The Brexit – UK’s decision to leave the EU will have a wide range of effects on the life sciences sector, from drug approvals and clinical research, to patents and trade. What will it mean for translation of official documents in the EU? Will they no longer need to be translated into English?
The Brexit | EMA or No EMA in the UK?
The Brexit will have far reaching implications, but it will especially impact the drug approval process in the UK and the EU. Its effects could be seen in the bio-pharmaceutical industry if the UK decides to leave the EU regulatory system, European Medicines Agency (EMA), and develops its own separate regulatory framework. Prior to the Brexit, the London-based EMA gave pharmaceutical companies a single marketing authorization which helped to deliver faster access to the EU market. If the UK does choose to implement their own separate system, there is speculation that this could lead to duplication, increased cost and delays, the need for more translation, and a decrease in the number of trials conducted in the UK.
According to experts, significant effects will be short term, and will most probably impact regulation, tax structures, intellectual property, funding and the ability to collaborate across national borders. The transition period, which is expected to last possibly up to two years, will probably be the most difficult for bio-pharmaceutical companies to navigate. During this time the new EU Clinical Trials Directive is to be replaced by the new EU Regulation in 2017. Although the UK may decide to use the new EU Regulation, British authorities will still have to perform an additional review of national regulatory compliance, and medical translators will need to be prepared to conform with the new regulations. Finally, if English is no longer an official EU language, what will this mean for translation requirements, particularly with regards to life sciences translation?
The Brexit | What Language Will the EMA Speak?
Since the current EMA headquarters are in London it is logical that the EMA will have to relocate if Britain decides to set up their own regulatory system. Drug companies and healthcare officials in Sweden, Denmark, Italy and Germany have all expressed interest in hosting the EMA, since firms in these countries are keen to be located close to the region’s key regulator. Many feel that closer association with the authorities will positively influence the local industry.
Where the EMA relocates will also determine language translation services and requirements. This may actually affect the importance of English translation in the EU. Since clinical trial documents, drug packaging inserts and marketing materials for EU approved drugs may no longer need to be translated into British English, the needs of pharmaceutical translation and healthcare translation may very well change. Current patent translation requirements under the EU unified patent system are English, French and German. There is the possibility that this will also change if Britain sets up its own separate system.
Other Brexit Implications
The UK bio-pharmaceutical industry currently accounts for 25% of all R&D spending. The risk for decreased returns from a separation, some argue, is a real concern. Others feel there will be a negative impact on the current robust collaboration between the UK and academic centers in the EU – England was one of the EU countries that received the most grants and funding for research. The UK is also presently involved in about 40% of all of the adult rare diseases trials conducted in the EU. If Britain sets up a separate regulatory system, there is concern that less of these trials will be conducted in the UK. While the EU is in the process of further harmonizing their regulatory framework, a UK separation may complicate matters for the industry.
The outcome of the Brexit is still unknown; and is even more so for bio-pharmaceutics. Whether or not the UK sets up a separate regulatory system, there are sure to be some changes as the EMA adapts to the new environment.
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