA asking them to ensure a minimum of six weeks’ additional supply in the UK, over and above existing business-as-usual buffer stocks, by 29 March 2019.
On 7 December, the Government published updated reasonable worst-case scenario border disruption planning assumptions in the event of a ‘no deal’ EU exit. Medicines and medical products are prioritised in cross-Government planning, and the Department is working with relevant partners across Government and industry to ensure we have sufficient roll-on, roll-off freight capacity on alternative routes to enable these vital products to continue to move freely into the UK.
Throughout enacting our plans, we have received very good engagement from industry, including on their plans to stockpile medicines. They share our aims of ensuring that the continuity of supply of medicines and medical products for patients is maintained and able to cope with any potential delays at the border that may arise in the short term in the event of a ‘no deal’ EU exit.
Asked by: Chris Stephens (Scottish National Party - Glasgow South West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he is taking to (a) protect patients and (b) ensure pharmaceutical companies have a minimum of six weeks’ additional supply of vital medications over and above existing business-as-usual buffer stocks in the event that the UK leaves the EU without a deal.
Answered by Stephen Hammond
Our number one priority is to ensure patients continue to have unhindered access to medicines as we exit the European Union and we are working with all sectors in the supply chain to ensure this happens.
We understand that medicines for rheumatoid arthritis are vitally important to many people in this country. Our ‘no deal’ medicines supply contingency plans include sensible mitigations for medicines that come to the United Kingdom from or via the EU/European Economic Area (EEA) to ensure that the supply of essential medicines, including medicines for patients with rheumatoid arthritis, is not disrupted.
In August 2018, the Department wrote to all pharmaceutical companies that supply prescription-only and pharmacy medicines, including those for rheumatoid arthritis, to the UK that come from, or via, the EU/EEA asking them to ensure a minimum of six weeks’ additional supply in the UK, over and above existing business-as-usual buffer stocks, by 29 March 2019.
On 7 December, the Government published updated reasonable worst-case scenario border disruption planning assumptions in the event of a ‘no deal’ EU exit. Medicines and medical products are prioritised in cross-Government planning, and the Department is working with relevant partners across Government and industry to ensure we have sufficient roll-on, roll-off freight capacity on alternative routes to enable these vital products to continue to move freely into the UK.
Throughout enacting our plans, we have received very good engagement from industry, including on their plans to stockpile medicines. They share our aims of ensuring that the continuity of supply of medicines and medical products for patients is maintained and able to cope with any potential delays at the border that may arise in the short term in the event of a ‘no deal’ EU exit.
Asked by: Chris Stephens (Scottish National Party - Glasgow South West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether he has made an assessment of the compliance of the Human Medicines (Amendment) Regulations 2019 with the NHS England Commissioning Framework for Biological Medicines in relation to switching medicines without consulting patients.
Answered by Steve Brine
No assessment has been made. However, the explanatory memorandum of the amending Statutory Instrument acknowledges that protocols for therapeutic or generic equivalents will not be suitable for all medicines and patients. For example, such protocols would not be suitable for medicines that need to be prescribed by brand for clinical reasons, such as biological medicines. In these cases, patients would always be referred to the prescriber for any decision about their treatment before any therapeutic or generic alternative is supplied.
The Serious Shortage Protocol provisions in the Human Medicines (Amendment) Regulations 2019 enable Ministers, in exceptional circumstances, to issue a protocol that enables retail pharmacies to dispense in line with a protocol for a specific prescription only medicine rather than against a prescription, without going back to the prescriber.
Any protocol would need to set out what alternative quantity, pharmaceutical form, strength, therapeutic equivalent or generic equivalent can be supplied in what circumstances.