RPP Impact on the MHRA and Notified Bodies

Overview

Migration and its impact on the European Union and EU referendum bubbled back to the surgace this week. With many European Leaders in New York for the UN summit on migration, the prime minister, Theresa May said the migration crisis had been "exacerbated" by "unprecedented" numbers of economic migrants. With all sides of the Brexit posturing ahead of negotiations in the years to come Theresa May also told the EU’s leaders that they will have no choice but to agree a trade deal with Britain. She said it was firmly in the interests of the 27 remaining members of the Brussels club to conclude successful talks with the UK. Understandably this strong line has put some backs up in Europe, with the Financial Times reporting today that the mood has hardened in Berlin over Brexit. The Prime Minister has earned herself a reputation in Europe as a tough negotiator but also pragmatic, from her time as Home Secretary. Only time will tell if her negotiating style and skills are up to the task.

Highlights

  • Jeremy Corbyn was re-elected as Leader of the Labour Party beating Owen Smith 61.8% to 38.2%.
  • Theresa May's honeymoon period will most likely last a little longer, but with significant criticism over her Grammar Schools policy and from all sides over the plan and direction of Brexit, it may not last much longer. George Osborne, made headlines this week following a speech in the USA warning against a "hard Brexit" - see more below.
  • Political memoirs being released at the moment to coincide with the UK's Party Conference season, have tried to shine light on some of the internal, behind the scenes, fights of the EU referendum. One of these books questioned Theresa May's support for Prime Minister Cameron during the Referendum campaign, and how she and Philip Hammond encouraged Cameron to water down his demands for greater control of immigration during his pre-Brexit negotiations.
  • Lord Andrew Lansley, speaking at the NHS Providers annual lecture, said the public had a right to expect extra funding for the NHS, which should be in place by 2019-2020, saying that "it frankly should be no less than £5bn a year,". He also called for ministers to commit to spending 7% of GDP on the NHS.

Written by RPP Head of London Office, Andrew Brown

The Groupings and Sub-groupings of Co-operation between EU Member States

Within the EU there have historically grown frameworks of cooperation, such as Schengen or the Euro countries, and many “ad-hoc” constructions and sub-groupings. These are gaining more and more ground and could be seen as an attempt to compete with the official structures of the EU such as the European Council (of the Heads of States and Governments) or the Council of Ministers in its various formations. This development shows that with the increased number of EU Member States, the interests of the Member States becomes more and more diverse.

Since the informal Bratislava summit, we have learnt about a format for leading EU decision makers, the famous 27 Head of State and Government (28 “minus” UK) format. It is not mentioned in the Treaties, therefore “EU” is missing in the title of that grouping and as a result that group could meet in Bratislava instead of Brussels, where the Heads of State and Government meet according to the Treaties. All groups and fora considered, seem to have one thing in common, the UK has not been participating in their meetings.

The BENELUX countries could be considered as some kind of core or laboratory for EU policies. Historically, it started with a customs union and still has its own institutions, something people tend to forget. Currently all governments of the three BENLUX countries are headed by Liberal Prime Ministers (Charles Michel, Belgium; Mark Rutte, Netherlands, Xavier Bettel, Luxembourg), and all three have recently agreed to better co-ordinate their policies, in particular with regards to Brexit. Although the three Prime Ministers do have different views about the level of future co-operation and integration within the EU.

The Weimar Triangle is a forum of loose co-operation and discussion which dates back to the early 90s and consists of Poland, France and Germany. It has recently gained more attention as policy makers, not only in France and Germany, consider this platform to somehow bring more “inclusion” for Poland’s current, rather euro-sceptical, government in dealing with the two biggest powers in the EU. To that end, the Weimar Triangle could have some kind of a renaissance.
The F6 group is consisting of the Foreign Ministers of the six founding members of the EU: the BENELUX countries, France, Italy and Germany. They meet on a regular basis in order to discuss EU issues on a broader scale. The EU’s other countries keep a close eye on that forum. As does the German Chancellery: as in the German context, it is run by the Foreign Minister and his Ministry (Auswärtiges Amt). In Foreign and EU policy related issues, there is always room for high degree of competition between the EU departments in both coalition government agencies as to conceptual EU policies, one run by the Christian Democrats and the other one run by a Social-Democrat Foreign Minister.

EU-Med: Two weeks ago, the Heads of State and Governments’ of Greece, Malta, Cyprus, Italy, France and Portugal met in Athens in order to discuss and to shift the focus in economic policies, from austerity to a more growth-oriented economic and financial policy. This grouping considers itself as a lobbying platform against the “Brussels based austerity” policy. Compared to the Northern EU countries, these countries are led by Social-Democrat governments of the Left. This explains why Spanish Prime Minster, Rajoy was not present for the gathering, in order not to be seen too close to “Tsipras et al”. Instead, the Spanish government was represented by the Secretary of State for EU-Affairs, Fernando Eguidazu. The future will tell to what extent that format will be able to develop. Needless to say that in the Northern Member States of the EU this format is often referred to as the “Club Med.”

