People in the life sciences sector are wondering what it all means for them. There is currently uncertainty over what sort of relationship the UK will have with the EU in the future and when anything might change. The best practice right now is to carry on with business as usual unless and until anything changes that, and to watch carefully for signs of what may change.
Laws and regulations that are specific to the pharmaceuticals and life sciences sector are still in force. Anything which is coming through, such as the Falsified Medicines Directive, is still on track unless decisions are made to change that.
- The General Data Protection Regulation (GDPR), which will come into effect across the European Union in May 2018 and replace the current data protection regime in the EU, will still apply to the UK if the UK has not yet left the EU by then.
However, even when the UK leaves the EU, and whether this is prior to the GDPR coming into effect, it is highly likely that the UK will adopt a similar piece of legislation so that the UK's data protection laws are in line with the EU's and are deemed to be adequate by the EU. The UK's data protection regulator, the Information Commissioner's Office, has already indicated this.
- The European Medicines Agency will continue operating from Canary Wharf, for now at least. The regulatory basis for obtaining marketing authorisations, CE certifications and clinical trial approvals remain unchanged for now. The UK's regulator, the Medicines and Healthcare products Regulatory Agency, is likely to continue to play a key role in global regulation, and will probably work closely with the EMA, perhaps forming a close deal.
- Anyone obtaining funding from the EU can continue receiving that funding for as long as the UK is a member of the EU. When the results of the UK's exit negotiations are clear, there may be other routes for funding opportunities.
- The new unitary patent system was expected to launch in January 2017, but that will probably be delayed now. It is unclear whether the UK will be a part of that or not. The Unified Patent Court was going to have its life sciences seat in London, but that must now be highly doubtful to continue.
- Currently, EU trade marks still apply, but depending on the deal that is negotiated they may need to be split out into EU and UK trade marks. There is plenty of time before that will happen, and trade mark owners should watch the situation.
- Linked to this are the rules on parallel trade in medicines between Member States of the EU. Products that are put on the market in the UK or a country in the EU may or may not be able to be exported or imported between the UK and the EU in the future - but that again depends on the final deal that the UK and the EU agree, and whether the UK is part of a single market. For the time being, though, it is business as normal.
The basis position is it is business as normal, but anyone in this sector needs to watch developments closely, because there will inevitably be changes. This will only become clear over the coming months.