What s Next? The 4th Acorn Regulatory Brexit Whitepaper

Transcription

1 What s Next? The 4th Acorn Regulatory Brexit Whitepaper

2 Contact Us If you want to discuss this issue further Dr. Gemma Robinson Managing Director T: M: E: Brian Cleary Chief Marketing Officer T: M: E:

3 Contents Introduction - Dr Gemma Robinson, 4 Managing Director of Acorn Regulatory Page What the Industry Thinks About Brexit: 5 Results of our exclusive Brexit survey Acorn Regulatory Brexit Case Studies 12 The information contained herein is accurate and reliable as of the date of publication; however, we do not assume any liability whatsoever for the completeness of the above information. Copyright 2017 Acorn Regulatory Consultancy Services.

4 Welcome We have spent almost a year pondering the next steps and now, here we are at a point where Article 50 has been triggered and the negotiations for the UK to depart the EU are about to begin. In recent months, I, along with my colleagues, have been travelling around Europe and meeting with senior management and regulatory teams to look at the potential implications of Brexit on their businesses. We have listened to the concerns of many like-minded industry professionals about the possible impact of Brexit on their businesses. In this edition of the Acorn Regulatory Brexit whitepaper we publish the results of our exclusive survey of almost 250 regulatory affairs professionals. We highlight their thoughts on the future of the EMA, the location of the agency, the challenges facing their companies and much more. I would like to take this opportunity to thank everybody who took the time to complete the survey. If you did not get a chance to complete this survey but would like to share your thoughts on the issue then please get in touch. Finally, I would encourage all professionals in the regulatory affairs sector to ensure that your company is prepared for Brexit. We can help. On pages 12 to 14 we highlight how we have been helping companies prepare for Brexit. Dr. Gemma Robinson, Managing Director 4

5 What The Industry Thinks About Brexit Brexit has been the main talking point amongst life science professionals across the EU for almost twelve months. In this edition of the Acorn Regulatory Brexit whitepaper we bring you the results of our first ever Brexit survey. Almost 250 life science professionals responded to our Brexit survey and on the following pages we look at the Brexit issues that matter most to them.

6 Overview 30% of respondents believe that Dublin is the best option for the EMA. 27% of respondents believe that their company has NO plan in place for dealing with Brexit

7 64% of respondents believe that Brexit is providing the EMA with an opportunity to change the way that it works 50% of respondents believe that the MHRA will not be able to deal with the increased workload 7 7

8 Introduction Summary Methodology Methodology Dublin is the favoured location for the European Medicines Agency of 30% of our survey respondents. The Irish capital is regarded as the ideal location by almost one third of those surveyed in our first Brexit survey. Dublin, however, is not without competition. Frankfurt and Stockholm also scored highly amongst our respondents. Brexit, as we have pointed out consistently in our whitepapers, will impact on every element of the life sciences sector. The MHRA will be impacted more than most. However, the majority of our respondents were not confident of the British agency s ability to deal with its increased workload. Unsurprisingly, more than a quarter of the companies surveyed believe that they do not have the resources required to deal with the increased regulatory burden that will now evolve post Brexit.. The issue of opportunities for regulatory affairs professionals in the UK post Brexit was raised consistently in the survey responses. One respondent said: I can see many multinationals currently based in UK moving wherever the EMA goes. I would then expect very limited opportunities within UK for Regulatory Affairs professionals at HQ level. The spectre of diminished opportunities for professionals was one of the greatest concerns for our UK respondents and it is an issue that we will cover in greater details in an upcoming whitepaper. The Acorn Regulatory Brexit survey for the second first quarter quarter of 2017 of 2017 received received almost almost life science sector responses. The respondents life science sector were responses. survey online The over the period respondents February were 21st surveyed to March online 14th. over the period February 21st to March 21st. The respondents were based in a multitude of countries and the details of the geographic The respondents spread were of responses based across is the detailed EU and the in this details survey. of the geographic spread of responses is The number of individuals employed by manufacturing detailed below. firms constituted XX% of overall responses. The number of individuals The number employed of by individuals services firms employed constitured XX% of overall responses. by manufacturing firms constituted 53% of overall responses. The number of individuals employed by services Number of responses firms constitured Manufacturing 47% firms of overall responses. Services firms Number of responses 243 No. of exporters Manufacturing firms 129 Manufacturing exporters Services firms 114 Service exporters No. of exporters 217 Manufacturing exporters 134 Service exporters 83 Respondents*: (in alphabetical order). Belgium 7.5% Denmark 10% France 11% Germany 7.5% Ireland 15% Netherlands 7% Sweden 9% UK 21.5% Others (all individually less than 3%) 11.2% *Percentages in the survey were rounded down to one decimal point where possible. All countries listed under Others represented less than 3% of the total respondents.

