Thermo Fisher Scientific – Written evidence (LSI0012)
This submission constitutes Thermo Fisher Scientific Horsham’s response to the Lords Select Committee on Science and Technology call for evidence into Life Sciences and the Industrial Strategy.
1. Introduction – Thermo Fisher Scientific
1.1 Thermo Fisher is delighted that the Committee has launched this inquiry and would very much welcome the opportunity to give oral evidence if the opportunity arose.
1.2 Thermo Fisher is a world leading multi-national biotechnology product development company, serving science through an unrivalled combination of innovative technologies, purchasing convenience and comprehensive support.
1.3 Our Mission is to enable our customers to make the world healthier, cleaner and safer which we deliver through our premier brands; Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services.
1.4 Thermo Fisher’s bio-services division in Horsham is an intelligence logistics hub providing all types of clinical supplies to clinical trials across the world – from ambient to cold chain biologics, comparator medication, controlled drugs and ancillaries.
1.5 Established 20 years ago, the facility comprises of seasoned primary and secondary packaging, labelling and logistics professionals dedicated to executing clinical trials of any size and complexity from investigator initiated studies to Phase I studies and larger Phase II and Phase III studies.
1.6 We offer a flexible, efficient and risk-controlled clinical supply chain to investigators and patients worldwide, with an unrivalled track record of getting clinical supplies to the right place, at the right time, in the right conditions.
1.7 We employ 680 staff (with a pay bill of £24m), 40-50% of which are skilled workers.
1.8 We make 2,200 shipments per week across the world, 15% to the UK and 62% to the EU although the latter was as high as 82% before the EU Referendum vote.
1.9 Our Horsham facility is integral to the life sciences ecosystem, as we ensure the smooth running of clinical trials and supplies for essential research and development across the life sciences sector. Our customers span across the entire life sciences industry, from large ‘pharma’ companies, bio techs and start-ups, to NHS hospitals and universities. We provide a viable route to market for new medicines developed by university researchers, supporting them to overcome major barriers. In particular, our base in Horsham allows an accessible supply chain for our customers based in the UK which can be critical when there is an urgent need for experimental treatment for disease patients in severe conditions. Our Horsham site is a fantastic example of foreign investment in UK life sciences manufacturing, yet this and future investment is under threat from Brexit.
1.10 In addition, we fund a local training programme to train the next generation of scientists in STEM subjects, and our senior staff lecture at local universities.
1.11 Given the critical part we play in the supply chain, the local economy, and the wider economy, we are fundamental to helping achieve the Government’s Industrial Strategy objective to “make the UK the best place in the world to invest in life sciences”.
1.12 However, the site has seen a 30% year-on-year decline in growth because customers fear their drugs from the relevant trial would not be easily exportable to the EEA.
2. Impact of Brexit on Life Science
2.1 The inquiry’s focus on this crucial topic is commendable; for Thermo Fisher, the key priority is Qualified Person (QP) status. Specifically, Brexit jeopardises the entire clinical trials industry as pharmaceutical companies feel they cannot now commission new trials in the UK as the drugs would not be easily exportable to the EEA.
2.2 A QP is someone who is legally responsible for certifying that each batch of a medicinal product is suitable for release for sale or for use in a clinical trial. They are essential in the quality assurance of medicines and ensuring that good manufacturing practice is in place.
2.3 European Union regulations dictate that when carrying out clinical trials within the European Economic Area (EEA) using Investigational Medicinal Products (IMPs) that may have been manufactured outside the EEA, there is a requirement for a QP to sign a QP Declaration. Put simply, without QPs you cannot supply medicines to clinics and it would immeasurably slow down the progress of clinical trials.
2.4 Currently, QPs based in the UK can act as QPs across the EEA – offering a competitive advantage compared to non-EEA countries, as they can sign off IMPs to be distributed across the continent from the same site.
2.5 The EU referendum result has thrown the recognition of British QPs’ status in the rest of the EEA into serious doubt and confusion, which is already having an immediate impact on businesses like the Horsham facility. If QPs in the UK are no longer recognised as such in other EEA countries, then there will be a requirement for any IMPs exported from Britain to have a QP based in each customer’s country. This added layer of complexity and bureaucracy will increase the cost of doing business and thus dissuade companies from investing in British trials.
2.6 We have not received an assurance or recognition of QP status as a lynchpin in the life sciences ecosystem. Without this, it is likely that the Horsham facility and others like it cannot continue to function in the long-term. Our UK competitors are facing similarly bleak prospects and have given recent announcements of building new facilities in other EEA countries to ensure continuity of service after Brexit.
