“Following its latest survey, the EMA has warned that the supply of more than 100 medicines manufactured solely in the UK is at risk of disruption post-Brexit because the necessary work to ensure they can be licensed and released for sale in mainland Europe has not been carried out,” says Thomas Beck, Senior VP of quality management at Recipharm.
“Of course, ensuring the reliable supply of medicines post-Brexit is paramount and should be one of the main focuses of the industry in the coming months. We would like to see more action and guidance from the EMA to help pharmaceutical manufacturers understand the implications and make the required preparations. The initiatives shown by the UK government regarding a pragmatic approach to Brexit have not received any pragmatic response from the EMA, which remains firm in its hard-Brexit approach,” Beck says.
He continues: “The best outcome is that a mutual recognition agreement is maintained between the EU and UK, meaning there will be limited to no immediate regulatory changes. The worst-case scenario, where no agreement is reached, may result in medicine shortages, which is extremely concerning. Treating the UK as a ‘third country’ post-Brexit also has the potential to create additional layers of complexity that manufacturers will have to adapt to if they are not already familiar with third-party importation practices.”
“On the 17 July 2018, MPs backed an amendment to the government’s suggested Trade Bill on the regulation of medicines after Brexit. MPs voted for the UK to take “all necessary steps” to participate in the regulatory network operated by the EMA after it leaves the EU, which is certainly a positive step in favour of ensuring the smooth flow of medicines to British patients,” Beck comments.
Beck concludes: “The Brexit challenge needs to be faced in a pragmatic way and details need to be confirmed and communicated as a matter of priority or, as the EMA survey has found, patients across the UK and EU could suffer.”
Paul Brooks, executive director of Regulatory Affairs Professionals Society (RAPS), says: “The UK Parliament voted 305-301 in favour of continuing the UK’s involvement with the EMA after the island leaves the EU. But what does this mean for the pharmaceutical industry and patient healthcare after 2020?”
“The pharmaceutical industry is in a state of significant uncertainty. We are now less than a year away from the official exit yet there is still ambiguity and important negotiations to take place."
However, now MPS have voted to participate in the regulatory network operated by the EMA after it leaves the EU, this is likely to instil some confidence within the industry.
"Of course, EMA has yet to determine the terms on which the UK could remain part of the agency post-Brexit,” says Brooks.
“There have been many warnings from experts within the industry that Brexit could affect access for all Europeans to the most effective, affordable, safe and innovative healthcare products. As negotiations continue, new legislation must protect the links between the UK and the EMA to ensure the smooth flow of medicines and new drugs for British patients after Brexit,” he continues.
“RAPS is committed to informing regulatory professionals with the latest news and insights as they develop and is closely monitoring this period of transition. This new development from the House of Commons is a step forward towards a more aligned UK and EU regulatory landscape and should instil confidence in drug manufacturers for a smoother transition post-Brexit, most importantly safeguarding the continuous supply of vital medicines,” Brooks concludes.
“One of the key considerations for the pharma industry when it comes to Brexit is pharmacovigilance (PV)” adds David Hukin, head of pharmacovigilance at Quanticate. “ The current situation is that, from 30 March 2019, pharmacovigilance activities which must take place in an EU member state (or other EEA territory) will no longer be able to be conducted in the UK.“
“There is very little time to prepare for what the pharmaceutical industry will look like post-Brexit and it is likely that it will affect companies and sponsors at a wider business level. As we move forward, it is vital that the industry carefully monitors output from the EMA and UK MHRA to guide their strategy," says Hukin.
The concerns surrounding Brexit and its impact on the wider industry, including the registration, manufacture and supply of medicines, mean that it will be all too easy for companies to take their eye off the ball when it comes to ensuring they meet the new PV regulations, so it is vital that departments ensure the necessary changes are made.
“In preparing for this however, we are faced with a multitude of unknowns and an ever-moving target. The government lost the vote against the amendment and so this is significant for PV and access to medicines in general as it could mean the UK remains much more tightly aligned to EU than in other areas. What that means regarding the licensing of medicines and alignment/cooperation on a range of PV factors is still unknown.”
"The Parliamentary vote to remain part of the European Medicines Agency is a promising sign that this could be simpler than previously though. We trust that the ongoing talks between the UK and EU will be constructive and keep patients at the forefront of discussions, ensuring access to new medicines is not delayed and the huge efforts towards pharmacovigilance harmonisation, improving patient safety, are not undone. However, it is possible that the UK walk away from the negotiating table with no deal and no arrangements, transitional or otherwise, for the continued cooperation on the regulation or medicines and PV," he concludes.
- Companies:
- ABPI Association of the British Pharmaceutical Industry
- Recipharm
- RAPS Regulatory Affairs Professionals Society
- BioIndustry Association
- EMA European Medicines Agency
- Quanticate
