Written evidence submitted by British In-Vitro Diagnostics Association (CLL0019)
October 2020
Contact: Jon Harrison, External Affairs Manager
Contents
Number | Description | Page |
1 | Foreword | 2 |
2 | Summary | 2 |
3 | Process | 3 |
4 | Quality | 3 |
5 | Capacity | 3 |
6 | Transparency & Communication | 3 |
7 | Methods of Procurement | 4 |
8 | Decision Making | 5 |
9 | Recommendations | 5 |
BIVDA (British In Vitro Diagnostics Association) is the national industry association for the manufacturers and distributors of in vitro diagnostic (IVD) products in the UK, representing almost 200 organisations including multi-nationals and SME’s.
There is a highly active and competitive UK IVD Sector with products such as equipment, tests and quality pre-analytical consumables available within robust, highly regulated supply chains. In consultation and collaboration with government, we are confident that our members can work together to increase capacity to further increase supply in the volumes required to support the Government in the fight against COVID-19.
Our members provide the quality tests of differing methodologies, such as PCR, Antigen, Rapid, Lateral Flow, Point of Care, Antibody and now also non-invasive tests such as Saliva and molecular multiplexing for identification of COVID-19 alongside the seasonal and non-seasonal respiratory conditions.
The paper submission incorporates a reflective view; capitalising on lessons learned and is intended to also highlight improvements that the Industry has experienced over time due to increased communication and inclusion.
BIVDA and its members are keen to ensure that continued collaboration and consultation occurs throughout the next stages of managing this pandemic through testing and robust supply chains.
The IVD Industry recognises that the Pandemic required urgent and decisive action when COVID-19 reached the UK as early as February 2020, and the use of emergency regulations and direct awards to suppliers was perceived to be the most appropriate course of action to secure the necessary stock of health supplies and testing. However, BIVDA as the industry trade association was not utilised to best effect at the outset and selection of suppliers and awards of contracts were not satisfactorily transparent.
Issues relating to multiple departments and individuals being involved probably contributed to this. Splitting focus between PHE, NHS England and other organisations likely contributed to reduced efficiency and transparency. This has improved significantly, particularly with the creation the New Supplier Mapping - Labs, Supplies and Innovation team, Test and Trace but must be consistent moving forwards.
There was some interaction; but BIVDA’s subsequent involvement in the wider scope was only after many decisions and actions had been taken. Therefore, an opportunity for an overall faster response, and one of quality was unfortunately missed under the assumption that there was no UK Diagnostics industry – as publicly stated and subsequently retracted by the Right Honourable Matt Hancock. BIVDA understands that the DHSC was inundated by suppliers with products to offer, many were likely unsuitable and passably looking for a quick profit, but these suppliers were also unlikely to have been BIVDA members.
Even today there is the belief that “one of the things that is a constraint of the nation is that there are no domicile UK companies, there is no ability to scale up and manufacture and the holistic piece cannot be achieved without this” Sir John Bell. 28.09.2020. This is something we seek to re-dress and where required improve by working closely and collaboratively to respond to demand. A report is being written by BIVDA to demonstrate the current and future potential capacity of UK domicile IVD manufacturers.
The process to acquire testing for both supplies and capacity was unclear from the start and embedded and existing procurements were not utilised. Whilst PHE states publicly that products do not have to be approved [by them] and they do not mandate the use of particular products, this was the message that laboratories were given (and many still believe to be the case). The evaluation of tests particularly the well-publicized antibody test evaluations was disjointed and there was no apparent process with some suppliers having the same kits returned with materially different evaluation reports, and many suppliers receiving no response at all (or kits supplied for evaluation being lost altogether). This means that supplies were and are available but there is no way to provide them due to laboratories not realizing they are free to procure as they choose. Even now when the initial urgency is over, until recently, suppliers reported that they were still unable to secure contracts with laboratories nor submit products for approval, since there is was no clear instruction as to the method to do this. BIVDA were able to derive the correct process and notify our members collectively following a very informative discussion with the Deputy Chief Scientific Officer at DHSC and the Technical Manager at PHE in August. It has since been clarified that centrally procured kits and instrumentation are provided to the NHS with no cost to the Trust, however where Trusts procure directly (which is accepted by PHE, DSHC and the NHS); they will be reimbursed a cost per test price. BIVDA are not aware of the process to do this and would welcome guidance for members.
