Author: QHC Administrator

Accelerated assessment of COVID-19 products

QHC Administrator QH Regulatory Updates , , ,

Regulatory health agencies around the world have responded to the COVID-19 pandemic by offering accelerated review of applications related to detection or treatment of the disease, while providing assurance that scrutiny of product quality and patient safety would not be compromised. Such a position is understandable, given the global impact of the disease and the public expectation that nothing should impede developments to minimise the human, economic and social cost.

The regulatory stance has some interesting implications for potential pharmaceutical manufacturers and marketing authorisation holders. Those with products which are relevant to the management of SARS CoV-2/COVID-19 could benefit from accelerated review, as would individuals and society as a whole. However, health agency resources are finite, which prompts three observations yet to be widely considered:

  • Accelerated review of COVID-19 related applications will probably delay the review of non-COVID-19 related applications. Over the short- to mid-term, this could defer the availability of treatment for patients with other, non-COVID-19, conditions no less than the prioritisation of hospital beds to severely-ill COVID-19 patients deprives other patients of critical care.
  • If accelerated review is possible for COVID-19 applications without compromising product quality or patient safety and without delaying other applications, then it may be possible to establish a routine accelerated review process for all applications.
  • While maintaining that product quality and patient safety will not be compromised, the hazard from COVID-19 may allow for greater risk when assessing risk-benefit, than for other non-COVID-19 medicinal products. This may be easier to justify for COVID-19 patients who are already critically-ill, but presents interesting philosophical questions when comparing COVID-19 and other conditions which have not progressed to critical illness but may have the potential to do so.

The above three scenarios are not accusations; the response of all parties involved in tackling the COVID-19 challenge has been to find solutions as quickly and as safely as possible, in the context of data available at the time. Rather, these scenarios highlight the unchanged responsibility of developers.

Accelerated review is dependent on the applicant (whether academic institution, public sector provider or commercial company) ensuring the quality and safety of  product throughout the pre-licensing development programme from concept to market. Notwithstanding the perceived urgency, the developer needs to maintain a critical scrutiny of their data and underlying assumptions continually, in order to minimise risk at the regulatory review stage and in the clinic.

Queen’s House Consulting can offer independent review to support that critical scrutiny, acknowledging that the developer is most expert in that field. A detached view can challenge assumptions and interpretations, either confirming an already-robust package of data, or prompting enhancement of the eventual regulatory process. If you are a developer and would like to explore such a service, please contact Queen’s House Consulting to discuss your particular needs.

Medicine Labelling Errors: Why?

QHC Administrator QH Drug Development Updates

Each year, there are multiple alerts from regulatory agencies regarding wrongly-labelled medicines. The term “labelling”, includes the physical label on primary and secondary packaging, the insert or leaflet accompanying the product packaging, the published prescribing information (PI) and the summary of product characteristics (SmPC).

Labelling errors are often identified by pharmaceutical companies, either during routine quality examination of finished product or in response to customer quality complaints. The regulatory agency alerts are usually prompted by self-notification from the marketing authorisation holder.

The impact, or risk, from these labelling errors can vary; some are cosmetic, while others can result in the wrong dosage or wrong product being administered. The direct result of such labelling errors are compounded by reputational damage (in terms of public trust and regulatory confidence in the company’s quality management system) and additional corrective/preventative costs to the manufacturer.

The labelling errors themselves can include:

  • the wrong strength being printed on the primary or secondary packaging (product label or product container respectively);
  • the prescribing information or patient information leaflet omitting text required by the core summary of product characteristics (SPC), possibly due to a delay in implementing a revision of the core SPC;
  • the wrong medicine being shown on the labelling;
  • additional and/or erroneous information included in the text;
  • inconsistent or contradictory information in the different labelling components of a single product.

Public notifications of such labelling errors are factual and focus on corrective actions relating to affected product lots. The unspoken question is “how did this happen”? There can be many reasons why the answer is not openly acknowledged, though it is surely a hot-topic for conversations around the water-cooler in most companies.

