Category Archives: Health

gk - How is the ambition for NHS transformation being impacted by COVID19’s ‘new normal’_

How is the ambition for NHS transformation being impacted by COVID19’s ‘new normal’?

GK Strategy is frequently asked to outline the landscape of healthcare spending and reform, what services will see increased demand over the next decade and whether the coronavirus pandemic will accelerate or inhibit wider transformation within the NHS. We are also asked how the role of private providers might change and how they can best anticipate and address changes
in commissioning and service delivery.

In this blog, GK Consultant, Joe Cormack examines these questions to show where there is alignment between COVID related changes and longer-term plans to develop a more sustainable healthcare system.

Download the full piece here: How is the ambition for NHS transformation being impacted by COVID19’s ‘new normal’

gk - testing is the key to the success of the adult social care winter plan

Testing is the key to success of the Adult Social Care Winter Plan

By Phil Hope, former Care Minister and GK Adviser

The Adult Social Winter Care Plan published recently is hugely important as it sets out the national support available for the social care sector for the next six months of the winter and the main actions to be taken by local authorities, NHS organisations and social care providers including the voluntary and community sector (VCSE).

There is a sense that older people have borne the brunt of this pandemic and that care homes earlier this year did not receive the support they needed in terms of protective equipment, staff training, access to testing and infection management to ensure their residents were safely cared for.

The wide-reaching Plan responds directly to many of these concerns and includes much needed additional £500 million for the Infection Control Fund (ICF), free PPE via the PPE portal and local resilience forums, free flu vaccines for all health and care staff, a new Adult Social Care dashboard of critical data, and the welcome appointment of a chief nurse for social care in the Department for Health and Social Care.

The Plan sets out a series of key actions to be taken by local authorities that relate to both self-funded care providers and local authority commissioned services. It requires them to put in place their own local winter plans that address local inequalities and involve the NHS and the VCSE in their development. It expects local authorities to distribute the additional ICF funding as quickly as possible, provide free PPE to all care providers including to personal assistants and ensure care providers carry out Covid-19 testing as set out in the sperate testing strategy.

The Plan also expects care providers to update their business continuity plans with a particular focus on workforce resilience, make use of the additional ICF funding, reduce the movement of staff between care settings, provide relevant data through the Capacity Tracker and ensure symptomatic staff and recipients of care are able to access Covid-19 testing as soon as possible. Care providers are also expected to develop a policy for limited visits in line with local and national PHE guidance.

The requirement that patients being discharged to care homes must be tested prior to discharge from hospital is welcome but it is essential that results are made available. Care homes must not again be put under undue pressure to accept COVID-positive patients from hospital, and must be supported to provide adequate accommodation and isolation facilities for residents returning from hospital. The development of a designation scheme for premises that are safe for people leaving hospital who have tested positive for Covid-19 or are awaiting a test result is of particular importance.

Most, if not all, councils care providers will also have stocked up with months of PPE supplies in advance of the Plan as part of their pandemic planning and the government should make clear that they will be compensated for these costs through the free PPE pledge.

The main concern in the sector is the effectiveness and efficiency of the testing system. The success of the winter plan will fundamentally depend upon ready availability of Covid-19 testing for care home residents and staff. Work to ensure that tests can be turned around rapidly, and the results conveyed to care homes, should be an immediate priority. The failure to provide sufficient testing capacity or deliver rapid results from test samples will make action by care providers to ensure the safety of their residents, staff and volunteers extremely difficult. Test results that take 5-7 days to turn around for example are of no use to care home providers. Many will take a precautionary approach in the absence of reliable data and this could lead to higher costs and increased isolation of care recipients from their families and friends.

For the long term it is unclear when a new settlement for social care will be put in place. System and funding reform is still on the government’s agenda but is on hold whilst the focus for adult social care is for everyone to receive the care they need throughout this pandemic. So, the challenge for social care remains – to be given parity of esteem with the NHS and to receive a very substantial funding increase in order to provide affordable care for many more people who need it.

