BRX0038

Written evidence from Boston Scientific

1. About Boston Scientific

1.1.  Boston Scientific is a Medical Technology company dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Further information about Boston Scientific is available via our website http://www.bostonscientific.com/en-EU/home.html. Boston Scientific welcomes the opportunity to respond to this timely inquiry.  

2. Executive Summary

2.1.  The EU Medical Device legislation has played a key role in protecting patients through the provision of safe and effective products in the UK, Europe and beyond.  Importantly, it has also eliminated non-tariff barriers in this key sector and is largely responsible for creating a seamless market in devices in the EU and other International markets which recognize the CE Marking process. 

2.2.  Post Brexit the UK will require a sovereign regulatory system for medical devices. We therefore recommend a pragmatic approach from the UK Government to the development of such a system, which should ensure regulatory continuity and stability by adopting the new EU Regulation, and the secondary legislation arising from it. This will help to ensure that in so far as device product regulation is concerned, there will be frictionless trade with our European neighbours.  An element of flexibility however, should be retained to ensure the ability to make bilateral agreements with other regional jurisdictions and to allow for a scenario in which any breakdown in negotiations with the EU (so called ‘cliff edge‘) might otherwise affect the free movement of devices.

2.3.  The principles crucial to this are:

2.3.1. Continued alignment to the EU system

• The UK remains part of the CE marking regime, requiring mutual recognition of the CE-mark (for MedTech) between the UK and EU.
• UK Notified Bodies (NBs) remain within the network of c.50 EU NBs, and continue to be overseen by MHRA ensuring they are designated to assess devices for the EU and UK market. They should additionally remain members of TEAM-NB (EU network).
• Authorised Representatives of manufacturers outside of the EU can continue to be domiciled in the UK.  Additionally, UK manufacturers should not be mandated to contract Authorised Representatives within the EU.
• MHRA retains influence over, and some oversight of, the EU regulatory system, through formal engagement in the European Commission’s new stakeholder body, the Medical Devices Co-ordination Group (MDCG); and full access to Eudamed (EU-wide pre, and post-market data, registration of economic operators, details of clinical investigations, adverse incident reports, field safety corrective actions etc.).
• Additional factors apply to ‘combination’ devices such as those incorporating medicinal products; particular attention should be paid to ensuring continuity where the requirements of more than one regulatory regime apply, e.g. continued validation of drug-device combination CE certificates, which have used the MHRA for the drug consultation.
• Some measure of alignment with other industry sectors using the CE marking system within the New Legislative Framework (formerly EU New Approach) may be desirable although this should not be to the detriment of patient safety or the ability of the medical device industry to innovate.
• Provision should be made by the MHRA for the period between the UK leaving the EU (March 2019) and the final Date of Application of the MDR (May 2020) to ensure that the UK‘s regulatory system ‘shadows’ developments (e.g. secondary legislation) in the EU in a way that will secure the principles outlined.
• Provision should also be made by the MHRA to ensure that in the event of a breakdown in negotiations with the EU, the principles outlined above for regulatory continuity and stability are adhered to. This could be done on the basis that medical devices is a sector which works well to the benefit of both the EU and the UK and should therefore be subject to an appropriate agreement to achieve continuity on regulatory matters.
• An overriding concern should be protection of patient safety.  The EU regulations have developed over a quarter of a century and the latest revision draws on a wealth of experience gained by manufacturers, users and regulators in working to ensure that patient safety is front and centre of the regulatory system.

3. The Boston Scientific’s responses to the inquiry’s questions

3.1.  What are the key considerations that arise for companies, healthcare services and regulatory bodies in the UK as a result of the UK’s withdrawal from the EU? Focussing on patients and the public, what needs to be done to ensure that any adverse impact is minimised or eliminated, and that opportunities to enhance services are maximised?

3.1.1. We are concerned about the future changes in the regulatory environment after the UK’s withdrawal from the EU.  More clarity on future regulatory changes is critical to help the Industry to prepare for Post-Brexit.

For companies

3.1.2. We are concerned about the potential impact Brexit may have on talent acquisition/retention as both UK and not UK employees may face travel disruption post Brexit. Restrictions on EU citizens’ post Brexit need to be avoided.

3.1.3.      Regulatory certainty – industry has been working towards implementation of the MDR for nearly a decade.  Taking a different regulatory course at this stage will result in significant disruption for companies and some might choose to withdraw from the UK market rather than incur the costs involved in complying with another system, with the result that UK patients no longer have access to the range of product currently available.

3.1.4.      Continued sales to the EU – those companies wishing to continue placing medical devices on the EU market (the vast majority) will continue to work towards MDR compliance in order to retain their presence in the EU market.

3.1.5.      Continuity of sales outside the EU – numerous international markets require compliance with a recognised regulatory system and many companies use CE marking under the EU regulations as their ‘passport’ to enable sales in such markets.  In terms of sales to more developed markets such as the US, companies will still have to comply with their regulations whether or not the UK chooses to remain aligned to the MDR.

3.1.6.      Transition period – any change to a different regulatory system will require a lengthy transition period to enable business to adapt to the new operating environment and avoid any unintended consequences on the availability of healthcare products both in the UK and the EU-27.  Industry is currently in the transition period for the move from the Medical Devices Directive to the Medical Devices Regulation (and their IVD equivalents); this transition period runs to 2020 and beyond.