Underneath the simple answer that the error was not identified before product was released to the market, there are several potential root causes. The most straightforward cause is a mix-up during the packing operation of a particular product lot. Although this is a frustrating “own-goal” which highlights a gap in the quality management system, it is relatively easy to correct and prevent in the future. The cause of error becomes more complex when it is embedded in the labelling itself, and some of these are considered below.

  • Proximity to the text drafting can play a big part; author and checker(s) both make assumptions about the validity of source content or about the detail exercised by other reviewers.

 

  • Pressure to finalise; labelling is usually the final stage of a long regulatory approval process and the expectation for rapid completion, coupled with a “good-enough” culture (to avoid reinvention of the wheel and last-minute pedantic changes), can work against accurate proof-reading and late revision requests.

 

  • Using previous or similar documents as the template; the “Save As” efficiencies to avoid reinventing the wheel, or to ensure continuity of the house style, can allow the original information to be perpetuated, when it should be revised or deleted. This is more likely when the individuals performing these tasks are goal-oriented but far-removed from the context, the meaning, or the basic arithmetic, which underpins the content.

 

  • Printer’s errors; these may similarly arise from use of a previous template which was then checked by readers at the procurement stage who lack sufficient knowledge of content. There are additional challenges when the proof for a three-dimensional object (such as a carton) is presented for checking, because the two-dimensional plate requires particular spacial skills to confirm that all printed elements are oriented correctly.

Queen’s House Consulting can offer independent proof-reading checks for new or revised medicinal labelling. While recognising that the originating company will have the best expertise in that field, our fresh and detached view can identify inconsistencies which may have slipped through in-house review at the end of a lengthy regulatory process. We can also flag those elements which may need particular confirmation by the in-house experts. If you would like to benefit from these services, please contact Queen’s House Consulting to discuss your particular needs.




Organs, Tissues, Cells and Brexit

QHC Administrator QH Regulatory Updates

The UK Government Department of Health and Social Care has published advice that existing quality and safety standards for work with human organs, tissues and cells will be retained,  when the UK leaves the EU. Arrangements also cover the possibility of the UK leaving the EU without a deal. This means that facilities working with these materials can continue to follow existing quality and safety procedures.

However, after UK leaves the EU, it will no longer be party to the Single European Code or the EU Coding Platform, so UK establishments will not be included or required to use them. Any UK facility working with tissues or cells which are moved in or out of the EU will require approval of import/export licences from the UK Human Tissue Authority. For movement of reproductive cells, authorisation will be needed from the UK Human Fertilisation and Embryology Authority. There will be a 6-month grace period for users to comply with the new requirements.

The UK government has drafted three statutory instruments, covering Human Tissue, Organs for Transplantation and Human Fertilisation and Embryology, to ensure that these arrangements remain codified in UK law after departure from the EU. These may need to be amended or revoked, depending on the final outcome of negotiations between the UK and the EU.

NOTE: Arrangements for the UK departure from the EU are subject to change. This summary is not binding. Please use the embedded links the official UK websites for the most current and definitive information.

This summary has been prepared by Queen’s House Consulting, which provides consultancy services to the pharmaceutical and healthcare industry. Please contact Queen’s House Consulting to discuss your particular needs.




Medicines and Brexit

QHC Administrator QH Regulatory Updates

As the United Kingdom (UK) departure from the European Union (EU) approaches the target date of 29 March 2019, both the UK Medicines and Healthcare Regulatory Agency (MHRA) and the European Medicines Agency (EMA) have updated their guidance to pharmaceutical companies.

Generally, these guidance notes are mirror images, with the common underlying message that any functions performed under the auspices of UK’s current membership of the EU will no longer be recognised in Europe or the UK after Brexit, particularly in the event of departure without a negotiated deal. Non-manufacturing functions currently performed in the UK must be transferred to individuals/facilities within the EU or the European Economic Area (EEA). Those functions currently performed in Europe will need to be replicated in UK, in order to maintain supplies of medicines from the EU. While MHRA provides a transition period until the end of 2020 for such establishment in UK, it appears that EMA will apply this requirement immediately after 29 March 2019.

