Supply of Medicines post #Brexit

SUPPLY OF MEDICINES FOLLOWING A NO-DEAL BREXIT

SITUATION AT 12 SEPTEMBER 2020

NOTES BY LEEDS HOSPITAL ALERT

Sources of information:

Cabinet paper: “Operation Yellowhammer: Government’s Worst Case Planning Assumptions” (11 September 2019).
Statements from the British Medical Association and the Healthcare Regulatory Authority.
Statement by Meg Hillier MP, Chair of Public Accounts Committee.
Audit Office report: “Exiting the EU: Supplying the Health and Social Care Sectors” (27 September 2019).
British Medical Journal articles dated 14 November 2018 and 20 August 2019.
Letter from Michael Gove, Chancellor of the Duchy of Lancaster, to Stuart Andrew MP, dated 3 October 2019, in response to his letter about supplies of medicines, dated 18 June 2019.

In addition: Leeds Hospital Alert was advised by Leeds’s Director of Public Health to send questions about the supply of medicines following a No Deal Brexit to the Ministerial Correspondence and Public Enquiries Unit at the Department of Health, and wrote on 20 February 2020. The Unit replied on 30 March to say that it could not answer the enquiry. A follow-up call to the Unit on 11 September revealed that the Unit “has no specific information” about the supply of medicines.

The Basic Problem and the Government’s Proposals

Three quarters of medicines used in the UK come from the European Union, mainly by the “Short Straits” route to Dover and Folkestone. After Brexit, access will be reduced to 40% – 60% of current supplies for up to six months.

The government proposes to deal with this in three ways:

Stockpiling: The government told medical suppliers in August to stockpile six weeks’ worth of medicines as a “buffer” against disruption when the Brexit transition period ends on 31 December.

New freight routes: the government has finalised a contract (£87m) with four ferry groups to bring in medicines on seven other routes rather than on the “Short Straits” route. There will also be aircraft chartered to bring in medicines with a short life, and a dedicated courier service.

Changes to Regulatory Requirements: using the government’s existing “Serious Shortage Protocols”, pharmacists will be able to provide alternative medicines of the same quality and pharmaceutical content, with different strengths up to the same dose; the therapeutic equivalent of any medicines not available.

Questions to the Government

Why is the proposed period for stockpiles planned for six weeks, when disruption of supplies is forecast to last six months?

The British Medical Association and the Royal College of Nursing have pointed out that “many medicines cannot be stockpiled”. What are the government’s plans for these medicines?

How will stockpiling work for medicines that need to be kept at a controlled, low temperature during transport and storage? These medicines include insulin and medicines derived from blood plasma. Sir Michael Rawlins, Chair of the Medicines and Healthcare Regulatory Authority, has expressed particular concern about the storage of insulin in stockpiling.

The Audit Office reported that ministers do not know if there will be enough freight capacity in place to cope. Will the government issue new information confirming that the capacity exists?

How will the new freight routes work? Which companies will be running them? How will medicines such as insulin be transported safely? What professional oversight will there be of the process?

When will the government issue information to patients and their families who are worried about the supply of medicines? Attempts to get information directly have not proved successful (e.g. correspondence with the Department of Health, quoted above). Diabetes UK states: “We are concerned that the government has not communicated its plans regarding the continued supply of insulin in the event of a no deal Brexit, which is causing unnecessary concern for people with diabetes”.

Matt Hancock, Secretary of State, has apparently refused to rule out that people could die because of shortages of medical supplies following a No Deal Brexit (Evening Standard, 15 November 2018). Does Mr Hancock still stand by this statement?

Brexit medicines

12092020

Letter for Parliamentary candidates – please use and share

Dear General Election Candidate,

HEALTH CARE: WHAT A BREXIT DEAL MUST INCLUDE

The British Medical Association has published a Briefing on what a Brexit deal must include to safeguard health care for people in the UK.

The Briefing calls for the following safeguards for patients and the NHS in any Brexit deal. Please let me know how once you are elected you will ensure that the government will implement each of these safeguards:

A Brexit deal must include:

Free movement for healthcare and medical research staff

Permanent residence for EU doctors and medical researchers currently in the UK

Continued rights for EEA medical students in the UK to live, train and work in UK health services

Continuation of the existing open border arrangements between Northern Ireland and the Republic of Ireland

Ongoing cross-border co-operation in the delivery of healthcare to patients on both sides of the border between Northern Ireland and the Republic of Ireland

Freedom of movement for healthcare workers to live and work on both sides of the border between Northern Ireland and the Republic of Ireland

Ongoing MRPQ (Mutual Recognition of Professional Qualifications) to provide doctors the means to move and work between both Irish jurisdictions

Ongoing participation by the Medicines and Healthcare Products Regulatory Agency in the regulatory framework for pan-European clinical trials

A formal agreement between the UK and European Medicines Agency to continue to support and participate in their assessments for medicine approvals

Mutual recognition of, and ongoing participation in, the CE scheme for medical devices

The retention, or comparable replacement, of reciprocal health care arrangements and access to healthcare for both UK and EU citizens

The maintenance of reciprocal arrangements, such as the MRPQ (Mutual Recognition of Professional Qualifications), to facilitate the ongoing exchange of medical expertise across Europe and ensure quick access to the UK healthcare system be appropriately trained EU doctors

Ongoing access to the IMI (Internal Market Information) alert system, which enables regulators across Europe to send and receive alerts about doctors’ fitness to practise across the EU

The retention of measures to protect public health standards, including those affecting food, alcohol, air quality, and tobacco regulations

An agreement between the UK and the EU to continue to share data and emergency preparedness planning in relation to cross-border threats

Ongoing access to EU research programmes and research funding

Immediate certainty for UK researchers who currently access Horizon 2020 funding about funding and collaboration on existing and future research projects

Continued access to the European Investment Bank to fund research programmes

Ongoing access to and participation in the European Reference Networks, enabling healthcare providers across Europe to tackle complex or rare medical conditions requiring highly specialised treatment

Abolition of the charge to migrants from outside the EEA to use the NHS.

I look forward to your reply.

Kind regards,

Yours sincerely,

Public Meeting: “What will Happen to the Supply of Medicines after 31st Oct”

Please share. More details or press enquiries please get in touch

Leeds Hospital Alert have organised a public meeting on 17th October, 7.30pm at St. Margaret’s Parish Church ,Church Lane, Horsforth LS18 5LA

Everyone is concerned about the supply of medicines now and after 31st October. Please share the meeting details with everyone you know.