Gregory Bacon and Zac Fargher
In light of a string of high-profile resignations, it is questionable whether the Government’s proposed EU Withdrawal Agreement (Agreement) will even make it to Parliament. If it does, its journey to passage is likely to be treacherous, so its future remains highly uncertain. Nevertheless, the Agreement contains some valuable insights into the possible form of medicines and medical devices regulation in the UK and the EU during the potential transition period and possibly further on.
Our previous update on the Draft Agreement describes the process of reaching the Agreement, and sets out the basic position for medicines and medical devices, which the current text does not substantially alter. There are, however, points worthy of consideration, as a result of the two, perhaps most substantial, changes arising from this final version of Agreement, which are:
- The Transition period: this will be capable of being extended for an unspecified period beyond 31 December 2020 (if agreement to an extension is reached prior to 1 July 2020); and
- The Northern Irish Border: in the event no comprehensive agreement is reached on the Northern Irish border during the transition period, and until such a point, or otherwise agreed by both the EU and the UK, Northern Ireland and the UK will remain in a limited customs union within the EU. This would apply to all goods with the exception of fisheries, and would include non-regression clauses to prevent the UK departing from minimum EU standards in a number of areas.
In view of these, we have briefly set out below how medicines and medical devices may be treated under each scenario.
Impact of the prolonged Transition period:
- In terms of medicines, the basic position is that authorised medicinal products would be able to move freely between the UK and the EU for the transition period. Among other reasons, this could be welcomed by industry and the public as a means of avoiding medicines shortages and the need for stockpiling (which have become a source of considerable anxiety), at least temporarily.
- For new applications, Article 45 of the Agreement provides that dossiers from past applications must be provided by the EMA, UK or any other Member State, to one another, to allow for new applications to be processed, including those made under Article 10 of Directive 2001/83/EC.
- In light of the MHRA signalling (most recently in the contingency legislation circulated for consultation) that centralised marketing authorisations will likely be converted to UK marketing authorisations on exit date, we consider it likely that if the Agreement is acceded to, most new applications for marketing authorisations will be made from within the EU during this period. Reinforcing this, at exit date, anyone wanting to market a product in the EU will need to be based in a Member State (which will no longer include the UK).
- This coupled with the inability of the UK to act as a ‘lead Member State’ for assessment and authorisation processes, including those under Directive 2001/83/EC, which likely includes acting as rapporteur or co-rapporteur on applications, means a (potentially longer) period of uncertainty regarding the MHRA’s future role.
- For devices, the provisions for the duration of the transition period are similar to those above. Namely, CE marked goods will be capable of moving freely between states, as will information in respect of past and current applications. In particular, Article 46 of the Agreement sets out that certificate holders can request UK Notified Bodies to pass information to EU based Notified Bodies, and vice versa, and the bodies must comply.
- Given EU law will continue to be in force during the transition period, it is also notable for devices that this will provide more time for the new EU Medical Devices Regulations to come into effect, given this happens in a staged manner. This potentially provides more scope for high alignment between the UK and the EU in terms of the new regime, although the UK has signalled its appetite for this in any event.
The Northern Irish Border:
The situation if the Northern Ireland backstop is triggered is less clear, and further detailed analysis will be required, but it could include some of the following, of major significance to medicines and medical devices.
- In terms of medicines, it appears that during this period, the starting position would be that the EU and the UK would be part of a single customs union. In effect, this would mean medicines authorised in the EU and UK would be capable of moving freely between each, without being subject to any additional tariffs, controls or procedures. This would potentially be welcomed by industry and the public, as an ongoing assurance of the supply of medicines.
- However, there does appear to be an ability to introduce additional regulatory restrictions on both sides. For example, Article 7(4) of the Protocol on Northern Ireland states that the UK can regulate goods coming from Northern Ireland to the rest of the UK, where these have been assessed and authorised under EU law. The EU is capable of doing the same, and among other things, has included a restriction in Annex 5 of the Protocol on products on the market in Northern Ireland that were authorised in the UK from being used as reference medicinal products for EU applications during this period.
- The situation for devices appears to be similar. The starting position of a single customs union would seem to entail the free movement of goods. However, as with medicines, the UK and the EU retain the ability to place regulatory restrictions on goods leaving Northern Ireland for either territory. For example, Article 8(2) and (3) of the Protocol provide that where competent authorities, economic operators or other bodies in either territory affix a product with a conformity marking, that mark shall be accompanied by the indication “UK(NI)”. This would presumably be the basis on which further regulatory constraints could be applied.
Generally, regulatory certainty achieves the best outcome for industry and the public. To an extent, the Agreement could provide this, as against a full no-deal scenario from March 2019. However, it is unclear how much of this would operate in practice, and that itself could present many issues for industry. In any case, it seems we will know shortly whether the Agreement was an interesting exercise in hypotheticals, or sets the pathway for the future of regulation for medicines and medical devices in the EU and the UK.