Insights from The Pharma Market Access and Pricing Summit Asia by our analyst Sophie Cairns who is at the event https://t.co/PZVhsvm4E0
Spain bets on Barcelona to get the EMA as the independence movement in Catalonia reaches climax
On 28 June 2016, merely days after the UK's pivotal vote to leave the European Union, the government of Spain's autonomous region of Catalonia - the "Generalitat" - set up a special commission tasked with fleshing out a plan to pitch the region's capital, Barcelona, as a candidate to host the European Medicines Agency (EMA). From early on the Catalan capital garnered wide political support in Spain and became a favourite of the government led by Prime Minister Mariano Rajoy. The monumental Torre Agbar, one of the most iconic skyscrapers in the city's skyline, was earmarked to host the new office and a promotional campaign was launched, with high-profile supporters including the Barcelona Football Club.
In April this year, the government named the city the official Spanish contestant for the relocation, and on 31 July the bid was formally presented to the European Commission. Although as many as 19 cities are officially in contention to host the prized regulator, with Copenhagen and Paris named among the frontrunners in the media, the Catalan and Spanish authorities appear confident of their chances. Their hopes are no doubt fomented by the memory of narrowly missing it the first time round: in 1992, when the EMA location was first disputed, Barcelona was a finalist; the winner, as we know, was London, and the rest is history.
Another critical vote hangs in the balance
So here we are, 25 years later, and the nearly 1,000 EMA professionals will have to find a new home after the UK leaves the EU in 2019. But as the EMA relocation vote is set to take place in October, so is another: a referendum in Catalonia on the region's independence from Spain. In June, the Generalitat announced that it will hold a popular vote on 1 October to decide if the region's future should be outside of the Kingdom. The independence movement in Catalonia reached a new high following the recession in the early 2000s and subsequent years of austerity, and an unofficial, "dry run" referendum took place in 2014, with 81% voting in favour of leaving according to Catalan authorities. However, determination may not be enough: the Spanish government has not authorised the October vote and has made it clear that any attempts at self-determination will be considered unconstitutional and therefore invalid. Other European countries won't offer Catalonia any moral support either, not wanting to interfere in Spain's internal matters.
In defiance, Catalan authorities have vowed that they will declare independence unilaterally if Madrid refuses to recognise a "Leave" result in the poll. And in yet another bold move in early August, the Generalitat approved a draft law that would create an independent Catalan Medicines Agency, the region's equivalent of the national Agency for Medicines and Health Products (AEMPS) that regulates pharmaceutical products for all of Spain. Perhaps to avoid the project being struck down right away, Catalonia's secretary of health, Toni Comín, clarified that the agency would assume an "administrative role" only and would not replace the AEMPS' in its regulatory function; that is, "for now", as it is exactly what the new body would do in a Catalan independence scenario. The project is yet to be voted on in the Catalan Parliament, which could happen early in September after the summer recess, and could potentially have implications for the pharma industry.
Could the drug regulator come to the Republic of Catalonia?
It might seem, therefore, as something of a paradox that authorities in Madrid and Barcelona appear so firmly united over the latter's candidacy for the EMA, despite being in such fierce opposition over Catalonia's future. Asked by the media, both the Spanish government and EU officials have been playing down the issue as having no bearing on Barcelona's chances. So what should we make of it, and is an EMA in the Republic of Catalonia a genuine possibility?
While the Spanish government's support may seem paradoxical, bringing the EMA to Barcelona could help add political pressure on the region in the longer term, besides bringing the obvious advantages of winning. As for Barcelona itself, the city has many qualities that make it a strong candidate - and EMA staff seem to agree, voting the city their top choice in an internal poll earlier this year. But the implications of the political climate in Catalonia will be difficult to ignore by decision makers representing the 27 member states. The ability to guarantee a seamless transition, a key criterion for candidates, requires the type of cooperation that could prove problematic if Madrid and Barcelona remain at loggerheads in the crucial weeks and months after the EMA vote.
The Generalitat's hasty efforts to set up a Catalan Medicines Agency are poorly timed at best and could be seen as diverting attention and resources away from where they need to be if Barcelona is to get the EMA. Then there's the big question - what happens if on 1 October the Catalans vote to leave Spain? While the central government will almost certainly not recognise the result, a period of tugging and political instability is likely to follow. While EU officials have avoided discussing the issue in the context of the EMA race, some have - perhaps as a veiled reference - mentioned the importance of political stability. An although still a rather distant possibility at the moment, an independent Republic of Catalonia would open a whole new Pandora's box of issues as the new state would not necessarily retain its EU membership automatically.
It is difficult to imagine that EU decision makers will be able to ignore these considerations, but whether they prove decisive in this highly political race is anyone's bet. We will find out soon enough if Barcelona improves on its 1992 runner-up positioning, and Torre Agbar becomes the home of European drug regulation. But the EMA vote aside, Catalonia's efforts at self-governance will continue to frustrate the government in Madrid, and "protecting" the region's healthcare system has been one of the major selling points of the independence campaign. The plan to create a Catalan Medicines Agency is clear proof of that and could have implications for pharma regulation further down the line, regardless of the result of the October referendum.
Ewa Oliveira da Silva is a Research Analyst with the Life Sciences group at IHS Markit
Posted 29 August 2017
- Regulatory convergence or divergence for Asian pharma
- Is healthcare reform in the cards with new socialist government in Spain
- Culture shift at Takeda a sign of things to come
- Nevermore ignore the role of digital health in health decision making
- ISPOR 2018 Baltimore
- Trump speech on drug prices: Much ado about nothing
- Drug supply shortages in Germany
- Impact of passing through rebates at the POS for diabetes medicines
We thought it was time for an update... https://t.co/h1zq9RFM7p