9 Question 1 Question 2 Does Brexit present the EMA with an opportunity to change the way that it works? Results Do you have confidence in the MHRA s ability to deal with the increased workload post Brexit? Results Yes: 64% No: 18% Don t Know: 18% Yes: 36% No: 50% Don t Know: 14% Brexit affords the EMA a unique opportunity to change the way that it works according to 64% of our survey respondents. Many of the respondents highlighted the heavy lifting carried out by the MHRA on behalf of the EMA. They pointed out that the break from the UK would give the European agency the opportunity to reassess its processes and how it interacts with its stakeholders. Only 18% of respondents said that they did not believe that Brexit was an opportunity for change. Another 18% said said that they didn t know. The MHRA s ability to handle the increased workload is a concern for 50% of our respondents. Comments from some respondents pointed to a fear that procedural issues will need to be addressed, sooner rather than later, in order to prevent undue delays. One respondent said What I fear is that if they (the MHRA) don t discuss internally how they will handle procedural issues that we may be forced to wait even longer for key strategy decisions. 9

10 Question 3 Where do you think the European Medicines Agency will relocate to? Results Dublin 30% Frankfurt 22% Stockholm 17% Copenhagen 13% Others 18% Ireland s capital city is the preferred future location of 30% of our survey respondents. Dublin s bid to host the European Medicines Agency has, to date, been somewhat muted as the Irish government deals with the issue of the border between the Republic of Ireland and Northern Ireland. The city is seen by respondents as a viable option to house the 885 staff of the EMA. Frankfurt is not that far behind with 22% of the vote. Many commentators expect that the European Banking Agency, currently headquartered in London, will relocate to the German city and that the European Medicines Agency will be placed elsewhere. Acorn Regulatory s John McIntyre has prepared a brief SWOT analysis of Dublin as a likely location for the EMA. You can read it and watch a video interview with John by clicking HERE 10 10

11 Question 4 Do you believe that your company has the resources to deal with the increased regulatory burden once Britain leaves the EU? Results Yes: 44% No: 27% Don t Know: 29% Almost every one of our respondents touched upon the issue of increased workload for their company once Brexit becomes a reality. 44% of those taking the survey said that their company was prepared/preparing for the changes that Brexit would bring about and had the requisite resources available. However, 27% of respondents said that their company had not started to look at the impact that Brexit might have on their company and their products/services. This is something that we are seeing with many small to medium sized companies across Europe and, particularly, in the UK. A further 29% said that they didn t know if their company had the resources to handle the increased workload post Brexit. One survey respondent said: Brexit is already impacting our business in terms of the resources required right now to follow all the updates. (The updates are coming in on an) almost on a daily basis. (These have to be understood and researched) in addition to the detailed planning for Brexit that is already being undertaken. Comments, such as the one shown above, were not uncommon among respondents. Furthermore, we have experiened this ourselves as companies have contacted us seeking updates on the Brexit process. 11

12 Acorn Regulatory Case Studies Are You Prepared? The UK s decision to leave the European Union will have a significant impact on life science companies in Europe. Companies need to start preparing now to ensure that disruption to their business is minimised once Brexit happens. We can help. How Can We Help You? Acorn Regulatory is the only regulatory affairs consultancy in Europe with a dedicated Brexit department. Our team of specialists are working with companies across Europe on issues such as regulatory strategy, EU QPPV requirement, EU Authorised Representative services and much more. Since June 2016 our Brexit specialists have been meeting with board members, senior management and regulatory departments at a diverse range of companies. All of these companies have engaged Acorn Regulatory to help them to navigate through the most tumultous political decision to impact on the business sector in over half a century. Our Brexit department draws upon the resources of our expert pharmaceutical, pharmacovigilance, clinical trials and medical device consultants. 12

13 What Can We Do? We can meet with your company and assess the potential impact of Brexit upon your regulatory department. We can then present an assessment of the issues that need to be considerered to ensure that you minimise interruption to your business. We can also offer a service where Acorn Regulatory can act as EU QPPV for pharmacovigilance. At present the majority of EU QPPV s are based in the United Kingdom. We can assist you in facilitating a smooth transfer of EU QPPV services to a new EU member state. Likewise, our medical device specialists can assist you in transferring your EU Authorised Representative to another EU member state. Case Study One In January 2017 our Brexit specialists were engaged by the board of a top five global pharmaceutical company. They asked us to present to them on the consequences of Brexit and to advise them on the options that were available to them in a post Brexit economy. Our team prepared a briefing that considered the wider political issues and the specific implications for their European operations. The presentation was used by the board as a conversation starter for a day long meeting on the implications of Brexit for the company. Acorn Regulatory pharmaceutical and pharmacovigilance specialists presented to the board and a member of our Brexit team facilitated the day long offsite meeting. Now, the company has a road map to guide them through the coming years as the UK seeks to extract itself from the EU. Talk To Us Today Time is of the essence in ensuring that your business does not face disruption to its services because of Brexit. Acorn Regulatory can tailor our suite of Brexit related services to meet your company s needs. Call us in Ireland on or us at info@acornregulatory.com 13

14 Case Study Two Late last year we began working with a global pharmaceutical company to assist them in moving their licensing, regulatory, pharmacovigilance and head office operation out of the United Kingdom and into an EU member state. The project involved our team of experts working with their pharmacovigilance, legal, R&D, HR, and regulatory departments of the company. We assisted the company at every stage of the process. In doing so, we were able to identify cost efficiencies. As a result, the company has moved to a location in an EU member state that is a committed member of the union and the company has reduced operating costs in the process. We now provide EU QPPV and virtual pharmacovigilance services to the company, as we do with many other companies. We have mapped out a comprehensive regulatory strategy for the client and we are also supporting them with performance reviews and project management. The entire project was project managed by a dedicated team at Acorn Regulatory and reassured the shareholders about their trading options. The Brexit Experts Now that Article 50 has been triggered there is a greater need than ever to prepare for the UK s departure from the European Union. We can help you to navigate the Brexit maze. Speak to us today. Call us in Ireland on , us at info@acornregulatory.com or visit our website: 14

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