Countdown to Brexit: 50 Days - No-Deal Impacts on life sciences and healthcare
8 Feb 2019
From 29 March 2019 in the event of a no-deal Brexit, the impacts on the life sciences and healthcare are profound.
The UK has a strong presence in the life sciences and healthcare sector. There are tax incentives, and high levels of investment and funding for R&D. The UK presently accounts for approximately 25% of the EU market - and will remain key mutual markets. Switzerland – which is not in the EU - is one model for the sector successfully working outside the EU.
The implementation of uniform product safety laws across the EU has allowed advanced standards of product safety for products both imported and exported into and out of the EU. This has allowed increased safety standards for consumers and a level playing field for enforcement within Europe.
Following Brexit, it is expected that the UK would continue to apply product safety standards in common with those in the EU - or higher - because failure to do so could affect the competitiveness of UK goods and suppliers given the global drive to higher standards.
Clinical Trials: The present clinical trial regime in the EU came into force in 2018. The new Regulation sets the framework for clinical trials - and ensures harmonisation across the EU. It provides for a single application for clinical trials across the EU via a single portal with an associated EU wide database – reducing administrative burdens on applicants.
The UK will be outside this system – posing additional administrative burdens on companies wishing to conduct multi-centre clinical trials in the EU and the UK. Separate centralised and national clinical trial authorisation procedures will need to be followed.
Regulation of quality assurance of medicinal products: is managed at a national level. In order to ensure that high quality standards are maintained in respect of medicinal products for consumption in the UK, they must be manufactured in accordance with UK laws – which are presently based on EU Directives which lay down the principles of good manufacturing practice (GMP). This requires all manufacturers and importers of medicines located in the EEA to hold a ‘manufacturing authorisation’. The medicines regulatory authorities in each EU member state carry out periodic checks to ensure that GMP is being complied with. The current UK/EU GMP are similar to those within other developed countries such as the USA.
UK Manufacturers would be able to continue exporting medicines to the EU - and vice versa - so long as the UK and EU regulatory frameworks remain ‘equivalent’. The UK is likely to maintain the GMP standard in order to facilitate mutual recognition agreements with the EU and other trading partners and aid imports into those areas. The cost of imports into the EU from the UK may, however, increase if additional checks would be required for non-EU imports.
A no-deal Brexit means the UK will be outside the EEA. All medicines must be authorised before they can be marketed and made available to patients in the EEA – and the authorisation holder has to be located in an EEA state.
Pharmacovigilance: EU legislation governs the procedures for pharmacovigilance throughout the EU. It is comprehensive – setting out requirements for prompt collection of data, adverse reaction reporting, risk management, and transparency on marketing authorisation holders, national competent authorities and the EMA. The EU pharmacovigilance system is coordinated by the EMA - which ensures effective and coordinated analysis, evaluation of risk, information sharing and periodic checks on market-authorisation holders throughout the EU.
Following Brexit the - yet-to-be-established - UK competent authority will have smaller data sets than those in the EU - and the EU would be deprived of data from the UK. Less co-operation and sharing of expertise and information will result in pharmacovigilance being less efficient and more costly.
IPR: Territorial limits apply to intellectual property rights (IPR). A purchaser’s freedom to deal with a protected product is typically limited to the territory in which the product is purchased. Presently, free movement of goods extends the territory to the whole of the EEA.
Parallel imports have always been acute for pharmaceutical companies particularly during the life of the patent because the pricing and reimbursement of medicines are not harmonised and falls under the exclusive competence of EU member states. This means that third parties are free to buy up branded medicines in an EU member state where the price is low - and make profit by selling in a more expensive EU member state - undercutting pharmaceutical companies’ market pricing.
A no-deal Brexit means the UK leaving the single market. Pharmaceutical companies may be able to prevent importation into the UK by asserting their intellectual property rights (typically patents or trade marks) against the parallel importers – subject to any other defences that may already apply to parallel imports from outside of the EU.
The present system of national patent protection obtained through the UK Intellectual Property Office (UKIPO) or the European Patent Office (this is not an EU institution) remains unchanged.
Businesses have been urged to review their patent protection and future enforcement strategies.
Supplementary Protection Certificates: are an additional right for patentees for medicinal, veterinary, and plant protection products which have obtained market authorisation in the EU. An SPC can extend the patent protection of a product by up to five years. Given the high investment, the 20 year patent term and the long lead time to market, SPCs are valuable in protecting a patented product at the point when sales may be highest. Equivalent extensions to patent protection are available in other countries, for example Japan and the US.
The EU introduced the SPC via two EU Regulations which will no longer bind the UK upon Brexit.
Trade Secrets: the UK presently has a unilateral strong trade secret protection regime. The level of protection of trade secrets currently varies between EU member states. The EU Trade Secrets Directive (Directive (EU) 2016/943) came into force on 5 July 2016 – and addresses this issue by setting a minimum level of protection.
Illustration of UK Government No-Deal Technical Notice on “batch testing of medicines”.
We have illustrated one of the 20 UK Technical Notices on leaving the EU with no-deal in place. We have access to the list of notices set out at the end of this article – and the equivalent set published by the European Commission on impacts of a no-deal Brexit for the remaining EU27 Nations. Please 1. Batch testing medicines if there's no Brexit deal
Regulating veterinary medicines
This article first appeared on the website for Brexit Partners (www.brexit-partners.com).