The UK Life Sciences industry is waiting to see the Government's plans for product and other regulation: -will we go for a "soft" Brexit, largely following and harmonising with EU laws, or a "hard" Brexit, looking at a completely sovereign system: a British solution?
The benefits of harmonisation with EU laws are myriad and have been enjoyed over 4 decades by the industry, and also by patients. In the UK EU Life Sciences Transition Programme Report of 6th September 2016, an industry group reported to the government that having a "common regulatory framework" is the preferred position.
The press reports of the reception of that Transition Programme Report were that it was not well received: the government was looking for more blue-sky thinking, answering their question: "what if we DON'T have to harmonise with EU law: how would you redesign the system?"
Government is now pressing industry to come up with an "Industrial Strategy" which will then determine how the UK will redesign policies including regulatory strategies. This makes sense: regulation should not be the tail wagging the dog, but rather should be designed to contribute to wider commercial and consumer protection goals.
The UK government has been playing its cards close to its chest, whilst continuing to actively engage with industry on fact-finding and determining the UK's Industrial Policy for Life Sciences. We still have no clear idea of what "Brexit" will mean from a legal and regulatory perspective, but there have been some interesting developments, which we discuss below.
Brexit and GDPR
First of all, at the end of October 2016, the government confirmed that the UK will be implementing the EU's General Data Protection Regulation (GDPR), although with the added comment that they will "look later at how best we might be able to help British business with data protection while maintaining high levels of protection for members of the public".
Brexit and Patents
The UK government also announced on 28 November that it will continue with preparations to ratify the Unified Patent Court Agreement (UPCA). The UPCA will allow companies to enforce their unified patent rights through a unified court system, across Europe. The court for life sciences is to be in London. The decision to continue with ratification means that the physical preparations of the court can continue. The government has said that "the decision to proceed with ratification should not be seen as pre-empting the UK's objectives or position in the forthcoming negotiations with the EU". However, to engage in substantial sunk-costs in establishing that court might be seen to indicate some kind of intention of a closer rather than a more distant relationship with the EU. The UK government will want to consider though whether the fact that the final appeal court for the UPC is the European Court of Justice is something which might be acceptable to the Brexit lobby.
Brexit and Medical Device Laws
The GDPR was due to be implemented, and the UPCA was due to be ratified before the UK's likely exit from the EU, two years after article 50 is triggered (expected March 2017). However, the implementation date for the EU's Medical Device Regulations' (MDR) and Invitro-Diagnostic Regulations' (IVDR) is likely to fall after that exit date.
Once outside the EU, EU Regulations such as the MDR and IVDR would not be effective in the UK. The government has not yet set out an official position with respect to MDR and IVDR, although the MHRA has informally indicated that it anticipates implementing the MDR and IVDR.
If the Great Repeal Bill (GRP) becomes law before the MDR and IVDR are directly effective and the UK government does decide to implement laws equivalent to MDR and IVDR, then steps will need to be taken in advance of the GRP to bring forward legislation to remove the UK's current medical device laws from the statute books and replace them with a UK equivalent of the MDR and IVDR.
A major issue with the MDR and IVDR for the UK government is that each Regulation envisages around 60 pieces of delegated legislation to be drafted by the EU to explain and implement them. If outside the EU, we should assume that the UK will not be able to influence those delegated pieces of legislation. If we do move forwards with implementing the MDR and IVDR, the UK government will need to determine how they will deal with these as yet unknown EU laws. It is likely though, that unless the UK's legislation is significantly in step with EU legislation, mutual recognition will not be acceptable to the EU. This is a balance to be struck in the negotiations, assuming that the outcome of the review of Industrial Strategy is that for medical devices, harmonisation with or mutual recognition of EU laws is the better solution for business.
What Next?
The UK cannot possibly rewrite its own completely new sovereign laws regulating medicinal products and medical devices, patents and data privacy before the two year negotiation period following the Article 50 notice. Common sense dictates that we will have to continue with the laws we have, or in the case of EU regulations, UK versions of these, for a number of years. The government is perhaps recognising this need in their agreement to ratify the UPCA, and to implement the GDPR and potentially also the MDR/ IVDR. The MHRA is very familiar with and indeed has been fully engaged in the development of the EU product regulation laws, including the MDR and IVDR. It will take time for the UK to rethink its way around regulation if we are to develop parallel and not harmonised regulations.
The big question remains whether the UK government will try to negotiate a level of harmonisation for those laws. Switzerland has medical device laws which are harmonised with the EU, but their pharmaceutical laws are not, except for manufacturing inspections. We could similarly see a divergence between the treatment of medicinal products and of medical devices, with perhaps harmonisation in selected areas, such as the regulation of clinical trial applications. The UK government is putting together a shopping list of desired outcomes, which will then be subject to negotiation.
For now, businesses most need to hear from government that there will be a transitional period during which the status-quo will continue for a specific time period after the end of the 2 year exit negotiations. This is going to be absolutely necessary for them to be able to plan their future business operations. We cannot reach the end of that 2 year period only to find that the outcome is different from that anticipated and is one that has not been planned for. Let's hope that government and the EU negotiators will agree and set in stone the transitional period as a starting point, before getting down to the detail of the long-term future of their regulatory relationship in the life sciences sector.