Counsel at Hogan Lovells
Tara Dougal: Is this your first trip to Medtec Europe or do you come regularly?
Fabien Roy: No I think this is my fourth or fifth participation
TD: And how do you find the show? Why do you attend annually?
FR: Well, I like the show because I like to hear speakers from different environments…I think the industry and quite diverse also here…well represented so I like to walk around and meet new people, meet new companies and also some very small companies, or start-ups, you know, just starting the business.
TD: Did you have a chance to look at our Start-up academy?
FR: Not yet, but I will!
TD: You’re going to be talking about Brexit - a scenario where there is a lot of uncertainty, nobody really knows what’s going to happen at the moment, how do you find trying to advise companies on Brexit, how does that work for you?
FR: Well, there is uncertainty, as you say and there is uncertainty also for lawyers because we do not know what’s going to happen but we have taken the position that while we should not scare companies about the potential consequences of Brexit, we should inform them of those potential consequences and that will be the purpose of my presentation in an hour. There are a lot of things to consider because it could be a difficult Brexit. It’s possible that there will be no agreement between the UK and the EU so from one day to the next it could be that nothing will work as it used to in the past so it’s better to anticipate and to raise awareness within a company. Maybe set up a small team just to focus on Brexit, the regulatory, the commercial and the trade aspect as well so that everything is on paper and there is no surprise if this happens because the company has taken steps to address that.
TD: Are you, at Hogen Lovells, running through all the potential scenarios at the moment, of Brexit, you know, how it’s going to go, what the outcome will be?
FR: Yes, we try to. Of course it’s hard to anticipate everything but at least from a regulatory perspective there are some specific provisions in the current directives which make a link between the EU member states and the EU in any case. If UK is leaving the EU, some adaptations will be needed and this is what we can try to highlight to clients.
TD: What do you think the biggest impact will be of Brexit on the medical device industry?
FR: I think there are two elements here: the first one relates to the authorized representatives. At the moment, if you are not established in the EU you need to appoint an authorized representative within the EU. If UK leaves the EU, manufacturers based in the UK will have to appoint an authorized representative in the EU. All companies which already have authorized representatives in the UK, and that’s about 60% at the moment, may be required to appoint another authorized representative. This requirement aligns with the medical device regulation which states that the authorized representative in the future will be directly liable for defective products. So, the combination of Brexit plus the new MDR means that there will be a lot of pressure on authorized representatives, it might be more difficult to find a suitable one and all companies will be looking for authorized representatives simultaneously. That may be a big issue.
The second component is related to the notified bodies in the UK - they are appointed or designated by the competent authority to conduct performative assessment for medical devices on the basis of the directive. If the directive is not applicable to the UK because it has left the EU they will lose their designation. For all the companies working with BSI, SGS and other UK notified bodies that could be quite a difficult situation so they might have to think about changing notified bodies or really asking their notified bodies to confirm their situation post Brexit, which is not the case at the moment.
TD: You just mentioned to me the EMA looking to move to Ireland, could you tell me a bit more about that and maybe any other examples you have of companies who are now having to explore different options?
FR: The European Medicines Agency is currently responsible of different tasks in the Pharma sector. One of them is to provide opinion on the basis of which the European Commission will grant marketing authorization through the centralized procedure. If the UK is leaving the EU the agency will have to relocate in another EU member state. A lot of countries, EU member states, are currently pitching the commission to have the European Medicines Agency within their territories. There are a lot of business, commercial interest surrounding that.
TD: Where do you think it will end up?
FR: Well, Ireland is one of the favourite destination because it’s an Anglophone country, it’s not far from the UK, I don’t think it has any existing agency. But the Netherlands is pitching, Belgium is pitching, France, Italy and also some Nordic countries so there is a race going on between the competent authorities of the EU member states to make sure that they have made clear all the benefits to having the agency within their territory. We’ll see.
TD: What about one year down the line, thinking about Medtec 2018, if you had to present on this topic again, what direction do you think your presentation would take?
FR: I think the focus would be more the negotiations between the EU and the UK. Those have officially started since the notification letter from Theresa May to the European Council last week. I think it will be interesting to see what progress has been made in one years’ time. They have two years to negotiate and if they want to extend that two year period then there will be a need to have all the EU member states, all 27, to agree on that extension. I think we could focus on the negotiations and maybe start to work on the fears of companies because if no decision has been made one year short of the actual Brexit it will be quite intense.
TD: Then switching from the UK but along the same line, are you doing any advisory on the US considering the political landscape there at the moment, are you involved in anything there?
FR: Well, I myself am not, but I have a lot of colleagues involved in the regulatory angles of the US election and their consequences. We have a big Lifescience practice at Hogen Lovells so indeed we can advise clients on that as well.
TD: So a lot of uncertainty there as well…
FR: I think so, yeah. I read several things among which, for example, the president’s wish to reduce the number of guidance and legal documents around the regulation of Pharmaceutical products and medical devices so that’s maybe something that will also trigger some attention from the industry.