Author: QHC Administrator

Queen’s House Consulting at Advanced Therapies Integrates

QHC Administrator QH Drug Development Updates
Queen’s House Consulting at Advanced Therapies Integrates

Queen’s House Consulting is pleased to be a sponsor of Advanced Therapies Integrates 2023 on Thursday 30th November at the Stevenage Bioscience Catalyst.

The event provides the whole ATMP community with a programme of expert speakers, discussions and networking. The formal session streams will consider ATMP development/manufacture/implementation and sourcing of essential funding/skills. There will also be opportunities to tour the Cell & Gene Therapy Catapult or Cytiva‘s instrumentation laboratory.

Queen’s House Consulting looks forward to seeing you there. During your day, come and find out how Queen’s House Consulting can help you achieve your strategic, technical. developmental or investment goals.

Queen’s House Consulting sponsors Pharma Integrates 2023

QHC Administrator QH Drug Development Updates

Queen’s House Consulting is pleased to be a sponsor of Pharma Integrates 2023 on Thursday 16th November at an exciting new London venue, The Mermaid.

The event provides pharma and healthcare leaders with a programme of expert speakers, discussions and networking across three parallel subject streams :

  • – Solutions for the biggest challenges in healthcare
  • – Technology to improve health outcomes, supply chains and sustainability
  • – Enabling team skills to deliver for the needs of patients, providers, investors and regulators

During your day, visit the Queen’s House Consulting exhibition stand to discover how we can help you achieve your goals.

What Price the NHS?

QHC Administrator QH Healthcare Updates , ,

Queen’s House Consulting announces publication of its discussion paper “What Price the NHS?“. This independent report coordinates data about the United Kingdom National Health Service (NHS) pay and funding, alongside population change, inflation and government revenues since 2010. This is presented in the context of an ongoing pay dispute between NHS staff trade unions and the UK Government.

Analysis indicates that NHS staff pay has not matched inflation since 2010. In contrast, private sector pay has increased by more than inflation since 2010. Overall, total NHS spending has approximately matched inflation over the same period, if the exceptional costs of the COVID-19 pandemic are discounted. However, this has not taken account of population growth since 2010, or the disproportionate increase in the people over 65 years old who have greater need for NHS services.

The currently-disputed pay offer provides an average 4% salary increase, which is less than the 7.0% annual inflation to March 2022. The incremental cost of this pay offer in England would be up to £2.8bn, or 7.3% of the NHS pay budget. This offer would add 1.8% to the total NHS budget.

The discussion paper proposes three different models for NHS pay, which may offer options for settlement of the current dispute. Model 1 provides a pay increase based on the annual inflation rate in the preceding year. Model 2 provides a pay increase which corrects the gap between salary in each pay band and the cumulative inflation since 2010. Model 3 provides a pay increase which delivers parity with the growth in private sector pay since 2010. In England, the incremental costs of these models are up to £3.8bn, £6.5bn and £12.3bn. They would add 9.8%, 16.9% and 31.8% to NHS pay costs, representing an increase of 2.5%, 4.3%, and 8.1% of the total NHS budget respectively.

The cost of additional funding to provide for demographic changes since 2010 has also been calculated. Applied to pay models 1-3, these costs in England are £17.6bn-£18.7bn, which is approximately 11.7%-12.5% of the total NHS budget.

To build additional resilience into the NHS, the cost of an extra 10% capacity has been calculated. This would allow normal service delivery during times of high demand, with the opportunity for service improvement at other times. Applied to pay models 1-3, these incremental costs are estimated to be £16.1bn-£17.1bn, which is approximately 10.8%-11.4% of the total NHS budget.

Although the demographic and capacity investment are not directly associated with pay, they offers a potential reduction of staff workload. Along with pay, that outcome may facilitate staff recruitment and retention, to benefit both staff and patients.

