The United Kingdom’s referendum in favor of withdrawal from the European Union, colloquially known as “Brexit,” has already sent shockwaves through the business world, both within the UK, and abroad. The impact of Brexit on the pharmaceutical industry has yet to be determined, but some fear that Brexit will cause the UK to lag behind in the biosimilar sphere in particular.
For example, Tim deGavre, the inaugural chair of the newly minted British Biosimilars Association, stated: “European states are all governed by the same rules and procedures. There’s a common approach to use when developing drugs. If it’s easier to do business in Europe because it’s a common market, drugmakers may have second thoughts about carrying out their clinical trials in Britain.” deGavre also explained that in his view, Brexit could place the UK into a period of “regulatory uncertainty,” because the UK currently has no regulatory pathway to approve biosimilars, and it would not necessarily be bound by previous and future decisions of the EMA.
However, others are more optimistic, pointing out that the EMA is currently headquartered in London, and relocation of that headquarters to another EU country is not likely to happen soon. Moreover, the UK may not want to force drug makers to pursue two separate and costly regulatory processes to launch their products. And the EMA reflects a global effort toward harmonization of regulatory processes that is decades in the making. Both the UK and the EU will be invested in having the UK remain part of that regulatory scheme. Nor is the UK required to be a part of the EU to conform to the EMA regulatory scheme – non-EU countries such as Norway conform to the EMA regulatory scheme, and others such as Switzerland have largely seamless sharing agreements. Finally, the UK may decide to remain within the European Economic Area (EEA) as an EFTA (European Free Trade Association) state. EFTA states that are party to the EEA Agreement participate in the EU’s internal market without being EU members.
Regardless, pharmaceutical companies are closely monitoring potential fallout from Brexit, and some have already been in contact with the EMA.
For more biosimilar news, stay tuned to Big Molecule Watch.