Monthly Archives: March 2020

gk Building an effective trade organisation

Building an effective trade organisation

Achieving desirable policy change is one of the main rationales for trade organisations, especially in regulated and politically-sensitive sectors, as most businesses and third sector organisations are often unable to achieve significant change on their own.

How can a trade body be truly effective in achieving such change? And how can they engage their members best to achieve such change?

We have set out a number of problems that trade bodies can face in this regard and how they can overcome them.

Getting the basics right first

For new membership bodies, putting the foundations in place for a group to be established is the most important first step. For existing organisations, making sure there is a clear articulation of the purpose of a group and that it is run on a sound, sustainable basis is key to maintaining growth and attracting new members.

Defining the overarching purpose of the group is vital. There is a diverse range of membership bodies, each with their own raison d’etre and serving the particular needs of their members. Bodies might be set up to campaign on a single issue or formed in response to a policy development – to repeal a specific aspect of legislation, or to raise or lower a particular tax, to name some examples. They might be formed as a splinter group from an existing trade body, if they are dissatisfied with its direction or feel that there are separate issues that need to be addressed in a different forum. Whichever category they fall into, all successful trade bodies will have a clearly-defined purpose.

Deciding on the right structures to have in place – membership criteria, governance, financial management, clarifying the legal status of the body – as well as the foundational purpose of the group is essential to being able to move forward as a representative body that has genuine buy-in and a collaborative approach from its members, and continues to grow in its membership.

Providing tangible benefits for members

Simply put, membership bodies will only grow if they are able to show how businesses can materially benefit from joining. This can manifest in different ways. It could be to do with provision of high-quality external services and products to members, such as training and development, internal advice on policy change and regulatory requirements, or even access to particular financial benefits such as insurance.

However, the most fundamental benefit for businesses subscribing to a membership body, especially in a regulated or politically-sensitive industry, should be gaining a level of representation and influence that they could not achieve on their own. Whether with central government, local authorities, key statutory regulators or independent decision-makers in their own markets, membership need to be able to show how they are able to communicate the views and priorities of their members on the relevant issues in their industry to key decision-makers and stakeholders.

Developing a clear strategy

This is arguably the most important aspect of a successful membership body, but can also often be the most challenging to get right. Attracting a growing and diverse membership is a real strength for organisations seeking to represent a whole industry, but naturally presents obstacles to reaching clear agreement over strategy. Managing internal politics is often one of the trickiest parts of running a trade organisation, and can be their undoing if not handled in the right way.

No membership body can achieve unanimity on its policy positions given members’ different interests and priorities, but as long as disagreement is managed effectively – ensuring that all voices are heard and respected, and clear baselines agreed – then there should be few barriers to communicating a message and carrying forward priorities that at least a majority of the membership can support. Bodies should not try to be all things to all people – individual members should be free to communicate their own priorities individually, as long as it is not opposing or undermining the core purpose of the group – but seek to listen to all views and reach a fair conclusion that does not materially disadvantage any member.

That members are heard during this process is vital, as for many this will be one of the key benefits of subscribing to the body – that they have a seat at the table and a real say in what the organisation is proposing for the whole industry. This is so often a difficult balancing act with many different interests and priorities within the group, but successful bodies prove that it is possible to achieve. Membership bodies need to have a good understanding of their members and the dynamics between them, so that any potential disagreements can be pre-empted and quickly addressed, and good communication between the body and its members is essential.

A good starting point for uniting or galvanising members may be to commission a piece of external market research to be published by the group, which not only acts as a helpful piece of marketing and publicity for the body, but also provides an objective analysis of a particular question or set of issues around which a common view and potential solutions can form among members. If a group is struggling to decide on coherent messaging or specific points to communicate to policy-makers, a research report could prove a useful hook for external engagement and help to garner consensus among members.

Demonstrating progress and credibility

Developing and maintaining momentum is key for an effective membership body, not only for it to achieve its goals as an organisation but also to prove to its members that it is providing them with the value for money and the level of representation and influence they want from the group.

Effective management of internal communications is essential to demonstrating credibility, ensuring that all members receive clear communication, and have equal opportunity to feed into the development of the body’s priorities. Consulting members regularly is vital, as is keeping them ahead of the curve on the actions the body is taking a result and how members’ views are informing its approach.

