Loose Lips Sink Ships
There’s an old American idiom that was used frequently during the Second World War: “Loose Lips Sink Ships”. That’s how Donald Tusk must have felt when he let slip the details of his conversation with Prime Minister Theresa May. By letting everyone know that the newly installed Prime Minister intends to invoke Article 50 of the Lisbon Treaty in the first months of 2017, he pulled the trigger on the race for the exit. There is no doubt that his ‘momentary slip of the tongue’ hastened Prime Minister May’s announcement at the Conservative Party Conference that Britain will seek to invoke Article 50 before the end of the first quarter of 2017. And while at every turn in this fascinating geopolitical intrigue people continue to half heartedly say that there is no going back, we now know that very soon there will certainly be no more time for pleas and second chances. Since dawn broke over Britain on Friday, June 24th there has been a paucity of new investment announcements, cautious signals about the impact of the decision to leave the EU and a very public media battle between pro and anti Brexit elements. In the pharmaceutical sector there has been a scramble to decipher possible changes and to seek to calm companies and human talent in the event of the exit becoming a reality. Most notably in all of this, there has been feverish speculation about the future location of the European Medicines Agency. There has been a constant throughput of politicians and lobbyists from across the European Community travelling around seeking to secure the glittering prize of the European Medicines Agency for their bailiwick. In this whitepaper we will look at the endeavours being taken by various governments and city leaders to bring the prestigious agency to a new location. As the acknowledged Brexit experts in the regulatory affairs sector, we have seen a considerable uplift in enquiries and projects from new and existing client companies around the world since Britain voted to leave the EU. Many companies have moved to guarantee the continued presence of their licensing needs within the EU. There is a consistent thread in a high percentage of these projects; to move the RMS from the UK to a new EU based authority. Furthermore, our colleagues in the Acorn Regulatory Medical Devices division have experienced an unprecedented increase in new requests from companies across the world seeking to change their EU Authorised Representative from UK to Ireland, or to support the CE marking process of their device in Europe. Despite the increased demands that the new projects have brought we have been handling them in a timely manner. The Acorn Regulatory team has expanded by over 30% in first three quarters of 2016. The increase in staffing is due in no small part to the UK’s decision to leave the EU and the industry’s response to that decision. In this whitepaper, the second in our Brexit series, we will look at the opportunities that Brexit presents for the life sciences sector. We will also look at the concerns for companies in areas such as regulatory affairs, the ability to attract talent and concerns for the PV sector in the post Brexit world. As always, our team welcomes any comments that you may have on the thoughts contained herein or any other aspect of our work. I would be delighted to hear from you. In the meantime, I do hope that you find this informative and useful to you as we move towards Brexit.Where Next for the European Medicines Agency?
For those of us working in the sector, the future location of the European Medicines Agency has been a consistent topic of conversation since the outcome of the Brexit vote became known. There is no doubt that the UK’s decision to leave has caused some upset for the 600 members of staff at the agency. In a human context, their livelihoods and the location of their employer are now in the air. The EMA is one of a number of agencies that are now being courted actively by European governments in an attempt to persuade them to choose their cities. The intervention of the Japanese government in early September 2016 brought the EMA issue further into the open and threw down the gauntlet to the British government in relation to current and further Japanese investment in the UK’s life sciences sector. In a 15 page letter, Japanese officials told their counterparts in the UK that if the EMA leaves the UK then the budgets of biopharma companies may follow. The letter stated: “If the EMA were to transfer to other EU Member States, the appeal of London as an environment for the development of pharmaceuticals would be lost, which could possibly lead to a shift in the flow of R&D funds and personnel to Continental Europe”. Despite the threat and the large scale of Japanese investment in the sector in the UK, it is unlikely that there will be any acquiescence to their demands. Moderate voices in the UK media are increasingly indicating that we will see a ‘Hard Brexit’ i.e. a move to exit the single market and to restrict the free flow of people into the UK. In this instance, the departure of the EMA from its headquarters in London is all but guaranteed. But where will it end up? The weeks and months since the June vote have seen a constant trouping of elected officials and representatives from numerous governments in and out of the Canary Wharf headquarters of the agency. Already, a number of countries have moved ‘into the lead’ in the race to land the agency.
The Future of the EMA
Many see Milan as being the front runner. It’s charismatic Mayor, Giuseppe Sala (pictured right), was one of the first elected officials to meet with officials at the EMA once the outcome of the vote became known. Milan is regarded as Italy’s financial services centre and an ideal location for start up businesses. One of the main reasons that so many cities are seeking this asset is that there is a belief that its presence will incentivise pharmaceutical companies to locate in proximity to the EMA. To that end, there are reports in Italian media that the Mayor, in association with the embattled Prime Minister Matteo Renzi, will seek to create a tax-free zone in the city in an attempt to entice foreign direct investment from pharmaceutical companies. Milan, it must be argued, is a significant contender, if not the main contender in this endeavour. The country’s pharmaceutical sector is Europe’s second largest in production terms and Italy is the world’s largest exporter of medicines per capita. The city is not just seeking to secure the presence of the EMA in the capital of Lombardy. The Consiglio Comunale are also keen to bring the European Banking Authority to Milan. The Danish government has also made overtures, albeit obliquely, at this stage. There have been numerous media reports that Danish firm Novo Nordisk has lobbied the Danish government to seek to host the EMA. The country has a track record of hosting such agencies as it currently hosts the European Environment Agency. Copenhagen faces stiff competition from Stockholm. The Swedish city has already established a working group to manage the projects. Speaking in July of 2016 Anders Lonnberg, the Swedish Life Sciences Coordinator told ‘The Times’ that “you cannot have an agency of the EU if you are not a member”.