‘Doing nothing is not an option’ is the overriding message from pharmaceutical experts who attended the recent Pharmaceutical Industry Network Group (PING) seminar, held in conjunction with Ethical Medicines Industry Group (EMIG).
Brexit
After the initial welcome speeches the seminar started with an interview with the chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA), Dr Ian Hudson, who provided the audience with an overview of the agency’s position on Brexit and where it sees its future relationship and opportunities as being. He said: “The UK government’s preferred position is in line with the government’s desire to see the UK have associate membership of the European Medicines Agency. The MHRA are also looking to develop other opportunities with our international work.”
Providing a practical overview of the regulatory implications of Brexit, executive director of NSF Pharma Biotech, Dr Peter Gough stressed that shortages could arise if extra admin or customs procedures are introduced. Additionally, he emphasised the importance of other factors, such as the EMA's relocation to Amsterdam, the role of the MHRA, centralised marketing authorisations and safety features around data. Peter reminded delegates that “if we are to avoid issues with the supply of medicines we need sensible, pragmatic decisions from both UK and EU politicians… the time to act is now, sitting on the fence is no longer an option.”
Looking at the post-Brexit trading between the UK and EEA, the British Association of European Pharmaceutical Distributors (BAEPD)’s legal adviser, Julian Maitland-Walker, discussed the EU membership and the impact of Brexit on intellectual property rights in the pharmaceutical sector, covering European patents, trademarks, access to the market to trade and exhaustion of rights.
He revealed that the impact of Brexit on parallel distribution could result in the loss of 3,000 UK jobs, elimination of NHS clawback savings, loss of access to certain specialist drugs and an increased risk of supply chain shortages. As a result of this, the BAEPD is adopting an approach to try and ensure that parallel imports survive and one that also sustains the free circulation of medicines within the EU through the maintenance of regulatory convergence and preserving exhaustion of rights on trade between the EU and UK.
Recently, there have been reports published confirming that the pharmaceutical and life sciences setors are struggling to attract and retain key talent from overseas due to the uncertainty surrounding Brexit. Specialist immigration senior associate from VWV, Tom Brett-Young, looked at this access to talent in more detail. He explained: “Nearly two years after the vote to leave the EU, there continues to be lots of uncertainty amongst employers in all sectors as well as EEA nationals in the UK. The unique challenges facing the UK's pharmaceuticals and life sciences sector as Brexit approaches means that access to talent is just one of a number of important issues the sector must face. There are a number of practical steps that employers can take now to secure talent.”
In assessing the free movement of people from an academic perspective, Professor Darragh Murnane, professor of Pharmaceutics at the University of Hertfordshire's Centre for Research in Topical Drug Delivery and Toxicology, set out a number of initiatives designed to work with business in light of Brexit, including apprenticeships, student placements and the £6 million Hertfordshire Science Partnership.
Surmising the seminar as a whole, Paul Gershlick, chair of PING and Head of Pharmaceuticals and Life Sciences at VWV commented: “The event focused on the key areas of uncertainty surrounding Brexit's future impact on the UK pharma sector and economy. It was clear to all that much will still depend on the outcome of the Brexit negotiations between the UK and EU. However, the speakers showed delegates that there are practical steps that should be done now to prepare in light of the regulatory changes, trading with Europe, access to talent, and funding. Despite the uncertainty, what remains clear is that doing nothing is not an option. Pharma businesses need to follow big pharma's lead and act now to prepare.”