The most public of these changes is the relocation of EMA offices themselves from London to Amsterdam. After some delays, the interim “SPARK” offices in Amsterdam are now fully-operational; however, the relocation of staff and procedures will limit meetings and product certificates from now until 14 March 2019.

As these circumstances mainly relate to medicines which are already approved in the EU, this is primarily an administrative change, albeit costly for UK-based companies. In contrast, medicines currently supplied in the UK under a European (EMA) product marketing authorisation will require new marketing authorisations licenced by MHRA. Pragmatically, MHRA have provided guidelines on “grandfathering”, whereby a new UK marketing authorisation may be generated on the basis of a pre-existing (pre-Brexit) EU licence. However, there are likely to be long-term cost implications for companies to maintain these additional marketing authorisations only for the UK.

Both EMA and MHRA are adopting a risk-based approach to facilities inspections, while establishing their rights to require EU inspection of UK sites and MHRA inspection of European sites.

During this period of transition, consistent and coherent regulatory submissions, specifications and batch testing are needed to ease pharmaceutical manufacturers’ interaction with both UK and EU agencies. Queen’s House Consulting can provide   authoring and checking services for Pharmaceutical and Non-Clinical packages, helping to deliver the additional workload resulting from Brexit. Please contact Queen’s House Consulting to discuss your particular needs.

NOTE: Arrangements for the UK departure from the EU are subject to change. This summary is not binding. Please refer to the official UK and EU websites for definitive information.




Medical Innovations April 2018

QHC Administrator QH Healthcare Updates

Queen’s House Consulting was among the delegates at the Royal Society of Medicine 16th Medical Innovations Summit. Covering four general themes, presenters from around the world presented their novel approaches to problems of mental health, issues around the delivery of healthcare, new treatments for disease, and the potential of digital medicine.

Approaches to Mental Health:

While news reports are highlighting the dangers of social media, the Summit heard about two schemes aimed at young people. “MeeTwo” is a peer-oriented, moderated app which allows the posting of problems, concerns and anxieties. It allows users to share solutions and reassurance that they are not alone in their experiences, while also offering links to relevant information, other support groups and expert help.

Moving to the physical world, new procedures have been developed in primary and secondary schools which could reduce exclusions and referrals to mental health services. Adopting a holistic approach to the problems, the system embeds fully-funded and trained pastoral support staff within the school, to work with teaching staff, students and parents/carers. Although the approach is adaptable to different circumstances of age, affluence, education and environment, the benefits of full-time staff appears to offer benefits to everyone and reduce the burden on outside social/health services.

A novel therapeutic approach for some mental health problems was presented, which uses virtual reality to reproduce anxiety-inducing situations in a safe environment. It appears that repeated exposure to the cause of anxiety may induce tolerance and coping strategies which improved the patient’s quality of life.

These presentations prompted discussion about the sustainability of provision; if positive outcomes reflect long term efficacy then these approaches will be sustainable (subject to maintained funding); however, if continued intervention is needed to maintain the outcome then demand will rapidly exceed the capacity to deliver and the programmes will become unsustainable.

Healthcare Delivery

A chance family event prompted the design of an interactive cup to promote hydration of people in hospital or nursing care. The Droplet® device combines a machine-washable mug or beaker with a digital base which can alert user and carer about the frequency, quantity and need to drink. An anti-spill lid without a humiliating “baby” spout completes the design. It is more expensive than an ordinary mug, but probably not if the secondary cost of dehydration (confusion, organ failure, hospitalisation and recovery time) is included in the calculation.

Parental experience of paediatric oncology services prompted a digital innovator to create an app which accompanies children through the bewildering and frightening experience of cancer treatment. The interactive app, which is still in development, uses virtual reality inform and prepare the child, who remains in control by “pulling” information at the level and rate they can cope with, rather than having information “pushed” upon them regardless of their emotional and cognitive state. It also allows physically-restricted and sometimes lonely patients to play virtual-reality games with other children. Presumably there is a significant cost in developing and maintaining such a platform, which would be ripe for charitable investment so that no child with a mobile device need want for such 24/7 virtual support.

