Category Archives: Government

gk brexit where next_

Brexit: Where next?

Only a year ago, British politics was dominated by the debate about Brexit. It says a lot for the impact of COVID-19 that since early March the virus and its huge economic, health and social impacts have relegated Brexit news to a few paragraphs on the inside pages of one or two Brexit-focused newspapers. But Brexit has in no sense gone away. The end of the transition period on 31st December 2020 looms ever closer, and Boris Johnson has made clear that in spite of COVID, he is not willing to contemplate an extension of this transition period. Boris Johnson may not wish to disappoint the Eurosceptic voters he was able to win over in the December 2019 election, and he may also be calculating that pushing Brexit through during this period of extraordinary economic turbulence will both mask any negative impacts and also put pressure on other EU member states (more nervous than ever about the state of their economies) to strike a pragmatic deal

To download the paper click here: Brexit Where next

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

gk - GK - David Laws' take on the cabinet reshuffle

David Laws’ take on the cabinet reshuffle

“Some reshuffles are about changing policy directions. Others are about chopping out the Cabinet “dead wood”. This one was about control – specifically, increasing the control over government from 10 Downing Street, including Boris Johnson’s powerful adviser, Dominic Cummings. Out went some senior ministers who Number 10 didn’t consider to be sufficiently “on side”. But the most significant move to “take control” was the insistence that Chancellor Sajid Javid should either consent to joint policy making between Numbers 10 and 11 Downing Street, or leave his post. Mr. Javid chose the latter option.

“Boris Johnson is not the first PM to discover in office that the Treasury can be far more powerful than the centre of government at Number 10. Number 10 has few human resources compared with the mighty Treasury, and limited direct options to shape economic and social policy. There are only three ways of resolving the power imbalance – for the PM to support a Chancellor he completely trusts and works with closely (Cameron/Osborne); for the PM to cede economic policy to the Chancellor but make occasional bids for influence (Blair/Brown), or for the PM to try to create a mechanism to force the Treasury to work hand in glove with his own advisers. The latter is now the option being pursued with the new Chancellor, Rishi Sunak.

“Just how much will the change in Chancellor result in a big change in policy – with extra public spending, and more borrowing to fund it? I doubt that the policy consequences will be quite as big as now predicted by many – Javid was already committed to extra borrowing to fund infrastructure spending, and the new Chancellor’s  CV hardly indicates that he is likely to turn into a big spender or pursue fiscally incontinent policies. What Mr. Cummings and Mr. Johnson clearly hope is that there will now be a much closer working relationship between Numbers 10 and 11 – and though Mr. Johnson cannot afford to lose another Chancellor anytime soon, the ruthlessness that he has demonstrated in this reshuffle will concentrate the minds of all senior ministers.

“What else is worth noting from the reshuffle? Certainly the appointment of Suella Braverman to the post of Attorney General – serious friction between the government and the judiciary seems likely. And while the fate of junior ministers usually doesn’t matter much, the departure of universities minister Chris Skidmore looks interesting. Skidmore was well respected by the universities sector, and appeared to take their “side” on many policy issues. Can we now expect a more radical approach to higher education policy and a revisiting of some of the Augar Review recommendations? This should be watched closely.”

GK - How important are select committees and their new chairs_

How important are select committees and their new chairs?

As we wait for both Labour and the Liberal Democrats to complete their respective leadership elections, some other significant elections have taken place within the House of Commons recently. The chairs of the Commons select committees – the prominent cross-party groups of MPs that scrutinise the activity of each government department and other political issues – were confirmed at the end of last month. Alongside frontbench opposition MPs, committee chairs are some of the highest-profile politicians outside of the Government.

With a majority of the committees chaired by Conservative MPs, how important are these committees, and how will their new make-up affect how policy is made?

A chance for Tory sceptics to find a new outlet…

Of the 16 Conservative MPs who will chair a select committee in this parliament, only one – Julian Knight, the newly-elected chair of the Digital, Culture, Media and Sport Committee – supported Boris Johnson in last year’s Conservative leadership election. While that is not to say that all of the others are necessarily opposed to Johnson’s political project, it is an opportunity for well-known chairs such as Jeremy Hunt – the former Health Secretary and Johnson’s leadership rival, now chair of the Health and Social Care Committee – to challenge the Government, and sustain their influence and profile within the party and across the Commons.

…and for new MPs to make a name for themselves…

Being active on a select committee is one of the ways in which ambitious new MPs can begin to carve out an identity for themselves. Whether loyal Conservatives with an eye on junior ministerial posts later in the parliament, critics of the Government wanting to build their profile, opposition members looking to catch Ministers out or subject-specialists wanting to contribute their experience, committee membership is one of the best opportunities for new MPs to make themselves known and advance their parliamentary careers. If you are looking for a parliamentary advocate for a particular cause or interest, understanding these dynamics is important.

Will select committees provide meaningful parliamentary opposition to the Government?

As well as chairing many of the committees, a large majority for the Conservatives means that they also hold sway over the broader committee memberships, as each party’s share of committee members is proportionate to the overall size of their parliamentary party. This means that while all MPs will take their committee responsibilities seriously in terms of providing scrutiny of government policy, in many cases it may be reasonable to assume that a significant proportion of members of any given committee are likely to be at least sympathetic to the aims of the Government.