Whilst the urgency has currently subsided, in the event of a second wave, lessons from the outbreak of the Pandemic should be considered.
Quality has been at the forefront of the fight against the pandemic, with much being reported in the media about low quality and unapproved methods, the BIVDA membership are all highly reputable companies who sell high quality, regulated products and who work in an arena where reputation, quality and safety is what drives success. The reputation and quality of the organisations would have ensured that the quality and performance of the products available would have been to the desired specification and in line with the regulations to which the companies adhere and register products (IVDD/IVDR).
The insistence that there is no capacity in the UK is not fully understood, since capacity in terms of supply chain and ability to supply from our members seems to be at odds with the view of government. It would be useful to understand if there is another criteria included in the government view that is not considered by Industry. We recognize that this may relate to local manufacturing and the recognition that there are a limited number of high profile UK headquartered organisations in our industry. However, this is not a limitation of our industry but an opportunity for government to make the UK a desirable place to manufacture. Supporting investment and incentives for IVD’s as put forward by BIVDA in the comprehensive spending review submission would help to address this situation.
Finished Goods – All UK suppliers had access to significant volumes or actual stock of test kits and materials required for the demand, and whilst the demand was significant and there may have been some issues they would have been reduced and stocks could have been secured with a much lower risk of failure to supply.
Analytic Platforms – Within the NHS laboratories and several other private laboratories which support the NHS there was (and likely still is) spare capacity to undertake testing. This was largely due to the routine and non-COVID-19 testing reducing by as much as 60-70% for suppliers and laboratories where analytic platforms were idle due to the core laboratory business – much of which is GP driven – reducing drastically. The emergency response could have scale up much more quickly. Many NHS Trusts would have been able to deliver the requirements and – given the opportunity – BIVDA members could easily have helped identify this capacity utilization opportunity and shared it. BIVDA supports the calls from the RCPath, ACB and IBMS to be more involved in the next steps of the testing strategy, and the need for laboratory capacity properly scoped.
Manufacturing – similarly, manufacturing lines and scheduled orders were no longer required for many manufacturers and contract manufacturers who BIVDA are proud to have within the membership. This would have enabled the rapid and responsive manufacture of any additional tests. Partnerships between R&D and Contract manufacturers already exist in the UK and these were not utilised. Many suppliers would have been able to scale up UK manufacturing to re-purpose existing manufacturing capability and there would be less reliance on overseas imports and the supply chain risks associated. This becomes increasingly important in a post Brexit UK.
Whilst Industry understands that this Pandemic, and the response to it, was sensitive and required media control, the industry itself would have benefitted from regular communication, updates of procurement requirements and requests for the necessary information. The communication both formally and informally across NHS Trusts, Industry Webinars and through direct communications was often inconsistent and the process around submission, evaluation and approval of COVID-19 test kits was confusing (as previously stated). There has been an improvement seen by members, and this is largely to do with procurement teams ensuring that contacts and contracts were updated, and introductions made when internal personnel changes occur on these projects and this will need to continue improving.
The UK usually enjoys a fair and transparent competitive IVD market, with both the NHS and the private sector, and there was no change in law to suggest anything other should have been expected. The use of Regulation 32 (2) (C) was understandable in some circumstances, but the transparency and call for competition could have been handled differently, it seemed to the suppliers and industry who were leading the R&D and manufacture of COVID-19 tests that only certain suppliers with direct influences were being awarded contracts and there were many different people involved and all giving conflicting factual information.
Routes to market and communication channels are already in place and ready to be utilised regardless of capacity needs. Utilizing these established routes, would not only enable procurement compliance and transparency, but also ensure cost control.
BIVDA members still do not feel that procurement is as transparent as it should be and BIVDA would like to see more communication with members – within commercial limitations – in the months ahead.
