My husband and I woke up in the early hours of 24 June 2016 to the astonishing news that the UK had voted to leave the EU. It’s fair to say both of us shuddered and, while our perspectives were different, our concerns with regard to the complexity and uncertainty that would ensue were broadly the same.
My husband immediately anticipated shock in the financial markets. In his 30-year banking career he had witnessed currency fluctuations and share price adjustments over many market blips and long‑term shifts in trading environments.
For me, the pharmaceutical industry has been my home and passion for over 20 years. Having worked in multiple European and Global roles across the UK and Ireland, I have seen pharma evolve in a more European, centralized, process-driven and complex trading environment. Many of these changes have been good, allowing the industry to adapt to market needs and become more efficient. It has also brought huge reward in terms of the therapies brought to market. For example, between 2011–2015, 75 chemical or biological entities were developed in Europe.1 I believe industry has adapted to ensure its long-term viability, and I feel the patient focus it has embraced has driven this adaptation. So, with the changes that are now coming, I ask, how will the patient benefit? It’s certainly the question that has guided me over the last 20 years in everything I do. A massive shift in how we do business should have patient benefits as a driver.
I can think of at least one way in which patients might not benefit (at least in the short term). At the start of my career, the Irish Medicines Board (now the HPRA) licenced new products. They were ultimately responsible for the evaluation of new treatments and licensing, where appropriate. As a brand manager at the time, we waited patiently for new treatments to be licenced so that we could roll out our marketing and communication plans and make treatments available for suitable patients. This local approval, aside from being lengthy, was arguably a hugely inefficient process as our European counterparts were conducting the same process in parallel.
The demand for efficiency and expediency won out when the European Medicines Agency (EMA), a decentralized agency of the EU, began operating in 1995 from its base in London. Over the past 22 years, the EMA has been responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. Their job is to ensure that all medicines available on the EU market are safe, effective and of high quality. The people who benefit are ultimately the 500 million people living in the EU who rely on the EMA to provide timely evaluation and approval of new medicines. More than 600 full-time staff currently deliver this service in London, but many people are now asking whether the EMA has been made homeless. Certainly, other member states are pitching to attract this influential EU agency. Will patients benefit? I would suggest not, as ensuing chaos in the short term will only serve as a huge distraction for all staff, scuppering the timely delivery medicines. On paper, contingency plans may be in place, but in reality, a sense of focus will surely be lost.
The EMA is just one example of the huge changes required in this whole adaptation process. Countless other challenges remain, but we need to move forward, especially now that we have witnessed the triggering of article 50. Regardless of how individuals voted in the referendum, fear is a predominant emotion, and when it comes to negotiations, my only hope is that diplomacy and pragmatism will prevail. There is no place for egos on the table. The lives of millions of people rely and depend upon politicians to be fair and balanced in discussions that will affect us all, and to find solutions that will underpin a fair future for everyone.
We are told negotiations will be complete in 2019, but we shouldn’t delude ourselves. Negotiations may indeed finish on time, but only then will work start to adapt and unravel the integration that the UK has previously enjoyed with the EU. We are facing a decade of amendments and adjustments to how we work and live, regardless of the industries we work in. However, the pharmaceutical industry will certainly need the UK and EU to work together to build a flexible, up-to-date and attractive post-Brexit environment. It will be a major challenge, but there is a need to prioritize on both sides so that ultimately and importantly, patients remain the focus.
1. European Federation of Pharmaceutical Industries and Associations. The Pharmaceutical Industry in Figures – Key Data. 2016. Available from: http://www.efpia.eu/uploads/Modules/Documents/the-pharmaceutical-industry-in-figures-2016.pdf (accessed April 2017).