In her last Editor's Desk focus, Felicity Thomas analyses how Brexit is going to affect the pharma industry and what we can expect from the EMA and MHRA.
Brexit
It is fair to say that Brexit has offered a substantial amount of ‘editorial fodder’ since I started my tenure here as editor of European Pharmaceutical Manufacturer. Even just over the past couple of months, we have seen some huge stories emerge around this topic.
Most recently, there have been reports about the government discussing the issue of funding the extra costs of stockpiling vital medicines with drug companies just in case a ‘no-deal’ Brexit transpires, including the potential viability of flying in medicines.
Major pharmaceutical companies have already confirmed preparative works are underway for a hard Brexit outcome and the Medicines and Healthcare products Regulatory Agency (MHRA) has ratified that the issue of a medicines’ supply has its highest attention.
Sanofi UK’s MD, Hugo Fry, and the chief executive of AstraZeneca, Pascal Soirot, have both stressed that their respective companies are doing all they can to maintain a continuous supply of medicines, although an overwhelming sentiment coming from industry is that clarification from both sides of the Brexit negotiating table is urgently needed.
In light of this, the UK government issued an initial series of technical notices, which set out to inform businesses and the public about what steps they should be taking to prepare for a ‘no deal’ scenario. These preliminary documents have been welcomed by the industry.
“By agreeing to recognise and use medicines and vaccines licensed and manufactured in the EU, the UK government has taken an important step to protect patients. We urge the EU Commission to do the same,” stated Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry (ABPI). “We need to be clear that a ‘no deal’ scenario is not in the interest of patients. Both sides must rapidly agree the terms of the UK’s withdrawal and a future relationship based on cooperation to protect public health, control infectious diseases and manage medicine safety.”
Additionally, we have witnessed the shock that the MHRA will no longer be allocated any centralised marketing authorisation applications as a result of the UK potentially becoming a ‘third country’ come March 2019.
“The news that EMA has announced it will discontinue awarding contracts to the MHRA, is no surprise. It is, nonetheless, a shocking blow to MHRA,” stated Martin MacLean, life sciences partner at intellectual property firm, Mathys & Squire.
“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,” asserted Paul Brooks, executive director, Regulatory Affairs Professionals Society (RAPS). “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.”
And this impact has not been lost on the EMA itself, which announced the scaling back and suspension, albeit temporarily, of certain activities as they are experiencing higher than expected staff losses due to the agency’s relocation to Amsterdam.
So, as the UK and the EU prepare their ultimate farewells, I too must say my goodbyes as I close on my last edition as editor of EPM magazine. Thanks for your support and engagement with this esteemed publication, it has truly been an honour.