The Friday Blog: Toronto's Other Big Gig
Which, this week, comes to you from Toronto, as our breathless month continues with AdvaMed’s annual MedTech Conference. This year, in the absence of an official UK delegation, Peter and I had intended for this to be a bit lower key and an opportunity to sit in on a selection of the sessions on offer. Not a bit of it. We have never had a busier conference. We met a number of US based CEOs of our member companies, as well as spending quality time with DBT’s North American, Head of Health, who had made the short trip across the lakes from Chicago, colleagues from other trade associations and the officials who had made the trip on their own account from the UK.
The conference is quite an endeavour, with some 4,000 delegates from over 40 countries, and this was the first year it had been held outside of the US. Not that the US was far from anyone’s mind with a general election just a few weeks away. We had hoped to gain some insights on who the next resident of the White House might be, but all some very, very insightful people could do was shrug their shoulders and talk about crystal balls. We do reflect that a Trump Presidency might actually help UK / EU relations, as Europe, rocked by the rise of right-wing populism on its own continent, let alone on the other side of the Atlantic, looks for friends and allies. The upcoming review of the UK / EU Trade and Cooperation Agreement, intended just as an assessment of how it had been implemented thus far, looks like it might end up being far more significant. It is the number one priority for our joint working group with MedTech Europe, and I look forward to providing updates for you in the months ahead.
Speaking of joint working, the MedTech conference always allows us to reflect on our relationship with AdvaMed, recently bolstered by an ambitious MOU. I think we should expect to see more in the way of joint working and advocacy, not least in responses to such things as the consultation on a new structure of MHRA fees. International feedback on the genuine concerns of industry will be very powerful in highlighting how the decisions made on local regulatory arrangements impact on the attractiveness of the UK for our sector. The consultation remains open for another week, and we have been busy collecting your feedback. It is not too late to share your thoughts with us, but submitting them directly to the consultation would also be tremendously helpful. If it helps, there are three areas over which we have specific concerns.
The proposed increase in statutory fees is out of step with inflation, and in some cases it may no longer be viable to supply certain products to NHS patients. Next, we do not believe that the proposals for some charges based on the number of GMDN codes registered by a company, offer an appropriate or fair methodology for determining fees. If implemented, we anticipate significant cost increases for the vast majority of manufacturers, with no consideration of risk classification, company size, or the number of products on the market. There is a very real risk that such measures could force companies to withdraw products from the UK, at a time when our business survey reveals that over 50% of companies are already delaying bringing innovation into the UK. Finally, the proposals also include a new regulatory advice service for medical devices, which is priced at almost £1,000 per hour. For comparison, the US Food and Drug Administration (FDA) does not charge for its equivalent service.
On top of this, Approved Bodies, who currently certify product approvals, are also facing a proposed 15% increase in their designation fees, another cost that will ultimately be borne by HealthTech companies. Regulatory costs in the UK are already significantly higher compared with those in other countries, such as the US. This situation is further exacerbated by the fact that the NHS remains unwilling to accept any inflationary costs from its supplier base. Part of our presence at AdvaMed this week is to promote UK PLC, and we really do, but we also have to push back hard on things that detract from the attractiveness of our country for our sector. The MHRA fees proposal is case in point, and we need your help in providing the evidence to allow us to do so.
Closer to home, I did mention last time that our old friend Sir Julian Hartley is to head up the Care Quality Commission. Well, I am not sure if his job got easier or not with the publication this week of the full independent report into the CQC’s operational effectiveness, confirmed significant failings, and the Secretary of State came out to fully support recommendations of the review to drive urgent improvements.
The report, led by Dr Penny Dash, Chair of the North West London Integrated Care Board, identifies significant internal failings at the regulator which are hampering its ability to identify poor performance at hospitals, care homes and GP practices. Its interim conclusions, published in July, prompted young Wes to order immediate action to restore public confidence in the effectiveness of health and social care regulation. The report provides seven specific recommendations for improvement, which Wes fully supports. This includes recommending that the CQC formally pauses the implementation of its assessments of Integrated Care Systems as it works to restore public confidence in health and care regulation. This will allow the CQC to focus on getting the basics right when assessing the organisations it regulates.
Streeting has now asked Dr Dash to conduct two further reviews moving her focus from operational effectiveness to patient safety and quality. The first review will examine the roles and remits of six key organisations and make recommendations on whether patient safety could be bolstered through a different approach.
These are:
- Care Quality Commission (CQC) including the maternity programme (MNSI).
- National Guardian’s Office (NGO).
- Healthwatch England (HWE) and the Local Healthwatch (LHW) network.
- Health Services Safety Investigation Body.
- Patient Safety Commissioner.
- NHS Resolution (quality and safety functions only).
A further review will focus on quality and its governance. This will guide the government’s next steps as it continues its drive for positive cultural change across health and social care. All findings will also inform the government’s 10-Year Health Plan to transform the NHS and social care and make them fit for the future. Of course they will. Absolutely everything is leading to the 10-year plan and it is going to be a blockbuster.
A glimmer of hope for integrated care as a former local authority leader has been appointed Chair of an ICB. Paul Najsarek was announced as the chair of North Central London. Najsarek was Chief Executive of Ealing Council for six years until 2021 and replaces former Camden Council boss Mike Cooke at the ICB.
In a statement Mr Najsarek said there were “undoubtedly challenges” on the NCL patch but added: “NCL is a place where partnerships are central and where different organisations are aligned around a shared population health ambition. North Central London ICB serves the populations of Camden, Islington, Barnet, Enfield and Haringey boroughs. NHS England Regional Director for London Caroline Clarke said in a statement: “The Chair of any ICB is an extremely important position, so it gives me great pleasure to announce the appointment of Paul Najsarek to North Central London. “As the Darzi report sets out, staff are the beating heart of the NHS with a shared passion and determination for making the NHS better for patients - but it is also clear they are facing unprecedented challenges. ICBs are integral to the work that needs to be done, working with NHS England and the government, to create a 10-year-plan to improve healthcare. I am really looking forward to Paul’s extensive and broad experience bringing real value to supporting the clear plans and progress that north central London is already implementing.” NCL ICB Chief Executive Frances O’Callaghan said: “The wealth of local government and healthcare experience that Paul brings from his 30 years will be invaluable in supporting north central London.”
As I have said before, joining up the NHS pound in a given geography is the first step in the integration of health and care. Beyond that it is joining up the wider determinants of health pound and ultimately running the NHS along the same lines as local authorities. If that is to happen we will need more people like Najsarek to take on possibly the most challenging leadership roles on the planet.
The biggest gig on the planet seems to be any one involving Taylor Swift and, while we have been here in Toronto, it has been announced that the singer possessing probably more universal appeal than any other at the moment, will play a series of six shows in the city. It is undoubtedly good, and lucrative, news. Last week at the event to launch our joint report with Imperial College, we were treated to an overview of industry plans in Singapore. One such was for tourism, and the presenter was quick to point out that Swift’s concerts in the city-state had attracted 300,000 visitors in the week she was in town. More than the Formula One Grand Prix. Go girl!