There is also one important committee chairmanship that is yet to be decided: that of the Liaison Committee, membership of which comprises the chairs of all other committees and frequently calls the Prime Minister to give evidence on a range of areas of government policy. Outside of Prime Minister’s Questions, this should be one of the main ways in which MPs can scrutinise Johnson, but he has not yet appeared in front of the committee during his time in Downing Street and its new chair is unlikely to be elected for several weeks, further delaying the Prime Minister’s debut in front of the committee.

Select committees can be powerful and influential stakeholders in the policy-making process but, like many other political and parliamentary actors, their role is likely to be different with an executive that has a large Commons majority. For businesses thinking about engaging with MPs and the parliamentary process, understanding these changes is essential.

GK new government

The New Conservative Government: the current political landscape

The 2019 general election has led to several big changes in how Parliament and Government will do business over the next five years. What are they, and what do they mean for businesses affected by policy and regulatory change who want to make their voice in Westminster and Whitehall?

The Conservatives’ victory in December – securing them the largest parliamentary majority of any single-party government for more than a decade – means that the way in which businesses engage with government and Westminster politics has to evolve. While ‘getting Brexit done’ is a natural priority for Boris Johnson, there is a host of domestic policy issues that his administration has the political capital to address over the course of the next five years. This will be dictated to some extent by the shape of the Conservative majority, having taken seats in the North and Midlands that the party has not won for decades; there will be a prioritisation of these parts of the country as they seek to retain these seats at the next election, including further discussions about devolution and new infrastructure, as well as relating developments in education, health and other areas to the concerns of voters in these constituencies. The emerging policy responses to this will be at the forefront of the minds of savvy businesses who are engaging with government and political stakeholders.

While accounting for the importance of new MPs’ priorities, the scale of the Conservatives’ victory last month also means that the overall balance of power between Government and Parliament shifts again. A minority administration attempting to push through contentious Brexit-related bills had meant that Parliament had effectively seized control of the legislative agenda a much greater extent than in recent times; with a healthy majority, the Government will rarely have to worry about finding the path of least parliamentary resistance and will instead feel emboldened in putting radical policies before the House of Commons. Individual parliamentary champions for specific causes might still hold some sway around issues that chime with the Government’s own priorities; there may be less space for opposition MPs to influence the agenda, but there are likely to be ambitious new Conservative MPs with designs on junior ministerial posts speaking up from the backbenches. If seeking to engage with MPs and peers, this new dynamic will be an important consideration for businesses.

It is not only the size of the majority in Parliament that will influence the Prime Minister’s policy agenda and approach to governing. Johnson’s very different style of leadership from his predecessor will come to the fore over the coming months, with Secretaries of State and junior ministers taking more direct responsibility for leading the charge on their respective policy areas and less of a ‘command and control’ approach from Downing Street. Alongside this, there is also the possibility of wider changes to how the machinery of government works as consequence of Johnson’s victory. Dominic Cummings, the Prime Minister’s key aide, and Rachel Wolf, author of the Conservative election manifesto, have both called for radical structural changes to be made to the civil service – not just in Downing Street and the cabinet, but across Whitehall. These ongoing shifts in decision-making and accountability within government will mean that businesses need to find new and different ways of engaging as they seek to understand where individual ministerial priorities lie and how a reshaped civil service will deliver them.

GK has worked for more than a decade with businesses to help them understand and engage with policy-makers. For more information on how we could help your business, please get in touch emma@gkstrategy.com.

GK Jan 2020

How the Conservative majority will change political risk for investors

The Conservatives’ majority of 80 seats has removed one of the biggest political risks to investors. A hung parliament, let alone a Labour administration, will remain a distant possibility. The Prime Minister no longer needs to tread carefully to win votes in the Commons.

Yet, the actions of this single-party government – the first significant majority in the UK for over a decade – will be more complex to forecast. The dynamics of Parliament and politics have changed dramatically.

The unpredictability lies mainly in the tension between the pro-market impulses of the Conservatives and their awareness that their majority rests on a host of newly won seats, where concerns are very different from Tory heartlands.

There are several areas where the direction of Government policy – and the appropriate responses to it – can only be understood by in-depth analysis of these tensions and how various stakeholders inside and outside government will respond.

The new government will be more pragmatic than May’s and more willing to be flexible, but many ministers and advisors are keen to pursue radical agendas where it’s politically viable. Below we address some of the risks and opportunities the new government will bring, and how investors can use political and regulatory due diligence to address them.

1. Brexit

  • The Conservatives’ majority allows Boris Johnson to pursue a Brexit deal without having to compromise with the ERG (the European Research Group of Tory MPs in favour of a hard Brexit) in one direction, or opposition parties in another.
  • Johnson’s priority is likely to be greater divergence from EU regulations, which may increase costs and impact exports (especially where the EU makes imports more difficult).
  • However, the 2020 timetable for negotiating trade talks may force more Government compromises as its priority is to ‘get Brexit done’ and move on to a domestic agenda.
  • New limitations on EU migrant labour might affect labour costs and availability, especially in health & social care, hospitality, and food & agriculture.
  • Financial and administrative burdens of hiring skilled workers from abroad could also increase, though overall access to skilled workers is likely to remain high under a new immigration system.

