Asked by: Kevin Hollinrake (Conservative - Thirsk and Malton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, when he expects the first pilots of the Global Antimicrobial Resistance Innovation Fund on reimbursement models to incentivise the development of new classes of antibiotics to begin.
Answered by Baroness Blackwood of North Oxford
The Global Antimicrobial Resistance (AMR) Innovation Fund is a £50 million investment over five years to tackle AMR, with the aim of attracting significant additional investment internationally to stimulate global research. It is not looking at reimbursement models to incentivise the development of new classes of antibiotics or planning to fund pilots at this stage.
Domestically, the Department is working with the National Institute for Health and Care Excellence and the Association of the British Pharmaceutical Industry to develop a new reimbursement model for antimicrobials, and has secured broad agreement to principles that would permit a model to ‘de-link’ company revenues from sales. The aim of this work is to support good antimicrobial stewardship. Discussions with a number of leading pharmaceutical companies have highlighted challenges in evaluating antimicrobial medicines, and the Department is working closely with industry partners to address these.
Asked by: Kevin Hollinrake (Conservative - Thirsk and Malton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, when he expects the Global Antimicrobial Resistance Innovation Fund to be open to research applications for the repurposing of antibiotics.
Answered by Baroness Blackwood of North Oxford
The Government has committed £50 million towards setting up a Global Antimicrobial Resistance (AMR) Innovation Fund to increase global investment in AMR. The fund aims to leverage substantial new international investment in AMR research and development for new and repurposed antimicrobials and alternative medicines, rapid diagnostic tests, vaccines and other important technologies, interventions and therapies.
Professor Dame Sally Davies, the Chief Medical Officer for England and United Kingdom Government adviser, has appointed an expert advisory board to make recommendations on the scope and focus of the investment.
These discussions are ongoing.
Asked by: Kevin Hollinrake (Conservative - Thirsk and Malton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, with reference to the study published by Oxford Academic on 17 February 2017 on inappropriate checks undertaken by online pharmacies, if he will discuss with the Medicines and Healthcare Products Regulatory Agency means to prevent the online sale of antibiotics and other medicines without appropriate checks.
Answered by Baroness Blackwood of North Oxford
Standards for United Kingdom online pharmacy services are the responsibility of the relevant professional regulatory bodies. These are the General Pharmaceutical Council and the Pharmaceutical Society of Northern Ireland.
The Medicines and Healthcare products Regulatory Agency is working with the General Medical Council, the General Pharmaceutical Council and the Care Quality Commission to monitor issues arising from online services. The four regulatory bodies issued a joint statement on 3 March stressing that providers and healthcare professionals working for online services must provide safe and effective care, including following professional guidelines on this matter. The Department is aware and supportive of this important work.
Asked by: Kevin Hollinrake (Conservative - Thirsk and Malton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what steps his Department is taking to regulate the online sale of (a) antibiotics and (b) other medicine.
Answered by Baroness Blackwood of North Oxford
In the United Kingdom, there are legal controls on the retail sale, supply and advertising of medicines which are set out in the Human Medicines Regulations 2012. These apply without distinction to medicines advertised, sold or supplied through the internet.
This means that Prescription Only (POM) and Pharmacy medicines (P) can only be sold or supplied at registered pharmacy premises by, or under the supervision of, a pharmacist. Furthermore, POMs can only be sold or supplied in accordance with a prescription from a doctor, dentist or relevant healthcare professional. POMs cannot be advertised to the general public.
The vast majority of antibiotics are only available as POM for supply only under the supervision of a suitably qualified healthcare professional.
Websites offering to supply POMs without a relevant prescription are in breach of UK legal requirements and the Medicines and Healthcare Products Regulatory Agency will investigate and take appropriate action including criminal investigation and prosecution.
Asked by: Kevin Hollinrake (Conservative - Thirsk and Malton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, if his Department will take steps to set up a National Antibiotic Register for recording all hospital and community patients who have an antibiotic resistant infection.