On a different business level, the potential benefits of social finance to fund preventative medicine and healthcare compliance was described. The money comes from investors, rather than insurers or national bodies, who fund treatments or prevention programmes while receiving a dividend calculated from the resulting lifetime healthcare savings. The first medical model for such a system is the treatment and prevention of diabetes, where investing in the promotion of healthy lifestyle can reduce the incidence of type 2 disease and the long-term treatment costs for primary and secondary healthcare needs.

Finally, there was discussion about the Access to Medical Treatment (Medical Innovation) Act which could change the basis for new drug availability and clinical trial enrolment. There was a healthy debate about the possible benefits for some patients and the potential to undermine scientifically-based demonstration of efficacy.

A common strand through these presentations was the assumption that funds would flow to the product on the promise of larger healthcare savings in the future. It is not clear whether any cash-strapped provider can afford to make that leap of imagination. The schemes have an implicit expectation that future savings will then be available for re-investment in other healthcare needs; however, the temptation merely to pocket the savings will be strong in any cost-conscious healthcare organisations. Furthermore, the business model should not combine savings based on costs in developed healthcare systems with maximum growth in countries with limited healthcare provision.

New Treatments

The Summit showcased three new pharmaceutical developments which address the challenges of immunisation, genetic disease and treatment compliance/efficacy.

Pathogen mutation which confounds vaccine efficacy may be overcome by the development of vaccine-vector combinations. These can recognise and disrupt the less-mutable internal molecules, rather than raising antibodies against surface antigens which evolve to evade recognition. By overcoming the natural mutation of the pathogen, this technology offers long-term protection against, e.g., influenza, avoiding the need for regular re-immunisation. As well as most stable long-term pathogen recognition, the new approach delivers pathogen-destroying agents, in contrast to conventional vaccines which rely upon the host’s natural defence and elimination pathways. This ability to recognise and destroy internal structures within cells and pathogens also promises improved targeting of cancer cells.

The progress in gene therapy was also discussed, with a growing number of gene therapy clinical trials. The challenges of validating safety and efficacy in a new branch of medicine are great, even though the limited patient numbers seem to indicate long-term correction of the defective gene expression and disease phenotype. The challenge is to determine the need (if any) for repeat dosing with the viral vector and the long-term monitoring for delayed adverse effects. In a commercial world, the high development cost and potentially one-time treatment of a life-long morbidity are not easy to monetarise. Outside the sphere of experimental medicine, such therapies will probably require deep pockets, lease-for-life contracts, or both.

The final area for consideration was the use of intelligent drugs containing a sensor which reports information such as patient compliance, drug function and other physiological response. If used in the formulation of an antipsychotic drug, where patient non-compliance can lead to a spiral of decline, it was suggested that the additional information could inform and justify future clinical treatment decisions. Delegates at the Summit were exercised by ethical, financial and technical concerns around this development. Again, the business model seemed reliant on revenues from grateful healthcare funders whose future costs of poor compliance/efficacy would be avoided.

Potential for Digital Medicine

Finally, the use of technology to improve access and delivery of healthcare was described by three different approaches.

For developing nations, where disperse populations cannot always verify their identity, peripatetic healthcare professionals can use digital fingerprint recognition to confirm the correct medical history of an individual on their mobile device. This device is climatically and physically robust in the poorest parts of the world, even without reliable electric power or internet.

In a different digital field, computer networks are being used to gather, collate, analyse and feedback data on healthcare staff well-being, motivation and delivery, as well as being a scaffold to progress and promote ground-up improvement programmes. It will be interesting to see if the reported benefits over the early months of the scheme within an NHS Foundation Trust can be sustained by both staff and management. In the non-digital world the initial enthusiasm of such scheme’s early-adopters is defeated by: creeping cynicism; realisation that second-wave improvements are more complex than the high-profile initial “quick wins”; and distraction as newer, glossier or urgent distractions emerge. If the digital systems can buck this trend, they would be transformative.