2.7 Given the lack of quality assurance for their new drugs, the likely result – which we have already seen through a steep drop off in our inward investment – will be businesses moving their manufacturing sites out of the UK and onto the continent instead. Given the typical length of clinical trials (4-5 years), this threat is as likely as it is imminent unless a solution is found quickly.
2.8 QP release is arguably the most urgent issue facing the life sciences industry given the ripple effect that would occur if clinical trial suppliers were forced to relocate to other EU member states. There are several negative consequences should this occur.
2.9 Firstly, if these companies were forced to relocate to the EU it will result in a loss of jobs impacting the local economy. Secondly, this loss will significantly delay and likely prevent the progress of cutting edge research, undermining Britain’s status as the premier place for life sciences in Europe. Finally, the lack of clinical trials will result in NHS patients with severe long-term diseases not having early access to experimental medicines that could be life-saving.
3. Regulatory framework
3.1 The EU currently provides a very favourable regulatory environment for clinical trials, drugs licensing, and medicines safety.
3.2 We recognise and respect the British public’s decision to leave the EU, but believe there are two possible solutions which would resolve the QP issue while also reflecting the referendum result:
3.3 The simplest and most frictionless solution would be for the UK to remain inside the EEA, as opposed to full EU membership, such as countries like Norway and Iceland. This would not require any changes to EU regulations on pharmacovigilance as there is no difference between the EU’s recognition of QPs based in EEA countries as opposed to their own member states. As such, the rules surrounding QP release would remain exactly the same as at present, which would provide stability and reassurance to customers to continue investing in clinical trials in the UK with the knowledge they can export medicines to the rest of the EU.
3.4 We are confident that the UK’s membership of the EEA would ensure the continued running of our Horsham facility and likely allow us to revisit the expansion plans that were put on hold following the referendum vote.
3.5 We would not wish to prescribe how EEA membership could be gained, although one route would be through the UK re-joining the European Free Trade Association (EFTA).
3.6 If maintaining EEA membership is not a real possibility for the Government, there is a possibility the UK could forge a Mutual Recognition Agreement (MRA) with the EU. There are currently several MRAs in operation between the EU and countries like Australia, Canada, New Zealand and Switzerland. While each MRA has different conditions attached to each country, they have a shared purpose to “reduce technical barriers to trade by facilitating market access” as well as “grant mutual acceptance of reports, certificates, authorisations, conformity marks issued by regulated authorities of the parties and manufacturers’ declarations of conformity”.
3.7 This would not be our preferred option as the current MRAs in existence do not satisfactorily resolve the QP release problems (e.g. the Switzerland MRA still requires a QP in the EU member state to export to them), but a bespoke MRA negotiated by the UK could feasibly include additional measures that would seek to resolve this issue.
3.8 If the Government were to decide on this MRA route, we would be very keen to work with officials to ensure the agreement satisfactorily resolves the QP release challenge as well as protecting and enhancing the UK’s life sciences industry.
3.9 Regardless of the option taken by the Government, it is imperative that the sector is offered as much certainty as possible to reassure sponsors of clinical trials and clinical trial providers, as well as maintain a robust clinical trials supply chain in the UK. We would urge the Government to consider QP release as a key part of these transitional arrangements and to agree them as soon as possible to ensure in the short-term that UK-based QPs retain their recognised status across the EEA.
4. Involvement with EU Bodies
4.1 Cooperation across EU countries is essential to the continued health and prosperity of the life sciences sector both at home and abroad. Therefore, we wish to collaborate alongside and remain actively involved with EU institutions as much as possible; as much as we benefit from strong ties, we also have a key part to play in their continued success.
4.2 Membership of the EMA is essential to ensuring fast access to new treatments, most of which come from clinical trials.
4.3 We strongly support any negotiation which prioritises continued working with the EMA, and the position of the MHRA within that.
5. Recommendations
5.1 We strongly believe that there are options open to the British Government which will reduce the impact of Brexit on the UK’s thriving life sciences industry.
5.2 It is imperative that the sector is offered as much certainty as possible to reassure sponsors of clinical trials and clinical trial providers, as well as maintain a robust clinical trials supply chain in the UK.
5.3 The Chancellor of the Exchequer has indicated his intention to seek transitional arrangements to avoid a ‘cliff-edge’ once the UK’s EU membership ends in 2019. We fully support this intention and believe it is critical to the continued success of the life sciences sector.
5.4 We urge the Government to consider QP release as a key part of these transitional arrangements and to agree them as soon as possible to ensure in the short-term that UK-based QPs retain their recognised status across the EEA.
5.5 We would welcome assurances to this effect as soon as possible.
13 September 2017