In the UK the procurement landscape can be difficult to navigate with differing routes to market and selling to the NHS. BIVDA and its members fully support the Public Health England Microbiology Framework which is designed to incorporate Covid-19 test kits and associated services within its published Lots, but this is only one of a number of different mechanisms, with the NHSSC Category Tower 8 framework which has recently been awarded yet not fully implemented and the Managed pathology Service Contracts which govern almost 90% of the general laboratory spend which attract VAT re-claim for an outsourced service under either Heading 31 or 45 of COS. If the VAT status of COVID does not remain exempt, the Public Health England Microbiology Framework will not deliver the best cost to the NHS. It would be helpful to determine a common method of procurement which is kept up to date and standardized with regards to process and delivery. The PHE Framework is intended to be a form of procurement if there is not a more suitable one available to the purchaser, which is confusing to suppliers and purchasers alike.
Throughout the Covid-19 crisis, it has been difficult to determine who was making decisions on testing and which organisation suppliers needed to communicate with. Communication and alignment weren’t obvious between the differing agencies in NHSE, NHSI, PHE and DHSC as well as there being direct Cabinet involvement. Suppliers were also experiencing this lack of clarity in communications from customers who were also unclear as to the hierarchy of decision making during this time with often conflicting information being released. BIVDA members would very much welcome a clear and well defined command and cascade structure and approach.
Working with BIVDA will enable DHSC to conduct transparent interaction with suppliers, to deal fairly and offer equal treatment to all and ensure that risk and uncertainty is managed through requests for information and clear communication channels. This alongside a clear and understandable evaluation process is critical when determining access to market for suppliers, and quality and continuity of supply for the DHSC. NHS Trusts need to be independent and understand that they should be able to make local decisions based on clinical needs. BIVDA can also support the cascade of information to suppliers when the Government or DHSC requires alignment with information and messaging which will help ensure clarity at Trust level as well as with Industry.
NHS England runs the risk of undermining efforts in each Pillar if procurement teams do not inform each other of the continued needs of each Pillar, and thus the needs required of Pillar Supplier. Disparity between Pillars is evident and Pillars are not working to congruent goals, nor being overseen to deliver to those goals in a manner which is mutually beneficial to both pillars and further allows for the Pillars to capitalize on the negotiation benefits of a combined purchasing approach. Working through BIVDA will help to drive a consolidated message across all suppliers to ensure clarity on supply across all Pillars/Programmes where testing volumes is weakened and behind target. To be effective discussions would need to be centralized at the NHS level as well.
Many BIVDA members are already conducting discussions with the relevant allocations team with NHS England on the Pillar(s) they support. However, these discussions are often led by non-scientific personnel. Inclusion of scientific understanding within these procurement discussions would support speed and clarity on decisions from both entities as well as effective onward management of information where new or alternative options on constrained supply routes or alternative Pillar needs can be managed effectively.
Whilst NHS England is considering this through their central allocation’s teams, this appears to be mainly reserved for those Companies with centrally organized supply contracts. Opening dialogue on this with BIVDA members may lend support ensuring sustainable supply levels where and when appropriate to enable the swift action of DHSC to address further infection spikes and the impact this has on all testing Pillar needs.
All BIVDA members are familiar with regulatory compliance and, indeed BIVDA has a Regulatory Working Group and strong relationships with the MHRA and MedTech Europe, to address needs required to meet market changes. Working with BIVDA gives you direct access to members who are already well-versed in this area. BIVDA would welcome the opportunity to create a channel where “calls for action” are shared with its members, enabling high caliber companies to respond providing accurate information on relevant products and/or services.
In order to fulfil the immediate requirements of laboratories to combat Covid-19, there has been significant manufacture and delivery of analytical equipment and ancillary laboratory equipment (not just for IVD and testing but many types of medical equipment) and this means that the market has effectively been flooded for up to 7-10 years in some cases. Many suppliers will have reduced forecasts and significantly fewer long term opportunities. BIVDA members want to be able to work with users and government to manage replacement and maintenance and ensure that operating remains viable for future years in the UK, as it is clear that strengthening the Diagnostics industry is key to future strategy and if suppliers are unable to make sales for a long period of time due to market saturation, this will be difficult to achieve.
Nov 2020