Collective implementation of such pay models, demographic adjustment and capacity improvement would raise the UK from 16th to 5th ranking in a global comparison of national healthcare expenditure. Together, they would cost £27.4bn-£38.6bn, adding 18.3%-25.8% to the NHS budget in England. Extrapolating this to the whole UK would cost £32.7bn-£47.0bn. This would increase healthcare spending as a proportion of personal taxation from 26.0% to between 30.8% and 32.8%. As a proportion of total government income, these combined options would increase healthcare spending from 14.2%-15.1% to between 17.9% and 19.1%.

These models identify the cost and value of different investments in healthcare. It may be timely to consider what level of healthcare service the UK wants and how much of the national wealth should be committed to deliver it.

The discussion paper analyses the problems and offers solutions for consideration by stakeholders. This approach is in line with the broader offering from Queen’s House Consulting.

Click here to read the full report.

Queen’s House Consulting at Pharma Integrates 2022

QHC Administrator QH Healthcare Updates

Queen’s House Consulting is pleased to be a sponsor of Pharma Integrates 2022, which brings together pharma and healthcare leaders from around the UK and beyond. Promoting discussion and collaboration on parallel tracks, the meeting considers future demands for pharmaceutical healthcare.

We are also showcasing Queen’s House Consulting services as one of the exhibitors, welcoming delegates to discuss how we can support their needs.

Cause of rare thrombotic reactions to Covid vaccine: new hypothesis

QHC Administrator QH Drug Development Updates , , , ,

A new hypothesis proposes the cause of extremely rare blood clots and platelet depletion associated with the use of Oxford AstraZeneca or Johnson & Johnson/Jansen COVID-19 vaccines. Several studies have suggested physiological mechanisms to explain such reactions, but the underlying root cause and rarity of these events have not yet been explained.

A paper published in the journal Medical Hypotheses[1] now proposes that the reaction is due to inadequate protection of the adenovirus vaccine vector. Normally, each virus particle can be protected by a coating of the naturally-occurring coagulation factor X protein. The new hypothesis suggests that the factor X in affected individuals is unable to bind to the virus surface, leaving it exposed to other proteins such as platelet factor 4 and immunoglobulins. These can then form a compound structure with the adenovirus which the body identifies as foreign, eliciting an immune response, thrombosis and platelet depletion.

Testing a hypothesis relating to such rare events is challenging, because the experimental samples are scarce. This paper identifies an experimental route to prove or disprove the hypothesis, which acknowledges in the best scientific tradition that either outcome will be informative. Intriguingly, if proven correct, it also offers a solution which could potentially avoid this adverse side effect, enhancing confidence in the use of these vaccines to deliver global immunisation against COVID-19.

Queen’s House Consulting is pleased to have provided non-financial support for the research which generated this hypothesis in April 2021 and also for the subsequent efforts to publish the idea, so that other appropriately-resourced research groups can test the concept experimentally.

[1]Feldman PA. Proposed mechanism for rare thrombotic events after use of some Covid-19 vaccines. Med Hypotheses 159 (2022). doi: 10.1016/j.mehy.2021.110756  

New UK Life Sciences Vision

QHC Administrator QH Healthcare Updates

The UK government has announced their new UK Life Sciences Vision which lays out decade-long plans to solve targeted major healthcare problems, such as cancer and dementia. The new Vision, which was published on Wednesday 7th July, builds on the rapid response to the COVID-19 pandemic across the life science sector. It aims to combine government, industry, the NHS, academia and research charities to solve 7 critical healthcare “missions” by accelerating the development and implementation of new drugs, diagnostics, medical technology and digital tools. These missions will focus on preventing, diagnosing, monitoring and treating diseases earlier and will seek to enhance the efficiency of clinical trials.

The 7 missions focus on:

  • Dementia treatment
  • Early diagnosis and treatments 
  • Vaccine discovery, development and manufacturing.
  • Treatment/prevention of cardiovascular disease and contributory risk factors
  • Reducing mortality/morbidity from respiratory disease
  • Biology of ageing
  • Definition, understanding and management of impaired mental health

The Vision aims to recreate the successes of the UK Vaccines Taskforce by removing unnecessary administration and engaging with private sector expertise. It is intended that the UK Medicines and Healthcare products Regulatory Agency (MHRA) will be influential in supporting the timely availability of safe drugs and technologies.