The so-called Visegrad Group (V4) currently captures the attention of national and European policy makers. Set up in the early 90s, it used to be a loose forum of co-operation between Poland, Hungary, the Czech Republic and Slovakia, named after a small Hungarian town. The importance of this group is steadily increasing, in particular as to migration policy. The rather populist tone during the past and current debate regarding migration and against refugees, has somehow united the four countries. They also have a lot in common with regards to energy policy, but they have traditionally disagreed on various policy areas (e.g. relations with Russia). The members of the Visegrad Group have recently agreed to increase the frequency of its meetings. Interestingly, there has been the idea to expand the scope of the Visegrad Group by also inviting Austria and Slovenia to the meetings, but this plan did not materialise in the end. Additionally, only Slovakia is a Euro country so far.

Last but not least, with the (for the time being unique) meeting at Ventotene in Italy this summer, we could witness the attempt of Germany (Chancellor Merkel) and France (President Hollande) to include Italy when it comes to setting the European agenda. In particular regarding this format, it could have well been the case that the UK would have been present too, if there hadn’t been the Brexit decision…

Brexit could even trigger the creation of a new organisation or grouping to allow a “soft Brexit halfway house” for the UK. Geert Bourgeois, Prime Minister of Flanders, Belgium’s dominant region, in August suggested the revisiting of the idea of a North Sea Union, consisting of Denmark, Germany, the Netherlands, France, Sweden, Norway and the UK.
Whether this is likely or not, these numerous groupings and sub-groupings within the EU show how complicated the internal politics will be relating to the Brexit negotiations.

Written by RPP Senior Director of Policy & Advocacy, Thomas Krings

Brexit – what will be the impact on the MHRA and Notified Bodies?

During the EU Referendum campaign, little was said about the future of the Life Sciences Industry by both sides of the campaign, even though it is a crucial part of the UK economy upon which thousands of jobs currently depend.

Now that the UK has voted to the Leave it is important to consider the key parts of the UK's life sciences industry, including its regulatory regime. This newsletter has already looked at the European Medicines Agency (EMA). The Medicines and Healthcare products Regulatory Agency (MHRA) is therefore now under the spotlight with regards to the future of this agency and how it might interact with the other European regulatory agencies in the future. For example, what will become of the CE marking system?

There are also broader questions, such as, what will the UK medical device industry look like after Brexit? Will the UK continue be part of the Single Market and the European Union Customs Union? If not, how will that affect UK based medical device companies?

This article will not seek to answer all of these questions, which are currently unanswerable, but will instead reflect upon the issue of the CE mark and CE marking of medical devices, and the Notified Bodies system.

With regards to UK domiciled manufacturers, regulatory approval in the rest of Europe will still be via the CE mark. However, gaining a CE mark from a British Notified Body might prove to be a lot more difficult for UK manufacturers of medical device companies once the UK has left the EU. It is not just UK companies that seek UK CE marking for their products. Given the good reputation of UK Notified Bodies, other EU Member State countries have companies that also use UK Notified Bodies so some of this business may transfer to other Member States, in the future. This could mean the UK losing highly skilled jobs in the life sciences industry and also influence in how medical devices in Europe are regulated.

It is likely that, for reasons of practicality, that the UK will continue to recognise EU CE marks for those goods that the remaining 27 EU Member States want to export to the UK. UK Notified Bodies are regulated by the national competent authority, in this case the MHRA. The MHRA is recognised by the EU as a European Competent Authority and it remains to be seen whether it still will be after Brexit has taken place.

It should be said that there are notified bodies operating in Switzerland, Norway and Turkey, none of which are EU Member States, so much of how the MHRA and the UK Notified Bodies operate after UK withdrawal from the EU will be up for negotiation once Article 50 of the Lisbon Treaty is triggered. Notified Bodies in Switzerland and Norway operate via Mutual Recognition Agreements. Will the UK Government, led by Prime Minister May, seek to do the same?

Interestingly, Australia has a Mutual Recognition Agreement with the EU and can award EU recognised CE marks for some products that will end up in the EU Common Market so it is highly likely the UK Government will reach agreement here.

Lastly, what is the future of the MHRA? The European model of regulation devolves a lot of assessment tasks to the Notified Bodies, leaving the Competent Authority, the MHRA, to conduct post-market activities such as adverse event reporting and product recalls. Again, Brexit now means that those unanswered questions from the start of the EU Referendum campaign will now need to be clarified by the UK Government, particularly the nature of medical device regulation after UK withdrawal and the role of the MHRA in that regulation.

Furthermore, the sharing of expertise may be affected by Brexit, with the MHRA, which at present has had a very strong influence on the development of medical device regulation, being unable to send its officials to EU level meetings discussing the future of EU regulations. European Representatives going to such meetings from UK based medical device manufacturers may also be affected.