At the very sharp end of healthcare provision is the monitoring and diagnostic power of artificial intelligence (AI) such as the Google DeepMind programme. Such systems can gather and analyse immense amounts of information and retrieve it very quickly. The challenge, which was discussed by the audience, is the weight and credibility given to the AI output, compared to the judgement of the human physician. This becomes particularly relevant when the AI reports unique events which are not detected by the human physician. If the subsequent AI-generated treatment plan is different to the physician’s diagnosis, will the human being be confident (and legally protected) in following their own judgement rather than that of the AI? Conversely, is the human being liable for implementing an unsuccessful AI-generated treatment?

Queen’s House Consulting

Queen’s House Consulting does not claim answers to all the issues raised by this Summit, but can offer strategies which navigate the process/product development cycle from concept to patient. Please contact Queen’s House Consulting to discuss your particular needs.

 




EMA and MHRA prepare for BREXIT

QHC Administrator QH Regulatory Updates

The European Medicines Agency (EMA) has published plans to relocate from London to Amsterdam when the U.K. leaves the European Union in March 2019. The limited time means that preparations have started for a two-phase transfer to a new purpose-built headquarters, even though Italy has questioned the process by which Amsterdam was chosen. As the new Netherlands facility will not be ready in time, EMA will first relocate to temporary offices, before a second move to their permanent home. By the end of February 2018, progress towards the establishment of both buildings was delayed, according to the  tracking tool .  

While the set-up of new offices presents logistical challenges, the availability of EMA staff to support and progress the development of new medicines may also be delayed, while new European personnel are recruited and trained to replace the outgoing UK experts. At the same time, staff at the UK MHRA will be surrendering their role as a reference member state for EMA regulatory submissions. Their focus will either be a new possible mutual recognition process with Europe or the creation of systems which secure the continued supply of existing EMA-registered medicines in the UK.

In such circumstances, the need for well-presented regulatory submissions has never been more important. A dossier which is easy to review will progress through the system faster than one which is confusing or ambiguous. Queen’s House Consulting can help you negotiate this workload leading up to Brexit, offering regulatory authoring of Pharmaceutical and Non-Clinical modules, whether for pre-meeting packages or full product marketing authorisation applications. Please contact Queen’s House Consulting to discuss your particular needs.




Medical Innovations Summit

QHC Administrator QH Healthcare Updates

Medical, healthcare and pharmaceutical speakers from around the world have presented their work at the Royal Society of Medicine 2017 Medical Innovations Summit. The meeting considered developments in mental health provision, diagnostic methods and the handling of Big Data, and targeted biotechnology .  Key messages were:

Mental Healthcare Provision:

What happens when family and carers are kept away from patients needing hospital and nursing care? The negative effects of isolation and insufficient staffing resource can result in chronic and sometimes terminal decline in the patient’s welfare. A programme of open access, positive encouragement and partnership between healthcare professionals and family/carers can result in improved clinical outcomes and quality of life. More and more healthcare providers are signing up to the “John’s Campaign” initiative.

To counter the isolation of a society fragmented by age, particularly among older people, a number of mixed-age experiences are being developed: locating nursery schools in homes for the elderly, with integrated activities for both age groups; allocating accommodation for young people in retirement/assisted living housing developments in return for help and social interaction; and specific projects in local student communities whereby the skills of the young are offered to help the less-able elderly.

 

Diagnostic Methods

New apps are being developed and used to provide doctors and patients with more information to optimise treatment. One such allows the patient’s individual condition to be matched with clinical trials for which they are particularly eligible. This can avoid uncertainty about whether a particular trial is appropriate for a particular patient, narrowing the bewildering number of trials which may be suitable. It also helps the trial sponsor to avoid wasteful effort in identifying study subjects who subsequently do not meet trial’s entry criteria.

