Countdown to Brexit: 50 days – No-deal impacts on Life Sciences and Healthcare

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 contact us at if you would like to explore further impacts on life sciences and healthcare in more detail.

Up to 29 March 2019:

  • pharmaceutical manufacturers can batch test medicines anywhere in the EU - or other third countries with whom the EU has a ‘Mutual Recognition Agreement’ (MRA) - under Article 51(2) of Directive 2001/83/EC (“the Directive”).

  • for human medicines manufactured in the UK, a UK-based Qualified Person must certify the batch testing and ensure compliance with the MA and Good Manufacturing Practice (GMP) guidelines.  these medicines can then be sold or supplied anywhere in the EU or EEA - including the UK - without further certification.

  • for human medicines manufactured in the EU/EEA, the batch testing and certification or release by an EU or EEA based QP allows a batch of human medicines to be sold in any other EU or EEA country (subject to the requirements of the country) - including the UK - without the need for any further certification.

  • for human medicines manufactured in a third country outside the EU or EEA and imported into the UK through the EU or EEA, batch testing is required within the UK, EU or EEA, unless the medicine has been manufactured in a third country with which the EU has an MRA.

  • human medicine manufactured in a third country requires a QP based in the UK, EU or EEA to certify that it meets all the required standards and specifications of the Marketing Authorisation, before it can be sold or supplied in the EU or EEA (including the UK).

After 29 March 2019

If there’s no-deal, the UK would no longer be a member of the European Medicines Agency EMA.  In order to ensure continuity of supply in medicines:

  • the UK will continue to accept batch testing of human medicines carried out in countries named on a list set out by the MHRA.  On exit day, this list would include EU countries, other EEA countries and those third countries with which the EU has an MRA.

  • the UK will continue to accept batch testing of Investigational Medicinal Products (IMPs) – substances being used in medical trials - manufactured in EU and EEA states.  There will be no change to the present arrangements for batch testing of IMPs manufactured in third countries.

  • for human medicines manufactured in the UK, there will continue to be a requirement for a UK-based QP to certify the batch testing and to ensure compliance with the Marketing Authorisation and GMP guidelines before these medicines can be sold or supplied in the UK.

  • for human medicines manufactured in a third country and directly imported into the UK, there will continue to be a requirement for a UK-based QP to certify the batch testing, as well as to ensure compliance with the MA and with GMP guidelines, before they can be sold or supplied in the UK.

  • where human medicines are manufactured in a third country but are imported into the UK from a country on a separate list maintained by MHRA (on exit day, this list will contain EU and EEA countries), there will continue to be a recognition of certification, release and assurance of compliance with the MA and with GMP guidelines, if conducted by a QP based in the listed country, without the need for any further certification.

  • for human medicines manufactured in a country on the MHRA’s QP list, which have the relevant QP certification, there will continue to be a recognition of certification, release and assurance of compliance with the MA and with GMP guidelines, if conducted by a QP based in the listed country, without the need for any further certification.

  • the approaches to QP certification of licensed medicines set out above will also apply to IMPs.

These arrangements will continue until the Government considers any further change is necessary.

References:

Regulating medicines and medical equipment

1. Batch testing medicines if there's no Brexit deal

2. Ensuring blood and blood products are safe if there’s no Brexit deal

3. How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal

4. Quality and safety of organs, tissues and cells if there’s no Brexit deal

5. Submitting regulatory information on medical products if there’s no Brexit deal

6. Trading in drug precursors if there’s no Brexit deal

Regulating veterinary medicines

1. Accessing animal medicine IT systems if there's no Brexit deal

2. Registration of veterinary medicines if there’s no Brexit deal

3. Regulation of veterinary medicines if there’s no Brexit deal

 

 
John ShuttleworthComment