GK are experts in social care policy and have supported many providers in the space over the past 11 years. If you would like to speak to one of our consultants please contact emma@gkstrategy.com

gk - What is the policy and regulatory environment for online pharmacies

What is the policy and regulatory environment for online pharmacies?

Online pharmacy is a sector that has seen considerable growth over recent years, and policy and regulation is evolving quickly as a result. Those with an interest in the market should be aware of the issues to consider and the likely future direction of travel.

 Overview and market development

 The growth of the online pharmacy market has arisen in the context of severe financial constraints on the NHS. Increases in the level of demand for NHS services, increasing complexity of patient conditions, complex structural changes within the NHS and the overall constraints on fiscal policy pursued by the Government since 2010 have resulted in an environment in which traditional pharmacies have struggled. The expectation for community pharmacies in particular to offer additional health services in light of funding constraints elsewhere in the health ecosystem at the same time as suffering direct funding cuts, as well as the high fixed costs associated with a bricks-and-mortar pharmacy, has meant that the traditional model has come to be seen by senior stakeholders – including NHS England chief executive Sir Simon Stevens – as expensive and inefficient.

 Although community pharmacy figures in the NHS Long Term Plan and the Government is enshrining in legislation a commitment to increase NHS funding each year to 2023/24, the traditional pharmacy model should not be assumed to be an immediate beneficiary of these funding uplifts. Online pharmacy will, therefore, continue to benefit from an environment in which financial resources for pharmacies continue to be limited and online providers can offer a more efficient alternative.

 Despite a shift in focus towards online pharmacies, the Government and regulators are increasingly conscious of public and health stakeholder concerns that the online market has been under-regulated. While policy-makers will be keen to ensure that efficient and cost-effective alternatives to traditional service models are actively promoted, they will also be mindful of the risk to patients where apparent loopholes exist. Recent regulatory debates have focused on introducing more stringent checks of patient identification before prescribing medicines for conditions such as diabetes, epilepsy and asthma, and broadening the remits of the Care Quality Commission and General Pharmaceutical Council to ensure online pharmacies are fully covered by regulations regarding workforce qualifications.

Drug pricing

The Drug Tariff is set by the NHS Business Services Authority (NHS BSA) and is split into three categories: Category A, popular generic drugs where prices are set according to a weighted average of list items from four large suppliers; Category C, drugs that are not available as generics; and Category M, popular generics where prices are set according to information submitted by manufacturers and are changed on a quarterly basis. Drug pricing is monitored through the Pharmaceutical Price Regulation Scheme. Category M, which contains more than 500 generic medicines, has often been widely criticised by the pharmacy industry on the basis that products in this category are often not available to purchase for the amount by which pharmacies are reimbursed by the NHS, a key driver in funding squeezes on community pharmacy and growing demand for online pharmacy. The reimbursement rate for pharmacy contractors is also subject to clawback – a discount deduction that is set according to the monthly value of the medicines dispensed for each contract. The average clawback rate is currently 8%.

Current issues

The regulatory environment for online pharmacies is still developing. The sector is in a strong position to benefit from existing pressures on traditional and community pharmacies which are unlikely to ease in the short term but must be agile in responding to inevitable policy and regulatory change. The main challenge for online pharmacies is to be able to demonstrate to policy-makers and regulators that they are not only compliant with current regulatory requirements, but are proactively ensuring that they are taking steps to ensure that they are prioritising patient safety, and offering a reliable and consistent service across local commissioning areas.

Businesses in this space should also be mindful of potential reputational issues associated with the growth of other areas of online primary care such as the online GP market, and political attitudes towards high-profile providers such as Babylon, where there is also an evolving regulatory framework that is responding to the twin challenges of addressing diminished capacity within traditional NHS services, and concerns from local commissioners and others over patient safeguarding and sharing of sensitive medical data in relation to use of new technologies. Businesses should take note of these issues and understand where similar political and media scrutiny might arise in relation to online pharmacies, and the risk of these businesses being caught up in clampdowns on other online primary care services.