Another app provides physicians with a guide through the symptoms to identify compatible diagnosis. This can alert the health professional to broader diagnosis and eliminate the most unlikely diagnoses.

In countries where doctors have to serve patients who live over large geographical area, a digital stethoscope and thermometer have been developed. This allows patients to collect the data for analysis and diagnosis by their physician who may be a long way away. It is then possible to conduct a remote consultation with the most essential information available to the doctor. The company are now looking to extend the data available by adding scales, blood pressure monitor and pulse oximeter to the app package.

Another award-winning idea is the use of an easy-to-wear vest which monitors heart rate and body temperature as a predictive alarm of epileptic seizure. Without advance notice, seizures can be highly disruptive and place the patient at risk from secondary injury. This is particularly true for young children, who are less able to identify the changes which occur just before a seizure occurs. The vest provides an unobtrusive device for holding the monitors in place, without the social stigma or discomfort of more visible technology.

The opportunity to use augmented reality can support less experienced surgeons to conduct complex procedures under the guidance of remote consultant surgeons. Not only does this provide audio advice, but it can also overlay the consultant’s hand and devices on a screen image of the surgical field, with very high precision. Further developments are promised, including 3D-imaging which would provide even greater support for complex internal surgery.

As an aid to cardiac surgery, a code has been developed whereby the wire fixings used to join the sternum after coronary by-pass surgery can be used to leave an X-ray visible code inside the chest which identifies the location of the implanted vascular shunts. This can save time and uncertainty if the patient presents on a later date with a suspected blockage; if there is no access to their surgical history, life-threatening time can be lost trying to locate the blockage  during emergency corrective surgery. The direction of the wires (up or down, left or right) and the number of wires will show up on X-ray and identify the location and number of by-passes previously performed.

Another development for improved surgical outcomes is a programme of active intervention to prepare patients for surgery. In many cases, the underlying condition, and/or the prior medication, can leave a patient in sub-optimal physical and psychological condition for the rigours of surgery and post-operative recovery. By applying a holistic approach in the pre-operative period, which optimises diet and nutrition, physical fitness and psychological well-being, the patient is better prepared for surgery. Experience of the programme to date indicates that the post-operative recovery period is shorter and the patient’s confidence and attitude is greatly improved. This initial work has been done with cancer patients, but may be equally applicable to many or all forms of major surgery.

Biotechnology

The summit heard about two biotechnology advances which could change the shape of medicine in the future. The development of biotechnology to target therapies in oncology and immunology diseases will be a first for a Chinese biotech company, both in meeting the needs of the large Chinese population and in providing therapeutic drugs outside China for the first time.

In Scotland, a company has addressed the evolutionary success of sharks, to adapt and humanise shark antibodies for the treatment of inflammatory disease. The first targets for these therapeutic molecules are as treatments of inflammatory eye and gut diseases.

Queen’s House Consulting

Queen’s House Consulting was among delegates at the Medical Innovations Summit. Offering expertise in system process analysis, technical “health-check” for start-ups and investors, and programming/troubleshooting biotech product development from laboratory bench to market, Queen’s House Consulting is able to support medical innovation. If you would like to discuss your particular pharmaceutical/healthcare needs, please contact Queen’s House Consulting.

 

 

 




Talk NHS

QHC Administrator QH Healthcare Updates

Queen’s House Consulting joined Talk NHS, a public debate on the past, present and future of the National Health Service (NHS) in the United Kingdom. This one day meeting, organised jointly by the Royal Society of Medicine and Discourse, was led by expert panels representing healthcare practitioners, lawyers, patients, politicians and think-tanks. The meeting ended with a keynote lecture by Professor Stephen Hawking who described his personal experience, in support of a publicly-funded health service which is free at the point of use. Before this, the panels and audience had spent the day in lively discussion, considering the economic basis, political control, funding, structures and accountability of the NHS, which is organised differently in England, Wales, Scotland and Northern Ireland. There was also debate about the impact of these elements on the recruitment, retention, motivation and professional support for NHS staff. It was recognised that incorporation of enhanced preventative medicine (in its broadest terms) and social care into the mainstream scope of the NHS could offset the growth in demand for NHS services. The meeting was characterised by a considerable agreement about the past and present state of the NHS, but greater variety of opinion about its future. This may reflect the focus and diverse interests of the audience and panel members.