Meanwhile, for the rest of Europe and the remaining Member States, it will be business as usual, albeit with all the detail of the implementation of the new EU Medical Device Regulation to consider.

Written by RPP Director of Policy & Advocacy UK, Mark Walker

Corbyn to the Left of May, James to the Right. Here she is, stuck in the middle with Johnson, Davis and Fox!

Other than "Brexit means Brexit", and the more recent expansion of "Brexit means Leaving the European Union", we're still none the wiser of what Prime Minister May's intentions or plans are for Brexit. To be fair to her, she is quite sensibly keeping her negotiating cards close to her chest ahead of the triggering of Article 50 at some point in 2017. Boris Johnson, David Davis and Liam Fox, the three Brexiteers, keep getting slapped down by the Prime Minister and her spokesmen whenever they stray too far from that position and discuss too openly the UK's negotiating positions. The Prime Minister's closest political ally, Chancellor of the Exchequer, Philip Hammond has also been guilty of overstepping this policy with his remarks about the future of the UK's finanical services sector post-Brexit.

Whilst it may be sensible for the Prime Minister and her Government to be coy about their intentions for the Brexit negotiations, this also puts the Prime Minister in a difficult position. There is already a lot of demands within British politics and from the media for the Government's position on Brexit to be more widely known and scrutinised. We have already seen huge differences of opinion from many different directions on when to trigger Article 50 and more recently on whether Britain should or should not remain within the Single Market.

After the challenge of negotiating with the EU and the leaders of the remaining 27 EU Member States, the Prime Minister's biggest challenge will most likely be managing the internal disagreements within the Conservative Party over Europe. However, there will also be external scrutiny and pressure. From the Right, UKIP have recently elected Diane James MEP to replace the high profile, controversial, enigmatic, Nigel Farage. On the Left, the most outspoken parties and politicians have been the SNP and their leader Nicola Sturgeon, who have championed Scotland's vote to Remain and argued for independence from the UK, as well as the Liberal Democrats and their leader Tim Farron, who are the only UK wide party to be advocating a re-run of the Referendum, and are heavily burnishing their pro-European credentials.

This leaves Her Majesty's Loyal Opposition, the Labour Party and their leader Jeremy Corbyn who has re-elected as leader on Saturday 24th September with 62% of the vote over challenger Owen Smith. Corbyn and the Labour Party have been relatively quiet about Brexit, and Corbyn himself has been criticised from within the party and outside for his lacklustre performance during the Referendum campaign. This is fairly understandable, with Jeremy Corbyn historically holding a Eurosceptic opinion, and viewing the EU as part of the capitalist system. Many say that it was only his election as Leader of the Labour Party, and having to keep his overwhelming Europhile MPs happy, that led to him publicly backing Remain – some believe that in the privacy of the voting booth, he may have even voted to Leave. This elephant in the room, is perhaps why the Labour Party conference, being held in Liverpool from the 24th to the 28th September, is not debating Brexit, which is by virtually every measure the most important political event of the moment.

With Jeremy Corbyn and the Labour Party finding it so difficult to scrutinise the PM and Government over Brexit, then that will have to mean the important work of holding the Government to account is left to the Parliamentary Select Committees, to the Liberal Democrats, SNP, Plaid Cymru, the Northern Irish Parties, UKIP as well as internal scrutiny from within the Conservative Party.

George Osborne, who rather than leaving politics like his close friend, former Prime Minister, David Cameron, has made it clear over the last week that he will continue for the long run, may be the champion within the Conservative Party of more Pro-EU policies. In a speech in America last week he said that "he wants to position himself as the head of the “liberal mainstream majority” and for Tories who want a “soft” Brexit."

Think tanks and the media will also contribute significantly to the scrutiny process. Gisela Stuart has recently been made Chair of Vote Leave's successor organisation, Change Britain. Also from a Leave perspective, BrexitCentral has been set up by former Chief Executive of the Taxpayers Alliance, Jonathan Isaby.

Diane James MEP – Profile

Diane James has been a member of the European Parliament for South East England since July 2014. On 16th September 2016 she was elected as the new leader of the UK Independence Party (UKIP), succeeding Nigel Farage. Prior to this Diane James has held multiple high profile roles in the party most recently she was the Justice and Home Affairs Spokesperson. She first came to prominence within UKIP as the party's candidate for the 2013 Eastleigh by-election, where she came second, with subsequent assured performances in the national media. Ms James was briefly UKIP’s parliamentary candidate in North West Hampshire during the 2015 general election, but dropped her bid for “personal reasons”. Once a Conservative supporter, she distanced herself from the party and became an independent councillor in 2007, before joining UKIP. Before starting her career in politics Ms James was a business analyst in the healthcare sector. She has controversially spoken of her admiration for Russian President, Vladimir Putin.

Written by RPP Head of London Office, Andrew Brown