 Points to consider
  •  Implementation of the Long Term Plan – how will this play out for community pharmacy and will it mean that limited capacity in other areas of the health service continues to drive demand for online alternatives?
  • Reputational and regulatory risks – what changes could be introduced to the regulatory framework to address concerns over patient safeguarding? What steps can businesses take to pre-empt any regulatory change and demonstrate that they are proactively responding to these concerns?
  • Drug pricing – what scope is there for changes to drug pricing and the current approach to pharmacy remuneration, reimbursement and clawback? How well are businesses set up to respond to changes in pricing for different categories of medicine, and can online pharmacies maintain a competitive advantage if the funding model for community pharmacy were to change and clawback increased for online contractors 

For more information on how GK can help you navigate policy and regulatory change in this market, please contact jamie@gkstrategy.com

gk - The Medicines and Medical Devices Bill- the impact and opportunity

The Medicines and Medical Devices Bill: the impact and opportunity

On the 2nd March 2020, the Medicines and Medical Devices Bill 2019-20 went through its second reading in parliament. It has been one of the first pieces of domestic legislation to be introduced since the Queen’s Speech in December 2019 and represents a critical area of post-Brexit regulatory change.

The Bill is politically uncontroversial. It passed first and second readings unopposed by the Labour Party and is more about the need for legislation to return regulatory powers to central government rather than a Brexit-fuelled political move.

Nevertheless, the legislation can define the medicines and medical devices regulatory environment for years to come.

Specifically, the legislation could have a significant impact on contract research organisations (CROs) whose interest is in stymying excessive divergence from US and EU clinical trial regulation. The following are just a few areas the bill might interfere:

  1. The speed of approval processes for clinical trial applications

The UK has a reputation for world-leading standards in clinical research. It has several world-leading universities, research organisations, institutes and scientists operating around the ‘Golden Triangle’ (London, Cambridge and Oxford) and beyond. These hubs ensure pharmaceutical companies get the most out of phase I-III research, while also having applications approved quickly by the renowned Medicines and Healthcare products Regulatory Agency (MHRA). The combination of an effective and accessible regulator in the MHRA and its close relationship with NICE must be protected.

  1. Alignment to the EU Clinical Trial Regulations (CTR)

The UK and, specifically, the Clinical Trials Unit of the MHRA played an active and leading role in the development of the EU Clinical Trial Regulations over the past five years – due for implementation during 2020. The regulations aim to create a single set of standards across the EU, establish a single method for submissions to assessment processes and increase transparency, collaboration and information sharing across EU Member States.

While the UK’s departure from the EU means that it won’t be implementing the regulations it helped to develop, CROs across the country will want to ensure that the future of the UK’s clinical research regulation is as closely aligned to the EU as possible. This will ensure its ability to deliver competitive, expeditious and high-quality research. The Medicines and Medical Devices Bill should facilitate this alignment.

  1. The introduction of bureaucratic processes and regulatory burden for CROs

There is some anxiety in the CRO sector that the new regulatory environment will cause a significant bureaucratic burden when it comes to clinical trial applications. If the legislation oversees a divergence in regulatory standards and processes from other markets, applications to the MHRA could require more and different information to the U.S. Food and Drug Administration and the European Medicines Agency. CROs will be eager to mitigate this risk.

These are just a handful of areas where the Bill might affect CROs and the life sciences industry. Others include patient safety, pharmacies and medicine supply chains, as well as manufacturing, labelling and packaging.

GK Strategy are experts in political and government engagement, with long-standing experience and understanding of the life sciences and clinical research sectors. To discuss further with our team, please do get in touch via ian@gkstrategy.com