To provide financial support for these missions, the UK government has launched its Life Sciences Investment Programme, which will invest £200 million into the life sciences industry via the British Patient Capital division of the British Business Bank. A further £800 million will be provided by an agreement with the UAE’s Abu Dhabi-based Mubadala Investment Company which will also be delivered by British Patient Capital to support identified funds and sectors.

Steve Bates OBE, Chief Executive of the BioIndustry Association (of which Queen’s House Consulting is a member), has welcomed this initiative, saying:

“I am pleased that the Vision identifies 4 preconditions for success which must be met over the next decade, giving industry and government clear goals. Working together, we must simplify the governance and oversight of NHS health data, make the NHS an Innovation Partner, increase UK R&D spend and broaden UK access to finance to scale at pace to deliver this rightly ambitious vision.”

Queen’s House Consulting can offer support to this Vision, providing specialist services which enhance and augment the UK’s life sciences expertise from laboratory to licensing. Please contact us to discuss your particular needs.

EU-UK Trade & Cooperation Agreement

QHC Administrator QH Regulatory Updates , ,

(First published 28 December 2020, updated 31 December 2020).

The Trade and Cooperation agreement between the European Union and the United Kingdom published on 24 December 2020 identifies particular areas of interest to pharmaceutical and healthcare sectors. The following brief guide describes the overall structure of the agreement and identifies/directs to specific topics, but it should not be considered a full precis, analysis or advice of the 1246-page document. There is also discussion of some scientific elements which are excluded from the agreement.

Overall Agreement Structure

The Agreement comprises 7 Parts covering:

  • The Agreement comprises 7 Parts covering:
  • Common and Institutional Provisions
  • Trade, Transport, Fisheries and Other Arrangements (including intellectual property, transport of goods)
  • Law Enforcement and Cooperation on Crime
  • Thematic Cooperation (including health security)
  • Programme Participation and Finance
  • Dispute Settlement and Horizontal Provisions
  • Final Provisions

Each Part is divided into topics called Titles, designated by roman numerals.

The seven Parts are supported by 49 Annexes, of which the following are particularly relevant to the pharmaceutical and healthcare sectors:

  • Annex ORIG-1 to -5: product origin (page 415)
  • Annex TBT-2: medicinal products (page 492)
  • Annex TBT-3: chemicals (page 504)
  • Annex TBT-4: organic products (page 507)
  • Annex SERVIN-1 to -6: services and professional recognition (page 530)
  • Annex ROAD -1 to -3: Transport of goods by road (page 800)

There are also a series of Protocols (each subdivided into Titles, designated with roman numerals, and Annexes) relating to tax, administration and social security.

Science

At the outset, there is acknowledgement that agreement about the UK access to European programmes could not be finalised within the negotiating timetable. The intent of both parties to progress these is documented, including one of which seeks to encourage future cooperation in science programmes. There appears to be sufficient confidence in this aspiration that a draft has been included in the appended joint declarations allowing UK to participate in (among others) the Horizon Europe Framework Programme for Research and Innovation (Draft Joint Declaration Article 1.b & 1.c, page 16; Article 4, page 18; Article 5, page 19). It is expected that this will form the basis for subsequent agreement. Details of Horizon funding and finance arrangements up to 2027 are set out in this 26-page document. The first healthcare mission priority within the Horizon programme is cancer. Although the UK will participate on an equal footing, it will only have observer status on the Joint Research Centre Board of Governors and will not participate in the European Innovation Fund (Draft Joint Declaration Article 6, page 21).

