ABHI Membership

The Friday Blog: WHO Saw That Coming?

Wherever we happen to be, whatever the niche is we have found ourselves in this world, we are not immune from the impact of geopolitics. On Monday, Peter and I had one of those conversations that tends to make one’s head hurt. It was an update on some work done on our behalf by the Global Medical Technology Alliance (GMTA). GMTA brings together industry associations from across the world to advance issues of common concern and help national governments understand the global impact for the sector of policies emanating from individual jurisdictions. It also plays a key role in supporting supranational initiatives, which is where Monday’s call came in. We were receiving a briefing from Geneva on GMTA’s work with the WHO, and a fairly comprehensive programme it is too.

Current initiatives include preparation for a Global Forum on Medical Devices (Geneva, 2-4 June 2025), there is also work on a Diagnostics coalition. To date, WHO has only had an internal Diagnostics taskforce to coordinate the implementation of the WHA Resolution on Strengthening Diagnostics Capacity. WHO would like to broaden the taskforce to also include external stakeholders, including the GMTA and GMTA members. WHO is organising a meeting with non-State actors, including the GMTA, on the sidelines of the February WHO Executive Board, to discuss the idea of a broader coalition. The intent is to officially launch the coalition during the May 2025 World Health Assembly. Supporting this will work in the Definition of “diagnostics”. The WHO will share with the GMTA, the definition of “diagnostics” developed by the Strategic and Technical Advisory Group on Medical Devices (STAG MEDEV). There is also a medical imaging resolution, where efforts continue to find (preliminary) agreement on a draft medical imaging resolution, that will be submitted to the WHO Executive Board for discussion. Finally, and very significantly, of course, talks continue on the WHO Pandemic Agreement. The next round of negotiations is scheduled for 17-21 February. If all this is not enough, and under Addie MacGregor’s leadership, GMTA has convened a committee to consider the global impacts of sustainability initiatives by national health and care systems.

By Monday evening, we were contemplating to what extent this work might be disrupted by the flurry of Executive Orders being signed, live on stage in Washington DC, by President Trump. Catching our eye were those removing the US from the Paris Accord on climate change and membership of the WHO. It will take time for both to come to fruition, at least a year, and both were instructed by Trump in his previous term, only to be overturned by the incoming President Biden. The WHO move would also remove a huge chunk of funding from the organisation, which has played a straight bat in response saying on that this was “a government in transition,” so we would have to wait and see. Which is much as any of us can do to understand how things might pan out, with much interest also in what may yet to come in terms of trade. I think I wrote here previously that there was some speculation that a Trump Presidency might not be unhelpful when it came to EU / UK relations. The rational being that, with the potential rise of right-wing populism, the Union would need as many friends as it can get, and a new administration in London might look more favourably on closer ties than has been the case since 2016. It may well be that things are beginning to move in that direction.

Maroš Šefčovič, the European Union's new trade chief responsible for post-Brexit negotiations has said that a "pan-European [customs] area is something we could consider" as part of "reset" discussions between the UK and EU, and referred to the idea of the UK joining the Pan-Euro-Mediterranean Convention (PEM).

The PEM is a set common rules that allow parts, ingredients and materials for manufacturing supply chains to be sourced from across dozens of countries in Europe and North Africa to be used in tariff-free trade. The previous Government did not pursue PEM as part of its post-Brexit deal, but some believe that it would help the UK rejoin complex supply chains that have been hit by customs barriers. Speaking at the World Economic Forum in Davos, Šefčovič said the idea has not been "precisely formulated" by London yet and the "ball is in the UK's court".

Šefčovič also said that a full-scale veterinary agreement that helped reduce frictions on farm and food trade should also be reviewed. Single market treatment for UK food and farm exports would mean "we would have to have the same rules and we have to upgrade them at the same time, we call it dynamic alignment". The EU-UK fisheries deal, a major sticking point for negotiations, is also due to expire next year. “A solution for fisheries is very important for the EU, again, we communicated this on multiple occasions," Šefčovič said. He also believes that relations between the UK and the EU were "definitely" in a better place and his British counterpart Nick Thomas-Symonds was "on speed dial".

Significantly, and one for us all to follow is that Šefčovič acknowledged that the EU needed to be “extremely cautious and responsible" in addressing trade with the Trump administration in Washington but said he was willing to negotiate. He added that while the EU did have a surplus in goods such as cars, the US had a surplus in services.

