TOKYO – The Japanese government said a letter it wrote to the EU and Britain expressing trepidation about the future of the region after the U.K. voted to leave the union – a decision known as the Brexit – was penned after discussions with companies of all sizes. (See BioWorld Today, Sept. 14, 2016.)

On pharmaceuticals, the letter read, “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 U.K. establishes its own framework distinct from the EU’s, in a move away from international efforts at the harmonization of pharmaceutical regulations, the framework of mutual recognition of GMPs and the approval scheme operated by the European Medicines Agency.”

Japan’s government also requested that the EU secure the location within the U.K. of the EMA.

“Many Japanese pharmaceutical companies are operating in London, due to the EMA’s location in London,” the letter read. “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. This could force Japanese companies to reconsider their business activities.”

Since Britain voted, however, Sweden and Italy have both said they would like to see the EMA’s headquarters relocated to their nations. The agency itself released a statement soon after the referendum: “We are confident that the member states will take the most appropriate decision on EMA’s location and arrangements in due course, taking also into account the complex political and legal environment generated by the outcome of the U.K. referendum.”

Companies in Japan have told BioWorld Today that they see no risk in the short-term of doing business in the U.K. Over the longer term, companies have refrained from commenting.

Since the breakup occurred, Takeda Pharmaceutical Co. Ltd., has announced it will be restructuring its research and development operations and, as a result, closing a facility in the U.K. “Brexit was not a factor in Takeda’s decision regarding the proposed changes to our U.K. facilities,” Juli Ellwanger, head of R&D communications at Takeda, told Bioworld Today.

“This global R&D transformation had been in the planning stages for several months, well before the referendum result, which was not a factor,” she added.

Fujifilm Holdings Corp. also denied fears of Brexit. It recently invested in Cynata Therapeutics Ltd., an Australian company conducting trials in regenerative medicine in the U.K. “There is no risk” from Brexit, Kana Matsumoto, a Fujifilm spokeswoman, said of Cynata trials, set to begin in the U.K. later this year. (See BioWorld Today, Sept. 15, 2016.)

Tokyo, however, confirmed that its letter closely reflected the sentiment of Japanese corporations. “We are unable to disclose specific names of the Japanese businesses since we do not have their consent, but one thing we can say is that we covered as many Japanese businesses as possible, from large corporates to SMEs in various sectors, including pharmaceuticals,” an official from the European Union Economic Affairs section of the Ministry of Foreign Affairs told Bioworld Today.

The letter was written “based on interviews with relevant industries conducted by ministries and agencies participating in the government task force regarding the withdrawal of the United Kingdom from the European Union, as well as Embassies and Consulate Generals of Japan located in Europe,” the official added. “We have also consulted major economic organizations.”

A recent poll by Japan’s Teikoku Databank Ltd. showed that 87.9 percent of the Japanese companies surveyed had yet to feel any impact from Brexit. However, when asked about the influence it would have on the Japanese economy, 51.3 percent said they expected a negative impact and 35.8 percent said they thought it was difficult to tell; 0.9 percent of the 10,058 Japanese companies surveyed expected Brexit to have a positive impact.

Concerns are rising that the inaction of the British government, and its apparent lack of a plan for exiting the EU, will have a detrimental effect on the British and global economy once Article 50, which triggers official negotiations on an exit, is invoked.

“It is imperative for the U.K. and the EU to regain the confidence of the world and ensure their unwavering competitiveness by increasing the predictability of the Brexit process, ensuring the outcome is free of unpleasant surprises and reducing the risks emanating from uncertainty,” the Japanese government wrote. “From this perspective, we strongly hope that the U.K. and the EU will present to the world the whole picture of the Brexit process as early as possible.”

Despite its requests, however, the Japanese government seems to have as little idea about the terms, timing and consequences of Brexit as the rest of the world. It has, however, set up a task force that will act if the situation changes. “We plan to hold task force meetings and consider actions when necessary,” the foreign ministry official said.