The declaration builds on a shorter version previously published alongside the Withdrawal Agreement recently.
The declaration makes a number of positive noises around close co-operation on trade and regulation in pharma. However, the document remains a political aspiration without anything legally binding at this stage. In addition, the future of the document depends very much on whether the Withdrawal Agreement and proposed future ties with Europe are approved by the UK Parliament and the EU27 Member States.
Here are some of the provisions in the declaration:
- Regulation - The parties will "explore the possibility of cooperation of UK authorities with EU agencies such as the European Medicines Agency". This may require the UK to align with EU rules. The wording here is open-ended, and the UK may end up diverging from the EMA. Nevertheless, regulatory co-operation is one of the negotiation objectives.
- Trade - The parties will pursue an "ambitious, wide-ranging and balanced economic partnership". This will encompass a free trade area as well as "sectoral cooperation where it is in the best interest of both parties". This suggests negotiations on a sector-by-sector basis, but it should also be noted that nothing would be agreed that would weaken the integrity of the Single Market or Customs Union. The wording also does not extend to 'frictionless trade', which was the UK’s negotiating objective.
- Facilitated customs arrangement - The EU would consider this UK proposal. A future trading relationship is envisaged that would make use of all available facilitative arrangements and technologies, with the intention of allowing mutual recognition of trusted traders’ schemes and assistance to recover taxes and duties. There is an intention to avoid a hard border on the island of Ireland. This solution would rely on technology being ready at the end of the transition period.
- Border checks and controls - Whether border checks will take place will depend on how closely the UK is aligned with the EU's rules and regulations and how available possible technological solutions and facilitative arrangements are.
- Free movement of people - Free movement would no longer apply. However, the parties would negotiate visa-free travel for short-terms visits. The parties would also negotiate conditions to allow free movement of people for the purposes of research, study and training – which is likely to have implications for the movement of scientists. However, as with the other proposals, the details are currently vague.
- IP exhaustion of rights - The parties have agreed to maintain protection and enforcement of IP rights. There will be a mechanism for cooperation and exchange of information on IP issues. Although cooperation would continue, the UK and EU could establish their own regimes for exhaustion of IP rights.
- Health security - The parties would cooperate in line with existing EU arrangements with third countries, to cooperate on prevention, detection, preparation for and response to health threats.
Once the UK has left the EU, there would be a schedule and programme of negotiation rounds, with a "high level conference at least every six months… to take stock of progress and agree… actions to move forward".
The statement is positive and collaborative, which the pharma and life sciences sector will be pleased to see. However, there remains a lot of uncertainty - not least arising out of the current political uncertainty in the UK's Parliament.
We will be holding a PING (Pharmaceutical Industry Network Group) Conference, in association with EMIG, on 3 April 2019 just after Brexit date, on how Brexit is affecting the pharma supply chain. If you are interested in attending the event, please contact Paul Gershlick in our Pharmaceuticals and Life Sciences team on 01923 919 320.