[At present, the UK will no longer participate in the Erasmus programme for academic exchange, which starts a new 7-year cycle in 2021. Existing UK participants may complete their current assignment. Non-EU countries can participate in the scheme (subject to financial contribution) but this is not currently envisaged by the UK government, which has independently flagged its intention to establish a system for global academic exchange (the Turing Programme)].

Pharmaceuticals & Healthcare

From the outset, there is agreement to cooperate on measures which address antimicrobial resistance (Article SPS.17, page 51) by control of antibiotic use.

Considering cross-border health security, the UK may ask for access to the EU Early Warning and Response System (EWRS) and the UK may be invited to participate in committee(s) which address such hazards, but these would be limited to the specific need and would not continue in perpetuity (Article HS.1, pages 362-363).

Annex ORIG (pages 415-486) covers the requirements for rules of origin. This may be relevant to pharmaceutical and healthcare product packaging materials and also to the materials used in the manufacture of the products themselves. Of particular relevance in this section is Note 5 (pages 417-419) which provide definitions for manufacturing processes which are used in the pharmaceutical and healthcare sectors. Similarly, Notes 6 and 7 (pages 419-422) cover definitions of woven materials which may be relevant to medical dressings. Based on the established 2017 Harmonised System on rules of origin, medicines and pharmaceuticals are specifically listed on page 419 (considering definitions of purity), with a Change of Tariff Sub-Heading for pharmaceutical products on page 430 and a Change of Tariff Heading for medical or surgical instruments on page 468. In general, there is a maximum limit of 50% on the ex-works product value attributable to all costs of components obtained outside the stated country of origin.

Annex TBT-2 covers Medicinal Products (pages 492-503): including GMP, quality, inspections and national statutory authorities.

Shipping and Transport of Goods

Goods for humanitarian purposes, which include medical, surgical and laboratory equipment, are allowed to pass through a country’s customs without import duties, taxes or other restrictions, if they are to be re-exported without material change (Article CUSTMS.16, page 71/72). Such goods may also be carried by transport without normal licence (Article ROAD.6, page 248-249).

Distribution of pharmaceuticals is covered in Reservation No. 13 (pages 675-676).

Intellectual Property

Protection of intellectual property, including medicinal products, is covered in TITLE V: Intellectual Property pages 125-147. In particular, patents are covered in Section 4: Patents, pages 136-147.

Future arrangements will be channelled through the Working Group on Medicinal Products which will operated under the supervision of the Trade Specialised Committee on Technical Barriers to Trade (article INST.3: Working Groups, page 15).

Health and Pharmaceutical Professional Services

Although service industries are not the focus of this Agreement, the provision of healthcare and pharmaceutical professional services is covered in a series of Reservations. These appear to cover service areas which do not conform with the Agreement terms for:

  • investment liberalisation (Articles SERVIN.2.2 & SERVIN.2.3, page 79),
  • cross-border trade (Articles SERVIN.3.3 & SERVIN.3.4, page 84),
  • most favoured nation treatment (Article SERVIN.2.4, page 80),
  • senior management and boards of directors (Article SERVIN 2.5, page 80), performance management (Article 2.6, page 80) or
  • legal services (Article SERVIN.5.49, page 115)

but which may be subject for improvement in subsequent negotiations.

Of particular relevance are:

  • Reservation No. 3 – health and pharmaceutical professional services  (pages 563-574; pages 658-661; pages 721-722)
  • Reservation No. 10 – health and social services (pages 731-732),
  • Reservation No. 13 –health and social services (pages 604-608; page 675)
  • Reservation No. 17 – energy related activities (pages 691-693).

Queen’s House Consulting will continue to offer services to the pharmaceutical and healthcare industries in the areas of pre-clinical pharmaceutical development, technical assessment for pharma start-up and follow-on investment/due diligence, regulatory authoring, pharmaceutical and healthcare strategy and systems analysis. Please contact Queen’s House Consulting to discuss your particular needs.