2. Deregulation and disruption

  • The Conservatives can now pursue deregulatory agendas far more extensive than would have been possible in a hung parliament, including in areas like public health.
  • This might mean that the regulatory costs of entry and participation in many sectors might go down, and incumbents might face more competition.
  • The scope for challenger brands and regulatory space for disruptive tech and business models should also increase in this scenario.
  • This would clearly bring associated risks. A decline in business standards as a result of lower scrutiny could threaten the reputation of a sector, and over the long term lead to a reinstatement or even tightening of regulation.

3. Public spending and taxes – increases and cuts

  • Public spending is likely to go up in several well-flagged areas – especially health, education and transport.
  • Adult social care could emerge as a medium-term priority, with a healthy majority potentially giving it the political capital to propose radical solutions, as well as a growing impetus for policy-makers to act to increase access.
  • However, despite election campaign promises, Conservative fiscal impulses for sounder public finances are bound to make themselves felt, especially given the reluctance to countenance any significant tax increases to finance higher levels of public spending.
  • This may result in slower-than-expected or negative real growth in public funding for certain sectors, restricting growth opportunities for some investor-backed businesses.
  • Johnson and Sajid Javid’s instincts are to reduce the tax burden on households and businesses, but some wider tax reform beyond simply cutting headline rates is likely. Measures such as Entrepreneur’s Relief – which narrowly avoided being scrapped by Philip Hammond last year – could be candidates for reform or abolition if they are judged to be inefficient ways of stimulating economic activity.

4. Labour markets

  • Nowhere will Conservative tensions be more apparent than in labour market reform.
  • Post-Brexit restrictions on EU unskilled labour have already been mentioned as part of a future immigration system – an important issue for Conservatives as it links departure from the EU with tangible post-Brexit changes that many new Conservative voters will welcome.
  • The Conservatives also know that the proposed IR35 reforms (very much a fiscally driven Treasury/HMRC initiative) could also negatively affect many self-employed voters, as well as the ability of business to access a flexible workforce. It might also affect the cost and timing of proposed new infrastructure projects.
  • The Government is also committed to strong enforcement of labour market regulations: the director of labour market enforcement is Matthew Taylor – the author of the very influential Taylor Review of Modern Working Practices.
  • The outcome could be some changes to the IR35 reforms and their implementation, alongside a renewed focus on better enforcement in order to regulate the gig economy – especially around the most egregious practices.

5. Private pay

  • The Conservatives are determined that they cannot ever be portrayed by the Opposition again as being in favour of NHS privatisation or at risk of becoming an American-style health service.
  • In practice this means that the Conservatives are likely to further increase NHS funding and avoid any high profile contracting out of clinical services.
  • But this would not rule out measures to facilitate more private pay options, in health and social care and education, either through insurance or direct payment.

6. Public procurement and structure of government

  • Dominic Cummings, the Prime Minister’s key adviser, has written at length about problems with Whitehall (from poor project management, inertia and weak incentives).
  • Significant short term change is unlikely, but one can expect big changes in procurement and government project management (with perhaps more rigorous management and appraisal of current and potential projects and contractors).
  • But the Conservatives – or, rather the Cabinet Office – have been pursuing a quiet revolution in procurement for some time – driving a more systematic approach to procurement across Whitehall and creating more opportunities for SMEs to bid successfully, while trying to loosen the hold of some of the biggest government contractors, especially post-Carillion.
  • We can expect this to continue but married to significant reforms to change incentives in Whitehall and bring in more private sector expertise (mainly through recruitment than via contracts with the big consultancies).
  • Exit from the EU may also bring a more ‘UK-first’ approach to tendering, though the UK has historically been very open to awarding contracts to foreign companies in infrastructure, energy and defence.

7. Education

  • Skills and technical education have been made a clear priority by the Government, and this is likely to be reinforced by the Conservatives’ election victory. One of the dynamics that emerged in analysis of the 2019 election result is a swing among non-graduates towards Johnson’s party and a shift away from it by graduates.
  • This is already an area subject to significant change with the introduction of T-levels and likely reform to the apprenticeship levy; outside of the focus on schools spending, we can expect this to be at the forefront of the Government’s thinking.

In short, while a comprehensive Commons majority allows the Prime Minister to be decisive on Brexit, the new complexion of the parliamentary Conservative party will be important in how domestic policy priorities are shaped over the next five years.

This new environment requires a different approach to political and regulatory due diligence. Identifying and responding to policy-driven risks and opportunities will take a more nuanced approach, alert to rapidly changing dynamics within government and Conservative policy making circles. Actions to mitigate risks and leverage opportunities will also need to be different, to resonate with new political stakeholders and agendas.

For more information on how GK can help investors and companies negotiate and adapt to this new environment, please contact us at martin@gkstrategy.com.