Thinking creatively about external engagement, communications and campaigning is also vital to making and sustaining progress. Holding events with interesting themes can attract publicity; they also help to demonstrate credibility if they include speakers who are influential and well-respected within the sector, as well as relevant decision-makers who can engage directly with the issues raised by members. A strategic approach to interaction with key decision-makers – whether Ministers, officials, local MPs, regulators, councillors or others – is important and will have been informed by the group’s original purpose and strategy. Making effective use of publicity material, social media and other campaigning tools and techniques

How GK can help

GK has more than a decade of experience in creating, developing and supporting membership bodies across a range of sectors. Our consultants have worked alongside groups of businesses in some of the most significant and challenging sectors in the UK, helping trade associations and their members to have their voices heard by senior decision-makers in Westminster, Whitehall and local government.

Whether providing secretariat support, advising on policy and communications strategies or simply adding extra capacity to public and corporate affairs teams that find themselves under pressure, GK’s expertise has helped membership bodies to achieve their goals. GK’s in-house research team has also worked with membership bodies, and produces a risk matrix and policy stability index that can help bodies and their members to understand and negotiate the implications of policy and regulatory change.

Download Building an effective trade organisation here. To find out more about how GK can work with your trade organisation, please get in touch

gk - strategy-scaled

COVID-19: Short and long term policy impacts for investors and companies

The policy impacts of COVID-19 will not just extend to the many measures designed to help the economy over the next few months. The political and regulatory world will change profoundly and for the long term.

We are advising investors, portfolio companies and other organisations on what help is available and how they can best advocate for and access assistance.

The Government has shown its willingness to engage with business and respond to requests for greater clarity, revised eligibility criteria or additional support, and indeed offers of help, as we have found in our work for clients.

But there are six key questions that investors and management teams should also pose about some of the policy assumptions underlying their growth plans and existing risk assessments, as they model their businesses under a range of COVID-19 scenarios:

Will gig economy and labour regulation be revaluated?

The IR35 reforms have been delayed till April 2021, allowing time for a more significant review. But COVID-19 has highlighted how exposed many gig economy workers are to any sort of crisis.

This – as well as the criticism that the Government has received from its own benches over how it has handled the issue of employment security and workers’ lost income in the early stages of this crisis – is likely to reinforce the argument for employers to bear a greater burden of responsibility for their workers and contractors, as well as their permanent employees.

As the Government loosens some of the restrictions on access to and the generosity of Universal Credit, there may be more permanent change to how this part of the welfare system works. There are longstanding political criticisms of the design of this policy that the crisis will force policy makers to address, again particularly for households in insecure work. All of this could impact labour costs and flexibility significantly.

How reliant is your business on migrant labour?

The impact of Brexit on the availability of migrant labour has been a regular theme of our due diligence for the last two years, but this crisis has shown how many other factors – relating to pandemic control and people flows – could have a much more significant, sudden and less predictable impact than Brexit.

Will the tax holidays last longer than 12 months?

It will be extremely difficult for the government to revert to pre-holiday tax levels, unless the economy bounces back strongly, and particularly difficult to reinstate taxes on nurseries, which are already permanently exempted in Scotland and Wales. It will also be difficult because of the uncertainty of current Brexit timings (which may be revised).

This could lead to a more fundamental review of business rates or indeed any other tax measure that has a big impact on businesses that rely heavily on good cash flow. As the crisis has revealed, many businesses risk extinction even after short periods of massively depressed demand.

How might new public funding priorities impact your business?

The massive fiscal stimulus will inevitably require a reallocation of resources, if not cuts in some areas. Funding for health and social care will no doubt increase to improve long term resilience and deal with the immediate impact of COVID-19. However, some aspects of health and social care may receive less resource – particularly if they are seen as less critical to ensuring prevention and improving the capacity of the system.

Local government resourcing and priorities may also change, especially to ensure that vulnerable groups and schools and other civic amenities are better prepared (especially as COVID-19 will inevitably reappear until a vaccine is developed and made widely available).

How will public and private procurement change?

Public procurement will change to reflect new government funding priorities, but will also change to reflect the need to have more resilient supply chains in the event of further similar shocks.

This may mean encouraging more local and more national supply (especially post-Brexit), to lower exposure to long supply chains that might be vulnerable to multi-country measures that could slow exports. Some public sector bodies might choose to bring more provision in-house for similar reasons.

It may also mean that procurement tenders will be broken down into more lots, to encourage a broader supply base and reduce reliance on just one or two providers.

Procurement criteria is also more likely to require more comprehensive demonstrations of business continuity preparedness.