3.1.7.      Tariff and barrier-free trade – continuation as far as possible of ‘business as usual’ will help to minimize disruption to the supply chain.  This relates both to the supply chain for medical devices themselves but also materials and components used in their manufacture.

3.1.8. Physical movement of medical technology products: we are concerned about future arrangements on the movement of goods and products between the UK and Europe. One of the economic consequences may be the increase in cost of products and this could became a barrier for NHS to allocate appropriate reimbursements and a barrier for the patient in terms of access to therapies.

3.1.9. Healthcare funding: we have some concern about future arrangements for the treatment of foreigner patients in the UK (for instance tourists in the UK territory).

3.1.10.  If after Brexit the UK will not be subject to the European Court of Justice, we recommend setting up options to resolve future disputes in an effective and efficient way.

For patients

3.1.11.  Continued supply of safe and effective medical devices.  As mentioned above, the EU regulations draw on a wealth of experience gained in real-life use of medical devices and have been designed to ensure patient safety.

3.1.12.  Continuity of supply of products currently on the UK market will be ensured by continued alignment with the MDR.  This will also benefit patients from a safety perspective, by ensuring that the UK has access to the latest and most complete adverse event data. 

3.1.13.  Continued access to the latest medical technologies as they are developed – currently the EU enjoys significantly swifter access to new technologies than other developed markets with different regulatory systems, e.g. US, Japan. 

3.2.  Following the UK’s withdrawal from the EU, what alternative arrangements for the regulation of medicines, medical devices, medical products and substances of human origin could be introduced? What are the respective opportunities, risks and trade-offs involved?

3.2.1. Boston Scientific worked with ABHI to carry out a SWOT analysis of four scenarios:

• Implementation of the new Medical Device Regulation into UK law.  The Regulation, as it currently stands, will be adopted as part of the EU Withdrawal Bill; the Implementing and Delegated Acts that are still to come would also need to be adopted but if the UK commits to MDR it will need to find a legal mechanism to get these additional pieces of legislation on to the statute books.
• Adoption of an ‘MDR-lite’, specific to the UK market but along New Legislative Framework principles.
• Alignment and adoption of another regulatory system, such as the US FDA.
• Recognition of other significant regulatory regimes, with regulatory approval being assured under well-established regimes (FDA, EU, Australia, Canada etc.,). This will allow for a ‘free market’ in the UK as UK manufacturers would be able to apply the regulatory approval system of their choice.

      The conclusion was that for the UK medical technology industry, including Boston Scientific, the preferred scenario is the first one, i.e. retain regulatory continuity through adoption of the Medical Device Regulation.

3.2.2. It is critical that the Government provides greater clarity on the Brexit arrangements related to the Medical Technology sector ensuring appropriate consultation with companies in the sector. Without this information, companies are currently unable to assess the possible impact of any proposed alternative arrangements.

3.3.  How much time is needed to facilitate a smooth transition to new arrangements? Is it possible, or desirable, to move directly to new arrangements post-29 March 2019, or are transitional arrangements needed?

3.3.1. The time taken to develop and implement a new regulatory system would vary considerably depending on whether a complete break with the EU system were undertaken.  The transition from the Medical Devices Directives to the Medical Device Regulations will have taken well over a decade from the time that new proposals were first tabled to the end of the transition period.  The Medical Devices Directives themselves took several years to write and implement.  Drafting began in the late 1980s and three directives were implemented: Active Implantable Medical Devices Directive (1990), Medical Devices Directive (1993) and In Vitro Diagnostics Directive (1998). 

3.3.2. It should be noted that all regulatory regimes aim at delivering safe products to the patient in a timely manner and as such they largely cover the same aspects albeit via different administrative routes.  It is misguided to believe that a significantly more efficient system could be developed than those already in existence given the huge amount of resource that has already been devoted to their development.  At best a UK-specific system might deliver some minor efficiencies but these would need to be balanced against the fact that almost all companies will have to continue to comply with the other regulatory regimes around the world.  So while the UK might have a stand-alone system with some advantages over others these would likely be offset by the additional compliance costs.

3.3.3. As the Prime Minister set out in her Florence speech, it is important that businesses ‘should only have to plan for one set of changes in the relationship between the UK and the EU’.

3.3.4. The length of time for any transition period should reflect the time needed for businesses to adapt.  This should be based on discussions with business and should not be an arbitrary number.

3.4.  How will withdrawal from the European Union affect the UK’s ability to influence international standards in life sciences?

3.4.1. After Brexit, new legislations may become a barrier for innovative products and cause delays in access to the market. We are concerned that new legislations can make the UK an unattractive location in terms of investments.

3.4.2. A strong collaboration and cooperation between the NHS, decision-making bodies and industry is critical. In preparation of the transition to the new conditions we need to minimize the risk to lose the worldwide leader position of the UK in the Healthcare sector. NICE is a well-recognised body followed by the EU and the rest of the world in regards to decisions around market access and reimbursement.

3.5.  What are the implications for medical research and development, including for the timely patient access to new medicines, technologies and other relevant medical innovations developed within or outside the UK? How can any adverse consequences be avoided or mitigated and any potential opportunities be enhanced?

3.5.1. Several factors may delay the access to innovative medical technologies (please see the previous sections). We urge the Government to provide more clarity on the new arrangements for the development and the commercialization of medical technologies in the UK. In addition we urge the Government to provide clarity on how projects/investments that are currently co-funded by EU will be managed and adapted to the new conditions. We encourage the Government to ensure experience sharing and collaboration with the EU in regards of R&D.