Want to know more about regulatory reforms in United Kingdom? Read on! Prepared in association with Clyde & Co, a leading law firm in United Kingdom, this is an extract from The Pharma Legal Handbook: United Kingdom, available to purchase here for USD 99.
1. Are there proposals for reform or significant change to the healthcare system?
The UK is currently due to leave the EU on 31 October 2019. There is much uncertainty as to the effect that this will have on the laws and regulations governing all areas of commercial activity, including the healthcare, pharmaceutical/biotech and medical devices sectors, as it is not yet known whether:
- the Withdrawal Agreement negotiated by the former prime minister, Mrs Theresa May, and her government will be ratified by the UK Parliament as it stands;
- the current prime minister, Mr Boris Johnson, and his government will negotiate amendments to the Withdrawal Agreement or a new exit agreement with the EU;
- the UK will leave without a deal (referred to hereinafter as a “no deal Brexit”); or
- the deadline for leaving the EU, extended from 29 March to 31 October 2019, will be extended further.
The issues that the different scenarios give rise to are outside the scope of this Handbook. However, the key points are as follows:
- The European Union (Withdrawal) Act 2018 came into effect on 25 June 2018 and enables the transposition of already-existing and directly applicable EU law into UK law so that, in general terms, current EU law will be converted into and continue as UK law at the moment of exit (with changes where necessary to make sure that the rules continue to work in a UK context – for example by transferring responsibilities of the EMA in the regulation of medicines to the MHRA).
- Therefore, if a no deal Brexit occurs, then the UK’s involvement in the EU will come to an immediate end and EU laws will cease to have effect (save insofar as they have been incorporated into UK law) without a new frame- work having been put in place for a future relationship between the UK and the EU.
- If, on the other hand, there is a negotiated withdrawal in line with the Withdrawal Agreement, a transition period will be entered, which is due to end on 31 December 2020 (although it can be extended by agreement between the EU and UK). During this transition period the UK will continue to be treated as a member state of the EU (subject to all existing EU laws as well as new ones that come into being during the period) but it will not take part in any decision-making and will no longer be a part of any the EU institutions, agencies and bodies. Therefore, for example, the UK will not have any say in the grant of market authorisations for new medicines by the EMA. The intention is that, during the transition period, a new framework governing the future relationship between the UK and the EU will be negotiated and put in place.
The implications for healthcare institutions and pharma/biotech and medical devices companies are numerous, particularly on a no deal Brexit. Accordingly, the UK government has published detailed guidance to enable them to prepare for a no deal scenario. This guidance is being updated as the 31 October dead- line approaches and there will also be a public consultation during Autumn 2019. In addition, the UK Parliament has passed a series of statutory instruments under the powers given by the Withdrawal Act to retain and modify EU law and generally make provision for a no deal Brexit. Relevant statutory instruments for the life sciences field are the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019/7751 and the Medicines For Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019/774.
In summary, the Human Medicines (Amendment etc.) (EU Exit) Regulations:
- amend the HMR by revoking and restating all relevant EU law so that all law governing the regulation of medicinal products is contained in one domestic instrument;
- allow the MHRA to function as a standalone regulator for medicines taking on the roles currently conducted by the EMA (and other EU bodies);
- provide for the automatic conversion of marketing authorisations granted under the CP to a UK marketing authorisation (unless the MAH requests otherwise) and for new routes for the authorisation of medicines (the “targeted” and “accelerated” assessment routes) to replace the CP (and other EU) routes as they will cease to have effect for the UK upon exit;
- provide for a new conditional marketing authorisation scheme for medicinal products that fulfil an unmet medical need;
- maintain the ability for abridged applications for marketing authorisations, including where the reference product is approved by a converted authorisation granted under the CP or was approved under an authorisation granted under the CP before exit day but which did not convert to a UK authorisation;
- maintain the current data and marketing exclusivity periods;
- ensure that a UK-based MAH and a UK-based qualified person for pharmacovigilance are in place for all medicines with a UK marketing authorisation (and the same for holders of registrations for traditional herbal and homeopathic medicines);
- maintain the current rules on the advertising of medicines; and
- modify the MHRA’s fees.
