At more than 1,200 pages long, it is hard to call it a 'thin deal', but that is what it is in many respects. However, at least there is a deal, there are zero tariffs on goods and there is much to build on a spirit of co-operation. Future discussions and ways of working together are a theme within the deal.
With a series of Paragraphs within Articles within Sections within Chapters within Titles within Headings within Parts, not to mention plenty of Annexes and references to other documents and treaties, with a lack of navigational assistance for the reader - this is not for the faint-hearted! So much for light Christmas Day reading!
For a general overview of the legal implications, please see our article, "Brexit - Our New Relationship with the European Union".
This is still being worked out, but more continues to become clear. Here is what we have gleaned:
- The UK for now is unilaterally recognising any products that have been put on the market in the EEA as having been exhausted - ie can be freely sold in the UK.
- Any products that had been put on the market in the UK before the end of the transition period on 31 December 2020 are exhausted as far as the EEA is concerned - ie can be freely sold in the EEA.
- Any products that had been put on the market in the UK after the end of the transition period on 31 December 2020 are not exhausted as far as the EEA is concerned - ie would need to have the rights holder's consent to be sold.
- The IPO plans to consult further on its future exhaustion of rights position in the next few months.
Despite a lot that is not yet clear, there are good reasons to be hopeful. There is a deal when many people predicted there would not be. The mood music is in a totally different place now that has happened, the deal itself has the foundations in the Partnership Council and many different committees that are intended to work together and find common standards and ways of working that will build on this initial deal.
In fact, in the Medicines Products Annex itself, Article 10 Paragraph 2 says: "The Parties shall endeavour to cooperate with a view to strengthening, developing and promoting the adoption and implementation of internationally agreed scientific or technical guidelines including, where feasible, through the presentation of joint initiatives, proposals and approaches in the relevant international organisations and bodies referred to in Article 4."
So, there will be continued discussion, and we hope one day the MHRA and the EMA will return to the close relationship they had before the Brexit process.
In the meantime, though, there is much that gives the UK the freedom to go down a different path if it so chooses, including with relationships with others to the West and East of Europe.
There is potential for regulatory divergence as the laws and practices develop in each of the UK/EU, but for now that seems more theoretical - there is still an appetite for regulatory alignment, but with the flexibility to go down a different route. Who knows what the future will hold if deals with others push the UK in a different path from the EU, but for now this is a good base to build on.
And as we saw in the 2020 PING Conference with leading speakers on Genomics, Personalised Medicine and AI, as well as the UK's leading role in the COVID-19 pandemic response with use of drugs, discovery of vaccines an use of data - there is so much where the UK is leading the way in academia, industry and with the NHS.
We will be exploring these areas further in PING meetings this year.