The UK will leave the EU at 11pm on 31 January 2020. What does this mean for the regulation of medicines and medical devices, in particular their authorisation and market exclusivity rights?
In essence, on this date, the European Union (Withdrawal) Act 2018 will repeal the European Communities Act 1972, meaning the UK will no longer be subject to EU law.
But, the similarly titled European Union (Withdrawal Agreement) Act 2020, which will shortly come into force to implement the Withdrawal Agreement agreed between the UK and EU into UK law, contains provisions (in Article 127) to "save" much EU law so that it continues to apply in the UK until the end of the transition period (which ends on 31 December 2020).
Saved EU law governing life sciences product authorisation and exclusivity rights – in particular, marketing authorisation and market surveillance of medicines, data and market exclusivity, supplementary protection certificates, orphan drug protection and CE marking of medical devices – will continue to apply to the UK during the transition period.
There are, however, a number of provisions in the Withdrawal Agreement relating to the above to be aware of (see below). In particular, note that under Article 128(6), the HMRA would be prohibited from acting as the lead authority for marketing authorisation applications at the EU level during the transition period.
In other words, the UK cannot be a reference member state for marketing authorisation applications made under the decentralised or mutual recognition procedures during this period.
Transition Period arrangements under the Withdrawal Agreement
- Certain goods (including pharmaceuticals and medical devices) lawfully placed on the market of the EU27 or the UK before the end of the transition period may continue to circulate until they reach their end user (Article 41 Withdrawal Agreement).
- Exchange of information between UK and EU market surveillance bodies (including where requested in respect of conformity assessments by notified bodies). The European Commission must be notified of goods posing a serious risk (Articles 43(1) and (2) Withdrawal Agreement).
- All relevant files or documents relating to procedures led by the MHRA including marketing authorisation applications under Directive 2001/83 that are ongoing on the day before the entry into force of the Withdrawal Agreement must be transferred to the competent authority of a designated Member State (Article 44 Withdrawal Agreement).
- The obligation to transfer marketing authorisation dossiers for products authorised before the end of the transition period, where they are necessary for the assessment of an abridged application under Directive 2001/83. This applies upon a "reasoned request" made by a competent authority of a Member State (or the EMA) to the MHRA, and vice versa (Articles 45(1) and (2) Withdrawal Agreement).
- If requested by the certificate holder, information held by a conformity assessment body established in the UK, in relation to its activities as a notified body before the end of the transition period, must be made available to a notified body established in a Member State, and vice versa (Article 46 Withdrawal Agreement).
- The MHRA will not act as a lead authority for marketing authorisation applications at the EU level during the Transition Period (Article 128(6) Withdrawal Agreement).
The role of the UK in European Patent Convention system of European patent prosecution and grant will remain unchanged during the transition period and after it. The exhaustion of patent rights for goods placed in the EU/EEA market will also continue to apply to the UK during the transition period, but will then depend on any future terms agreed with the EU.
The SPC Regulation will also continue to apply during the transition period, with direct effect on those SPC applications made during that period that are ongoing when it ends – these must provide for the same level of protection as that provided for in the SPC Regulation. This includes recent amendments made to the SPC Regulation allowing for a manufacturing and stockpiling waiver.
Once the UK leaves the EU on 31 January 2020, attention will quickly move to the negotiation of a free trade relationship between the UK and the EU, which is intended to pertain from 1 January 2021, once the transition period has finished. This will be based on the draft Political Declaration setting out the framework for the future relationship between the UK and the EU.
There is already speculation on whether the transition period will need to be extended in order to provide enough time for the future relationship to be negotiated. However, having fixed the current date in the European Union (Withdrawal Agreement) Act 2020, the UK Government is so far holding firm.
The most likely scenario is that some aspects of a trade deal will be completed, together with separate agreements on critical issues, while other, lower priority issues will be agreed later. It remains to be seen where the system of regulation of life sciences products, described above, will fit into this process.