The Medicines For Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations:
- amend the Medicines for Human Use (Clinical Trials) Regulations 2004 so that all interventional clinical trials conducted in the UK are authorised by the MHRA, have a favourable ethics opinion and are conducted in accordance with good clinical practice;
- allow the MHRA to operate as regulator outside the EU system for clinical trials and taking on the roles currently conducted by the EMA (and other EU bodies);
- maintain the ability for the sponsor or legal representative for a trial to be based in the UK or a country on an approved list (which will initially include all EEA countries); and
- with the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, align transparency provisions with those currently operating in the EU, including the strengthened provisions that are to be introduced by Regulation (EU) No 536/2014 (if that Regulation has not come into force by exit day), and provide for a UK portal that will give UK public, patients, clinicians and researchers a single reference point for all UK clinical trials.
The MHRA has issued guidance supplementing both of the above Regulations, including specific guidance on the new assessment routes which includes a third “rolling review” route. This is aimed at reducing the attrition rate for applications by giving ongoing guidance to applicants so that they avoid regulatory pitfalls.
Similar regulations (The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019/792) and MHRA guidance have been issued regarding medical devices. Essentially these Regulations amend the MDR so that it mirrors all the key elements of the EU MDR and EU IVDR and follows the same transitional timetable for the full implementation of their provisions (the timetable is discussed in the answer to Question 2 of Regulatory, Pricing and Reimbursement Overview and, regarding labelling, in the answer to Question 35 of Chapter 3). Further, the MHRA will become the standalone regulator and registration body for all medical devices in the UK and will accordingly be given a strengthened role in market surveillance and assurance. The UK, though, intends to continue to recognise CE marks for devices, and certifications by EU Notified Bodies for low risk devices, for a limited period. Certificates from UK Notified Bodies would also continue to be recognised, though they will not be able to issue certificates for new products.
Regarding intellectual property on a no deal Brexit:
- the EPO is not an EU body nor the EPC an EU instrument, therefore most aspects of patent law will be unaffected by Brexit;
- the Patents (Amendment) (EU Exit) Regulations 2019/801 will retain such EU patent law as does exist (e.g. the Biotech Directive);
- these Regulations will also modify the law relating to SPCs as necessary to reflect the effects of Brexit (for example so that an application for an SPC will need to be based on a UK marketing authorisation or an authorisation granted by the EMA that has been converted to a UK authorisation) while retaining the requirements, timescales for grant and same term of protection as at present (i.e. based on the first authorisation to place the product on the market in the UK or EEA);
- UK registered trade marks will also continue unaffected by Brexit whereas EU trade marks will cease to have effect in the UK once exit occurs – therefore, unless the owner decides to opt-out, the UK government intends to provide owners of EU trade marks with an equivalent UK right from the date of exit, which will be granted with minimal administrative burden and for no fee;
- the same will apply to international trade marks designating the EU;
- applicants for an EU trade mark that has not been registered by the time of Brexit will need to apply within 9 months of the exit date for a UK trade mark, which will have the same filing and priority dates as the original EU application;
- these measures are contained in the Trade Marks (Amendment etc.) (EU Exit) Regulations 2019/269; and
- the UKIPO has issued guidance on the effect of a no deal Brexit on patents, SPCs, trade marks and other IP rights.
As can be seen from the above, even on a no deal Brexit, the UK is likely to remain largely aligned with EU law. If an exit agreement is reached with the EU, the alignment is likely to be closer still (and EU law may continue in effect during any transitional period). However, the UK government is taking the opportunity to streamline regulation and to consider ways in which the UK healthcare and life sciences sectors can remain competitive and benefit from any commercial advantages that departure from the EU gives rise to. The new procedures for the authorisation of medicines are examples of the latter.