If the European Medicines Agency (EMA) transfers its headquarters to another EU member state, which is all but certain following the Brexit vote, Japan’s Ministry of Foreign Affairs is warning that the “appeal of London as an environment for the development of pharmaceuticals would be lost.”
The harsh critique comes as the EMA, which has 890 employees of various nationalities at its headquarters in London, has said the decision on where to move from its current locale in London’s Canary Wharf financial district will be decided by the member states.
A number of EU countries have been lobbying for the new headquarters, among them Spain, Sweden, Denmark, Italy and Germany.
Japan’s Ministry of Foreign Affairs, in a message to the UK and the EU, warned: “Japanese companies are concerned about the relocation of EU agencies currently located within the UK. Many Japanese pharmaceutical companies are operating in London, due to the EMA’s location in London. 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 [research and development] funds and personnel to Continental Europe. This could force Japanese companies to reconsider their business activities.”
The warning comes as the EMA, MHRA and politicians try to figure out the best possible way to allow the withdrawal of the UK from the EU with as little disruption as possible. Such a withdrawal from a pharmaceutical regulatory standpoint could mean the UK has to re-work how drugs are authorized on the island.
“There are concerns over the possible occurrence of a cumbersome or lengthy process for pharmaceutical approvals and an increase in the clerical burden once the UK establishes its own framework distinct from the EU’s, in a move away from international efforts at the harmonisation of pharmaceutical regulations, the framework of mutual recognition of GMPs [good manufacturing practices] and the approval scheme operated by the European Medicines Agency,” the ministry said.
The comments follow similar warnings from Sir Kent Woods, former EMA chairman of the board and former chief executive of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), who told Focus in June: “At the operational level, there has hitherto been close working between MHRA and EMA (and between MHRA and the other national regulatory agencies). The MHRA is the largest such agency in the EU and well placed to provide a national function though one would want to minimise duplication of effort wherever possible.
But he also said he thinks Brexit could offer some time to re-work the UK's medicines and devices regulations.
“At the policy level, there is a large body of EU legislation underpinning all UK medicines and devices regulation which has either been transposed into UK law or (in the case of Regulations) has direct effect. Across the whole of government, it will be a large task to review that legislation in depth, but potentially it gives an opportunity to take the Better Regulation agenda forward faster than is possible through the EU institutions," Woods added.