New UK Government Capital Fund for Pharma

QHC Administrator QH Drug Development Updates

The UK Government has announced a new capital investment fund to support Medicines and Diagnostics Manufacturing. Planned to launch in mid-2021 with an initial provision of £20m, it is intended to build capacity and resilience in the UK medicines supply chain. The initial announcement and press release indicate that the emphasis will be on the manufacture of advanced medicines and may favour investment in UK regions outside London and the South-East. Details have yet to be announced, but funding will be subject to competitive bids and managed by the Department for Business, Energy and Industrial Strategy.

This initiative shows government intent to support the pharmaceutical sector in the UK. However, £20m does not go very far in the pharmaceutical manufacturing industry and the aspiration that it will create thousands of highly-skilled jobs must rely on significantly greater parallel investment (capital and revenue) by the industry itself. Even if this multi-year fund receives further cash, great care will be needed to ensure sufficient focus, if the desired outcomes are to be achieved. Assuming that the fund has been created out of prior government discussions with the industry, such engagement should continue while the operational details of the fund are developed, to ensure that it is fit for purpose from the start.

Queen’s House Consulting can support such a partnership between government and industry, offering independent review of proposed mechanisms, so that the fund arrangements offer net value to pharmaceutical sector of the economy. If you are involved in this collaboration and would benefit from such a service, please contact Queen’s House Consulting to discuss your particular needs.

2020: the year of e-medicine?

QHC Administrator QH Healthcare Updates , , ,

It is possible that social historians will look back on 2020 as the year when e-medicine came of age. In countries with well-established healthcare services, internet cables hummed the louder as the COVID-19 drawbridge was raised in surgeries, clinics, hospitals and care homes. Indeed, future generations may shake their heads in disbelief that as soon as people got ill, whether infectious or not, they congregated in close proximity to other ill people in order to seek treatment. Our own pride in eradicating the horrors of the isolation hospital may seem misplaced to our children’s children.

However, although remote diagnosis and treatment have become the norm, we should guard against a new complacency based on the internet, microprocessors and 5G-communications. They can be as severely affected by virus infection (adventitious or malign) as any human being. In the rush to embrace technology, there should be a back-up “plan B” to cope when the cables break, the electricity supply fails, or a mistaken coding loop cannot be remedied by switching off and switching back on again. Maybe thoughts on Plan B will be the basis for a future post.

There is also the human-machine interface, beloved by acronymists as HMI. In conjunction with the demands of data protection, e-medicine has not yet resolved the most obvious challenge of the real-world clinic – most medical appointments are made by the elderly. No matter how computer-literate older people have become as their aging has tracked the internet age, the combined effects of gradual physical, sensory and cognitive impairment are ultimately not compatible with the operation of current technology.

Although it is convenient for both healthcare professional and active patient to  deliver primary community healthcare by newly-adopted technology, that benefit falls away as the gap in technical ability widens between the youthful provider and the aging patient. Even if the technology is left predominantly in the hands of the provider by continuing to offer face-to-face consultations, it cannot be utilised if the patient cannot manipulate the technology for booking an appointment in the first place.

Recognising that effective communication is as important for the development and delivery of healthcare as the science and technology that underpins it, Queen’s House Consulting suggests the following provocative eight-point prompt for developers to simulate the experience of less-able users when designing and testing e-medicine systems:

  • Try locating the device “on” switch on a rotating wheel somewhere inside the device, operated by finger proximity alone
  • Try using a keyboard/touchscreen interface with blurred letters/numbers
  • Try wearing thick, rigid gardening gloves while using the software
  • Try controlling access with 100-digit passwords which must be memorised
  • Try using instructions (written or audio) translated into a foreign language
  • Try waiting 60 seconds between each required input
  • Try running the sequence of tasks in random order
  • Try entering information which is not offered as an option

Sometimes the developer is so attuned to their product that it is difficult to see it through the eyes of a novice. Queen’s House Consulting can offer an independent assessment to maximise the ease of use in real-world situations. If you are a developer and would like to explore such a service, please contact Queen’s House Consulting to discuss your particular needs.

Share