With British politicians scrambling to define Brexit, UK pharma companies are currently in the dark about what breaking away from the EU will mean for business. According to experts from patent attorney Beck Greener, one of the (many) difficult questions about Brexit is, what happens to pharma’s intellectual property? Currently, British-based pharma IPs are covered under the European Commission’s Summary of Product Characteristics (SPC), but if an appropriate deal isn’t struck between the UK and EU, it could lead to an IP grey-area. “SPC protection will almost certainly be available to UK-based pharma companies post-Brexit, but what they’ll have to do in order to obtain that protection largely depends on the outcome of negotiations,” says Jamie Fraser, UK and European patent attorney at Beck Greener. “However, if the Brexit negotiations end in a ‘no-deal’ situation, there may be no other option for UK-based pharma companies than to expand or relocate at least some of their business to an EU member state.”
Fraser recently co-authored a paper outlining the potential consequences of pharma IP and SPCs (1), which raises the possibilities of both “hard Brexit” and “soft Brexit” scenarios. Regarding market authorization (MA) in relation to the EU, the paper stated, “A recent EU Commission and EMA Notice (EMA 2017a) would appear to be a warning shot to UK-based companies who currently hold an MA issued by the EMA. The notice reiterates certain residency and activity requirements for MA holders (EMA 2017b):
- EU law requires that marketing authorization holders are established in the EU or EES.
- Some activities must be performed in the EU or EEA, related for example to pharmacovigilance, batch release, etc.” (1)
References
- J Fraser, J Stones, “Brexit – What are the potential consequences for pharma patents and SPCs?”, B J Pharm, 2, (2017). European Commission, “Position paper transmitted to EU27 on intellectual property rights (including geographical indications)”, (2017). Available at: http://bit.ly/2eJqMdM. Accessed: October 6, 2017.