Reactions to the EU Referendum
Posted: 24 June 2016 | | 4 comments
The BioIndustry Association and EFPIA have reacted to the news that Britain has voted to leave the European Union (EU)…
Britain has voted to leave the European Union (EU).
Steve Bates, Chief Executive of the UK BioIndustry Association (BIA), commented on the news: “This is not the outcome that the BIA wanted but we accept the views of the UK people. The life sciences sector is a resilient community, unfazed by new challenges and staffed by great management teams used to working in a global environment. The fundamentals of UK bioscience remain strong. In terms of potential new therapies in the pipeline, the UK is by far the strongest in Europe. But several key issues for our sector are now in flux.”
At the moment, it is unclear what the exact implications will be for the life sciences and pharmaceutical industries in the UK. Bates explained more about the issues that need to be addressed: “Key questions about the regulation of medicine, access to the single market and talent, intellectual property and the precise nature of the future relationship of the UK with Europe are now upon us. This will require detailed and dispassionate thinking and the BIA will make its and its members’ expertise available to the government and its key agencies in the coming weeks and months as we work through these complex issues.”
Remain patient focused
In a statement, the European Federation of Pharmaceutical Industries and Association (EFPIA) emphasised that patient care should remain at the forefront of future negotiations: “As everyone involved in European healthcare considers the implications of the UK ’s decision to leave the European Union, EFPIA underscores the importance of ensuring that the patient is at the centre of all subsequent decisions.
“EFPIA shares the common goal of ensuring rapid access to innovative medicines for patients across Europe, as well developing a regulatory and policy environment that fosters innovation and supports the research and development of new medicines to meet the needs of patients, healthcare systems and society. As an industry, over the coming months, we are committed to engaging with stakeholders both in Europe and in the UK to support these objectives.”
Similarly, the UK Medicines and Healthcare products Regulatory Authority (MHRA) said: “Following the result of the referendum on the UK’s membership of the European Union, the focus of the Medicines and Healthcare products Regulatory Agency continues to be on our public health role. We will continue to work to the highest levels of excellence and quality, working with and supporting our customers, partners and stakeholders to protect health and improve lives.
“Working closely with government we will consider the implications for the work of the Agency. We will continue to make a major contribution globally to improving public health through the effective regulation of medicines and medical devices, underpinned by science and research.”
What are your thoughts on the results of the EU Referendum? Let us know in the comments section below.
The UK imports £1.483 BN of pharmaceutical products annually compared with £0.916 BN of exports to the rest of the EU so EU has potentially more to lose financially. UK pharma exports to the Rest of the World, excluding the EU, amount to £1.975 BN to which currently EU standards of GMP etc. are applied except in the case of exports to the US. It is in the best interests of the rest of the EU to keep the UK aligned in terms of pharmaceutical regulations etc.
The UK has always been in the vanguard of countries leading in quality and safety standards in matters such as food and pharmaceuticals and will continue to be so but will now be able to discard regulations which have no place in promoting high standards but which add considerable cost to manufacturing.
There will be no changes re. the set of regulations that the British pharmaceutical industry has to comply with. It will still be the EU GMP/GLP/GCP. For the European outside-of-EU countries, the EU is the major market, and will probably also be in the future. Everyone has to comply with the regulations in the market where the products are sold, regardless of this being EU or the US, and regardless of the industry’s location. Switzerland and Norway have never been a part of the EU, and the industry knows that in order to have their products on the EU market, the EU GxPs have to be complied with.
what about a new location for the EMA ? What about inspections agreements MHRA with other european agencies ?
A very interesting question; is there any need to relocate the EMA? It looks very likely that other countries are going to follow the UK in leaving the EU so it will be a case of not “throwing the baby out with the bath water”, as we Brits say. We must watch how the process of forging new relationships between the EU and the UK proceeds; there are many other trade/scientific organisations which are headquartered in Brussels and other parts of the EU. The UK will continue to participate in the activities of these organisations because there are no borders in these matters.