How will Brexit and the future of the EU be affected and what impact could this have on your business

Brexit could be delayed, justified by a more plausible and politically acceptable need for a longer implementation period.

But much bigger changes could be seen across the EU, as France and Germany’s authority and appetite for further EU integration is undermined by their own trouble managing the crisis domestically, as well as the manifest desire of all EU countries to pursue their own self-interest and impose strict border controls.

We expect many other changes, in terms of how Whitehall and Westminster and major public sector bodies operate.

Over the next 12 months, GK will be tracking these developments systematically and advising clients on how best to anticipate, prepare for and influence these changes, both in the near term and beyond the end of the immediate crisis period.





gk - How is the policy and regulatory environment for rail changing_

How is the policy and regulatory environment for rail changing?

With the resolution – for now – of the ongoing debate over the High Speed 2 rail line, as well as debates over public ownership of passenger services, what should businesses with an interest in the rail sector be bearing in mind from a policy and regulatory perspective?


 Rail policy is one of the most important aspects of infrastructure spending by the UK Government and often the front line of greater ideological debates over public and private ownership of essential services. A priority for parties across the House of Commons, it is viewed as both an essential contributor to economic growth and a magnet for media scrutiny when failures arise. Its wide public reach offers significant political influence to stakeholders across the sector, including Train Operating Companies (TOCs), SMEs and larger companies in the multi-product supply chains of UK and overseas rail networks, as well as retailers and caterers operating at railway stations and their own supply chains.

 Over recent years, much of the political attention has naturally been on the approach of both the Government and the Labour Party to passenger services and the role of private companies in operating these, particularly in the context of problems faced by Southern Rail and Govia Thameslink, and the transfers of Northern and East Coast Main Line services to the Government’s Operator of Last Resort. The Government commissioned the Williams Rail Review in 2018 to examine the current franchising model, and Labour’s policy of ‘re-nationalisation’ – waiting for existing franchises to expire and bringing them in-house – has been one of the flagship policies of its last three general election manifestos.

 Outside of the high-profile issues in relation to passenger service franchising and public ownership, as well as the ongoing debate over HS2 and other large projects like Crossrail, there are a number of policy priorities for the Government in terms of expansion of rail capacity, as well as ongoing projects to maintain and improve existing rail infrastructure across the country led by Network Rail. The decision to proceed with HS2 can be taken as an indication of Ministers’ commitment to additional capacity in the rail network, while Network Rail is engaging in an ambitious programme focused on maintenance and renewals.

 Network Rail sets out its priority workstreams according to five-year ‘control periods’. The last control period (CP5) concentrated on electrification (such as the Gospel Oak – Barking line in London and the Transpennine line between Manchester and Leeds), renovation of large stations (including London Bridge) and improving speed and capacity across a range of lines. A number of these projects have been significantly delayed and have come in over budget, creating some pressure on the Government and Network Rail to review how future investment programmes are decided. Control period 6 (CP6) began in April 2019 and will end in March 2024. There is a new programme of work focused on maintenance and renewals, and Network Rail is also aiming to complete outstanding projects from CP5 as part of CP6.

Current issues

Much of the Government’s time on rail policy will inevitably be spent on franchised passenger services as the Williams Review draws to a close and it continues to be a topic of political contention. Beyond this, the timely and cost-effective completion of CP6 projects will be a key issue given the overspend and delays to projects from CP5. The scale of what Network Rail is seeking to achieve in CP6 as it seeks also to complete outstanding elements from CP5 means that there should be ongoing opportunities for contractors to Network Rail, though suppliers should be aware of the continued pressure for the Government to change how rail investment decisions are made. The political priority attached to HS2 as a major national infrastructure should also provide opportunities, despite likely political and media scrutiny of spending and procurement decisions as the cost of the project continues to be debated.

Points to consider
  • Progress of CP6 and flow of funding – where are the opportunities for suppliers and contractors, and which are the priority projects for Network Rail and the Government? What are the prospects for further delays to existing and new projects under CP6 and how is the Government trying to prevent more overspend?
  • The Williams Rail Review – final recommendations for reforming the franchising system for passenger services and potential consequences for other parts of the sector
  • Overall approach to public procurement – in a post-Carillion environment, how does the Government think about outsourcing elements of significant infrastructure and construction projects to the private sector, and how might the regulatory framework for awarding Network Rail contracts change in this context?
  • Brexit and workforce – how will the new immigration system affect recruitment of skilled and unskilled workers, and domestic changes to employment status and IR35 affect engagement with the contractor workforce?

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

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

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