The clock is ticking for Brexit. By 31 October 2019, a final agreement on the matter must be reached. There is no doubt that the UK leaving the European Union (EU) will have an enormous impact on the UK and EU member states. This also accounts for the pharmaceutical industry. However, the impact of the various outcomes of Brexit is hard to assess and is still unpredictable. What we do know is that the first big change has already taken place. The European Medicines Agency (EMA), which looks after the safety, effectivity and quality of medicines marketed in the EU, has moved its headquarters from London to Amsterdam. What other changes will Brexit entail for the pharmaceutical industry? Below, some developments to take into account.
Marketing Authorisation Holders
Although there are still several possible Brexit scenarios, we do know that a so-called hard Brexit means that manufacturers of medicines will face quite a few challenges. If the UK leaves the EU without any agreements, pharmaceutical companies located in the UK and holding a centralised market authorisation (granted by the European Commission after scientific assessment of the applied medicine by EMA) will no longer be allowed to market their medicine in the EU. If a company wants to market its impacted medicine in the EU, the Marketing Authorisation Holder (MAH) needs to relocate from the UK to an entity located in the EU. This change impacts the artwork in which the medicine is packaged (e.g. the leaflet). Since the MAH address is mentioned on the packaging, the artwork needs to be adapted for the new situation.
Role of Qualified Persons
In addition to the marketing, a hard Brexit will also affect the release of medicines by Qualified Persons (QPs). Every medicine on the EU market has to be released by a QP of a manufacturer located in the EU. However, if the QP releasing site is based in the UK, it will have to relocate its QP releasing activities to a pharmaceutical company located in the EU. Again, this change impacts the packaging artwork, since the manufacturer performing the QP release is mentioned on the artwork. Obviously, in case of a hard Brexit, the consequences of changes in the areas of MAH and QP can be solved simultaneously.
Release of medicines from the UK into the EU
In case of a hard Brexit, medicines manufactured in the UK will have to be imported into the EU. Import of medicines into the EU implies EU release, before the medicines can be sold onto the EU market. EU release entails that every medicine batch made outside of the EU has to be tested and reviewed by a pharmaceutical company located in the EU. Be aware of the fact that the term manufacturing is very broad in this matter, and concerns among others the formulation, filling and packaging of products. So even if the UK site only takes care of the packaging of products, an EU release is still required.
Release of vaccines from the EU into the UK
A special category of medicines are the vaccines that have to be tested and reviewed by specialised European labs, the so-called Official Medicines Control Laboratories or OMCLs. Following testing and review, these institutions certify a vaccine batch. The manufacturer can only perform QP release of a vaccine batch onto the EU market once that certificate has been received. OMCLs are national laboratories. In the UK, the NIBSC is the local entity. It’s still unclear how a possible Brexit will affect the testing, reviewing and certification of vaccines by NIBSC.
Whatever the final decision in the UK on 31 October, the pharmaceutical industry can expect quite a number of challenges. Fortunately, many companies – both in de UK and the EU – have been preparing themselves for some time already.