BIA Brexit update
Steve Bates writes about the latest news of Brexit talks, as another deadline for a free trade deal between the Government and the European Union is missed. Steve also explores issues around marketing authorisation holder (MAH) and local representative naming, on product information for products on the Northern Ireland market.
We need detailed practical guidance, agreed by both sides on how to operate Medicines Regulations in Northern Ireland, as well as time to implement any changes. This cannot be done at the drop of a hat. On 30 November we raised specific and practical concerns about how the European Commission (EC) and the European Medicines Agency (EMA) are approaching key issues of marketing authorisation holder (MAH) and local representative naming on product information for products on the Northern Ireland market.
The following issues, raised with industry only at the end of November, are highly concerning for us. Firstly, the EC and EMA stated that the MAH must be located in the EU/EEA or Northern Ireland in order for UK Nationally Authorised Products to be supplied to Northern Ireland. Secondly, the EC and EMA stated that the local representative named in the product information for Northern Ireland must also be located in the EU/EEA or Northern Ireland for centrally authorised products (CAP). Industry representatives from the EU and the UK strongly disagreed with these two interpretations of the Protocol. We believe the Northern Ireland Protocol (NIP) of the Withdrawal Agreement is open to a different interpretation. Other EC guidance pre-dates the NIP and does not take into account the implications of the Protocol on medicine supply to patients in Northern Ireland.
These EC/EMA positions, if maintained, could severely impact the continued supply of medicines to NI patients. If these interpretations stand, significant time will be needed to make suitable arrangements for Northern Ireland local representatives, and to complete MAH transfers. Furthermore, the above-stated positions will prevent the vast majority of national products -either from Decentralised Procedure (DCP)/ Mutual Recognition Procedure (MRP) or purely national from entering Northern Ireland on 1 January 2021, in the middle of a pandemic, which would result in a public health crisis in Northern Ireland. Because this affects a very significant number of licences that cannot be remedied in the next couple of weeks, we continue to ask for flexibility in order to avoid a cliff-edge on 1 January 2021, or there will be a significant negative impact for patients.
Industry is as ready as we can be for the end of the Brexit transition period as we have repeatedly stated. However, regarding the NIP, which was only agreed in 2020 and will apply from 1 January 2021, time to prepare following receipt of the necessary joint interpretation and guidance has been too short and, at present, remains a concern even with a phased-in approach.
We therefore ask the European Commission and EMA, with the Government and MHRA, jointly to provide the clarity needed for industry to start preparations for the phase-in of medicines’ regulations regarding the NIP implementation. These considerations are key to support the paramount aim and purpose of ensuring continuity in the supply of medicines and vaccines to patients in Northern Ireland.
We plan to hold a further webinar this week to update on developments. Do keep an eye on the BIA twitter feed for the latest over the Christmas and New Year period. While the transition period may or may not be ending without a deal on 1 January, the UK’s relationship with the EU is not over. In 2021 we will be arguing for patients’ and the sector’s best interests and exploring the implications for companies and patients of future divergence between the UK and EU.
Steve Bates has been the CEO of the UK Bioindustry Association since 2012. He currently chairs the International Council of Biotech Associations and has been a Board member of Europabio since 2015. Steve is the visible face of the vibrant UK life sciences industry to government and media. He sits on the UK’s Life Sciences Council and Life Sciences Industrial Strategy Implementation Board. Steve has championed with government effective industrial incentives like the Biomedical Cataylst which have crowded-in private sector investment into UK SMES. He has forged links for the sector across the USA, Europe and in China. In his time at the BIA Steve has developed new member groups focused on cell and gene therapy, genomics and engineered biology. A strong advocate of partnership working, Steve champions sector collaboration with research charities and academia. Proud to lead an organisation with a diverse Board with over 40% female representation, Steve is committed to next generation talent and developing the skills needed for the sector to flourish. Before the BIA, Steve worked for Genzyme and as an advisor to the UK Government of Tony Blair. He was made OBE for services to innovation in 2017.