Since Britain voted to leave the EU, there has been much speculation on how this decision will affect the pharmaceutical industry and healthcare system within the country.
Proponents of Brexit remain optimistic. However, there are others who are concerned that a stand-alone Britain could make it harder for patients across the country to gain access to important new medications. These concerns are growing as it becomes more and more likely that the UK will decide not to remain part of the European Medicines Agency (EMA) when it leaves the EU.
What is the EMA?
Although each EU member state has its own medical regulatory body, the EMA is charged with authorizing drugs for use across all member states. This centralized procedure allows drug companies to gain approval in multiple European countries without having to seek approval from each individual national regulatory agency.
The EMA has been located in London since 1995. However, it is considered almost a certainty, at this point, that it will soon be relocated due to the Brexit vote. Countries including Spain, Denmark, Sweden and Ireland are among those reported to be interested in becoming the new home for the organization.
What will leaving the EMA mean for Britain?
If Britain decides to leave the EMA, the centralized European route will no longer be applicable to the UK, and drug companies will need to go through a separate process with British regulators for new products. This will force companies to spend additional time and money if they want to get their drugs approved in the UK.
Because of this, some are worried that drug companies will no longer prioritize the UK market, which represents only 3% of the global market, and will instead focus on applications to the EMA, United Sates, and Japan.
Health officials have warned that this could result in slower access to new drugs and devices, and have estimated that British patients could be forced to wait up to two years longer than patients living in countries with larger markets to access new developments. This delay would be particularly damaging for cancer and infective and rare disease patients, who are among those most desperate for new treatment options.
How has the government responded to these concerns?
To try and appease the growing concerns, the UK Department of Health has released a statement saying that efforts will be made to continue to align the UK regulatory system with that of the EU. It has also stated that ensuring patients have timely access to important new medicines will remain one of the government’s top priorities moving forward.