Most people understand that the Life Sciences industry is highly regulated. This comes with being a member of the EU and the complex mix of medical Directives and/or Regulations that apply to EU members. Directives are required to be implemented into the national law of an EU member state. An EU Regulation is directly applicable as the law of a member state unless the EU member wants to supplement the provisions in its own statute.
So the crucial questions which now arise for the Life Sciences industry sector relate to all that legislation in force on the day that the UK ceases to be an EU member on the 29th March 2019 (“Brexit Day”). First, to what extent will existing national laws relating to Life Sciences remain on the UK statute book and not be repealed? Second, will the UK pass laws to mirror current and future EU Regulations for Life Sciences not already part of UK law together with those Regulations due to be coming into force after Brexit Day?
The new Clinical Trials Regulation (EU 536/2014) was intended to be implemented by the EU during 2018 but has been delayed. Although the Regulation entered into force on 16 June 2014 the timing of its application depends on the separate development of a fully functional EU clinical trials portal and database. This will be confirmed by an independent audit when complete. The Regulation then becomes implemented six months after the European Commission publishes a notice of this confirmation. This is currently estimated to occur in 2019. This Regulation provides for a single application for clinical trials across the EU, by way of a single portal, together with an associated EU wide database. Also, the European Medicines Agency is moving from London to Amsterdam and may further delay the implementation of the new Regulation. There is much uncertainty as to how, or even if, the UK will adopt the new Regulation into its national law if implemented after Brexit Day. The new Regulation is wider in scope when compared with the existing Regulation. It has, for example, new definitions of both ‘Clinical Trial’ and also ‘Clinical Study’. It will extend to cover diagnostic or monitoring procedures as well as normal clinical practice. Therefore, there will need to be guidance as to how this Regulation will fit together with current EU Medical Device Legislation.
An interesting example of how matters may be dealt in the UK post Brexit Day can be seen in the recently passed Data Protection Act 2018. This is important legislation which, of course, affects the processing of clinical trial data. This Act incorporates the EU General Data Protection Regulation by reference as well as supplementing its terms. This may happen with other EU legislation, but nothing is certain.
The majority of marketing authorisations are applied for under the decentralised procedure (national) or the centralised procedure (EU wide) which is dealt with under the existing EU Directive. Marketing authorisations granted by the UK will be unaffected. It is likely that marketing authorisations granted in the EU under the centralised procedure prior to Brexit Day will be recognised by the UK. However, centralised marketing authorisations covering the EU held by UK companies will need to be transferred to companies established in EU countries under current rules unless of course mutual recognition agreements are put in place.
Having to apply for both marketing authorisations in the UK as well as the EU will add to the regulatory burden and costs for the Life Sciences industry. It is likely that quality assurance procedures will need to be maintained in the UK consistent with EU good manufacturing practices so that products can be sold in the EU. UK manufacturers could continue exporting medicines to the EU but only if equivalence is maintained in the UK/EU regulatory frameworks. This is likely to be the case for the UK in order to facilitate importation through mutual recognition agreements with the EU and other trading nations. The cost of importing into the EU may increase if the EU imposes additional requirements and inspections on non-EU imports.
The EU pharmacovigilance system is coordinated by the European Medicines Agency which as mentioned above is being re-located to Amsterdam. UK companies will therefore need to revise their pharmacovigilance reporting system as a single person cannot perform the pharmacovigilance function for the EU and UK. The appropriately qualified person must reside and operate in the EU under current rules.
The result of this will create extra burden on the UK’s Medicines & Healthcare Products Regulatory agency (“MHRA”). The MHRA has stated their need to increase employee numbers to carry out additional regulatory work. The MHRA will now need to negotiate its own cooperation agreements with countries worldwide such as the USA and also Japan.
Patents and Other IP
The new EU patent regime will provide patentees with the option to apply for a single pan-EU Unitary Patent (“UP”) covering most of the EU. It will also create the Unified Patent Court (“UPC”) to hear and determine patent disputes on an EU-wide basis.
The UK ratified the UPC Agreement on 26 April 2018 so the division of the UPC that will hear cases concerning chemical and Life Sciences patents should be situated in London. Some 40 years of negotiations relating to the establishment of the UP/UPC system has created considerable political pressure to complete the project, so UK participation would seem likely to continue after Brexit Day.
The additional protection afforded to patentees by Supplementary Protection Certificates (“SPCs”) is part of UK law by virtue of two EU Regulations. These extensions to patent protection of up to 5 years are very valuable and similar extensions are available in many countries around the world. After Brexit Day it will of course be possible to apply for SPCs in all remaining EU member states under the present system. It is likely that equivalent regulations will be enacted by the UK Government but it is unclear what the nature of these will be and how far SPC rights will extend to the UK in the future.
After Brexit Day, European Union Trade Marks (“EUTMs”) and Registered Community Designs (“RCDs”) will cease to be in force in the UK. However, from those parts of the European Commission’s draft withdrawal agreement that have been agreed in principle a solution has been found. The protection that EUTMs and RCDs afford in the UK will be converted into “cloned” UK registered trademarks and design rights but not until the end of any post-Brexit Day transition period currently ending on 31st December 2020. There is still some uncertainty, for example, with regard to the level of fees payable to the UK Intellectual Property Office. Owners of existing EUTMs and RCDs may want to consider applying for separate UK rights for equivalent trademarks and designs before Brexit Day. It is likely that the filing dates of existing EUTMs and RCDs will be maintained in some way when “cloned” UK rights are granted. For trade mark and design owners filing new applications now, there is a choice. That is to apply now for EUTMs and RCDs and hope to be able "convert" those rights into UK rights later. Alternatively, to file both UK and EUTM/RCD applications now in order to avoid having to rely on any conversion mechanism to ensure long-term protection in the UK.
The coming months will be vitally important to the Life Sciences industry. Could all relevant EU legislation affecting Life Sciences follow the example of the Data Protection Act 2018 and be adopted wholesale into UK law? Britain and the EU will need to agree the approach in order for the Life Sciences industry to have certainty.
By Tim Matthews
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