 

As an independent pharmaceutical and healthcare advisor, Queen’s House Consulting can distinguish between the long-term strategic development of the NHS, and the short- to mid-term tactics needed to deliver health and social care within defined budgets.  With experience in analysis, long-term planning and short-term implementation, Queen’s House Consulting can help NHS practitioners, managers, civil servants and politicians develop the structures needed for each. At the core, is the existing expertise of professionals in these areas, along with the expectations and needs of the patients/clients of NHS services. Queen’s House Consulting can work alongside these NHS stakeholders, offering additional time and skills without diverting these professionals from their daily provision of healthcare. Recognising the perception that external consultants can be a financial drain on limited public finances, Queen’s House Consulting offers competitive, transparent and cost-effective options for its services. Click here for more information about the relevant services offered by Queen’s House Consulting, or contact us to discuss your particular needs.

 

 




FDA asks pharma to present their expanded access positions

QHC Administrator QH Drug Development Updates

The US Food and Drug Administration have invited pharmaceutical companies to make public the contact details and policy under their Expanded Access programme. This FDA programme enables companies to supply drugs in special circumstances, even though they have not yet received marketing authorisation and may still be under development.

The physician-led request to FDA on behalf of their patient must first confirm that the particular drug manufacturer will supply it under the terms of the Expanded Access programme. Such requests may involve critical care and be time-constrained, so it can be difficult to access all the necessary information.

To facilitate this process, the Reagan-Udall Foundation has launched an on-line Expanded Access Navigator. Using dedicated portals, patients/carers and physicians can learn how the Expanded Access programme works and identify possible treatment options and company contacts who can confirm availability of the drug. To encourage use of this programme, the FDA has asked manufacturers to upload information about their expanded access policies and procedures along with contact details for a rapid response to physicians about specific drugs. You can read more about the Expanded Access Navigator on the FDA blog.

Similar schemes are operated in other countries; Early Access (U.K.), Compassionate Use (EU), Conditional Approval (Japan), Special Access (Australia), with other territories considering their impact and potential. One concern is that the impact could be financially damaging for both the payers (in terms of drug cost and administration burden) and the developers (in terms of return on investment, particularly for smaller companies). If you would like to discuss options for enhances access to medicines, whether focussed on investment, strategy, or procurement, please contact Queen’s House Consulting.




EMA issues first Q&A about Brexit Impact

QHC Administrator QH Regulatory Updates

The European Medicines Agency has issued its first set of questions and answers about the impact of Brexit on companies based in the United Kingdom. In most instances, if the U.K. ceases to be a member of the European Economic Area (EEA) on 20 March 2019, then:

  • UK companies will need to operate through companies located within the EEA;
  • Pharmacovigilance and product release will have to be performed by companies within the EEA;
  • Active ingredients, bulk drug substances and final drug products which are manufactured in the U.K. will be treated as imports with regard to provision within the European Union;
  • Small and medium sized enterprises (SME) will only be eligible for EMA SME Benefits if they operate through an SME within the EEA and both U.K. and EEA entities meet the definition of an SME.

Although these Q&A reflect the current legislation, the actual outcome will all depend on the final settlement terms agreed by EU and U.K. governments. If an existing or new structure can be utilised to keep the UK under the EEA umbrella, then many of these potential barriers will disappear. As any arrangements are likely to be reciprocal, affecting pharmaceutical companies based inside and outside the EEA, negotiations may lead to a greater concensus than is apparent at the start.

Queen’s House Consulting is based in U.K. and will continue to offer its services to clients inside and outside the EU. Please contact Queen’s House Consulting to discuss your particular needs.

To read the EMA Q&A, click here.




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