Brexit Implications on Pharma
Drug approval and Brexit
The exit from the European Union (EU) by the United Kingdom (UK) is expected to take 2 years from when Article 50 of the Lisbon Treaty is ‘triggered ’. For now the UK remains a member state of the EU and as such is obliged to follow the regulatory requirements of the EU. Therefore it is unlikely that the UK life sciences and healthcare sector will undergo any major changes until late 2018 at the very earliest.
How do medicines get approved?
Under the current system, for a medicine to be marketed in the EU the medicine must be granted marketing authorisation (MA). To receive an MA in the EU an application is made to the European Medicines Agency (EMA) which reviews the application and provides recommendations to the European Commission. The EMA can grant a MA whereby the medicine can be marketed in every EU member state and countries in the European Economic Area (EEA). An added requirement is that the authorisation holder has to be situated in an EU state. The majority of medicines follow this central approval routes.
An alternative method of gaining market authorisation is through an application at a national level. Each EU member state has its own medical regulatory body; in the UK any company wanting to sell new medicines has to apply to the Medicines and Healthcare Products Regulatory Agency (MHRA). In principle once the regulatory body of an EU state, such as the MHRA, has approved a new medicine for sale all other member states should approve as well.
What is the EMA?
The EMA is a decentralised agency of the European Union (EU) established in 1995 and is currently located in London. The mission statement of the EMA is as follows1:
“The mission of the European Medicines Agency (EMA) is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the European Union (EU)”
To achieve its set mission the EMA works directly with national authorities such as the MHRA and brings together scientific experts from across Europe in a partnership known as the European medicines regulatory network.
What happens next?
This is the key question being debated but the answer is largely dependent on the type of exit from the EU. If the UK choses to be part of EEA then the consensus are that the regulation of medicinal products will continue along the lines of today. An exception is that MA approvals under the centralised route would need to be nationally implemented as they would not apply automatically in the UK.
However, if the UK is not part EEA, which is a distinct possibility, then the Swiss model is the most commonly proposed. In Switzerland the regulatory body is Swissmedic who independently authorise medical products and conduct any work with EMA under mutual recognition and sharing agreements. In this scenario the MHRA would act in a similar way to Swissmedic.
It is important to note that most of the UK life sciences law is developed from EU law via either
directives implemented in the UK or through EU regulations which directly effect the UK. Therefore, it is likely that under the transition from EU member state to non-member state, measures to ensure EU directives and regulations remain in place until an amendment can be proposed will be taken.
In response to Brexit the MHRA has reassured the public by pledging to continue playing a full, active role in European regulatory procedures for medicines and are working closely with the Government to analyse the best options and opportunities available for the safe and effective regulation of medicines in the UK2.
Drug approval through the EMA has been a mainstay for the last two decades it has provided a platform for collaboration between scientific regulatory experts across the EU. Following Brexit if the UK is outside the EEA then a separate national authorisation would need to be obtained for the UK. This could lead to an increased administrative burden of separate applications in the EU and UK. However, it may provide an opportunity to streamline an approval process which has been criticised in the media for being a bureaucratic and slow-moving process3.
- http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000091.jsp&mid=WC0b01ac0580028a42 (Accessed 20-September-2016)
- https://www.gov.uk/government/news/medicines-and-healthcare-products-regulatory-agency-statement-on-the-outcome-of-the-eu-referend (Accessed 20-September-2016)
- http://www.telegraph.co.uk/news/2016/06/07/eu-red-tape-condemning-cancer-victims-to-early-death/um (Accessed 20-September-2016)