People will be watching with interest as President Trump beams in to address the latest World Economic Forum in Davos this week. Attending in person was Rachel Reeves, who knows as much as anyone about the impact of geopolitics. Meeting her colleagues from around the world may have actually come as a bit of light relief for the Chancellor who has been busy touring our nation’s Regulators. Her meeting with the Competition and Markets Authority was certainly impactful, resulting in the immediate replacement of the Chair. I understand that both the MHRA and NICE are in the frame shortly, and we have communicated to officials how crucial getting regulation right is to ensure growth in HealthTech. Particularly pertinent is the current consultation on pre-market regulations, and we continue our advocacy work with the MHRA and Government to ensure that a UK regulatory framework supports both innovation and early patient access. We are advocating for indefinite recognition of CE marking to ensure smooth market access and to reduce duplication for manufacturers, as well as streamlined reliance on trusted approvals from jurisdictions such as the US, Australia, and Canada, to create efficiencies and align with global best practices. The regulator also needs to be adequately resourced to ensure that it has sufficient HealthTech sector expertise in the organisation, as well as the capacity to be sufficiently responsive, and really needs to consider its proposed fee structure if it is going to fulfil its obligations to the Government to be pro-growth.

Regulators in the health space, who may not be in-line for a cosy chat with the Chancellor, are having enough troubles of their own to be going on with. There is chaos at the Care Quality Commission with 500 reports “stuck” in an IT system and 5,000 expressions of concern awaiting triage or action, and the Nursing and Midwifery Council, which has just appointed its fourth chief executive in under seven months.

My old mate Andrea Sutcliffe, the last permanent post holder, left due to ill health last year to be replaced by interim Dawn Brodrick, who never actually started, who was in turn replaced by Helen Herniman, who was acting up. Now Paul Rees has been appointed as interim for 12 months with a brief to develop a “clear mission and plan” to get the regulator out of the mire. The search for a permanent Chief Executive will start when a new chair is appointed to replace Sir David Warren, who is stepping down. Nurses watching on may well wonder what on earth they are paying their compulsory annual fees for.

I wrote last time about the troubled new hospital programme, and this week action. Maybe not what a lot of people wanted and maybe not the kind of action that will address the ongoing issues facing our crumbling NHS estate, but an indication that the Government is happy enough, for now, to make itself unpopular. Eighteen of the 40 ‘new hospital’ schemes which were originally due to open in 2030 will now not even start construction until then, with some potentially facing a wait of until 2039 to even get spades in the ground.

The significant delays were set out in a review, and were described by NHS Providers as a “major blow” and by another trust CEO as “devastating”.

The review, “New Hospital Programme: plan for implementation”, reveals five schemes may have to wait until between 2037 and 2039 to start construction. These are Hampshire Hospitals, Royal Berkshire Hospital, Nottingham’s Queen’s Medical Centre and City Hospital, the Royal Preston Hospital, and East Sussex’s scheme. A further four projects will now wait until between 2035 and 2038 to start construction. These are both of the Imperial College Healthcare schemes, as well as North Devon District Hospital and Royal Lancaster Infirmary.

There is some good news, seven hospitals have been given the green light to start construction between 2025 and 2030, in addition to the seven hospitals with RAAC concrete risks, and other schemes which were already more advanced. The seven to start first include North Manchester General Hospital, Hillingdon Hospital, and Milton Keynes Hospital. The announcement follows Labour’s decision after taking office to review the NHP, which was launched back in 2019 by then prime minister Boris Johnson, due to concerns over affordability, timelines and prioritisation. 25 schemes had been awaiting the outcome of the review since summer. The announcement means all projects have now been given an indicative window for when construction of their scheme will start, with their funding to be confirmed later.

Interim CEO at Providers, and good friend of ABHI, Saffron Cordery said: “Trusts who are part of the new hospital programme account for more than 40 per cent (£5.7bn) of the total bill for backlog repairs and maintenance. Today’s announcement will make a difficult situation even more challenging. While today’s announcement finally gives trusts some certainty and clarity over their long-awaited building projects, this is still a bitter pill to swallow.” Imperial College Healthcare CEO Professor Tim Orchard was even more to the point, saying it was “devastating” news saying “The simple truth is that St Mary’s Hospital, in particular, will not last until the 2040s.” 

Young Wes was sticking to his guns, and that the Government had set out “an honest, funded, and deliverable programme” to rebuild the NHS. Be that as it may, I would not want his job, and quite how the maintenance issues will impact on the election busting promise to return the NHS to its constitutional 18-week Referral to Treatment standard, remains to be seen.

Could be worse. You could be in one of the England cricket teams. The Women are taking a serious beating in the Ashes, and the Men have made an auspicious start to the start of what is going to be very long tour of the sub-Continent. Players in both squads, whilst enjoying the warmth, are doubtless craving some of the wet and windy weather we are enjoying in Blighty.