Preparing for Brexit: pharmaceutical industry

Please note that views expressed in guest blogs on our website are the authors' own and do not necessarily reflect the views of the Nuffield Trust.

At MSD, a leading global bio-pharmaceutical company, the focus has always been on patients, and our preparations for Brexit have been no different.

The UK’s membership of the EU has provided us with much of the scientific, regulatory and trade infrastructure that is key to the UK pharmaceutical industry – there are few sectors of the economy so closely entwined with our European counterparts.

Retaining the UK’s world-leading status for life sciences means we can continue to deliver innovative new medicines to patients. We want the UK to continue to be a key strategic market for our sector – it is essential negotiations are progressed and we gain clarity about our future relationship with the EU.

What are the challenges we face?

As we prepare to leave the EU, there are some significant issues critical to creating a stable environment for economic growth and to our ability to continue to make a positive difference for patients.

1. Ensure early access for UK patients to innovative new medicines

Should the UK not be aligned with the European system of medicines regulation after Brexit, there will be a substantial additional workload to get approval in the UK, which may result in the loss of the UK’s status as an attractive investment proposition and early launch market, resulting in delays in patient access to innovative medicines.

It is imperative the future regulatory environment recognises existing and pipeline medicines licences, avoids the duplication of regulatory processes and a divergence in standards, and maintains harmony with the EU regulatory environment.

2. Maintain the UK’s world-leading status in research and development

Scientific research collaboration between the UK and EU strengthens their collective global position in life sciences, attracting global life science investment to the region. The Government should seek to maintain funding levels for science and the ability for UK academics to lead EU-wide collaboration and access research programmes.

Additionally, it is important a future agreement ensures clinical trials undertaken in the UK are recognised by the EU; a system that supports the free and easy movement of talent to the UK from within the EU and around the world; and new UK-based R&D systems that do not expand timescales, increase workloads for companies, or are held back by EU processes.

3. Deliver a robust manufacturing framework and supply chain

For our company, like many in the industry, the UK serves as an important part of a global supply chain, including formal regulatory product release procedures to multiple countries. Given the complexity of our commercial supply chains, it is essential we are able to trade and move goods and capital across EU borders without delays or being subjected to trade tariffs.

The UK is currently required to meet the EU’s testing and inspection standards that allow companies to trade freely across the EU. We would like to see a mutual recognition agreement in place with the EU before March 2019 for the testing and inspection of medicines; the implementation of the Falsified Medicines Directive in the UK – a new EU regulation to improve safety features and authenticity verification for medicines – to ensure a robust supply chain across Europe; and legislation on packaging labelling replicated in UK law.

What are we doing at MSD?

Preparing for Brexit has taken a number of forms at MSD, including internal activity, external engagement with the Government and taking a leading position within the industry in the UK and EU in order to secure the best possible scenario for patients.

Internally we are working through an established cross-divisional Strategic Response Group. Representatives from across MSD are considering the critical time-bound decisions and risk-mitigation contingency plans we face, particularly around ‘no deal’ scenarios that could potentially arise in 2019. This means that uncertainty is the biggest threat to the company as Brexit talks continue, so we have tried to put the company in the best position it can be whatever the eventuality of the current Brexit negotiations.

We have, and continue to, engage extensively with the Government, communicating what our concerns are about the future post-Brexit. The success of industry engagement with the Government can be shown by the letter to the Financial Times from the Secretary of State for Health Jeremy Hunt MP and Secretary of State for Business Greg Clark MP in July, which called for post-Brexit cooperation with the EU on medicines regulation. MSD welcomed this public statement and the desire for collaboration shown within the Government’s science and innovation collaboration paper.

But preparing for Brexit also requires a holistic view of the environment, and the Life Sciences Industrial Strategy (LSIS) is important for providing greater certainty and reassurance following the UK’s exit from the EU. As a member of the LSIS task board, we were pleased to be involved in this collaboration and are committed to continuing to work in partnership with the Government, NHS and health care partners.

As part of this commitment to collaboration and to support Brexit preparations, we partnered on an event with the Nuffield Trust. We brought together stakeholders from different parts of the health industry to seek to understand the pressures the NHS will face following the UK leaving the EU, and to jointly develop solutions to these challenges.

In this evolving environment, we remain convinced that this country can continue to lead the world in delivering high-quality care for patients. However, to do so it is essential we address some very real concerns about the potential impact of the UK’s exit from the EU for our supply chain, regulatory environment and ability to attract global talent. Addressing these issues will be fundamental to creating a stable environment for economic growth and our ability to continue to make a positive difference for patients.

Lisa Timothy is Director of Policy & Government Relations at MSD (MSD is a tradename of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A.)

Please note that views expressed in guest blogs on our website are the authors' own and do not necessarily reflect the views of the Nuffield Trust.