Lord O’Shaughnessy on medical technologies and Brexit
The Parliamentary Under Secretary of State outlines the government's commitment to the medtech sector as the
Introduction
Good morning, and thank you for giving me the opportunity to speak to you today.
I would like to use the next few minutes to outline the government's commitment to the medtech sector, and then to set out the opportunities and challenges we face together as the
We all know the medtech sector plays a vital role in the operation of the
As a government, and as ministers, we are deeply committed to helping you – and the wider life sciences sector – to flourish. It's good for your businesses, it's good for
As I'm sure many of you were, I was at the
There are also exciting new frontiers around medical software, 3D printing and companion diagnostic devices – which have the potential to revolutionise the provision of healthcare in the coming decades.
The
Or look at Siemens Magnets, part of what was Oxford Instruments in
So I don't think our problem is innovation in this country. We're a creative bunch, with both public and private investment ready to help. The real challenge is taking innovation, getting it into the
That is one reason I was delighted to announce yesterday that Abbott's Freestyle Libre product will be available on the
Encouraging access and uptake is a challenge that we are aiming address in the government's response to the Accelerated Access Review, which I plan to publish by the end of October.
Please be assured that medtech plays a central role in our plans, not least because it can offer genuine cost-savings while also transforming outcomes. We have already shown our commitment in a range of programmes that I announced in July to help companies like yours to change more patients' lives in the
In addition, with the launch of Professor
Brexit and devices regulation
Brexit offers a major opportunity to build on our existing strengths - and we should look upon the challenge both pragmatically and with optimism. There is a collective determination and will in government to make a success of exit from the EU.
In July at the BIA/MHRA Annual Conference, I set out the core principles that will underpin the government's approach to medicines regulation, trade and support for the life sciences sector in the
- First: patients, whether in the
- Second: the
- Third: industry must be able to get their products into the
Devices regulation
Let me start with the regulation of medtech, which is of importance to everyone in the room.
To reiterate the principles above, our top priority for life sciences during the negotiations is to protect the safety of patients and ensure the integrity of cross-European public health systems.
I want to give this promise: no matter what the outcome of the negotiations – on basic patient safety and public health issues – the
This partnership is perhaps best illustrated by the leading role played by the
Notified bodies
The
While this has undoubtedly created more reassurance in our de-centralised regulatory system, any loss in capacity of third-party assessments, at a time when the new EU regulations will significantly increase demand, is not to be under-estimated.
The 5 UK notified bodies assess a disproportionate number of medical devices. According to a recent independent assessment of the market,
We also host over 50% of the EU's authorised representatives for manufacturers based in third countries. We urge the EU to respond positively to the principles in our recent position paper on the availability of goods in the
It is also right to acknowledge that the
This arrangement has allowed the
Sharing this expertise across the EU has led to significant public health and safety improvements. Knowledge and innovation is not and cannot be exclusive to one country.
As the PM declared in her
Patients across the EU27 and the
And I know it is what industry wants too, which is why I am asking for your continued support in helping to achieve it. The recent letter from MedTech Europe, ABHI and COCIR to
No deal scenario
A future partnership between the
However, as with other departments, we will be prepared for both a negotiated settlement but also for the unlikely scenario in which no mutually satisfactory agreement can be reached.
Both the
I understand the specific legal and operational issues around implementing the new EU regulations, in light of Brexit.
Elements of the new regulations have been applied directly in
I think it is important to make this clear for everyone involved in the sector, as your preparations to meet the requirements of the new EU regulations are already well underway. I hope this provides some certainty.
Trade
Regulation isn't our only consideration as we leave the EU.
The
We want to have a new customs agreement with the EU that supports these objectives, as set out in the paper on future customs arrangements, which was published in August. This is central to our principle of ensuring that
The
The
We will also be ambitious in pursuing new trading relationships globally, to ensure that medical devices developed and manufactured in the
We recognise that medical research and development is a mobile, global business – and we want the best and the brightest, wherever they are from – to be able to study, work and innovate in the
I want to assure you that as the Brexit process progresses, we will continue to work closely with industry and trade bodies, including the ABHI, to plan our policy for a prosperous future as a great, global trading nation.
Conclusion
I hope that by setting out our domestic policy commitment to the medtech sector, as well as setting out clear principles for Brexit and explaining the expected regulatory requirements for medtech in the
We have challenging but exciting times ahead of us, and we have a superb opportunity to reinforce the
I am proud that the government is able to work so closely with industry, and am pleased with the very positive level of engagement and debate that has occurred so far between us.
I am confident that the Life Science industry will be able to make the most of the opportunities offered by Brexit, and help reaffirm the
Thank you very much.
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