As we move into 2018, we also move into the second phase of the negotiations surrounding the UK exiting the European Union. Amongst the top Brexit stories in 2017 were statements from the EMA regarding delays in new medicine approvals, and from the ABPI warning of the impact Brexit could have on Europe's capacity to respond to a continent-wide public health emergency.
The future of the UK's pharmaceutical industry, partnered with increasing cost pressures on the NHS and recent innovations in medical technology, is causing a large amount of uncertainty within the sector.(1) However, the severity and potential impacts of this uncertainty is increasingly being recognised by policymakers and payers.
The MHRA recently stated that "following Brexit, European Union (EU) regulation is likely to continue to apply for the foreseeable future". With the good news that: "goods placed on the market under Union law before the withdrawl date may freely circulate on the markets of the UK and the Union with no need for product modifications or re-labelling; be put into service where provided in Union law, and that the goods concerned should be subject to continuned oversight." (2)
Understandably there are still a large number of concerns, in particular in the event of a no-deal brexit, with no implementation and adjustment period. However the Agency has confirmed that plans are in place for this eventuality and will be released as appropriate.
The UK government has positively reacted to the statements and uncertainty, with the recent announcement that an analysis is being commissioned into the impact of Brexit on the UK medicines supply chain. With "the UK [supplying] 45m packs of medicine to the EU and European Economic Areas countries and [importing] more than 37m packs in the other direction"(3) the issue is important not just for patients and companies, but also the wider economy.
The results may not be publically available due to the commercial sensitivity of inputs from the pharmaceutical sector, however this demonstrates that the Department of Health and Social Care has been taking industry feedback seriously.
Jeremy Hunt pledged that as far as the government is concerned "It is an absolute priority to make sure that access to new drugs does not slow down as a result of Brexit"(4). This is good news for both patients and the sector itself, many companies having announced that millions have already been spent preparing for the withdrawl.
This is promising for the future of public health and the UK pharmaceutical industry, whilst also recognises the important role the industry plays across the UK and Europe. It is important that the industry continues to be vocal around specific brexit-related concerns if a regulatory and approvals framework ensuring access to medicines and viability of research and development is to be guaranteed post-brexit.
“We are confident that we can avoid that. When it comes to importing drugs from overseas we are the customers. It would be against our national interest to make it harder to import life-saving drugs.”