With the UK deciding by referendum to leave the EU, the vote will have major implications for the regulation of medicines and medical devices across the entire continent.
Not only will the European Medicines Agency (EMA) have to uproot its headquarters from London (presumably shifting more than 600 full-time employees), but the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will have to decide if they want to continue conducting drug manufacturing and clinical trial site inspections alongside EMA, and whether the UK will now have to develop its own drug approval system as UK pharmaceutical regulations are primarily determined at the EU level.
As lawyers have pointed out: EU Directives, such as Directive 2001/83/EC governing medicinal products, require the UK to implement relevant legislation into national law. This is done by reference to the European Communities Act of 1972 and through the implementation of the Human Medicines Regulation of 2012. The UK's departure from the EU would mean these laws remain in place unless the UK government decided to change them.
MHRA and EMA also currently work closely on the inspections of manufacturing facilities, and on Friday, EMA released the result of such a collaboration as an MHRA inspection resulted in an EMA review of medicines made at a US manufacturing site. One of the potential solutions would be for the MHRA to function like Switzerland’s regulator, Swissmedic, where medical products are independently authorized but work with EMA is conducted under mutual recognition and sharing agreements. Or UK’s MHRA could function like other regulators in Norway, Iceland and Liechtenstein, which are outside the EU but work with EMA.
MHRA spokesman James Rose told Focus the agency has “no comment to make at this early stage.” He later added that the agency will issue a statement on Monday.
EMA spokeswoman Rebecca Harding explained to Focus: “We respect the UK citizens’ decision to no longer be a part of the European Union. The people in the UK have taken their vote and it is now up to the UK government to decide how to act upon the outcome of the referendum.
“Article 50 of the Treaty on the Functioning of the EU foresees the procedure to be followed in case a Member State notifies the European Council of its decision to withdraw from the Union. No country has ever decided to leave the EU, so there is no precedent for this situation. It is too early to foresee the implications of this decision and we will be in close contact with the EU institutions. When we have concrete information, we will share it with our stakeholders,” she said. “EMA will continue with its work with the goal to protect human and animal health and ensure access to medicines that are safe, effective and of good quality.”
A number of questions remain to be answered, particularly on whether EMA would lose access to MHRA experts who, as the Financial Times points out, led the review of more drug applications than any other domestic EU regulator in 2014.
Mike Thompson, CEO of the Association of the British Pharmaceutical Industry (ABPI) said in a statement: "The voice of the British people has been heard. This creates immediate challenges for future investment, research and jobs in our industry in the UK. With that being the case, we are committed to working closely with the government to agree what steps need to be taken to send a strong signal that the UK is open for business."