As the industry realigns itself to some major changes, EPM magazine also has a shake up.
Shaking things up
As the UK is going through the motions of leaving the EU, now that Article 50 has been triggered, and the pharmaceutical industry worldwide is experiencing vast changes, we at EPM magazine have also experienced a shake-up (of sorts)!
Firstly, I would like to introduce myself, Felicity Thomas, as the new editor for the publication. With an extensive background in scientific B2B publishing, I hope to continue the thought-provoking and well-rounded nature of the content that you, as the readers, have come to enjoy and look forward to each issue. I would also like to welcome any comments and opinions you may have on this issue and potential features and stories that you would like to see covered in future issues.
Obviously, a huge discussion point currently hitting headlines is that of Brexit. How will the UK pharma industry adjust to this departure and what changes might the rest of Europe encounter?
One question highlighted by the New Statesman is what will happen to the EMA? Since beginning operations in the mid 90s, the EMA — a decentralised agency of the EU based in London — has been responsible for scientifically evaluating and monitoring the safety of medicines developed by pharmaceutical companies to be distributed within the EU.
With patients in Europe generally able to access medicines about six months to a year sooner than patients in Australia and Canada, there is concern over how the departure of the EMA from the UK will affect British treatment waiting times and drug prices. If the UK decides to go completely independent from the EMA, creating its own guidelines and standards, how will pharma companies from other EU based countries manage these extra complexities or will they simply decide to overlook the UK altogether?
Also, we must consider where the EMA will be based in the future. From Italy to Sweden and possibly the Republic of Ireland, there are many contenders applying to be EMA’s new home. This decision, however, is fi rmly in the hands of EU member states.
Although the certainty of location is, as of yet, unknown, what we are sure about is that with the departure of the EMA from London the UK pharma industry will be affected. With increasing regulation and scrutiny of drug efficacy and the new set of regulatory changes coming into force to combat counterfeiting these effects must be compounded.
This brings us to the EU Falsified Medicines Directive (EU FMD) to be brought into full force across all EU countries by February 2019. Although the UK government has asserted that Brexit will not affect the implementation of the EU FMD, potential repeals and amendments to EU guidance and regulations post-exit have been highlighted as a positive outcome of the UK’s departure by Brexit campaigners. If the UK does decide to create independent regulations surrounding these issues then we must anticipate effects on global distribution of medicines manufactured within the UK and a potential withdrawal of other EU manufacturers from the British market.
Either way, these coming months of negotiations are vital for both UK and European pharmaceutical companies and most definitely the patients requiring treatments. We will have to wait and see what the next few years hold, but it will surely be exciting to see the situation unfold and EPM will be there to provide a resource to guide you through the ups and downs.