Answered by Baroness Blackwood of North Oxford
Such a system already exists. Hospital microbiology laboratories routinely record the results of testing bacteria isolated from infections for susceptibility or resistance to antibiotics. These data are voluntarily submitted to a national antimicrobial resistance (AMR) database called Second Generation Surveillance System (SGSS) maintained by Public Health England. Currently, 98% of hospital laboratories submit their AMR data to SGSS.
Asked by: Kevin Hollinrake (Conservative - Thirsk and Malton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, whether all blood assay results showing infection or resistance to antibiotics go onto a national register.
Answered by Baroness Blackwood of North Oxford
Hospital microbiology laboratories routinely record the results of testing bacteria isolated from blood for susceptibility or resistance to antibiotics. Since 1989, Public Health England (and its predecessors, the Public Health Laboratory Service and the Health Protection Agency) have requested that laboratories submit their stored data on resistance in bacteria isolated from blood to a national database called Second Generation Surveillance System (SGSS). Currently, 98% of hospital laboratories submit their antimicrobial resistance data.
Asked by: Kevin Hollinrake (Conservative - Thirsk and Malton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, if his Department will take steps to record on death certificates antibiotic resistant infection as the patient's cause of death.
Answered by David Mowat
There is currently provision for recording resistant infections on death certificates. For example, guidance on recording deaths from MRSA was issued in 2005 by the then Chief Medical Officer. However, it is often the case that by the time someone dies they may have a number of diseases and complications of illness or treatment. It is, therefore, a matter of clinical judgment to decide whether a condition present at or just before death was a primary or secondary cause of a patient’s death.
The World Health Organization is currently working on a revision (ICD 11) of its diagnostic coding system ICD 10. This is due in 2018 and will have a more comprehensive coverage of types of antimicrobial resistance.
Asked by: Kevin Hollinrake (Conservative - Thirsk and Malton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what assessment he has made of (a) the effect of the National Tariff on the choice of antibiotic therapy available in hospitals and (b) the implications of the cost of such therapy for that availability.
Answered by Baroness Blackwood of North Oxford
The Health and Social Care Act 2012 Act transferred responsibility for developing payment systems for health care services from the Department to NHS England and NHS Improvement (formerly Monitor). The costs of drugs that are used in the course of a patient’s stay in hospital are reimbursed via the Healthcare Resource Group tariff that the provider receives for that spell.
We are advised by NHS England that they are not aware of issues with the national tariff having an impact on the choice of antibiotic therapy available in hospitals.
The decision on whether to prescribe an antibiotic is entirely a matter for the clinician, based on his or her clinical judgement.
Asked by: Kevin Hollinrake (Conservative - Thirsk and Malton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what role he plans for the UK in discussing antimicrobial resistance at the G20 summit in September 2016.
Answered by Baroness Blackwood of North Oxford
Antimicrobial resistance (AMR) is growing, presenting huge costs to both society and the global economy – it is estimated that AMR will have a cumulative cost of $100 trillion by 2050. One of the main issues driving the increase in AMR is a market failure preventing enough new antibiotic drugs from getting to market. The United Kingdom sees the G20 as the best forum to discuss this economic issue and take action. The UK is calling for the G20 to look at how it can put in place innovative financing mechanisms to reinvigorate the antimicrobial development pipeline and help rectify this market failure.
Asked by: Kevin Hollinrake (Conservative - Thirsk and Malton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, with reference to recommendation 9 of the final report of The Review on Antimicrobial Resistance, published in May 2016, whether and within what timescale the Government plans to consider possible changes to its purchase and distribution systems for antibiotics.
Answered by Jane Ellison
The Government will work with the international community to develop and agree a system which encourages the pharmaceutical industry to develop new antibiotics in line with the recommendations made in the final report of the Review on Antimicrobial Resistance. The Department will meanwhile continue its ongoing dialogue with the Association of the British Pharmaceutical Industry on antibiotic pricing and reimbursement in the hope of reaching agreement by the end of the year on a set of potential options for a reimbursement model suitable for piloting in England.