Britain’s exit from the European Union (EU) has created much stir and disputes worldwide, also possibly resulting in the departure of the nation from the European Medicines Agency (EMA) and leaving the future of regulating and accessing medicines in limbo.
Based in London, EMA is EU’s decentralized agency that is responsible for ensuring the safety, efficiency, and quality of medicines.
Together with the University College of London, Anthony Hatswell, an independent health economist at BresMed Health Solutions, decided to investigate the effect of Brexit on the pharmaceutical industry.
Exposing the effect of British exit from EMA, his editorial said the withdrawal might delay the availability of new drugs to UK market.
Hatswell argued that such a predicament also jeopardizes not just the present treatment of the patients but their cheaper off brand counterparts as well, which can bring an enormous harm to patients.
The author continued that with Britain possibly leaving the EMA, the cost of the EMA can be more expensive not only in inspecting manufacturing plants worldwide but in licensing new medicines.
Hatswell said that this is an important topic, considering that there appears to be no policy yet whatsoever.
“There is a sense that the UK could try and emulate the US model, which has a national system for drug regulation managed by the Food and Drug Administration (FDA) who lead the way in access. However this outcome is unrealistic as the US is a special case due to high prices, a large patient population, few restrictions to access, and direct to consumer advertising3. A more likely outcome can be seen with Japan’s sovereign regulator, which is despite a market size twice the size of the UK due to both population and GDP, lags the EU (including the UK) in timely access to novel medicines,” he added.
One solution that Hatswell sees towards this case is that if the UK’s Medicines & Healthcare products Regulatory Agency remains part of the EMA but at the same time has the liberty to adopt decisions from other regulators such as the Food and Drug Administration.
Such move can bring about the speedy delivery of medicines to their shelves, after all, and retaining the British nation at the forefront of medical technology.
The author ended on a positive note, however, saying: “With careful planning and collaboration – the UK can maintain or even advance its position as a leader in life sciences. Not only do patients require [this], the life sciences sector is a large source of well-paid employment, and a large net exporter for the UK. As long as ideology does not trump the benefits of cooperation it does not have to be the end of a productive relationship that has done great things for patients across Europe.”